CYCLOSPORINE A AND PENTOSAN POLYSULFATE SODIUM FOR THE TREATMENT OF INTERSTITIAL CYSTITIS: A RANDOMIZED COMPARATIVE STUDY

ABSTRACTPurposeIn a previous retrospective analysis, cyclosporine A (CyA) was highly efficient in treating patients with interstitial cystitis. A prospective randomized study with this immunosuppressive agent was warranted. We compared CyA to pentosan polysulfate sodium (PPS) in patients with interstitial cystitis.Materials and MethodsA total of 64 patients with interstitial cystitis meeting the National Institute of Diabetes and Digestive and Kidney Diseases criteria were enrolled in a randomized prospective study. Patients were randomized in a 1:1 ratio to 1.5 mg/kg CyA twice daily (27 women, 5 men) or 100 mg PPS 3 times daily (26 women, 6 men) for a period of 6 months. The primary end point was daily micturition frequency, and secondary end points were mean and maximal voided volume, number of nocturia episodes, O’Leary-Sant symptom and problem indexes, visual analogue scale for pain, and subjective global response assessment.ResultsCyA was superior to PPS in all clinical outcome parameters measured at 6 months. Micturition frequency in 24 hours was significantly reduced in the CyA arm compared to the PPS arm (-6.7 ± 4.7 vs -2.0 ± 5.1 times). The clinical response rate (according to global response assessment) was 75% for CyA compared to 19% for PPS (p <0.001). Although there were more adverse events in the CyA arm than in the PPS arm, 29 patients completed the 6-month followup in both groups.ConclusionsCyA is more effective than PPS in interstitial cystitis.