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

BMJ Open ◽  
2018 ◽  
Vol 8 (9) ◽  
pp. e022930 ◽  
Author(s):  
James P Sheppard ◽  
Jenni Burt ◽  
Mark Lown ◽  
Eleanor Temple ◽  
John Benson ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Systolic Blood Pressure ◽  
Usual Care ◽  
Antihypertensive Medication ◽  
Clinical Care ◽  
Economic Modelling ◽  
Host Institution ◽  
South Central ◽  
Randomised Controlled

IntroductionRecent 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 significant changes in blood pressure control at follow-up.Methods and analysisThis trial will use a primary care-based, open-label, randomised controlled trial design. A total of 540 participants will be recruited, aged ≥80 years, with systolic blood pressure <150 mm Hg and receiving ≥2 antihypertensive medications. Participants will have no compelling indication for medication continuation and will be considered to potentially benefit from medication reduction due to existing polypharmacy, comorbidity and frailty. Following a baseline appointment, individuals will be randomised to a strategy of medication reduction (intervention) with optional self-monitoring or usual care (control). Those in the intervention group will have one antihypertensive medication stopped. The primary outcome will be to determine if a reduction in medication can achieve a proportion of participants with clinically safe blood pressure levels at 12-week follow-up (defined as a systolic blood pressure <150 mm Hg), which is non-inferior (within 10%) to that achieved by the usual care group. Qualitative interviews will be used to understand the barriers and facilitators to medication reduction. The study will use economic modelling to predict the long-term effects of any observed changes in blood pressure and quality of life.Ethics and disseminationThe protocol, informed consent form, participant information sheet and all other participant facing material have been approved by the Research Ethics Committee (South Central—Oxford A; ref 16/SC/0628), Medicines and Healthcare products Regulatory Agency (ref 21584/0371/001–0001), host institution(s) and Health Research Authority. All research outputs will be published in peer-reviewed journals and presented at national and international conferences.Trial registration numberEudraCT 2016-004236-38;ISRCTN97503221; Pre-results.

scholarly journals First line drug treatment for hypertension and reductions in blood pressure according to age and ethnicity: cohort study in UK primary care

BMJ ◽  
2020 ◽  
pp. m4080
Author(s):  
Sarah-Jo Sinnott ◽  
Ian J Douglas ◽  
Liam Smeeth ◽  
Elizabeth Williamson ◽  
Laurie A Tomlinson
Keyword(s):  
Blood Pressure ◽  
Primary Care ◽  
Cohort Study ◽  
Systolic Blood Pressure ◽  
Black People ◽  
Angiotensin Receptor Blockers ◽  
Clinical Care ◽  
Treatment Recommendations ◽  
First Line

Abstract Objective To study whether treatment recommendations based on age and ethnicity according to United Kingdom (UK) clinical guidelines for hypertension translate to blood pressure reductions in current routine clinical care. Design Observational cohort study. Setting UK primary care, from 1 January 2007 to 31 December 2017. Participants New users of angiotensin converting enzyme inhibitors/angiotensin receptor blockers (ACEI/ARB), calcium channel blockers (CCB), and thiazides. Main outcome measures Change in systolic blood pressure in new users of ACEI/ARB versus CCB, stratified by age (< v ≥55) and ethnicity (black v non-black), from baseline to 12, 26, and 52 week follow-up. Secondary analyses included comparisons of new users of CCB with those of thiazides. A negative outcome (herpes zoster) was used to detect residual confounding and a series of positive outcomes (expected drug effects) was used to determine whether the study design could identify expected associations. Results During one year of follow-up, 87 440 new users of ACEI/ARB, 67 274 new users of CCB, and 22 040 new users of thiazides were included (median 4 (interquartile range 2-6) blood pressure measurements per user). For non-black people who did not have diabetes and who were younger than 55, CCB use was associated with a larger reduction in systolic blood pressure of 1.69 mm Hg (99% confidence interval −2.52 to −0.86) relative to ACEI/ARB use at 12 weeks, and a reduction of 0.40 mm Hg (−0.98 to 0.18) in those aged 55 and older. In subgroup analyses using six finer age categories of non-black people who did not have diabetes, CCB use versus ACEI/ARB use was associated with a larger reduction in systolic blood pressure only in people aged 75 and older. Among people who did not have diabetes, systolic blood pressure decreased more with CCB use than with ACEI/ARB use in black people (reduction difference 2.15 mm Hg (−6.17 to 1.87)); the corresponding reduction difference was 0.98 mm Hg (−1.49 to −0.47) in non-black people. Conclusions Similar reductions in blood pressure were found to be associated with new use of CCB as with new use of ACEI/ARB in non-black people who did not have diabetes, both in those who were aged younger than 55 and those aged 55 and older. For black people without diabetes, CCB new use was associated with numerically greater reductions in blood pressure than ACEI/ARB compared with non-black people without diabetes, but the confidence intervals were overlapping for the two groups. These results suggest that the current UK algorithmic approach to first line antihypertensive treatment might not lead to greater reductions in blood pressure. Specific indications could be considered in treatment recommendations.

