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This Week’s Question:
An obese 20-year-old male patient with Pre-diabetes who you have counseled
on life style changes to no avail and despite your strong advice and
attempts to enlist his family for support, he is still gaining weight.
He now has a fasting plasma glucose of 122 mg/dL, dangerously close
to meeting the definition for diabetes.
According to the available information what medication might you recommend?
1. Orlistat
2. Acarbose
3. Metformin
4. A Glitazone
5. None of the above, continue with lifestyle counseling.
In summary, there are now 3 published randomized trials that have examined
the use of medications in the prevention of diabetes. It is difficult
to compare and extrapolate the results because the trials were significantly
dissimilar and involved different populations. Some observations about
the profile of the patients can be made, however. In the DPP, significant
efficacy from metformin in preventing diabetes was seen in subjects
who were younger, heavier men with a higher baseline fasting glucose.
In the STOP-NIDDM, significant efficacy from acarbose in preventing
diabetes was seen in older, leaner, normotensive women with a lower
baseline fasting insulin level. In the TRIPOD study, significant efficacy
from troglitazone in preventing diabetes was seen in women who had significant
insulin resistance and hyperinsulinemia at baseline.
To return to the question, the best choice of action for this patient
remains the same. Intensive lifestyle efforts including diet, exercise,
behavior modification, weight loss, and cardiac risk reduction are still
the recommended methods for preventing diabetes. A referral to a comprehensive,
multidisciplinary weight management center may provide assistance beyond
what can be offered in a private practice setting. From the studies
described above, however, a clinician may wish to consider including
a medication for selected patients who seem to be losing the battle.
In this case, the patient may already have converted to type 2 diabetes,
and a medication in addition to lifestyle changes would then be considered.
From the patient profiles noted, a medication such as metformin would
seem to be a reasonable choice.
More Data:
There have been several additional articles published over the last
year. The Diabetes Prevention Program (DPP) was a landmark study involving
3234 patients with IGT followed for an average of 2.8 years.[1] Some
patients in the DPP were randomized to lifestyle interventions. The
lifestyle intervention consisted of a minimum of 150 minutes of physical
activity per week, and resulted in a 7% reduction in weight. The risk
reduction in conversion of IGT to diabetes from lifestyle was 58%. The
DPP also included a group that was assigned to metformin 850 mg twice
daily. The risk reduction in progression to diabetes was significant
-- 31% -- but not as dramatic as the lifestyle-intervention group. This
led the ADA to issue a Position Statement, stating that lifestyle intervention
is both significantly more effective and better studied than are medications.
With the lack of available data to support using drugs, the ADA has
concluded that "there is insufficient evidence to support the use
of drug therapy as a substitute for, or in addition to, lifestyle modification
to prevent diabetes."[2]
Two additional studies have looked at diabetes prevention using medication.
The Study to Prevent Noninsulin-Dependent Diabetes Mellitus, or STOP-NIDDM,
was a multinational, randomized, controlled trial. A total of 1429 patients
with IGT were randomized to either 100 mg of acarbose thrice daily or
to placebo, and were followed for a mean of 3.3 years. Forty-two percent
of placebo-treated patients developed diabetes, compared with 32% of
patients treated with acarbose, representing a 25% reduction. When patients
who discontinued treatment early were dropped from the analysis, acarbose-treated
patients experienced a 91% reduction in acute myocardial infarction,
and were 49% less likely to develop any cardiovascular event. [3]
References
1. Diabetes Prevention Program Research Group. Reduction in the incidence
of type 2 diabetes with lifestyle intervention or metformin. N Engl
J Med. 2002;346:393-403.
2. American Diabetes Association and National Institute of Diabetes,
Digestive and Kidney Diseases. Position Statement. The prevention or
delay of type 2 diabetes. Diabetes Care. 2002;25:742-749.
3. Chiasson JL, Josse RG, Gomis R, et al. STOP-NIDDM Trail Research
Group. Acarbose for prevention of type 2 diabetes mellitus: the STOP-NIDDM
randomised trial. Lancet. 2002;359:2072-2077.
4. Buchanan TA, Xiang AH, Peters RK et al. Preservation of pancreatic
beta-cell function and prevention of type 2 diabetes by pharmacological
treatment of insulin resistance in high-risk Hispanic women. Diabetes.
2002;51:2796-2803.
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