A trial of 2 strategies to reduce nocturnal blood pressure in blacks with chronic kidney disease

Abstract

The objective of our study was to determine the effects of 2 antihypertensive drug dose schedules (PM dose and add-on dose) on nocturnal blood pressure (BP) in comparison with usual therapy (AM dose) in blacks with hypertensive chronic kidney disease and controlled office BP. In a 3-period, crossover trial, former participants of the African American Study of Kidney Disease were assigned to receive the following 3 regimens, each lasting 6 weeks, presented in random order: AM dose (once-daily antihypertensive medications taken in the morning), PM dose (once-daily antihypertensives taken at bedtime), and add-on dose (once-daily antihypertensives taken in the morning and an additional antihypertensive medication before bedtime [diltiazem 60-120 mg, hydralazine 25 mg, or additional ramipril 5 mg]). Ambulatory BP monitoring was performed at the end of each period. The primary outcome was nocturnal systolic BP. Mean age of the study population (n=147) was 65.4 years, 64% were men, and mean estimated glomerular filtration rate was 44.9 mL/min per 1.73 m(2). At the end of each period, mean (SE) nocturnal systolic BP was 125.6 (1.2) mm Hg in the AM dose, 123.9 (1.2) mm Hg in the PM dose, and 123.5 (1.2) mm Hg in the add-on dose. None of the pairwise differences in nocturnal, 24-hour, and daytime systolic BP was statistically significant. Among blacks with hypertensive chronic kidney disease, neither PM (bedtime) dosing of once-daily antihypertensive nor the addition of drugs taken at bedtime significantly reduced nocturnal BP compared with morning dosing of antihypertensive medications.

Trial registration: ClinicalTrials.gov NCT00582777.

Conflict of interest statement

6. Conflict of interest/disclosures

Dr. Rahman has research support from NIH, and has received honoraria from Boehringer Ingelheim. Dr. Bakris has served as a consultant/ advisory board for Takeda, Servier, Abbott, CVRx, Johnson and Johnson, Eli Lilly and Medtronic. Dr. Jamerson has research grant support from NIH, NIDDK and NHLBI, serves on the speakers bureau for Daichi-Sankyo pharmaceuticals, has received honoraria from Boehringer-Ingelheim, Daichi-Sankyo, Forest, Novartis and Xuma Pharm, served as a consultant advisory board for Boehringer-Ingelheim, Daichi Sankyo, Forest, Pfizer, Novartis, Xoma pharm, and Invasc Therapeutics. Dr. Rostand holds shares of common stock in Merck. Dr. Toto has served on the speakers bureau for Amgen and Merck, has served as consultant/advisory board for Boehringer-Ingelheim and Amgen. Dr. Wright has served as consultant/advisory board Medtronics, Takeda and Medical Letter.

Figures

Fig 1

Study schema; 3 period randomized, cross over design