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

• Main Authors: Yu J (Author), Tang J (Author), Li Z (Author), Sajjan S (Author), O'Regan C (Author), Modi A (Author), Sazonov V (Author)
• Format: Book
• Published: Dove Medical Press, 2015-11-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.
• Notes: 1179-1411
• Keywords: Gynecology and obstetrics; RG1-991
• Source: International Journal of Women's Health, Vol 2015, Iss default, Pp 913-918 (2015)

Jingbo Yu,1 Jackson Tang,2 Zhiyi Li,2 Shiva Sajjan,1 Christopher O&rsquo;Regan,3 Ankita Modi,1 Vasilisa Sazonov11Center for Observational and Real-World Evidence (CORE), Merck&nbsp;& Co., Inc., Kenilworth, NJ, USA; 2Asclepius Analytics Ltd., Wanchai, Hong Kong; 3Merck Sharp &&nbsp;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 &ge;1 prescription of strontium from September 1, 2008 to August 31, 2013, were aged &ge;50 as of the index date (the date of the first ever strontium ranelate prescription), and had &ge;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 &ge;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