Grube Barbara, Chong Pee-Win, Alt Felix, Uebelhack Ralf
Practice for General Medicine, Kurfürstendamm 157/158, 10709 Berlin, Germany.
Zaluvida Corporate Sdn Bhd, E-16 Plaza Mont Kiara, 2 Jalan Kiara, 50480 Kuala Lumpur, Malaysia.
J Obes. 2015;2015:953138. doi: 10.1155/2015/953138. Epub 2015 Sep 7.
Litramine (IQP-G-002AS) was shown to be effective and safe for weight loss in overweight and obese subjects. However, long-term effectiveness on maintenance of body weight loss has yet to be ascertained.
To assess effect of Litramine on maintenance of body weight loss.
A double-blind, randomised, placebo-controlled trial on overweight and obese patients was conducted over two sites in Germany for 24 weeks. Subjects with documented previous weight loss of 3% over the last 3-6 months were randomised to groups given either Litramine (3 g/day) or a matching placebo. Primary endpoints were difference of mean body weight (kg) between baseline and end of study and maintenance of initially lost body weight in verum group, where maintenance is defined as ≤1% weight gain.
Subjects who were taking Litramine lost significantly more body weight compared to the subjects taking placebo who gained weight instead (-0.62 ± 1.55 kg versus 1.62 ± 1.48 kg, p < 0.001). More importantly, 92% of subjects in Litramine group were able to maintain their body weight after initial weight loss, versus 25% in placebo group. No serious adverse events were reported throughout.
Litramine is effective and safe for long-term body weight maintenance. Trial Registration. This trial is registered with Clinicaltrials.gov identifier: NCT01505387.
利曲明（IQP-G-002AS）已被证明对超重和肥胖受试者的体重减轻有效且安全。然而，其对维持体重减轻的长期有效性尚未确定。
评估利曲明对维持体重减轻的效果。
在德国的两个地点对超重和肥胖患者进行了一项为期24周的双盲、随机、安慰剂对照试验。在过去3至6个月内有记录显示体重减轻3%的受试者被随机分为接受利曲明（3克/天）或匹配安慰剂的组。主要终点是基线与研究结束时的平均体重（千克）差异，以及试验组中最初减轻的体重的维持情况，其中维持定义为体重增加≤1%。
服用利曲明的受试者体重减轻明显多于服用安慰剂反而体重增加的受试者（-0.62±1.55千克对1.62±1.48千克，p<0.001）。更重要的是，利曲明组92%的受试者在最初体重减轻后能够维持体重，而安慰剂组为25%。整个试验期间未报告严重不良事件。
利曲明对长期维持体重有效且安全。试验注册。本试验已在Clinicaltrials.gov注册，标识符为：NCT01505387。
