History of cardiovascular events and cardiovascular risk factors among patients initiating strontium ranelate for treatment of osteoporosis

Abstract

Jingbo Yu,1 Jackson Tang,2 Zhiyi Li,2 Shiva Sajjan,1 Christopher O’Regan,3 Ankita Modi,1 Vasilisa Sazonov11Center for Observational and Real-World Evidence (CORE), Merck & Co., Inc., Kenilworth, NJ, USA; 2Asclepius Analytics Ltd., Wanchai, Hong Kong; 3Merck Sharp & Dohme Corp., Hoddeson, UKPurpose: To estimate the proportion of osteoporosis patients in whom initiating strontium ranelate treatment, under new EMA guidelines, should be contraindicated because of a history of cardiovascular events or risk for cardiovascular events.Materials and methods: This was a retrospective analysis of medical and pharmacy claims using the Clinical Practice Research Datalink database. Patients were included if they had ≥1 prescription of strontium from September 1, 2008 to August 31, 2013, were aged ≥50 as of the index date (the date of the first ever strontium ranelate prescription), and had ≥1 year of medical records pre-index. Cardiovascular events occurring any time pre-index were identified, which included ischemic heart disease, cerebrovascular disease, uncontrolled hypertension, and peripheral arterial disease. Cardiovascular risk factors assessed included 1) diabetes or hypertension any time pre-index; 2) hyperlipidemia in the 12 months pre-index; or 3) obesity in the 12 months pre-index.Results: A total of 7,474 patients were included: 90.4% were women, with an average age of 76.5 years, and 84.5% used osteoporosis therapy, either bisphosphonates or non-bisphosphonates, prior to strontium initiation. A total of 23.6% of patients experienced ≥1 cardiovascular event prior to strontium initiation; the rate was lower among female patients than in male patients (22.4% vs 35.3%, P<0.01). A total of 45.9% had risk factors for cardiovascular events (without cardiovascular event history). Conclusion: More than one-fifth of osteoporosis patients in the UK who used strontium had a cardiovascular event history, and one-half had cardiovascular risk factors prior to strontium initiation.Keywords: osteoporosis, cardiovascular diseases, risk of cardiovascular event, drug therapy, drug safety