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Effect of antihypertensive medication reduction vs usual care on short-term blood pressure control in patients with hypertension aged 80 years and older: The OPTIMISE randomized clinical trial

Effect of antihypertensive medication reduction vs usual care on short-term blood pressure control in patients with hypertension aged 80 years and older: The OPTIMISE randomized clinical trial
Effect of antihypertensive medication reduction vs usual care on short-term blood pressure control in patients with hypertension aged 80 years and older: The OPTIMISE randomized clinical trial

Importance: Deprescribing of antihypertensive medications is recommended for some older patients with polypharmacy and multimorbidity when the benefits of continued treatment may not outweigh the harms.

Objective: This study aimed to establish whether antihypertensive medication reduction is possible without significant changes in systolic blood pressure control or adverse events during 12-week follow-up.

Design, Setting, and Participants: The Optimising Treatment for Mild Systolic Hypertension in the Elderly (OPTIMISE) study was a randomized, unblinded, noninferiority trial conducted in 69 primary care sites in England. Participants, whose primary care physician considered them appropriate for medication reduction, were aged 80 years and older, had systolic blood pressure lower than 150 mm Hg, and were receiving at least 2 antihypertensive medications were included. Participants enrolled between April 2017 and September 2018 and underwent follow-up until January 2019.

Interventions: Participants were randomized (1:1 ratio) to a strategy of antihypertensive medication reduction (removal of 1 drug [intervention], n = 282) or usual care (control, n = 287), in which no medication changes were mandated.

Main Outcomes and Measures: The primary outcome was systolic blood pressure lower than 150 mm Hg at 12-week follow-up. The prespecified noninferiority margin was a relative risk (RR) of 0.90. Secondary outcomes included the proportion of participants maintaining medication reduction and differences in blood pressure, frailty, quality of life, adverse effects, and serious adverse events.

Results: Among 569 patients randomized (mean age, 84.8 years; 276 [48.5%] women; median of 2 antihypertensive medications prescribed at baseline), 534 (93.8%) completed the trial. Overall, 229 (86.4%) patients in the intervention group and 236 (87.7%) patients in the control group had a systolic blood pressure lower than 150 mm Hg at 12 weeks (adjusted RR, 0.98 [97.5% 1-sided CI, 0.92 to ∞]). Of 7 prespecified secondary end points, 5 showed no significant difference. Medication reduction was sustained in 187 (66.3%) participants at 12 weeks. Mean change in systolic blood pressure was 3.4 mm Hg (95% CI, 1.1 to 5.8 mm Hg) higher in the intervention group compared with the control group. Twelve (4.3%) participants in the intervention group and 7 (2.4%) in the control group reported at least 1 serious adverse event (adjusted RR, 1.72 [95% CI, 0.7 to 4.3]).

Conclusions and Relevance: Among older patients treated with multiple antihypertensive medications, a strategy of medication reduction, compared with usual care, was noninferior with regard to systolic blood pressure control at 12 weeks. The findings suggest antihypertensive medication reduction in some older patients with hypertension is not associated with substantial change in blood pressure control, although further research is needed to understand long-term clinical outcomes.

Trial Registration: EudraCT Identifier: 2016-004236-38; ISRCTN identifier: 97503221.

