PMID- 20214718 OWN - NLM STAT- MEDLINE DCOM- 20100930 LR - 20220419 IS - 1743-6109 (Electronic) IS - 1743-6095 (Linking) VI - 7 IP - 5 DP - 2010 May TI - Efficacy and tolerability of lodenafil carbonate for oral therapy of erectile dysfunction: a phase III clinical trial. PG - 1928-36 LID - 10.1111/j.1743-6109.2010.01711.x [doi] AB - INTRODUCTION: This is a phase III, prospective, randomized, double-blind, placebo-controlled clinical trial on lodenafil carbonate (LC), a novel phosphodiesterase 5 inhibitor developed in Brazil. AIM: Expanding information on LC efficacy and safety. MAIN OUTCOME MEASURES: International Index of Erectile Function (IIEF) erectile domain, positive answers to the sexual encounter profile (SEP)-2 and SEP-3 questions and incidence of adverse events (AEs). METHODS: A total of 350 men with erectile dysfunction (ED) of all degrees were randomized to placebo, LC 40 mg or LC 80 mg and followed for 4 weeks. They completed the IIEF and answered the SEP questions 2 and 3 after each intercourse without and with the use of LC. RESULTS: IIEF Erectile Domain scores without and with the use of medication were the following (mean [M] +/- standard deviation [SD]): placebo = 13.9 +/- 5.2 and 14.8 +/- 7.8; LC 40 mg = 13.6 +/- 5.3 and 18.6 +/- 8.0; LC 80 mg = 13.4 +/- 4.9 and 20.6 +/- 7.7 (analysis of variance [ANOVA] P < 0.01). Positive answers to SEP-2 without and with the use of medication were the following (M +/- SD): placebo = 55.3 +/- 43.2% and 52.1 +/- 41.4%; LC 40 mg = 46.4 +/- 44.3% and 63.5 +/- 42.0%; LC 80 mg = 50.2 +/- 40.9% and 80.8 +/- 32.3% (ANOVA P < 0.01). Positive answers to SEP-3 were the following: placebo = 20.2 +/- 32.3% and 29.7 +/- 38.1%; LC 40 mg = 19.6 +/- 34.3% and 50.8 +/- 44.4%; LC 80 mg = 20.8 +/- 33.2% and 66.0 +/- 39.3% (ANOVA P < 0.01). The patients with at least one AE were placebo = 28.7%, LC 40 mg = 40.9%, and LC 80 mg = 49.5%. AEs whose incidence was significantly higher with LC than with placebo included rhinitis, headache, flushing, visual disorder, and dizziness. CONCLUSIONS: LC showed a satisfactory efficacy-safety profile for oral therapy of ED. FAU - Glina, Sidney AU - Glina S AD - Department of Urology, Hospital Ipiranga, Sao Paulo, SP, Brazil. glinas@terra.com.br FAU - Fonseca, Gilvan N AU - Fonseca GN FAU - Bertero, Eduardo B AU - Bertero EB FAU - Damiao, Ronaldo AU - Damiao R FAU - Rocha, Luiz C A AU - Rocha LC FAU - Jardim, Carlos R F AU - Jardim CR FAU - Cairoli, Carlos E AU - Cairoli CE FAU - Teloken, Claudio AU - Teloken C FAU - Torres, Luiz O AU - Torres LO FAU - Faria, Geraldo E AU - Faria GE FAU - da Silva, Marcelo B AU - da Silva MB FAU - Pagani, Eduardo AU - Pagani E LA - eng PT - Clinical Trial, Phase III PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial DEP - 20100225 PL - Netherlands TA - J Sex Med JT - The journal of sexual medicine JID - 101230693 RN - 0 (Carbonates) RN - 0 (Phosphodiesterase 5 Inhibitors) RN - 0 (Phosphodiesterase Inhibitors) RN - 0 (Piperazines) RN - 0 (Pyrimidines) RN - 29X84F932D (lodenafil carbonate) SB - IM MH - Aged MH - Carbonates/adverse effects/therapeutic use MH - Dose-Response Relationship, Drug MH - Double-Blind Method MH - Humans MH - Male MH - Middle Aged MH - Patient Satisfaction MH - Penile Erection/drug effects MH - *Phosphodiesterase 5 Inhibitors MH - Phosphodiesterase Inhibitors/adverse effects/*therapeutic use MH - Piperazines/adverse effects/therapeutic use MH - Prospective Studies MH - Pyrimidines/adverse effects/therapeutic use MH - Treatment Outcome EDAT- 2010/03/11 06:00 MHDA- 2010/10/01 06:00 CRDT- 2010/03/11 06:00 PHST- 2010/03/11 06:00 [entrez] PHST- 2010/03/11 06:00 [pubmed] PHST- 2010/10/01 06:00 [medline] AID - S1743-6095(15)33027-7 [pii] AID - 10.1111/j.1743-6109.2010.01711.x [doi] PST - ppublish SO - J Sex Med. 2010 May;7(5):1928-36. doi: 10.1111/j.1743-6109.2010.01711.x. Epub 2010 Feb 25.