R-Vera, a promising new antidiabetic medication? Study sheds light
Taiwan: In type 2 diabetes patients, the twice-daily addition of R-Vera to ongoing metformin therapy notably improved blood sugar patients, researchers state in a recent study in the Journal of Clinical Endocrinology & Metabolism. This implies that the favorable safety and efficacy profile of R-Vera 300 mg/day can be considered as a suitable dose for clinical practice.
There is a medical requirement for effective insulin-independent antidiabetic drugs in type 2 diabetes (T2DM) patients that have a low risk of hypoglycemia and promote pancreatic β-cell function, the researchers note. R-form verapamil (R-Vera) was shown to have the ability to enhance the survival of β-cells and has a higher margin of cardiovascular safety than verapamil. R-Vera was developed as a novel approach for the treatment of T2DM.
Against the above background, Wayne Huey-Herng Sheu, National Yang-Ming Chiao Tung University, Taipei, Taiwan, and colleagues designed a randomized, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of 3 dosages of the addition of R-Vera in ongoing metformin therapy in T2DM patients having inadequate glycemic control on metformin alone.
For this purpose, the researchers randomly assigned the participants to receive an equal ratio of R-Vera 450, 300, or 150 mg per day, or a matching placebo, in combination with metformin. A change in hemoglobin A1c (HbA1c) after 12 weeks of treatment was the primary endpoint.
Based on the study, the researchers found the following:
- 184 eligible participants were randomized to receive either R-Vera or placebo plus metformin.
- At week 12, significant reductions in HbA1c were observed for R-Vera 300 mg/day and 450 mg/day compared with placebo.
- The reduction in HbA1c correlated with decreasing fasting plasma glucose levels and improved HOMA2-β score.
- Treatment with R-Vera was well tolerated with no hypoglycemic episodes occurring during the trial.
"Twice daily oral administration of R-Vera in addition to metformin significantly improved glycemic control in patients with type 2 diabetes by reducing FPG and HbA1c levels, and also helped in achieving the HbA1c goal of < 7.0% in a greater proportion of patients," the researchers wrote.
They further found the treatment with R-Vera to be well tolerated. They conclude that the favorable safety and efficacy profile of R-Vera 300 mg/day, combined with the potential for beta cell preservation and reduction in high blood pressure, make R-Vera a promising new antidiabetic medication.
Reference:
Chih-Yuan Wang, Kuo-Chin Huang, Chia-Wen Lu, Chih-Hsun Chu, Chien-Ning Huang, Harn-Shen Chen, I-Te Lee, Jung-Fu Chen, Ching-Chu Chen, Chung-Sen Chen, Chang-Hsun Hsieh, Kai-Jen Tien, Hung-Yu Chien, Yu-Yao Huang, Jui-Pao Hsu, Guang-Tzuu Shane, Ai-Ching Chang, Yen-Chieh Wu, Wayne Huey-Herng Sheu, A Randomized Controlled Trial of R-Form Verapamil Added to Ongoing Metformin Therapy in Patients with Type 2 Diabetes, The Journal of Clinical Endocrinology & Metabolism, 2022;, dgac436, https://doi.org/10.1210/clinem/dgac436
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