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Diabetes drug scare

Rosiglitazone, the diabetes drug that increases users' risk of heart attack by 43 per cent and from dying of heart problems by 64 per cent, is prescribed under 10 different brand names to an estimated 8 million people in India. Introduced in the country in 2001, Rosiglitazone shot to popularity on prescription pads because besides regulating insulin and blood sugar, the drug was said to have a favourable impact on lipids (blood fats such as cholesterol), coagulation and fat in liver, besides blood sugar.

"The mechanism for the increased risk of death from heart attacks and heart failure may be due to adverse effect of Rosiglitazone on lipids (blood fats), particularly because of the increase in bad cholesterol (low density lipoprotein or LDL ) by 18.6 per cent. Interestingly, the drug was claimed to have favourable effect on lipids when launched; which was a completely false claim," says Dr C M Gulati, drug specialist and the editor of Monthly Index of Medical Specialities.

Though the US Food and Drug Administration issued a safety alert for Rosiglitazone earlier this week, it stopped short of a warning label, saying more analysis was needed. No such warning has been issued in India. Rosiglitazone is a third-line diabetes drug prescribed after the first two lines of treatment - sulfisoxazole and biguanides - become ineffective. More than 2 million people worldwide take Rosiglitazone for type 2 diabetes. The drug was first approved for the treatment of diabetes in 1999.

In India, however, some drug companies were promoting Rosiglitazone as a drug that prevents diabetes. The lesson in this, says Dr Anoop Misra, head of the department of endocrinology, Fortis Group of Hospitals, is that both physicians and patients should refrain from blindly accepting new medicines as cure-alls when existing therapies have been established to be equally effective.

"Rosiglitazone was found to cause a 60 per cent reduction in the incidence of diabetes, which led to some doctors to prescribe it as a drug to prevent diabetes. That is not required, especially a healthy diet and regular exercise can help achieve a similar reduction (58 per cent) in diabetes incidence," says Misra.

A considered approach to the safety of Rosiglitazone is needed to avoid unnecessary panic among patients, says the editorial in The Lancet.

Of studies to date, the two most reliable to inform decision making are DREAM (The Lancet) and ADOPT (New England Journal of Medicine). DREAM, which involved over 5,000 patients, found small increases in cardiovascular events compared to controls. ADOPT involved more than 4,000 patients, and showed some excess of congestive heart failure episodes for Rosiglitazone-treated patients compared with glyburide (22 versus nine cases).

"When taken together, the new findings are a matter of concern. With the results of RECORD - a phase III trial specifically designed to analyse cardiovascular events connected to Rosiglitazone - patients prescribed the drug should get their prescriptions reviewed and go for insulin, if need be," says Dr Misra.

Source: The World Wide Web! - Back to Homepage

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