Zofenopril or irbesartan plus hydrochlorothiazide in elderly patients with isolated systolic hypertension untreated or uncontrolled by previous treatment: a double-blind, randomized study.

OBJECTIVE: To compare zofenopril + hydrochlorothiazide (Z + H) vs. irbesartan + hydrochlorothiazide (I + H) efficacy on daytime SBP in elderly (>65 years) patients with isolated systolic hypertension (ISH), untreated or uncontrolled by a previous monotherapy. METHODS: After a 1-week run-in, 230 ISH patients (office SBP ≥ 140  mmHg and DBP < 90  mmHg + daytime SBP ≥ 135  mmHg and daytime DBP < 85  mmHg) were randomized double-blind to 18-week treatment with Z + H (30 + 12.5  mg) or I + H (150 + 12.5  mg) once daily, in an international, multicenter study. Z and I doses could be doubled after 6 and 12 weeks, and nitrendipine 20  mg added at 12 weeks in nonnormalized patients. RESULTS: In the full analysis set (n = 216) baseline-adjusted average (95% confidence interval) daytime SBP reductions after 6 weeks (primary study end point) were similar (P = 0.888) with Z + H [7.7 (10.7, 4.6)  mmHg, n = 107] and I + H [7.9 (10.7, 5.0)  mmHg, n = 109]. Daytime SBP reductions were sustained during the study, and larger (P = 0.028) with low-dose Z + H at study end [16.2 (20.0, 12.5)  mmHg vs. 11.2 (14.4, 7.9)  mmHg I + H]. Daytime SBP normalization (<135 mmHg) rate was similar under Z + H and I + H at 6 and 12 weeks, but more common under Z + H at 18 weeks (68.2 vs. 56.0%, P = 0.031). Both drugs equally reduced SBP in the last 6 h of the dosing interval and homogeneously reduced SBP throughout the 24 h. The proportion of patients reporting drug-related adverse events was low (Z + H: 4.4% vs. I + H: 6.0%; P = 0.574). CONCLUSION: Elderly patients with ISH respond well to both low and high-dose Z or I combined with H.

Accelerated streptokinase in ST-elevation myocardial infarction--a Romanian (ASK-ROMANIA) multicenter registry.

BACKGROUND: The classical streptokinase regimen (1.5 M.U. over 60 min) may be too slow in patients with ST-elevation myocardial infarction (STEMI). OBJECTIVE: To compare the efficacy and safety of four streptokinase regimens in STEMI patients. METHODS: 1880 consecutive patients admitted within 6 h of STEMI onset were allocated one of the following four streptokinase regimens: 1.5 M.U. over 60 min (n=517); 1.5 M.U./30 min (n=355); 1.5 M.U./20 min (n=507); 0.75 M.U./10 min, repeated or not after 50 min if no electrocardiographic criteria of reperfusion (n=501). RESULTS: Rates of coronary reperfusion (non-invasively detected) for SK1.5/30 (72.39%), SK1.5/20 (75.34%) and SK0.75/10 (72.85%) were similar and higher than for SK1.5/60 (64.03%, p=0.019, p<0.0001, and p=0.006, respectively). In-hospital mortality was significantly lower for SK1.5/20 (7.10%) and SK0.75/10 (7.38%) and at the limit of significance for SK1.5/30 (7.60%) compared with SK1.5/60 (11.60%, p<0.0001, 0.006, and 0.053, respectively). Intracerebral haemorrhage and other major bleeding had similar incidence in the four groups. CONCLUSIONS: Compared to the classical 1.5 M.U. over 60 min streptokinase regimen, significantly higher rates of coronary reperfusion and lower in-hospital mortality can be obtained by infusing the same dose over only 20 min, or either one or two half doses over only 10 min, without risk increase.