title: Cardiac concerns associated with strontium ranelate.
abstract: BACKGROUND
  Strontium ranelate is proven to reduce vertebral and non-vertebral fracture risk in osteoporosis. Concerns about cardiac safety have led to a new contraindication to strontium ranelate in patients with uncontrolled hypertension and/or current or past history of ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease.
  
  
  METHODS
  A literature search was performed; data were also collected from the European Medicines Agency website. Randomised controlled trial (RCT) data indicate a higher incidence of non-adjudicated myocardial infarction (MI) with strontium ranelate versus placebo (1.7 vs 1.1%; odds ratio [OR]: 1.6; 95% CI: 1.07 - 2.38; p = 0.020) (Mantel-Haenzel estimate of the OR). There was no increase in cardiovascular mortality. MI risk was mitigated by excluding patients with cardiovascular contraindications (OR: 0.99; 95% CI: 0.48 - 2.04; p = 0.988). Three observational studies performed in the context of real-life medical practice in the UK and Denmark did not report a signal.
  
  
  CONCLUSIONS
  The increased risk for cardiac events with strontium ranelate has been detected in RCTs but not in real life. Excluding patients with cardiovascular contraindications appears to be an effective measure for controlling the risk of MI. Strontium ranelate remains a useful therapeutic alternative in patients with severe osteoporosis without cardiovascular contraindications who are unable to take another osteoporosis treatment.
authors.affiliation: University of Liège, Department of Public Health, Epidemiology and Health Economics , CHU Sart-Tilman, 4020 Liège , Belgium +32 4270 3257 ; +32 4270 3253 ; jyreginster@ulg.ac.be.
authors.forename: Jean-Yves
authors.initials: JY
authors.lastname: Reginster
mesh_terms: D050071:Bone Density Conservation Agents / Q000009:adverse effects* / Q000627:therapeutic use; D002318:Cardiovascular Diseases / Q000209:etiology* / Q000503:physiopathology / Q000517:prevention & control; D000075202:Contraindications; D050723:Fractures, Bone / Q000209:etiology / Q000517:prevention & control; D006801:Humans; D010024:Osteoporosis / Q000150:complications / Q000188:drug therapy; D016032:Randomized Controlled Trials as Topic; D012307:Risk Factors; D013876:Thiophenes / Q000009:adverse effects* / Q000627:therapeutic use
chemical_list: D050071:Bone Density Conservation Agents; D013876:Thiophenes; C081587:strontium ranelate
keywords: cardiac safety; myocardial infarction; osteoporosis; strontium ranelate