Cyclosporine A and pentosan polysulfate sodium for the treatment of interstitial cystitis: a randomized comparative study.
OBJECTIVE
In 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.


METHODS
A 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.


RESULTS
CyA 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.


CONCLUSIONS
CyA is more effective than PPS in interstitial cystitis.
Sairanen
Jukka
J
Department of Urology, Helsinki University Hospital, 00029 HUS, Helsinki, Finland. jukka.sairanen@hus.fi
Tammela
Teuvo L J
TL
Leppilahti
Mikael
M
Multanen
Markku
M
Paananen
Ilkka
I
Lehtoranta
Kari
K
Ruutu
Mirja
M
D000328:Adult; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects / Q000627:therapeutic use*; D016572:Cyclosporine / Q000009:adverse effects / Q000627:therapeutic use*; D018856:Cystitis, Interstitial / Q000150:complications / Q000188:drug therapy* / Q000453:epidemiology; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010426:Pentosan Sulfuric Polyester / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D013575:Syncope / Q000209:etiology / Q000517:prevention & control; D016896:Treatment Outcome
D000894:Anti-Inflammatory Agents, Non-Steroidal; D007166:Immunosuppressive Agents; D010426:Pentosan Sulfuric Polyester; D016572:Cyclosporine