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Abstract
Objective: The objective of this study was to compare the efficacy and safety of pregabalin for painful diabetic peripheral neuropathy (pDPN) in subjects with type 1 (T1DM) or 2 diabetes mellitus (T2DM).
Methods: Pooled data from 10 randomized clinical trials (pregabalin-treated T1DM and T2DM subjects with pDPN) were analyzed for change from baseline (CFB) scores (pain and sleep disturbance) using mixed model repeated measures (MMRM) through Week 12 and last observation carried forward (LOCF). Adverse events (AEs) were recorded.
Results: Pregabalin-treated (T1DM 156 [8.7%]; T2DM 1632 [91.3%]) and placebo subjects (T1DM 92 [9.6%]; T2DM 868 [90.4%]) had comparable baseline demographic characteristics between treatment groups within the same diabetes type. T2DM (vs. T1DM) subjects were ∼10 years older. With pregabalin and placebo, respectively, mean ± SD baseline pain (T1DM: 6.2 ± 1.4 and 6.5 ± 1.6; T2DM: 6.5 ± 1.5 and 6.4 ± 1.5) and sleep scores (T1DM: 5.2 ± 2.4 and 5.2 ± 2.7; T2DM: 5.3 ± 2.5 and 5.1 ± 2.5) were comparable. Using MMRM, mean CFB treatment differences (pregabalin minus placebo) were significantly different for pain and sleep with either diabetes types (all weeks p < .05). With LOCF, pregabalin’s odds ratios (ORs) of achieving 30% pain reduction were similar with T2DM (OR, 1.91, 95% CI [1.61, 2.27]) and T1DM (2.01 [1.18, 3.44]) (both p ≤ .01). Pregabalin’s ORs of 30% improvement in sleep quality were 1.81 (95% CI, 1.06, 3.09) with T1DM and 2.01 (1.69, 2.39) with T2DM (both p < .05). AEs were consistent with the known safety profile of pregabalin.
Conclusions: Pregabalin significantly improved pain and sleep quality, without a clinically meaningful difference between diabetes types.
ClinicalTrial.gov registration: NCT00156078, NCT00159679, NCT00143156, NCT00553475.
Transparency
Declaration of funding
This study was sponsored by Pfizer, New York, NY, USA.
Declaration of financial/other relationships
A.I.V. has disclosed that he has served as a speaker or consultant or has received grant support from Abbott, Ansar, GlaxoSmithKline, Beecham, KV Pharmaceuticals, Merck & Co., Pfizer, RW Johnson Pharmaceutical Research Institute, Sanofi and Tercica. B.P., C.L. and B.E. have disclosed that they are employees of Pfizer and own stock or stock options.
CMRO peer reviewers on this manuscript have no relevant financial or other relationships to disclose.
Previous presentation: Early results of these analyses were presented as a poster at the American Academy of Neurology 67th Annual Meeting, Washington, DC, 18–25 April 2015, which publishes its abstracts in a supplement for Neurology (Parsons B et al. Neurology 2015;84:P3.304.
Data sharing statement
Upon request, and subject to certain criteria, conditions and exceptions (see https://www.pfizer.com/science/clinical-trials/trial-data-and-results, for more information), Pfizer will provide access to individual de-identified participant data from Pfizer-sponsored global interventional clinical studies conducted for medicines, vaccines and medical devices (1) for indications that have been approved in the US and/or EU or (2) in programs that have been terminated (i.e., development for all indications has been discontinued). Pfizer will also consider requests for the protocol, data dictionary, and statistical analysis plan. Data may be requested from Pfizer trials 24 months after study completion. The de-identified participant data will be made available to researchers whose proposals meet the research criteria and other conditions, and for which an exception does not apply, via a secure portal. To gain access, data requestors must enter into a data access agreement with Pfizer.
Acknowledgements
Medical writing support was provided by Ray Beck Jr, PhD of Engage Scientific Solutions, part of the Envision Pharma Group and was funded by Pfizer Inc.
Additional information
Notes on contributors
B. Parsons
B.P., B.E., C.L. and A.I.V. were involved in the design of the study. B.P. and A.I.V. contributed to the clinical interpretation of its results. A.I.V. was a study investigator. B.E. and C.L. conducted and verified the statistical analyses. All authors were involved in the drafting of the manuscript and have thoroughly reviewed it and approved the final draft.
C. Li
B.P., B.E., C.L. and A.I.V. were involved in the design of the study. B.P. and A.I.V. contributed to the clinical interpretation of its results. A.I.V. was a study investigator. B.E. and C.L. conducted and verified the statistical analyses. All authors were involved in the drafting of the manuscript and have thoroughly reviewed it and approved the final draft.
B. Emir
B.P., B.E., C.L. and A.I.V. were involved in the design of the study. B.P. and A.I.V. contributed to the clinical interpretation of its results. A.I.V. was a study investigator. B.E. and C.L. conducted and verified the statistical analyses. All authors were involved in the drafting of the manuscript and have thoroughly reviewed it and approved the final draft.
A. I. Vinik
B.P., B.E., C.L. and A.I.V. were involved in the design of the study. B.P. and A.I.V. contributed to the clinical interpretation of its results. A.I.V. was a study investigator. B.E. and C.L. conducted and verified the statistical analyses. All authors were involved in the drafting of the manuscript and have thoroughly reviewed it and approved the final draft.