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| 2. |
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| 3. |
- Adolfsson, Peter, 1963, et al.
(author)
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Safety and patient perception of an insulin pen with simple memory function for children and adolescents with type 1 diabetes - the REMIND study.
- 2012
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In: Current medical research and opinion. - : Informa Healthcare. - 1473-4877 .- 0300-7995.
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Journal article (peer-reviewed)abstract
- Abstract Objectives NovoPen Echo is a durable pediatric insulin pen incorporating half-unit dosing starting at 0.5 units and a last-dose memory function. The REMIND (Rating the Effects of Memory function in pediatric INsulin Devices) study primarily examined the safety of this new device by collecting data on technical complaints (TCs) related to adverse reactions (ARs) during use in a clinical setting. Methods REMIND was an observational, multicenter study involving patients with type 1 diabetes on injection therapy, aged 2-18 years, from Canada, Finland, Israel and Sweden. Questionnaires and case report forms were completed at baseline and after using NovoPen Echo for 12-18 weeks. Results In total, 358 patients participated and 315 completed. No serious ARs were reported. Three ARs related to TCs were reported, equated to one every 29 patient-years. Most patients found it 'easy' or 'somewhat easy' to read amount (99%) and hours lapsed (95%) since last dose using the memory function. The proportion of children self-injecting was significantly higher (71%) compared with those on previous device (66%, p=0.006). 80% of physicians answers reported they could train users in ≤10 minutes. Conclusions Only three device safety events were reported for NovoPen Echo. Physicians found it easy and quick to educate users. Patients/caregivers missed fewer injections and reported greater confidence in managing their insulin injections. As this was an observational study without controls or centralized laboratory testing, caution should be used in interpreting outcomes in glycaemic control. Further studies are required to examine the effects of features such as memory function and half-unit dosing on HbA1c and hypoglycemia over a longer time period.
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| 4. |
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| 5. |
- Andersson, Morgan, et al.
(author)
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Barrier-enforcing measures as treatment principle in allergic rhinitis: a systematic review
- 2014
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In: Current Medical Research and Opinion. - : Informa Healthcare. - 1473-4877 .- 0300-7995. ; 30:6, s. 1131-1137
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Research review (peer-reviewed)abstract
- Background and objectives Barrier-enforcing measures have been suggested as treatment options for allergic rhinitis. This review identifies and describes the literature on the subject. Methods Relevant publications were searched for in the PubMed database (search entries: 'allergic rhinitis' and 'treatment'). The evaluation comprised condition (seasonal or perennial allergic rhinitis), type of intervention, duration of treatment, study design, peer review status or not, number of test subjects, type of allergen exposure, and outcome in terms of effects or not on nasal symptoms of allergic rhinitis. Results Fifteen studies were either identified in the PubMed database search or from the reference lists of identified publications. Seven were placebo-controlled, randomized, and peer-reviewed, and symptom-reducing effects were reported by all of these reports. Limitations of this review reflect that the remainder of the studies had inferior designs, particularly lack of placebo control. Conclusions Barrier-enforcing measures as achieved by nasal administrations of cellulose powder and microemulsions, respectively, have symptom-reducing effects in allergic rhinitis.
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| 6. |
- Antonini, Angelo, et al.
(author)
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Developing consensus among movement disorder specialists on clinical indicators for identification and management of advanced Parkinson’s disease : a multi-country Delphi-panel approach
- 2018
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In: Current Medical Research and Opinion. - : Informa UK Limited. - 0300-7995 .- 1473-4877. ; 34:12, s. 2063-2073
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Journal article (peer-reviewed)abstract
- Background: Lack of a global consensus on the definition of advanced Parkinson’s disease (APD) and considerations for timing of device-aided therapies may result in heterogeneity in care. Objectives: To reach consensus among movement disorder specialists regarding key patient characteristics indicating transition to APD and guiding appropriate use of device-aided therapies in the management of PD symptoms. Methods: A Delphi-panel approach was utilized to synthesize opinions of movement disorder specialists and build consensus. Results: A panel was comprised of movement disorder specialists from 10 European countries with extensive experience of treating PD patients (mean =24.8 ± 7.2 years). Consensus on indicators of suspected APD and eligibility for device-aided therapies were based on motor symptoms, non-motor symptoms, and functional impairments. Key indicators of APD included: (i) motor—moderate troublesome motor fluctuations, ≥1 h of troublesome dyskinesia/day, ≥2 h “off” symptoms/day, and ≥5-times oral levodopa doses/day; (ii) non-motor—mild dementia, and non-transitory troublesome hallucinations; (iii) functional impairment—repeated falls despite optimal treatment, and difficulty with activities of daily living. Patients with good levodopa response, good cognition, and <70 years of age were deemed as good candidates for all three device-aided therapies. Patients with troublesome dyskinesia were considered good candidates for both levodopa-carbidopa intestinal gel and Deep Brain Stimulation (DBS). PD patients with levodopa-resistant tremor were considered good candidates for DBS. Conclusion: Identifying patients progressing to APD and suitable for device-aided therapies will enable general neurologists to assess the need for referral to movement disorder specialists and improve the quality of care and patient outcomes.
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| 7. |
- Baron, Ralf, et al.
