OPtimising Treatment for MIld Systolic hypertension in the Elderly (OPTiMISE): protocol for a randomised controlled non-inferiority trial

  title={OPtimising Treatment for MIld Systolic hypertension in the Elderly (OPTiMISE): protocol for a randomised controlled non-inferiority trial},
  author={James Peter Sheppard and Jenni Burt and Mark Lown and Eleanor Temple and John M. Benson and Gary A. Ford and Carl J. Heneghan and F. D. Richard Hobbs and Sue Jowett and Paul Little and Jonathan Mant and Jill Mollison and Alecia Nickless and Emma Ogburn and Rupert A. Payne and Marney Williams and Ly-Mee Yu and Richard J. McManus},
  journal={BMJ Open},
Introduction Recent evidence suggests that larger blood pressure reductions and multiple antihypertensive drugs may be harmful in older people, particularly frail individuals with polypharmacy and multimorbidity. However, there is a lack of evidence to support deprescribing of antihypertensives, which limits the practice of medication reduction in routine clinical care. The aim of this trial is to examine whether antihypertensive medication reduction is possible in older patients without… 

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.

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.

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.

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.

Blood Pressure Changes Following Antihypertensive Medication Reduction, by Drug Class and Dose Chosen for Withdrawal: Exploratory Analysis of Data From the OPTiMISE Trial

These exploratory data suggest withdrawal of higher dose calcium channel blockers should be avoided if the goal is to maintain BP control, however, low dose beta-blockers may be removed with little impact on blood pressure over 12-weeks of follow-up.

University of Birmingham Generalisability of blood pressure lowering trials to older patients

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, and caution should be exercised when applying results from existing trials to patients with frailty or multimorbidity.

Deprescribing Antihypertensive Drugs in Patients of Older Age Groups

An analysis of current literature showed the benefits of deprescribing of antihypertensive drugs for elderly patients with frailty, which avoids potential harm to their health, improves the quality of life and reduces the economic cost of treatment.

Hypertension Management in Nursing Homes: Review of Evidence and Considerations for Care

Randomized trials and rigorous observational studies examining effects of deintensified BP management on patient-centered outcomes in complex, older populations are needed to inform improved guidelines and treatment for nursing home (NH) residents.

Cost-Effectiveness of Antihypertensive Deprescribing in Primary Care: a Markov Modelling Study Using Data From the OPTiMISE Trial

Findings suggest that antihypertensive medication reduction should not be attempted in many older patients with controlled systolic blood pressure, and for populations at high risk of adverse effects, deprescribing may be beneficial, but a targeted approach would be required in routine practice.

Blood Pressure Control in Older Adults: Toward a More Personalized Medicine Approach

  • J. Williamson
  • Medicine
    Journal of the American Geriatrics Society
  • 2020
New results show that approximately 34% of adults aged 80 and older in a group of primary care practices in the United Kingdom would be eligible for hypertension guidelines based on the Systolic Blood Pressure Intervention Trial (SPRINT), consistent with those previously published by the SPRINT investigators showing that approximately 36% of older adults would qualify for SPRINT-based guidelines.

Deprescribing antihypertensives in patients with multimorbidity

The Optimising Treatment for Mild Systolic Hypertension in the Elderly (OPTIMISE) trial examined the safety and efficacy of antihypertensive deprescribing in older patients taking more than one treatment for hypertension.

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

The proportion and characteristics of patients eligible for hypertension trials conducted in older people and how these trials represent the general population attending routine clinical practice are defined are defined.



Effect of Discontinuation of Antihypertensive Treatment in Elderly People on Cognitive Functioning--the DANTE Study Leiden: A Randomized Clinical Trial.

In older persons with mild cognitive deficits, discontinuation of antihypertensive treatment did not improve cognitive, psychological, or general daily functioning at the 16-week follow-up.

Predictors of normotension on withdrawal of antihypertensive drugs in elderly patients: prospective study in second Australian national blood pressure study cohort

Age, blood pressure control, and the number of antihypertensive drugs are important factors in the clinical decision to withdraw drug treatment and all patients from whom such treatment is withdrawn should be monitored indefinitely to detect a recurrence of hypertension.

Deprescribing preventive cardiovascular medication in patients with predicted low cardiovascular disease risk in general practice – the ECSTATIC study: a cluster randomised non-inferiority trial

The results of the ECSTATIC study show that an attempt to deprescribe preventive cardiovascular medication in low-CVD-risk patients is safe in the short term when blood pressure and cholesterol levels are monitored after stopping.

Withdrawal of antihypertensive therapy in people with dementia: feasibility study

A withdrawal trial of antihypertensive medication in normotensive people with dementia may not be feasible in the UK because of low recruitment rates and the study procedures including assessments and home blood pressure monitoring were acceptable to participants and their carers.

Withdrawal of antihypertensive medication: a systematic review

Prescribers should consider offering patients with well controlled hypertension a trial of withdrawal of antihypertensive treatment with subsequent regular blood pressure monitoring, and monotherapy, lower blood pressure before withdrawal and body weight were reported as predictors for successful withdrawal.

Treatment With Multiple Blood Pressure Medications, Achieved Blood Pressure, and Mortality in Older Nursing Home Residents: The PARTAGE Study.

The findings of this study raise a cautionary note regarding the safety of using combination antihypertensive therapy in frail elderly patients with low SBP, and dedicated, controlled interventional studies are warranted to assess the corresponding benefit to risk ratio in this growing population.

Effect of self-monitoring and medication self-titration on systolic blood pressure in hypertensive patients at high risk of cardiovascular disease: the TASMIN-SR randomized clinical trial.

Among patients with hypertension at high risk of cardiovascular disease, self-monitoring with self-titration of antihypertensive medication compared with usual care resulted in lower systolic blood pressure at 12 months.

Treatment of hypertension in patients 80 years and older: the lower the better? A meta-analysis of randomized controlled trials

Treating hypertension in very old patients reduces stroke and heart failure with no effect on total mortality with the most reasonable strategy associated with significant mortality reduction; thiazides as first-line drugs with a maximum of two drugs.