Safety and efficacy of alprostadil sterile powder (S. Po., CAVERJECT®) in diabetic patients with erectile dysfunction

Yuh Shyan Tsai, Johnny Shinn Nan Lin, Yung Ming Lin

Research output: Contribution to journalArticle

5 Citations (Scopus)

Abstract

Objectives: To evaluate the long-term efficacy and safety of intracavernosal alprostadil (CAVERJECT®) in diabetic patients with erectile dysfunction (ED). Patients and Methods: This study included 31 diabetic men (aged 44-75 years) with ED of ≥4 months duration. All patients were initially instructed in the self- injection technique at the investigator's clinic. The optimal dose was determined for each patient and set at one of the following: 5, 10, 20, 30, 40, 50, or 60 μg. After the optimal dose was determined and the patient was well trained, the self- injection home phase was followed for 6 months. The efficacy and adverse events were documented. Results: An optimal dose was determined for 29 men (93.5%) and in 16 men (55%) it was ≥20 μg. During the home phase, 76.5% of injections assessed by the patients resulted in satisfactory sexual activity and 72.5% of injections assessed by partners resulted in satisfactory intercourse. A total of 16 patients dropped out during the titration phase (n = 2) and the home phase (n = 14). The most common reasons included lack of efficacy (n = 3, all in the home phase), intolerable penile pain (1 in the titration phase, 2 in the home phase) and dissatisfaction with the higher dosage (n = 2). Penile pain occurred in 19 (61%) of 31 patients. Most were tolerable, and the incidence decreased with time. Prolonged erection occurred in 2 men (6.5%), and no priapism was noted. Penile fibrosis occurred in 1 patient (3.2%). None of the systemic medical events were related to the study mediction. However, 1 patient suffered from right putaminal hemorrhage in the last month, and this was considered to be caused by underlying hypertension and not drug-related. Conclusion: Despite the high incidence of penile pain, most of the occurrences were tolerable. Despite a higher withdrawal rate in this study, intracavernosal alprostadil is still considered as a relatively effective and safe treatment in some diabetic patients with ED if the individual dose is established by titration and patients are trained in the self-injection technique with period supervision. Copyright (C) 2000 S. Karger AG, Basel.

Original languageEnglish
Pages (from-to)177-183
Number of pages7
JournalEuropean Urology
Volume38
Issue number2
DOIs
Publication statusPublished - 2000 Jan 1

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Alprostadil
Erectile Dysfunction
Powders
Safety
Injections
Pain
Putaminal Hemorrhage
Priapism
Incidence
Patient Rights
Sexual Behavior
Fibrosis
Research Personnel
Hypertension

All Science Journal Classification (ASJC) codes

  • Urology

Cite this

@article{04969886405c4c518506b617d0d804c0,
title = "Safety and efficacy of alprostadil sterile powder (S. Po., CAVERJECT{\circledR}) in diabetic patients with erectile dysfunction",
abstract = "Objectives: To evaluate the long-term efficacy and safety of intracavernosal alprostadil (CAVERJECT{\circledR}) in diabetic patients with erectile dysfunction (ED). Patients and Methods: This study included 31 diabetic men (aged 44-75 years) with ED of ≥4 months duration. All patients were initially instructed in the self- injection technique at the investigator's clinic. The optimal dose was determined for each patient and set at one of the following: 5, 10, 20, 30, 40, 50, or 60 μg. After the optimal dose was determined and the patient was well trained, the self- injection home phase was followed for 6 months. The efficacy and adverse events were documented. Results: An optimal dose was determined for 29 men (93.5{\%}) and in 16 men (55{\%}) it was ≥20 μg. During the home phase, 76.5{\%} of injections assessed by the patients resulted in satisfactory sexual activity and 72.5{\%} of injections assessed by partners resulted in satisfactory intercourse. A total of 16 patients dropped out during the titration phase (n = 2) and the home phase (n = 14). The most common reasons included lack of efficacy (n = 3, all in the home phase), intolerable penile pain (1 in the titration phase, 2 in the home phase) and dissatisfaction with the higher dosage (n = 2). Penile pain occurred in 19 (61{\%}) of 31 patients. Most were tolerable, and the incidence decreased with time. Prolonged erection occurred in 2 men (6.5{\%}), and no priapism was noted. Penile fibrosis occurred in 1 patient (3.2{\%}). None of the systemic medical events were related to the study mediction. However, 1 patient suffered from right putaminal hemorrhage in the last month, and this was considered to be caused by underlying hypertension and not drug-related. Conclusion: Despite the high incidence of penile pain, most of the occurrences were tolerable. Despite a higher withdrawal rate in this study, intracavernosal alprostadil is still considered as a relatively effective and safe treatment in some diabetic patients with ED if the individual dose is established by titration and patients are trained in the self-injection technique with period supervision. Copyright (C) 2000 S. Karger AG, Basel.",
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Safety and efficacy of alprostadil sterile powder (S. Po., CAVERJECT®) in diabetic patients with erectile dysfunction. / Tsai, Yuh Shyan; Lin, Johnny Shinn Nan; Lin, Yung Ming.

