| 1. |
- Aalbers, René, et al.
(författare)
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Randomized, Double-Blind, Dose-Finding Study for Tiotropium when Added to Olodaterol, Administered via the Respimat(®) Inhaler in Patients with Chronic Obstructive Pulmonary Disease.
- 2015
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Ingår i: Advances in Therapy. - : Springer Science and Business Media LLC. - 0741-238X .- 1865-8652. ; 32:9, s. 809-822
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Tidskriftsartikel (refereegranskat)abstract
- Combining long-acting muscarinic antagonists (LAMAs) and long-acting β2-agonists (LABAs) is beneficial in chronic obstructive pulmonary disease (COPD), as the two classes of bronchodilator have complementary modes of action. The optimal dose for the fixed-dose combination of the LAMA tiotropium and the LABA olodaterol needed to be determined. In this phase II trial, the dose response of tiotropium on top of olodaterol was investigated in a free-dose combination, while other phase II studies have explored different doses of olodaterol on top of tiotropium, with both drugs delivered using the Respimat(®) inhaler.
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| 2. |
- Albayaty, Muna, et al.
(författare)
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Pharmacokinetic Evaluation of Once-Weekly and Once-Monthly Buprenorphine Subcutaneous Injection Depots (CAM2038) Versus Intravenous and Sublingual Buprenorphine in Healthy Volunteers Under Naltrexone Blockade : An Open-Label Phase 1 Study
- 2017
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Ingår i: Advances in Therapy. - : Springer Science and Business Media LLC. - 0741-238X .- 1865-8652. ; 34:2, s. 560-575
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Tidskriftsartikel (refereegranskat)abstract
- Introduction: CAM2038 q1w (once weekly) and q4w (once monthly) are investigational buprenorphine subcutaneous (SC) formulations based on FluidCrystal® injection depot technology. These two drug products are being developed for opioid dependence treatment, with a target for once-weekly and once-monthly SC dosing. The rationale for developing two products with different dosing frequencies is that treatment strategies/routines, and hence different treatment preferences, can vary between patients, different stages of opioid maintenance treatment, and countries. This study evaluated the pharmacokinetics and safety of buprenorphine and norbuprenorphine following administration of CAM2038 q1w or q4w versus active controls. Methods: Healthy volunteers were randomized to five treatment groups. All received a single intravenous dose of buprenorphine 600 µg, followed post-washout by a single dose of CAM2038 q4w 96 mg, a single dose of CAM2038 q4w 192 mg, or sublingual buprenorphine 8, 16, or 24 mg daily for 7 days, followed post-washout by a single dose of CAM2038 q4w 64 or 128 mg or four repeated weekly doses of CAM2038 q1w 16 mg. All subjects received daily naltrexone. Results: Eighty-seven subjects were randomized. Median buprenorphine tmax after CAM2038 q4w was 4–10 h (24 h for CAM2038 q1w); mean terminal half-life was 19–25 days (5 days for CAM2038 q1w). CAM2038 q4w showed dose-proportional buprenorphine release, with similar exposure to repeat-dose CAM2038 q1w at comparable monthly dose level. Both CAM2038 formulations showed complete absolute bioavailability of buprenorphine and 5.7- to 7.7-fold greater buprenorphine bioavailability versus sublingual buprenorphine. CAM2038 q1w and q4w were well tolerated; subjects’ acceptance was higher for CAM2038 than for sublingual buprenorphine 1 h post-dose. Conclusions: The pharmacokinetic profiles of CAM2038 q1w and q4w versus sublingual buprenorphine support expected treatment efficacy with once-weekly and once-monthly dosing, respectively. CAM2038 formulations were safe and showed good local tolerability. Trial registration: ISRCTN24987553. Funding: Camurus AB.
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| 3. |
- Alonso-Cotoner, Carmen, et al.
(författare)
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The Role of Purported Mucoprotectants in Dealing with Irritable Bowel Syndrome, Functional Diarrhea, and Other Chronic Diarrheal Disorders in Adults
- 2021
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Ingår i: Advances in Therapy. - : Springer. - 0741-238X .- 1865-8652. ; 38:5, s. 2054-2076
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Forskningsöversikt (refereegranskat)abstract
- Chronic diarrhea is a frequent presenting symptom, both in primary care medicine and in specialized gastroenterology units. It is estimated that more than 5% of the global population suffers from chronic diarrhea. and that about 40% of these subjects are older than 60 years. The clinician is frequently faced with the need to decide which is the best therapeutic approach for these patients. While the origin of chronic diarrhea is diverse, impairment of intestinal barrier function, dysbiosis. and mucosal micro-inflammation are being increasingly recognized as underlying phenomena characterizing a variety of chronic diarrheal diseases. In addition to current pharmacological therapies, there is growing interest in alternative products such as mucoprotectants, which form a mucoadhesive film over the epithelium to reduce and protect against the development of altered intestinal permeability, dysbiosis, and mucosal micro-inflammation. This manuscript focuses on chronic diarrhea in adults, and we will review recent evidence on the ability of these natural compounds to improve symptoms associated with chronic diarrhea and to exert protective effects for the intestinal barrier.
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| 4. |
- Andersen, Grit, et al.
(författare)
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Clinical Characteristics of a Non-Alcoholic Fatty Liver Disease Population Across the Fibrosis Spectrum Measured by Magnetic Resonance Elastography: Analysis of Screening Data
- 2020
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Ingår i: Advances in Therapy. - : Springer Science and Business Media LLC. - 0741-238X .- 1865-8652. ; 37:12, s. 4866-4876
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Tidskriftsartikel (refereegranskat)abstract
- Introduction: Non-alcoholic fatty liver disease (NAFLD), one of the most common liver diseases, is associated with liver-related complications and metabolic comorbidities. The phenotype is wide, ranging from simple steatosis to non-alcoholic steatohepatitis with advanced fibrosis. In this analysis of a phase 1 trial, clinical characteristics of screened subjects with NAFLD were studied according to the extent of fibrosis assessed using magnetic resonance elastography (MRE). Methods: One hundred ninety-four subjects with body mass index (BMI) of 25–40 kg/m2 and suspected NAFLD were assessed by MRE and grouped by MRE thresholds as a proxy for fibrosis staging (groups 0–4). Data were summarized by group levels, and correlation analyses between MRE values and clinical parameters (including magnetic resonance imaging-proton density fat fraction) were performed. Results: Most subjects had MRE values in the lower range (groups 0–1; N = 148). Type 2 diabetes (T2D) and BMI > 35 kg/m2 were more frequent in groups with higher than lower MRE values. Subjects in the highest MRE groups also tended to be older and have higher liver enzyme concentrations compared with lower MRE groups. No, or weak, correlations were found between MRE values and clinical parameters (all r values ≤ 0.45). Conclusions: There was considerable variation and overlap in clinical characteristics across the spectrum of liver stiffness. Although groups with high MRE values generally included more subjects with T2D and obesity, and had higher age and concentrations of liver enzymes, the clinical characteristics did not strongly correlate with MRE scores in this population. Trial Registration: Registered on Clinicaltrials.gov on November 29, 2017 (NCT03357380).
