Long-term safety and efficacy of mirogabalin in Asian patients with postherpetic neuralgia: Results from an open-label extension of a multicenter randomized, double-blind, placebo-controlled trial

Jitsu Kato, Norimitsu Matsui, Yoshihiro Kakehi, Emiko Murayama, Shoichi Ohwada, Jitsu Kato, Norimitsu Matsui, Yoshihiro Kakehi, Emiko Murayama, Shoichi Ohwada

Abstract

Objective: Postherpetic neuralgia (PHN) is a condition that results from nerve dysfunction following an episode of acute herpes zoster (shingles). Mirogabalin is a novel, selective oral α2δ ligand that demonstrated safety and efficacy in a multicenter, randomized, double-blind, placebo-controlled 14-week study in Asian patients with PHN. This 52-week, open-label extension study investigated the long-term safety and efficacy of flexible-dosage mirogabalin in Asian patients with PHN.

Methods: This open-label extension study enrolled patients who completed the placebo-controlled study. Patients started with a dose of 5 mg mirogabalin twice daily (BID), which was followed by a flexible dose of 10 or 15 mg BID. During the study, patients assessed their pain using the Short-Form McGill Pain Questionnaire (SF-MPQ). Adverse events were monitored throughout the study.

Results: Of 239 enrolled patients, 184 (77.0%) completed the study and 185 patients (77.4%) received the 15 mg BID dose most during the treatment duration. Most treatment-emergent adverse events (TEAEs) were mild or moderate. The most common TEAEs were nasopharyngitis, somnolence, dizziness, weight increased, and edema. All SF-MPQ scales decreased from baseline to week 52.

Conclusions: This study showed the safety and stable pain management of a long-term flexible dosing regimen of mirogabalin 10 or 15 mg twice daily for 52 weeks in patients with PHN. CLINICAL TRIAL REGISTERED AT CLINICALTRIALS.GOV:: NCT02318719.

Summary for table of contents: Mirogabalin-a novel α2δ oral ligand-was shown to be effective and well tolerated for treating postherpetic neuralgia (PHN) in an Asian multicenter, randomized, double-blind, placebo-controlled, 14-week study. This open-label, 52-week study was conducted as an extension of the double-blind study to demonstrate long-term safety and efficacy of mirogabalin.

Figures

Figure 1
Figure 1
Study design. BID = twice daily, MGB = mirogabalin.
Figure 2
Figure 2
Change from baseline in pain based on short-form McGill Pain Questionnaire Data is shown as mean ± standard deviation. LOCF = last observation carried forward, SF-MPQ = short-form McGill Pain Questionnaire, VAS = visual analogue scale.

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Source: PubMed

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