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Randomized Controlled Trial
. 2024 Jan 1;42(1):169-178.
doi: 10.1097/HJH.0000000000003585. Epub 2023 Oct 18.

Antihypertensive drug concentration measurement combined with personalized feedback in resistant hypertension: a randomized controlled trial

Laura E J Peeters  1   2 , M H W Kappers  3 , D A Hesselink  2 , J B van der Net  4 , S C C Hartong  4 , R van de Laar  5 , M Ezzahti  6 , P J G van de Ven  7 , I M van der Meer  8 , E L E de Bruijne  9 , A A Kroon  10 , S Indhirajanti-Tomasoa  11 , N A J van der Linde  12 , S Bahmany  1 , E Boersma  13 , E K Massey  2 , L van Dijk  14   15 , T van Gelder  1   2 , Birgit C P Koch  2 , Jorie Versmissen  1   2
Affiliations
Randomized Controlled Trial

Antihypertensive drug concentration measurement combined with personalized feedback in resistant hypertension: a randomized controlled trial

Laura E J Peeters et al. J Hypertens. .

Abstract

Background: Adherence to antihypertensive drugs (AHDs) is crucial for controlling blood pressure (BP). We aimed to determine the effectiveness of measuring AHD concentrations using a dried blood spot (DBS) sampling method to identify nonadherence, combined with personalized feedback, in reducing resistant hypertension.

Methods: We conducted a multicenter, randomized, controlled trial (RHYME-RCT, ICTRP NTR6914) in patients with established resistant hypertension. Patients were randomized to receive either an intervention with standard of care (SoC) or SoC alone. SoC consisted of BP measurement and DBS sampling at baseline, 3 months (t3), 6 months (t6), and 12 months (t12); AHD concentrations were measured but not reported in this arm. In the intervention arm, results on AHD concentrations were discussed during a personalized feedback conversation at baseline and t3. Study endpoints included the proportion of patients with RH and AHD adherence at t12.

Results: Forty-nine patients were randomized to receive the intervention+SoC, and 51 were randomized to receive SoC alone. The proportion of adherent patients improved from 70.0 to 92.5% in the intervention+SoC arm ( P = 0.008, n = 40) and remained the same in the SoC arm (71.4%, n = 42). The difference in adherence between the arms was statistically significant ( P = 0.014). The prevalence of resistant hypertension decreased to 75.0% in the intervention+SoC arm ( P < 0.001, n = 40) and 59.5% in the SoC arm ( P < 0.001, n = 42) at t12; the difference between the arms was statistically nonsignificant ( P = 0.14).

Conclusion: Personalized feedback conversations based on DBS-derived AHD concentrations improved AHD adherence but did not reduce the prevalence of RH.

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Conflict of interest statement

L.E.J.P. has received lecture fees from Astellas Pharma. D.A.H. has received lecture fees and consulting fees from Astellas Pharma, Astra-Zeneca, Chiesi Pharma, Medincell, Novartis Pharma, Sangamo Therapeutics, and Vifor Pharma. He has received grant support from Astellas Pharma, Bristol-Myers Squibb, and Chiesi Pharma (paid to his institution). D.A.H. does not have employment or stock ownership at any of these companies, and neither does he have patents or patent applications. In the last 3 years, T.vG. has received lecture fees and study grants from Chiesi and Astellas, in addition to consulting fees from Roche Diagnostics, Thermo Fisher, Vitaeris, CSL Behring, Astellas, and Aurinia Pharma. In the last 3 years, L.vD. has received a research grant from Teva for a study not related to this one. The other authors declare no conflicts of interest.

Figures

None
Graphical abstract
FIGURE 1
FIGURE 1
Inclusion flowchart RHYME-RCT.
FIGURE 2
FIGURE 2
Proportion of patients with resistant hypertension (n = 82) at four time points. aOnly patients with t0, t3, or t6 and t12 are included in this figure.
FIGURE 3
FIGURE 3
SBP and DBP at four time points (n = 82). aOnly patients with t0, t3 or t6 and t12 are included in this figure.
FIGURE 4
FIGURE 4
Adherence rate of antihypertensive drugs at four time points. aOnly patients with t0, t3, or t6 and t12 are included in this figure.
See this image and copyright information in PMC

Comment in

References

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