Efficacy and Safety of Mirogabalin Treatment in Patients with Diabetic Peripheral Neuropathic Pain: A Systematic Review and Meta-analysis of Randomized Controlled Trials.

Alyoubi, Reem Abdullah; Alshareef, Aysha Abdulmalek; Aldughaither, Saud Musaab; Aljaroudi, Abeer Mahdi; Alabdulwahed, Alwaleed; Alduraibi, Faisal Muhammed; Taher Masoud, Ahmed; Abu-Zaid, Ahmed

AIM We aimed to perform a systematic review and meta-analysis to examine the efficacy and safety of mirogabalin in patients with diabetic peripheral neuropathic pain (DPNP). METHODS We searched four databases from inception to July 1st, 2020. We included all randomized controlled trials (RCTs) which assessed the effectiveness and safety of mirogabalin in patients with DPNP. We evaluated the quality of the included RCTs using the Cochrane risk of bias assessment tool. We pooled dichotomous outcomes as risk ratios and continuous outcomes as mean differences with 95% confidence intervals, both under the random- or fixed-effects model. RESULTS Three RCTs matched our inclusion criteria with a total of 1732 patients with DPNP: 1057, 534, and 141 patients received mirogabalin, placebo, and pregabalin, respectively. The quality of included RCTs was marked as moderate-to-high. Mirogabalin treatment was significantly associated with a significant reduction in the average daily pain score (ADPS) compared to placebo over seven weeks. Compared to pregabalin, mirogabalin was significantly associated with more decrease in ADPS only after three, four, and five weeks. The proportion of patients with ≥30% and ≥50% reduction in the ADPS was significantly higher in the mirogabalin versus placebo and pregabalin groups. Compared to placebo, mirogabalin was significantly associated with more adverse events of dizziness, increased weight, peripheral edema, and somnolence. The safety profile was comparable between mirogabalin and pregabalin. CONCLUSIONS Our systematic review and meta-analysis revealed that in patients with DPNP, mirogabalin treatment was superior to placebo and pregabalin in decreasing the ADPS over time. Besides, mirogabalin was largely safe and associated with some adverse events that could be managed conservatively.