Next Article in Journal
In-Silico Mining of the Toxins Database (T3DB) towards Hunting Prospective Candidates as ABCB1 Inhibitors: Integrated Molecular Docking and Lipid Bilayer-Enhanced Molecular Dynamics Study
Previous Article in Journal
New Imadazopyrazines with CDK9 Inhibitory Activity as Anticancer and Antiviral: Synthesis, In Silico, and In Vitro Evaluation Approaches
 
 
Search for Articles:
Title / Keyword
Author / Affiliation / Email
Journal
Article Type
 
 
Advanced Search
 
Section
Special Issue
Volume
Issue
Number
Page
 
Journals
Pharmaceuticals
Volume 16
Issue 7
10.3390/ph16071017
pharmaceuticals-logo
Submit to this Journal Review for this Journal Propose a Special Issue
► Article Menu

Article Menu

share Share announcement Help format_quote Cite question_answer Discuss in SciProfiles
first_page
settings
Order Article Reprints
Font Type:
Arial Georgia Verdana
Font Size:
Aa Aa Aa
Line Spacing:
Column Width:
Background:
Article

Efficacy of Pregabalin and Duloxetine in Patients with Painful Diabetic Peripheral Neuropathy (PDPN): A Multi-Centre Phase IV Clinical Trial—BLOSSOM

by
Martin Rakusa
1,2,*,
Iris Marolt
3,
Zorica Stevic
4,5,
Sandra Vuckovic Rebrina
6,
Tatjana Milenkovic
7,8 and
Adam Stepien
9
1
Division of Neurology, University Medical Centre Maribor, 2000 Maribor, Slovenia
2
Faculty of Medicine, University of Maribor, 2000 Maribor, Slovenia
3
Outpatient Diabetes Clinic, Community Health Centre Koper, 6000 Koper, Slovenia
4
Neuropathy Center, Neurology Clinic, Clinical Center of Serbia, 11000 Belgrade, Serbia
5
School of Medicine, University of Belgrade, 11000 Belgrade, Serbia
6
University Clinic Vuk Vrhovac, Clinical Hospital Merkur, 10000 Zagreb, Croatia
7
University Clinic of Endocrinology, Diabetes and Metabolic Disorders, 1000 Skopje, North Macedonia
8
Faculty of Medicine, Ss. Cyril and Methodius University in Skopje, 1000 Skopje, North Macedonia
9
Department of Neurology, Military Institute of Medicine—National Institute of Science, 04-052 Warsaw, Poland
*
Author to whom correspondence should be addressed.
Pharmaceuticals 2023, 16(7), 1017; https://doi.org/10.3390/ph16071017
Submission received: 12 May 2023 / Revised: 28 June 2023 / Accepted: 3 July 2023 / Published: 18 July 2023
(This article belongs to the Topic Research in Pharmacological Therapies)
Browse Figure
Versions Notes

Abstract

Introduction: Our trial (ClinicalTrials.gov Identifier: NCT04246619) evaluates the efficacy of two generic medications, pregabalin and duloxetine, for treating pain in PDPN patients. Methods: The patients were randomised either into the pregabalin (99) or the duloxetine (102) arm. Pain was evaluated using the DN-4 questionnaire, and visual analogue scales (VASs, 0–100 mm) were used to measure the average pain intensity (API), worst pain intensity (WPI) in the last 24 h and current pain intensity (CPI). Results: The proportion of patients with a clinically significant improvement in the API at Week 12 was 88.3% [CI 81.7%, 94.8%] in the pregabalin arm and 86.9% [CI 76.7%, 97.1%] in the duloxetine arm. After 12 weeks, the CPI, API, and WPI decreased by −35.3 [−40.5, −30.0], −37.0 [−41.4, −32.6], and −41.6 [−46.6, −36.5] in the pregabalin arm, and by −35.0 [−39.2, −30.7], −36.9 [−41.5, −32.3], and −40.0 [−44.8, −35.2] in the duloxetine arm (all in mm, all p < 0.001). Conclusion: Our results demonstrate that pregabalin and duloxetine are effective medications for treating pain in PDPN in more than 86% of all randomised patients.
Keywords: neuropathic pain; diabetic polyneuropathy; duloxetine; pregabalin; randomised clinical trial neuropathic pain; diabetic polyneuropathy; duloxetine; pregabalin; randomised clinical trial

Share and Cite

MDPI and ACS Style

Rakusa, M.; Marolt, I.; Stevic, Z.; Rebrina, S.V.; Milenkovic, T.; Stepien, A. Efficacy of Pregabalin and Duloxetine in Patients with Painful Diabetic Peripheral Neuropathy (PDPN): A Multi-Centre Phase IV Clinical Trial—BLOSSOM. Pharmaceuticals 2023, 16, 1017. https://doi.org/10.3390/ph16071017

AMA Style

Rakusa M, Marolt I, Stevic Z, Rebrina SV, Milenkovic T, Stepien A. Efficacy of Pregabalin and Duloxetine in Patients with Painful Diabetic Peripheral Neuropathy (PDPN): A Multi-Centre Phase IV Clinical Trial—BLOSSOM. Pharmaceuticals. 2023; 16(7):1017. https://doi.org/10.3390/ph16071017

Chicago/Turabian Style

Rakusa, Martin, Iris Marolt, Zorica Stevic, Sandra Vuckovic Rebrina, Tatjana Milenkovic, and Adam Stepien. 2023. "Efficacy of Pregabalin and Duloxetine in Patients with Painful Diabetic Peripheral Neuropathy (PDPN): A Multi-Centre Phase IV Clinical Trial—BLOSSOM" Pharmaceuticals 16, no. 7: 1017. https://doi.org/10.3390/ph16071017

APA Style

Rakusa, M., Marolt, I., Stevic, Z., Rebrina, S. V., Milenkovic, T., & Stepien, A. (2023). Efficacy of Pregabalin and Duloxetine in Patients with Painful Diabetic Peripheral Neuropathy (PDPN): A Multi-Centre Phase IV Clinical Trial—BLOSSOM. Pharmaceuticals, 16(7), 1017. https://doi.org/10.3390/ph16071017

Note that from the first issue of 2016, this journal uses article numbers instead of page numbers. See further details here.

Article Metrics

Back to TopTop