A clinical study to compare the efficacy and safety of pregabalin sustained release formulation with pregabalin immediate release formulation in patients of diabetic peripheral neuropathic pain

Maseeh, Arun; Srivastava, Ambrish Kumar; Vyasa, Bhargav; Balaji, Malur R.; Bhatter, S; Buch, P; Dantara, D; Karnani, J; Kumar, Vikash; Lodha, Sanjay; Maji, D; Moses, Arnold M.; Phatak, Suresh; Polarappu, S; Shah, Sweety; Upadhayay, B

doi:10.4103/2230-8210.104137

Cited by 2 publications

(2 citation statements)

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“…11 Other SR tablets of pregabalin that used a conventional SR formulation technology has been reported. 22 This was the first randomized, double-blind study to evaluate the efficacy and safety of the new SR pregabalin formulation compared with IR pregabalin in South Korean patients with peripheral neuropathic pain. The primary efficacy assessment was to compare the mean DPRS score at the end of treatment between patients receiving SR pregabalin and those receiving IR pregabalin.…”

Section: Discussionmentioning

confidence: 99%

“…A new, once-daily SR pregabalin formulation has been developed using a floating and swelling gastroretentive drug delivery system to prolong gastric retention of pregabalin 11. Other SR tablets of pregabalin that used a conventional SR formulation technology has been reported 22. This was the first randomized, double-blind study to evaluate the efficacy and safety of the new SR pregabalin formulation compared with IR pregabalin in South Korean patients with peripheral neuropathic pain.…”

Section: Discussionmentioning

confidence: 99%

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Efficacy and Safety of a New Sustained-release Pregabalin Formulation Compared With Immediate-release Pregabalin in Patients With Peripheral Neuropathic Pain

Han

Lee

Son

et al. 2022

The Clinical Journal of Pain

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Objective: This study investigated whether a new sustained-release (SR) pregabalin formulation is noninferior to immediate-release (IR) pregabalin in alleviating peripheral neuropathic pain in Korean patients. Materials and Methods: This was a randomized, double-blind, active-controlled phase 3 study of patients with diabetic peripheral neuropathy or postherpetic neuralgia from 41 sites in South Korea in 2017-2018. Eligible patients were randomized (1:1) to receive once-daily SR pregabalin or twice-daily IR pregabalin (150 to 600 mg/d) in a double-dummy manner for 12 weeks according to a stratified permuted block randomization scheme. The primary endpoint was the Daily Pain Rating Scale score at the end of treatment, averaged from the last 7 available scores. Results: A total of 319 of 371 (86.0%) randomized patients completed the 12-week treatment (SR pregabalin: n=154; IR pregabalin: n=165; per-protocol set: n=296). The least square mean difference between both groups for the primary endpoint was 0.06 (SE 0.19); (95% confidence interval −0.31 to 0.42), with the lower limit of the confidence interval above the pre-specified margin (−0.78; P noninferiority<0.0001). Drug-related treatment-emergent adverse events (TEAEs) were comparable between both groups. The incidence of drug-related TEAEs leading to treatment discontinuation was low (SR pregabalin: 2.7%; IR pregabalin: 1.1%). No serious drug-related TEAEs or deaths occurred. Discussion: The results demonstrate that the new once-daily SR pregabalin formulation is noninferior to twice-daily IR pregabalin in reducing peripheral neuropathic pain and is well tolerated in Korean patients with diabetic peripheral neuropathy or postherpetic neuralgia after 12 weeks of treatment.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Efficacy and Safety of a New Sustained-release Pregabalin Formulation Compared With Immediate-release Pregabalin in Patients With Peripheral Neuropathic Pain

Han

Lee

Son

et al. 2022

The Clinical Journal of Pain

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Comparison of the Efficacy and Safety of Duloxetine and Gabapentin in Diabetic Peripheral Neuropathic Pain: A Meta‐Analysis

Xiong

CUI

2022

Contrast Media & Molecular Imaging

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Background. Diabetic peripheral neuropathic pain (DPNP) is a common chronic pain condition affecting diabetic patients and has growing importance because of the increasing prevalence of patients with type 2 diabetes mellitus. Pain is the most troublesome symptom of DPNP, increasingly recognized as an important and independent feature of DPNP. This meta-analysis aims to compare the efficacy and safety of duloxetine and gabapentin in the treatment of diabetic peripheral neuropathic pain (DPNP) and therefore to provide evidence-based medicine for clinical treatment. Methods. Relevant randomized controlled trials on duloxetine versus gabapentin for DPNP were searched from PubMed, Embase, Cochrane Library, Web of Science, CNKI, WanFang, VIP, and Chinese Biomedical Literature Database from database inception to October 2021. The data were analyzed by RevMan 5.3 software. Results. Seven studies were included. The results showed that, at the end of the study, duloxetine was significantly superior to gabapentin in terms of the incidence of adverse reactions (RR = 0.59, 95% CI: 0.45–0.79, P < 0.01), sleep interference score (SMD = −0.35, 95% CI: −0.63 to −0.08, P < 0.05), but no significant differences in VAS score (SMD = −0.14, 95% CI: −0.31–0.03, P > 0.05), overall response rate (RR = 1.05, 95% CI: 0.92–1.20, P > 0.05), and clinical global impression of change (SMD = 0.07, 95% CI: −0.20–0.35, P > 0.05). Conclusion. Compared with gabapentin, duloxetine has no obvious advantage in the treatment of diabetic peripheral neuralgia, but it has less side effects and significantly higher safety.

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A clinical study to compare the efficacy and safety of pregabalin sustained release formulation with pregabalin immediate release formulation in patients of diabetic peripheral neuropathic pain

Cited by 2 publications

References 2 publications

Efficacy and Safety of a New Sustained-release Pregabalin Formulation Compared With Immediate-release Pregabalin in Patients With Peripheral Neuropathic Pain

Efficacy and Safety of a New Sustained-release Pregabalin Formulation Compared With Immediate-release Pregabalin in Patients With Peripheral Neuropathic Pain

Comparison of the Efficacy and Safety of Duloxetine and Gabapentin in Diabetic Peripheral Neuropathic Pain: A Meta‐Analysis

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