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