Lowe F C
Department of Urology, St. Luke's-Roosevelt Hospital Center, New York, New York, USA.
Clin Ther. 1997 Jul-Aug;19(4):730-42. doi: 10.1016/s0149-2918(97)80097-5.
Tamsulosin, an alpha 1A-adrenoceptor antagonist, has recently been approved to treat patients with symptomatic benign prostatic hyperplasia (BPH). Tamsulosin is highly selective for prostatic receptors with minimal affinity for vascular receptors. Therefore, it should have little effect on blood pressure and should not potentiate other agents' antihypertensive activity. To test this hypothesis, we conducted three randomized, double-masked, placebo-controlled studies to evaluate how coadministration of tamsulosin would affect the pharmacodynamic profiles of nifedipine, enalapril, and atenolol. Each study enrolled 12 hypertensive men aged 45 years or older whose blood pressure was being controlled with maintenance doses of nifedipine (study 1), enalapril (study 2), or atenolol (study 3). All 36 subjects were treated with placebo for 5 days and then randomly assigned to either placebo (control group) or tamsulosin therapy (0.4 mg/d for 7 days followed by 0.8 mg/d for 7 days) in addition to continuing their maintenance antihypertensive therapy. Blood pressure and pulse rate were monitored over a 24-hour period on study days 4, 11, and 19. Coadministration of tamsulosin in these small studies had no clinically significant effects on the pharmacodynamic action of nifedipine, enalapril, or atenolol; it produced no clinically significant differences in pulse rate and blood pressure, did not alter electrocardiographic or Holter monitoring results, and did not cause increased side effects. Coadministration of tamsulosin with the three antihypertensive agents studied had a favorable safety profile. Our results in these small studies indicate that the dose of nifedipine, enalapril, or atenolol did not require adjustment in patients given tamsulosin, which may give tamsulosin an advantage over other alpha-blocking agents used to treat patients with BPH. Now that tamsulosin has been approved in the United States, further clinical use may confirm these findings.
坦索罗辛是一种α1A肾上腺素能受体拮抗剂,最近已被批准用于治疗有症状的良性前列腺增生(BPH)患者。坦索罗辛对前列腺受体具有高度选择性,对血管受体的亲和力极小。因此,它对血压的影响应该很小,并且不应增强其他药物的降压活性。为了验证这一假设,我们进行了三项随机、双盲、安慰剂对照研究,以评估坦索罗辛与硝苯地平、依那普利和阿替洛尔合用时如何影响它们的药效学特征。每项研究招募了12名年龄在45岁及以上的高血压男性,他们的血压通过硝苯地平(研究1)、依那普利(研究2)或阿替洛尔(研究3)的维持剂量得到控制。所有36名受试者均接受5天的安慰剂治疗,然后除继续维持降压治疗外,随机分配至安慰剂组(对照组)或坦索罗辛治疗组(0.4mg/d,共7天,随后0.8mg/d,共7天)。在研究的第4、11和19天,对血压和脉搏率进行24小时监测。在这些小型研究中,坦索罗辛与硝苯地平、依那普利或阿替洛尔合用时对其药效学作用没有临床显著影响;在脉搏率和血压方面没有产生临床显著差异,未改变心电图或动态心电图监测结果,也未导致副作用增加。坦索罗辛与所研究的三种抗高血压药物合用时具有良好的安全性。我们在这些小型研究中的结果表明,给予坦索罗辛的患者不需要调整硝苯地平、依那普利或阿替洛尔的剂量,这可能使坦索罗辛比用于治疗BPH患者的其他α阻滞剂具有优势。既然坦索罗辛已在美国获得批准,进一步的临床应用可能会证实这些发现。