Janssen Scientific Affairs, LLC, 1125 Trenton-Harbourton Rd, Titusville, NJ, 08560, USA.
Massachusetts General Hospital Diabetes Center and Harvard Medical School, Boston, MA, USA.
Patient. 2018 Jun;11(3):341-352. doi: 10.1007/s40271-017-0290-4.
Evidence from patient-reported outcomes in clinical trials may explain health-related behaviors observed in the real world.
The purpose of this analysis was to evaluate the effect of treatment with canagliflozin, a sodium glucose co-transporter 2 inhibitor, compared with placebo or sitagliptin on health-related quality-of-life outcomes in participants with type 2 diabetes mellitus from the clinical development program.
Patient-reported outcomes data from four randomized controlled trials of canagliflozin (n = 2536) were pooled and analyzed to evaluate participants' interest in continuing study medication; satisfaction with weight; and physical, mental, and emotional health after 26-52 weeks of treatment with canagliflozin vs. placebo or sitagliptin.
Upon trial completion, participants treated with canagliflozin were more likely to express interest in continuing study medication than participants treated with placebo or sitagliptin [odds ratio (95% confidence interval) of 1.54 (1.19-1.99); p = 0.001]. Those treated with canagliflozin were also more likely to be satisfied with their weight and report favorable outcomes (score improvement or maintenance of good scores) related to physical and emotional health.
The results of this pooled analysis suggest that people with type 2 diabetes mellitus treated with canagliflozin generally had positive experiences with treatment and improvements in health-related quality of life. Future research is needed to determine if these improvements result in improved type 2 diabetes mellitus management and treatment adherence. CLINICALTRIALS.
NCT01106625, NCT01106677, NCT01137812, NCT02025907.
临床试验中的患者报告结局证据可以解释在现实世界中观察到的与健康相关的行为。
本分析的目的是评估钠-葡萄糖共转运蛋白 2 抑制剂坎格列净与安慰剂或西他列汀相比，对来自临床试验开发项目的 2 型糖尿病患者的健康相关生活质量结局的治疗效果。
对坎格列净四项随机对照试验（n=2536）的患者报告结局数据进行汇总和分析，以评估参与者在 26-52 周治疗后继续使用研究药物的意愿；对体重的满意度；以及坎格列净与安慰剂或西他列汀相比治疗后身体、精神和情绪健康。
在试验完成时，与安慰剂或西他列汀相比，接受坎格列净治疗的参与者更有可能表示有兴趣继续使用研究药物[比值比（95%置信区间）为 1.54（1.19-1.99）；p=0.001]。接受坎格列净治疗的患者也更有可能对体重感到满意，并报告与身体和情绪健康相关的有利结局（评分改善或保持良好评分）。
这项汇总分析的结果表明，接受坎格列净治疗的 2 型糖尿病患者通常对治疗有积极的体验，并改善了健康相关的生活质量。需要进一步的研究来确定这些改善是否会导致 2 型糖尿病管理和治疗依从性的改善。临床试验。
NCT01106625、NCT01106677、NCT01137812、NCT02025907。
