Achieving blood preSsure goals sTudy in uncontrolled hypeRtensive pAtients treated with a fixed-dose combination of ramipriL / hydrochlorothiazide : the ASTRAL study

I.G Okpechi,D.A Oke,B Longo-Mbenza,J.L Nkoua,H.S Schoeman,B.L Rayner,S Kingue

doi:10.5830/cvja-2010-086

Abstract

Hypertension is a common cardiovascular disease, affecting adults worldwide and it accounts for up to 30% of all deaths. The need for better control of arterial hypertension justifies observational studies designed to better understand the real-life management of hypertensive patients. The ASTRAL study was primarily designed to evaluate the percentage of hypertensive patients achieving blood pressure goals after eight weeks of treatment with a fixeddose combination of ramipril/hydrochlorothiazide (HCTZ). The study was a multi-centre, non-comparative, Open-label, observational study conducted in 36 centres in five sub-Saharan African countries, namely Cameroon, Congo Brazzaville, Democratic Republic of Congo (DRC), Madagascar and Nigeria. Four hundred and forty-nine men and women 18 years of age or older with hypertension not controlled by an ACE inhibitor, a diuretic or any other monotherapy or anti-hypertensive combination not containing a diuretic in a fixed dose were considered eligible for inclusion in this eight-week study. The study consisted of three visits, visit one (V1) at baseline, visit two (V2) after four weeks and visit three (V3) after eight weeks. The mean age of the patients was 54.7 ± 11.7 years (20-90 years) and most were categorised by the WHO criteria as either overweight or obese (71.6%). After four and eight weeks of treatment with the study drug, systolic and diastolic blood pressures significantly changed from baseline: -24.7/-14.2 mmHg (p < 0.001) and -31.7/-17.9 mmHg (p < 0.001), respectively. There were 60.2% of the non-diabetics on prior monotherapy who, at eight weeks, fulfilled the primary blood pressure goal for SBP and DBP, versus 26.5% of the diabetic patients, also on monotherapy. Few adverse events were reported, with facial oedema and dry cough recurring twice in two patients. Fixed-dose combination of ramipril/HCTZ is therefore effective, tolerable and has a good safety profile for blood pressure control in black Africans.

Highlights

Hypertension is a common cardiovascular disease, affecting adults worldwide and it accounts for up to 30% of all deaths
The primary outcome of the ASTRAL study was to evaluate the percentage of hypertensive patients achieving blood pressure (BP) goals after eight weeks of treatment with a fixed-dose combination of ramipril/HCTZ, to generate data on the effectiveness of the fixed-dose combination
Men and women 18 years of age or older with arterial hypertension uncontrolled by an ACE inhibitor, a diuretic, or any other monotherapy or anti-hypertensive combination not containing a diuretic in a fixed dose were considered eligible for inclusion in the study

Summary

Methods

The study was a multi-centre, non-comparative, open-label, observational study conducted across 36 centres in five subSaharan African countries (Cameroon, Congo Brazzaville, DRC, Madagascar and Nigeria). At visit one (week 0), demographic data, history of co-morbidities, duration of hypertension, blood pressures at first diagnosis of hypertension and previous anti-hypertensive treatment given, concomitant medications, and CV risk factors were recorded. The primary outcome of the ASTRAL study was to evaluate the percentage of hypertensive patients achieving BP goals after eight weeks of treatment with a fixed-dose combination of ramipril/HCTZ. A logistic regression analysis was performed with goal achievement as a dependent variable and the following predictor variables: age, gender, history of diabetes, alcohol consumption, renal dysfunction, diabetic nephropathy, microalbuminuria, cerebrovascular accident and heart failure, BMI, concomitant treatment with NSAIDs, daily dose of study drug and BP at inclusion. In the logistic regression analysis, the following predictor variables were numeric: age, systolic blood pressure, diastolic blood pressure and daily doses of study drugs. A p-value < 0.05 was considered as significant

Results

Discussion

Conclusion