In: European Urology, Vol. 38, No. 2, 01.01.2000, p. 177-183.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Safety and efficacy of alprostadil sterile powder (S. Po., CAVERJECT®) in diabetic patients with erectile dysfunction

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N2 - Objectives: To evaluate the long-term efficacy and safety of intracavernosal alprostadil (CAVERJECT®) in diabetic patients with erectile dysfunction (ED). Patients and Methods: This study included 31 diabetic men (aged 44-75 years) with ED of ≥4 months duration. All patients were initially instructed in the self- injection technique at the investigator's clinic. The optimal dose was determined for each patient and set at one of the following: 5, 10, 20, 30, 40, 50, or 60 μg. After the optimal dose was determined and the patient was well trained, the self- injection home phase was followed for 6 months. The efficacy and adverse events were documented. Results: An optimal dose was determined for 29 men (93.5%) and in 16 men (55%) it was ≥20 μg. During the home phase, 76.5% of injections assessed by the patients resulted in satisfactory sexual activity and 72.5% of injections assessed by partners resulted in satisfactory intercourse. A total of 16 patients dropped out during the titration phase (n = 2) and the home phase (n = 14). The most common reasons included lack of efficacy (n = 3, all in the home phase), intolerable penile pain (1 in the titration phase, 2 in the home phase) and dissatisfaction with the higher dosage (n = 2). Penile pain occurred in 19 (61%) of 31 patients. Most were tolerable, and the incidence decreased with time. Prolonged erection occurred in 2 men (6.5%), and no priapism was noted. Penile fibrosis occurred in 1 patient (3.2%). None of the systemic medical events were related to the study mediction. However, 1 patient suffered from right putaminal hemorrhage in the last month, and this was considered to be caused by underlying hypertension and not drug-related. Conclusion: Despite the high incidence of penile pain, most of the occurrences were tolerable. Despite a higher withdrawal rate in this study, intracavernosal alprostadil is still considered as a relatively effective and safe treatment in some diabetic patients with ED if the individual dose is established by titration and patients are trained in the self-injection technique with period supervision. Copyright (C) 2000 S. Karger AG, Basel.

AB - Objectives: To evaluate the long-term efficacy and safety of intracavernosal alprostadil (CAVERJECT®) in diabetic patients with erectile dysfunction (ED). Patients and Methods: This study included 31 diabetic men (aged 44-75 years) with ED of ≥4 months duration. All patients were initially instructed in the self- injection technique at the investigator's clinic. The optimal dose was determined for each patient and set at one of the following: 5, 10, 20, 30, 40, 50, or 60 μg. After the optimal dose was determined and the patient was well trained, the self- injection home phase was followed for 6 months. The efficacy and adverse events were documented. Results: An optimal dose was determined for 29 men (93.5%) and in 16 men (55%) it was ≥20 μg. During the home phase, 76.5% of injections assessed by the patients resulted in satisfactory sexual activity and 72.5% of injections assessed by partners resulted in satisfactory intercourse. A total of 16 patients dropped out during the titration phase (n = 2) and the home phase (n = 14). The most common reasons included lack of efficacy (n = 3, all in the home phase), intolerable penile pain (1 in the titration phase, 2 in the home phase) and dissatisfaction with the higher dosage (n = 2). Penile pain occurred in 19 (61%) of 31 patients. Most were tolerable, and the incidence decreased with time. Prolonged erection occurred in 2 men (6.5%), and no priapism was noted. Penile fibrosis occurred in 1 patient (3.2%). None of the systemic medical events were related to the study mediction. However, 1 patient suffered from right putaminal hemorrhage in the last month, and this was considered to be caused by underlying hypertension and not drug-related. Conclusion: Despite the high incidence of penile pain, most of the occurrences were tolerable. Despite a higher withdrawal rate in this study, intracavernosal alprostadil is still considered as a relatively effective and safe treatment in some diabetic patients with ED if the individual dose is established by titration and patients are trained in the self-injection technique with period supervision. Copyright (C) 2000 S. Karger AG, Basel.

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