Evidence map›Paper›PMID 38713475›Full record

Trial reportAmerican journal of hypertension2024

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

Lene V Halvorsen, Camilla L Søraas, Anne Cecilie K Larstorp, Ulla Hjørnholm, Vibeke N Kjær, Knut Liestøl, Arleen Aune, Eirik Olsen, Karl Marius Brobak, Ola U Bergland and 11 more

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in American journal of hypertension, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03209154 (Individualized Blood Pressure Treatment), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03209154 naactive not recruitingnot on this map

Individualized Blood Pressure Treatment: a Multidisciplinary Approach to Uncontrolled Hypertension in Order to Reduce Morbidity and Mortality

TypeinterventionalSponsorOslo University HospitalRan2017 to 2025Enrolled1,000ConditionsUncontrolled HypertensionArmsTherapeutic drug monitoring, Home blood pressure monitoring
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

21 authors.

Lene V HalvorsenDepartment of Nephrology, Oslo University Hospital Ullevål, Oslo, Norway.
Camilla L SøraasSection for Cardiovascular and Renal Research, Oslo University Hospital Ullevål, Oslo, Norway.
Anne Cecilie K LarstorpSection for Cardiovascular and Renal Research, Oslo University Hospital Ullevål, Oslo, Norway.
Ulla HjørnholmSection for Cardiovascular and Renal Research, Oslo University Hospital Ullevål, Oslo, Norway.
Vibeke N KjærSection for Cardiovascular and Renal Research, Oslo University Hospital Ullevål, Oslo, Norway.
Knut LiestølDepartment of Informatics, University of Oslo, Oslo, Norway.
Arleen AuneDepartment of Clinical Science, University of Bergen, Bergen, Norway.
Eirik OlsenNorwegian University of Science and Technology, Trondheim, Norway.
Karl Marius BrobakMetabolic and Renal Research Group, UiT, The Arctic University of Norway, Tromsø, Norway.
Ola U BerglandSection for Cardiovascular and Renal Research, Oslo University Hospital Ullevål, Oslo, Norway.
Stine RognstadSection for Cardiovascular and Renal Research, Oslo University Hospital Ullevål, Oslo, Norway.
Nikolai R AarskogSection for Cardiovascular and Renal Research, Oslo University Hospital Ullevål, Oslo, Norway.
Sondre HeimarkDepartment of Nephrology, Oslo University Hospital Ullevål, Oslo, Norway.
Fadl Elmula M Fadl ElmulaSection for Cardiovascular and Renal Research, Oslo University Hospital Ullevål, Oslo, Norway.
Eva GerdtsDepartment of Clinical Science, University of Bergen, Bergen, Norway.ORCID 0000-0003-4109-2311
Rune MoDepartment of Emergency Medicine, St. Olav's University Hospital, Trondheim, Norway.
Marit D SolbuMetabolic and Renal Research Group, UiT, The Arctic University of Norway, Tromsø, Norway.
Mimi S OpdalInstitute of Clinical Medicine, University of Oslo, Oslo, Norway.
Sverre E KjeldsenDepartment of Nephrology, Oslo University Hospital Ullevål, Oslo, Norway.ORCID 0000-0003-2389-0272
Morten RostrupSection for Cardiovascular and Renal Research, Oslo University Hospital Ullevål, Oslo, Norway.
Aud HøieggenDepartment of Nephrology, Oslo University Hospital Ullevål, Oslo, Norway.

Funding

North Norwegian Regional Health AuthorityResearch Council of Norway 273563South-East Norwegian Regional Health Authority, the University of Oslo, Oslo University Hospital, Ullevål
6 · The paper itself

Abstract

backgroundDrug 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).

methodsPatients 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.

resultsFrom 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.

conclusionsIn 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.

Indexed as

Antihypertensive AgentsBlood PressureDrug MonitoringHypertensionMedication AdherenceAgedBlood Pressure Monitoring, AmbulatoryFemaleHumansMaleMiddle AgedTime FactorsTreatment OutcomeAntihypertensive Agentsadherenceantihypertensive drugsblood pressurehypertensionnonadherencerandomized clinical trialtherapeutic drug monitoring

Identifiers

PMID38713475
PMCPMC11403020

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.