ECTS2014 Late Breaking Abstracts (1) (5 abstracts)
History of cardiovascular events and risk factors for cardiovascular events among osteoporotic patients initiating strontium ranelate in the UK
Jingbo Yu 1 , Jackson Tang 2 , Zhiyi Li 2 , Vasilisa Sazonov 1 , Shiva Sajjan 1 , Michaela Lion 1 & Christopher O’Regan 1
1Merck & Co., Inc., Whitehouse Station, New Jersey, USA; 2AsclepiusJT LLC, New York, New York, USA.
Objective: To estimate the proportion of patients who experienced cardiovascular (CV) events or were at risk for CV events prior to initiation of strontium ranelate among osteoporotic (OP) patients.
Methods: This was a retrospective database analysis using the Clinical Practice Research Datalink (CPRD) database. Patients were included if they had ≥1 prescription (Rx) of strontium from 9/1/2008 to 8/31/2013, were aged ≥50 years as of the index date, and had ≥1 year of medical records pre-index. A CV event was identified any time pre-index and included uncontrolled hypertension, or diagnosis (Dx) of ischemic heart disease, peripheral arterial diseases and cerebrovascular disease. CV risk factors assessed included i) Dx or Rx for type 2 diabetes mellitus or hypertension any time pre-index; ii) Dx or Rx of hyperlipidemia in 12 months pre-index; or iii) Dx of obesity or BMI ≥30 kg/m2 in the 12 months pre-index.
Results: 7474 patients (patients) were included: 90.4% were female with an average age of 76.5 years (S.D.=10.3), 63.5% had record of OP Dx, and 84.5% used bisphosphonate (BIS) (27.2% used ≥2 different BIS) or non-BIS medication prior to strontium initiation. 23.6% of patients (20.8% of patients with OP Dx) experienced ≥1 CV events prior to strontium initiation; the rate was lower among female patients than that of male patients (22.4 vs 35.3% P<0.01). 45.9% had risk factors for CV events (without CV event history).
Conclusion: More than one fifth of UK OP patients who used strontium had CV event history, and one half of them had CV risk factors and no previous CV event prior to strontium initiation. In response to the EMA (European Medicines Agency) recommendation related to strontium use for patients with history of the included CV events, OP treatment among this cohort may be re-considered.
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