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Efficacy and safety evaluation of pregabalin treatment over 52?weeks in patients with diabetic neuropathic pain extended after a double-blind placebo-controlled trial.

ABSTRACT: Aims/Introduction:? Diabetic peripheral neuropathy (DPN) is often associated with pain, and thus a new treatment option is anticipated. We recently showed the efficacy of pregabalin in a randomized, double-blind, placebo-controlled, 14-week trial in Japanese patients with painful DPN. In the present study, we evaluated the long-term efficacy and safety of pregabalin for the relief of painful DPN.? A total of 123 patients were enrolled in a 52-week open-label study, from among those who participated in the preceding double-blind trial. The subjects received pregabalin 150-600?mg/day. Pain intensity was measured using the short-form McGill pain questionnaire (SF-MPQ: total score, visual analog scale and present pain intensity).? The efficacy parameter SF-MPQ showed a decrease over the treatment period. The changes in visual analog scale and present pain intensity at the final evaluation were -25.4?mm and -0.7, respectively, suggesting an analgesic effect of pregabalin. Commonly reported adverse events were somnolence, weight gain, dizziness and peripheral edema, but most of them were mild to moderate in intensity. No new concerns about safety as a result of long-term administration of pregabalin were identified.? The findings from this trial suggest that long-term treatment with pregabalin is beneficial for pain relief in patients with DPN. This trial was registered with ClinicalTrials.gov (no. NCT00553280). (J Diabetes Invest, doi: 10.1111/j.2040-1124.2011.00122.x, 2011).

SUBMITTER: Satoh J

PROVIDER: S-EPMC4014905 | biostudies-literature | 2011 Nov

REPOSITORIES: biostudies-literature

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Efficacy and safety evaluation of pregabalin treatment over 52 weeks in patients with diabetic neuropathic pain extended after a double-blind placebo-controlled trial.

Satoh Jo J Yagihashi Soroku S Baba Masayuki M Suzuki Makoto M Arakawa Akio A Yoshiyama Tamotsu T

Journal of diabetes investigation 20111101 6

<h4>Unlabelled</h4>Aims/Introduction: Diabetic peripheral neuropathy (DPN) is often associated with pain, and thus a new treatment option is anticipated. We recently showed the efficacy of pregabalin in a randomized, double-blind, placebo-controlled, 14-week trial in Japanese patients with painful DPN. In the present study, we evaluated the long-term efficacy and safety of pregabalin for the relief of painful DPN.<h4>Materials and methods</h4> A total of 123 patients were enrolled in a 52-week ...[more]

PMID: 24843530

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Project description:IntroductionAlmost one-quarter of Asian patients with diabetes experience diabetic peripheral neuropathic pain (DPNP), which may be associated with moderate or severe levels of pain, insomnia, mood disorders, and worsened quality of life. Current treatments are generally ineffective and may be poorly tolerated. We evaluated mirogabalin as a treatment for DPNP in Asian subjects.MethodsThis phase 2, randomized, double-blind, controlled study was conducted in Japan, South Korea, and Taiwan. Subjects (n = 450) with DPNP were randomized (1:1:1:1:1) to treatment with 5, 10, or 15 mg twice-daily (BID) mirogabalin, 150 mg BID pregabalin, or placebo. The primary endpoint was change from baseline in average daily pain score (ADPS) at week 7; secondary endpoints included responder rates, Short-Form McGill Pain Questionnaire (SF-MPQ), Patient Global Impression of Change (PGIC), average daily sleep-interference score (ADSIS), and incidence of treatment-emergent adverse events (TEAEs).ResultsA greater improvement was noted for each mirogabalin treatment group for change from baseline in ADPS at week 7 compared with both placebo and with pregabalin, although these improvements were not statistically significant. The percentage of 30, 50, and 75% responders and subjects with PGIC improvements was greater in each mirogabalin group versus placebo. Mirogabalin 15 mg BID significantly improved the SF-MPQ sensory (p = 0.0313) and visual analog scale scores (p = 0.0093), and ADSIS (p = 0.0002), versus placebo. Treatment was generally well tolerated; the most frequently reported TEAEs in the mirogabalin groups were somnolence (14.7%) and dizziness (11.0%), and most AEs were mild or moderate even at the highest dose.ConclusionsIn Asian subjects with DPNP, mirogabalin (5, 10, and 15 mg BID) was well tolerated. Although no significant differences were observed in the primary endpoint, there was a tendency toward improvement of pain with mirogabalin treatment, and this trend was also observed in the secondary endpoints.Trial registrationClinicalTrials.gov identifier, NCT01504412.

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Efficacy and safety evaluation of pregabalin treatment over 52?weeks in patients with diabetic neuropathic pain extended after a double-blind placebo-controlled trial.

Publications

Efficacy and safety evaluation of pregabalin treatment over 52 weeks in patients with diabetic neuropathic pain extended after a double-blind placebo-controlled trial.

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