Reproductive System & Sexual Disorders: Current Research
Open Access
ISSN: 2161-038X
+44 1300 500008
ISSN: 2161-038X
+44 1300 500008
Haidy M. Sami, Noha Alaa Hamdy, Hanan Nabil, Ahmed I. ElMallah
Delta University Drug Information Center, Egypt Alexandria University, Egypt
Scientific Tracks Abstracts: Reprod Syst Sex Disord
Problem/Background: Polycystic ovarian syndrome (PCOS) is a widespread female endocrine condition that affects between 8 and 18% of female population. The major factors of PCOS, hyperandrogenism, ovarian dysfunction, and metabolic abnormalities, all appear to have a synergistic role in pathogenesis of PCOS. Women with PCOS were only treated with estrogen, progestin until a few years ago. In recent years, clinical research has concentrated on insulin sensitizing medications for treatment of PCOS. The purpose of this study is to investigate the safety, efficacy of Linagliptin and Empagliflozin versus Metformin therapy in PCOS patients to regulate menses cycles, ovulation through the assessment of these therapies impact on fertility, metabolic parameters. Methodology: In this prospective randomized controlled trial, 135 PCOS women in reproductive age were classified into three-groups: group-1, 45 PCOS patients received Metformin (1500 mg orally/day); group-2, 45 PCOS patients received Empagliflozin (25 mg orally/day); and group-3, 45 PCOS patients received Linagliptin (10 mg orally/ day). Patients were recruited from the Gynecologic and Obstetric outpatient’s clinics, Mansoura-University-Hospitals, Egypt and assessed before, 3-months after intervention for determination of menstrual-cycle, FSH, LH, AMH, progesterone, totaltestosterone, SHBG, FAI, DHEAS, HbA1C% and HOMA-IR. Data were statistically analyzed by (ANOVA) test, (p < 0.05). Findings: The present study revealed that after 3-months of drug administration, androgens significantly reduced among all groups (p=0.0001), highly decreased among group 3 compared with its baseline values from 7.25±1.14 to 1.81±0.53 (p=0.0001), and also when compared with group 1, 2 after 3-months of therapy (6.82±2.40, 8.79±2.47), respectively (p=0.0001). Conclusion: The present work represents the first remarkable clinical study evaluating the effectiveness of Linagliptin and Empagliflozin as alternative to Metformin in treatment of PCOS patients. This research came to clarify the potential roles of these drugs on fertility parameters and metabolic parameters in PCOS patients, also other SGLT-2 and DPP-4 inhibitors could be examined.
Haidy M. Sami, Clinical pharmacy instructor and Director of DIC at Delta University. I have expertise in clinical practice in different facilities, specialties and a passion for improving the clinical application of medications. I have built this model after years of experience in research, teaching, and residence in hospitals and educational institutions. This approach includes reviewing the research idea in terms of how to apply it and benefit patients from it. In this work, I participated in determining the criteria for inclusion, exclusion of patients and reviewing the methods of randomization of patients into groups and the drugs used. I participated in determining the required laboratory analysis. Finally, I calculated and personalized the dosage regimen of these pharmacotherapies based on patient preferences, the risk of adverse effects of therapy, and patient comorbid conditions in relation to the cost-effectiveness analysis.