Conlin P R, Elkins M, Liss C, Vrecenak A J, Barr E, Edelman J M
Endocrinology-Hypertension Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, USA.
J Hum Hypertens. 1998 Oct;12(10):693-9. doi: 10.1038/sj.jhh.1000687.
We conducted a randomised, double-blind, parallel design study comparing the efficacy and tolerability of the angiotensin II receptor antagonist, losartan, alone or with low-dose hydrochlorothiazide (HCTZ) to the dihydropyridine calcium channel blocker, nifedipine GITS (gastro-intestinal therapeutic system), in elderly patients (> or =65 years old) with a diastolic blood pressure (DBP) between 95 and 115 mm Hg. After a placebo wash out period, 140 patients were randomly assigned to receive either losartan 50 mg or nifedipine GITS 30 mg. Patients were evaluated at 4-week intervals during a 12-week treatment period. Patients receiving losartan had HCTZ 12.5 mg added and increased to 25 mg to reduce DBP <90 mm Hg. Patients receiving nifedipine GITS had their dose increased to 60 mg and 90 mg to reduce DBP <90 mm Hg. Efficacy, tolerability and quality of life were assessed during the 12 weeks on each regimen. Patients treated with the losartan regimen (n = 73) had reductions in trough sitting DBP of -10, -13, and -13 mm Hg after 4, 8, and 12 weeks of therapy, respectively. Patients receiving the nifedipine GITS regimen (n = 67) had DBP reductions of -14, -15, and -15 mm Hg, respectively. There were no significant differences in the DBP response between the treatment groups except at week 4 (P < 0.05). Similar reductions in systolic BP (SBP) between the two treatment groups were observed at all time points. The percentages of patients in the two treatment groups reaching goal DBP (<90 mm Hg or DBP > or =90 mm Hg with a reduction from a baseline of > or =10 mm Hg) were comparable (81% on the losartan regimen and 90% on the nifedipine GITS regimen). There were significantly more adverse events reported in patients receiving nifedipine GITS when compared to the losartan regimen (54% vs 36%, P < 0.05). A patient-reported symptom inventory also showed that swollen ankles was bothersome in significantly more patients treated with the nifedipine GITS regimen when compared to the losartan regimen (24% vs 5%, P = 0.001). Thus, in elderly patients with diastolic hypertension, a regimen of losartan alone or with HCTZ has similar efficacy to a regimen of nifedipine GITS with greater tolerability and less symptom bother due to swollen ankles.
我们开展了一项随机、双盲、平行设计研究，比较血管紧张素II受体拮抗剂氯沙坦单独使用或与低剂量氢氯噻嗪（HCTZ）联用，与二氢吡啶类钙通道阻滞剂硝苯地平胃肠道治疗系统（GITS），对舒张期血压（DBP）在95至115 mmHg之间的老年患者（≥65岁）的疗效和耐受性。在经过安慰剂洗脱期后，140例患者被随机分配接受氯沙坦50 mg或硝苯地平GITS 30 mg。在12周的治疗期内，每隔4周对患者进行评估。接受氯沙坦治疗的患者加用12.5 mg HCTZ，并增至25 mg以将DBP降至<90 mmHg。接受硝苯地平GITS治疗的患者将剂量增至60 mg和90 mg以将DBP降至<90 mmHg。在12周的每种治疗方案期间评估疗效、耐受性和生活质量。接受氯沙坦治疗方案（n = 73）的患者在治疗4、8和12周后，静息谷值DBP分别降低了-10、-13和-13 mmHg。接受硝苯地平GITS治疗方案（n = 67）的患者DBP分别降低了-14、-15和-15 mmHg。除第4周外，各治疗组之间的DBP反应无显著差异（P < 0.05）。在所有时间点均观察到两个治疗组之间收缩压（SBP）有类似程度的降低。两个治疗组中达到目标DBP（<90 mmHg或DBP≥90 mmHg且较基线降低≥10 mmHg）的患者百分比相当（氯沙坦治疗方案组为81%，硝苯地平GITS治疗方案组为90%）。与氯沙坦治疗方案相比，接受硝苯地平GITS治疗的患者报告的不良事件显著更多（54%对36%，P < 0.05）。一份患者报告的症状清单还显示，与氯沙坦治疗方案相比，接受硝苯地平GITS治疗方案的患者中脚踝肿胀困扰的患者明显更多（24%对5%，P = 0.001）。因此，在老年舒张期高血压患者中，氯沙坦单独使用或与HCTZ联用的治疗方案与硝苯地平GITS治疗方案疗效相似，但耐受性更好，因脚踝肿胀引起的症状困扰更少。
