Orlistat in clozapine- or olanzapine-treated patients with overweight or obesity: a 16-week randomized, double-blind, placebo-controlled trial.
OBJECTIVE
Undesirable metabolic effects of modern antipsychotics, especially clozapine and olanzapine, merit development of new weight-control strategies, including pharmacologic ones. We investigated the feasibility of treatment with orlistat, a weight-control drug with no central effects, for overweight/obesity in clozapine- or olanzapine-treated male and female patients.


METHODS
Add-on orlistat was prescribed for 16 weeks in a randomized, double-blind, placebo-controlled clinical trial to patients who were receiving stable clozapine or olanzapine medication and were aged 18 to 65 years, with no compliance with nonpharmacologic programs or hypocaloric diet required. The primary efficacy variable was body weight change. The study was conducted from 2004 through 2005.


RESULTS
Of 71 randomly assigned subjects, 63 were eligible for modified intent-to-treat analysis. While no statistically significant effect was observed in the whole population, male (but not female) patients benefited from treatment with orlistat (-2.36 kg vs. 0.62 kg on placebo, p = .011). There were 5 responders (16.1%) (those with >or= 5% weight loss) that received orlistat versus 2 responders (6.3%) that received placebo (number needed to treat = 11), but the difference was not statistically significant.


CONCLUSIONS
Without a hypocaloric diet, the effect of orlistat in overweight/obese clozapine-or olanzapine-treated patients is modest and may only be seen in men. More studies should define the optimal length of treatment and feasibility of combination of orlistat with behavioral programs in this population.
Joffe
Grigori
G
Kellokoski Hospital, Kellokoski, Finland. grigori.joffe@hus.fi
Takala
Pirjo
P
Tchoukhine
Evgueni
E
Hakko
Helinä
H
Raidma
Mirjam
M
Putkonen
Hanna
H
Eronen
Markku
M
Räsänen
Pirkko
P
D000293:Adolescent; D000328:Adult; D000368:Aged; D019440:Anti-Obesity Agents / Q000627:therapeutic use*; D014150:Antipsychotic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D001569:Benzodiazepines / Q000009:adverse effects* / Q000627:therapeutic use; D015992:Body Mass Index; D003024:Clozapine / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007783:Lactones / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000139:chemically induced* / Q000188:drug therapy*; D000077152:Olanzapine; D000077403:Orlistat; D050177:Overweight; D011618:Psychotic Disorders / Q000188:drug therapy*
D019440:Anti-Obesity Agents; D014150:Antipsychotic Agents; D007783:Lactones; D001569:Benzodiazepines; D000077403:Orlistat; D003024:Clozapine; D000077152:Olanzapine