Older, Cheaper Diabetes Drugs As Good As New Ones - Study
THE ASSOCIATED PRESS
Older, cheaper diabetes drugs are as safe and effective as newer ones,
concludes an analysis that is good news for diabetics and may further hurt sales
of Avandia, a blockbuster pill recently tied to heart problems.
The clear winner: metformin, sold by Bristol-Myers Squibb Co. (BMY) as
Glucophage and generically for about $100 a year. It works as well as other
diabetes pills but doesn't cause weight gain or too-low blood sugar, the
analysis found. It also lowers LDL, or bad cholesterol.
"It looks to be the safest," said Dr. Shari Bolen, a Johns Hopkins University
researcher who led the review, which was published online Monday by the Annals
of Internal Medicine.
Consumer Reports also published a consumer guide of the results. Besides
metformin, it rates glipizide and glimepiride, sold as Pfizer Inc.'s (PFE)
Glucotrol and Sanofi-Aventis' (SNY) Amaryl, as best bets.
"This is truly significant information for the millions of people with
diabetes struggling to control their disease, but also struggling with the high
cost of their medications," said Gail Shearer, project director of Consumer
Reports Best Buy Drugs.
All diabetes pills can cause problems, so patients should pick the medication
based on what side effects matter most in their own situation, the guide said.
Diabetes is epidemic, afflicting more than 18 million Americans, or 7% of the
population. Most have Type 2, which occurs when the body makes too little
insulin or can't use what it produces. Being overweight raises this risk.
The federal Agency for Healthcare Research and Quality commissioned the
analysis of diabetes drugs in 2005, long before a study published in May
suggested Avandia, made by GlaxoSmithKline PLC (GSK), raised the risk of heart
attacks. The new analysis said that evidence is insufficient to settle this
issue.
The goal was to do the first in-depth comparison of oral medications that have
come out in the last decade, as well as older ones like sulfonylureas that have
been sold for 50 years. The report didn't evaluate insulin or other injected
diabetes drugs.
Researchers reviewed more than 200 published studies and obtained unpublished
information from some drug companies and the federal Food and Drug
Administration.
They found that most oral diabetes drugs lower "A1c" levels - a key measure of
high blood sugar - by about one percentage point - from 8 to 7, for example (5
is normal for non-diabetics).
Taking two medications can improve blood sugar control, but also costs more
and can raise the risk of side effects.
Despite heavy marketing for newer drugs, which cost as much as $262 a month, "
we didn't find any benefit" unless a patient could not tolerate an older one,
Bolen said.
Other results:
-Metformin and acarbose - sold by Bayer AG (BAY) as Precose - don't increase
weight. Others add 2 to 11 pounds.
-LDL drops by about 10 milligrams per deciliter of blood with metformin and
increases by that amount with Avandia or with Actos, which is made by Takeda
Pharmaceutical Co. (4503.TO).
-Glimepiride, glipizide, glyburide and repaglinide lead to too-low blood sugar
more often than other drugs do.
-Metformin and acarbose more often cause diarrhea and other digestive problems
than the others.
-Actos and Avandia slightly raise HDL or good cholesterol.
-Actos and Avandia significantly raise the risk of heart failure.
Avandia's safety will be debated at an FDA hearing on July 30. GlaxoSmithKline
says Avandia is safe but hasn't denied reports that sales have fallen about 30%
since May 21, when a study linked it to heart attacks.
Company spokeswoman Mary Anne Rhyne said the analysis published Monday was
done before one study had been completed that showed Avandia to better control
blood sugar than two rival medications.
However, several diabetes specialists said the results are no surprise. The
conclusions mirror those of an expert panel that leading U.S. and European
diabetes groups convened last year, said Dr. David Nathan, diabetes chief at
Massachusetts General Hospital. He has received speaker fees from several
diabetes drug makers.
Metformin is "an incredibly inexpensive generic drug, which is why we found it
so appealing," Nathan said.
But it can cause a rare but dangerous side effect called lactic acidosis, the
buildup of lactic acid in the blood. It also shouldn't be given to diabetics who
have moderate kidney disease or heart failure. This is true of many other
diabetes pills, too.
A key question is how well any of these drugs prevent long-term consequences,
said Dr. Brian Strom, epidemiology chief at the University of Pennsylvania and a
consultant to several diabetes drug makers.
"Part of what makes the Avandia question so important is it's been assumed
that Avandia will decrease mortality" by better controlling blood sugar long-
term - not raise the risk of heart attacks or death, he said. Right now, "the
data aren't there - we don't know one way or another." |
