Evaluation of Effectiveness and Safety of Firstline Drugs Used in the Treatment of Peripheral Neuropathy Among Elderly Population-A Randomised, Open-label, Active Comparator Study.

Abstract

Background: Peripheral neuropathy is four times more common in geriatric age group patients compared to younger ones. Most of the trials have targeted adult population, and there is scarcity of data in the geriatric age group.

Purpose: A real-world study was planned on geriatric patients suffering from peripheral neuropathy to analyse the effectiveness and safety of first-line drugs used in the management of peripheral neuropathy.

Methods: It was a randomised, open-label, active comparator clinical trial in which first-line drugs for peripheral neuropathy were compared [amitriptyline (10 mg), duloxetine (30 mg), gabapentin (300 mg), pregabalin (75 mg)] for their effectiveness and safety. The trial duration was eight weeks. The modified Toronto Clinical Neuropathy Score (mTCNS), Verbal Rating Scale (VRS) and Geriatric Depression Scale (GDS) were used for effectiveness. Safety was assessed by monitoring adverse events. Multiple groups were compared with Kruskal-Wallis test, and post hoc analysis was performed with Dunn's test. A p value <.05 was considered significant.

Results: A total of 80 patients were recruited (20 patients in each arm) with a mean age of 65.4 years, and 56.3% were male. Pregabalin was superior to amitriptyline (p = .04) and duloxetine (p = .02) in reducing mTCNS. Similarly, pregabalin was superior to amitriptyline (p = .041 and duloxetine (p = .009) in reducing GDS score. All drugs were comparable in reducing VRS (p = .17). A total of 14 adverse events were observed, out of which constipation, sedation and dizziness were common. Maximum adverse events were observed in the duloxetine arm (6/14).

Conclusion: Pregabalin was superior to amitriptyline and duloxetine, whereas it was comparable to gabapentin in effectiveness. Constipation was the most common adverse event, but the central nervous system was the most involved in adverse events.