Combination Hydralazine and Isosorbide Dinitrate in Dialysis-Dependent ESRD (HIDE): A Randomized, Placebo-Controlled, Pilot Trial.

Background

Combination therapy with isosorbide dinitrate (ISD) and hydralazine (HY) reduces heart failure mortality. The safety and tolerability in individuals requiring maintenance hemodialysis (HD) is unknown.

Methods

Single-center, randomized, placebo-controlled, double-blind pilot trial to explore safety and tolerability of ISD/HY in maintenance HD. Participants were randomized to placebo or combination ISD/HY. Dose was escalated over 3 weeks from ISD 10 mg/HY 10 mg to ISD 40 mg/HY 75 mg three times per day with the maximum tolerated dose maintained for the subsequent 21 weeks. Primary endpoints included adverse events, adverse events precluding further treatment with study medication, serious hypotension (

Results

A total of 17 individuals were randomized to ISD/HY (

Conclusions

ISD/HY appears to be well tolerated in patients being treated with maintenance HD, but headache and gastrointestinal side effects occur more frequently with ISD/HY compared with placebo.

Informations de copyright

Copyright © 2020 by the American Society of Nephrology.

Déclaration de conflit d'intérêts

D. Charytan reports receiving research support from Gilead, Janssen, Medtronic Inc, and NovoNordisk, and consulting fees or fees for service on data safety or clinical events committees from Allena Pharmaceuticals, AstraZeneca, Fresenius, Gilead, Janssen, Merck, and NovoNordisk. L. Dember reports receiving compensation from the National Kidney Foundation for serving as Deputy Editor of the American Journal of Kidney Diseases, and consulting fees from Merck. M. DiCarli reports receiving research grants from Gilead Sciences and SpectrumDynamics, and consulting honoraria from Sanofi and General Electric. T. Ikizler reports receiving personal fees from Abbott Renal Care, Fresenius Kabi, and the International Society of Nephrology during the conduct of the study. R. Mehrotra reports receiving honoraria from Baxter HealthCare and he is a member of the Board of Trustees of the Northwest Kidney Centers. H. Skali reports receiving stock options from OptimizeRx for consulting/advisory roles, outside the submitted work. S. Waikar reports receiving grants and personal fees from Allena Pharmaceuticals and personal fees from Barron and Budd (versus Fresenius), Bunch and James, Cerus, Consumer Value Store, GE Health Care, Glaxo Smith Kline, Harvard Clinical Research Institute (aka Baim), Johnson and Johnson, Kantum Pharma, Mallinckrodt, Mass Medical International, Public Health Advocacy Institute Pfizer, Roth Capital Partners, Strataca, Takeda, Venbio, and Wolters Kluewer, outside the submitted work. All remaining authors have nothing to disclose.