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| 5. |
- Antonini, Angelo, et al.
(författare)
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The Long-Term Impact of Levodopa/Carbidopa Intestinal Gel on ‘Off’-time in Patients with Advanced Parkinson’s Disease : A Systematic Review
- 2021
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Ingår i: Advances in Therapy. - : Springer Science and Business Media LLC. - 0741-238X .- 1865-8652. ; 38:6, s. 2854-2890
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Forskningsöversikt (refereegranskat)abstract
- Introduction: Levodopa/carbidopa intestinal gel (LCIG; carbidopa/levodopa enteral suspension) has been widely used and studied for the treatment of motor fluctuations in levodopa-responsive patients with advanced Parkinson’s disease (PD) when other treatments have not given satisfactory results. Reduction in ‘off’-time is a common primary endpoint in studies of LCIG, and it is important to assess the durability of this response. This systematic literature review was conducted to qualitatively summarise the data on the long-term effects of LCIG therapy on ‘off’-time. Methods: Studies were identified by searching PubMed, EMBASE and Ovid on 30 September 2019. Studies were included if they reported on patients with PD, had a sample size of ≥ 10, LCIG was an active intervention and ‘off’-time was reported for ≥ 12 months after initiation of LCIG treatment. Randomised clinical trials, retrospective and prospective observational studies, and other interventional studies were included for selection. Data were collected on: ‘off’-time (at pre-specified time periods and the end of follow-up), study characteristics, Unified Parkinson’s Disease Rating Scale (UPDRS) II, III and IV total scores, dyskinesia duration, quality of life scores, non-motor symptoms and safety outcomes. Results: Twenty-seven studies were included in this review. The improvement in ‘off’-time observed shortly after initiating LCIG was maintained and was statistically significant at the end of follow-up in 24 of 27 studies. ‘Off’-time was reduced from baseline to end of follow-up by 38–84% and was accompanied by a clinically meaningful improvement in quality of life. Stratified analysis of ‘off’-time demonstrated mean relative reductions of 47–82% at 3–6 months and up to 83% reduction at 3–5 years of follow-up. Most studies reported significant improvements in activities of daily living and motor complications. Most frequent adverse events were related to the procedure or the device. Conclusion: In one of the largest qualitative syntheses of published LCIG studies, LCIG treatment was observed to provide a durable effect in reducing ‘off’-time. Infographic: [Figure not available: see fulltext.] [MediaObject not available: see fulltext.]
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| 6. |
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| 7. |
- Bepari, A. K., et al.
(författare)
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Factors Driving Antimicrobial Resistance in Rural Bangladesh : A Cross-Sectional Study on Antibiotic Use-Related Knowledge, Attitude, and Practice Among Unqualified Village Medical Practitioners and Pharmacy Shopkeepers
- 2023
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Ingår i: Advances in Therapy. - : Springer. - 0741-238X .- 1865-8652. ; 40:8, s. 3478-3494
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Tidskriftsartikel (refereegranskat)abstract
- Introduction: Inappropriate antibiotic use in community settings significantly contributes to antimicrobial resistance (AMR) globally, compromising the quality of life and threatening public health. This study aimed to identify AMR contributing factors by analyzing the knowledge, attitude, and practice (KAP) of the unqualified village medical practitioners and pharmacy shopkeepers in rural Bangladesh. Methods: We performed a cross-sectional study where the participants were pharmacy shopkeepers and unqualified village medical practitioners aged ≥ 18 years and living in Sylhet and Jashore districts in Bangladesh. Primary outcome variables were knowledge, attitude, and practice of antibiotic use and AMR. Results: Among the 396 participants, all were male aged between 18 and 70 years, 247 were unqualified village medical practitioners, and 149 were pharmacy shopkeepers, and the response rate was 79%. Participants showed moderate to poor knowledge (unqualified village medical practitioners, 62.59%; pharmacy shopkeepers, 54.73%), positive to neutral attitude (unqualified village medical practitioners, 80.37%, pharmacy shopkeepers, 75.30%), and moderate practice (unqualified village medical practitioners, 71.44%; pharmacy shopkeepers, 68.65%) scores regarding antibiotic use and AMR. The KAP score range was 40.95–87.62%, and the mean score was statistically significantly higher for unqualified village medical practitioners than pharmacy shopkeepers. Multiple linear regression analysis suggested that having a bachelor’s degree, pharmacy training, and medical training were associated with higher KAP scores. Conclusion: Our survey results demonstrated that unqualified village medical practitioners and pharmacy shopkeepers in Bangladesh possess moderate to poor knowledge and practice scores on antibiotic use and AMR. Therefore, awareness campaigns and training programs targeting unqualified village medical practitioners and pharmacy shopkeepers should be prioritized, antibiotic sales by pharmacy shopkeepers without prescriptions should be strictly monitored, and relevant national policies should be updated and implemented.
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| 8. |
- Berg, Mats, et al.
(författare)
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A Novel Formulation of Mometasone Furoate in Psoriasis Patients: A Multicenter, Randomized, Double-Blind Clinical Study
- 2013
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Ingår i: Advances in Therapy. - : Springer Science and Business Media LLC. - 0741-238X .- 1865-8652. ; 30:5, s. 503-516
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Tidskriftsartikel (refereegranskat)abstract
- Further formulations of mometasone furoate are needed for treatment of patients with plaque psoriasis to meet individual patient preferences. This has motivated the development of Ovixan(A (R)) (Galencia, Malmoe, Sweden), a formulation of mometasone furoate with different cosmetic properties than the commonly used formulation, Elocon(A (R)) (Merck [Schering Plough], Whitehouse Station, New Jersey, USA). This novel formulation of mometasone furoate was examined in a vasoconstrictor assay comparing its efficacy with that of Elocon. Subsequently, the new formulation was tested in a multicenter, randomized, double-blind clinical study in patients with plaque psoriasis. Healthy volunteers were included in the vasoconstrictor study. The treatments were randomly assigned to test fields on the forearms. The test fields were gently cleaned after treatment for 6 h. Skin color was measured during the following 24 h and area under the time curve was calculated. The clinical efficacy and tolerance of Ovixan was as compared to that of Elocon and their vehicles in a double-blind study in patients with plaque psoriasis. Patients with four symmetrically placed lesions on the arms or the legs were treated for 6 weeks. Primary endpoint was the change from baseline of the Total Severity Sign score for each treated lesion. The cosmetic characteristics of the two test preparations were assessed by an independent cosmetological institute. Ovixan was shown to have skin blanching potency almost identical to the vasoconstrictor potency of Elocon. Clinical equivalence of Ovixan to Elocon was demonstrated in the clinical study of the efficacy in patients with plaque psoriasis. A professional testing team clearly documented the cosmetic superiority of Ovixan as compared to Elocon. The results of the investigations show that Ovixan is equipotent to the commonly used formulation Elocon. However, the cosmetic properties are in favor of Ovixan. The effect of the cosmetic differences on patient preferences and patient adherence to prescribed treatment has to be investigated in further studies.
