By Robert Bazell
These days researchers label all large clinical trials with acronyms. The diabetes trial was called DREAM (for Diabetes REduction Assessment with with ramipril and rosiglitazone Medication). DREAM enrolled 5,269 volunteers in 21 countries. They all had a elevated blood sugar or other indications of high risk for developing diabetes.Half got a drug called Avandia, already on the market to treat diabetes. The other half took a placebo, a dummy pill. After three years, 62 percent fewer people on the medication developed diabetes – results so good that the study leader called them “the kind of thing you don’t expect to see in a clinical trial.”
From one perspective, this suggests enormous potential benefit. Already 21 million Americans suffer Type 2 diabetes, putting them at increased risk for heart disease, kidney damage, blindness, amputations and early death. An estimated 54 million others have the pre-diabetic condition that would have qualified them for the DREAM trial.
And with this country’s ever growing waistlines, the number of high-risk Americans increases by millions every year. Think of the misery that could be avoided if more than half those people never developed diabetes.
The new statins?
From the viewpoint of pharmaceutical companies nothing looks better than a pill that healthy people take every day for the rest of their lives. Anti-cholesterol statins, with U.S. sales exceeding $15 billion a year, serve as the shining example. It is hardly surprising that GlaxoSmithKline, the manufacturer of Avandia, along with two other drug companies, paid for the DREAM trial and actively publicized the results.
Will Avandia and other drugs like it become the new statins? That is the big argument among diabetes specialists. Avandia’s side effects pose one problem. The DREAM trial revealed a slight increase in the rate of heart failure among those taking the drug plus more widespread weight gain. People at risk for diabetes hardly need to be adding extra pounds.
Drug therapy vs. exercise
And then there is the matter of another clinical trial. Its acronym DPP (for Diabetes Prevention Program) sounds far less catchy than DREAM. But this trial of 3,234 people carried out by the National Institutes of Health and released in August of 2001 revealed that modest weight loss (5 to 7 percent of body weight) and light exercise (a 30 minute walk each day) brought a 58 percent reduction in progression to diabetes in the same at-risk people – almost identical to the drug benefit in DREAM.
So why take a pill instead of a stroll? Many Americans refuse to get off their backsides. Health professionals seldom have the tools, time or motivation to help. So, drug therapy may find a prominent role in diabetes prevention after all – especially when newer drugs with fewer side effects come along.
A month’s supply of Avandia in the dose needed for reducing diabetes risk costs about $120.
“Wouldn’t it be interesting if we just gave people some of that money to join a health club?”, mused Dr. Irl Hirsch, a diabetes specialist at the University of Washington in Seattle.
Come to think of it, we could be spending a lot less on statin drugs, too, if more people exercised and lost weight. But, then again, it could all be just a DREAM.