1.
Multicentre, placebo-controlled trial of lorcaserin for weight management in Chinese population.
Lu, CW, Chang, CJ, Yang, YC, Lin, WY, Huang, KC
Obesity research & clinical practice. 2018;(5):465-471
Abstract
OBJECTIVE This study aimed to evaluate the effects of lorcaserin on body weight, cardiovascular risk factors, and safety in obese patients in Taiwan. METHODS In this double-blind, randomised controlled trial, 171 obese adults were assigned to receive lorcaserin at a dose of 10mg, or placebo, twice a day for 24weeks. Diet and exercise counselling were given to all patients through the treatment period. Primary outcomes were proportion of patients achieving at least 5% and 10% reduction in body weight and mean change in body weight. Safety and tolerability endpoints such as Beck Depression Inventory-II, blood biochemistry, vital signs, and electrocardiogram were monitored. RESULTS More patients receiving lorcaserin lost at least 5% body weight than receiving placebo (52.4% and 28.1%, P=0.001) with an average weight reduction of 5.8kg (95% CI: -6.91, -4.70) in lorcaserin group and those of 3.6kg (95% CI: -4.95, -2.33) in placebo group (P<0.05). The most common adverse effect with greater incidence in the lorcaserin group was self-limited dizziness. Serious adverse effect were rare and was reported by slightly more patients taking placebo than lorcaserin. CONCLUSIONS In this multicentre, double-blinded placebo-controlled trial, lorcaserin was effective and well-tolerable in Asia group.
2.
Efficacy and safety of very-low-calorie diet in Taiwanese: a multicenter randomized, controlled trial.
Lin, WY, Wu, CH, Chu, NF, Chang, CJ
Nutrition (Burbank, Los Angeles County, Calif.). 2009;(11-12):1129-36
Abstract
OBJECTIVE Very-low-calorie diets (VLCDs) are an effective method for weight reduction in Caucasians. This study investigated the efficacy and safety of two different VLCDs (450 or 800kcal/d) in obese Taiwanese. METHODS 132 participants with BMI > or =30kg/m(2) were randomized to two VLCD groups for body weight reduction for 12 weeks. Each group had 66 participants. Anthropometric and metabolic parameters were measured. RESULTS The intention-to-treat analysis revealed that the percentage change in body weight over the 12-week treatment period was -9.14% in the VLCD-450 group and -8.98% in the VLCD-800 group. A total of 27 (40.9%) participants in the VLCD-450 group and 29 (43.9%) participants in the VLCD-800 group achieved 10% or more weight loss at the end of treatment. The body weight, waist circumference, hip circumference, fat mass, blood pressure, triglycerides, and blood glucose were statistically improved from baseline but not between the two groups. The improvement rate of nonalcoholic fatty liver disease (NAFLD) was 41.5% in the VLCD-450 group and 50.0% in the VLCD-800 group. The incidence of adverse events did not differ significantly between the groups and no serious adverse events were reported in either group. CONCLUSION Both the VLCD-450 and 800kcal/d can effectively and safely reduce body weight and improve NAFLD in 12 weeks in obese Taiwanese participants. However, there is no additional benefit in prescribing the more restrictive diet intervention in Taiwanese.
3.
Phase II study of weekly oxaliplatin and 24-h infusion of high-dose 5-fluorouracil and folinic acid in the treatment of advanced gastric cancer.
Chao, Y, Yeh, KH, Chang, CJ, Chen, LT, Chao, TY, Wu, MF, Chang, CS, Chang, JY, Chung, CY, Kao, WY, et al
British journal of cancer. 2004;(3):453-8
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Abstract
To investigate the efficacy and safety of combining weekly oxaliplatin with weekly 24-h infusion of high-dose 5-fluorouracil (5-FU) and folinic acid (FA) in treatment of patients with advanced gastric cancer. Patients with histologically confirmed, locally advanced or recurrent/metastatic gastric cancer were studied. Oxaliplatin 65 mg m(-2) 2-h intravenous infusion, and 5-FU 2600 mg m(-2) plus FA 300 mg m(-2) 24-h intravenous infusion, were given on days 1 and 8, repeated every 3 weeks. Between January 2001 through January 2002, 55 patients were enrolled. The median age was 64 years (range: 22-75). In all, 52 patients (94.5%) had recurrent or metastatic disease and three patients had locally advanced disease. Among 50 patients evaluable for tumour response, 28 patients achieved partial response, with an overall response rate of 56% (95% confidence interval (CI): 41.8-70.3%). All 55 patients were evaluated for survival and toxicities. Median time to progression and overall survival were 5.2 and 10.0 months, respectively, during median follow-up time of 24.0 months. Major grades 3-4 toxicities were neutropenia in 23 cycles (7.1%) and thrombocytopenia in 16 cycles (5.0%). Treatment was discontinued for treatment-related toxicities in nine patients (16.4%), of whom eight were due to oxaliplatin-related neurotoxicity. One patient (1.8%) died of neutropenic sepsis. This oxaliplatin-containing regimen is effective in the treatment of advanced gastric cancer. Except for neurotoxicity that often develops after prolonged use of oxaliplatin, the regimen is well tolerated.