Blood Pressure Reduction by Fixed-dose Compared to Free Dose Combination Therapy of ACE Inhibitor and Calcium Antagonist in Hypertensive Patients

Study Population

Our study included 100 patients referred to the Hypertension Clinic of Salerno Medical School Hospital in Salerno, with the first diagnosis of arterial hypertension and in the absence of a previous treatment. At the time of enrollment visit, patients signed a consent to anonymous participation, in compliance with the regulations of good clinical practice and privacy. Study participants were 18-75 years old with essential hypertension (defined according to the ESH / ESC 2013 guidelines). Patients were excluded if patients had secondary hypertension, malignant hypertension, CRF (chronic renal failure), oncological conditions or cirrhosis. Patients were also excluded if patients had medical and surgical disorders that alter absorption, distribution, metabolism and excretion of drug treatment. The study protocol was approved by the competent University Hospital Ethical Committee.

Study Design

Patients were randomized to either fixed dose or free dose combination therapy, with Perindopril (5 or 10 mg) and Amlodipine (5 or 10 mg) with a 2:1 randomization design based on a power analysis. Doses were decided according to anthropometric, clinical, biochemical and instrumental doses by experienced medical staff. The Fixed group received one single tablet containing Perindopril/Amlodipine at the appropriate dose. The Free group, received Perindopril and Amlodipine in separate tablets at the appropriate dose. Groups were matched for age, sex, BMI, systolic BP (SBP) and diastolic BP (DBP). At baseline and at follow-up the investigators evaluated clinical (weight, height, BMI, heart rate, BP) and biochemical parameters (blood glucose, serum cholesterol, LDL, HDL, triglycerides, blood urea nitrogen, creatinine, creatinine clearance), as well as Electrocardiogram (ECG) and cardiac ultrasound.

Clinical parameters