Post-marketing Surveillance of the Safety of Dutasteride Prescribed to Korean Patients with Benign Prostate Hyperplasia

Joon Hyung Kim; Ji-Young Bae; Shin-Young Oh; Yil-Seob Lee

doi:10.0000/jkscpt.2012.20.1.85

Journal List > J Korean Soc Clin Pharmacol Ther > v.20(1) > 1055118

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Kim, Bae, Oh, and Lee: Post-marketing Surveillance of the Safety of Dutasteride Prescribed to Korean Patients with Benign Prostate Hyperplasia

Original Article

Journal of Korean Society for Clinical Pharmacology and Therapeutics

Journal of Korean Society for Clinical Pharmacology and Therapeutics 2012; 20(1): 85-94.

Published online: 30 June 2012

DOI: https://doi.org/10.0000/jkscpt.2012.20.1.85

Post-marketing Surveillance of the Safety of Dutasteride Prescribed to Korean Patients with Benign Prostate Hyperplasia

Joon Hyung Kim, Ji-Young Bae, Shin-Young Oh, Yil-Seob Lee

GlaxoSmithKline Korea, Seoul, Korea.

Corresponding author (Yil.S.Lee@gsk.com)

Received 22 May 2012 Revised 11 June 2012 Accepted 14 June 2012

Abstract

Background

Dutasteride is an inhibitor of both types I and II 5 alpha-reductase and was approved in Korea in April 2004. This post-marketing surveillance was to assess the safety of dutasteride in Korean patients with benign prostate hyperplasia in real life and to elucidate the risk factors related adverse events.

Methods

From December 2004 to January 2010, 3,977 patients were enrolled by 184 urologists. According to post-marketing surveillance regulation, patients were enrolled consecutively. Patients administered dutasteride at least once were included in safety assessment. The incidences of any adverse events and serious adverse events were evaluated. Multiple logistic regression method was used to identify risk factors related to adverse events.

Results

The safety assessment included 3,870 patients with the mean age of 67.3 years. The incidence of adverse events was 3.8 %. The most frequent adverse event was impotence (75 cases, 1.9 %), libido decrease (49 cases, 1.3 %), ejaculation disorder (30 cases, 0.8 %), and gynecomastia (5 cases, 0.1 %). The incidence of unexpected adverse events was 0.5 % and cerebral infarction, lung cancer, pulmonary embolism, and diarrhea were reported as serious adverse events.

Conclusion

In this survey, impotence was the most frequently reported adverse events. Dutasteride was well tolerated in Korean patients with benign prostate hyperplasia. These results updated the safety information and would provide important additional information for prescribers.

Keywords: Dutasteride, Safety, Drug toxicity, Post-marketing, 5 alpha-reductase inhibitors

Figures and Tables

Table 1

Baseline characteristics of patients

Table 2

Concurrently prescribed α-blockers

Table 3

Reported adverse events and adverse drug reaction

Table 4

Adverse events by seriousness and expectedness

Table 5

Time to development of adverse events

Table 6

Risk factors for adverse event development

^*P-value from Logistic regression model.

Table 7

Efficacy analysis based on parameters including prostate volume, Qmax, residual urine volume, PSA and IPSS

^*Log (PSA), ^†P-value from paired t-test.

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