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)

Objective We analyzed the efficacy and safety of Preminent (R) [losartan(50 mg/day)/HCTZ(12.5 mg/day)] compared to CodioMD (R) [valsartan(80 mg/day)/HCTZ(6.25 mg/day)]. Methods In this study, 31 hypertensive patients after receiving 3 months of Preminent (R) (Stage A) were enrolled. We applied a changeover with switching from Preminent (R) to CodioMD (R) (Stage B). We then applied another changeover with switching from CodioMD (R) to Preminent (R) 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 (R). Since these adverse effects did not disappear after the return to Preminent (R) 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 (R) showed significant 24-h BP-lowering effects and was safe when compared with CodioMD (R).