Study Questions Effectiveness of Statins

Raleigh, NCA new study suggests that statins—a class of drug that includes Crestor—may not be as effective as previously thought. That calls into question whether the risk of Crestor side effects, which reportedly include a risk of Crestor issues such as rhabdomyolysis and other health problems, outweigh the potential benefits.

The study was published in the September 2012 issue of PLoS Medicine (plosmedicine.org). Researchers sought to determine whether statins, "substantially reduce the risk of venous thromboembolic events." A previous study, called the JUPITER trial, suggested that use of statins halved the risk of venous thromboembolic events among healthy adults. Researchers for this most recent study, however, noted that fewer than 100 participants in the JUPITER trial developed deep vein thrombosis or pulmonary embolism, making the study sample size relatively small and meaning the results could have been attributed to chance.

For the PLoS study, researchers examined the results of various randomized controlled trials that compared statins with placebos or that compared intensive statin therapy with standard therapy. They also studied unpublished information about venous thromboembolic events that occurred during those trials.

Researchers found that although the number of venous thromboembolic events was lower in the group given statins, it was not significantly lower (0.9 percent of participants who received a statin had a venous thromboembolic event versus 1.0 percent of participants given a placebo). "The findings of the meta-analysis do not support the suggestion that statins, either at the standard dose or at higher doses, reduce the risk of venous thromboembolic events substantially among healthy adults," the study's authors concluded. They suggested that further research be conducted to determine if statin use does reduce the risk of venous thromboembolic events in adults.

Statins are used to lower blood cholesterol levels, thereby lowering the risk of atherosclerosis, which is linked to chest pain, strokes and heart attacks. Statins, including Crestor, have been linked to an increased risk of rhabdomyolysis—a condition in which muscle tissue breaks down and enters the bloodstream, potentially resulting in kidney failure—and cardiomyopathy.

In February 2012, the US Food and Drug Administration (FDA) announced that the warning label on statins would be strengthened to alert patients to the potential risk of hyperglycemia and Type 2 diabetes. Crestor, known generically as rosuvastatin, is marketed by AstraZeneca.