(author)
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5% lidocaine medicated plaster versus pregabalin in post-herpetic neuralgia and diabetic polyneuropathy : an open-label, non-inferiority two-stage RCT study
- 2009
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In: CURRENT MEDICAL RESEARCH AND OPINION. - : Informa Healthcare. - 0300-7995 .- 1473-4877. ; 25:7, s. 1663-1676
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Journal article (peer-reviewed)abstract
- Objective: To compare efficacy and safety of 5% lidocaine medicated plaster with pregabalin in patients with post-herpetic neuralgia (PHN) or painful diabetic polyneuropathy (DPN). Study design and methods: This was a two-stage adaptive, randomized, open-label, multicentre, non-inferiority study. Data are reported from the initial 4-week comparative phase, in which adults with PHN or painful DPN received either topical 5% lidocaine medicated plaster applied to the most painful skin area or twice-daily pregabalin capsules titrated to effect according to the Summary of Product Characteristics. The primary endpoint was response rate at 4 weeks, defined as reduction averaged over the last three days from baseline of greater than= 2 points or an absolute value of less than= 4 points on the 11-point Numerical Rating Scale (NRS-3). Secondary endpoints included 30% and 50% reductions in NRS-3 scores; change in allodynia severity rating; quality of life (QoL) parameters EQ-5D, CGIC, and PGIC; patient satisfaction with treatment; and evaluation of safety (laboratory parameters, vital signs, physical examinations, adverse events [AEs], drug-related AEs [DRAEs], and withdrawal due to AEs). Results: Ninety-six patients with PHN and 204 with painful DPN were analysed (full analysis set, FAS). Overall, 66.4% of patients treated with the 5% lidocaine medicated plaster and 61.5% receiving pregabalin were considered responders (cor-responding numbers for the per protocol set, PPS: 65.3% vs. 62.0%). In PHN more patients responded to 5% lidocaine medicated plaster treatment than to pregabalin (PPS: 62.2% vs. 46.5%), while response was comparable for patients with painful DPN (PPS: 66.7% vs 69.1%). 30% and 50% reductions in NRS-3 scores were greater with 5% lidocaine medicated plaster than with pregabalin. Both treatments reduced allodynia severity. 5% lidocaine medicated plaster showed greater improvements in QoL based on EQ-5D in both PHN and DPN. PGIC and CGIC scores indicated greater improvement for 5% lidocaine medicated plaster treated patients with PHN. Improvements were comparable between treatments in painful DPN. Fewer patients administering 5% lidocaine medicated plaster experienced AEs (safety set, SAF: 18.7% vs. 46.4%), DRAEs (5.8% vs. 41.2%) and related discontinuations compared to patients taking pregabalin. Conclusion: 5% lidocaine medicated plaster showed better efficacy compared with pregabalin in patients with PHN. Within DPN, efficacy was comparable for both treatments. 5% lidocaine medicated plaster showed a favourable efficacy/safety profile with greater improvements in patient satisfaction and QoL compared with pregabalin for both indications, supporting its first line position in the treatment of localized neuropathic pain.
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| 8. |
- Baron, Ralf, et al.
(author)
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Efficacy and safety of combination therapy with 5% lidocaine medicated plaster and pregabalin in post-herpetic neuralgia and diabetic polyneuropathy
- 2009
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In: CURRENT MEDICAL RESEARCH AND OPINION. - : Informa Healthcare. - 0300-7995 .- 1473-4877. ; 25:7, s. 1677-1687
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Journal article (peer-reviewed)abstract
- Objective: Neuropathic pain is often difficult to treat due to a complex pathophysiology. This study evaluated the efficacy, tolerability and safety of combination therapy with 5% lidocaine medicated plaster and pregabalin for neuropathic pain in patients with post-herpetic neuralgia (PHN) or painful diabetic polyneuropathy (DPN). Methods: Patients completing 4-week monotherapy with 5% lidocaine medicated plaster or pregabalin were enrolled in an 8-week combination phase. Patients with adequate response to monotherapy (recalled average pain intensity of 4 or less on 11-point numeric rating scale in the previous 3 days [NRS-3 score]) continued their previous therapy, whereas those with insufficient response received combination therapy. Efficacy endpoints included change in NRS-3 from combination phase baseline, Patient and Clinical Global Impression of Change (PGIC/CGIC), and patients satisfaction with treatment. Safety evaluation included adverse events (AEs), drug-related AEs (DRAEs), and withdrawal due to AEs. Clinical trial registration: EudraCT No. 2006-003132-29. Results: Of 229 patients in the per-protocol set(PPS: 68 PHN and 161 DPN), 71 received 5% lidocaine medicated plaster monotherapy, 57 had pregabalin added to 5% lidocaine medicated plaster, 57 pregabalin monotherapy and 44 received 5% lidocaine medicated plaster in addition to continued pregabalin treatment. There were no meaningful differences in demographic data between the treatment groups. Patients continuing on monotherapy demonstrated additional decreases in NRS-3 scores. Patients receiving combination therapy achieved clinically relevant reduction in NRS-3 values in addition to improvement achieved during the 4 weeks of monotherapy. Improvement was similar between the two combination therapy groups. Considerable improvements in patients treatment satisfaction were reported. Incidences of AEs were in line with previous reports for the two treatments and combination therapy was generally well tolerated. Conclusions: In patients with PHN and painful DPN failing to respond to monotherapy, combination therapy with 5% lidocaine medicated plaster and pregabalin provides additional clinically relevant pain relief and is safe and well-tolerated.
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| 11. |
- Brod, Meryl, et al.
(author)
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Perceptions of diabetes control among people with type 2 diabetes treated with basal insulin in Sweden, Switzerland, and the United Kingdom
- 2016
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In: Current Medical Research and Opinion. - : Informa UK Limited. - 0300-7995 .- 1473-4877. ; 32:10, s. 1653-1661
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Journal article (peer-reviewed)abstract
- Objective: To investigate perceptions of control among people with uncontrolled and well controlled type 2 diabetes (T2D) treated with basal insulin, as well as differences in perceptions and diabetes management practices between the two groups. Research design and methods: Web surveys of 1012 people with uncontrolled T2D (HbA1c >8.0% or 64 mmol/mol) on basal insulin in Sweden, Switzerland, and the UK and 295 people with well controlled T2D (HbA1c 1c value (78.9%), times per day insulin taken (78.8%), insulin units taken per day (77.6%), and energy levels (74.5%). Fifty-one percent of uncontrolled respondents considered the past week or more recently when thinking about control. Perceived major obstacles to control included stress (75.4%), other health issues (70.8%), medicine side effects (69.9%), food cravings (69.8%), doctor not understanding individual situation (67.6%), and life crises (66.9%). Many uncontrolled respondents reported that diabetes was very/extremely interfering with their lives, including energy level (71.0%), performance at work (70.0%), general health (69.9%), and doing what one wants (69.3%). Analyses showed significant differences between well controlled and uncontrolled UK respondents. Compared to the uncontrolled, people with well controlled T2D were significantly more likely to consider the last 24 hours/current time when thinking about control (50% vs. 21%, p
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| 12. |
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| 13. |
- Bruyere, O., et al.
