An evaluation of the initial and long‐term antihypertensive efficacy of zofenopril compared with enalapril in mild to moderate hypertension

Figures & data

Table I. Demographics of the study patient cohort

	Zofenopril	Enalapril	p‐value
n	152	156
Gender (male/female)	73/79	76/80	0.946
Age (years)	52.0±9.7	53.3±10.3	0.236
Body mass index	28.1±5.0	27.7±4.5	0.430
Previously treated/untreated	57/95	65/91	0.483
Supine SBP/DBP (mmHg)	160.3±9.7/101.0±5.5	160.3±9.7/100.8±4.0	0.614/0.628
Supine HR (beats/min)	72.7±8.3	73.6±9.4	0.374
Race
Caucasian	142 (93%)	150 (96%)	0.342
Black	3 (2%)	3 (2%)
Oriental	4 (3%)	3 (2%)
Other	3 (2%)	0 (0%)

Shown are actual numbers or means±SD. Statistical comparison by Student t‐test or Fisher's exact probability test. SBP, systolic blood pressure; DBP, diastolic blood pressure; HR, heart rate.

Table II. Supine systolic (SBP) and diastolic blood pressures (DBP) in zofenopril‐ and enalapril‐treated patients during 12 weeks of follow up.

	Zofenopril (SBP/DBP)	Enalapril (SBP/DBP)	p‐value
Baseline	160.7±12.1/101.3±4.6	161.3±12.5/101.1±4.5
Week 2	143.1±9.5/87.5±6.2	147.0±13.1/89.8±8.4	0.006/0.005
Week 4	140.9±9.2/85.7±5.5	144.2±13.5/87.4±8.9	0.030/0.038
Week 8	140.5±9.9/85.2±7.0	141.7±13.4/86.0±9.1	0.621/0.296
Week 12	140.6±10.5/84.6±7.1	141.7±12.5/85.7±8.1	0.678/0.187

Shown are means±SD of blood pressure values in mmHg from the 12 weeks intention‐to‐treat population (zofenopril 30–60 mg od = 152; enalapril 20–40 mg od = 156).Dose up‐titration was optional in non‐responders at week 4. Statistical comparison between treatments denotes baseline corrected differences between treatments by ANOVA. SBP and DBP reductions at weeks 4, 8 or 12 vs baseline value all p<0.001.

Table III. Standing systolic (SBP) and diastolic blood pressures (DBP) in zofenopril‐ and enalapril‐treated patients during 12 weeks of follow up.

	Zofenopril (SBP/DBP)	Enalapril (SBP/DBP)	p‐value
Baseline	159.6±12.1/101.7±5.8	160.6±13.5/101.9±8.2
Week 2	142.5±9.5/87.7±5.3	146.8±13.8/91.9±9.7	0.015/<0.001
Week 4	140.4±9.2/85.8±5.8	143.8±14.1/89.2±9.6	0.099/0.001
Week 8	140.3±9.9/86.1±6.5	141.6±14.0/88.1±9.8	0.771/0.075
Week 12	140.4±10.5/85.9±6.4	142.5±14.1/87.3±8.7	0.464/0.228

Shown are means±SD of blood pressure values in mmHg from the 12 weeks intention‐to‐treat population (zofenopril 30–60 mg od = 152; enalapril 20–40 mg od = 156). Dose up‐titration was optional in non‐responders at week 4. Statistical comparison between treatments denotes baseline corrected differences between treatments by ANOVA. SBP and DBP reductions at weeks 4, 8 or 12 vs baseline value all p<0.001.

Table IV. Adverse events during exposure to the study medications.

	Zofenopril	Enalapril	p‐value
n	155	168
Total AEs reported	142	186
Mild	78	65
Moderate	57	105
Severe	7	16
Subjects with AEs	67	81	0.369
Subjects with SAE	1	2
Subjects discontinued for an AE	6	5
AEs possibly, probably or definitely drug related	32	49
Mild	18	13
Moderate	13	31	0.008
Severe	1	5

Shown are actual numbers of subjects with events as well as number of events in zofenopril‐ and enalapril‐treated patients over the course of the trial. AEs, adverse event; SAE, severe adverse event. The SAEs experienced were not judged to be related to treatments. Statistical comparison by Student t‐test or Fisher's exact probability test.