Elderly Diabetic Patients are Susceptible to Anti Diabetic Rosiglitazone Increasing Risks of Cardiovascular Problems

An observational study conducted on the elderly diabetes patients provided sufficient evidence that treatment with the ‘anti diabetic rosiglitazone’ is associated with an increased risk for ‘ischemic cardiovascular events’ as well as heart failure and death.

The research study was conducted at ‘Institute for Clinical Evaluative Sciences, Toronto, Ontario, Canada’, by Lorraine Lipscombe and colleagues. Results of this study were published in the “Journal of the American Medical Association”. This new study has now boiled up the ongoing heated debate over safety and labeling of ‘thiazolidinediones’.

Lorraine Lipscombe and colleagues studied the outcomes of almost 160,000 diabetes patients with more than 66 years and over age group who were treated with at least one ‘oral hypoglycemic agent’ between a period of 2002 and 2005, using health care databases for Ontario.

The researchers pointed out that although clinical studies have indicated that thiazolidinediones are associated with an excess risk for HF, and, in the case of ‘rosiglitazone’, for ‘myocardial infarction (MI)’, the impact of these drugs on cardiovascular events has not been evaluated on a population level. In addition to that, elderly patients have been under-represented in clinical trials of ‘thiazolidinediones’, despite having a high prevalence of diabetes and being at greater risk for complications.

Study involved a median follow-up period of 3.8 years and observed that 12,491 patients visited hospital for HF, 12,578 had ‘acute myocardial infarction (AMI)’, and 30,265 died. The researchers matched each of these results with up to five control individuals from the cohort by age, gender, diabetes duration, and history of cardiovascular disease.

Researchers then compared the risks for each of these outcomes among the individuals treated with thiazolidinediones and other oral hypoglycemic combinations.

It was observed that in comparison to the patients taking other agents, current users of ‘thiazolidinedione monotherapy’ had a significantly increased risk for HF .The increased risk in each case had a close link with the rosiglitazone use. Detailed analysis of the thiazolidinediones on individual basis showed significant relationship with each outcome with rosiglitazone but it did not indicate any association with pioglitazone.

The researchers also found that the studies conducted before for analyzing protective effects of pioglitazone the results thus obtained were not observed. They say that the study may have been underpowered to detect adverse effects because relatively few patients were prescribed pioglitazone monotherapy.

Researchers concluded that “These findings provide evidence from a real-world setting and support data from clinical trials that the harms of thiazolidinediones may outweigh their benefits, even in patients without obvious baseline cardiovascular disease”.

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