THE EFFICACY AND SAFETY OF THE NEW DRUG FISSARIO IN CLINICAL USAGE FOR THE TOPICAL TREATMENT OF THE ACUTE ANAL FISSURE ASSOCIATED WITH CHRONIC HEMORRHOID DISEASE

Abstract

AIM. To prove primary efficiency of Fissario in comparison with RelifAdvansfor anal fissure therapy and to confirm previously received safety data. MATERIAL AND METHODS. Multicenter, open, randomized, comparative clinical trial in parallel groups with active control (RelifAdvans) was conducted at 18 clinical centers in Russia, 188 patients participated.. Patients with deep and superficial analfissure in combination with chronic hemorrhoids were eligible for participation in trial. Patients administered investigational drugs 2 times a day for 28 days. Efficacy primary endpoint assessed as part ofpatients withfull healing of analfissure and epithelization on Day 28 from start of therapy. Also pharmacokinetics research was performed.: concentration of Nifedipinein blood plasma was assessed. Safety assessment was performed based on frequency and character of registered adverse events. RESULTS. Efficacy analysis showed statistically significant differences in favor of investigational drug in comparison with comparator on efficacy primary endpoint -part of patients with healing of anal fissure at Day 28. Difference of parts of defendants between group of investigational drug and comparator in full data population (with replacement of missed data) was 24,5 % (two-sided confidence interval 95 % for a difference of parts [11,9; 37,0 %], р <0,001), ratio of parts 1,4. Pharmacokinetics analysis based on Nifedipine concentration in plasma showed that observed concentration of Nifedipine in plasma after single rectal and topical use are significantly lower than therapeutic range. Most common adverse events registered during trial were gastrointestinal tract reactions and reactions at investigational drug application site. No serious adverse events, no serious unexpected adverse drug reactions nor cases of death were registered during trial. No influence of Fissario on results of clinical blood tests, biochemical blood tests, general urinalysis and ECG were registered during trial. CONCLUSION. Fissario, ointment for rectal and topical use, is an effective and safe drug for local therapy of acute anal fissure in combination with a chronic hemorrhoids. Fissario achieved more than 40 % superiority in comparison with Relif Advans based on anal fissure epithelizationrate at Day 28 of treatment.