Clinical Trials For Diabetes Drugs Should Measure Outcomes Important
To Patients, Doctors Urge

Science Daily - Most clinical trials for new diabetes drugs do not
consider the impact medication will have on a patient's quality of
life or other outcomes that are important to patients, such as the
risk of developing complications associated with diabetes, according
to a Mayo Clinic commentary in The Lancet.

Rather, drug trials focus on the effect of a particular medication on
blood sugar levels. The result is smaller, shorter and cheaper trials
that 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," writes 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. "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 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 randomized 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, such as death, heart attack, stroke, amputation, blindness
and dialysis. Ongoing trials do not promise much more, the author
states.

Dr. Montori and colleagues call for clinical trials that consider and
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," the authors state. "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."

In summary, the authors say:

Diabetes medications have been approved without requiring proof of
reducing the risk of complications associated with diabetes, such as
heart attack, stroke, amputation, blindness and kidney dialysis.
The majority of diabetes trials focus on the ability of medications to
reduce blood sugar, not on outcomes that matter to patients.
Diabetes medications may reduce the risk of complications, but we do
not know this with confidence.
The focus should shift from getting new drugs to market to testing the
effect of diabetes medications against outcomes important to patients.