P6212The NAILED ACS trial - telephone-based long-term follow-up reduces risk factors after 36 months

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
R Henriksson ◽  
D Huber ◽  
T Mooe
Keyword(s):  
Blood Pressure ◽  
Systolic Blood Pressure ◽  
Usual Care ◽  
Diastolic Blood Pressure ◽  
Intervention Group ◽  
Control Group ◽  
Treatment Targets ◽  
Coronary Syndrome ◽  
Target Values

Abstract Background Cardiovascular secondary preventive strategies need improvement. The proportion of patients reaching guideline recommended treatment targets are low. Purpose We investigated if nurse-led, telephone-based follow-up including medical titration was superior to usual care in controlling blood pressure (BP) and low-density lipoprotein cholesterol (LDL-C) levels 36 months after an acute coronary syndrome (ACS). Methods All patients admitted with ACS at the local county hospital between 1st January 2010 and 31st December 2014 were screened for inclusion based on their ability to participate in a telephone-based follow-up. Participants were randomized into two parallel groups, an intervention group and a control group receiving usual care. BP and LDL-C were measured at one month, 12, 24 and 36 months. The intervention group received counseling and medical titration to attain treatment targets of BP (<140/<90 mmHG) and LDL-C (<2.5/<1.8 mmol/L). The primary outcome was LDL-C at 36 months. Results Out of 962 randomized patients, 797 were available for analysis after 36 months. In the intervention group, mean systolic blood pressure (SBP) was 4.1 mmHg lower (95% CI 1.7 - 6.4, p=0.001), diastolic blood pressure (DBP) was 2.8 mmHg lower (95% CI 1.4- 4.4, p<0.001) and mean LDL-C was 0.26 mmol/L lower (95% CI 0.12 - 0.4, p<0.001) when compared to the control group. The proportion of patients reaching treatment target goals was also significantly higher in the intervention group. Conclusions After 36 months of follow-up the nurse-led, telephone-based intervention led to significantly lower systolic blood pressure, diastolic blood pressure and LDL-C levels when compared to the control group. The intervention group also had a larger proportion of patients reaching target values. Acknowledgement/Funding The study received funding from the research and development unit, Region Jämtland Härjedalen.

scholarly journals Home and Online Management and Evaluation of Blood Pressure (HOME BP) using a digital intervention in poorly controlled hypertension: randomised controlled trial

BMJ ◽  
2021 ◽  
pp. m4858
Author(s):  
Richard J McManus ◽  
Paul Little ◽  
Beth Stuart ◽  
Katherine Morton ◽  
James Raftery ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Primary Care ◽  
Systolic Blood Pressure ◽  
Usual Care ◽  
Controlled Trial ◽  
Self Monitoring ◽  
Digital Intervention ◽  
Online Management ◽  
One Year ◽  
Randomised Controlled

Abstract Objective The HOME BP (Home and Online Management and Evaluation of Blood Pressure) trial aimed to test a digital intervention for hypertension management in primary care by combining self-monitoring of blood pressure with guided self-management. Design Unmasked randomised controlled trial with automated ascertainment of primary endpoint. Setting 76 general practices in the United Kingdom. Participants 622 people with treated but poorly controlled hypertension (>140/90 mm Hg) and access to the internet. Interventions Participants were randomised by using a minimisation algorithm to self-monitoring of blood pressure with a digital intervention (305 participants) or usual care (routine hypertension care, with appointments and drug changes made at the discretion of the general practitioner; 317 participants). The digital intervention provided feedback of blood pressure results to patients and professionals with optional lifestyle advice and motivational support. Target blood pressure for hypertension, diabetes, and people aged 80 or older followed UK national guidelines. Main outcome measures The primary outcome was the difference in systolic blood pressure (mean of second and third readings) after one year, adjusted for baseline blood pressure, blood pressure target, age, and practice, with multiple imputation for missing values. Results After one year, data were available from 552 participants (88.6%) with imputation for the remaining 70 participants (11.4%). Mean blood pressure dropped from 151.7/86.4 to 138.4/80.2 mm Hg in the intervention group and from 151.6/85.3 to 141.8/79.8 mm Hg in the usual care group, giving a mean difference in systolic blood pressure of −3.4 mm Hg (95% confidence interval −6.1 to −0.8 mm Hg) and a mean difference in diastolic blood pressure of −0.5 mm Hg (−1.9 to 0.9 mm Hg). Results were comparable in the complete case analysis and adverse effects were similar between groups. Within trial costs showed an incremental cost effectiveness ratio of £11 ($15, €12; 95% confidence interval £6 to £29) per mm Hg reduction. Conclusions The HOME BP digital intervention for the management of hypertension by using self-monitored blood pressure led to better control of systolic blood pressure after one year than usual care, with low incremental costs. Implementation in primary care will require integration into clinical workflows and consideration of people who are digitally excluded. Trial registration ISRCTN13790648 .

