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Data are presented as mean ± standard mmHg or DBP ≥ 105 mmHg), hypertrophic
deviation. cardiomyopathies due to etiologies other than
M males, F females, BMI body mass hypertension, history of heart failure, history
index, HbA 1c glycated hemoglobin. of angina, stroke, transient ischemic cerebral
overweight (body mass index between attack, coronary artery bypass surgery or
25.0 and 29.9 kg/m 2); myocardial infarction any time prior to visit 1,
mild to moderate hypertension defined concurrent known symptomatic arrhythmia,
by systolic blood pressure (SBP) ≥ liver dysfunction (AST or ALT values
140 mmHg < 180 mmHg and/or exceeding twofold the upper limit), creatinine
diastolic blood pressure (DBP) ≥ 90 >1.5 mg/dl, known hypersensitivity to the
mmHg < 105 mmHg; study drugs. Patients with previous gastric or
normocholesterolemic [low density duodenal bleedings and patients with previous
lipoprotein cholesterol (LDL-C) <160 intolerance to ASA were also excluded.
mg/dl]; Pregnant women as well as women of
well controlled type 2 diabetes childbearing potential were excluded.
mellitus (HbA 1c ≤ 7.5%); all classes For all the study duration, no other anti-
of anti-diabetic medications were inflammatory drugs (NSAIDs,
allowed; immunosuppressive agents, antibiotics, etc.)
in primary prevention; other than ASA were allowed during the 6
naïve to anti-hypertensive and anti- months follow-up.
platelet treatment in order to avoid Suitable subjects, identified from review of
possible interactions on primary case notes and/or computerized clinic registers
objective of our study. were contacted personally or by telephone.
The exclusion criteria were secondary Treatments
hypertension, severe hypertension (SBP ≥ 180
The patients fulfilling the inclusion criteria, mmHg), patients terminated the study;
were randomized to amlodipine 5 mg/day, or otherwise, they proceeded in Phase B of the
amlodipine 5 mg/day + ASA 100 mg for 3 trial, where amlodipine was up-titrated to 10
months (Phase A); then, if adequate blood mg/day for further 3 months and compared to
pressure control was reached (BP < 140/90 amlodipine 10 mg + ASA 100 mg (Fig. 1).
Figure 1.