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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Efficacy of mirogabalin (DS-5565) on patient-reported pain and sleep interference in patients with diabetic neuropathic pain: Secondary outcomes of a phase II proof-of-concept study
Pain Medicine (United States), Volume 18, No. 11, Year 2017
Notification
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Description
Objective. To evaluate the effects of mirogabalin on patient-reported pain and sleep interference in diabetic peripheral neuropathic pain (DPNP). Subjects. Adults (≥18 years) with type 1 or 2 diabetes, glycosylated hemoglobin of 10% or less at screening, and DPNP for six months or more were eligible for participation. Methods. Subjects (N5452) were randomly assigned (2:1:1:1:1:1:1) to receive placebo, doseranging mirogabalin (5, 10, 15, 20, 30 mg/day), or pregabalin (300 mg/day) for five weeks. Secondary efficacy end points studied here included patient global impression of change (PGIC), modified brief pain inventory (BPI), and average daily sleep interference score (ADSIS). Correlation plots were generated to examine the relationship between ADSIS and average daily pain score (ADPS). Results. At week 5, significant reductions in ADSIS were observed in the mirogabalin 15, 20, and 30 mg/ day groups, compared with placebo (P < 0.05). Baseline ADSIS and ADPS were strongly correlated (R250.4407), as were mean changes from baseline in ADSIS and ADPS at week 5 (R250.6694). The mirogabalin 30 mg/day group showed significant improvement compared with placebo in four of six BPI subscales at end point; the mirogabalin 15 mg/day group showed significant improvement in three of six BPI subscales (P < 0.05). At end of treatment, the percentage of subject with PGIC status of "much improved or better" was greater in all mirogabalin dose groups than in the placebo group (P < 0.05). A low incidence of treatment-related adverse events was reported for mirogabalin. Conclusions. Results support the effectiveness of mirogabalin in improving patient-reported pain and sleep interference in DPNP. © 2017 American Academy of Pain Medicine. All rights reserved
Authors & Co-Authors
Rosenstock, Julio
Unknown Affiliation
Vinik, Aaron I.
United States, Norfolk
Eastern Virginia Medical School
Statistics
Citations: 27
Authors: 2
Affiliations: 3
Identifiers
Doi:
10.1093/pm/pnw342
ISSN:
15262375
Research Areas
Health System And Policy
Noncommunicable Diseases
Study Design
Cohort Study