Key result
Zofenopril matches candesartan for office blood pressure reductions in grade I-II primary hypertension.
Why the study?
Does zofenopril provide similar blood pressure reduction compared to candesartan in patients with grade I-II primary hypertension?
RCT (n=236)
Double-blind
randomized
Does zofenopril provide similar blood pressure reduction compared to candesartan in patients with grade I-II primary hypertension?
p-value: p=NS
Zofenopril and candesartan provide similar and effective office and 24-hour blood pressure reductions in patients with mild to moderate primary hypertension.
Zofenopril matches candesartan for BP control in grade I-II hypertension; confirms ACEI-ARB equivalence in mild-moderate disease.
Objective. To compare the antihypertensive effect of treatment with zofenopril vs candesartan by office and ambulatory blood pressure (BP). Design and methods. Following a 2‐week wash‐out from previous treatment, 236 grade I–II primary hypertensive patients were randomized double‐blind to 12 weeks treatment with zofenopril 30 mg or candesartan 8 mg od. After 4 weeks, treatment was doubled in responder non‐normalized (office systolic BP⩾140 mmHg and office diastolic BP reduction ⩾10 mmHg) or non‐responder patients (office systolic BP⩾140 mmHg and office diastolic BP reduction <10 mmHg). Following a further 4 weeks, non‐responder or non‐normalized patients were withdrawn. Results. In the intention‐to‐treat population, office systolic BP and diastolic BP reductions after 12 weeks of treatment were similar between the two groups (zofenopril: 21±11/15±8 mmHg, n = 114 vs C: 20±11/15±7 mmHg, n = 122; p = NS). In the 163 patients of the per‐protocol population, office BP dropped by 22±11/15±8 mmHg (zofenopril) and 20±10/15±7 mmHg (candesartan; p = NS). Also 24‐h ambulatory BPs were equally reduced by zofenopril and candesartan ( 7±13/5±8 mmHg vs 7±12/5±8 mmHg; p = NS). The trough‐to‐peak ratio and smoothness index were not significantly different between zofenopril and candesartan. Tolerability of both drugs was good. Conclusions. Monotherapy with zofenopril and candesartan similarly reduced office and 24‐h BPs. Since almost 90% of patients were normalized by either zofenopril or candesartan, this result supports the importance of considering low‐ or high‐dose monotherapies as initial treatment for most hypertensive patients of mild degree.
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Leonetti et al. (2006) conducted an RCT in Grade I-II primary hypertension (n=236). Zofenopril vs. Candesartan 8 mg od was evaluated on Office systolic and diastolic blood pressure reductions (p=NS). Zofenopril and candesartan produced similar reductions in office blood pressure (21/15 mmHg vs 20/15 mmHg; p=NS) after 12 weeks in patients with grade I-II primary hypertension.
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