2 Drugs Fail to Prevent Diabetes in the Overweight (HealthDay)
Sunday, March 14th, 2010SUNDAY, March 14 (HealthDay News) — Hopes that two available
drugs could help prevent diabetes and the problems it causes in overweight
people with poor sugar metabolism have been dashed by a major
international study.
The trial involved two drugs prescribed for other reasons — Diovan
(valsartan), a blood pressure medication; and Starlix (nateglinide), which
is given to control existing type 2 diabetes.
The study was financed by Novartis, the drug company that markets both
products.
The Starlix portion of the five-year trial, involving more than 9,300
overweight adults, found the drug had no benefit in reducing the incidence
of newly diagnosed diabetes, cardiovascular death or events such as heart
attack, stroke and heart failure.
The Diovan portion did find a modest effect — 14 percent — in
preventing new diabetes cases. However, as was the case in the Starlix
part of the trial, using Diovan led to no reduction in the cardiovascular
conditions for which diabetes is a major risk factor.
Results of the trial were reported in two papers released early on
March 13 by the New England Journal of Medicine, and slated for
presentation Sunday at the American College of Cardiology’s annual
meeting, in Atlanta.
“It would be great if we had something that would prevent diabetes and
cardiovascular disease at the same time,” said Dr. Robert M. Califf, vice
chancellor for clinical research at Duke University, and one of the
leaders of the trial. “We didn’t get that.”
And despite the faintly positive results of the Diovan portion of the
trial, “in neither case would we recommend such prophylactive [preventive]
treatment in people who don’t have diabetes but have abnormal glucose
tolerance,” Califf said.
So, lifestyle remains the key factor in preventing obesity and poor
blood sugar control from turning into full-blown type 2 diabetes, he said.
“It looks like diet and exercise are the mainstays of prevention,” he
said. “If people could lose a few pounds more and exercise more, there
would be a lot less diabetes.”
It’s an old message, but one that is difficult to get across, said
Califf, who noted that more than 35 percent of the people in the trial did
go on to develop diabetes in just five years. “We need to keep looking for
better treatments, but lifestyle modification is the best thing we have
going,” he said.
The people in the trial, which was done at 806 centers across 40
countries, had diagnosed cardiovascular disease, known risk factors such
as obesity and impaired ability to metabolize sugar.
They were divided into groups — some receiving Diovan, some getting
Starlix, and some taking a placebo. All entered a lifestyle modification
program aimed at reducing weight and dietary fat intake and increasing
physical activity.
Over five years, 36 percent of those taking Starlix developed diabetes,
compared to 34 percent of those taking a placebo. Diabetes developed in
about a third of those taking Diovan, compared to about 37 percent of
those taking a placebo. The rates of cardiovascular problems and deaths
were similar in all groups.
“We must continue to develop new therapies while encouraging people to
exercise and pay attention to what they eat,” Dr. John McMurray, professor
of cardiology at the University of Glasgow in Scotland and a member of the
trial’s executive board, said in a Duke University news release. “Losing
at little as 5 percent of body weight has been shown to make a dramatic
difference in other studies.”
Diabetes is a growing world-wide medical problem, McMurray and Califf
noted. Some 150 million people now have the disease — 90 percent have
type 2 diabetes — and the incidence is predicted to increase 50 percent
by 2025.
There is an inexpensive drug available that has been shown to help
prevent diabetes, added Dr. David M. Nathan, a professor of medicine at
Harvard University and director of the Diabetes Research Center at
Massachusetts General Hospital, who wrote an accompanying editorial in the
New England Journal of Medicine. It is metformin, a leading drug
for diabetes treatment that has been used for decades.
A study he led reported in 2002 that metformin reduced new diagnoses of
diabetes by 58 percent over three years and by 34 percent over 10 years,
Nathan wrote. But lifestyle changes, such as eating less and exercising
more, are equally effective preventive measures, he said.
More information
Find out how you can help prevent diabetes at the American Diabetes Association.