[A comparison of the efficacy and safety of domestic orlistat and imported orlistat in Chinese overweight and obese patients].
OBJECTIVE
To compare the clinical efficacy and safety of domestic orlistat and imported orlistat in Chinese overweight and obese patients.


METHODS
In a randomized, double-blinded and positive-controlled study, 228 adults (BMI 24- < 40 kg/m(2)) evaluated at seven research centers were randomized to receive domestic orlistat or imported orlistat 120 mg 3 times a day with an energy-controlled diet for 24 weeks.


RESULTS
After 24 weeks, domestic orlistat treated patients got significant weight-loss (5.0 +/- 3.7) kg, which was comparable with that of imported orlistat treated patients (4.5 +/- 3.5) kg (P = 0.3922). Compared with the findings before treatment, there was significant decrease of systolic blood pressure (4.4 +/- 11.5) mm Hg (1 mm Hg = 0.133 kPa) and serum levels of TC (0.54 +/- 0.79) mmol/L and LDL-C (0.32 +/- 0.64) mmol/L in the domestic orlistat treated group (compared with levels of baseline, P < 0.0001). There was no significant difference between the two groups in the changes of blood pressure and lipid levels. Both groups had similar adverse event profiles, most of which were mild and transient gastrointestinal events. There were no serious adverse events in both groups.


CONCLUSIONS
Domestic orlistat combined with a light low-energy diet promoted significant weight loss, which was comparable with that of imported orlistat after 24 weeks of treatment. There was also improvement in blood pressure and serum levels of TC and LDL-C. Domestic orlistat was as effective and safe as imported orlistat in the treatment of obesity.
Zhu
Hui-juan
HJ
Department of Endocrinology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing 100730, China.
Pan
Hui
H
Gong
Feng-ying
FY
Lü
Xiao-feng
XF
Peng
Yong-de
YD
Liu
Zhi-min
ZM
Li
Cheng-jiang
CJ
Yu
Ye-rong
YR
Ji
Qiu-he
QH
Xing
Xiao-ping
XP
D000293:Adolescent; D000328:Adult; D000368:Aged; D019440:Anti-Obesity Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D044466:Asian People; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007783:Lactones / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000188:drug therapy*; D000077403:Orlistat; D050177:Overweight / Q000188:drug therapy*; D016896:Treatment Outcome; D055815:Young Adult
D019440:Anti-Obesity Agents; D007783:Lactones; D000077403:Orlistat