Antihypertensive treatment in elderly patients aged 75 years or over: a 24-week study of the tolerability of candesartan cilexetil in relation to hydrochlorothiazide.
OBJECTIVE
To assess the safety and tolerability of the AT1-receptor blocker candesartan cilexetil in relation to the diuretic hydrochlorothiazide (HCTZ) in elderly patients.


METHODS
A multicentre, double-blind, randomised, parallel group study. 32 general practice centres and 3 hospital centres in Denmark and Finland participated in this study.


METHODS
185 patients aged > or =75 years with mean sitting diastolic blood pressure (DBP) of 95 to 114mm Hg.


METHODS
After a placebo run-in period of 4 to 8 weeks, patients were randomised to once daily treatment with candesartan cilexetil 8mg or HCTZ 12.5mg for 24 weeks. In both treatment groups the dosage could be doubled after > or =2 weeks [according to blood pressure (BP) response] and, if necessary, subsequently decreased if the higher dosage was poorly tolerated.


METHODS
Proportion of patients with at least 1 adverse event; changes in laboratory values, electrocardiogram and BP during the double-blind treatment period.


RESULTS
Once daily candesartan cilexetil 8 to 16mg was very well tolerated. The most common adverse events in both treatment groups were dizziness or vertigo and headache. Although the profile of adverse events was generally similar in the 2 treatment groups, it was notable that hypokalaemia and hyperuricaemia were not found in patients treated with candesartan cilexetil but occurred in 8.1 and 6.5%, respectively, of patients treated with HCTZ. At week 24, the adjusted mean changes in sitting DBP (24 hours postdose) from baseline were -12.0mm Hg [95% confidence interval (CI) -1 0.4 to -13.6] in patients treated with candesartan cilexetil and -11.4mm Hg (95% CI -9.3 to -13.6) in patients treated with HCTZ. The difference between treatments in favour of candesartan cilexetil was not statistically significant.


CONCLUSIONS
This study shows that antihypertensive treatment with candesartan cilexetil in elderly patients (aged > or =75 years) is well tolerated with a good safety profile and avoids the metabolic adverse effects of diuretic therapy.
Neldam
S
S
Rødovre Centrum, Denmark. neldam@dadlnet.dk
Forsén
B
B
D000368:Aged; D000369:Aged, 80 and over; D000959:Antihypertensive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001562:Benzimidazoles / Q000009:adverse effects / Q000627:therapeutic use*; D001713:Biphenyl Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D001794:Blood Pressure / Q000187:drug effects / Q000502:physiology; D004311:Double-Blind Method; D005260:Female; D006339:Heart Rate / Q000187:drug effects / Q000502:physiology; D006801:Humans; D006852:Hydrochlorothiazide / Q000009:adverse effects / Q000627:therapeutic use*; D006973:Hypertension / Q000188:drug therapy* / Q000503:physiopathology; D008297:Male; D013777:Tetrazoles
D000959:Antihypertensive Agents; D001562:Benzimidazoles; D001713:Biphenyl Compounds; D013777:Tetrazoles; D006852:Hydrochlorothiazide; C077793:candesartan cilexetil