Rosuvastatin may not be as effective as other statins and is associated with higher risks of serious side-effects, a US academic has claimed.
Writing in the BMJ, Dr Sidney Wolfe – senior adviser to US pressure group Public Citizen – argues that although rosuvastatin is more effective at lowering cholesterol than other statins, there is only relatively weak evidence for its effects on long-term outcomes.
He says the Jupiter trial, which led to rosuvastatin’s approval for use in cardiovascular prevention, may have exaggerated the drug’s benefits because it was stopped early.
And there is now growing evidence the drug is associated with higher risks of serious side-effects than are other statins, in particular for diabetes, with research suggesting this relates to its more potent cholesterol-lowering mechanism, says Dr Wolfe.
He claims that drugs company AstraZeneca, which markets rosuvastatin under the brand name Crestor, has been promoting the drug aggressively, using misleading information about the drug’s superiority to other statins.
According to the article, worldwide sales of rosuvastatin are the third-highest for any branded drug.
Dr Wolfe concludes: ‘The patent for rosuvastatin expires in 2016, and with it AstraZeneca’s need to promote it. But for the sake of the public’s health, we must hope that the drug’s disadvantages will lead to a sharp decline in its use before next year.’
AstraZeneca said in a statement: ‘Crestor is an effective treatment for lowering LDL cholesterol and raising HDL cholesterol, when compared to other statins, and it has been shown to slow the progression of atherosclerosis.
‘AstraZeneca takes it commitment to patient safety extremely seriously and Crestor has a well-established safety profile backed by peer-reviewed clinical research spanning 13 years and 120 ongoing or completed clinical trials. It is approved by healthcare authorities in over 109 countries and used by tens of millions of patients worldwide.’
Dr Kailash Chand, former GP and deputy chair of the BMA, has been a vocal critic of NICE guidelines expanding statin use for primary prevention.
He said: ‘I’m not against statins for secondary prevention, for people who have had a heart attack. But now we have these questions of the benefit of this drug, even in secondary prevention.
‘So it is high time we have this statin debate in full perspective. NICE’s decision to lower the primary prevention threshold is definitely overboard and is not acceptable to the profession and it is not doing patients any good.
‘The people promoting these drugs have got to release their data on side-effects.’