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Effect of Therapeutic Drug Monitoring on Adherence and Blood Pressure: A Multicenter Randomized Clinical Trial.

Authors :
Halvorsen LV
Søraas CL
Larstorp ACK
Hjørnholm U
Kjær VN
Liestøl K
Aune A
Olsen E
Brobak KM
Bergland OU
Rognstad S
Aarskog NR
Heimark S
Fadl Elmula FEM
Gerdts E
Mo R
Solbu MD
Opdal MS
Kjeldsen SE
Rostrup M
Høieggen A
Source :
American journal of hypertension [Am J Hypertens] 2024 Sep 16; Vol. 37 (10), pp. 826-836.
Publication Year :
2024

Abstract

Background: Drug concentration in blood or urine is an acknowledged method to detect nonadherence. Observational studies suggest that informing patients about low or absent serum drug levels improves blood pressure (BP). We performed a multicenter randomized clinical trial to test the hypothesis that therapeutic drug monitoring (TDM) could improve drug adherence and BP in patients with uncontrolled hypertension (HT).<br />Methods: Patients were ≥18 years on stable treatment with at least 2 antihypertensive agents. We planned to randomize 80 nonadherent patients with a systolic daytime ambulatory BP ≥135 mm Hg to TDM intervention or not. The control group and the study personnel who measured BP remained uninformed about serum drug measurements throughout. All patients and physicians were blinded for BPs. Lifestyle advice and detailed information on the disease process and the importance of BP treatment were given to both groups.<br />Results: From 2017 to 2022, we randomized 46 diagnosed nonadherent from a total of 606 patients with uncontrolled HT. The TDM group had a 6.7 (±14.5) mm Hg reduction from 147.9 (±10.3) to 141.1 (±14.1) mm Hg, and the control group experienced a 7.3 (±13.2) mm Hg reduction from 147.1 (±9.2) to 139.1 (±17.4) mm Hg, P = 0.9 between groups. Adherence improved in both groups, 73% in the TDM group and 59% in the control group became adherent at 3 months, P = 0.51.<br />Conclusions: In our prospective multicenter clinical trial of uncontrolled and nonadherent hypertensive patients, we found no additional effect of TDM on BP and drug adherence compared with standard care.<br />Clinical Trials Registration: Trial Number NCT03209154, www.clinicaltrials.gov.<br /> (© The Author(s) 2024. Published by Oxford University Press on behalf of American Journal of Hypertension, Ltd.)

Details

Language :
English
ISSN :
1941-7225
Volume :
37
Issue :
10
Database :
MEDLINE
Journal :
American journal of hypertension
Publication Type :
Academic Journal
Accession number :
38713475
Full Text :
https://doi.org/10.1093/ajh/hpae059