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

Abstract

BackgroundHypertension 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 fixed-dose combination of ramipril/hydrochlorothiazide (HCTZ).MethodsThe 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.ResultsThe 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.ConclusionFixed-dose combination of ramipril/HCTZ is therefore effective, tolerable and has a good safety profile for blood pressure control in black Africans.

Antihypertensive Effectiveness of a Fixed-Dose Combination of Ramipril/Hydrochlorothiazide in the Gulf Region: Results From the Pacha Registry.

“…Based on our results and those of others (Heidbreder et al, 1992, Oigman et al, 2003, Okpechi et al, 2011, Scholze et al, 1993, a large body of evidence suggests that combined therapy with ramipril/HCTZ is effective and welltolerated in the management of hypertension in the real-world treatment setting. It is of particular interest in patients who are sub-optimally controlled by antihypertensive monotherapy, especially non-diabetic patients and those with grade I hypertension.…”

Recent advances in hypertension in sub-Saharan Africa

“…It is well established that escalating monotherapy results in a small increment in BP lowering, but with more side effects, while the adoption of combination therapy even in low doses is five times more effective in lowering BP. In the ASTRAL study involving patients with essential hypertension from 36 centres in five SSA countries, treatment with a fixed drug combination of ramipril and hydrochlorothiazide resulted in a highly significant reduction in both SBP and DBP from baseline at 4 and 8 weeks (−24.7/−14.2 mm Hg, p<0.001 and −31.7/−17.9 mm Hg, p<0.001), respectively 58. The South African guideline also recommends spironolactone for the management of resistant hypertension, a strategy that has been shown to be effective in large studies such as the Anglo-Scandinavian Cardiac Outcomes Trial,59 but which lacks any definitive data from SSA.…”

Pathophysiologically based antihypertensive pharmacotherapeutics rationality, efficacy and safety in Sub Saharan African Nations – A review

“…Intense BP control using ACEI with TD or CCB over a 2 year period, caused significant mortality reduction of HT-DM from 26.6% to 12.6% [ 79 ]. A recent multinational study of the efficacy of a FDC of ACEI-Thiazide (Ramipril/HCTZ), reported a better BP control in non –diabetic hypertensives than in HT-DM [ 80 ], 13/49 patients or 26.5% attained a SBP <130 DBP <80 mmHg [ 80 ].…”