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| 9. |
- Bjermer, Leif H., et al.
(författare)
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Efficacy and Safety of Umeclidinium/Vilanterol in Current and Former Smokers with COPD : A Prespecified Analysis of The EMAX Trial
- 2021
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Ingår i: Advances in Therapy. - : Springer Science and Business Media LLC. - 0741-238X .- 1865-8652. ; 38:9, s. 4815-4835
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Tidskriftsartikel (refereegranskat)abstract
- Introduction: Smoking may reduce the efficacy of inhaled corticosteroids (ICS) in patients with chronic obstructive pulmonary disease (COPD), but its impact on bronchodilator efficacy is unclear. This analysis of the EMAX trial explored efficacy and safety of dual- versus mono-bronchodilator therapy in current or former smokers with COPD. Methods: The 24-week EMAX trial evaluated lung function, symptoms, health status, exacerbations, clinically important deterioration, and safety with umeclidinium/vilanterol, umeclidinium, and salmeterol in symptomatic patients at low exacerbation risk who were not receiving ICS. Current and former smoker subgroups were defined by smoking status at screening. Results: The analysis included 1203 (50%) current smokers and 1221 (50%) former smokers. Both subgroups demonstrated greater improvements from baseline in trough FEV1 at week 24 (primary endpoint) with umeclidinium/vilanterol versus umeclidinium (least squares [LS] mean difference, mL [95% CI]; current: 84 [50, 117]; former: 49 [18, 80]) and salmeterol (current: 165 [132, 198]; former: 117 [86, 148]) and larger reductions in rescue medication inhalations/day over 24 weeks versus umeclidinium (LS mean difference [95% CI]; current: − 0.42 [− 0.63, − 0.20]; former: − 0.25 − 0.44, − 0.05]) and salmeterol (current: − 0.28 [− 0.49, − 0.06]; former: − 0.29 [− 0.49, − 0.09]). Umeclidinium/vilanterol increased the odds (odds ratio [95% CI]) of clinically significant improvement at week 24 in Transition Dyspnea Index versus umeclidinium (current: 1.54 [1.16, 2.06]; former: 1.32 [0.99, 1.75]) and salmeterol (current: 1.37 (1.03, 1.82]; former: 1.60 [1.20, 2.13]) and Evaluating Respiratory Symptoms–COPD versus umeclidinium (current: 1.54 [1.13, 2.09]; former: 1.50 [1.11, 2.04]) and salmeterol (current: 1.53 [1.13, 2.08]; former: 1.53 [1.12, 2.08]). All treatments were well tolerated in both subgroups. Conclusions: In current and former smokers, umeclidinium/vilanterol provided greater improvements in lung function and symptoms versus umeclidinium and salmeterol, supporting consideration of dual-bronchodilator therapy in symptomatic patients with COPD regardless of their smoking status.
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| 10. |
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| 11. |
- Borgå, Olof, et al.
(författare)
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Maximum Tolerated Dose and Pharmacokinetics of Paclitaxel Micellar in Patients with Recurrent Malignant Solid Tumours : A Dose-Escalation Study
- 2019
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Ingår i: Advances in Therapy. - : Springer. - 0741-238X .- 1865-8652. ; 36:5, s. 1150-1163
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Tidskriftsartikel (refereegranskat)abstract
- Introduction: A water-soluble Cremophor EL-free formulation of paclitaxel, in which retinoic acid derivates solubilize paclitaxel by forming micelles (paclitaxel micellar), was studied for the first time in man to establish the maximum tolerated dose (MTD) and to characterize the pharmacokinetics (PK).Methods: This was an open-label, one-arm, dose-escalating study in patients with advanced solid malignant tumours, for which no standard therapy was available or had failed. Paclitaxel micellar was given as 1-h intravenous infusion every 21 days for 3 cycles, mainly without premedication. Plasma samples were collected during 24 h at the first cycle and paclitaxel concentrations were assayed by high-performance liquid chromatography. PK was evaluated using a two-compartment model.Results: Thirty-four patients received paclitaxel micellar at doses ranging between 90 and 275 mg/m2. MTD was established as 250 mg/m2. Fatigue and neuropathy were the most frequent dose-limiting toxicities. No hypersensitivity reactions were observed. PK of paclitaxel was evaluated in 25 data sets. Paclitaxel micellar had a rapid initial distribution phase, mean half-life 0.55 h, estimated to be completed 3 h after dosing and a mean terminal half-life of 8.8 h. Mean clearance was 13.4 L/h/m2 with fivefold interindividual variability. The residual areas after 10 h and 24 h were 15.7 ± 8.6% and 5.7 ± 3.9% of the area under the plasma concentration–time curve to infinite time (AUCinf), respectively.Conclusion: No new side effects unknown for paclitaxel were observed. Maximum plasma concentration (Cmax) and AUCinf showed a tendency to increase linearly with dose within the 150–275 mg/m2dose range. The possibility to administer paclitaxel micellar without steroid premedication makes it an attractive candidate for further studies in combination with immunotherapy.Trial Registration: EudraCT no: 2004-001821-54.
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| 12. |
- Busch, R., et al.
(författare)
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Therapeutic effect of 1,5-pentanediol for herpes simplex labialis: a randomized, double-blind, placebo-controlled clinical trial
- 2009
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Ingår i: Advances in Therapy. - : Springer Science and Business Media LLC. - 0741-238X .- 1865-8652. ; 26:7, s. 719-27
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Tidskriftsartikel (refereegranskat)abstract
- INTRODUCTION: Most episodes of recurrent herpes labialis are self-limited and mild, but can be troublesome when they occur frequently with painful and unsightly lesions. Therefore, there has been much interest in developing agents that can suppress outbreaks in addition to being therapeutically effective. The objective of the present study was to examine the prophylactic and therapeutic efficacy of 1,5-pentanediol (PD) gel in patients with recurrent episodes of herpes labialis. METHODS: In this placebo-controlled, randomized, double-blind clinical trial, a total of 105 patients with frequent episodes of recurrent herpes were randomized to either PD or placebo. During the 26-week prophylactic phase of the study, the patients applied PD gel or placebo gel twice daily to both lips. Upon recurrence of an episode, a 5-day therapy phase started during which the gel was to be applied eight times daily. After the therapy phase, the patient resumed prophylactic treatment twice daily until the next herpes episode. The main outcome measures were number of herpes episodes during the prophylactic phase of 26 weeks, and successful therapy of occurring herpes episodes with a 5-day treatment. RESULTS: There was no significant difference in recurrence rate between the two groups (P>0.05). During recurrence there was a statistically significant improvement regarding the therapeutic effect of the symptoms "blistering," "swelling," and "pain" in the PD group. The global evaluation of efficacy by the investigators and patients showed a statistically significant superiority for PD as opposed to placebo (P<0.001). CONCLUSION: Under the conditions used in the present study, PD did not show any prophylactic effect against recurrence of herpes episodes. A significantly better therapeutic effect of PD over placebo could be demonstrated on the symptoms "blistering," "swelling," and "pain." PD was very safe as no side effects were observed during the course of the study.
