Island experts play down fears
Alarm bells raised in the US over the safety of a diabetes medication also has local impact. Avandia — the drug deemed to increase the risk of heart attack and death due to heart failure was used in the Dream Trial carried out through the Bermuda Diabetes Centre at King Edward VII Memorial Hospital.
Debbie Jones, a registered nurse, heads the Diabetes Centre. She said several physicians called the centre when the disturbing findings appeared in the New England Journal of Medicine at the end of May.
Over a hundred locals took part in the Dream Trial, which tested two drugs to see if their use could forestall the development of type 2 diabetes. One of the drugs was rosiglitazone (marketed under the name Avandia).
Patients in the trial were not diabetic but rather considered pre-diabetic or at high risk of contracting the illness. The study was a double blind trial so that patients did not know what medication they were on.
Some people would not have been on any medication as their pills would have been placebos. The possibilities were:
1) rosiglitazone and a placebo;
2) rosiglitazone and ramipril (the other drug being tested);
3) Ramipril and a placebo;
4) or, a placebo and a placebo.
The five-year-study finished last year and all patients have been told which medication they were taking or if they were on placebos. Fifty-two of the 107 people in the local trial were taking rosiglitazone and Ms Jones said all participants have been made aware of the concern raised by the May 21 study.
Participants in the Dream Trial are not the only ones who would have taken the drug locally. Ms Jones said as many as 10,000 locals are estimated to have type 2 diabetes and while rosiglitazone is not the primary drug used to treat the condition, she estimated that a few hundred people take the drug locally.
This fits with what local pharmacists said. While the Phoenix drug stores would not say how sales of the drug are going, all the other local pharmacies said they saw no fall. Andrew Kelley at People’s Pharmacy said: “We have had some questions and we refer patients to their doctor. Doctors here (in Bermuda) are not advising their patients to withdraw so we have not seen a drop in sales.”
Stephanie Simons at Lindo’s Pharmacy said although she has only a small pool of patients she received a number of enquires. Like Mr. Kelley she directs patients to their GP. “But I do stress to them the importance of talking to their doctor and not taking themselves off the medication,” she said. “I point out this could be dangerous. While there are risks to taking prescriptions I tell them the benefit has to outweigh the risk.”
Andrea King, the chief pharmacist at Somerset Pharmacy said she explains the alarming findings to her patients.
“There hasn’t been any further study supporting the finding and most refute it,” she said. “I put it in perspective relative to their safety concerns. I explain that it (the findings) have been hyped in the media and tell them their personal need has to be assessed.”
Pharmacists at Robertson’s in St. George’s said a representative from GlaxoSmithKline, the company that manufacture Avandia had visited to see if there were any problems or concerns. Apart from that, pharmacists there said they have not had a single enquiry.
Sheryl Martins at Caesar’s pharmacy in Somerset said she too has no enquiries.
Pharmacists at White’s Pharmacy and Hamilton Pharmacy said sales of the drug have remained consistent since January.
All the pharmacists I spoke with estimated client bases of between 30 and 50 people.
Although heart disease is the number one killer in Bermuda, Ms Jones said the Diabetes Centre has not looked at the correlation between heart attacks and the use of Avandia since the news broke.
“During the five-year trial which followed 5,600 people worldwide, there were 15 heart attacks in the group taking Avandia, compared to nine in the control group not taking Avandia,” she said.
“We are recommending that people discuss taking Avandia with their physician. Switching patients from rosiglitazone (Avandia) to another drug in the same class is not risk free but may offer the solution,” she said.
“Diabetes and elevated blood sugars are risk factors for cardiovascular disease. Aggressive efforts must be made to treat elevated blood sugars, hypertension and elevated blood fat levels.
“Patients should redouble their attempts to follow healthy meals and increase their physical activity.”
And she said the Dream Trial made sure participants understood the importance of both of these in controlling their blood sugar. She also made it clear that rosiglitazone was approved by the American Food and Drug Administration long before the Dream Trial began.
“The Dream Trial was not testing whether rosiglitazone was a safe medication,”she said. “The trial was looking at whether rosiglitazone could prevent type 2 diabetes.”
Pharmacists play down diabetes drug fears
