Effectiveness and Safety of Lidocaine-Nifedipine Combination in Patients With Acute and Chronic Anal Fissure: A Retrospective, Multi-centric, Post-marketing Surveillance Study.

Background Anal fissures (AFs) are common and painful conditions that are frequently managed surgically; however, they are limited by fecal incontinence. Pharmacological management with calcium channel blockers has recently gained acceptance. This study aimed to evaluate the effectiveness and safety of twice-daily nifedipine (0.3% w/w) and lidocaine (1.5% w/w) cream in patients with acute AF (AAF) and chronic AF (CAF). Methods This retrospective, multi-centric, post-marketing surveillance study was conducted over a period of four weeks in the Department of Gastroenterology and Surgery across 46 institutes. The study included data of 431 patients with AAF (n=290) and CAF (n=141). The primary outcome measure was the percentage of patients with healed AFs, assessed at Weeks 1, 4, and 8. The secondary outcome measures were pain relief, evaluated using a 5-point VAS; percentage of patients with bleeding per anus; and adverse events (AEs), assessed at baseline and weekly follow-up intervals for eight weeks. Results At eight weeks, AF resolved significantly compared to the baseline (p<0.0001). During similar intervals, the incidence of bleeding per anus decreased significantly (p<0.0001), coupled with a significant reduction in the VAS score (p<0.0001). Though the resolution of AFs was comparable between AAF and CAF (p>0.05), the patients with AAF had a significantly greater reduction in bleeding per anus at Weeks 7 and 8 (p<0.05), with a significant decrease in the VAS score at Week 8 (p<0.05). All reported AEs were mild and self-limiting. Conclusion Topical nifedipine-lidocaine resulted in significant AF resolution, with significant pain relief and reduction in bleeding per anus, together with excellent tolerability.