Comparison of the efficacy and safety of single-pill fixed-dose combinations of losartan/hydrochlorothiazide and valsartan/hydrochlorothiazide in patients with hypertension (SALT-VAT study)

Abstract

Objective We analyzed the efficacy and safety of Preminent® [losartan(50 mg/day)/HCTZ(12.5 mg/day)] compared to CodioMD® [valsartan(80 mg/day)/HCTZ(6.25 mg/day)]. Methods In this study, 31 hypertensive patients after receiving 3 months of Preminent® (Stage A) were enrolled. We applied a changeover with switching from Preminent® to CodioMD® (Stage B). We then applied another changeover with switching from CodioMD® to Preminent® after 3 months (Stage C). Results Average values of 24-h blood pressure (BP), daytime BP and nighttime BP using ambulatory BP monitoring (ABPM) significantly increased from Stage A to B [4/3 mmHg, 5/3 mmHg and 3/3 mmHg, respectively]. Average values of 24-h BP, morning BP, daytime BP, nighttime BP significantly decreased from the end of Stage B to C [-5/-5 mmHg, -4/-6 mmHg, -5/-5 mmHg and -6/-4 mmHg, respectively]. Interestingly, the serum levels of uric acid and the urinary albumin/creatinine ratio showed a significant increase after the change to CodioMD®. Since these adverse effects did not disappear after the return to Preminent® at the end of Stage C, we performed an additional 3-month follow-up (extended stage). These adverse effects finally disappeared at the end of this extended stage. Conclusion Single-pill fixed-dose combination therapy using Preminent® showed significant 24-h BPlowering effects and was safe when compared with CodioMD®. © 2011 The Japanese Society of Internal Medicine.