Abstract
We performed a prospective, randomized, multicenter, parallel-group, per-protocol study to compare the effects of hydrochlorothiazide (HCTZ) and amlodipine as add-on to losartan treatment in hypertensive type 2 diabetic patients. A total of 49 Japanese type 2 diabetic patients with inadequate control of blood pressure while receiving losartan 50 mg were randomly allocated to receive a fixed-dose single-pill combination of HCTZ 12.5 mg plus losartan (N = 26) or a free combination of amlodipine 5 mg plus losartan (N = 23). During 8 weeks of follow-up, changes in blood pressure and laboratory data including HbA1c, uric acid, and potassium were compared between the groups using analysis of covariance. Systolic and diastolic blood pressure decreased in both groups, the reductions of which were greater in the amlodipine group. However, the least square mean (95 % CI) differences between groups were not statistically significant [2.3 (−6.8 to 11.4) mmHg, p = 0.618 and 2.7 (−2.4–7.9) mmHg, p = 0.293, respectively]. HbA1c increased in patients receiving HCTZ but not in the amlodipine group. Uric acid also increased in patients receiving HCTZ but decreased in patients receiving amlodipine, yielding a significant between-group difference of 1.0 (0.5–1.5) mg/dl (p < 0.001). No intra- or intergroup change was observed in serum potassium levels. This pilot study suggests that HCTZ and amlodipine result in nonsignificant effects on systolic and diastolic blood pressure reduction when administrated as add-on therapy to losartan in hypertensive patients with type 2 diabetes; however, addition of HCTZ may be associated with less favorable effects on metabolic profiles than amlodipine.
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This study was supported by the Japan Kidney Foundation.
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T. B. has received lecture fees from MSD, Pfizer, and Sumitomo Dainippon and research funding from MSD. O. T. has received lecture fees from MSD and Sumitomo Dainippon. Y. U has received lecture fees from MSD and research funding from MSD, Pfizer, and Sumitomo Dainippon. N. T., M. T., and Y. S. declare that they have no conflict of interest.
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All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1964 and later versions. Informed consent or a substitute for it was obtained from all patients for being included in the study.
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Tanaka, N., Babazono, T., Tanaka, M. et al. Antihypertensive and metabolic effects of hydrochlorothiazide versus amlodipine when added to losartan in patients with type 2 diabetes. Diabetol Int 7, 266–273 (2016). https://doi.org/10.1007/s13340-015-0243-x
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DOI: https://doi.org/10.1007/s13340-015-0243-x