Key result
Losartan plus hydrochlorothiazide combination therapy significantly reduced microalbuminuria levels compared to amlodipine monotherapy (p<0.0001), while providing similar blood pressure reductions.
Why the study?
Microalbuminuria predicts CVD in hypertension, and fixed-dose losartan plus HCTZ can improve BP control and cardiovascular prognosis, prompting a direct comparison with high-dose amlodipine monotherapy.
Does losartan plus hydrochlorothiazide improve blood pressure and microalbuminuria compared to amlodipine monotherapy in patients with newly diagnosed hypertension?
RCT (n=184)
Open-label
Chit method
No
Does losartan plus hydrochlorothiazide improve blood pressure and microalbuminuria compared to amlodipine monotherapy in patients with newly diagnosed hypertension?
Absolute Event Rate: 73.15% vs 108.72%
p-value: p=<0.0001
Should not yet change practice; leaves open confirmatory trials of a possible albuminuria advantage for losartan-HCTZ.
Background: Microalbuminuria has been shown to predict cardiovascular disease (CVD) in patients with hypertension. Recently the FDC of losartan and hydrochlorothiazide (HCTZ) has been reported to be effective for achieving a target BP level and also improvement in cardiovascular prognosis. The present study was conducted to compare effect of losartan plus hydrochlorothiazide combination therapy and high dose amlodipine monotherapy on blood pressure and microalbuminuria.Methods: Total 184 patients with hypertension were randomly allocated to two groups. The patients in group 1 received Amlodipine 5 mg orally for first 4 weeks. The patients from group 2 received losartan 50 mg orally for first 4 weeks. Patients in group 1 were titrated to amlodipine 10 mg orally for next 4 weeks. The patients in group 2 were titrated to FDC of losartan (50 mg) plus HCTZ (12.5 mg) for next 4 weeks. Follow–up visits were scheduled at 4 weeks and 8 weeks. Pulse rate, sSBP and sDBP were estimated at each follow–up. Microalbuminuria was estimated at 8 weeks.Results: There was no significant difference in mean change in sSBP, sDBP and pulse rate between two treatment groups (p>0.05). There was greater reduction in microalbuminuria in group 2 patients (p<0.0001). The adverse effects such as flushing and lower extremity oedema were significantly more in amlodipine group (p<0.05).Conclusions: Losartan plus HCTZ has similar effect on BP, better safety profile and superior effect on microalbuminuria level reduction.
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Sawant et al. (2019) conducted an RCT in Hypertension (n=184). Losartan plus hydrochlorothiazide vs. Amlodipine 10 mg was evaluated on Microalbuminuria level at 8 weeks (mg/L) (p=<0.0001). Losartan plus hydrochlorothiazide combination therapy significantly reduced microalbuminuria levels compared to amlodipine monotherapy (p<0.0001), while providing similar blood pressure reductions.
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