Efficacy and tolerability of carbamazepine for the treatment of painful diabetic neuropathy in adults: a 12-week, open-label, multicenter study

Abstract

Objective

Anticonvulsants are increasingly being used in the symptomatic management of several neuropathic pain disorders. The present observational study was designed to evaluate the efficacy, tolerability, and quality of life (QoL) of carbamazepine use for 12 weeks in patients with painful diabetic neuropathy, in Pakistan.

Methods

This was a 12-week, multicenter, open-label, uncontrolled trial in adult type 2 diabetic patients (aged 18–65 years) suffering from clinically confirmed neuropathic pain (Douleur Neuropathique en 4 [DN4] score ≥4). Change in neuropathic pain at week 12 compared with baseline was assessed using the Brief Pain Inventory Scale–Short Form (pain severity score and pain interference score). QoL was determined by the American Chronic Pain Association QoL scale. Safety was assessed based on patient reported adverse events (AEs) and serious AEs.

Results

Of the total 500 screened patients, 452 enrolled and completed the study. The mean (± standard deviation [SD]) pain interference score decreased from 4.5±2.0 at baseline to 3.1±1.9 at week 12 (P<0.001). The mean (± SD) pain severity score decreased from 5.8±2.0 at baseline to 3.6±2.2 at week 12 (P<0.001). There was a decrease of ≥30% in the pain severity score between visits. The mean (± SD) QoL scale score improved from 5.9±1.6 at baseline to 8.0±1.7 at week 12. A total of ten (2.2%) patients reported AEs during the study period. No patient discontinued the study due to AEs.

Conclusion

In this real-life experience study, carbamazepine, when prescribed for 12 weeks to adult diabetic patients suffering from neuropathic pain, showed pain-relief effect, with reduced mean pain severity and mean pain interference scores and with improved QoL and good tolerability profile.

Keywords:

• anticonvulsant
• neuropathic pain
• quality of life

Acknowledgments

Authors thank Srujana Takkallapally and Venugopal Peta, professional medical writers (Novartis Healthcare Private Limited), for writing and editorial assistance. The study was funded by Novartis Pharma Pakistan, Karachi, Pakistan.

Author contributions

Tariq Saeed participated in the study design and in data collection and critical review. Muhammad Nasrullah and Nadeem Islam performed data collection and analysis and wrote the description of the results. Riaz Shahid, Adnan Ghafoor, and Mohammad Usman Khattak participated in data collection and wrote the Discussion. Ahson Siddiqi participated in design of the study and critical review. Neeta Maheshwary performed data management and data review. Muhammad Athar Khan performed data analysis. All authors participated in the drafting of the manuscript. All authors read and approved the final manuscript.

Disclosure

The sponsor of the study, Novartis Pharma Pakistan, was involved in study design, data management, data review, drafting and critical review of the manuscript.

NM and AS are full-time employees of Novartis Pharma Pakistan. The authors report no other conflicts of interest.