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Multicenter Study
. 2020 Nov;68(11):2508-2515.
doi: 10.1111/jgs.16749. Epub 2020 Sep 8.

Generalizability of Blood Pressure Lowering Trials to Older Patients: Cross-Sectional Analysis

James P Sheppard  1 , Mark Lown  2 , Jenni Burt  3 , Eleanor Temple  1 , Rebecca Lowe  1 , Hannah Ashby  1 , Oliver Todd  4 , Julie Allen  1 , Gary A Ford  5 , Rosalyn Fraser  1 , Carl Heneghan  1 , F D Richard Hobbs  1 , Sue Jowett  6 , Paul Little  2 , Jonathan Mant  7 , Jill Mollison  1 , Rupert Payne  8 , Marney Williams  9 , Ly-Mee Yu  1 , Richard J McManus  1
Affiliations
Multicenter Study

Generalizability of Blood Pressure Lowering Trials to Older Patients: Cross-Sectional Analysis

James P Sheppard et al. J Am Geriatr Soc. 2020 Nov.

Abstract

Background/objectives: Randomized controlled trials are used to inform clinical guidelines on the management of hypertension in older adults, but it is unclear to what extent these trials represent the general population attending routine clinical practice. This study aimed to define the proportion and characteristics of patients eligible for hypertension trials conducted in older people.

Design: Cross-sectional study.

Setting: A total of 24 general practices in England.

Participants: Anonymized electronic health record data from all individuals aged 80 and older.

Measurements: Descriptive statistics were used to define the proportion and characteristics of patients eligible for two previous medication intensification trials (HYVET, SPRINT) and one medication reduction trial (OPTiMISE). A logistic regression model was constructed to estimate predictors of eligibility for each trial.

Results: Of 15,376 patients identified, 268 (1.7%; 95% confidence interval [CI] = 1.5-2.0%), 5,290 (34.4%; 95%CI = 33.7-35.2%), and 3,940 (25.6%; 95%CI = 24.9-26.3%) were eligible for the HYVET, SPRINT, and OPTiMISE trials, respectively. Between 5.6% and 30.7% of exclusions from each trial were due to eligibility criteria excluding those with high or uncontrolled blood pressure. Frailty (odds ratio [OR] = .44; 95%CI = .36-.54 [OPTiMISE]), cardiovascular polypharmacy (OR = .61; 95%CI = .55-.68 [SPRINT]) and multimorbidity (OR = .72; 95%CI = .64-.82 [SPRINT]) were associated with a lower likelihood of being eligible for one or more of the trials.

Conclusion: A possible unintended consequence of blood pressure criteria used by trials attempting to answer different primary questions is that for many older patients, no trial evidence exists to inform treatment decisions in routine practice. Caution should be exercised when applying results from existing trials to patients with frailty or multimorbidity.

Keywords: cardiovascular disease; electronic health records; frailty; hypertension; randomized controlled trials.

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Conflict of interest statement

Conflict of Interest: Gary A. Ford has received personal payment for advisory and educational work from Amgen, Daiichi Sankyo, Medtronic, Pfizer, and Stryker. All other authors have declared no conflicts of interest for this article.

Figures

Figure 1
Figure 1. Proportion of patients eligible for each trial in the total population, those with cardiovascular disease and frailty.
[Color figure can be viewed at wileyonlinelibrary.com]
Figure 2
Figure 2. Proportion of patients excluded by each eligibility criteria (n = 15,376).
DBP, diastolic blood pressure; SBP, systolic blood pressure; SCr, serum creatinine; TIA, transient ischemic attack.
Figure 3
Figure 3. Coefficient plot showing results of logistic regression analysis examining predictors of eligibility for each trial (n = 15,376).
aPolypharmacy defined as being prescribed three or more cardiovascular medications. BMI, body mass index; CABG, coronary artery bypass graft; CI, confidence interval; DBP, diastolic blood pressure; eFI, electronic frailty index; OR, odds ratio; SBP, systolic blood pressure; TIA, transient ischemic attack. [Color figure can be viewed at wileyonlinelibrary.com]
See this image and copyright information in PMC

Comment in

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