GlaxoSmithKline’s diabetes drug Avandia will increase cardiac risks while Takeda’s Actos may reduce cardiac risks. These research results were published in the latest edition of Journal of the American Medical Association. The research was done on 14,000 patients in 4 clinical trials over 1 year period.       Actos protect patients from heart attacks, strokes and death. It lowers cardiac risks by 18% while Avandia increases heart attack risk by 42%. But both drugs raise risk for heart failure.     Both Actos and Avandia are Glitazones, diabetic drugs which lowers resistance to insulin. But Pioglitazone (Actos) reduces heart attack risk while Rosiglitazone (Avandia) increases heart attack risk.   FDA may come under tremendous pressure to remove Glaxo’s Avandia from the market. Until May 2007, Avandia is the best selling diabetic drug in the world. Its prescription levels are dropped after Cleveland clinic researchers reported 43% rise in heart attacks in diabetics who are using Avandia, Rosiglitazone. This was published in the New England Journal of Medicine on May 21.     Based on the analysis, the researchers estimate that for every 220 diabetic patients treated with Avandia for one year, one will have a heart attack linked to the drug. And, there would be one case of heart failure for every 30 people taking the drug for one year. Avandia received regulatory approval in 1999 and at that time no serious adverse events were recognized. However, since approval, Avandia has been linked to heart failure, vision loss, heart attacks and fractures in women.   In United States, 3.5 million diabetics are taking Avandia. This could translate into more than 4,000 excess heart attacks and 9,000 excess heart failure events.   Like Avandia, Actos also raised risk for heart failure by 40%. However, unlike Avandia, patients receiving Actos had an 18 percent lower risk of heart attack, stroke or death than patients in the control group. Both Avandia and Actos are carrying Blackbox warning on their labels.   Whether Glaxo will withdraw Avandia from markets or not, its prescription levels may decline by almost 100%. No physician in his right sense will prescribe a drug whose side effects are severe enough to cause a death. Avandia will face Vioxx fate.   Please share your opinion on this controversy.     … [Read more...]