(author)
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Post-fracture management of patients with hip fracture: a perspective
- 2008
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In: CURRENT MEDICAL RESEARCH AND OPINION. - : Informa Healthcare. - 0300-7995 .- 1473-4877. ; 24:10, s. 2841-2851
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Conference paper (peer-reviewed)abstract
- Background: Hip fracture creates a worldwide morbidity, mortality and economic burden. After surgery, many patients experience long-term disability or die as a consequence of the fracture. A fracture is a major risk factor for a subsequent fracture, which may occur within a short interval. Methods: A literature search on post-fracture management of patients with hip fracture was performed on the Medline database. Key experts convened to develop a consensus document. Findings: Management of hip-fracture patients to optimize outcome after hospital discharge requires several stages of care co-ordinated by a multidisciplinary team from before admission through to discharge. Further studies that specifically assess prevention and post-fracture management of hip fracture are needed, as only one study to date has assessed an osteoporosis medication in patients with a recent hip fracture. Proper nutrition is vital to assist bone repair and prevent further falls, particularly in malnourished patients. Vitamin D, calcium and protein supplementation is associated with an increase in hip BMD and reduction in falls. Rehabilitation is essential to improve functional disabilities and survival rates. Fall prevention and functional recovery strategies should include patient education and training to improve balance and increase muscle strength and mobility. Appropriate management can prevent further fractures and it is critical that high-risk patients are identified and treated. To foster this process, clinical pathways have been established to support orthopaedic surgeons. Conclusion: Although hip fracture is generally associated with poor outcomes, appropriate management can ensure optimal recovery and survival, and should be prioritized after a hip fracture to avoid deterioration of health and prevent subsequent fracture.
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| 14. |
- Coelho, Teresa, et al.
(author)
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THAOS - The Transthyretin Amyloidosis Outcomes Survey : initial report on clinical manifestations in patients with hereditary and wild-type transthyretin amyloidosis
- 2013
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In: Current Medical Research and Opinion. - : Informa Healthcare. - 0300-7995 .- 1473-4877. ; 29:1, s. 63-76
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Journal article (peer-reviewed)abstract
- Background: Transthyretin (TTR) amyloidosis is a rare, life-threatening, systemic, autosomal dominant condition occurring in adults, with two main forms: hereditary (associated with TTR gene mutations) and wild-type. Studies indicate considerable heterogeneity in disease presentation, with predominantly polyneuropathic, predominantly cardiac, or mixed phenotypes. Methods: THAOS - the Transthyretin Amyloidosis Outcomes Survey - is the first global, multicenter, longitudinal, observational survey that collects data on the natural history of TTR amyloidosis (ClinicalTrials.gov: NCT00628745). This paper presents data on signs and symptoms, neurological and cardiac assessments, biomarkers and quality of life in the patients enrolled in THAOS from its inception in December 2007 to September 2011. Results: At the time of this analysis, data were available from 611 symptomatic patients with hereditary TTR amyloidosis, 67 symptomatic patients with wild-type TTR amyloidosis, and 274 currently asymptomatic individuals with a TTR mutation. Nineteen countries were participating in the registry. The largest patient groups came from Portugal (n = 453), the USA (n = 129), Italy (n = 70), and Japan (n = 68). Predominant symptom presentation in patients with hereditary TTR amyloidosis differed according to the underlying disease-causing mutation (polyneuropathy for Val30Met, cardiomyopathy for Val122Ile and Leu111Met, and mixed for Glu89Gln). However, each mutation was associated with clear multisystem involvement. Similarly, although cardiomyopathy was predominant in patients with wild-type TTR amyloidosis, many also showed symptoms consistent with neuropathy. Quality of life in patients with hereditary TTR amyloidosis, but not asymptomatic carriers of disease-causing mutations, was severely impaired relative to that of the age-matched general US population. Conclusions: This preliminary analysis highlights the considerable phenotypic heterogeneity for neurological and cardiac manifestations in patients with hereditary and wild-type TTR amyloidosis and the necessity of providing multidisciplinary care. THAOS registry data will help better characterize the diverse presentation and course of TTR amyloidosis worldwide and aid in improving and standardizing diagnosis and treatment.
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| 15. |
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| 16. |
- Declerck, P, et al.
(author)
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Biosimilars - terms of use
- 2015
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In: Current medical research and opinion. - : Informa Healthcare. - 1473-4877 .- 0300-7995. ; 31:12, s. 2325-2330
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Journal article (peer-reviewed)
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| 17. |
- Devereux, R. B., et al.
(author)
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Blood pressure reduction and antihypertensive medication use in the losartan intervention for endpoint reduction in hypertension (LIFE) study in patients with hypertension and left ventricular hypertrophy
- 2007
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In: Curr Med Res Opin. - : Taylor & Francis. - 1473-4877 .- 0300-7995. ; 23:2, s. 259-70
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Journal article (peer-reviewed)abstract
- OBJECTIVE: To compare blood pressure response and antihypertensive medication use visit-by-visit from baseline in patients receiving losartan-based or atenolol-based therapy in the LIFE study. RESEARCH DESIGN: LIFE was a randomized, double-blind trial comparing losartan-based and atenolol-based treatment regimens on the primary composite endpoint of death, myocardial infarction (MI), or stroke in 9193 patients aged 55-80 years with hypertension and left ventricular hypertrophy. Systolic and diastolic, pulse, and mean arterial pressures, blood pressure responder rates, distribution of open-label antihypertensive agents utilized, and the proportion of patients on randomized treatment were determined for each group at each clinic visit over a follow-up period of at least 4 years. RESULTS: Overall blood pressure reductions were comparable in the losartan-based and atenolol-based treatment groups. The mean reductions in sitting trough systolic and diastolic blood pressures from baseline to the end of follow-up (or last visit before a primary endpoint event) were 30.2/16.6 mmHg in the losartan group and 29.1/16.8 mmHg in the atenolol group. The time-averaged difference in overall mean arterial pressure was similar between groups. The proportion of patients on individual dose combinations varied visit by visit but was generally comparable between groups. During the entire study, 56% (2579/4605) of losartan-treated patients received at least one dose of the combination of losartan 100 mg plus hydrochlorothiazide 12.5 mg and 51% of atenolol-treated patients received 100 mg of atenolol plus hydrochlorothiazide 12.5 mg at some time during the study. CONCLUSIONS: Differences in blood pressure or distribution of add-on medications between treatment groups were not evident in the LIFE trial and, thus, cannot account for the observed outcome difference in the primary endpoint of risk reduction of the composite of cardiovascular death, stroke and MI favoring losartan.