scholarly journals Association between systolic blood pressure trajectories and hypertension risk at late adolescence: results from 10-year longitudinal follow-up in Chinese boys

BMJ Open ◽  
2021 ◽  
Vol 11 (4) ◽  
pp. e042594
Author(s):  
Xijie Wang ◽  
Bin Dong ◽  
Sizhe Huang ◽  
Zhaogeng Yang ◽  
Jun Ma ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Systolic Blood Pressure ◽  
Late Adolescence ◽  
Population Based ◽  
Incidence Rates ◽  
Hypertension Risk ◽  
Logit Regression ◽  
Binomial Regression ◽  
Physical Examinations

ObjectiveTo identify various systolic blood pressure (SBP) trajectories in Chinese boys between 7 and 18 years of age, and to explore their high blood pressure (HBP) risk in their late adolescence years.Design and settingsA population-based cohort study in Guangdong, China.Participants4541 normal tensive boys who started primary school in 2005 in Zhongshan, Guangdong were included.OutcomesBlood pressure and relevant measurements were obtained by annual physical examinations between 2005 and 2016. HBP was defined by SBP or diastolic blood pressure ≥95th percentile for children under 13, and BP ≥130/80 mm Hg for children ≥13 years old. Logit regression for panel data and log-binomial regression model was used to estimate the risk of HBP among SBP trajectory groups.ResultsFour distinct SBP trajectory groups via group-based trajectory modelling: low stable (13.0%), low rising (42.4%), rising (37.4%) and high rising (7.3%). The overall incidence rates of HBP during the follow-up ranged from 40.24 (95% CI 36.68 to 44.19)/1000 person-years in the low stable group to 97.08 (95% CI 94.93 to 99.27)/1000 person-years in the high rising group. Compared with children with low stable SBP, those of other SBP trajectories suffered 3.05 (95% CI 2.64 to 3.46) to 4.64 (95% CI 4.18 to 5.09) times of higher risk of HBP in their late adolescence, regardless of their age, body mass index and BP level at baseline.ConclusionsSubgroups of SBP trajectories existed in Chinese boys, and are related to hypertension risk at late adolescence. Regular physical examinations could help identify those with higher risks at the beginning of pubertal growth.

scholarly journals Hypertensive response in exercise - a tool to predict stroke risk?

2021 ◽  
Vol 28 (Supplement_1) ◽  
Author(s):  
TE Graca Rodrigues ◽  
N Cunha ◽  
P Silverio-Antonio ◽  
P Couto Pereira ◽  
B Valente Silva ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Blood Pressure ◽  
Systolic Blood Pressure ◽  
Exercise Test ◽  
Cardiovascular Events ◽  
Protective Factor ◽  
Independent Predictor ◽  
Stress Test ◽  
Coronary Syndrome

