Effects of celiprolol and simvastatin on the calculated risk of coronary heart disease (the Celisimva study)

Figures & data

Figure 1.  Study design and different time points during the study. After a 5 week run-in period the patients were randomized to one of the four groups receiving the study medication. The main study period was 3 months. After that all the groups received the combination treatment (celiprolol + simvastatin) for another 3 months.

Table I.  Baseline characteristics.

	Group
	Celiprolol	Simvastatin	Combination	Placebo
Characteristic	n = 27	n = 27	n = 29	n = 29
Sex (n):
Male	26	26	27	27
Female	1	1	2	2
Age (years)	60±6	61±6	60±7	62±6
BMI (kg/m^2)	27±2	28±3	28±3	26±3
Smoking (n):
Smoker*	11	12	16	15
Non-smoker	16	15	13	14
Type 2 diabetes (n)	3	2	3	2

BMI = Body mass index; * = Smoking at screening or quitted smoking less than 12 months prior screening

Table II.  Effect of treatments on total CHD risk, blood pressure and lipids at 3 and 6 months compared to baseline (0 mo).

	Group
	Celiprolol	Simvastatin	Combination	Placebo
Characteristic	n = 27	n = 27	n = 29	n = 29
Coronary heart disease risk (%)
0 mo	24.0±3.1	26.0±4.7	25.7±5.0	25.3±6.2
3 mo	21.2±3.3	18.7±3.7	17.3±5.3	25.0±6.4
6 mo*	15.7±3.1	17.1±3.5	16.7±5.3	17.0±4.8
Systolic blood pressure (mmHg)
0 mo	158±10	156±12	160±12	161±12
3 mo	147±14	152±10	154±15	156±15
6 mo*	146±16	142±10	147±16	147±15
Diastolic blood pressure (mmHg)
0 mo	93±10	93±9	95±7	95±9
3 mo	90±10	91±7	90±7	92±9
6 mo*	87±11	86±8	87±7	88±9
Total cholesterol (mmol/l)
0 mo	6.7±0.6	6.9±0.7	6.6±0.8	6.8±0.9
3 mo	6.6±0.9	5.2±0.8	4.9±0.6	6.5±1.0
6 mo*	5.1±0.7	5.1±0.5	5.0±0.8	4.9±0.8
Low density lipoprotein cholesterol (mmol/l)
0 mo	4.7±0.6	4.7±0.7	4.4±0.8	4.6±0.8
3 mo	4.5±0.8	3.2±0.7	2.8±0.6	4.3±0.8
6 mo*	3.1±0.6	3.1±0.6	2.9±0.9	2.8±0.6
High density lipoprotein cholesterol (mmol/l)
0 mo	1.2±0.2	1.2±0.2	1.2±0.2	1.4±0.5
3 mo	1.2±0.2	1.3±0.3	1.3±0.2	1.3±0.3
6 mo*	1.3±0.2	1.2±0.3	1.3±0.3	1.3±0.3
Triglycerides (mmol/l)
0 mo	2.1±1.7	2.3±1.4	2.2±0.9	1.8±0.8
3 mo	2.1±1.7	1.6±0.9	1.9±1.3	2.0±1.0
6 mo*	1.6±0.8	1.6±0.6	1.7±0.9	1.6±0.8

* all groups on combination treatment