by Medindia Content Team on  September 29, 2007 at 12:04 PM Drug News
Drug Trials for Diabetes a Mirage or a Reality?
The suggestion was made by Mayo Clinic researchers who said that diabetes medications have been approved without requiring proof that they reduce the risk of complications associated with diabetes. Therefore it is important to understand the outcomes that are important to patients.

The authors pointed out that the majority of clinical trials focus on the effect of a particular medication on blood sugar levels. The result is that smaller, shorter and cheaper trials lead to more drug choices more quickly, but are not necessarily better or safer for patients.

"The apparent benefits of these trials are a mirage and the apparent savings represent false economy," The Lancet quoted Victor Montori, M.D., an endocrinologist at Mayo Clinic, along with Gunjan Gandhi, M.D., of Mayo Clinic, and Gordon Guyatt, M.D., of McMaster University in Canada, as writing in their commentary.

"Any savings are quickly overwhelmed by expenses associated with potentially ineffective, or even harmful, expensive therapies and the incremental costs of treating the harms these interventions might cause. Patients and society may end up paying dearly for medications that cause more harm than good," the authors added.

The authors have said that the medical community is increasingly aware of the need to engage patients with chronic conditions in decisions about their care. For example, clinicians and patients need to know the extent to which diabetes medications can help patients feel better and live longer.

Despite this need, only one in five randomised trials in diabetes published in top medical journals measured the effect of drugs on quality of life and on the risk of complications associated with diabetes.

Therefore, Dr. Montori and colleagues call for clinical trials that measure the impact of diabetes medications on outcomes that are important to patients.

"The medical community should insist that we invest the resources needed to do trials that ascertain the effect of interventions on patient-important outcomes. This policy will prevent the premature dissemination of therapies that ultimately prove harmful, facilitate patients' participation in decision making, and speed the day when we can confidently offer safe treatments that can provide important benefit to patients with diabetes," the authors said.

The authors have concluded that the focus should shift from getting new drugs to market to testing the effect of diabetes medications against outcomes important to patients

Source: Eurekalert

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