Predictive value of early weight loss in obesity management with orlistat: an evidence-based assessment of prescribing guidelines.
OBJECTIVE
To assess the clinical usefulness of published guidelines for the use of orlistat, by studying whether weight loss >/=2.5 kg during a 4 week dietary lead-in period, and weight losses of >/=5% after 12 weeks and >/=10% after 6 months of drug therapy predict weight loss and risk factor changes after 2 years.


METHODS
A retrospective analysis of pooled data from 2 multicentre, randomised, placebo-controlled clinical trials with similar design.


METHODS
Twenty-nine centres throughout Europe.


METHODS
Two hundred and twenty men and women (BMI 28-43 kg/m(2)) who completed 2 years of treatment.


METHODS
After a 4 week hypocaloric diet plus placebo, 2 years of treatment with orlistat 120 mg tid, plus a hypocaloric diet for the first year and a weight maintenance diet in year two.


METHODS
Weight loss and obesity-related risk factor changes.


RESULTS
Weight loss >/=5% body weight after 12 weeks of diet plus orlistat therapy was a good indicator of 2 year weight loss, whereas weight loss of >/=2.5 kg during the 4 week lead-in and >/=10% after 6 months did not add significantly to the prediction of 2 year outcomes. Patients who lost >/=5% of their weight at 12 weeks (n=104, 47.3%) lost significantly more weight after 2 years than others: -11.9% (95% confidence interval (CI) -13.4% to -10.3%) vs -4.7% (-5.7% to -3.7%) (P=0.0001), and had significantly greater reductions in total cholesterol, LDL-cholesterol, triglycerides, glucose, insulin, and blood pressure. Among those who achieved >/=5% weight loss at 12 weeks, the overall health benefits were not significantly greater in patients who went on to lose >/=10% body weight at 6 months compared with those who did not achieve >/=10% weight loss by month 6.


CONCLUSIONS
Of the criteria currently suggested for assessing response to orlistat treatment, weight loss of >/=5% at 12 weeks accurately predicts sustained improvements in weight and major risk factors at 2 years, while other suggested criteria are less useful.
Rissanen
A
A
Obesity Research Unit, Helsinki University Central Hospital, Helsinki, Finland. aila.rissanen@hus.fi
Lean
M
M
Rössner
S
S
Segal
K R
KR
Sjöström
L
L
D000328:Adult; D000368:Aged; D019440:Anti-Obesity Agents / Q000627:therapeutic use*; D015992:Body Mass Index; D019317:Evidence-Based Medicine; D005260:Female; D006801:Humans; D007783:Lactones / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000188:drug therapy*; D000077403:Orlistat; D017410:Practice Guidelines as Topic; D012189:Retrospective Studies; D012307:Risk Factors; D015431:Weight Loss / Q000187:drug effects
D019440:Anti-Obesity Agents; D007783:Lactones; D000077403:Orlistat