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

Autor: Halvorsen LV; Department of Nephrology, Oslo University Hospital Ullevål, Oslo, Norway.; Section for Cardiovascular and Renal Research, Oslo University Hospital Ullevål, Oslo, Norway.; Institute of Clinical Medicine, University of Oslo, Oslo, Norway., Søraas CL; Section for Cardiovascular and Renal Research, Oslo University Hospital Ullevål, Oslo, Norway.; Section for Environmental and Occupational Medicine, Oslo University Hospital Ullevål, Oslo, Norway., Larstorp ACK; Section for Cardiovascular and Renal Research, Oslo University Hospital Ullevål, Oslo, Norway.; Institute of Clinical Medicine, University of Oslo, Oslo, Norway.; Department of Medical Biochemistry, Oslo University Hospital Ullevål, Oslo, Norway., Hjørnholm U; Section for Cardiovascular and Renal Research, Oslo University Hospital Ullevål, Oslo, Norway., Kjær VN; Section for Cardiovascular and Renal Research, Oslo University Hospital Ullevål, Oslo, Norway., Liestøl K; Department of Informatics, University of Oslo, Oslo, Norway., Aune A; Department of Clinical Science, University of Bergen, Bergen, Norway.; Department of Heart Disease, Haukeland University Hospital, Bergen, Norway., Olsen E; Norwegian University of Science and Technology, Trondheim, Norway.; Department of Emergency Medicine, St. Olav's University Hospital, Trondheim, Norway., Brobak KM; Metabolic and Renal Research Group, UiT, The Arctic University of Norway, Tromsø, Norway.; Section of Nephrology, University Hospital of North Norway, Tromsø, Norway., Bergland OU; Section for Cardiovascular and Renal Research, Oslo University Hospital Ullevål, Oslo, Norway., Rognstad S; Section for Cardiovascular and Renal Research, Oslo University Hospital Ullevål, Oslo, Norway.; Institute of Clinical Medicine, University of Oslo, Oslo, Norway.; Department of Pharmacology, Oslo University Hospital Ullevål, Oslo, Norway., Aarskog NR; Section for Cardiovascular and Renal Research, Oslo University Hospital Ullevål, Oslo, Norway.; Institute of Clinical Medicine, University of Oslo, Oslo, Norway.; Department of Acute Medicine, Oslo University Hospital Ullevål, Oslo, Norway., Heimark S; Department of Nephrology, Oslo University Hospital Ullevål, Oslo, Norway.; Section for Cardiovascular and Renal Research, Oslo University Hospital Ullevål, Oslo, Norway.; Institute of Clinical Medicine, University of Oslo, Oslo, Norway., Fadl Elmula FEM; Section for Cardiovascular and Renal Research, Oslo University Hospital Ullevål, Oslo, Norway., Gerdts E; Department of Clinical Science, University of Bergen, Bergen, Norway.; Department of Heart Disease, Haukeland University Hospital, Bergen, Norway., Mo R; Department of Emergency Medicine, St. Olav's University Hospital, Trondheim, Norway.; Department of Cardiology, St. Olav's University Hospital, Trondheim, Norway., Solbu MD; Metabolic and Renal Research Group, UiT, The Arctic University of Norway, Tromsø, Norway.; Section of Nephrology, University Hospital of North Norway, Tromsø, Norway., Opdal MS; Institute of Clinical Medicine, University of Oslo, Oslo, Norway.; Department of Pharmacology, Oslo University Hospital Ullevål, Oslo, Norway., Kjeldsen SE; Department of Nephrology, Oslo University Hospital Ullevål, Oslo, Norway.; Section for Cardiovascular and Renal Research, Oslo University Hospital Ullevål, Oslo, Norway.; Institute of Clinical Medicine, University of Oslo, Oslo, Norway.; Department of Cardiology, Oslo University Hospital Ullevål, Oslo, Norway., Rostrup M; Section for Cardiovascular and Renal Research, Oslo University Hospital Ullevål, Oslo, Norway.; Department of Acute Medicine, Oslo University Hospital Ullevål, Oslo, Norway.; Department of Behavioral Sciences, Institute of Basic Medical Sciences, University of Oslo, Oslo, Norway., Høieggen A; Department of Nephrology, Oslo University Hospital Ullevål, Oslo, Norway.; Section for Cardiovascular and Renal Research, Oslo University Hospital Ullevål, Oslo, Norway.; Institute of Clinical Medicine, University of Oslo, Oslo, Norway.
Jazyk: angličtina
Zdroj: American journal of hypertension [Am J Hypertens] 2024 Sep 16; Vol. 37 (10), pp. 826-836.
DOI: 10.1093/ajh/hpae059
Abstrakt: 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).
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.
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.
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.
Clinical Trials Registration: Trial Number NCT03209154, www.clinicaltrials.gov.
(© The Author(s) 2024. Published by Oxford University Press on behalf of American Journal of Hypertension, Ltd.)
Databáze: MEDLINE