Incidence of dizziness and somnolence in Japanese patients with renal impairment treated with mirogabalin: a post-marketing surveillance

抄録

This multicenter, post-marketing surveillance study (August 2019–November 2021) investigated the risk of dizziness-/somnolence-related events in patients receiving mirogabalin for peripheral neuropathic pain for ≤14 weeks. By renal impairment group, 57.3％–86.2％ and 37.2％–58.5％ of patients received the initial (2.5–10 mg) and effective (7.5–30 mg) mirogabalin doses recommended in the package insert, respectively. Dizziness-/somnolence-related event incidences were 6.29％/6.55％, and 7.46％/7.33％ in patients with normal renal function/mild impairment (n＝1,160) and moderate/severe impairment (n＝764). Median risk ratios of moderate/severe impairment vs normal/mild impairment for dizziness- (1.188; posterior probability ≥1.2 and ≥2.0, 47.67％ and 0.09％, respectively) and somnolence-related events (1.121; posterior probability ≥1.2 and ≥2.0, 34.20％ and 0.03％, respectively) did not reach the predefined increased risk criteria (posterior probabilities of risk ratios ≥1.2 [probability ≥90％] and ≥2.0 [probability ≥10％]). Similar results were obtained after adjusting for confounding factors. In clinical practice, dizziness-/somnolence-related event risk did not increase with renal impairment severity except for patients with end-stage renal failure/requiring hemodialysis.