Kl. Schulte et al., Efficacy and tolerability of candesartan cilexetil monotherapy or in combination with other antihypertensive drugs - Results of the AURA study, CLIN DRUG I, 18(6), 1999, pp. 453-460
Objective: To evaluate the efficacy and tolerability of different dosages o
f candesartan cilexetil administered as monotherapy or in combination with
any pre-existing but insufficient antihypertensive treatment. The effects o
f candesartan cilexetil treatment on quality of life were also investigated
.
Design and Setting: This was an open, multicentre, nonrandomised study cond
ucted at 1575 centres throughout Germany.
Patients: 4531 patients with primary hypertension receiving no dr insuffici
ent antihypertensive treatment [diastolic blood pressure (DBP) >95mm Hg] pa
rticipated in the study.
Interventions: Patients received candesartan cilexetil 8mg once daily in ad
dition to any pre-existing antihypertensive therapy. The dosage was increas
ed to 16mg after 4 weeks and to 32mg after 8 weeks if sitting clinic DBP re
mained greater than or equal to 90mm Hg.
Results: Candesartan cilexetil (mean dose 14.8mg) reduced mean sitting DBP
and systolic blood pressure by 16 (from 102 to 86mm Hg) and 26mm Hg (from 1
72 to 145mm Hg), respectively. Blood pressure control (DBP <90mm Hg) was ac
hieved in 67.8% of patients by week 12. The mean Psychological General Well
-Being index was improved by 9.2 units. Candesartan cilexetil was well tole
rated with only 6.1% of patients reporting an adverse event.
Conclusions: This study demonstrates that treatment with candesartan cilexe
til is efficacious and well tolerated in patients with mild to moderate pri
mary hypertension. The efficacy of candesartan cilexetil is independent of
antihypertensive co-medication, achieving a DBP close to 85mm Hg in most pa
tients.