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| 14. |
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| 15. |
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| 16. |
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| 17. |
- Costabel, Ulrich, et al.
(författare)
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Pirfenidone in Idiopathic Pulmonary Fibrosis : Expert Panel Discussion on the Management of Drug-Related Adverse Events
- 2014
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Ingår i: Advances in Therapy. - : Springer Science and Business Media LLC. - 0741-238X .- 1865-8652. ; 31:4, s. 375-391
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Forskningsöversikt (refereegranskat)abstract
- Pirfenidone is currently the only approved therapy for idiopathic pulmonary fibrosis, following studies demonstrating that treatment reduces the decline in lung function and improves progression-free survival. Although generally well tolerated, a minority of patients discontinue therapy due to gastrointestinal and skin-related adverse events (AEs). This review summarizes recommendations based on existing guidelines, research evidence, and consensus opinions of expert authors, with the aim of providing practicing physicians with the specific clinical information needed to educate the patient and better manage pirfenidone-related AEs with continued pirfenidone treatment. The main recommendations to help prevent and/or mitigate gastrointestinal and skin-related AEs include taking pirfenidone during (or after) a meal, avoiding sun exposure, wearing protective clothing, and applying a broad-spectrum sunscreen with high ultraviolet (UV) A and UVB protection. These measures can help optimize AE management, which is key to maintaining patients on an optimal treatment dose.
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| 18. |
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| 19. |
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| 20. |
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| 21. |
- Dalén, Johan, et al.
(författare)
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Health-Care and Societal Costs Associated with Non-Persistence with Subcutaneous TNF-α Inhibitors in the Treatment of Inflammatory Arthritis (IA) : A Retrospective Observational Study
- 2022
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Ingår i: Advances in Therapy. - : Springer Science and Business Media LLC. - 0741-238X .- 1865-8652. ; 39:6, s. 2468-2486
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Tidskriftsartikel (refereegranskat)abstract
- Objective: A few studies have suggested that patients with inflammatory arthritis (IA) who remain persistent with subcutaneous TNF-α inhibitors (SC-TNFi) incur lower health care costs than patients who discontinue treatment, whereas data on the impact of non-persistence on indirect costs are largely lacking. Furthermore, existing estimates are based on fixed follow-ups, in relation to treatment initiation, and therefore do not measure costs in direct relation to treatment discontinuation. Therefore, by capturing costs in direct relation to treatment discontinuation, this study aimed to estimate direct and indirect costs associated with non-persistence with SC-TNFis in IA. Methods: Adult Swedish biologic-naïve IA patients initiating biologic treatment with a SC-TNFi (adalimumab, etanercept, certolizumab or golimumab) between May 6, 2010, and December 31, 2017, were identified in population-based registers with almost complete coverage. IA was defined as a diagnosis of rheumatic arthritis, ankylosing spondylitis/unspecified spondyloarthritis or psoriatic arthritis. Non-persistent patients were matched on propensity score to patients persistent with treatment by at least an additional 12 months. This enabled comparisons of direct healthcare costs and indirect costs for sick leave and disability pension, respectively, 12 months before and 12 months after treatment discontinuation. Results: A balanced cohort of 486 matched pairs was generated. The total direct and indirect costs were significantly higher among non-persistent patients already during the 12 months before index ($20,802 [18,335–23,429] vs. $16,600 [14,331–18,696]). However, while non-persistent patients increased their total direct and indirect costs, persistent patients significantly decreased the same, further widening the difference in costs during the 12-month period after index date ($22,161 [19,754–24,556] vs. $13,465 [11,415–15,729]). Conclusions: Among biologic-naïve Swedish IA patients treated with SC-TNFis, persistent patients incurred about 40% lower aggregated direct and indirect costs compared to non-persistent patients the year following SC-TNFi discontinuation. This highlights the impact of treatment persistence from an economic viewpoint, adding further aspects to the clinical perspective.
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| 22. |
- Dalén, Johan, et al.
(författare)
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Identifying Predictors of First-Line Subcutaneous TNF-Inhibitor Persistence in Patients with Inflammatory Arthritis : A Decision Tree Analysis by Indication
- 2023
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Ingår i: Advances in Therapy. - 0741-238X .- 1865-8652. ; 40:10, s. 4657-4674
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Tidskriftsartikel (refereegranskat)abstract
- Introduction: Treatment persistence is a proxy for efficacy, safety and patient satisfaction, and a switch in treatment or treatment discontinuation has been associated with increased indirect and direct costs in inflammatory arthritis (IA). Hence, there are both clinical and economic incentives for the identification of factors associated with treatment persistence. Until now, studies have mainly leveraged traditional regression analysis, but it has been suggested that novel approaches, such as statistical learning techniques, may improve our understanding of factors related to treatment persistence. Therefore, we set up a study using nationwide Swedish high-coverage administrative register data with the objective to identify patient groups with distinct persistence of subcutaneous tumor necrosis factor inhibitor (SC-TNFi) treatment in IA, using recursive partitioning, a statistical learning algorithm. Methods: IA was defined as a diagnosis of rheumatic arthritis (RA), ankylosing spondylitis/unspecified spondyloarthritis (AS/uSpA) or psoriatic arthritis (PsA). Adult swedish biologic-naïve patients with IA initiating biologic treatment with a SC-TNFi (adalimumab, etanercept, certolizumab or golimumab) between May 6, 2010, and December 31, 2017. Treatment persistence of SC-TNFi was derived based on prescription data and a defined standard daily dose. Patient characteristics, including age, sex, number of health care contacts, comorbidities and treatment, were collected at treatment initiation and 12 months before treatment initiation. Based on these characteristics, we used recursive partitioning in a conditional inference framework to identify patient groups with distinct SC-TNFi treatment persistence by IA diagnosis. Results: A total of 13,913 patients were included. Approximately 50% had RA, while 27% and 23% had AS/uSpA and PsA, respectively. The recursive partitioning algorithm identified sex and treatment as factors associated with SC-TNFi treatment persistence in PsA and AS/uSpA. Time on treatment in the groups with the lowest treatment persistence was similar across all three indications (9.5–11.3 months), whereas there was more variation in time on treatment across the groups with the highest treatment persistence (18.4–48.9 months). Conclusions: Women have low SC-TNFi treatment persistence in PsA and AS/uSpA whereas male sex and golimumab are associated with high treatment persistence in these indications. The factors associated with treatment persistence in RA were less distinct but may comprise disease activity and concurrent conventional systemic disease-modifying anti-rheumatic drug (DMARD) treatment.
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| 26. |
- Faraj, Alan, et al.