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| 18. |
- do Nascimento, RCRM, et al.
(author)
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Statin use in Brazil: findings and implications
- 2018
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In: Current medical research and opinion. - : Informa UK Limited. - 1473-4877 .- 0300-7995. ; 34:10, s. 1809-1817
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Journal article (peer-reviewed)
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| 19. |
- Fellström, Bengt, et al.
(author)
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Cardiovascular disease in patients with renal disease: the role of statins.
- 2009
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In: Current medical research and opinion. - : Informa Healthcare. - 1473-4877 .- 0300-7995. ; 25:1, s. 271-85
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Journal article (peer-reviewed)abstract
- OBJECTIVES: Atherosclerosis is common in patients with chronic kidney disease (CKD), and cardiovascular disease (CVD) represents a major cause of death. The National Kidney Foundation guidelines favour the use of statin therapy for treatment of dyslipidaemia in patients with CKD. Much evidence supports statin therapy for reducing CVD and improving outcomes in the general population, but there is less evidence in patients with CKD. Consequently, prevention of CVD in CKD is based primarily on extrapolation from non-CKD trials. Significantly, in trials specifically designed to investigate patients with CKD, evidence is emerging for improved cardiovascular outcomes with statin therapy. This review describes available data relating to cardiovascular outcomes and the role of statins in patients with CKD, including pre-dialysis, dialysis, and renal transplant patients. RESEARCH DESIGN AND METHODS: The PubMed database was searched (1998-present) to ensure comprehensive identification of publications (including randomised clinical trials) relevant to CKD patients, patterns of cardiovascular outcome in such patients and their relationship to lipid profile, and the role of statins for the prevention and treatment of cardiovascular complications. RESULTS: There are conflicting data on the relationship between dyslipidaemia and cardiovascular outcomes, with one major study of statin therapy (4D--Deutsche Diabetes Dialyse Studie) providing equivocal results. Further studies, including AURORA (A study to evaluate the Use of Rosuvastatin in subjects On Regular haemodialysis: an Assessment of survival and cardiovascular events; NCT00240331) in patients receiving haemodialysis, and SHARP (Study of Heart And Renal Protection; NCT00125593) in patients with CKD including those on dialysis, should help to clarify the role of statin therapy in these populations. CONCLUSIONS: More studies are needed to elucidate the role of statins in improving cardiovascular outcomes for CKD patients. It is anticipated that ongoing clinical trials geared towards the optimal prevention and treatment of CVD in patients with CKD will help guide clinicians in the management of CKD.
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| 20. |
- Fernandez, H. H., et al.
(author)
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Levodopa--carbidopa intestinal gel for treatment of advanced Parkinson''s disease
- 2011
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In: Current Medical Research and Opinion. - : Informa Healthcare. - 1473-4877 .- 0300-7995. ; 27:5, s. 907-919
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Research review (peer-reviewed)abstract
- Levodopa is the mainstay of Parkinson''s disease (PD) treatment, but is often eventually associated with disabling motor complications in patients with advanced PD. The inability of perorally administered levodopa to provide more physiologic continuous dopaminergic stimulation (CDS) is a leading hypothesis to explain these complications. To investigate the cumulative efficacy and safety, and re-evaluate the role, of levodopa--carbidopa intestinal gel (LCIG) infusion in treatment of advanced PD patients experiencing levodopa-associated motor complications, through its purported mechanism for providing CDS. Literature searches in the MEDLINE/PubMed database were used to identify peer-reviewed publications examining the role of CDS in levodopa-associated motor complications and pharmacologic strategies for CDS, focusing on LCIG infusion for advanced PD patients. LCIG, an aqueous gel, is continuously infused (daytime only or 24 h) via a portable pump and tube permanently inserted into the duodenum through percutaneous endoscopic gastrostomy (PEG). LCIG infusion provides stable levodopa plasma levels, which are significantly less variable than those with oral levodopa. Clinical trials indicate LCIG may significantly improve motor complications (reduction of time in ''off'' and time in ''on with dyskinesias''), motor scores using the Unified Parkinson''s Disease Rating Scale (UPDRS), non-motor symptomatology (Non-motor Symptom Scale) and health-related quality of life (HRQOL) in advanced PD patients. The adverse-event profile of LCIG is similar to that of oral levodopa, although technical problems with the infusion device have occurred in up to 70%% of patients. LCIG has demonstrated efficacy in reducing levodopa-associated motor complications in patients with advanced PD, and improving UPDRS and HRQOL scores. Because it involves PEG and its associated risks, LCIG is recommended for patients in whom motor fluctuations and dyskinesias are inadequately treated with traditional peroral medication. For these patients, LCIG can be a valuable alternative to deep brain stimulation (DBS), especially when DBS is contraindicated. These conclusions are limited by the modest number and size of completed randomized, controlled trials of LCIG.
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| 21. |
- Forbes, Carol A., et al.
