No bones about it: Statins a failure at reducing fractures in trial

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It could be called a bad break: Researchers hoping statins might secondarily reduce fractures in cardiovascular patients found their hopes shattered.

Intending to confirm previous findings that suggested fracture reduction with statins, the JUPITER (Justification for the use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin) trial compared the use of rosuvastatin (Crestor, AstraZeneca) with placebo. The randomized, double-blind, placebo-controlled trial was conducted at 1,315 centers in 26 countries.

Patients with no prior history of cardiovascular disease and a serum high-sensitivity C-reactive protein level of 2 mg/L and low-density lipoprotein cholesterol levels of 130 mg/dL at baseline were randomly assigned rosuvastatin or placebo. Patients were followed up to five years.

Jessica M. Peña, MD, MPH, of the Montefiore Medical Center at the Albert Einstein College of Medicine in New York City, and colleagues found that patients experienced a slight increase in the incidence of fractures compared to placebo, contrary to results from trials that injected statins in mice. Patients given rosuvastatin experienced fractures at a rate of 1.2 per 100 person-years vs. 1.14 per 100 person-years for patients given the placebo.

Likewise, they found no connection between high-sensitivity C-reactive protein and the risk for fracture, whether through increasing tertiles or continuous analysis (1.06 per unit increase and 1.09 per unit increase, respectively).

The study was terminated early after data revealed prolonged rosuvastatin use was “clearly indicated for specific patients.” However, patient observation continued an additional five months following the study’s termination.

Peña et al wrote that the levels of statin used in mouse trials with results seen in bone density were not appropriate for cardiovascular therapy. They noted their study does not support using statins for the dual use of cardiovascular disease and fracture prevention.

The study was published online Dec. 1 in JAMA: Internal Medicine.