(författare)
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Model-Informed Support of Dose Selection for Prophylactic Treatment with Dalcinonacog Alfa in Adult and Paediatric Hemophilia B Patients
- 2023
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Ingår i: Advances in Therapy. - : Springer Nature. - 0741-238X .- 1865-8652. ; 40:9, s. 3739-3750
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Tidskriftsartikel (refereegranskat)abstract
- IntroductionDalcinonacog alfa (DalcA), a novel subcutaneously administered recombinant human factor IX (FIX) variant is being developed for adult and paediatric patients with hemophilia B (HB). DalcA has been shown to raise FIX to clinically meaningful levels in adults with HB. This work aimed to support dosing regimen selection in adults and perform first-in-paediatric dose extrapolations using a model-based pharmacokinetic (PK) approach.MethodsA population PK model was built using adult data from two clinical trials (NCT03186677, NCT03995784). With allometry in the model, clinical trial simulations were performed to study alternative dosing regimens in adults and children. Steady-state trough levels and the time-to-reach target were derived to inform dose selection.ResultsAlmost 90% of the adults were predicted to achieve desirable FIX levels, i.e. 10% FIX activity, following daily 100 IU/kg dosing, with 90% of the subjects reaching target within 1.6-7.1 days. No every-other-day regimen met the target. A dose of 125 IU/kg resulted in adequate FIX levels down to 6 years, whereas a 150 IU/kg dose was needed below 6 down to 2 years of age. For subjects down to 6 years that did not reach target with 125 IU/kg, a dose escalation to 150 IU/kg was appropriate. The children below 6 to 2 years were shown to need a dose escalation to 200 IU/kg if 150 IU/kg given daily was insufficient.ConclusionThis study supported the adult dose selection for DalcA in the presence of sparse data and enabled first-in-paediatric dose selection to achieve FIX levels that reduce risk of spontaneous bleeds.
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| 27. |
- Green, Jane, et al.
(författare)
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Qualitative Interviews to Better Understand the Patient Experience and Evaluate Patient-Reported Outcomes (PRO) in RLBP1 Retinitis Pigmentosa (RLBP1 RP)
- 2020
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Ingår i: Advances in Therapy. - : Springer. - 0741-238X .- 1865-8652. ; 37:6, s. 2884-2901
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Tidskriftsartikel (refereegranskat)abstract
- Introduction: RLBP1 RP is an autosomal recessive form of retinitis pigmentosa (RP), characterized by night blindness, prolonged dark adaptation, constricted visual fields and impaired macular function. This study aimed to better understand the patient experience of RLBP1 RP and evaluate the content validity of existing patient reported outcome (PRO) instruments in this condition.Methods: Semi-structured concept elicitation and cognitive debriefing interviews were conducted with RLBP1 RP patients in Canada and Sweden. Interviews started with open-ended concept elicitation questioning, and then patients were cognitively debriefed on The National Eye Institute Visual Functioning Questionnaire (NEI VFQ-25), the Low Luminance Questionnaire (LLQ) and four light/dark adaptation items of the Visual Activities Questionnaire (VAQ). Qualitative interviews were also conducted with three expert clinicians. Anonymized, verbatim transcripts were analyzed using thematic analysis.Results: Twenty-one patients were interviewed (Canada n = 10; Sweden n = 11). Symptoms reported included night blindness (n = 21), difficulty adapting to changes in lighting (n = 21) and difficulties seeing in bright lighting (n = 18). Patients experienced substantial impacts on daily activities (n = 21) and physical functioning (n = 17). Patients had difficulty interpreting and selecting a response for some items in the NEI VFQ-25 and LLQ. Some items were not relevant to patients’ disease experience. There were both gaps and overlaps in the conceptual coverage of the instruments.Conclusions: Visual impairment due to RLBP1 RP has a substantial impact on physical functioning and daily activities. To adequately assess all important symptoms and associated functional impacts in RLBP1 RP, it is recommended to either modify one or more existing instruments or to develop a new non-syndromic RP specific instrument.
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| 28. |
- Hagström, Emil, et al.
(författare)
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Cardiovascular Event Rates After Myocardial Infarction or Ischaemic Stroke in Patients with Additional Risk Factors : A Retrospective Population-Based Cohort Study
- 2021
-
Ingår i: Advances in Therapy. - : Springer Nature. - 0741-238X .- 1865-8652. ; 38:9, s. 4695-4708
-
Tidskriftsartikel (refereegranskat)abstract
- Introduction: The impact of additional risk factors on major cardiovascular event (MACE) rates in patients with a history of myocardial infarction (MI) or ischaemic stroke (IS) treated with statins is not well defined.Methods: In this retrospective population-based cohort study, patients with a history of MI or IS treated with moderate- or high-intensity statins were identified using Swedish national register data. Patients were incident (index event between July 2006 and December 2014 and followed from diagnosis) or prevalent (MI or IS before July 2006 and followed thereafter). Four subgroups were defined on the basis of additional risk factors associated with increased cardiovascular risk: diabetes mellitus with target organ damage; chronic kidney disease stages 3-4; index event within 2 years after prior MI or IS; and polyvascular disease. First and total MACE rates (i.e. MI, IS, or cardiovascular death) were calculated, and first MACE 10-year risks (prevalent cohort only) were predicted.Results: Numerically, MACE rates in subgroups were 1.5-3 times higher than in overall populations, and were highest in the 2 years after the index event. First MACE rates in the additional risk factor subgroups were 17.2-33.5 per 100 person-years for the incident cohorts and 9.9-13.2 per 100 person-years for the prevalent cohorts. Total MACE rates per 100 person-years were 20.1-39.8 per 100 person-years and 12.4-17.6 per 100 person-years, respectively.Conclusion: Despite previous use of moderate- or high-intensity statins, patients with a history of MI or IS, and additional risk factors remain at very high cardiovascular risk.
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| 29. |
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| 30. |
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| 31. |
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| 32. |
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| 33. |
- Jacobson, Barry, et al.
