How
Safe Are Sibutramine, Orlistat and Metformin in the Treatment of
Obesity
Safe
medications that reduce cardiovascular risk and can decrease the
risk of type 2 diabetes mellitus in obese females
Some
of our obese patients who were receiving 10
mg/day
sibutramine reported feeling hunger at night. To address this, we
designed a randomized, prospective clinical trial to study the
efficacy and safety of 10
mg
sibutramine twice daily (bid), and compare this treatment with 120
mg
orlistat three times daily (tid) and 850
mg
metformin (bid).
A
total of 150 female patients with body mass index (b.m.i.)
>
30
kg/m2
were included. The subjects were all out
patients
at the Baskent University Endocrinology and Metabolism Clinic.
Each individual was assigned randomly to receive 10
mg
sibutramine bid (group 1; n
=
50;
mean age 42.27
±
1.40
years), 120
mg
orlistat tid (group 2; n
=
50;
mean age 42.13
±
1.32
years) or 850
mg
metformin bid (group 3; n
=
50;
mean age 43.58
±
1.40
years). All patients took the medications for 6 months. Two
patients from the sibutramine group and two from the orlistat
group were withdrawn from the study because of side
effects.
After
6 months of treatment, the sibutramine, orlistat, and metformin
groups all showed significantly reduced b.m.i. (13.57%, 9.06% and
9.90% respectively); waist circumference (10.43%, 6.64%, and 8.10%
respectively); fasting and postprandial blood glucose levels;
insulin resistance as assessed by the homeostasis model for
assessment of insulin resistance (HOMA) (38.63%, 32.73% and
39.28%, respectively); levels of total cholesterol, low
density
lipoprotein (LDLC) cholesterol, very low
density
lipoprotein (VLDLC) cholesterol, triglyceride, lipoprotein (a),
and apolipoprotein B; uric acid level; pulse rate; and systolic
and diastolic blood pressure. None of the groups showed any
significant changes in levels of high
density
lipoprotein (HDLC) cholesterol, or apolipoprotein A1. There was a
significantly greater fall in b.m.i. in the sibutramine group than
in either of the other groups (p
<
0.0001).
The
results of this study confirm that sibutramine, orlistat and
metformin are all effective and safe medications that reduce
cardiovascular risk and can decrease the risk of type 2 diabetes
mellitus in obese females. Overall, treatment with 10
mg
sibutramine bid is more effective than orlistat or metformin
therapy in terms of weight reduction.
Diabetes,
Obesity and Metabolism
Volume
4 Issue 1 Page 49 - January 2002
Did
You Know:
Data
from the third National Health and Nutrition Examination Survey of
1,507 adults with diabetes were used to estimate the blood
pressure level, awareness and control.
The
researchers found that 71% of adults with diabetes had high blood
pressure. The risk of high blood pressure increased with age. Of
those with high blood pressure, 29% were unaware that they had
high blood pressure, 57% were treated for the condition, but only
12% had reduced their high blood pressure to less than 130/85 mm
Hg.
Reference:
Am J Prev Med 2002; 22: 42-48.
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