Deprescribing preventive cardiovascular medication in patients with predicted low cardiovascular disease risk in general practice – the ECSTATIC study: a cluster randomised non-inferiority trial

Table 2 Secondary outcomes after 24 months^a

Outcome	Usual care group (n = 575)	PP intervention group (n = 319^b)		ITT intervention group (n = 492^c)
Outcome	t = 24	t = 24	P value^d	t = 24	P value^d
Systolic blood pressure (mmHg)	136.0 ± 0.8	142.4 ± 0.9	< 0.01	140.9 ± 0.8	< 0.01
Diastolic blood pressure (mmHg)	80.7 ± 0.5	84.8 ± 0.6	< 0.01	84.2 ± 0.5	< 0.01
Total cholesterol/HDL-cholesterol ratio	3.83 ± 0.04	3.89 ± 0.05	0.22	3.90 ± 0.05	0.35
Total cholesterol (mg/dl)^e	210.0 ± 1.4	217.2 ± 1.8	< 0.01	214.1 ± 1.6	0.05
HDL-cholesterol (mg/dl)^e	58.4 ± 0.5	59.1 ± 0.6	0.75	58.3 ± 0.5	0.84
LDL-cholesterol (mg/dl)^e	128.2 ± 1.3	135.1 ± 1.7	< 0.01	133.1 ± 1.5	0.01
Smokers – no. (%)^f	59 (10.3)	18 (5.6)	> 0.31	35 (7.1)	> 0.25
Body mass index (weigh tin kg/height in metres squared)	28.0 ± 0.1	27.6 ± 0.1	0.26	27.9 ± 0.1	0.57
Body weight (kg)	81.5 ± 0.3	80.4 ± 0.3	0.18	81.1 ± 0.3	0.35
Waist circumference (cm)	96.1 ± 0.4	96.2 ± 0.5	0.54	96.5 ± 0.4	0.53
Physical activity level (minutes per day)^g	137 ± 5	127 ± 6	0.18	130 ± 6	0.36
Fruit and vegetable consumption (grams per day)	329 ± 5	335 ± 7	0.41	333 ± 6	0.62
Alcohol consumption (glasses per day)	0.97 ± 0.05	0.90 ± 0.06	0.29	0.87 ± 0.05	0.10

HDL high-density lipoprotein, ITT intention-to-treat, LDL low-density lipoprotein, PP per-protocol
^aPlus or minus values are means ± standard error from linear mixed models
^bOnly participants who had (temporarily) deprescribed their preventive cardiovascular medication were analysed in the PP intervention group
^cOne participant who died of unknown cause during the follow-up without having attempted to have her preventive cardiovascular medication deprescribed was left out in the analyses at 24 months in the ITT population of the intervention group
^dCompared to the usual care group at 24 months
^eTo change value to mmol/l, multiply by 38.61033861
^fUsing a generalised logistic mixed linear model adjusting for cluster randomisation did not result in a pooled estimate. Therefore, we calculated estimates for the 15 imputation sets and reported the lowest P value in this table
^gFor patients < 55 years old, only activities with a metabolic equivalent (MET) score ≥ 4 kcal/kg/hour executed ≥ 60 minutes on one or more days were taken into account to assess physical activity level [22]. For patients ≥ 55 years old, only activities with a MET-score ≥ 3 kcal/kg/hour executed ≥ 30 minutes on one or more days were taken into account to assess physical activity level [22]

ISSN: 1741-7015