Weight Loss Drug Trial Conclusion
Specialized Obesity Clinics
Though the results of the STORM (sibutramine trial of obesity reduction
and maintenance) weight loss drug
study are important, they also raise several questions to address
in future studies. Firstly, the study used specialized obesity clinics,
often in academic settings, and a fairly sophisticated approach: assessment
of resting metabolic rate for estimating daily energy needs; adjustment
of the recommended energy intake over time to compensate for the body
weight loss; dietary supervision every two weeks; and a visit to the treating
physician every month. Thus, the results probably do not reflect what
could be achieved by most family physicians in routine practice.
Secondly, only the successful weight losers
(467/605) took part in the second part of the study. Thus, sibutramine
was effective in maintaining reduced body weight so long as the patient
had already "responded" to the drug. This result should again
be interpreted in the context of routine practice. It may be argued that
if a patient does not respond to a weight loss drug after a few months
there is little chance that its continued use would be beneficial. Studies
that have examined this issue suggest that a period of about three months
may be sufficient to identify responders.6-8
Finally, as in most weight loss trials,
the vast majority of patients enrolled (over 80%) were women. Though this
reflects the population of patients treated in most obesity clinics around
the world, men are generally characterised by a more dangerous form of
obesity - visceral, or abdominal, obesity. The current tragedy in medical
practice is that neither obese men nor their doctors recognise the tremendous
hazards of abdominal obesity. In the STORM study sibutramine therapy for
two years reduced the waist circumference (the best crude index of abdominal
fat accumulation) by more than 9 cm while also improving the cardiovascular
risk profile. However, as the sample consisted largely of women with only
moderate deterioration in their cardiovascular risk profile, even greater
improvement in cardiovascular risk might have been observed in abdominally
obese men.
Weight Loss Drug Trial Summary
In summary, the successful findings of the STORM study should pave the
way to the design of long term randomised trials in high risk abdominally
obese patients. Future trials should include proper evaluation of the
impact of such weight loss drug treatment on the risk of developing prevalent
chronic metabolic diseases such as type 2 diabetes and cardiovascular
diseases.
Source: bmj journals. 2001
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