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SummaryIn a retrospective cohort study using the General Practice Research Database (GPRD), there was a greater association of venous thromboembolism (VTE) in osteoporotic than in non-osteoporotic female patients. No greater association was shown in treated patients with strontium ranelate or alendronate compared to untreated osteoporotic female patients.IntroductionWe explored the risk of VTE in usual practice in osteoporotic and non-osteoporotic women with and without anti-osteoporotic treatment.MethodsA retrospective study was conducted using the GPRD in the UK. The cohorts consisted of untreated osteoporotic women (N = 11,546), osteoporotic women treated with alendronate (N = 20,084), or strontium ranelate (N = 2,408), and a sample of non-osteoporotic women (N = 115,009). Cohorts were compared using a Cox proportional hazards regression model.ResultsThere was a significantly increased relative risk for VTE in untreated osteoporotic women versus non-osteoporotic women (annual incidence 5.6 and 3.2 per 1,000 patient–years, respectively; relative risk 1.75 [95% confidence interval (CI), 1.09–1.84]). Results were confirmed using adjusted models. The annual incidences of VTE in osteoporotic patients treated with strontium ranelate and alendronate were 7.0 and 7.2 per 1,000 patient–years, respectively, with no significant difference between untreated and treated patients whatever the treatment. Adjusted hazard ratios for treated versus untreated osteoporotic women were 1.09 (95% CI, 0.60–2.01) for strontium ranelate and 0.92 (95% CI, 0.63–1.33) for alendronate.ConclusionThis study shows a greater association of VTE in osteoporotic compared to non-osteoporotic patients, but does not show any greater association in treated patients with strontium ranelate or alendronate compared to untreated osteoporotic patients.

DRESS is a well-identified and characterised adverse reaction to strontium ranelate. This risk should be integrated in the risk-benefit balance evaluation of patient treatment, and the occurrence of a rash should lead to prompt and permanent treatment discontinuation with careful follow-up.

Aims To gain information on serious adverse events in a large number of patients exposed to perindopril. Methods Four thousand seven hundred and eighty-eight general practitioners throughout France collaborated in the recruitment of 47 351 patients for a 12 month postmarketing study. Data collection was undertaken by company representatives under the supervision of nine regional medical officers. Computerised data entry was performed by six pharmaceutical officers. Serious adverse events were later individually reviewed medically. Results Withdrawals due to adverse events occurred in 6.1% of female and 3.2% of males patients. The ascertainment of adverse events in this study approved satisfactory, as shown by the reported incidence of cough, which was 11.3% in women and 7.8% in men, this being compatible with the best estimates of the true incidence of cough during ACE-inhibitor therapy. Serious adverse reactions-anaphylaxis and blood dyscrasias-were rare. Conclusions This study successfully followed a large cohort of patients treated with perindopril and failed to demonstrate any unexpected hazards.