Efficacy of Pregabalin and Duloxetine in Patients with Painful Diabetic Peripheral Neuropathy (PDPN): A Multi-Centre Phase IV Clinical Trial-BLOSSOM.
diabetic polyneuropathy
duloxetine
neuropathic pain
pregabalin
randomised clinical trial
Journal
Pharmaceuticals (Basel, Switzerland)
ISSN: 1424-8247
Titre abrégé: Pharmaceuticals (Basel)
Pays: Switzerland
ID NLM: 101238453
Informations de publication
Date de publication:
18 Jul 2023
18 Jul 2023
Historique:
received:
12
05
2023
revised:
28
06
2023
accepted:
03
07
2023
medline:
29
7
2023
pubmed:
29
7
2023
entrez:
29
7
2023
Statut:
epublish
Résumé
Our trial (ClinicalTrials.gov Identifier: NCT04246619) evaluates the efficacy of two generic medications, pregabalin and duloxetine, for treating pain in PDPN patients. 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). 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 Our results demonstrate that pregabalin and duloxetine are effective medications for treating pain in PDPN in more than 86% of all randomised patients.
Identifiants
pubmed: 37513930
pii: ph16071017
doi: 10.3390/ph16071017
pmc: PMC10386018
pii:
doi:
Banques de données
ClinicalTrials.gov
['NCT04246619']
Types de publication
Journal Article
Langues
eng
Subventions
Organisme : Krka (Slovenia)
ID : Blossom
Références
Diabetes Res Clin Pract. 2014 Mar;103(3):522-9
pubmed: 24438877
JAMA Netw Open. 2019 May 3;2(5):e194798
pubmed: 31150078
Clin Ther. 2017 Apr;39(4):787-803.e18
pubmed: 28365034
Diabetes Res Clin Pract. 2000 Feb;47(2):123-8
pubmed: 10670912
Pain Med. 2005 Sep-Oct;6(5):346-56
pubmed: 16266355
Ther Adv Drug Saf. 2014 Feb;5(1):38-56
pubmed: 25083261
Pain. 2005 Jul;116(1-2):109-18
pubmed: 15927394
Cochrane Database Syst Rev. 2019 Jan 23;1:CD007076
pubmed: 30673120
Diabetes Care. 2007 Mar;30(3):664-9
pubmed: 17327338
J Am Geriatr Soc. 2005 Apr;53(4):695-9
pubmed: 15817019
Behav Sleep Med. 2011;9(4):216-23
pubmed: 22003975
Ann Intern Med. 2014 Nov 4;161(9):639-49
pubmed: 25364885
BMJ. 2019 Jun 12;365:l2147
pubmed: 31189556
Pain. 2020 Mar;161(3):574-583
pubmed: 31693539
Sleep. 1991 Dec;14(6):540-5
pubmed: 1798888
Curr Med Res Opin. 2016 May;32(5):929-37
pubmed: 26854578
Continuum (Minneap Minn). 2020 Oct;26(5):1299-1322
pubmed: 33003003
Aust Fam Physician. 2014 Oct;43(10):705-8
pubmed: 25286428
Cochrane Database Syst Rev. 2014 Jan 03;(1):CD007115
pubmed: 24385423
Clin J Pain. 2006 Oct;22(8):681-5
pubmed: 16988563
Neurology. 2006 Oct 24;67(8):1411-20
pubmed: 17060567
BMJ. 2014 May 06;348:g1799
pubmed: 24803311
Pain. 2005 Mar;114(1-2):29-36
pubmed: 15733628
BMJ Open. 2019 Jan 21;9(1):e023600
pubmed: 30670513
Indian J Pharmacol. 2012 Jan;44(1):51-6
pubmed: 22345870
Eur J Neurol. 2023 Aug;30(8):2177-2196
pubmed: 37253688
J Pediatr Endocrinol Metab. 1999 Nov-Dec;12(6):867-72
pubmed: 10614545
Clin Drug Investig. 2019 Aug;39(8):775-786
pubmed: 31243706
Curr Med Res Opin. 2010 Feb;26(2):337-43
pubmed: 19968592
Handb Clin Neurol. 2014;126:3-22
pubmed: 25410210
BMC Neurol. 2009 Feb 10;9:6
pubmed: 19208243
Neurology. 2004 Dec 14;63(11):2104-10
pubmed: 15596757
Int J Clin Pract. 2021 Nov;75(11):e14576
pubmed: 34171158