지방대학병원의 사례분석: 성기능장애 개선 치료를 위한 Trazodone의 Unlabeled Use에 대한 평가
Evaluation for Unlabeled use of Trazodone in Sexual Dysfunction Treatment
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Sexual dysfunction is rising one of major diseases on modern society and it decreases the quality of life. Sildenafil, phosphodiesterase (PDE) inhibitor is a major medication for sexual dysfunction such as erectile dysfunction, uncomfortable sensation, or libido decrease. However, an antidepressant, trazodone which is serotonin-reuptake inhibitor is using for sexual dysfunction as the “unlabeled use” in Korea even the efficacy and safety of trazodone were not approved yet. Therefore, we tried to evaluate and compare the efficacy and safety of both trazodone and sildenafil for sexual dysfunction. This study was performed retrospectively based on the medical records of each 30 patients with one of drugs in Department of Urology, Chungbuk National University Hospital, from July 1st, 2006 to April 30th, 2007. All the prescribed doses were appropriate as trazodone 25 mg twice a day, sildenafil 50 or 100 mg daily. And efficacy were each at 14 patients (46.7%) per trazodone and 6 patients (20%) per sildenafil, respectively. Adverse drug reactions were showed at 5 patients (16.7%) in trazodone and 2 patients (6.7%) in sildenafil, respectively. In conclusion, the “unlabeled use” of trazodone for sexual dysfunction treatment is necessary for some selected patients by doctor's decision in Korea even though PDE inhibitors are still first choice. However, both medications are still recommended to monitor adverse drug reaction during the use.
Abstract
Sexual dysfunction is rising one of major diseases on modern society and it decreases the quality of life. Sildenafil, phosphodiesterase (PDE) inhibitor is a major medication for sexual dysfunction such as erectile dysfunction, uncomfortable sensation, or libido decrease. However, an antidepressant, trazodone which is serotonin-reuptake inhibitor is using for sexual dysfunction as the “unlabeled use” in Korea even the efficacy and safety of trazodone were not approved yet. Therefore, we tried to evaluate and compare the efficacy and safety of both trazodone and sildenafil for sexual dysfunction. This study was performed retrospectively based on the medical records of each 30 patients with one of drugs in Department of Urology, Chungbuk National University Hospital, from July 1st, 2006 to April 30th, 2007. All the prescribed doses were appropriate as trazodone 25 mg twice a day, sildenafil 50 or 100 mg daily. And efficacy were each at 14 patients (46.7%) per trazodone and 6 patients (20%) per sildenafil, respectively. Adverse drug reactions were showed at 5 patients (16.7%) in trazodone and 2 patients (6.7%) in sildenafil, respectively. In conclusion, the “unlabeled use” of trazodone for sexual dysfunction treatment is necessary for some selected patients by doctor's decision in Korea even though PDE inhibitors are still first choice. However, both medications are still recommended to monitor adverse drug reaction during the use.