Blood pressure control and response rates with zofenopril compared with amlodipine in hypertensive patients

Figures & data

Table I. Patient demographics and characteristics.

	Zofenopril	Alodipine	p‐value
n	151	152
Gender (male/female)	76/75	76/76	0.954
Age (years)	54.9±11.8	57.3±10.3	0.071
Body mass index	27.6±3.8	27.3±3.5	0.542
Sitting SBP/DBP (mmHg)	160.2±12.5/101.2±4.4	159.8±11.6/101.0±4.4	0.892/0.802
Sitting HR (beats/min)	73.8±8.3	74.0±8.7	0.280
Additional CV risk factors
Obesity	46	34	0.110
Smoker	22	25	0.670
Hyperlipidemia	50	47	0.621
CHD	42	42	0.910
Diabetes	11	15	0.422
PAD	1	3	0.317

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

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

	Zofenopril (SBP/DBP)	Amlodipine (SBP/DBP)	p‐value
Baseline	159.6±12.6/100.8±4.2	159.6±10.9/100.6±4.3
Week 2	148.7±13.2/93.0±7.5	147.8±13.7/92.6±6.8	0.473/0.872
Week 4	147.1±14.2/91.1±7.7	145.8±12.7/90.6±8.3	0.412/0.530
Week 6	143.7±12.4/89.2±6.8	143.3±11.4/88.8±6.6	0.995 /0.595
Week 8	143.9±12.8/88.8±7.2	142.5±11.5/88.4±6.2	0.470/0.772
Week 12	145.0±12.0/88.6±7.2	143.5±12.6/88.3±6.7	0.464/0.632

Shown are means±SD of blood pressure values in mmHg from the 12 weeks intention‐to‐treat population (zofenopril 30–60 mg od = 127; amlodipine 5–10 mg od = 127). 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 2, 4, 8, 6 or 12 vs baseline value all p<0.001.

Table III. Adverse events (AEs) during exposure to the study medications.

	Zofenopril	Amlodipine	p‐value
n	151	152
Subjects with AEs	69	78	0.328
Number of AEs (all events)	221	271
Mild	115	174
Moderate	96	86
Severe	10	10
Subjects with AEs possibly, probably or definitely drug related	24	37	0.067
Number of AEs possibly, probably or definitely drug related	79	127
Mild	48	81
Moderate	31	42
Severe	0	4

Shown are actual numbers of subjects with events as well as number of events in zofenopril and amlodipine‐treated patients over the course of the trial. AEs, adverse event. Statistical comparison by Student t‐test or Fisher's exact probability test.