Aged, 80 and over, Antihypertensive Agents/administration & dosage, Blood Pressure/drug effects, Deprescriptions, Female, Humans, Hypertension/drug therapy, Male, Polypharmacy
0098-7484
2039-2051
Sheppard, James P.
5468331c-e231-4103-b407-28c8161cc6d7
Burt, Jenni
af1903e7-2bb8-464d-8e82-ec1076fdbb2e
Lown, Mark
4742d5f8-bcf3-4e0b-811c-920e7d010c9b
Temple, Eleanor
02a2b007-950c-45dd-93e7-489ae924fe7f
Lowe, Rebecca
677baa34-e8ac-43ac-93ac-c1eb09cacf85
Fraser, Rosalyn
7d97bdb2-2630-4ae4-ad7b-cad4cb75a8c0
Allen, Julie
f478888a-0653-4505-acea-1134b5d80a1c
Ford, Gary A.
c03a4c65-e4ef-4d39-a8be-dbdc20cfef0b
Heneghan, Carl
ab54c700-8c86-420a-98b9-45e071b1c842
Hobbs, F. D.Richard
9a0f0240-ff92-43ed-882a-2c3be3472559
Jowett, Sue
97638e31-26f6-4d01-8a58-8bca0eb80053
Kodabuckus, Shahela
cd0649b4-de7a-46aa-b560-ab04f05e14ca
Little, Paul
1bf2d1f7-200c-47a5-ab16-fe5a8756a777
Mant, Jonathan
15d82dfc-6b6a-4dd4-b466-97c43fca38c6
Mollison, Jill
555564a2-d739-4725-aea0-74d6c89c5740
Payne, Rupert A.
510c53d5-e691-41ed-8c2e-5cc77e40a75a
Williams, Marney
aed0fd5f-500d-48d9-844f-814b08c037fd
Yu, Ly Mee
ae5bebd5-e49c-4fb1-ada1-a7d669f8a87f
McManus, Richard J.
481f6284-d599-4c77-8869-d1c6b63b9b02
Sheppard, James P.
5468331c-e231-4103-b407-28c8161cc6d7
Burt, Jenni
af1903e7-2bb8-464d-8e82-ec1076fdbb2e
Lown, Mark
4742d5f8-bcf3-4e0b-811c-920e7d010c9b
Temple, Eleanor
02a2b007-950c-45dd-93e7-489ae924fe7f
Lowe, Rebecca
677baa34-e8ac-43ac-93ac-c1eb09cacf85
Fraser, Rosalyn
7d97bdb2-2630-4ae4-ad7b-cad4cb75a8c0
Allen, Julie
f478888a-0653-4505-acea-1134b5d80a1c
Ford, Gary A.
c03a4c65-e4ef-4d39-a8be-dbdc20cfef0b
Heneghan, Carl
ab54c700-8c86-420a-98b9-45e071b1c842
Hobbs, F. D.Richard
9a0f0240-ff92-43ed-882a-2c3be3472559
Jowett, Sue
97638e31-26f6-4d01-8a58-8bca0eb80053
Kodabuckus, Shahela
cd0649b4-de7a-46aa-b560-ab04f05e14ca
Little, Paul
1bf2d1f7-200c-47a5-ab16-fe5a8756a777
Mant, Jonathan
15d82dfc-6b6a-4dd4-b466-97c43fca38c6
Mollison, Jill
555564a2-d739-4725-aea0-74d6c89c5740
Payne, Rupert A.
510c53d5-e691-41ed-8c2e-5cc77e40a75a
Williams, Marney
aed0fd5f-500d-48d9-844f-814b08c037fd
Yu, Ly Mee
ae5bebd5-e49c-4fb1-ada1-a7d669f8a87f
McManus, Richard J.
481f6284-d599-4c77-8869-d1c6b63b9b02

Sheppard, James P., Burt, Jenni, Lown, Mark, Temple, Eleanor, Lowe, Rebecca, Fraser, Rosalyn, Allen, Julie, Ford, Gary A., Heneghan, Carl, Hobbs, F. D.Richard, Jowett, Sue, Kodabuckus, Shahela, Little, Paul, Mant, Jonathan, Mollison, Jill, Payne, Rupert A., Williams, Marney, Yu, Ly Mee and McManus, Richard J. (2020) Effect of antihypertensive medication reduction vs usual care on short-term blood pressure control in patients with hypertension aged 80 years and older: The OPTIMISE randomized clinical trial. JAMA - Journal of the American Medical Association, 323 (20), 2039-2051. (doi:10.1001/jama.2020.4871).

Record type: Article

Abstract

Importance: Deprescribing of antihypertensive medications is recommended for some older patients with polypharmacy and multimorbidity when the benefits of continued treatment may not outweigh the harms.

Objective: This study aimed to establish whether antihypertensive medication reduction is possible without significant changes in systolic blood pressure control or adverse events during 12-week follow-up.

