Orlistat
Helpful for Obese Type 2 Diabetics
But
lifestyle modification still needs to be the cornerstone of therapy.
Orlistat
(Xenical) is beneficial for obese type 2 diabetic patients, according
to results of a randomized, placebo-controlled trial reported in the
July issue of Diabetes Care. However, the reduction in
HbA1c was less than 0.5%, and lifestyle modification, diet,
and exercise still need to be the cornerstone of therapy. Despite
significantly more adverse effects in the orlistat group, the
withdrawal rate was higher in the placebo group, suggesting a
perceived benefit from being on the medication.
"The
results of this study show that the addition of orlistat plus a
reduced calorie diet to existing metformin therapy can benefit
patients by helping lower body weight and serum glucose levels,"
lead author John M. Miles, MD, from the Mayo Clinic in Rochester,
Minnesota, says in a news release. "The combination of Xenical
and metformin had a positive impact on many cardiovascular risk
factors, which are among the most common and potentially serious risks
associated with type 2 diabetes."
This
study enrolled 516 patients at 34 centers in the U.S. and six centers
in Canada who were receiving metformin, 1,000 to 2,550 mg/day for at
least six weeks, or a stable dose of sulfonylureas for 12 weeks before
study entry in addition to metformin. Subjects were randomized to
receive either orlistat, 120 mg three times daily, or placebo in
addition to a reduced-calorie diet. Of the original study group, 311
patients completed one year of treatment.
After
one year of treatment, twice as many patients in the orlistat-treated
group (39.0%) as in the control group (15.7%) lost 5% of baseline body
weight, and significantly more patients in the orlistat -treated group
(14.1%) than controls (3.9%) lost 10% of baseline body weight.
"Patients
in this study treated with orlistat plus diet also had a reduced need
for one or more diabetes medications," Miles says.
Twice
as many patients in the orlistat-treated group (17.1%) as in the
control group (8.2%) either reduced or discontinued one or more
diabetes medications, and 21.7% of patients in the control group but
only 12.2% of orlistat-treated patients required either additional or
increased dosages of diabetes medications.
HbA1c
decreased by 0.5% or 1.0% in significantly more patients treated with
orlistat than in control patients, and mean decrease in systolic blood
pressure was also greater in the orlistat-treated group (P<.05).
Beneficial effects on lipids in orlistat-treated patients compared
with control patients included improvements in total cholesterol
(-4.1% vs. +2.6%), low-density lipoprotein (LDL) cholesterol (-2.8%
vs. +3.9%) and LDL/high-density lipoprotein (HDL) cholesterol (-0.60
vs. -0.46); P<.05 for all.
Adverse
event profiles were similar in the two groups, except for
gastrointestinal symptoms, which were more common with orlistat (83%
vs. 62%; P<.05). Because the overall rate of study
withdrawal was higher in the control group than in the orlistat-treated
group (44% vs. 35%; P<.05), gastrointestinal events do not
generally seem to cause discontinuation of orlistat therapy.
"The
weight loss achieved in the current study was associated with
significant improvements in glycemic control and other cardiovascular
risk factors," the authors write. "Although lifestyle
changes to decrease energy intake and increase physical activity
should remain the cornerstone of weight loss therapy, data from the
present study suggest that anti-obesity medications can enhance weight
loss and provide benefits in the management of patients with type 2
diabetes." Hoffmann-La Roche Inc. supported this study.
Diabetes Care. 2002;25(7):000-000
Kristina
Sandstedt,
MS,
Clinical
Exercise
Physiologist,
Diabetes
Educator
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