A study of losartan, alone or with hydrochlorothiazide vs nifedipine GITS in elderly patients with diastolic hypertension

Abstract

We conducted a randomised, double-blind, parallel design study comparing the efficacy and tolerability of the angiotensin II receptor antagonist, losartan, alone or with low-dose hydrochlorothiazide (HCTZ) to the dihydropyridine calcium channel blocker, nifedipine GITS (gastro-intestinal therapeutic system), in elderly patients (⩾65 years old) with a diastolic blood pressure (DBP) between 95 and 115 mm Hg. After a placebo wash out period, 140 patients were randomly assigned to receive either losartan 50 mg or nifedipine GITS 30 mg. Patients were evaluated at 4-week intervals during a 12-week treatment period. Patients receiving losartan had HCTZ 12.5 mg added and increased to 25 mg to reduce DBP <90 mm hg. patients receiving nifedipine gits had their dose increased to 60 mg and 90 mg to reduce dbp <90 mm hg. efficacy, tolerability and quality of life were assessed during the 12 weeks on each regimen. patients treated with the losartan regimen (n = 73) had reductions in trough sitting DBP of −10, −13, and −13 mm Hg after 4, 8, and 12 weeks of therapy, respectively. Patients receiving the nifedipine GITS regimen (n = 67) had DBP reductions of −14, −15, and −15 mm Hg, respectively. There were no significant differences in the DBP response between the treatment groups except at week 4 (P < 0.05). similar reductions in systolic bp (sbp) between the two treatment groups were observed at all time points. the percentages of patients in the two treatment groups reaching goal dbp (<90 mm hg or dbp ⩾90 mm hg with a reduction from a baseline of ⩾10 mm hg) were comparable (81% on the losartan regimen and 90% on the nifedipine gits regimen). there were significantly more adverse events reported in patients receiving nifedipine gits when compared to the losartan regimen (54% vs 36%, P < 0.05). a patient-reported symptom inventory also showed that swollen ankles was bothersome in significantly more patients treated with the nifedipine gits regimen when compared to the losartan regimen (24% vs 5%, P = 0.001). Thus, in elderly patients with diastolic hypertension, a regimen of losartan alone or with HCTZ has similar efficacy to a regimen of nifedipine GITS with greater tolerability and less symptom bother due to swollen ankles.