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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:BackgroundDiabetic peripheral neuropathic pain (DPNP) is common and often distressing. Most guidelines recommend amitriptyline, duloxetine, pregabalin, or gabapentin as initial analgesic treatment for DPNP, but there is little comparative evidence on which one is best or whether they should be combined. We aimed to assess the efficacy and tolerability of different combinations of first-line drugs for treatment of DPNP.MethodsOPTION-DM was a multicentre, randomised, double-blind, crossover trial in patients with DPNP with mean daily pain numerical rating scale (NRS) of 4 or higher (scale is 0-10) from 13 UK centres. Participants were randomly assigned (1:1:1:1:1:1), with a predetermined randomisation schedule stratified by site using permuted blocks of size six or 12, to receive one of six ordered sequences of the three treatment pathways: amitriptyline supplemented with pregabalin (A-P), pregabalin supplemented with amitriptyline (P-A), and duloxetine supplemented with pregabalin (D-P), each pathway lasting 16 weeks. Monotherapy was given for 6 weeks and was supplemented with the combination medication if there was suboptimal pain relief (NRS >3), reflecting current clinical practice. Both treatments were titrated towards maximum tolerated dose (75 mg per day for amitriptyline, 120 mg per day for duloxetine, and 600 mg per day for pregabalin). The primary outcome was the difference in 7-day average daily pain during the final week of each pathway. This trial is registered with ISRCTN, ISRCTN17545443.FindingsBetween Nov 14, 2017, and July 29, 2019, 252 patients were screened, 140 patients were randomly assigned, and 130 started a treatment pathway (with 84 completing at least two pathways) and were analysed for the primary outcome. The 7-day average NRS scores at week 16 decreased from a mean 6·6 (SD 1·5) at baseline to 3·3 (1·8) at week 16 in all three pathways. The mean difference was -0·1 (98·3% CI -0·5 to 0·3) for D-P versus A-P, -0·1 (-0·5 to 0·3) for P-A versus A-P, and 0·0 (-0·4 to 0·4) for P-A versus D-P, and thus not significant. Mean NRS reduction in patients on combination therapy was greater than in those who remained on monotherapy (1·0 [SD 1·3] vs 0·2 [1·5]). Adverse events were predictable for the monotherapies: we observed a significant increase in dizziness in the P-A pathway, nausea in the D-P pathway, and dry mouth in the A-P pathway.InterpretationTo our knowledge, this was the largest and longest ever, head-to-head, crossover neuropathic pain trial. We showed that all three treatment pathways and monotherapies had similar analgesic efficacy. Combination treatment was well tolerated and led to improved pain relief in patients with suboptimal pain control with a monotherapy.FundingNational Institute for Health Research (NIHR) Health Technology Assessment programme.

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.

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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.

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