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.
Background Pregabalin (PGB) has been approved for the treatment of diabetic peripheral neuropathic pain (DPNP), but the mechanism of the PGB effect in this situation is not precisely known. Would it be via the reduction of inducible Nitric Oxide Synthase (iNOS) and thus the decrease of Nitric Oxide (NO) in type 2 diabetic patients? The current clinical trial was conducted to answer this question. Methods Twenty Seven diabetic patients with DPNP > 4, assessed by Visual Analogue Scale (VAS), were enrolled in this study. They received placebo/Bd for ten days as a washout period, then a starting dose of 75 mg/Bd PGB for one week and 150 mg/Bd for the next seven weeks. We took a fasting blood sample at baseline, before starting the treatment (BT) with PBG, then one month after the treatment (OMT), and also at the end of two months (TMT). The iNOS and NO serum levels were measured using the ELISA kit and the Griess method, respectively. Results Significant time-dependent reduction of iNOS of serum and DPNP intensities observed (P < 0.05). However, the serum levels of NO reduced significantly in OMT compared to BT (P < 0.05), but no significant differences were seen between OMT and TMT (P > 0.05). Conclusions Our study revealed a direct correlation between serum levels of iNOS and NO with the treatment of DPNP by PGB, thus introducing a possible mechanism for pain-relieving properties of PGB. Trial registration: This study was approved by the ethics committee of our University of Medical Sciences, (ethical code: IR.SBMU.MSP.REC.1395.41) and registered in our Registry of Clinical Trials (at 14/03/2016) and approved in 19/07/2017, the registration number is: (IRCT2017012932277N1). The study was conducted in the Diabetes Clinic of a teaching Hospital on 22/07/2017 till 18/03/2018. We have explained the study objectives and protocols to the subjects and obtained written informed consent before they participated in the study.
Background: Pregabalin (PGB) has been approved for the treatment of diabetic peripheral neuropathic pain (DPNP), but the mechanism of the PGB effect in this situation is not precisely known. Would it be via the reduction of inducible Nitric Oxide Synthase (iNOS) and thus the decrease of Nitric Oxide (NO) in type 2 diabetic patients? The current clinical trial was conducted to answer this question. Methods: Twenty Seven diabetic patients with DPNP>4, assessed by Visual Analogue Scale (VAS), were enrolled in this study. They received placebo/Bd for ten days as a washout period, then a starting dose of 75mg/Bd PGB for one week and 150mg/Bd for the next seven weeks. We took a fasting blood sample at baseline, before starting the treatment (BT) with PBG, then one month after the treatment (OMT), and also at the end of two months (TMT). The iNOS and NO serum levels were measured using the ELISA kit and the Griess method, respectively. Results: Significant time-dependent reduction of iNOS of serum and DPNP intensities observed (P<0.05). However, the serum levels of NO reduced significantly in OMT compared to BT (P<0.05), but no significant differences were seen between OMT and TMT (P>0.05). Conclusions: Our study revealed a direct correlation between serum levels of iNOS and NO with the treatment of DPNP by PGB, thus introducing a possible mechanism for pain-relieving properties of PGB. Trial registration: This study was approved by the ethics committee of our University of Medical Sciences, (ethical code: IR.SBMU.MSP.REC.1395.41) and registered in our Registry of Clinical Trials (at 14/03/2016) and approved in 19/07/2017, the registration number is: (IRCT2017012932277N1). The study was conducted in the Diabetes Clinic of a teaching Hospital on 22/07/2017 till 18/03/2018. We have explained the study objectives and protocols to the subjects and obtained written informed consent before they participated in the study.
The article Efficacy and safety of duloxetine and Pregabalin in Iranian patients with diabetic peripheral neuropathic pain: a double-blind, randomized clinical trial, written by Khojasteh Joharchi, Moosareza Memari, Eznollah Azargashb, and Navid Saadat, was originally published.
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