(author)
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A systematic literature review comparing methods for the measurement of patient persistence and adherence
- 2018
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In: Current Medical Research and Opinion. - : Taylor & Francis Group. - 0300-7995 .- 1473-4877. ; 34:9, s. 1613-1625
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Research review (peer-reviewed)abstract
- Objectives: A systematic literature review was conducted comparing different approaches estimating persistence and adherence in chronic diseases with polypharmacy of oral and subcutaneous treatments. Methods: This work followed published guidance on performing systematic reviews. Twelve electronic databases and grey literature sources were used to identify studies and guidelines for persistence and adherence of oral and subcutaneous therapies in hypercholesterolemia, type 2 diabetes, hypertension, osteoporosis and rheumatoid arthritis. Outcomes of interest of each persistence and adherence data collection and calculation method included pros: accurate, easy to use, inexpensive; and cons: inaccurate, difficult to use, expensive. Results: A total of 4158 records were retrieved up to March 2017. We included 16 observational studies, 5 systematic reviews and 7 guidelines, in patients with hypercholesterolemia (n=8), type 2 diabetes (n=4), hypertension (n=2), rheumatoid arthritis (n=1) and mixed patient populations (n=13). Pharmacy and medical records offer an accurate, easy and inexpensive data collection method. Pill count, medication event monitoring systems (MEMs), self-report questionnaires and observer report are easy to use. MEMS and biochemical monitoring tests can be expensive. Proportion of days covered (PDC) was recommended as a gold standard calculation method for long-term treatments. PDC avoids use of days' supply in calculation, hence is more accurate compared to medication possession ratio (MPR) to assess adherence to treatments in chronic diseases. Conclusions: Decisions on what method to use should be based on considerations of the route of medication administration, the resources available, setting and aim of the assessment. Combining different methods may provide wider insights into adherence and persistence, including patient behavior.
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| 22. |
- Freedman, Mark S., et al.
(author)
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Recognizing and treating suboptimally controlled multiple sclerosis: steps toward regaining command
- 2009
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In: Current Medical Research and Opinion. - : Informa UK Limited. - 1473-4877 .- 0300-7995. ; 25:10, s. 2459-2470
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Research review (peer-reviewed)abstract
- Objective: The therapies available today for multiple sclerosis (MS) reduce but do not fully control disease activity. The objective of this article is to review the definitions of and treatments for suboptimally controlled MS and highlight the challenges faced by clinicians to increase awareness of recognizing and managing patients with suboptimally controlled MS. Methods: Published literature describing treatment failure, treatment optimization paradigms or algorithms, clinical studies of therapies in patients with suboptimally controlled MS, or case reports of management of patients with suboptimally controlled MS were identified from searches of EMBASE and MEDLINE. This was supplemented with case reports and discussions from an expert panel meeting of MS specialists focused on the diagnosis and treatment of suboptimally controlled MS. Results: Several groups have created recommendations for evaluating suboptimal response to disease- modifying drugs (DMDs) in MS. Currently no robust evidence- based data exist to guide treatment decisions in patients who have suboptimal response to a particular therapy. In the absence of data, several treatment paradigms for suboptimally controlled MS have been proposed using a step therapy or platform therapy approach. Therapy modifications require consideration of diseaseand patient-specific factors while accounting for the risk-benefit profile of the agent(s). Unapproved drugs and combination therapies should be reserved as agents of last resort because of the experimental nature of these treatments. Conclusions: In the absence of evidence-based data, identifying and treating MS patients with suboptimal response to the available platform therapies remains challenging. Developing algorithms able to quantify breakthrough disease activity and suboptimal response to DMDs in individual MS patients remains an important target for the MS community. Consideration should be given for all reasons why a particular DMD may not be working for a given patient and for the use of an individualized step therapy.
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| 27. |
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| 29. |
- Grenabo, Lars, 1949, et al.
(author)
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Characteristics of antimuscarinic responders versus suboptimal responders in a randomized clinical trial of patients with overactive bladder symptoms
- 2017
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In: Current Medical Research and Opinion. - : Informa UK Limited. - 0300-7995 .- 1473-4877. ; 33:10, s. 1731-1736
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Journal article (peer-reviewed)abstract
- Objective: To assess the characteristics of tolterodine extended-release (ER) 4mg responders and suboptimal responders (<= 50% decrease in UUI episodes/24 h) among patients with overactive bladder (OAB), including urgency urinary incontinence (UUI), and identify predictors of a >50% UUI response with fesoterodine 8mg in tolterodine suboptimal responders. Methods: Adult patients with OAB symptoms for >= 6 months and >= 8 micturitions, and >= 2 and <15 UUI episodes/24 h at week -2 received open-label tolterodine ER 4mg during a 2 week run-in. Suboptimal responders after tolterodine treatment (week 0) were randomized to fesoterodine (4mg for 1 week, 8mg for weeks 2-12) or placebo once daily. Post-hoc analyses compared the percentage change from week -2 to week 0 in UUI episodes/24 h in tolterodine responders versus suboptimal responders and identified significant predictors of a UUI response at week 12 with fesoterodine 8mg among tolterodine suboptimal responders. Results: Of 897 patients, 610 (68%) were UUI suboptimal responders during the run-in period. UUI episodes/24 h at week -2 were similar in tolterodine responders and suboptimal responders (4.2 vs. 4.3), but responders showed a significantly greater median percentage decrease in UUI episodes/24 h after tolterodine treatment at week 0 (80.0% versus 15.3%; p<.0001). During double-blind treatment, the percentage of patients with a UUI response at week 12 was significantly greater with fesoterodine (69.9%) than placebo (57.0%; p = .0027). Fesoterodine (vs. placebo), no previous antimuscarinic use before tolterodine run-in, and less UUI severity at baseline were significant predictors of a UUI response. Conclusions: For patients with OAB, including UUI, who were treated initially with tolterodine and showed a suboptimal UUI response, nearly 70% demonstrated a UUI response with second-line fesoterodine 8mg. No antimuscarinic use before tolterodine and fewer baseline UUI episodes were significant predictors of a UUI response with fesoterodine.
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| 30. |
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| 31. |
- Jacobs, Maartje S., et al.
