Hypertension Clinical Trial
Official title:
Blood Pressure Reduction by Fixed-dose Compared to Free Dose Combination Therapy of ACE Inhibitor and Calcium Antagonist in Hypertensive Patients
The introduction of fixed combination of ACEi+CCB (Fixed) has significantly increased
patients compliance and adherence to therapy. At the moment, however, there are no data
suggesting the better control of once-daily fixed (Fixed) over free doses in separate
administrations combination therapy in hypertensives.
In a population of 39 consecutive outpatient patients referred to the departmental
Hypertension clinic of the University Hospital of Salerno Medical School with the first
diagnosis of arterial hypertension, the investigators tested the hypothesis that the Fixed
achieve a better control of blood pressure than the Free combination. Patients were
randomized to either strategy and after 3 months patients underwent a clinical assessment to
evaluate the antihypertensive effect.
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
In accordance with the ESH guidelines, BP assessment was carried out noting two measurements
in the supine, in sitting and in standing position, spaced apart from 1-2 minutes. For the
current study mean values in sitting position were considered. BP measurements were assessed
by trained personnel using a dedicated, upper arm, electronic machine (Afib screen,
Microlife, Italy) Anthropometric parameters.
The weight classes were defined by BMI [weight (kg)/height (m)2]. In adults, overweight is
identified by a BMI of 25-29.9 kg/m2, and obesity by a BMI≥30 kg/m2.
Biochemical parameters
For each patient, the following laboratory tests were evaluated: fasting glucose, total
cholesterol, LDL, HDL, triglycerides, blood urea nitrogen (BUN), serum creatinine and
creatinine clearance (calculated with MDRD or Cockroft formula).
Fasting blood glucose greater than 126 mg/dl was used for screening for diabetes.
Follow-up with computerized medical records
The patient population was included in a central database that uses Wincare software
(TSD-Projects, Milan, Italy), which contains separate electronic sheets for medical history,
physical examination, laboratory tests, electrocardiogram, cardiac ultrasounds, other
imaging tests and ambulatory blood pressure monitoring. The data was updated at each
follow-up visit with a revaluation deadline set at three months. The data of each patient
are stored on the hospital server and protected by a firewall system with password access.
Echocardiography
All patients were subjected to one-dimensional echocardiography (M-mode), two-dimensional
(B-mode) and Doppler function via the 5-1MHz probe (E9, GE Healthcare).
Statistical analysis
Categorical data are presented as percent while continuous data are indicated as means ±
standard error. The quantitative analysis was performed using T-test for unpaired data or
ANOVA as appropriate, while the qualitative analysis was performed using non-parametric
tests (χ2 test). A value of p-value <0.05 was considered statistically significant. All data
were analyzed using Prism 6.0 (GraphPad Software, Inc., San Diego, CA).
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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