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- Rydberg, Diana M., et al.
(författare)
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Sex differences in spontaneous reports on adverse bleeding events of antithrombotic treatment
- 2014
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Ingår i: European Journal of Clinical Pharmacology. - : Springer. - 0031-6970 .- 1432-1041. ; 70:1, s. 117-126
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Tidskriftsartikel (refereegranskat)abstract
- PURPOSE: To explore if sex differences are found in spontaneously reported adverse events for clopidogrel, low-dose aspirin and warfarin treatment in routine care.METHODS: A cross-sectional analysis combining data on bleeding events from the Swedish Spontaneous Adverse Drug Event Reporting System (SWEDIS) with data from the National Prescribed Drug register. Bleeding event reports from 1999 to 2010 and 2005 to 2010 were adjusted to the number of prescriptions and the number of exposed patients respectively among women and men. Co-medication and co-prescription were analysed.RESULTS: More men were dispensed clopidogrel although the reported bleeding event risk after adjustment for number of patients exposed was higher in women (RR 1.40; 95 % CI, 1.00-1.96). The difference disappeared when adjusting for the number of prescriptions (RR 0.99; 95 % CI, 0.71-1.39). The reported bleeding event risk with low-dose aspirin was lower in women, adjusted for patients exposed (RR 0.80; 95 % CI, 0.66-0.97). For warfarin, no sex difference in bleeding event reports could be found (RR 1.01; 95 % CI, 0.87-1.17).CONCLUSIONS: This ecological comparison of bleeding reports and dispensed prescriptions showed a signal towards a higher prevalence of bleeding reports in women on clopidogrel treatment while the opposite was found for low-dose aspirin. For warfarin, no significant sex difference was seen regarding bleeding event reports, suggesting individualised dosing being an important factor. Men were more commonly prescribed antithrombotic combinations, and this was reflected by a larger proportion of bleeding reports including more than one antithrombotic agent.
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| 2. |
- Rydberg, Diana M., et al.
(författare)
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Sex differences in spontaneous reports on adverse drug events for common antihypertensive drugs
- 2018
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Ingår i: European Journal of Clinical Pharmacology. - : Springer. - 0031-6970 .- 1432-1041. ; 74:9, s. 1165-1173
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Tidskriftsartikel (refereegranskat)abstract
- PURPOSE: To explore sex differences in spontaneously reported adverse drug events (ADEs) for antihypertensives in routine care.METHODS: A cross sectional analysis combining number of reports from the national pharmacovigilance database with data from the Swedish Prescribed Drug Register, from 2005 to 2012 for ACE inhibitors (ACE-I) and angiotensin receptor blockers (ARB), with or without thiazide, diuretics (thiazides, potassium-sparing agents, sulfonamides, aldosterone antagonists), selective betablockers, and dihydropyridine calcium-channel-blockers (DHPs). The total number of reports was adjusted to exposed patients and dispensed DDDs among women and men. Dose exposures, co-medications, and co-prescriptions were also analyzed.RESULTS: In women, a higher prevalence of ADE-reports was seen in ACE-I (odds ratio, OR 1.21; 95% CI 1.09-1.35), ACE-I-combinations (OR 1.61; 1.44-1.79), ARB-combinations (OR 2.12; 1.47-3.06), thiazides (OR 1.78; 1.33-2.39), diuretics and potassium-sparing agents (OR 1.62; 1.22-2.17), and DHPs (OR 1.40; 1.17-1.67), with a potential linkage to dose exposure. For aldosterone antagonists, we observed a higher prevalence of ADE reports in men (OR 0.75; 0.59-0.97) but without any sex difference in dose exposure.CONCLUSIONS: This ecological study of reported ADEs showed a higher prevalence of reports in women in six out of ten groups of antihypertensive drugs, and this may potentially be linked to dose exposure. Aldosterone antagonists was the only group with a higher prevalence of ADE-reports in men with a similar dose exposure between women and men.
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