Doxazosin for Benign Prostatic Hyperplasia: Long-term Efficacy and Safety in Hypertensive and Normotensive Patients

Objectives: To investigate (a) the magnitude and durability of symptom score reduction and HRQL score improvement (including sexual drive); (b) adverse outcomes; and (c) progression to acute urinary retention and prostate surgery up to three years of treatment with alfuzosin.Methods: Three thousand two hundred and twenty-eight BPH-patients out of 812 centers were included in a prospective three-year open-labelled study and treated with alfuzosin (immediate release formulation) at the recommended dosage. A symptom score (Boyarsky modi®ed) and a 20-item BPH speci®c HRQL score including three questions of sexuality (Urolife TM BPH QoL 20) were selfadministered at baseline, 3,6,12,18,24,30, and 36 months.Results: Two thousand ®ve hundred and seventy-nine patients (79.9%) completed the study at the end of three years. Symptom score was signi®cantly reduced by 54% at 3 months and this reduction was maintained up to 36 months (748.4%); HRQL score was signi®cantly improved by 45.4% at 12 months and this improvement was maintained up to 36 months ( 43.4%). Alfuzosin was well tolerated: the quantitative and qualitative distribution of adverse events was similar to that previously observed in placebo-controlled studies (vertigo/dizziness: 2.1%). Adverse events accounted for 4.2% of the drop-outs. 120 patients (3.7%) were operated on for BPH and nine patients (0.3%) experienced acute urinary retention.Conclusion: This medical outcomes study con®rms the long-term safety pro®le of alfuzosin in the naturalistic conditions of general practice and highlights the need to measure HRQL in the context of patient's preferences.

Section: Discussionmentioning

confidence: 63%

Three-year prospective study of 3228 clinical BPH patients treated with alfuzosin in General Practice

Lukacs

Grange

Comet

et al. 1998

“…Interim analysis of ongoing open-label extensions (up to 42 months) of these double-blind phase III studies, in which 450 patients with BPH with or without concomitant hypertension entered, has revealed no clear differences in the toleration pro®le of doxazosin between younger and older patients, whether hypertensive or normotensive. 18,19 As in the original phase III studies, most adverse events were not serious and the most commonly reported continue to be dizziness, headache and fatigue, none of which have occurred more frequently in older than younger men. Likewise, events related to the cardiovascular system, including syncope, have rarely occurred in either age group.…”

Section: Discussionmentioning

confidence: 90%

“…Data from long-term open studies of doxazosin in both hypertension 17 and BPH 18,19 indicate that doxazosin appears to be well tolerated in the longterm. Interim analysis of ongoing open-label extensions (up to 42 months) of these double-blind phase III studies, in which 450 patients with BPH with or without concomitant hypertension entered, has revealed no clear differences in the toleration pro®le of doxazosin between younger and older patients, whether hypertensive or normotensive.…”

Section: Discussionmentioning

confidence: 99%

Doxazosin in the treatment of benign prostatic hyperplasia. A review of the safety profile in older patients

Kirby

Jardin

1997

The objective of this paper is to review the safety of doxazosin in older patients ( ! 65 y) with benign prostatic hyperplasia (BPH) as reported in seven international clinical trials. Data from seven double-blind, placebo-controlled, phase III trials, in both normotensive and hypertensive patients with BPH were collated and analysed. Data on doxazosin were available for 341 men 65 y and over. Even though older patients can be at particular risk of adverse drug reactions, there was no apparent evidence of poor tolerability with doxazosin in older patients with BPH. The percentages of younger normotensive BPH patients (`65 y) experiencing at least one adverse event were 47 and 44% for doxazosin and placebo groups, respectively; for older normotensive BPH patients ( ! 65 y) the corresponding values were 42 and 38%. For the younger hypertensive BPH patients the incidence rates for adverse events were 55% (doxazosin) and 42% (placebo) and for older hypertensive BPH patients 43 and 30%, respectively. The most commonly reported adverse events for all groups were dizziness, headache and fatigue and few serious adverse effects were reported throughout these trials. It can be concluded that doxazosin is well tolerated in young and old, normotensive and hypertensive patients with BPH.

“…61 Doxazosin has been shown to improve AUA and modi®ed Boyarsky symptom scores for severity and bothersomeness 14 ± 31% from baseline and peak¯ow rates 19% (1.9 mLas) from baseline (10.0 mLas) for up to 48 months (n 450 at entry; n 28 at 48 months). 6 Tamsulosin has been shown to improve Boyarsky symptom scores 36% (3.4 units) from baseline (9.4 units) and peak¯ow rates 13.7% (1.4 mLas) from baseline (10.2 mLas) for up to 14 months (n 240 at entry; n 181 at 14 months). 7 A preliminary report has indicated that tamsulosin maintains improved symptom scores and¯ow rates for up to 36 months.…”

Section: Long-term Ef®cacymentioning

confidence: 97%

Alpha–1–adrenoceptor blockade in the treatment of benign prostatic hyperplasia

Lowe

1999

In light of the growing interest in the concept of`uroselectivity' and in the increased worldwide use of alpha-blockers for benign prostatic hyperplasia (BPH), this review evaluates the relative bene®ts of various alpha-blocking agents in the treatment of BPH. The pharmacological and physiological selectivity as well as the clinical ef®cacy and safety of alfuzosin, doxazosin (Cardura 1 ), tamsulosin (Flomax 1 ), and terazosin (Hytrin 1 ) are compared. In reviewing ef®cacy and safety, emphasis is given to 17 placebo-controlled, doubleblind trials of these alpha-blockers published in peer-reviewed journals. This review also considers long-term data, effects on blood pressure, costs, and dose ranges.