Short-term therapy with combination dipeptidyl peptidase-4 inhibitor saxagliptin/metformin extended release (XR) is superior to saxagliptin or metformin XR monotherapy in prediabetic women with polycystic ovary syndrome: a single-blind, randomized, pilot study

详细信息    查看全文

• 作者：Karen E. Elkind-Hirsch ; Ph.D. ; ^{karen.elkind-hirsch@womans.org} ; Martha S. Paterson ; M.D. ; Ericka L. Seidemann ; M.S. ; Hanh C. Gutowski ; R.N.
• 关键词：Dipeptidyl peptidase-4 inhibitor ; polycystic ovary syndrome ; prediabetic hyperglycemia ; saxagliptin
• 刊名：Fertility and Sterility
• 出版年：2017
• 出版时间：January 2017
• 年：2017
• 卷：107
• 期：1
• 页码：253-260.e1
• 全文大小：996 K
• 卷排序：107

文摘

To evaluate efficacy with the dipeptidyl peptidase-4 inhibitor saxagliptin (SAXA), metformin extended release (MET), and combination (SAXA-MET) in patients with polycystic ovary syndrome (PCOS) and impaired glucose regulation.DesignProspective, randomized, single-blind drug study.SettingOutpatient clinic.Patient(s)Patients (n = 38) with PCOS (aged 18–42 years) and prediabetic hyperglycemia determined by a 75-gram oral glucose tolerance test.Intervention(s)Patients were randomized to SAXA-MET (5 mg/2,000 mg), SAXA (5 mg), or MET (2,000 mg) for 16 weeks.Main Outcome Measure(s)Fasting and mean blood glucose, insulin sensitivity, insulin secretion, and insulin secretion-sensitivity index (IS-SI) by oral glucose tolerance tests. Free androgen index and lipid levels, average menstrual interval, and anthropometric measurements (body mass index, waist circumference, and waist/height ratio).Result(s)The study was completed by 34 patients. Nineteen patients had normal glucose tolerance: 3 of 12 (25%) on MET; 6 of 11 (55%) on SAXA; and 10 of 11 (91%) on SAXA-MET (SAXA-MET statistically superior to MET) at study completion. Body mass index, waist circumference, waist/height ratio, free androgen index, insulin sensitivity, IS-SI, and menses improved in all groups; however, IS-SI and menstrual regularity were significantly better with SAXA-MET vs. MET treatment. Triglyceride, triglyceride/high-density lipoprotein cholesterol ratio and mean blood glucose significantly declined in the SAXA-MET and SAXA groups only.Conclusion(s)This pilot work provides the first evidence regarding the effects of a dipeptidyl peptidase-4 inhibitor alone and in combination with MET in this patient population. Treatment with SAXA-MET was superior to either drug alone in terms of clinical and metabolic benefits in prediabetic patients with PCOS.Clinical Trial Registration NumberNCT02022007.