COMPARISON OF EFFICACY AND SAFETY PROFILE OF PREGABALIN AND GABAPENTIN IN PAINFUL DIABETIC NEUROPATHY
Keywords:D.M: Diabetes Mellitus, PDPN: Painful Diabetic Peripheral Neuropathy, DPN: Diabetic Peripheral Neuropathy,VAS: Visual Analog Scale
Major objective of the study was comparison of efficacy and safety profile of Pregabalin and Gabapentin in painful diabetic neuropathy. It was an open label 12 weeks randomized controlled trial which was conducted in Department of Pharmacology & Therapeutics Basic Medical Sciences Institute (BMSI), Jinnah Postgraduate Medical Center (JPMC) in collaboration of Diabetic Clinic of Medical Unit III of JPMC Karachi. Study was conducted from December 2010 to May 2011. 60 diagnosed patients of painful diabetic neuropathy were selected for 12 weeks’ trial after taking written consent. The patients were randomly placed into two groups, 30 patients each. One group received Pregabalin (n=30) while the other group received Gabapentin (n=30). The primary outcome was reduction in pain scale. It was compared on 11-point numerical visual analog scale (VAS). In Pregabalin group the reduction in pain VAS was 6.20±0.14 on day 0 to 2.37±0.09 on day 90. The percentage of change was 61.8% (p-value 0.001). In Gabapentin group the reduction in pain VAS was 6.17±0.15 on day 0 to 3.5±0.15 on day 90. The percentage of change was 43.3% from baseline (p-value 0.001). The secondary outcome was improvement in sleep interference that is measured on 11-point numerical VAS of sleep interference. It also improved in both groups which is highly significant. In patients of diabetic painful neuropathy Pregabalin and Gabapentin both are effective but Pregabalin is superior in relieving symptoms than Gabapentin.
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