High-Dose Terazosin Therapy (5mg) in Korean Patients with Lower Urinary Tract Symptoms with or without Concomitant Hypertension: A Prospective, Open-Label Study

PURPOSE: We determined the efficacy and safety of a relatively high dose of terazosin (5mg) in Korean patients with lower urinary tract symptoms (LUTS), with or without concomitant hypertension. MATERIALS AND METHODS: From July to December 2006, 200 men who consecutively presented with LUTS were prospectively studied. Eight weeks after treatment, blood pressure (BP), uroflowmetry, and International Prostate Symptom Score (I-PSS) were assessed. For analysis purposes, patients were stratified according to concomitant hypertension. Of the 200 patients, 173 completed the scheduled eight-week treatment period. RESULTS: At baseline, no differences were evident in the two groups in terms of I-PSS, Qmax, PVR and BP. After eight weeks of treatment-although I-PSS and uroflowmetry parameters were not significantly different in the two groups-systolic and diastolic BP in the non-hypertensive control group were higher than in the hypertensive group (p= 0.001 and p=0.0100, respectively). Changes in I-PSS, uroflowmetry parameters, and BPs measured at week eight post- treatment commencement did not significantly differ between the two groups. Moreover, the addition of 5mg of terazosin to antihypertensives did not cause a significant reduction in either systolic or diastolic BP in either group. CONCLUSION: Adding terazosin to existing antihypertensive regimens did not seem to increase the incidence of adverse events. Our findings suggest that 5mg terazosin is effective and that it has an acceptable safety profile as an add-on therapy for patients with LUTS and concomitant hypertension.

Eficácia anti-hipertensiva e tolerabilidade do cloridrato de prazosina de liberaçäo lenta. Estudo multicêntrico brasileiro / Anti-hypertensive efficacy and tolerability of sustained-release prazosin hydrochloride. A Brazilian multicenter study

Objetivo: Avaliar o efeito anti-hipertensivo e a tolerabilidade de dose única diária de cloridrato de prazosina de liberaçäo lenta (SR). Casuística e Métodos: 1393 portadores de hipertensäo arterial sistêmica primária (HAS) leve (644 pacientes e moderada (749 pacientes), com média etária de 47,63 anos, sendo 745 (53,52%) do sexo masculino, 1011 (72,84%) brancos e 279 (20,1%) negros. De acordo com protocolo multicêntrico aberto näo comparativo, os pacientes receberam cloridrato de prozosina SR em dose inicial de 1 mg, ajustada até máximo de 6 mg, de acordo com a resposta (objetivo = pressäo arterial diastólica (PAD) < ou = 90 mmHg), por prazo de 4 semanas. Resultados: A dose média diária foi de 2,08 mg, em tomada única. Ao final do estudo, 1274 (91,46%) pacientes atingiram PAD < ou = 90 mmHg, sendo 624 do grupo HAS leve e 650 do HAS moderada. O número de pacientes sob controle nas 3 primeiras semanas foi de 426 (1ª semana), 844 (2ª semana) e 1147 (3ª semana). APAD reduziu-se da média de 104 ñ 5 mmHg para a de 88 ñ 8 mmHg (p < 0,05). A freqüência cardíaca variou da média de 82 ñ 9 bpm pré-tratametno para 80 ñ 8 bpm na 4ª semana. Reaçöes adversas foram reconhecidas em 377 (27,06%) pacientes, total de 444 eventos, sendo mais freqüente a associaçäo de vertigem, tontura e lipotímia. Apenas 8 (2,12%) pacientes necessitaram reduzir as doses de cloridrato de prazosina SR e 5 (1,32%) tiveram de abandonar o estudo pelos efeitos indesejáveis da droga. Conclusäo: Cloridrato de prazosina SR em tomada única diária parece ser real avanço no tratamento da HAS leve e moderada, facilitando-o sem perda da eficácia e com boa tolerabilidade

