Efficacy and safety of duloxetine and Pregabalin in Iranian patients with diabetic peripheral neuropathic pain: a double-blind, randomized clinical trial

Khojasteh Joharchi,Eznollah Azargashb,Navid Saadat,Moosareza Memari

doi:10.1007/s40200-019-00427-w

Abstract

PurposeDiabetic peripheral neuropathic pain (DPNP) is one of the most sufferings, disabling, and dominant complications of diabetes. Duloxetine (DLX) and Pregabalin (PGB) are among first-line therapy and the most prescribed drugs for DPNP relief. The effectiveness-risk profile of drugs may differ from region to region due to variations in genetic and health situation of populations. This study aims to evaluate the efficacy and safety of DLX and PGB in a sample of Iranian population with DPNP.MethodsA double-blind, randomized clinical trial was conducted on 180 type-2 diabetic patients with DPNP≥40 mm according to Visual Analogue Scale (VAS), with other eligibility criteria throughout twelve weeks. We divided the patients randomly into two equal groups: DLX and PGB. Each patient received ten days placebo as a washout period, then blind capsules of DLX (group 1) or PGB (group 2). We assessed the efficacy and safety of drugs by VAS and recorded the Adverse Drug Reactions (ADRs) during the study.ResultsIn the DLX group, sixty-six and the PGB group, seventy-eight patients completed the study. The intensity of patients’ pain was improved by both drugs significantly (p˂0.001), but there was no significant difference between the two groups. Average daily doses of DLX and PGB were 42.5 and 235.5 mg, respectively. In the DLX group, 74% of patients and the PGB group, 37% reported ADRs. The discontinuation rates due to ADRs were 19% and 7% correspondingly.ConclusionWe found that in Iranian patients, the mean effective doses of these drugs are different in comparison with several other studies. Surprisingly intolerance and discontinuation of DLX in our patients were attributed to mild and severe Serotonin Syndrome, which had not much occurred in other studies. Accordingly, despite the same efficacy, PGB was better tolerated than DLX in our patients. Thus we would recommend PGB for DPNP treatment in Iranian patients.

Highlights

The original version of this article was revised due to a retrospective Open Access order.Nearly 4.5 million Iranians were suffering from diabetes in 2011 [1], and this number is expected to rise to 9.5 million by 2030 [2]
The prevalence of Diabetic peripheral neuropathic pain (DPNP) in patients with diabetic neuropathy was reported about 11%, 20% and 50% from the United States, England, and the Middle East, respectively [3,4,5]
We did not found any reports about the prevalence of DPNP in Iranian diabetic patients; regarding this high incidence of peripheral neuropathy, it can be estimated that a high proportion of Iranian diabetic patients are suffering from DPNP

Summary

Introduction

4.5 million Iranians were suffering from diabetes in 2011 [1], and this number is expected to rise to 9.5 million by 2030 [2]. The prevalence of DPNP in patients with diabetic neuropathy was reported about 11%, 20% and 50% from the United States, England, and the Middle East, respectively [3,4,5]. Some studies estimated that about 30% - 50% of Iranian diabetic patients have peripheral neuropathy [6, 7]. We did not found any reports about the prevalence of DPNP in Iranian diabetic patients; regarding this high incidence of peripheral neuropathy, it can be estimated that a high proportion of Iranian diabetic patients are suffering from DPNP.

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