Abstract Funding Acknowledgements Type of funding sources: None. Introduction There is some evidence suggesting that exaggerated hypertensive response to exercise (HRE) may be associated with higher risk of future cardiovascular events, however the relationship between systolic blood pressure (SPB) during exercise test and stroke is not fully understood. Purpose To evaluate the ability to predict the risk of stroke in patients with HRE in exercise test. Methods Single-center retrospective study of consecutive patients submitted to exercise test from 2012 to 2015 with HRE to stress test. HRE was defined as a peak systolic blood pressure (PSBP) &gt; 210 mmHg in men and &gt; 190 mmHg in women, or a rise of the SBP of 60 mmHg in men or 50 mmHg in women or as a diastolic blood pressure &gt; 90 mmHg or a rise of 10 mmHg. Patient’s demographics, baseline clinical characteristics, vital signs during the stress test and the occurrence of stroke during follow-up were analysed Results We included 458 patients with HRE (76% men, 57.5 ± 10.83 years). The most frequent comorbidities were hypertension (83%), dyslipidaemia (61%), previously known coronary disease (32%), diabetes (28%) and smoking (38%). Atrial fibrillation was present in 5.9% of patients. During a mean follow-up of 60 ± 2 months, the incidence of stroke was 2.1% (n = 8), all with ischemic origin. Considering the parameters analysed on exercise test, only PSBP demonstrated to be an independent predictor of stroke (HR 1.042, CI95% 1.002-1.084, p = 0.039,) with moderate ability to predict stroke (AUC 0.735, p = 0.0016) with a most discriminatory value of 203 mmHg (sensibility 56%, specify 67%). Regarding baseline characteristics, after age, sex and comorbidities adjustment, previously controlled hypertension was found to be an independent protective factor of stroke (OR 4.247, CI 95% 0.05-0.9, p = 0.036) and atrial fibrillation was an independent predictor of stroke occurrence (HR 8.1, CI95% 1.4-46.9, p = 0.018). Atrial fibrillation was also associated with hospitalization of cardiovascular cause and major cardiovascular events occurrence (mortality, coronary syndrome and stroke). Baseline SBP was associated with atrial fibrillation development (p = 0.008). Conclusion According to our results, PSBP during exercise test is an independent predictor of stroke occurrence and should be considered as a potencial additional tool to predict stroke occurrence, particularly in high risk patients. The identification of diagnosed hypertension as a protective factor of stroke may be explained by the cardioprotective effect of antihypertensive drugs.

scholarly journals Long-term outcome of two forms of randomised benzodiazepine discontinuation

2006 ◽  
Vol 188 (2) ◽  
pp. 188-189 ◽  
Author(s):  
R. C. Oude Voshaar ◽  
W. J. M. J. Gorgels ◽  
A. J. J. Mol ◽  
A. J. L. M. Van Balkom ◽  
J. Mulder ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Term Outcome ◽  
Long Term Outcome ◽  
Randomised Controlled

SummaryAbouttwo-thirds of long-term users of benzodiazepines in the population are able to discontinue this drug with the aid of supervised programmes for tapering off. Little is known about the long-term outcome of such programmes, and they have never been compared with usual care. After a 15-month follow-up of a randomised controlled trial comparing such a programme with and without psychotherapy with usual care, we found significantly higher longitudinal abstinence rates in long-term benzodiazepine users who received a benzodiazepine tapering-off programme without psychotherapy (25 out of 69, 36%) compared with those who received usual care (5 out of 33, 15%; P=0.03).

scholarly journals Randomised controlled study of two counselling models at the Swedish alcohol helpline: Effectiveness and sustainability outcomes at 12-month follow-up

2021 ◽  
pp. 145507252110078
Author(s):  
Thi-Thuy-Dung Nguyen ◽  
Eleonor Säfsten ◽  
Filip Andersson ◽  
Maria Rosaria Galanti
Keyword(s):  
Alcohol Use ◽  
Usual Care ◽  
Secondary Outcome ◽  
Controlled Study ◽  
Risk Level ◽  
Care Group ◽  
Structured Intervention ◽  
Randomised Controlled ◽  
Level Reduction

Aim: This two-arm parallel randomised controlled trial explored the effectiveness of a brief counselling model compared with the usual multi-session counselling at an alcohol telephone helpline. Methods: A total of 320 callers who contacted the Swedish Alcohol Helpline (SAH) because of hazardous or harmful alcohol use were randomised to either brief structured intervention (self-help booklet plus one proactive call) or usual care (multi-session telephone counselling). The primary outcome was a downward shift in risk level at 12-month follow-up compared with baseline, based on self-reports. Sustained risk level reduction throughout the whole follow-up was also assessed as secondary outcome. Results: Both interventions were significantly associated with a shift to a lower level of risky alcohol use (75% among participants in the brief structured intervention, and 70% in the usual care group) after 12 months. There was no difference between the two interventions in the proportions changing alcohol use or sustaining risk level reduction. Conclusion: In the context of telephone helplines, minimal and extended interventions appear to be equally effective in promoting long-term change in alcohol use.

