Long-Term Safety and Efficacy of a Once-Daily Formulation of Alfuzosin 10 mg in Patients with Symptomatic Benign Prostatic Hyperplasia: Open-Label Extension Study
2002; Elsevier BV; Volume: 41; Issue: 1 Linguagem: Inglês
10.1016/s0302-2838(01)00016-1
ISSN1873-7560
AutoresPhilip Van Kerrebroeck, A Jardin, Paul Van Cangh, K.U. Laval,
Tópico(s)Cardiac electrophysiology and arrhythmias
ResumoObjectives: To evaluate the long-term safety and efficacy of a new, once-daily (o.d.) prolonged-release formulation of the clinically uroselective α1-blocker, alfuzosin, in patients with symptomatic benign prostatic hyperplasia (BPH). Methods: This is a 9-month open-label extension of a 3-month double-blind, placebo-controlled evaluation of alfuzosin 10 mg o.d. and standard alfuzosin 2.5 mg, three times daily (t.i.d.), administered without dose titration in both cases. A total of 311 patients continued in the extension phase and all received alfuzosin 10 mg o.d. Efficacy was evaluated in all patients enrolled in the extension phase (n=311). Safety was assessed in all patients exposed to alfuzosin, whether in the double-blind or extension phase (n=360). Results: Mean international prostate symptom score (IPSS) improved significantly, from 17.1 to 9.3 (P<0.0001), and mean peak flow rate (PFR) (assessed at through plasma levels) increased significantly, from 9.1 to 11.3 ml/s (P<0.0001), between baseline (i.e. beginning of the double-blind phase) and the endpoint of the extension phase. Quality of life (QOL) index also improved significantly, from 3.3 to 2.1 (P<0.0001). Alfuzosin was well tolerated, with only 16 of 360 patients (4.4%) reporting adverse events potentially related to α-blockade (mainly dizziness). Ejaculation disorders were infrequent (0.6%) and did not show a relationship to treatment. The incidence of asymptomatic orthostatic hypotension was low (2.8%), and no age effect was identified. Conclusions: Alfuzosin 10 mg o.d. provides effective relief from BPH, and clinical benefits are maintained up to 12 months. This study also demonstrates the satisfactory long-term safety of this formulation, and its safe use even in at-risk populations.
Referência(s)