(författare)
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Safety and Efficacy of Enoxaparin in Pregnancy : A Systematic Review and Meta-Analysis
- 2020
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Ingår i: Advances in Therapy. - : Springer Science and Business Media LLC. - 0741-238X .- 1865-8652. ; 37:1, s. 27-40
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Forskningsöversikt (refereegranskat)abstract
- IntroductionInternational guidelines support the use of low molecular weight heparins for the treatment of thromboembolism and thromboprophylaxis during pregnancy. However, evidence of the benefit and harm associated with specific low molecular weight heparins such as enoxaparin is dated. No current systematic review and meta-analysis describing the safety and efficacy of enoxaparin for thromboembolism and thromboprophylaxis during pregnancy exists.MethodsPubMed, Embase, and Cochrane databases were searched on August 17, 2018 for clinical trials or observational studies in pregnant women receiving enoxaparin; patients with a prosthetic heart valve were excluded. Risk ratios (RR) with 95% confidence intervals (CI) were calculated using a random effects model, and heterogeneity was measured using the I2 statistic.ResultsOf the 485 records identified in the search, 24 studies published clinical trials, and observational studies were found dating back to 2000. Only one observational cohort and one randomized control trial focused on the use of enoxaparin for thromboprophylaxis and therefore efficacy was not assessed; the other studies included women with recurrent pregnancy loss (15 studies), history of placental vascular complications (five studies), and recurrent in vitro fertilization failure (two studies) and were therefore analyzed in terms of safety only. Bleeding events were non-significantly more often reported for enoxaparin compared to untreated controls (RR 1.35 [0.88–2.07]) but less often reported for enoxaparin versus aspirin (RR 0.93 [0.62–1.39]); thromboembolic events, thrombocytopenia, and teratogenicity were rarely reported events; in patients with a history of recurrent pregnancy loss, encouragingly the rates of pregnancy loss were significantly lower for enoxaparin compared to untreated controls (RR 0.58 [0.34–0.96]) and enoxaparin + aspirin versus aspirin alone (RR 0.42 [0.32–0.56]) as well as observably lower for enoxaparin versus aspirin alone (RR 0.39 [0.15–1.01]), though significant heterogeneity was observed (I2 > 60).ConclusionLiterature on the efficacy and safety of enoxaparin for thromboembolism and thromboprophylaxis remains scanty, and therefore efficacy was not assessed; in terms of safety, when including other indications for enoxaparin in pregnancy, we found that enoxaparin was associated with significantly lower complications than aspirin. Given differences in study design and study heterogeneity, pregnancy loss results should be interpreted with caution. Moreover, reports of thromboembolic events, thrombocytopenia, and congenital malformations were rare.
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| 34. |
- Janson, Christer, et al.
(författare)
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SABINA : An Overview of Short-Acting β2-Agonist Use in Asthma in European Countries
- 2020
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Ingår i: Advances in Therapy. - : Springer Science and Business Media LLC. - 0741-238X .- 1865-8652. ; 37:3, s. 1124-1135
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Tidskriftsartikel (refereegranskat)abstract
- IntroductionGlobally, individuals with asthma tend to overrely on short-acting β2-agonists (SABAs) and underuse inhaled corticosteroids, thereby undertreating the underlying inflammation. Such relief-seeking behavior has been reinforced by long-standing treatment guidelines, which until recently recommended SABA-only use for immediate symptom relief. We aimed to describe the current burden of SABA use among European individuals with asthma within the SABA use IN Asthma (SABINA) program.MethodsPrescription and/or dispensing data during 2006–2017 from electronic medical records and/or national patient registries in the United Kingdom (UK), Germany, Italy, Spain, and Sweden were analyzed. Individuals aged at least 12 years old with a current asthma diagnosis and no other chronic respiratory conditions were included. Asthma treatment step and severity were based on treatment guidelines in use in each individual country. The proportion of individuals prescribed SABA was measured during a 12-month period. SABA overuse was defined as at least three SABA canisters per year.ResultsMore than one million individuals with asthma were included across five European countries. Overall, the majority of individuals were over 45 years of age, except in Sweden (mean age 27.6 years) where individuals aged over 45 years were excluded to avoid a potential chronic obstructive pulmonary disease co-diagnosis. The study population was predominantly female (55–64%), except in the UK (46%). The prevalence of SABA overuse was 9% in Italy, 16% in Germany, 29% in Spain, 30% in Sweden, and 38% in the UK. In the UK, SABA overuse was greater in individuals with moderate-to-severe asthma versus individuals with mild asthma (58% versus 27%, respectively), while SABA overuse was similar in individuals with both mild (9–32%) and moderate-to-severe (8–31%) asthma in the other European countries.ConclusionsThe findings of this study from the SABINA program show that SABA overuse (at least three canisters per year) is common across Europe, despite the different healthcare and reimbursement policies of each country.
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| 35. |
- Larsson, Helen, 1982, et al.
(författare)
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Emotional Journey of Patients with Eosinophilic Esophagitis
- 2023
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Ingår i: ADVANCES IN THERAPY. - 0741-238X .- 1865-8652. ; 40:12, s. 5254-5270
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Tidskriftsartikel (refereegranskat)abstract
- IntroductionEosinophilic esophagitis (EoE) is a chronic and progressive disease associated with dysphagia and eosinophilic infiltration of the esophageal mucosa. EoE can have a negative impact on a patient's quality of life (QoL); however, there is very limited data reflecting the emotional journey of patients with EoE or their perceived unmet needs. The aim of this study was to determine the emotional impact of EoE on patients at each stage of the patient journey.MethodsIn this cross-sectional and qualitative research study, adult patients with EoE from eight different countries provided their experiences and feelings across each stage of the patient journey through one-on-one semi-structured interviews.ResultsTwenty-one patients with EoE were enrolled in the study. The results of the one-on-one interviews showed that patients living with EoE go through an exhausting emotional experience during the different stages of the patient journey. In the pre-seeking-care stage, patients feel confused, afraid, frustrated, anxious, lonely, and misunderstood. During the diagnostic process, patients feel highly frustrated and angry because of the long and burdensome process. When EoE is finally diagnosed, patients feel liberated and relieved. When treatment is initiated, patients feel relief and enthusiasm, and, once the treatment starts to be effective and during the monitoring stage, they feel happier, less stressed, more confident, more relaxed, less fearful, and more in control owing to the improvement of their symptoms.ConclusionsThis study pays attention to the different stages of the journey of patients with EoE. There is a lack of awareness by both physicians and patients that negatively affects every stage of the patient journey, but especially the initial phases of pre seeking care and diagnosis. We intend for this article to represent an opportunity to increase EoE awareness and to show the importance of considering the emotional impact on a patient with EoE's journey.
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| 36. |
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| 37. |
- Lorentzon, Mattias, 1970, et al.
(författare)
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Algorithm for the Use of Biochemical Markers of Bone Turnover in the Diagnosis, Assessment and Follow-Up of Treatment for Osteoporosis
- 2019
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Ingår i: Advances in Therapy. - : Springer Science and Business Media LLC. - 0741-238X .- 1865-8652. ; 36:10, s. 2811-2824
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Tidskriftsartikel (refereegranskat)abstract
- Introduction Increased biochemical bone turnover markers (BTMs) measured in serum are associated with bone loss, increased fracture risk and poor treatment adherence, but their role in clinical practice is presently unclear. The aim of this consensus group report is to provide guidance to clinicians on how to use BTMs in patient evaluation in postmenopausal osteoporosis, in fracture risk prediction and in the monitoring of treatment efficacy and adherence to osteoporosis medication. Methods A working group with clinical scientists and osteoporosis specialists was invited by the Scientific Advisory Board of European Society on Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO). Results Serum bone formation marker PINP and resorption marker beta CTX-I are the preferred markers for evaluating bone turnover in the clinical setting due to their specificity to bone, performance in clinical studies, wide use and relatively low analytical variability. BTMs cannot be used to diagnose osteoporosis because of low sensitivity and specificity, but can be of value in patient evaluation where high values may indicate the need to investigate some causes of secondary osteoporosis. Assessing serum levels of beta CTX-I and PINP can improve fracture prediction slightly, with a gradient of risk of about 1.2 per SD increase in the bone marker in addition to clinical risk factors and bone mineral density. For an individual patient, BTMs are not useful in projecting bone loss or treatment efficacy, but it is recommended that serum PINP and beta CTX-I be used to monitor adherence to oral bisphosphonate treatment. Suppression of the BTMs greater than the least significant change or to levels in the lower half of the reference interval in young and healthy premenopausal women is closely related to treatment adherence. Conclusion In conclusion, the currently available evidence indicates that the principal clinical utility of BTMs is for monitoring oral bisphosphonate therapy.
