Safety of anti-diabetic drugs has figured in many scientific discussions

With all the controversy surrounding the long-term side effects of anti-diabetic drugs, diabetologists have decided to put in extra effort to ensure that benefits overweigh the risks when they prescribe drugs.

One such recent study, conducted in Chennai, established that a much feared side-effect of a category of diabetes drugs did not manifest itself in patients.

In the August 2013 edition of the Journal of the Association of Physicians of India, a team from India Diabetes Research Foundation and Dr. A. Ramachandran’s Diabetes Hospitals showed that long term use of a particular category of anti-diabetes drug, DPP-4 inhibitor, did not lead to a painful inflammation of the pancreas, as feared.

“There have been huge scientific and public discussions regarding the safety of anti-diabetic drugs lately. The major concern is that diabetes being a chronic lifetime disorder, the drugs prescribed should be taken for a long period. Therefore, long-term efficacy and any adverse effect of the drugs are a big concern, Dr. Ramachandran, one of the authors, says.

The DPP-4 inhibitor is advantageous as it causes very few episodes of hypoglycaemia (or low sugar). These drugs, which are slightly more expensive than other anti-diabetes drugs, are prescribed mostly for the elderly patients and in those with mild diabetes.

“These ‘gliptins’ have been in the market for some years, and there has been some concern regarding long exposure to the drugs leading to pancreatitis,” he explains. These drugs come with the warning that they should not be prescribed to patients who are alcoholic or those with gall stones, as this would precipitate the risk of pancreatitis .

In the Indian population, there might be undiagnosed acute pancreatitis, often misdiagnosed as stomach pain, ulcer or gastritis. The fear is that if these patients are put on DPP-4 inhibitors, it might lead to pancreatitis with potentially fatal complications, says Dr. Ramachandran. “We do not prescribe these drugs to patients who are known alcoholics or who have gall stones, but we also decided to study how a batch of patients who have been on the drug for nearly five years now were faring with particular reference to the pancreatitis risk,” he says.

In about 1,000 patients, the secretion of pancreatic enzymes, indicating the health of the pancreas, was monitored periodically for a year. “We even used a lower conservative cut-off for enzyme levels so that even borderline changes could be picked up. But we found that there was no enhanced risk for them.”

The authors, Samith Shetty, Nanditha Arun, C.Snehalatha and Dr. Ramachandran, felt safe to conclude that the patients had a similar risk as in the diabetes control group (on non-gliptin drugs).