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A phase 4 randomized active-controlled clinical study to compare the efficacy and safety of sustained-release pregabalin with immediate-release pregabalin in type 2 diabetic patients with peripheral neuropathic pain.
- Source :
-
Journal of diabetes and its complications [J Diabetes Complications] 2024 Aug; Vol. 38 (8), pp. 108809. Date of Electronic Publication: 2024 Jul 14. - Publication Year :
- 2024
-
Abstract
- Aims: The objective of this study was to demonstrate that sustained-release (SR) pregabalin is non-inferior to immediate-release (IR) pregabalin in attenuating diabetic peripheral neuropathic (DPN) pain along with patient satisfaction and compliance.<br />Methods: This was an 8-week, randomized, active-controlled, open-label, phase 4 study. Eligible subjects who had been on IR pregabalin for 4 weeks were randomized to 1:1 ratio to either continue with twice-daily IR pregabalin (75 mg), or to switch to once-daily SR pregabalin (150 mg). Primary efficacy endpoint was the change in visual analogue scale (VAS) scores after 8 weeks of treatment compared to baseline in both SR and IR pregabalin groups.<br />Results: Among 130 randomized subjects, 125 patients were included in full analysis set. For the change in VAS pain score, the least squares (LS) mean were -17.95 (SR pregabalin) and -18.74 (IR pregabalin) and the LS mean difference between both groups was 0.79, with the upper limit of the 95 % confidence interval [-5.99, 7.58] below the pre-specified non-inferiority margin of 9.2 mm.<br />Conclusions: This study demonstrates that the new once-daily SR pregabalin formulation is not different to the twice-daily IR pregabalin in alleviating DPN pain, indicating its potential as a promising treatment for DPN pain with a comparable safety profile.<br />Trial Registration: ClinicalTrials.gov, NCT05624853.<br />Competing Interests: Declaration of competing interest The authors declare the following potential conflicts of interest with respect to the research, authorship, and publication of this paper: “ The authors declare no competing financial interest in the publication of our data.”<br /> (Copyright © 2024 Elsevier Inc. All rights reserved.)
- Subjects :
- Humans
Male
Middle Aged
Female
Aged
Treatment Outcome
Pain Measurement
Adult
Drug Administration Schedule
Patient Satisfaction
Pregabalin administration & dosage
Pregabalin therapeutic use
Pregabalin adverse effects
Diabetic Neuropathies drug therapy
Diabetes Mellitus, Type 2 complications
Diabetes Mellitus, Type 2 drug therapy
Delayed-Action Preparations
Analgesics administration & dosage
Analgesics therapeutic use
Analgesics adverse effects
Neuralgia drug therapy
Subjects
Details
- Language :
- English
- ISSN :
- 1873-460X
- Volume :
- 38
- Issue :
- 8
- Database :
- MEDLINE
- Journal :
- Journal of diabetes and its complications
- Publication Type :
- Academic Journal
- Accession number :
- 39018898
- Full Text :
- https://doi.org/10.1016/j.jdiacomp.2024.108809