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- Bejhed, Rebecca S., et al.
(author)
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Identification of Risk Factors for Bisphosphonate-Associated Atypical Femoral Fractures and Osteonecrosis of the Jaw in a Pharmacovigilance Database
- 2016
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In: The Annals of Pharmacotherapy. - : SAGE Publications. - 1060-0280 .- 1542-6270. ; 50:8, s. 616-624
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Journal article (peer-reviewed)abstract
- BACKGROUND: Atypical femoral fractures (AFs) and osteonecrosis of the jaw (ONJ) are well-known adverse drug reactions (ADRs) associated with bisphosphonates. To prevent these ADRs and to aid in the search for pathogenic mechanisms, knowledge of risk factors can be helpful. Objective: To identify risk factors for bisphosphonate-related ONJ and AF. Methods: In this case-control study of reports of bisphosphonate-related ADRs from February 16, 1984, to October 16, 2013, in the Swedish national database of ADRs, we compared characteristics for cases of ONJ (n = 167) and AF (n = 55) with all other bisphosphonate-related ADRs (n = 565) with regard to demographic variables, clinical characteristics, and concomitant drug treatments. We adjusted for multiple comparisons with Bonferroni correction. Results: Time to onset of ADRs differed statistically significantly between cases of AF and controls (2156 vs 111 days). For ONJ versus controls, differences were statistically significant for time to onset (1240 vs 111 days), intravenous administration (40% vs 20%), dental procedures (49% vs 0.2%) and prostheses (5% vs 0%), cancer disease (44% vs 12%), multiple myeloma (21% vs 1%), rheumatoid arthritis (14% vs 5%), and treatment with antineoplastic agents and oxycodone. Conclusion: These results lend further evidence to previously identified risk factors for ONJthat is, intravenous bisphosphonate administration; invasive dental procedures and dental prostheses; cancer disease, in particular multiple myeloma; and possibly, long-term bisphosphonate treatment. A putative further risk factor is rheumatoid arthritis. Only long-term bisphosphonate treatment was more common among AF cases. The lack of overlap of risk factors between ONJ and AF suggests different pathogenic mechanisms.
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2. |
- Hallberg, Pär, et al.
(author)
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Comparison of Clinical Factors Between Patients With Angiotensin-Converting Enzyme Inhibitor-Induced Angioedema and Cough
- 2017
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In: The Annals of Pharmacotherapy. - Thousand Oaks, USA : Sage Publications. - 1060-0280 .- 1542-6270. ; 51:4, s. 293-300
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Journal article (peer-reviewed)abstract
- Background: Angioedema is a rare and serious adverse drug reaction (ADR) to angiotensin-converting enzyme (ACE) inhibitor treatment. Dry cough is a common side effect of ACE inhibitors and has been identified as a possible risk factor for angioedema.Objective: We compared characteristics between patients with ACE inhibitor-induced angioedema and cough with the aim of identifying risk factors that differ between these adverse events.Methods: Data on patients with angioedema or cough induced by ACE inhibitors were collected from the Swedish database of spontaneously reported ADRs or from collaborating clinicians. Wilcoxon rank sum test, Fisher's exact test, and odds ratios (ORs) with 95% CIs were used to test for between-group differences. The significance threshold was set to P <0.00128 to correct for multiple comparisons.Results: Clinical characteristics were compared between 168 patients with angioedema and 121 with cough only. Smoking and concomitant selective calcium channel blocker treatment were more frequent among patients with angioedema than cough: OR = 4.3, 95% CI = 2.1-8.9, P = 2.2 × 10(-5), and OR = 3.7, 95% CI = 2.0-7.0, P = 1.7 × 10(-5) Angioedema cases were seen more often in male patients (OR = 2.2, 95% CI = 1.4-3.6, P = 1.3 × 10(-4)) and had longer time to onset and higher doses than those with cough (P = 3.2 × 10(-10) and P = 2.6 × 10(-4)). A multiple model containing the variables smoking, concurrent calcium channel blocker treatment, male sex, and time to onset accounted for 26% of the variance between the groups.Conclusion: Smoking, comedication with selective calcium channel blockers, male sex, and longer treatment time were associated with ACE inhibitor-induced angioedema rather than cough.
