Efficacy and safety of duloxetine and Pregabalin in Iranian patients with diabetic peripheral neuropathic pain: a double-blind, randomized clinical trial
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Diabetic 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.
A 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.
In 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.
We 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.
KeywordsAdverse drug reactions (ADRs) Diabetes Diabetic peripheral neuropathic pain (DPNP) Duloxetine (DLX) Pregabalin (PGB)
The present article is part of Dr. Moosareza Memari thesis for receiving Ph.D. degree in Pharmacology under the supervision of Dr. Khojasteh Joharchi at the Department of Pharmacology, School of Medicine, and was financially supported by “Research Department of the School of Medicine Shahid Beheshti University of Medical Sciences (SBUMS)” (Grant No 13/587). The authors would like to thank all faculty members in the pharmacology department of also Shohada and Mahdieh hospitals for their good corporations and also all the patients who participated in the study.
Compliance with ethical standards
Conflict of interest
The authors declare that they have no conflict of interest.
This study was approved by the ethics committee of SBUMS (ethical code: IR.SBMU.MSP.REC.1395.41) and registered in the Iranian Registry of Clinical Trials website: http://www.irct.ir and the registration number is: IRCT2017012932277N1.
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