Abstract P494: Long-term Outcomes of a Cluster-randomized Trial Testing the Effects Blood Pressure Telemonitoring and Pharmacist Management

Hypertension ◽  
2017 ◽  
Vol 70 (suppl_1) ◽  
Author(s):  
Karen L Margolis ◽  
Stephen E Asche ◽  
Anna R Bergdall ◽  
Steven P Dehmer ◽  
Beverly B Green ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Randomized Trial ◽  
Clinical Care ◽  
Cluster Randomized Trial ◽  
Home Blood Pressure ◽  
Uncontrolled Hypertension ◽  
Routine Clinical Care ◽  
Differential Reduction ◽  
Cluster Randomized

Background/Aims: Hypertension is a common condition and leading cause of cardiovascular disease. We previously reported results of a cluster-randomized trial evaluating a home blood pressure (BP) telemonitoring and pharmacist management intervention, with significant reductions in BP favoring the intervention arm over 18 months. This analysis examined the durability of the intervention effect on BP through 54 months of follow-up and compared BP measurements performed in the research clinic and in routine clinical care. Methods: The Hyperlink trial randomized 16 primary care clinics having 450 study-enrolled patients with uncontrolled hypertension to either Telemonitoring Intervention (TI) or usual care (UC) study arms. BP was measured as the mean of 3 measurements obtained at each research clinic visit. General linear mixed models utilizing a direct likelihood-based ignorable approach for missing data were used to examine change from baseline to 54 months in systolic and diastolic BP (SBP and DBP). Results: Research clinic BP measurements were obtained from 326 (72%) study patients at the 54 month follow-up visit. Routine clinical care BP measurements were obtained from 444 (99%) of study patients from 7025 visits during the follow-up period. For TI patients, based on research clinic measurements baseline SBP was 148.2 mm Hg and 54 month follow-up was 131.2 mm Hg (-17.0 mm Hg, p<.001). For UC patients, baseline SBP was 147.7 mm Hg and 54 month follow-up was 131.7 mm Hg ( -16.0 mm Hg, p<.001). The differential reduction by study arm in SBP from baseline to 54 months was -1.0 mm Hg (95% CI: -5.4 to 3.4, p=0.63). For TI patients, baseline DBP was 84.4 mm Hg and 54 month follow-up was 77.8 (-6.6 mm Hg, p<.001). For UC patients, baseline DBP was 85.1 mm Hg and 54 month follow-up was 79.1 mm Hg (-6.0 mm Hg, p<.001). The differential reduction by study arm in DBP from baseline to 54 months was -0.6 mm Hg (95% CI: -3.5 to 2.4, p=0.67). SBP and DBP results from routine clinical measurements closely approximated the pattern of results from research clinic measurements. Conclusion: Significant BP reductions in the TI arm relative to UC were no longer seen at 54 month follow-up. To maintain intervention benefits over a longer period of time additional intervention is needed.

Abstract P622: Racial Variation in White Matter Hyperintensity Progression in the ACCORDION MIND Study

Stroke ◽  
2021 ◽  
Vol 52 (Suppl_1) ◽  
Author(s):  
Alison L Herman ◽  
Adam H De Havenon ◽  
Guido J Falcone ◽  
Shadi Yaghi ◽  
Shyam Prabhakaran ◽  
...  
Keyword(s):  
Blood Pressure ◽  
White Matter ◽  
Systolic Blood Pressure ◽  
White Matter Hyperintensity ◽  
Diabetic Patients ◽  
Patient Race ◽  
Black Patients ◽  
The Mean ◽  
White Patients

Introduction: White matter hyperintensities (WMH) are linked to cognitive decline and stroke. We hypothesized that Black race would be associated with greater WMH progression in the ACCORDION MIND trial. Methods: The primary outcome is WMH progression in mL, evaluated by fitting linear regression to WMH volume on the month 80 MRI and including the WMH volume on the baseline MRI. The primary predictor is patient race, with the exclusion of patients defined as “other” race. We also derived predicted probabilities of our outcome for systolic blood pressure (SBP) levels. Results: We included 276 patients who completed the baseline and month 80 MRI, of which 207 were white, 48 Black, and 21 Hispanic. During follow-up, the mean number of SBP, LDL, and A1c measurements per patient was 21, 8, and 15. The mean (SD) WMH progression was 3.3 (5.4) mL for blacks, 2.5 (3.2) mL for Hispanics, and 2.4 (3.3) mL for whites. In the multivariate regression model (Table 1), Black, compared to white, patients had significantly more WMH progression (β Coefficient 1.26, 95% CI 0.45-2.06, p=0.002). Hispanic, compared to white, patients did not have significantly different WMH progression (p=0.392), nor was there a difference when comparing Hispanic to Black patients (p=0.162). The predicted WMH progression was significantly higher for Black compared to white patients across a mean SBP of 117 to 139 mm Hg (Figure 1). Conclusions: Black diabetic patients in ACCORDION MIND have a higher risk of WMH progression than white patients across a normal range of systolic blood pressure.

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