(author)
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Secondary adherence to non-vitamin-K antagonist oral anticoagulants in patients with atrial fibrillation in Sweden and the Netherlands
- 2018
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In: Current Medical Research and Opinion. - : TAYLOR & FRANCIS LTD. - 0300-7995 .- 1473-4877. ; 34:10, s. 1839-1847
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Journal article (peer-reviewed)abstract
- Objective: There is limited evidence on patients adherence and the impact of the prescribed dosing regimen in non-vitamin-K oral anticoagulants (NOACs). We aimed to assess secondary adherence to NOACs and to determine the impact of the dosing regimen in patients with atrial fibrillation. Methods: Patients using a NOAC between 2009 and 2013 were identified from the nation-wide Swedish Prescribed Drug Register and the Dutch regional IADB.nl database. Patients using a consistent dosage for at least 180 consecutive days were included. Adherence was calculated using the medication possession ratio (MPR) and adjusted for overlapping dates. Adherence was defined as a MPR amp;gt;= 0.8. Sensitivity analyses were performed using a MPR amp;gt;= 0.9. Logistic regression was performed to compare secondary adherence and to explore the influence of the dosing regimen. Results: A total of 5254 Swedish and 430 Dutch NOAC users were included. The mean MPR was 96.0% (SD 7.8%) in Sweden and 95.1% (SD 10.1%) in the Netherlands. Multivariable logistic regression analysis showed that a twice daily regimen had a lower likelihood of being secondary adherent compared to a once daily regimen in Sweden (odds ratio [OR] 0.21 [95% CI 0.12-0.35]). Limitations: The influence of selection bias introduced by the inclusion criterion of amp;gt;= 2 dispensations covering at least 180 days could not be excluded. Conclusions: This study demonstrated that secondary adherence was high in this specific setting among patients with at least two initial dispensations of a NOAC covering a minimum of 180 days. The use of NOACs in a once daily regimen showed higher adherence compared to a twice daily regimen.
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| 32. |
- Jendle, Johan, 1963-, et al.
(author)
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Willingness to pay for health improvements associated with anti-diabetes treatments for people with type 2 diabetes
- 2010
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In: Current Medical Research and Opinion. - : Informa Healthcare. - 1473-4877 .- 0300-7995. ; 26:4, s. 917-923
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Journal article (peer-reviewed)abstract
- Objectives: This study aimed to investigate the most important consequences of diabetes medication, as measured by the patients' willingness to pay (WTP). Research design and methods: People in Sweden were recruited using existing nationwide e-mail panels if they were adults (>= 18 years) with type 2 diabetes and were receiving pharmacological anti-diabetes treatment(s). Data were collected electronically and results were analysed using a standard statistical model designed for choice games (conditional logit). Six characteristics relating to treatment of diabetes were examined: weight (gain or loss), mean glycated haemoglobin level (HbA(1c)), hypoglycaemic events, nausea, need for injections (with or independently of meals), and blood glucose testing. Results: A total of 461 people with type 2 diabetes (291 males; 170 females) completed an internet questionnaire and were eligible for inclusion. Participants placed high value on weight loss and nausea avoidance; they would pay 176 Swedish Krona (SEK)/(sic)15.61 per month to lose 1 kg, and would pay SEK 560 ((sic)49.67) per month to avoid nausea completely. Patients wanting to reduce the number of hypoglycaemic events from three per month to none were willing to pay SEK 419 ((sic)37.17) per month. Patients valued a 1 percentage point reduction in HbA(1c) at SEK 414 ((sic)36.72) per month. Participants preferred taking tablets to injections and required a compensation of SEK 376 ((sic)33.35) to accept one injection/day. Injections independent of meals were preferred to injections with meals (WTP: SEK 140/(sic)12.42 per month). Potential limitations of this study are that the preferences expressed may not match preferences in real-life situations, and bias through the use of electronic questionnaire, which restricted participation to those with access to, and experience with, the internet. Conclusion: People with type 2 diabetes were willing to pay a considerable amount of money each month to lose weight, reduce or avoid hypoglycaemic events and reduce HbA(1C).
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| 33. |
- Johannsson, Gudmundur, 1960, et al.
(author)
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Improving outcomes in patients with adrenal insufficiency: a review of current and future treatments
- 2014
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In: Current Medical Research and Opinion. - : Informa Healthcare. - 0300-7995 .- 1473-4877. ; 30:9, s. 1833-1847
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Journal article (peer-reviewed)abstract
- Introduction: Adrenal insufficiency is a rare but life-threatening disease. Conventional therapy consists of glucocorticoid replacement using hydrocortisone administered two or three times daily. Although such therapy extends life expectancy, mortality is not normalized, and quality of life remains poor. This failure to restore normal health is thought to be due to the inability of conventional glucocorticoid replacement therapy to normalize total cortisol exposure and to respond to the increased need for glucocorticoids during illness and stress. Also, current management regimens do not restore or replicate the intrinsic circadian rhythm of cortisol secretion. This narrative review was based on a PubMed and Medline search of all English-language articles on the safety and efficacy of glucocorticoid replacement therapy in patients with adrenal insufficiency. Based on this search we discuss current treatment strategies in terms of the failure to maintain or normalize metabolism and quality of life in patients with adrenal insufficiency. The rationale for, and technology behind, the development of modified-release preparations of hydrocortisone are described, together with the evidence suggesting that hydrocortisone preparations that mimic the physiological circadian pattern of cortisol release are more effective than conventional glucocorticoid replacement therapies. Modified-release hydrocortisone treatments for patients with adrenal insufficiency more closely mimic the physiological circadian pattern of cortisol secretion than conventional twice or thrice daily treatment. The available evidence suggests that these modified-release preparations should improve metabolic outcomes and quality of life.
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| 34. |
- Kalso, Eija, et al.
(author)
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Do strong opioids have a role in the early management of back pain? Recommendations from a European expert panel
- 2005
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In: Current Medical Research and Opinion. - : Taylor & Francis. - 0300-7995 .- 1473-4877. ; 21:11, s. 1819-1828
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Journal article (other academic/artistic)abstract
- Background: Since chronic low back pain (CLBP) is a complex biopsychosocial problem the ideal treatment is multimodal and multidisciplinary. However, in many countries, primary-care physicians care for many people with CLBP and have a pivotal role in selecting patients for more intensive treatments when these are available. Guidelines on the general use of strong opioids in chronic non-cancer pain have been published but, until now, no specific guidelines were available on their use in chronic low back pain. Given the prevalence of CLBP, and the complex nature of this multifactorial condition, it was felt that specific, evidence-based recommendations, with a focus on primary-care treatment, would be helpful. Methods: An expert panel drawn from across Europe including pain specialists, anaesthetists, neurologists, rheumatologists, a general practitioner, an epidemiologist and the chairman of a pain charity was therefore convened. The aim of the group was to develop evidence-based recommendations that could be used as a framework for more specific guidelines to reflect local differences in the availability of specialist pain services and in the legal status and availability of strong opioids. Statements were based on published evidence (identified by a literature search) wherever possible, and supported by clinical experience when suitable evidence was lacking. Recommendations: Strong opioids have a role in the treatment of low back pain when other treatments have failed. They should be prescribed as part of a multimodal, and ideally interdisciplinary, treatment plan. The aim of treatment should be to relieve pain and facilitate rehabilitation.
