CARDIOVASCULAR JOURNAL OF AFRICA • Vol 22, No 2, March/April 2011
AFRICA
79
Achieving blood preSsure goals sTudy in uncontrolled
hypeRtensive pAtients treated with a fixed-dose
combination of ramipriL/hydrochlorothiazide:
the ASTRAL study
IG OKPECHI, HS SCHOEMAN, B LONGO-MBENZA, DA OKE, S KINGUE, JL NKOUA, BL RAYNER
Abstract
Background:
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 arte-
rial hypertension justifies observational studies designed to
better understand the real-life management of hypertensive
patients. The ASTRAL study was primarily designed to eval-
uate the percentage of hypertensive patients achieving blood
pressure goals after eight weeks of treatment with a fixed-
dose combination of ramipril/hydrochlorothiazide (HCTZ).
Methods:
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 anACE inhibitor, a diuretic or any other mono-
therapy 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.
Results:
The mean age of the patients was 54.7
±
11.7 years
(20–90 years) and most were categorised by the WHO crite-
ria 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.
Conclusion:
Fixed-dose combination of ramipril/HCTZ is
therefore effective, tolerable and has a good safety profile for
blood pressure control in black Africans.
Keywords:
hypertension, ramipril, black Africans, ACE inhibi-
tors, thiazides
Submitted 3/3/10, accepted 21/9/10
Cardiovasc J Afr
2011;
22
: 79–84
DOI: CVJ-21.069
Hypertension is the most prevalent cardiovascular (CV) disease
in adults worldwide and is a major risk factor for both cardio-
vascular and cerebrovascular morbidity and mortality.
1
Systemic
arterial hypertension is globally estimated to affect 30% of
adults
2,3
and to account for up to 30% of all deaths.
1
Although
the results of several cross-sectional and cohort epidemiological
studies show that the prevalence of hypertension varies signifi-
cantly,
4–9
the prevalence in sub-Saharan Africa varies between 12
and 29%, depending on the country.
10
In developed countries,
fewer than 27% of patients with arterial hypertension have
controlled blood pressure (BP),
3
whereas in developing countries
this number is less than 10%.
11
The relationship between BP and
CV risk is continuous, such that every 20-mmHg rise in systolic
blood pressure (SBP) or 10-mmHg rise in diastolic blood pres-
sure (DBP) doubles the risk of cardiovascular disease (CVD).
12
Therapy with anti-hypertensive drugs have shown a 35 to 40%
reduction in stroke, a 20 to 25% reduction in myocardial infarc-
tion, a more than 50% reduction in heart failure, and reductions
in CVD-related death rates.
3
Age, ethnicity, obesity, smoking, excessive consumption of
alcohol and physical inactivity are among the risk factors identi-
fied to be associated with hypertension. The JNC-7 and recent
European guidelines
3,11
have recommended BP goals at the
following levels:
<
140/90 mmHg in non-diabetic hypertensive
patients, and
<
130/80 mmHg in diabetic hypertensive patients.
Both the JNC-7 and the European guidelines have also recom-
mended BP treatment with at least two agents or using a combi-
nation of diuretic and another antihypertensive agent that has a
different mode of action for patients presenting with BP values
Division of Nephrology and Hypertension, Groote Schuur
Hospital, University of Cape Town, South Africa
IG OKPECHI, MB BS, FWACP, PhD, Cert Nephrol (SA) Phys,
BL RAYNER, MB ChB, FCP, MMed
Clinical Statistics, Doornpoort, Pretoria, South Africa
HS SCHOEMAN, DSc, Pr Sci Nat
Faculty of Health Sciences, Walter Sisulu University,
Mthatha, Eastern Cape, South Africa and Department
of Internal Medicine, University Hospital of Kinshasa,
Democratic Republic of Congo
B LONGO-MBENZA, MD, MMed, DSc, PhD
Division of Medicine, Lagos University Teaching Hospital,
Lagos, Nigeria
DA OKE, MD, MB BS
Division of Medicine, General Hospital and University of
Yaoundé, Cameroon
S KINGUE, MD
Division of Cardiology, University Hospital of Brazzaville,
Congo
JL NKOUA, MD