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| 38. |
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| 39. |
- Magalhaes, Isabelle, et al.
(författare)
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Mesothelin Expression in Patients with High-Grade Serous Ovarian Cancer Does Not Predict Clinical Outcome But Correlates with CD11c+ Expression in Tumor
- 2020
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Ingår i: Advances in Therapy. - : Springer. - 0741-238X .- 1865-8652. ; 37:12, s. 5023-5031
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Tidskriftsartikel (refereegranskat)abstract
- Introduction: Mesothelin (MSLN) is overexpressed in several tumors including ovarian cancer and is the target of current trials. There is limited and conflicting data on MSLN prognostic impact in ovarian cancer.Methods: We performed a retrospective study on patients with high-grade serous ovarian cancer, analyzing MSLN expression by immunohistochemistry and examining the correlation of its expression to overall and progression-free survival. Correlations of expression of MSLN, CD8, and macrophage markers in different tumor compartments were also investigated.Results: Positive MSLN expression was detected in 55.1% of primary tumors and 51.5% of the metastases. MSLN expression was not correlated with survival. We observed a significant positive correlation (r = 0.34, p = 0.01) between MSLN expression in the metastatic site and CD11c expression in total tumor area and perivascular area in the primary tumor.Conclusion: Our results show that MSLN expression does not correlate with clinical outcome. The impact of the correlation between MSLN and CD11c+ cells on immunotherapy outcome should be further explored.
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| 40. |
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| 41. |
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| 42. |
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| 43. |
- Morales, Javier O., et al.
(författare)
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Minimizing Hypoglycemia and Weight Gain with Intensive Glucose Control : Potential Benefits of a New Combination Therapy (IDegLira)
- 2015
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Ingår i: Advances in Therapy. - : Springer. - 0741-238X .- 1865-8652. ; 32:5, s. 391-403
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Tidskriftsartikel (refereegranskat)abstract
- Due to the progressive nature of type 2 diabetes (T2D), the majority of patients require increasing levels of therapy to achieve and maintain good glycemic control. At present, once patients become uncontrolled on oral antidiabetic therapies, the two primary treatment options are glucagon-like peptide-1 receptor agonists (GLP-1RAs) or basal insulin, although earlier use of GLP-1RAs has also been advocated. While both of these drug classes have proven efficacy in treating T2D, there can be limitations to their use in some patients, and resistance to further treatment intensification among both patients and physicians. More recently, treatment incorporating both a GLP-1RA and a basal insulin has been used successfully in the clinic and the first such combination product, IDegLira (insulin degludec + liraglutide), has recently been approved for use in Europe. IDegLira combines insulin degludec and the GLP-1RA liraglutide in a single injection. In both insulin-naïve and basal insulin-treated individuals with T2D, IDegLira has demonstrated greater reductions in glycated hemoglobin (HbA1c) than either of the individual components, with a low rate of hypoglycemia and weight loss. IDegLira may provide a new option for patients requiring treatment intensification but for whom increased weight or a higher risk of hypoglycemia are barriers. This article discusses the rationale behind combining these two drug classes and reviews the available clinical evidence for the efficacy and safety of IDegLira
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| 44. |
- Muller, Audrey, et al.
(författare)
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Real-world management of patients with pulmonary arterial hypertension : insights from EXPOSURE
- 2024
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Ingår i: Advances in Therapy. - : Springer Nature. - 0741-238X .- 1865-8652. ; 41:3, s. 1103-1119
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Tidskriftsartikel (refereegranskat)abstract
- Introduction: Further insights into real-world management and outcomes of patients with pulmonary arterial hypertension (PAH) are needed. This interim analysis of the ongoing, multicentre, prospective EXPOSURE (EUPAS19085) observational study describes characteristics, treatment patterns and outcomes of patients with PAH initiating a new PAH-specific therapy in Europe/Canada.Methods and Results: All analyses were descriptive. In total, 1944 patients with follow-up information were included; the majority were female, with World Health Organization functional class II/III symptoms and with idiopathic PAH or connective tissue disease-associated PAH. Most incident patients (N = 1100; diagnosed for ≤ 6 months) initiated treatment as monotherapy (48%) or double therapy (43%). Of those initiating monotherapy, 38% (199/530) escalated to double therapy (median [Q1, Q3] time to escalation 3.4 [1.9, 6.6] months), and of those initiating double therapy, 17% (78/457) escalated to triple therapy (median [Q1, Q3] time to escalation 7.0 [3.4, 12.7] months) during the observation period (median [Q1, Q3]: 17.0 [7.5, 29.9] months). The majority of the 834 prevalent patients (diagnosed > 6 months) entered the study on initiation of combination therapy and most did not change treatment regimen during the observation period (median [Q1, Q3]: 19.6 [10.2, 32.2] months). One-year survival was 88% for incident patients and 90% for prevalent patients.Conclusions: Results from EXPOSURE suggest a shift towards combination therapy and the alignment of real-world treatment patterns with current guideline recommendations. While survival estimates are encouraging, the extent of monotherapy use at treatment initiation and follow-up highlight an opportunity for further improvements through optimisation of treatment strategies in line with current guidelines.A graphical abstract is also available with this article.Trial Registration Number: EUPAS19085.
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| 45. |
- Nyberg, Fredrik, 1961, et al.