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| 35. |
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| 36. |
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| 37. |
- Kilpatrick, E. S., et al.
(author)
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Good glycaemic control: an international perspective on bridging the gap between theory and practice in type 2 diabetes
- 2008
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In: Current Medical Research and Opinion. - : Informa Healthcare. - 1473-4877 .- 0300-7995. ; 24:9, s. 2651-2661
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Journal article (peer-reviewed)abstract
- Background: Good glycaemic control is crucial in reducing the risk of diabetes-related complications. Despite the availability of evidence-based treatment guidelines, glycaemic control appears to remain suboptimal in most countries. Objectives: In this commentary we outline the extent to which diabetes guideline targets on HbA(1c) are being met in clinical practice and - where targets are being missed - to identify potential reasons for this shortfall. Furthermore, we discuss possible actions that may improve glycaemic control. Methods: A literature search of MEDLINE using 20 core terms was conducted to help assess the state of glycaemic control in patients with type 2 diabetes worldwide. Results: Despite clinical guidelines, evidence suggests that glycaemic control is suboptimal in most parts of the world, with average HbA(1c) values varying from 7.0% to 12.6% and thus above virtually all HbA(1c) recommendations. The potential reasons for this shortfall are numerous. However, lack of diabetes education and awareness of HbA(1c) appear to be particularly important. A number of education initiatives from around the world have been shown to improve HbA(1c) levels significantly and thus improve standards of care. Conclusions: Poor glycaemic control in patients with type 2 diabetes appears to be a worldwide problem. As the global rise in diabetes (and its complications) seems destined to affect many less affluent countries, it is essential that appropriate steps are taken to address the barriers to good glycaemic control and ultimately improve outcomes for all people with type 2 diabetes.
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| 38. |
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| 39. |
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| 40. |
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| 41. |
- Ljunggren, Östen, et al.
(author)
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Study description and baseline characteristics of the population enrolled in a multinational observational study of extended teriparatide use (ExFOS)
- 2014
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In: Current Medical Research and Opinion. - : Informa Healthcare. - 0300-7995 .- 1473-4877. ; 30:8, s. 1607-1616
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Journal article (peer-reviewed)abstract
- Objective: To better characterize patients who are currently being prescribed teriparatide in Europe, this article describes the study design and baseline characteristics of participants of the Extended Forsteo* Observational Study (ExFOS). Research design and methods: ExFOS is a noninterventional, multicenter, prospective, observational study in men and women with osteoporosis treated with teriparatide during the course of normal clinical practice for up to 24 months and with a post-treatment follow-up of at least 18 months. Main outcome measures: Baseline characteristics, including history of fracture and back pain, and health-related quality of life (HRQoL, assessed using the EuroQol-5 Dimension [EQ-5D]). Results: Of 1607 patients enrolled, 90.9% were women. At baseline, mean (standard deviation [SD]) age was 70.3 (9.8) years, and 85.8% of patients had a history of fracture (64.7% with >= 2 fragility fractures). Of those with historic fractures, 90.8% had vertebral fractures (67.8% had thoracic fractures). The mean (SD) of reported bone mineral density T-scores were -3.0 (1.2), -2.4 (1.0), and -2.5 (0.9) for lumbar spine, total hip (left), and femoral neck (left), respectively. Overall, 39.3% of patients had experienced >= 1 fall during the 12 months before enrollment. At baseline, 11.4% of patients were osteoporosis-treatment naive and 15% were currently using glucocorticoids. The mean (SD) visual analog scale score for back pain during the last month was 50.7 (26.9), and 62.1% of patients experienced daily or almost daily back pain. The median EQ-5D health state value at baseline was 0.62 (first and third quartiles: 0.19, 0.74). Conclusions: Baseline characteristics of the ExFOS study cohort indicate that patients prescribed teriparatide in Europe have severe osteoporosis with highly prevalent vertebral fractures, frequent and disabling back pain, and a poor HRQoL, despite previous pharmacotherapy for osteoporosis. Limitations include non-randomization, lack of a comparator group, and patient self-report for data on prior medication and fracture history.
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| 42. |
- Locatelli, Francesco, et al.
(author)
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Value of N-terminal brain natriuretic peptide as a prognostic marker in patients with CKD: results from the CREATE study
- 2010
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In: Current Medical Research and Opinion. - : Informa Healthcare. - 1473-4877 .- 0300-7995. ; 26:11, s. 2543-2552
-
Journal article (peer-reviewed)abstract
- Background and objectives: This study assessed plasma N-terminal prohormone brain natriuretic peptide (NT-proBNP) as a prognostic marker of cardiovascular risk in patients with chronic kidney disease stages 3-4 and anaemia treated with epoetin beta to two haemoglobin target ranges. Design, setting, participants & measurements: Of 603 patients enrolled in the C ardiovascular Risk Reduction by Early Anaemia Treatment with Epoetin Beta (CREATE) trial (baseline creatinine clearance 15-35 mL/min; haemoglobin 11.0-12.5 g/dL), 291 were included in this sub-study. Patients received subcutaneous epoetin beta either immediately after randomisation (target 13.0-15.0 g/dL; Group 1), or after their haemoglobin levels had fallen < 10.5 g/dL (target 10.5-11.5 g/dL; Group 2). Chronic heart failure New York Heart Association class III-IV was an exclusion criterion. (ClinicalTrials.gov Identifier: NCT00321919) Results: Cardiovascular event rates were higher in patients with baseline NT-proBNP > 400 vs. 400 pg/mL (39 vs. 13 events; p = 0.0002). Dialysis was initiated in 68 vs. 42 patients with NT-proBNP > 400 vs. 400 pg/mL (p = 0.0003). Amongst patients with NT-proBNP > 400 pg/mL, there was no significant difference between treatment groups in risk of cardiovascular events (HR = 0.57; p = 0.08) or time to dialysis (HR = 0.65; p = 0.08). The overall interpretation of this substudy is, however, limited by its relatively small sample size which, together with low clinical event rates, result in a lack of statistical power for some analyses and should be viewed as being hypothesis-generating in nature. Conclusions: In chronic kidney disease patients with mild-to-moderate anaemia, elevated baseline plasma NT-proBNP levels are associated with a higher risk of cardiovascular events and an accelerated progression towards end-stage renal disease.
