The objective of this study was to compare the long-term efficacy and safet
y of 6 months' treatment with barnidipine and hydrochlorothiazide (HCTZ) as
monotherapy in patients aged greater than or equal to 75 years with mild t
o moderate essential hypertension. This was a randomised, double-blind, dos
e-titration study performed at 62 centres in 8 countries. A total of 397 pa
tients were enrolled. Following a 4 week single-blind placebo run-in, 315 p
atients with a sitting diastolic blood pressure (SiDBP) of 95-115 mmHg and
a systolic blood pressure of 150-200 mmHg were randomised to receive barnid
ipine 10 mg (n=159) or HCTZ 12.5 mg (n=155) once daily. In patients who had
not responded (SiDBP >90 mmHg) after 6 weeks of double-blind treatment, th
e dose was titrated upwards to barnidipine 20 mg or HCTZ 25 mg. After 18 we
eks, those who did not respond to the higher dose had enalapril (up to 10 m
g once daily) added to their regimen.
Statistically equivalent reductions in SiDBP were achieved with barnidipine
and HCTZ monotherapy At week 18 of double-blind treatment on monotherapy,
84% of patients in both groups were responders. The addition of enalapril i
n non-responders produced a further reduction in blood pressure. Both drugs
were well tolerated. The incidence of drug-related adverse events was grea
ter in the barnidipine than HCTZ-treated group but they were consistent wit
h vasodilation and were categorised as mild to moderate. In conclusion, bar
nidipine and HCTZ are well tolerated and have equivalent long-term antihype
rtensive efficacy in older hypertensive patients. For patients whose blood
pressure is inadequately controlled on monotherapy, combination therapy wit
h enalapril is effective.