Design, Setting, and Participants: The Optimising Treatment for Mild Systolic Hypertension in the Elderly (OPTIMISE) study was a randomized, unblinded, noninferiority trial conducted in 69 primary care sites in England. Participants, whose primary care physician considered them appropriate for medication reduction, were aged 80 years and older, had systolic blood pressure lower than 150 mm Hg, and were receiving at least 2 antihypertensive medications were included. Participants enrolled between April 2017 and September 2018 and underwent follow-up until January 2019.

Interventions: Participants were randomized (1:1 ratio) to a strategy of antihypertensive medication reduction (removal of 1 drug [intervention], n = 282) or usual care (control, n = 287), in which no medication changes were mandated.

Main Outcomes and Measures: The primary outcome was systolic blood pressure lower than 150 mm Hg at 12-week follow-up. The prespecified noninferiority margin was a relative risk (RR) of 0.90. Secondary outcomes included the proportion of participants maintaining medication reduction and differences in blood pressure, frailty, quality of life, adverse effects, and serious adverse events.

Results: Among 569 patients randomized (mean age, 84.8 years; 276 [48.5%] women; median of 2 antihypertensive medications prescribed at baseline), 534 (93.8%) completed the trial. Overall, 229 (86.4%) patients in the intervention group and 236 (87.7%) patients in the control group had a systolic blood pressure lower than 150 mm Hg at 12 weeks (adjusted RR, 0.98 [97.5% 1-sided CI, 0.92 to ∞]). Of 7 prespecified secondary end points, 5 showed no significant difference. Medication reduction was sustained in 187 (66.3%) participants at 12 weeks. Mean change in systolic blood pressure was 3.4 mm Hg (95% CI, 1.1 to 5.8 mm Hg) higher in the intervention group compared with the control group. Twelve (4.3%) participants in the intervention group and 7 (2.4%) in the control group reported at least 1 serious adverse event (adjusted RR, 1.72 [95% CI, 0.7 to 4.3]).

Conclusions and Relevance: Among older patients treated with multiple antihypertensive medications, a strategy of medication reduction, compared with usual care, was noninferior with regard to systolic blood pressure control at 12 weeks. The findings suggest antihypertensive medication reduction in some older patients with hypertension is not associated with substantial change in blood pressure control, although further research is needed to understand long-term clinical outcomes.

Trial Registration: EudraCT Identifier: 2016-004236-38; ISRCTN identifier: 97503221.

Text
OPTiMISE results paper V13.0 05.03.20_clean - Accepted Manuscript
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Accepted/In Press date: 5 March 2020
e-pub ahead of print date: 26 May 2020
Published date: 26 May 2020
Keywords: Aged, 80 and over, Antihypertensive Agents/administration & dosage, Blood Pressure/drug effects, Deprescriptions, Female, Humans, Hypertension/drug therapy, Male, Polypharmacy

Identifiers

Local EPrints ID: 441653
URI: http://eprints.soton.ac.uk/id/eprint/441653
ISSN: 0098-7484
PURE UUID: bc0c02d6-3d70-454d-947a-4e5408b27585
ORCID for Mark Lown: ORCID iD orcid.org/0000-0001-8309-568X
ORCID for Paul Little: ORCID iD orcid.org/0000-0003-3664-1873

Catalogue record

Date deposited: 23 Jun 2020 16:30
Last modified: 12 Jul 2024 01:52

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Contributors

Author: James P. Sheppard
Author: Jenni Burt
Author: Mark Lown ORCID iD
Author: Eleanor Temple
Author: Rebecca Lowe
Author: Rosalyn Fraser
Author: Julie Allen
Author: Gary A. Ford
Author: Carl Heneghan
Author: F. D.Richard Hobbs
Author: Sue Jowett
Author: Shahela Kodabuckus
Author: Paul Little ORCID iD
Author: Jonathan Mant
Author: Jill Mollison
Author: Rupert A. Payne
Author: Marney Williams
Author: Ly Mee Yu
Author: Richard J. McManus

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