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| 43. |
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| 44. |
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| 45. |
- Mathus-Vliegen, Elisabeth, et al.
(author)
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Consensus guidelines for the use of bowel preparation prior to colonic diagnostic procedures: colonoscopy and small bowel video capsule endoscopy
- 2013
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In: Current Medical Research and Opinion. - : Informa Healthcare. - 1473-4877 .- 0300-7995. ; 29:8, s. 931-945
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Journal article (peer-reviewed)abstract
- Background: Adequate bowel preparation prior to colonic diagnostic procedures is essential to ensure adequate visualisation. Scope: This consensus aims to provide guidance as to the appropriate use of bowel preparation for a range of defined clinical circumstances. A consensus group from across Europe was convened and met to discuss appropriate bowel preparation. The use of polyethylene glycol (PEG), sodium picosulphate and sodium phosphate (NaP), together with other agents, prokinetics and simethicone, in colonoscopy and small bowel video capsule endoscopy were considered. A systematic review of the literature was carried out and additional unpublished data was obtained from the members of the consensus group where required. Recommendations were graded according to the level of evidence. Findings: PEG-based regimens are recommended first line for both procedures, since their use is supported by good efficacy and safety data. Sodium-picosulphate-based regimens are recommended second line as their cleansing efficacy appears less than PEG-based regimens. NaP is not recommended for bowel cleansing due to the potential for renal damage and other adverse events. However, the use of NaP is acceptable in patients in whom PEG or sodium picosulphate is ineffective or not tolerated. NaP should not be used in patients with chronic kidney disease, pre-existing electrolyte disturbances, congestive heart failure, cirrhosis or a history of hypertension. The timing of the dose, dietary restrictions, use in special patient groups and recording of the quality of bowel preparation are also considered for patients undergoing colonoscopy. During the development of the guidelines the European Society of Gastrointestinal Endoscopy (ESGE) issued guidance on bowel preparation for colonoscopy. The ESGE guidelines and these consensus guidelines share many recommendations; differences between the guidelines are reviewed. Conclusion: The use of bowel preparation should be tailored to the individual patient and their specific clinical circumstances.
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| 46. |
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| 47. |
- Nelson, J Craig, et al.
(author)
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Baseline patient characteristics associated with placebo remission and their impact on remission with duloxetine and selected SSRI antidepressants.
- 2013
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In: Current medical research and opinion. - : Informa Healthcare. - 1473-4877 .- 0300-7995. ; 29:7, s. 827-33
-
Journal article (peer-reviewed)abstract
- We examined whether identification of patients with placebo-remitter characteristics and placebo-nonremitter characteristics enhances the ability to identify drug-placebo treatment differences and, perhaps, differences between agents in major depressive disorder (MDD). We hypothesized: 1) that drug-placebo differences in remission rates would be greater for both duloxetine and selective serotonin reuptake inhibitors (SSRIs) among placebo nonremitters than placebo remitters and: 2) that the difference between active treatments would also be greater in placebo nonremitters than placebo remitters.
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| 48. |
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| 49. |
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| 50. |
- Ose, L, et al.
(author)
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Cerivastatin gender effect : Sub-analyses of results from a multinational, randomised, double-blind study
- 2000
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In: Current Medical Research and Opinion. - 0300-7995 .- 1473-4877. ; 16:2, s. 80-87
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Journal article (peer-reviewed)abstract
- We previously reported the results of a multicentre, randomised, double-blind, parallel-group study comparing the efficacy, and safety of cerivastatin 0.4 mg/day and cerivastatin 0.2 mg/day in patients with primary hypercholesterolaemia. Exploratory analysis in this study suggested a gender difference ill the 0.4 wry group: mean low-density lipoprotein cholesterol (LDL-C) decreased by 44.4 +/- 8.9% in women, compared with a mean decrease of 37.0 +/- 0.9% in men (p < 0.046). This paper reports the results of further sub-analyses from this study. Overall in the per-protocol (PP) population. 71.5% (n = 73) of women taking cerivastatin 0.4 mg had all LDL-C decrease of > 40%, compared with 38.0% (n = 76) of men taking the same dose. In the cerivastatin 0.2 mg PP population, 34% (n = 17) of women had an LDL-C decrease of > 40%, compared with 19% (n = Ig) of men. Mean LDL-C/HDL-C ratio decreased by 43% from baseline to the end of the study in the cerivastatin 0.4 mg PP group: -41.3% in males la. -48.3% in females. In the cerivastatin 0.2 mg group, the decrease in LDL-C/HDL-C ratio from baseline to endpoint did not markedly differ between genders: -37.0% for males vs. -37.3% for females. Categorial analysis of the LDL-C/HDL-C ratio found that 90% of PP patients taking cerivastatin 0.4 mg, and 84% of PP patients taking cerivastatin 0.2 my, had a low CHD risk (defined as a LDL-C/HDL-C ratio less than or equal to 3) after 8 weeks of treatment. The 6th and 95th percentiles of the distribution of LDL-C reduction from baseline revealed that 90% of PP patients taking cerivastatin 0.4 mg had all LDL-C reduction of between 22% and 56%. The mean LDL-C reduction for this 90% subset of patients uas 40.1%. The same analysis for PP patients taking cerivastatin 0.2 my found that 90% had all LDL-C reduction of between 13% and 49%. The mean LDL-C reduction in this 90% subset of patients was 31.5%. Of the patients raking cerivastatin 0.4 mg and valid for treatment according to National Cholesterol( Education Program (NCEP) criteria, 71% (149/211) achieved NCEP targets for LDL-C at Week 16.
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