PMID- 24192967 OWN - NLM STAT- MEDLINE DCOM- 20140103 LR - 20220410 IS - 1756-1833 (Electronic) IS - 0959-8138 (Print) IS - 0959-8138 (Linking) VI - 347 DP - 2013 Nov 5 TI - Tamsulosin treatment for benign prostatic hyperplasia and risk of severe hypotension in men aged 40-85 years in the United States: risk window analyses using between and within patient methodology. PG - f6320 LID - bmj.f6320 [pii] LID - 10.1136/bmj.f6320 [doi] LID - f6320 AB - OBJECTIVE: To characterize risk of hypotension requiring admission to hospital in middle aged and older men treated with tamsulosin for benign prostatic hyperplasia. DESIGN: Population based retrospective cohort study (between patient methodology) and self controlled case series (within patient methodology). SETTING: Healthcare claims data from the IMS Lifelink database in the United States. PARTICIPANTS: Men aged 40-85 years with private US healthcare insurance entering the cohort at their first dispensing for tamsulosin or for a 5alpha reductase inhibitor (5ARI) between January 2001 and June 2011 after a minimum of six months' enrolment. MAIN OUTCOMES MEASURES: Hypotension requiring admission to hospital. Cox proportional hazards models estimated rate ratios at time varying intervals during follow-up: weeks 1-4, 5-8, and 9-12 after tamsulosin initiation; weeks 1-4, 5-8, and 9-12 after restarting tamsulosin (after a four week gap); and maintenance tamsulosin treatment (remaining exposed person time). Covariates included age, calendar year, demographics, antihypertensive use, healthcare use, and a Charlson comorbidity score. A self controlled case series, having implicit control for time invariant covariates, was additionally conducted. RESULTS: Among 383,567 new users of study drugs (tamsulosin 297,596; 5ARI 85,971), 2562 admissions to hospital for severe hypotension were identified. The incidence for hypotension was higher for tamsulosin (42.4 events per 10,000 person years) than for 5ARIs (31.3 events per 10,000 person years) or all accrued person time (29.1 events per 10,000 person years). After tamsulosin initiation, the cohort analysis identified an increased rate of hypotension during weeks 1-4 (rate ratio 2.12 (95% confidence interval 1.29 to 3.04)) and 5-8 (1.51 (1.04 to 2.18)), and no significant increase at weeks 9-12. The rate ratio for hypotension also increased at weeks 1-4 (1.84 (1.46 to 2.33)) and 5-8 (1.85 (1.45 to 2.36)) after restarting tamsulosin, as did maintenance tamsulosin treatment (1.19 (1.07 to 1.32)). The self controlled case series gave similar results as the cohort analysis. CONCLUSIONS: We observed a temporal association between tamsulosin use for benign prostatic hyperplasia and severe hypotension during the first eight weeks after initiating treatment and the first eight weeks after restarting treatment. This association suggests that physicians should focus on improving counseling strategies to warn patients regarding the "first dose phenomenon" with tamsulosin. FAU - Bird, Steven T AU - Bird ST AD - Food and Drug Administration, Center for Drug Evaluation and Research, Office of Surveillance and Epidemiology, Department of Epidemiology, Silver Spring, MD, USA. FAU - Delaney, Joseph A C AU - Delaney JA FAU - Brophy, James M AU - Brophy JM FAU - Etminan, Mahyar AU - Etminan M FAU - Skeldon, Sean C AU - Skeldon SC FAU - Hartzema, Abraham G AU - Hartzema AG LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20131105 PL - England TA - BMJ JT - BMJ (Clinical research ed.) JID - 8900488 RN - 0 (5-alpha Reductase Inhibitors) RN - 0 (Adrenergic alpha-1 Receptor Antagonists) RN - 0 (Sulfonamides) RN - G3P28OML5I (Tamsulosin) SB - IM CIN - BMJ. 2013;347:f6492. PMID: 24192968 MH - 5-alpha Reductase Inhibitors/adverse effects/*therapeutic use MH - Adrenergic alpha-1 Receptor Antagonists/adverse effects/*therapeutic use MH - Adult MH - Aged MH - Aged, 80 and over MH - Cohort Studies MH - Follow-Up Studies MH - Hospitalization/*statistics & numerical data MH - Humans MH - Hypotension/chemically induced/*epidemiology MH - Incidence MH - Male MH - Middle Aged MH - Proportional Hazards Models MH - Prostatic Hyperplasia/*drug therapy MH - Retrospective Studies MH - Risk Assessment MH - Sulfonamides/adverse effects/therapeutic use MH - Tamsulosin MH - United States PMC - PMC3817852 COIS- Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare: support from the McGill University Health Center, Fonds de la Recherche en Sante du Quebec, and the Ministere de la Sante et des Services Sociaux for the submitted work; JMB has received peer review financial support from le Fonds de la Recherche en Sante du Quebec, JACD has a research grant from the Agency for Healthcare Research and Quality, AGH is a principal investigator for the Observational Medical Outcomes Partnership, a private-public partnership designed to help improve drug safety monitoring, and STB is employed by the US Food and Drug Administration; no other relationships or activities that could appear to have influenced the submitted work. EDAT- 2013/11/07 06:00 MHDA- 2014/01/05 06:00 PMCR- 2013/11/05 CRDT- 2013/11/07 06:00 PHST- 2013/11/07 06:00 [entrez] PHST- 2013/11/07 06:00 [pubmed] PHST- 2014/01/05 06:00 [medline] PHST- 2013/11/05 00:00 [pmc-release] AID - bmj.f6320 [pii] AID - birs014310 [pii] AID - 10.1136/bmj.f6320 [doi] PST - epublish SO - BMJ. 2013 Nov 5;347:f6320. doi: 10.1136/bmj.f6320.