CARDIOVASCULAR JOURNAL OF AFRICA • Vol 22, No 2, March/April 2011
82
AFRICA
Compliance with the fixed-dose combination of ramipril/
HCTZ was 89.2% at week four and 92.6% at week eight of
the study (Table 3). In all, six patients reported eight different
episodes of adverse events, with facial oedema and dry cough
being reported twice by two different patients at separate times.
Urinary retention, gout, repeated epistaxis and generalised body
weakness were all reported once by different patients (Table 6).
Adverse events occurred only in patients on half-standard or
standard-dose therapy.
The multivariate logistic regression analysis showed that in
the ASTRAL study, diabetes was the most significant factor
independently associated with BP goal attainment. The likeli-
hood of achieving BP control in diabetic patients was 4.94 times
less than in non-diabetic patients (OR: 4.92; 95% CI: 2.57–9.64;
p
<
0.05). Other factors associated with the attainment of BP
goal were age (OR: 0.98; 95% CI: 0.97–0.99;
p
<
0.05), DBP
(OR: 0.98; 95% CI: 0.97–0.99;
p
<
0.05) and SBP (OR: 0.99;
95% CI: 0.96–0.99;
p
<
0.05). However, with the logistic regres-
sion performed separately for diabetics and non-diabetics, no
statistically significant predictors were found for goal achieve-
ment for diabetic patients. SBP at visit one was the only signifi-
cant predictor of goal achievement in non-diabetic patients (OR:
0.969; 95% CI: 0.953–0.986;
p
=
0.0003).
Discussion
High blood pressure is a major risk factor for cardiovascular
morbidity and mortality worldwide. In sub-Saharan Africa,
hypertension is one of the greatest health challenges after HIV/
AIDS.
1,14
Some key issues related to hypertension management
in black Africans have been highlighted from this study: the
high prevalence of hypertension-related co-morbidities; the high
level of uncontrolled BP; the high prevalence of overweight and
obesity among black Africans; the effectiveness of a combination
of an ACE inhibitor and diuretic in controlling BP in Africans;
the lower BP control achieved with an ACE inhibitor and diuretic
combination in black African hypertensive patients with diabetes
within the first eight weeks; and the good tolerability of the ACE
TABLE 3. TREATMENT SCHEDULE OF TRITAZIDE,
MEAN BP CHANGES FROM BASELINEAND
STUDY DRUG COMPLIANCE.
Dose of Tritazide
(ramipril/HCTZ) (mg)
Number (%) of patients
Week 0 (V 1) Week 4 (V 2) Week 8 (V 3)
2.5/12.5
173 (38.7)
77 (18.7)
65 (16.0)
5/25
270 (60.4)
299 (72.8)
295 (72.7)
7.5/37.5
–
5 (1.2)
14 (3.4)
10/50
4 (0.9)
30 (7.3)
32 (7.9)
Blood pressures and BP changes from baseline
SBP (mmHg)
168.9
±
19.2 143.5
±
19.7 136.5
±
15.5
∆
SBP (mmHg)
NA
– 24.7*
–31.7*
DBP (mmHg)
102.6
±
12.3 88.7
±
11.9 84.8
±
9.9
∆
DBP (mmHg)
NA
–14.2*
–17.9*
Study drug compliance
n
=
449
n
=
408
n
=
407
Good
NA 364 (89.2)
377 (92.6)
Medium
NA
34 (8.3)
21 (5.2)
Poor
NA
10 (2.5)
9 (2.2)
HCTZ: hydrochlorothiazide, V1: visit one, V2: visit two, V3: visit
three, BP: blood pressure, SBP: systolic BP, DBP: diastolic BP,
∆
SBP: change in systolic BP from baseline,
∆
DBP: change in
diastolic BP from baseline, NA: not applicable; *
p
<
0.001.
TABLE 4. COMPARISON OF BLOOD PRESSURES BEFOREANDAFTER COMMENCEMENT OF STUDY DRUG IN
PATIENTSWHO RECEIVED MONOTHERAPYAND THOSEWHO RECEIVED DUAL OR MORE THERAPY
Monotherapy
Dual or more therapy
Visit 1 (
n
=
267)
Visit 2 (
n
=
247)
Visit 3 (
n
=
238)
Visit 1 (
n
=
142)
Visit 2 (
n
=
131)
Visit 3 (
n
=
132)
SBP (mmHg)
168.1
±
19.1
141.9
±
19.4
134.3
±
14.8
170.1
±
20.0
147.1
±
18.0
139.3
±
15.8
∆
SBP (mmHg)
NA
–25.3*
–32.9*
NA
–23.0*
–30.4*
DBP (mmHg)
102.0
±
11.7
88.2
±
12.1
83.3
±
9.6
102.4
±
11.8
89.6
±
10.7
86.7
±
9.6
∆
DBP (mmHg)
NA
–14.1*
–18.8*
NA
–13.3*
–16.0*
SBP: systolic BP, DBP: diastolic BP,
∆
SB: change in systolic BP from baseline,
∆
DBP: change in diastolic BP from baseline, NA: not applicable
*
p
<
0.001.
TABLE 5. BP GOALATTAINMENTATVISIT THREE IN
PATIENTSWHO RECEIVED MONOTHERAPYAND THOSE
WHO RECEIVED DUAL OR MORE THERAPY
Monotherapy
Dual or
more therapy
Non-diabetics
(
n
=
186)
(
n
=
106)
(a) SBP
<
140 mmHg and DBP
<
90 mmHg
112 (60.2)
44 (41.5)
(b) SBP
<
140 mmHg [including
patients counted in (a) above]
126 (67.7)
53 (50.0)
(c) DBP
<
90 mmHg [including
patients counted in (a) above]
134 (72.0)
62 (58.5)
Diabetics
(
n
=
49)
(
n
=
21)
(a) SBP
<
130 mmHg and DBP
<
80 mmHg
13 (26.5)
3 (14.3)
(b) SBP
<
130 mmHg [including
patients counted in (a) above]
21 (42.9)
5 (23.8)
(c) DBP
<
80 mmHg [including
patients counted in (a) above]
18 (36.7)
6 (28.6)
SBP: systolic blood pressure, DBP: diastolic blood pressure.
TABLE 6. SUMMARY OF REPORTEDADVERSE EVENTS
Adverse event
Number
of events
Severity
Events possibly caused by study drug
• Angio-oedema
2 Mild/moderate
• Urinary retention
1
Moderate
• Gout
1
Severe
• Dry cough
2
Severe
• Repetitive epistaxis
1
Severe
Events unlikely to have been caused by
study drug
• Asthenia and pain
1
Severe
