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, Stine Rognstad, Nikolai R Aarskog, Sondre Heimark, Fadl Elmula M Fadl Elmula, Eva Gerdts, Rune Mo, Marit D Solbu, Mimi S Opdal, Sverre E Kjeldsen, Morten Rostrup, Aud Høieggen
{"title":"药物监测对依从性和血压的影响:多中心随机临床试验。","authors":"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, Stine Rognstad, Nikolai R Aarskog, Sondre Heimark, Fadl Elmula M Fadl Elmula, Eva Gerdts, Rune Mo, Marit D Solbu, Mimi S Opdal, Sverre E Kjeldsen, Morten Rostrup, Aud Høieggen","doi":"10.1093/ajh/hpae059","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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).</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p><p><strong>Clinical trials registration: </strong>Trial Number NCT03209154, www.clinicaltrials.gov.</p>","PeriodicalId":7578,"journal":{"name":"American Journal of Hypertension","volume":" ","pages":"826-836"},"PeriodicalIF":3.2000,"publicationDate":"2024-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11403020/pdf/","citationCount":"0","resultStr":"{\"title\":\"Effect of Therapeutic Drug Monitoring on Adherence and Blood Pressure: A Multicenter Randomized Clinical Trial.\",\"authors\":\"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, Stine Rognstad, Nikolai R Aarskog, Sondre Heimark, Fadl Elmula M Fadl Elmula, Eva Gerdts, Rune Mo, Marit D Solbu, Mimi S Opdal, Sverre E Kjeldsen, Morten Rostrup, Aud Høieggen\",\"doi\":\"10.1093/ajh/hpae059\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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).</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p><p><strong>Clinical trials registration: </strong>Trial Number NCT03209154, www.clinicaltrials.gov.</p>\",\"PeriodicalId\":7578,\"journal\":{\"name\":\"American Journal of Hypertension\",\"volume\":\" \",\"pages\":\"826-836\"},\"PeriodicalIF\":3.2000,\"publicationDate\":\"2024-09-16\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11403020/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"American Journal of Hypertension\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1093/ajh/hpae059\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"PERIPHERAL VASCULAR DISEASE\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"American Journal of Hypertension","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1093/ajh/hpae059","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"PERIPHERAL VASCULAR DISEASE","Score":null,"Total":0}
Effect of Therapeutic Drug Monitoring on Adherence and Blood Pressure: A Multicenter Randomized Clinical Trial.
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.
期刊介绍:
The American Journal of Hypertension is a monthly, peer-reviewed journal that provides a forum for scientific inquiry of the highest standards in the field of hypertension and related cardiovascular disease. The journal publishes high-quality original research and review articles on basic sciences, molecular biology, clinical and experimental hypertension, cardiology, epidemiology, pediatric hypertension, endocrinology, neurophysiology, and nephrology.