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Heart at Serious Risk from Diabetes Drugs

      Volume: 36 (29/07/2007)
A major study on diabetes drugs has found that two of the most commonly prescribed medications for type-2 diabetes double the risk of heart failure. The study was conducted by researchers at the University of East Anglia and is published in the journal Diabetes Care.

Rosiglitazone and pioglitazone are two of the most commonly prescribed drugs for treatment of type-2 diabetes. More than 1.5 million people in the UK alone were prescribed these drugs last year. Prescriptions for these two drugs, which belong to the thiazolidinediones class of medications, have effectively doubled over the last three years.

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While highly effective, research published earlier this year found that rosiglitazone increases the risk of heart attacks. The latest analysis consisted of data gathered on more than 78,000 diabetics. The analysis of the data revealed that one in every 50 people taking the two drugs would require hospital admission on account of heart failure. This would be over a period of 26 months of treatment.

The researchers hypothesized that the increased heart risk might be on account of fluid retention caused by the drugs. Lead researcher Dr. Yoon Loke said, “This means that the diabetes drugs could have caused thousands of additional cases of heart failure, creating a substantial burden on hard-pressed NHS services.”

Additionally, the researchers carried out detailed analysis of data on more than 200 cases of patients, all of whom had suffered heart failure due to diabetes drugs. They found that even low doses of the drugs were enough to cause heart problems.

Heart failure is normally associated with older patients. The researchers however found that nearly 25% of the cases had occurred in people below the age of 60. Based on their findings, the researchers are calling for the regulatory authorities to rethink on their approval of the drugs.

According to information leaflets supplied with the drugs by manufacturers, both rosiglitazone and pioglitazone should not be used in patients with heart failure. The findings however suggest that even those without a history of heart disease can face heart problems once they start taking these drugs.

Dr. Loke said, “Most patients in the studies did not have heart failure prior to starting on treatment with these drugs. There doesn’t seem to be a group of patients who are safe from these side-effects.”

Commenting on the findings, Matt Hunt, of the charity Diabetes UK, said that the Medicines and Healthcare products Regulatory Agency (MHRA) had approved the drugs as being safe and effective treatment for type-2 diabetes.

“Obviously new evidence should be considered by the MHRA on an ongoing basis,” he said and added, “Both the MHRA and the European Medicines Agency say that people should not stop taking glitazones and if concerned they should consult their doctor.”

The EMEA and the MHRA have both confirmed that following safety concerns regarding heart health, their experts have already started re-evaluating the benefits and risks of both drugs. Both agencies are expecting the re-evaluation to be completed before the end of the year.

A spokesman from the drugs’ guidance watchdog NICE said, “If the EMEA decides on the basis of this new research that the risks posed by these two glitazones outweigh their benefits, they will issue updated prescribing advice to healthcare professionals. This will take precedence over the existing NICE guidance.”

Rosiglitazone manufacturer GlaxoSmithKline said, “The risk of heart failure in diabetes patients and with use of these medicines is well recognised and is clearly identified in prescribing information to doctors in the UK.”

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