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3. |
- Hyttinen, V, et al.
(author)
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Incident Use of a Potentially Inappropriate Medication and Hip Fracture in Community-Dwelling Older Persons With Alzheimer's Disease
- 2017
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In: The Annals of pharmacotherapy. - : SAGE Publications. - 1542-6270 .- 1060-0280. ; 51:9, s. 725-734
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Journal article (peer-reviewed)abstract
- Background: Potentially inappropriate medications (PIMs) increase the risk of adverse drug reactions and events and have been associated with greater health care service use, such as an increased risk of hospitalization. Objective: The aim of this study is to evaluate the association between PIM use and hip fractures in a nationwide cohort of community-dwelling persons ≥65 years old with Alzheimer’s disease (AD). Methods: The study, which is based on the Finnish nationwide MEDALZ cohort, included all persons diagnosed with AD between 2005 and 2011 (n = 70 718). After a 1-year washout period for PIM use and exclusion of persons with previous hip fracture before AD diagnosis or those who had been hospitalized, we included 47 850 persons ≥65 years old with AD. PIM use was identified using Finnish criteria. Associations between PIM use and hip fracture were analyzed with Cox proportional hazards regression. Results: Of the study population, 12.3% (n = 5895) initiated PIMs during the follow-up (maximum follow-up 2921 days and total number of person-years 139 538.7). Of those, 103 (1.7%) persons had hip fractures during the PIM use period. The results suggest that PIM use was only associated with an increased risk of hip fracture with incident PIM use (adjusted hazard ratio = 1.31; 95% CI = 1.06-1.63; P = 0.014). Conclusions: PIM use is associated with increased risk of hip fracture when a person uses PIMs for the first time. However, the association between PIM use and hip fracture should be investigated more comprehensively in future studies.
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4. |
- Wimmer, Barbara C., et al.
(author)
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Medication Regimen Complexity and Polypharmacy as Factors Associated With All-Cause Mortality in Older People : A Population-Based Cohort Study
- 2016
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In: The Annals of Pharmacotherapy. - : SAGE Publications. - 1060-0280 .- 1542-6270. ; 50:2, s. 89-95
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Journal article (peer-reviewed)abstract
- Objectives: To investigate whether medication regimen complexity and/or polypharmacy are associated with all-cause mortality in older people. Methods: This was a population-based cohort study among community-dwelling and institutionalized people >= 60 years old (n = 3348). Medication regimen complexity was assessed using the 65-item Medication Regimen Complexity Index (MRCI) in 10-unit steps. Polypharmacy was assessed as a continuous variable (number of medications). Mortality data were obtained from the Swedish National Cause of Death Register. Cox proportional hazard models were used to compute unadjusted and adjusted hazard ratios (HRs) and 95% Cls for the association between regimen complexity and polypharmacy with all-cause mortality over a 3-year period. Subanalyses were performed stratifying by age (<= 80 and>80 years), sex, and cognition (Mini-Mental State Examination [MMSE] <26 and >= 2.6). Results: During follow-up, 14% of the participants (n = 470) died. After adjusting for age, sex, comorbidity, educational level, activities of daily living, MMSE, and residential setting, a higher MRCI was associated with mortality (adjusted HR = 1.12; 95% CI = 1.01-1.25). Polypharmacy was not associated with mortality (adjusted HR = 1.03; 95% Cl = 0.99-1.06). When stratifying by sex, both MRCI and polypharmacy were associated with mortality in men but not in women. MRCI was associated with mortality in participants <= 80 years old and in participants with MMSE but not in participants >80 years old or with MMSE <26. Conclusion: Regimen complexity was a better overall predictor of mortality than polypharmacy. However, regimen complexity was not predictive of mortality in women, in participants >80 years old, or in those with MMSE<26. These different associations with mortality deserve further investigation.
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