July 2007 - New studies are needed to assess the trade-offs between potential benefits and potential harms when rosiglitazone is used by people with type 2 diabetes.
This Cochrane Systematic Review analysed data from 18 trials that involved a total of 8432 people and found no evidence that rosiglitazone led to better patient outcomes when compared with other therapies. Diabetic control (as measured by levels of HbA1c) was no better in patients given rosiglitazone when compared to other antidiabetic drugs. Patient oriented outcomes such as mortality, diabetes related morbidity, or quality of life were not addressed in most studies.
In addition to confirming the known risk of edema (people taking the treatment are at twice the risk of developing this condition) and an increase in body weight up to 5.0 kg, the authors found evidence from one large study indicating increased cardiovascular risk and an enhanced risk in women of having broken bones.
In people with type 2 diabetes, their body has a reduced ability to cause cells to remove glucose from the blood. The resulting high levels of blood-glucose can cause considerable damage especially to the eyes, nerves and kidneys. Rosiglitazone is one of a range of drugs that increase cell's sensitivity to insulin and therefore may restore some of the normal function.
"Unfortunately, the published studies where people have taken rosiglitazone for at least 24 weeks do not give relevant data about issues like mortality, morbidity, and changes in health-related quality of life," says lead author Associate Professor Bernd Richter, who works at the Department of General Practice, in Duesseldorf.
"Studies on patient-oriented outcomes are urgently needed, although it is questionable whether new studies with rosiglitazone will be ethical given the fact that less dangerous therapeutic alternatives exist," says Richter.
Source: John Wiley & Sons