Sh. Taylor et al., EFFICACY AND TOLERABILITY OF AMLODIPINE IN THE GENERAL-PRACTICE TREATMENT OF ESSENTIAL-HYPERTENSION IN AN ASIAN MULTINATIONAL POPULATION, Clinical drug investigation, 16(3), 1998, pp. 177-185
Objective: To evaluate the efficacy and tolerability of once-daily aml
odipine (Pfizer Pharmaceuticals Inc.) alone or in combination with oth
er antihypertensive drugs in an Asian population with essential hypert
ension. Patients: An open study was undertaken in 165 male and 158 fem
ale patients with uncomplicated hypertension (diastolic blood pressure
95 to 115mm Hg). Patients were recruited from 41 general practices in
seven Asian countries and received amlodipine 5mg daily for 4 weeks a
nd then 10mg once daily for a further 4 weeks if the target diastolic
blood pressure of less than or equal to 90mm Hg or a reduction from ba
seline by greater than or equal to 10mm Hg had not been achieved. This
one-step dose-adjustment period was followed by a 4-week maintenance
period on a constant dose. Amlodipine was the sole medication in 284 p
atients and was added to other antihypertensive drugs in 39 patients u
ncontrolled on previous medication. Results: 263 patients, including 1
31 males, were evaluated for efficacy at the final treatment visit. 16
6 (63%) patients achieved the target reduction in diastolic blood pres
sure with amlodipine 5mg once daily, while 84 patients achieved the ta
rget reduction with 10mg once daily. Systolic and diastolic blood pres
sure reductions were similar irrespective of gender or age, and there
were no significant changes in resting heart rate in any subgroup. In
68 patients who underwent ambulatory monitoring, the systolic and dias
tolic blood pressures were reduced by once-daily amlodipine throughout
the 24-hour period without change in the intrinsic circadian pattern.
Amlodipine was well tolerated in all patient sub groups; adverse even
ts accounted for less than 1% of treatment discontinuations, and there
were no hospitalisations or deaths during the study. Investigators ra
ted both the antihypertensive efficacy and tolerability of amlodipine
as excellent or good in 93% of patients. Conclusion: In 263 Asian pati
ents with uncomplicated essential hypertension treated in general prac
tice, once-daily amlodipine in a dose of 5 or 10mg provided significan
t antihypertensive efficacy either as monotherapy or in combination wi
th other antihypertensive drugs while maintaining a favourable tolerab
ility profile regardless of gender or age.