Adjunctive telmisartan treatment on body metabolism in clozapine or olanzapine treated patients with schizophrenia: a randomized, double blind, placebo controlled trial.
OBJECTIVE
This study examined the effect of adjunctive telmisartan on body metabolism in clozapine- or olanzapine-treated patients with schizophrenia.


METHOD
Each subject had been on stable dose of olanzapine or clozapine for at least 1 month. In a 12-week randomized, double-blind, placebo-controlled study, subjects received either telmisartan (80 mg once per day) or placebo. The homeostasis model of assessment of insulin resistance (HOMA-IR) was calculated based on fasting blood levels of insulin and glucose. Fasting blood levels of triglycerides and cholesterols, as well as serum levels of high-sensitivity C-reactive protein (hsCRP) and interleukin-6 (IL-6) were measured. The whole-body dual-energy X-ray absorptiometry (DXA) was used to assess body composition. Lipid particles were assessed using nuclear magnetic resonance (NMR) spectroscopy. All assessments were conducted at baseline and repeated at week 12.


RESULTS
Fifty-four subjects were randomized and 43 completed the study (22 in the telmisartan group, 21 in the placebo group). There were no significant differences between the two groups in week 12 changes for HOMA-IR or fasting triglycerides (- 0.18 ± 1.24 vs 0.39 ± 1.39, p = 0.181; - 26 ± 76 vs - 10 ± 81 mg/dL, p = 0.679, respectively) (telmisartan vs placebo). Further, there were no significant between group differences in week 12 changes for other fasting lipids, body weight, body mass index, waist circumference, as well as various measures of lipid particles (p's > 0.100). The DXA assessment showed no significant differences between the two groups in week 12 changes for fat mass, lean mass, or total mass (p's > 0.100).


CONCLUSION
In the present study, adjunctive treatment of telmisartan did not seem to improve body metabolism in schizophrenia patients receiving olanzapine or clozapine. The implications for future studies were discussed. CLINICALTRIALS.


GOV IDENTIFIER
NCT00981526.
['Fan|Xiaoduo|X|', 'Copeland|Paul|P|', 'Nawras|Shukair|S|', 'Harrington|Amy|A|', 'Freudenreich|Oliver|O|', 'Goff|Donald C|DC|', 'Henderson|David C|DC|']
D000328:Adult D014150:Antipsychotic Agents D001823:Body Composition D015992:Body Mass Index D001835:Body Weight D003024:Clozapine D004311:Double-Blind Method D004359:Drug Therapy, Combination D005260:Female D005947:Glucose D006801:Humans D007328:Insulin D008297:Male D008875:Middle Aged D000077152:Olanzapine D012559:Schizophrenia D000077333:Telmisartan D016896:Treatment Outcome D014280:Triglycerides
Telmisartan Schizophrenia Body composition Lipids Inflammation