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From October 2013 to September 2014, rosuvastatin (CRESTOR) was the most prescribed brand-name drug in the U.S., with 22.3 million prescriptions filled and $5.8 billion in sales. However, even though the drug lowers cholesterol, it has no proven health benefit — such as a decreased risk of heart attack or stroke — in people with high cholesterol. Four statins on the market have demonstrated such a benefit for patients with high cholesterol: Atorvastatin (LIPITOR), lovastatin (ALTOPREV,...
From October 2013 to September 2014, rosuvastatin (CRESTOR) was the most prescribed brand-name drug in the U.S., with 22.3 million prescriptions filled and $5.8 billion in sales. However, even though the drug lowers cholesterol, it has no proven health benefit — such as a decreased risk of heart attack or stroke — in people with high cholesterol. Four statins on the market have demonstrated such a benefit for patients with high cholesterol: Atorvastatin (LIPITOR), lovastatin (ALTOPREV, MEVACOR), pravastatin (PRAVACHOL) and simvastatin (ZOCOR) all decrease the risk of a first heart attack or stroke (primary prevention) or a subsequent heart attack or stroke in people who have already had such a cardiovascular event (secondary prevention).
Moreover, there is increasing evidence that rosuvastatin carries a higher risk of several adverse effects than do other statins. Adding to the known risks of the drug, a new statistical review recently showed an increased risk of developing diabetes in users of rosuvastatin, compared with other statins.
Drug-induced diabetes
A 2013 review of 17 different randomized, controlled studies, involving 113,394 patients, compared the risk of developing diabetes in patients taking statins.[1] The studies compared either a statin versus a placebo or high-dose versus moderate-dose statin therapy.
The authors found that pravastatin was associated with the lowest risk for new-onset diabetes compared with a placebo. Conversely, rosuvastatin was associated with the largest increased risk for diabetes (25 percent) compared with a placebo. The risk of diabetes appeared to be intermediate with atorvastatin compared with a placebo. Simvastatin performed poorly in the trials (21 percent increased risk of diabetes). The study concluded that “high-dose pravastatin had the highest probability to be the safest treatment in terms of new-onset [diabetes], with rosuvastatin and simvastatin performing least well.”
An earlier study by Ireland’s national health agency involving about 240,000 patients beginning treatment with various statins also found that rosuvastatin was associated with the highest increase in risk of new-onset diabetes compared with other statins.[2]
Previously known problems
In addition to this newer evidence of the increased danger of diabetes with rosuvastatin use, other serious problems were identified even before its approval.
Public Citizen testified against approval of rosuvastatin in 2003[3] and, the following year, asked the Food and Drug Administration (FDA) to ban the drug especially because of two serious adverse reactions.[4] The first was rhabdomyolysis, a life-threatening, muscle-destroying adverse reaction that can lead to kidney failure and death. Rosuvastatin is the only statin in which rhabdomyolysis was detected in controlled clinical trials before the drug was approved. Even with cerivastatin (BAYCOL), eventually banned because of rhabdomyolysis, no cases had occurred in the clinical trials before its approval.
The second pre-approval problem seen with rosuvastatin was unique among the statins: Early signs of kidney damage and blood and protein in the urine were seen in pre-approval clinical trials. The kidney problems alone should have been sufficient for the FDA not to approve the drug. This issue was also reviewed in an article in The Lancet in 2004.[5]
Over rosuvastatin’s first year on the market, researchers reviewed FDA adverse reactions reports associated with the drug. They then calculated the rates of adverse reactions per million rosuvastatin prescriptions during that year and compared it with the rates seen with other statin drugs: atorvastatin, simvastatin and pravastatin. The researchers found that rosuvastatin was significantly more likely to be associated with a higher rate of a combined endpoint of rhabdomyolysis, protein in the urine, kidney toxicity or kidney failure than the other statin drugs in the study. The differences in rates were even more highly significant when the rhabdomyolysis and kidney failure were looked at separately.[6]
What You Can Do
As Public Citizen’s Health Research Group has previously advised, if you have high cholesterol, there is no medical reason why you should be taking rosuvastatin. If you are already taking rosuvastatin to lower your high cholesterol, talk to your physician about switching to another statin that carries fewer risks, such as atorvastatin, lovastatin, pravastatin or simvastatin. Importantly, all of these drugs, unlike rosuvastatin, provide a benefit in terms of reducing the serious cardiovascular consequences of high cholesterol, such as a first or second heart attack or stroke, rather than simply lowering high cholesterol.
References
[1] Navarese EP, Buffon A, Andreotti F, et al. Meta-analysis of impact of different types and doses of statins on new-onset diabetes Mellitus. Am J Cardiol. 2013;111(8):1123-1130.
[2] Zaharan NL, Williams D, Bennett K. Statins and risk of treated incident diabetes in a primary care population. Br J Clin Pharmacol. 2013;75(4):1118-1124.
[3] Public Citizen. FDA testimony opposing approval of Crestor. https://www.citizen.org/Page.aspx?pid=3287.
[4] Public Citizen’s Health Research Group. Petition to ban cholesterol-lowering drug rosuvastatin (Crestor). https://www.citizen.org/Page.aspx?pid=3212.
[5] Wolfe SM. Dangers of rosuvastatin identified before and after FDA approval. Lancet. 2004;363(9427):2189-2190.
[6] Alsheikh-Ali AA, Ambrose MS, Kuvin JT, Karas RH. The safety of rosuvastatin as used in common clinical practice: A postmarketing analysis. Circulation. 2005; 111(23): 3051 - 3057.