Purpose: To evaluate the efficacy and tolerability of a single daily dose of sustained-release (SR) formulation of prazosin hydrocloride. Patients and Methods: 1393 outpatients in a multicenter open comparative trial. 644 patients had mild hypertension and 749 patients had moderate hypertension. The mean age was 47.63 years, 745 (53.52%) were male, 1011 (72.84%) white and 279 (20.1%) black. The patients received prazosin hydrocloride SR during 4 weeks in an initial dose of 1 mg, adjusted to a maximum of 6 mg in order to decrease the diastolic blood pressure (DBP) to 90 mmHg or less. Results: The mean daily dose was 2.08 mg. At the end of the study, 1274 (91.46%) patients had DBP £ 90 mmHg or less. 624 patients were in the mild hypertension group and 650 patients were in the moderate hypertension group. The number of patients under DBP control in the first three weeks was 426 (first week), 844 (second week) and 1147 (third week). The DBP decreased from the mean value of 104 ± 5 mmHg to 88 ± 8 mmHg (p < 0.05)’. The mean heart rate ranged from 82 ± 9 beats/min (pre-treatment) to 80 8 beats/min (fourth week). Adverse effects were identified in 377 (27.06%) patients, total of 444 episodes, the more frequent being dizziness. Only 8 (2.12%) patients had to reduce the doses of prazosin hydrocloride SR and 5 (1.32% ) had to discontinue the treatment on account of the adverse effects of the drug. Conclusion: Prazosin hydrocloride SR in a single daily dose seems to be an advance in the treatment of patients with mild and moderate hypertension.

Prazosin no tratamento inicial da hipertensäo arterial / Prazosin in the initial treatment of arterial hypertension

As alteraçöes metabólicas, recentemente observadas principalmente a nível lipídico, com o uso a longo prazo de diuréticos ou betabloqueadores, têm estimulado vários pesquisadores ao emprego de outros medicamentos anti-hipertensivos, como agentes de primeira escolha no tratamento da hipertensäo arterial. Assim, foi realizado um estudo multicêntrico, aberto, näo comparativo com o objetivo de avaliar a eficácia e tolerabilidade do prazosin no tratamento inicial da hipertensäo arterial leve ou moderada, bem como observar as possíveis alteraçöes promovidas pelo medicamento sobre o metabolismo lipídico. O ensaio constava de 3 fases: fase 1 - placebo (2 semanas); fase II - prazosin (5 semanas) - 1,0 mg/dia (0,5 mg de 12/12h) a 10 mg/dia (5,0 mg de 12/12h); fase III - adiçäo de clortalidona 50 mg/dia ou propranolol 80 a 240 mg/dia (4 semanas). As avaliaçöes clínicas foram semanais e ao final das fases I, II e II realizaram-se exames laboratoriais, incluindo-se em 5 centros um perfil lipídico e lipoprotéico. Registrou-se uma reduçäo significativa (p < 0,05) da pressäo arterial diastólica e sistólica, tanto na posiçäo supina, quanto na ortostática a partir da 2ª semana. Após a 5ª semana de uso isolado do prazosin, 79% dos pacientes apresentavam seus níveis pressóricos controlados. Neste grupo de pacientes, a posologia média de prazosin foi de 4,75 mg/dia, sendo o período médio de controle de 2,7 semanas. A avaliaçäo dos dados laboratoriais, após 5 semanas de uso do prazosin näo evidenciou nenhuma alteraçäo significativa sobre o perfil bioquímico e lipídico. A tontura, palpitaçäo e cefaléia foram as reaçöes adversas mais comuns. Apenas 5,7% dos pacientes estudados interromperam a terapêutica devido a reaçöes adversas mais significativas. Conclui-se que o prazosin administrado isoladamente, como agente de primeira escolha no tratamento da hipertensäo arterial leve ou moderada mostrou ser eficaz e seguro, näo promovendo alteraçöes deletérias sobre o metabolismo lípidico e lipoprotéico após 5 semanas de uso