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How safe is rosuvastatin?

Q: I have been taking simvastatin 10 mg since 1996 for my raised cholesterol condition. Recently I was advised to switch to the latest family of statins, Rosuvastatin and the dosage is 10 mg. The available literature on this drug shows that it is three times as potent as the old generation of statins albeit with some stray cases of side effects on the skeletal muscles and urine protein. Another doctor has advised me to go off rosuvastatin and prescribed the more popular and tested atorvastatin; the dosage is at 20 mg equivalent to rosuvastatin 10 mg so that I have the same benefits of controlling cholesterol. How safe is rosuvastatin? What is the experience of medical fraternity in the last one year? Is it advisable to stick to atorvastatin until more research emerges on the efficacy and safety of rosuvastatin? The side effects described above were noticed in cases where the daily ingestion was of the order of 80 mg and below 40 mg rosuvastatin was considered safe.

A:While reviewing the results of clinical trials of rosuvastatin, the United States Food and Drugs Administration (USFDA) noted that side effects were more pronounced in Asian communities compared to Caucasians. It is also known that when administered to Asians, the blood levels of the medicine are quicker and higher pointing out to some genetic angle. Therefore the innovator of the medicine, AstaZeneca, was ordered to conduct more elaborate trials in Asians. Higher levels are associated with severe, potentially life-threatening muscle injury that can end up in multi-organ failure. Significantly, the only Company AstaZeneca, that has received legal permission to market the drug in India has not done so. Even otherwise, it is always better to take well tested medicines rather than jump on the band wagon of latest is the best philosophy advanced by commercial interests. Rosuvastatin has been tested in India on just 23 patients - statistically not adequate to come to any scientific conclusion. The figure also does not meet legal requirements of Phase III trials as per Drugs and Cosmetics Rules where a minimum of 100 subjects should be given the medicine. Out of four investigators who tested the drug, two were employees of a commercial company that is marketing the drug. Till more evidence is available, I am inclined to agree with the doctor who has prescribed atorvastatin.


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