(författare)
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Comorbidity Burden in Trial-Aligned Patients with Established Gout in Germany, UK, US, and France: a Retrospective Analysis
- 2016
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Ingår i: Advances in Therapy. - : Springer Science and Business Media LLC. - 0741-238X .- 1865-8652. ; 33:7, s. 1180-1198
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Tidskriftsartikel (refereegranskat)abstract
- Patients with gout have numerous comorbidities. We aimed to estimate the prevalence and incidence rates of renal and cardiovascular morbidities in trial-aligned patients with established gout in Germany (DE), the United Kingdom (UK), the United States (US), and France (FR). This longitudinal cohort study used retrospective data from IMS Disease Analyzer (TM) (DE, FR), Clinical Practice Research Datalink-Hospital Episode Statistics (UK), and IMS' PharMetrics Plus database linked with outpatient laboratory results (US). Included patients were a parts per thousand yen18 years at index date (January 1, 2010; all dates +1 year for FR), with continuous enrollment during the pre-index year, had "prevalent established gout" determined by data in the pre-index year, and a parts per thousand yen1 documented visit after index date; additional inclusion/exclusion criteria were aligned with recent gout clinical trials. Look-back for comorbidity prevalence extended to January 1, 2003 (US: January 1, 2009). Follow-up for incidence extended from index date to at most March 26, 2013 (FR: May 31, 2014). Events of interest were identified by diagnostic codes and/or laboratory data. The trial-aligned cohorts included 35,118 (DE), 24,607 (UK), 121,591 (US), and 17,338 (FR) patients. Among renal conditions, baseline diagnosis of chronic kidney disease/renal failure was most prevalent in the UK followed by DE; abnormal serum creatinine was most prevalent in the UK. Hypertension was the most prevalent cardiovascular diagnosis in all countries, followed by ischemic heart disease (IHD) and myocardial infarction. Incidence rates (per 100 patient-years) for new/worsening renal impairment ranged from 1.67 (DE) to 4.34 (US) and for nephrolithiasis diagnosis from 0.31 (FR) to 3.79 (US). The incidence rates for hypertension diagnosis were highest among cardiovascular-related events, ranging from 3.23 (UK) to 20.27 (US), followed by IHD. Patients with established gout such as those included in gout trials have a high burden of established morbidity and new diagnoses of morbid events. Consideration of comorbidities, which greatly exacerbate disease burden, is important in gout management.
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| 46. |
- Ofori-Asenso, Richard, et al.
(författare)
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Adherence, Persistence, and Switching Among People Prescribed Sodium Glucose Co-transporter 2 Inhibitors: A Nationwide Retrospective Cohort Study
- 2019
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Ingår i: Advances in Therapy. - : Springer Science and Business Media LLC. - 0741-238X .- 1865-8652. ; 36:11, s. 3265-3278
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Tidskriftsartikel (refereegranskat)abstract
- Introduction : Non-adherence and non-persistence to diabetes medications are associated with worse clinical outcomes. In this study, we aimed to characterise the 1-year switching, adherence, and persistence patterns among people with diabetes aged 18 years and older prescribed sodium-glucose co-transporter 2 inhibitors (SGLT2is) in Australia. Methods : Using data from Australia’s national Pharmaceutical Benefits Scheme (PBS), we identified 11,981 adults (mean age 60.9 years; 40.5% female) newly initiated on SGLT2is (5993 dapagliflozin; 5988 empagliflozin) from September 2015 to August 2017. Adherence was assessed via the proportion of days covered (PDC), persistence was defined as the continuous use of SGLT2i without a gap of ≥ 90 days, and switching was defined as the first change from dapagliflozin to empagliflozin or vice versa. Generalised linear models (GLMs) were used to compare the adherence (PDC = continuous), logistic regression models were used to compare the likelihoods of being adherent (PDC ≥ 0.80), and Cox proportional hazard models were used to compare the likelihoods of persistence and switching between people prescribed empagliflozin and dapagliflozin. Results : Overall, 65.8% (7879/11,981) of people dispensed SGLT2is were adherent (PDC ≥ 0.80) and 72.1% (8644/11,981) were persistent at 12 months. The mean PDC was 0.79 ± 0.27. The use of empagliflozin was associated with higher adherence (PDC = continuous) [odds ratio (OR) 1.04, 95% confidence interval (CI) 1.03–1.05], being adherent (OR 1.39, 95% CI 1.29–1.51), and persisting for 12 months [hazard ratio (HR) 1.14, 95% CI 1.06–1.22] compared with dapagliflozin. Only 4.3% (509/11,981) of people switched between the SGLT2i. Compared with dapagliflozin, people initiated on empagliflozin were less likely to switch [HR 0.46, 95% CI 0.38–0.55]. Conclusions : A considerable proportion of Australians prescribed SGLT2is were non-adherent or non-persistent. However, empagliflozin was associated with better adherence and persistence rates and a lower likelihood of switching compared with dapagliflozin.
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| 47. |
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| 48. |
- Ou, C. -Y, et al.
(författare)
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Maternal Delivery at Home : Issues in India
- 2021
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Ingår i: Advances in Therapy. - : Springer Science and Business Media LLC. - 0741-238X .- 1865-8652. ; 38, s. 386-398
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Tidskriftsartikel (refereegranskat)abstract
- Introduction: Maternal delivery at home without skilled care at birth is a major public health issue. The current study aimed to assess the various contributing and eliminating factors of maternal delivery at home in India. The reasons for not delivering at healthcare facilities were also explored. Methods: The study used the National Family Health Surveys (NFHS)-4 (2015–2016) data from states and union territories of India for analysis. A national representative sample of 699,686 women of reproductive age group (15–49 years) was used. Cross-tabulation and multivariate logistic regression analyses were performed. Results: The prevalence of home delivery in India was 22%, among which 34% of women believed that institutional delivery was not a necessity. Financial constraints, lack of proper transportation facilities, non-accessibility of healthcare institutions and not getting permission from family members were the main reasons cited by the women for delivering at home. The proportion of home deliveries was much higher among women from more disadvantaged socioeconomic areas than women from less disadvantaged socioeconomic areas. Domestic violence and partner control were essential factors contributing to the prevalence of home delivery. However, the women who owned mobile phones and used a short message service (SMS) facility delivered at home less often. Conclusion: Policymakers should focus more on the women living in disadvantaged socioeconomic areas and other marginalised populations with less education and low economic levels to provide them with optimum delivery care utilisation. Strengthening of public healthcare facilities and more effective use of skilled birth attendents and their networking are essential steps. Electronic and economic empowerment of women should be emphasised to bring about a significant reduction in the proportion of home deliveries in India.
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| 49. |
- Pergolizzi, Joseph V., et al.
(författare)
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What Do We Need to Know About Rising Rates of Idiopathic Pulmonary Fibrosis? A Narrative Review and Update
- 2023
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Ingår i: Advances in Therapy. - : Springer. - 0741-238X .- 1865-8652. ; 40, s. 1334-1346
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Forskningsöversikt (refereegranskat)abstract
- The most common type of idiopathic interstitial pneumonia is idiopathic pulmonary fibrosis (IPF), an irreversible, progressive disorder that has lately come into question for possible associations with COVID-19. With few geographical exceptions, IPF is a rare disease but its prevalence has been increasing markedly since before the pandemic. Environmental exposures are frequently implicated in IPF although genetic factors play a role as well. In IPF, healthy lung tissue is progressively replaced with an abnormal extracellular matrix that impedes normal alveolar function while, at the same time, natural repair mechanisms become dysregulated. While chronic viral infections are known risk factors for IPF, acute infections are not and the link to COVID-19 has not been established. Macrophagy may be a frontline defense against any number of inflammatory pulmonary diseases, and the inflammatory cascade that may occur in patients with COVID-19 may disrupt the activity of monocytes and macrophages in clearing up fibrosis and remodeling lung tissue. It is unclear if COVID-19 infection is a risk factor for IPF, but the two can occur in the same patient with complicating effects. In light of its increasing prevalence, further study of IPF and its diagnosis and treatment is warranted.
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