Combinatie van diabetes medicijnen niet ongevaarlijk*
Een veel toegepaste combinatie van twee medicijnen te weten Metformine en Sulfonylureumderivaten verhogen duidelijk de kans om opgenomen te worden in het ziekenhuis met een hart- of vaatziekte en een mogelijke dood. Dit blijkt uit een nieuwe studie waarbij gekeken werd naar ruim 100.000
patiënten met diabetes type-2 die een medicijn of de combinatie kregen of alleen een dieet behandeling. Ongeveer 25.000 van deze patiënten ontving de combinatie therapie. Deze laatste groep had 43% meer kans om opgenomen te worden in het ziekenhuis met een hart- of vaatziekte. Deze groep had ook nog eens 19% meer kans om dood te gaan en liefst 29% meer kans om dood te gaan aan een hart- of vaatziekte.
Uit
een andere studie blijkt dat voor het bij diabetes gebruikte medicijn Beyetta
een duidelijke waarschuwing afgegeven wordt omdat dit medicijn de kans op
ontstekingen van de pancreas kan veroorzaken.
Combo of diabetes drugs may increase mortality
Combination treatment for type 2 diabetes using two classes of drugs -- metformin and sulfonylureas -- may increase the risk of hospitalization for cardiovascular disease and mortality, according to a report in the current issue of Diabetes Care.
Researchers came to this conclusion after an analysis of pooled data from nine large observational studies.
"The paper highlights a real dilemma we have today in diabetes treatment," senior investigator Dr. Vivian A. Fonseca told Reuters Health. "We have drugs that lower glucose but we seem to run into problems over time with improving outcomes -- particularly cardiovascular outcomes."
"A big question," he added, "is whether it is due to the disease or the drugs increasing cardiovascular risk."
To help answer that question, Fonseca of Tulane University School of Medicine, New Orleans, and colleagues performed a review of data from more than 101,000 study participants, about one quarter of whom received combination therapy with metformin and sulfonylurea. The other patients were treated with one of these agents or diet therapy.
In the combination group, the risk of mortality from any cause was increased by 19 percent and by 29 percent for cardiovascular mortality. There were no statistically significant differences, however, when compared with the mortality rates in the other groups.
However, the combined end-point of death or hospitalization due to cardiovascular disease was increased by 43 percent in the group on combination therapy, which was significantly greater than in the other groups.
"So it appears," continued Fonseca, "that there is some increased risk with this combination that is the most widely used diabetes treatment of two drugs that are cheap and generic."
Our findings, he concluded, "clearly demonstrate that further studies are needed not only to assess the association of combination therapy of metformin and sulfonylurea with all-cause and/or cardiovascular mortality, but also to understand the potential underlying mechanism of its
effects."
FDA seeks stronger warnings for Amylin's Byetta
U.S. health regulators are seeking stronger warnings about the risk of pancreatitis after the deaths of two patients taking Amylin Pharmaceuticals Inc's injectable diabetes drug Byetta, sending the company's shares down as much 16 percent.
The U.S. Food and Drug Administration said it had received six reports of hemorrhagic or necrotizing pancreatitis requiring hospitalization. Two of the patients died and the four others were recovering at the time of the reports.
The FDA said it was working with Amylin "to add stronger, more prominent warnings in the product label." Amylin co-markets the drug, generically known as exenatide, with Eli Lilly and Co.
Pancreatitis is an inflammation of the pancreas, which helps aid in digestion by releasing vital hormones. The condition usually subsides quickly, according to the Merck Manual of Medical Information.
Complications or death are rare, Amylin and Lilly said in a statement. Rates of such problems are about as common in patients taking the drug as in others who have pancreatitis.
In October, the FDA said it had reviewed 30 reports of pancreatitis in patients being treated with Byetta. At the time, Amylin agreed to add information about the risk on its drug label and to alert doctors about the problem.
It was not immediately clear if the FDA would order new so-called "black box" warnings, the strongest type available, and representatives for the agency could not immediately be reached.
The companies said they would work with the agency to update the drug's label.(November
2008)
