The appropriate treatment target for systolic blood pressure (SBP) in older patients with hypertension remains uncertain.
To evaluate the effects of intensive (<120 mm Hg) compared with standard ...(<140 mm Hg) SBP targets in persons aged 75 years or older with hypertension but without diabetes.
A multicenter, randomized clinical trial of patients aged 75 years or older who participated in the Systolic Blood Pressure Intervention Trial (SPRINT). Recruitment began on October 20, 2010, and follow-up ended on August 20, 2015.
Participants were randomized to an SBP target of less than 120 mm Hg (intensive treatment group, n = 1317) or an SBP target of less than 140 mm Hg (standard treatment group, n = 1319).
The primary cardiovascular disease outcome was a composite of nonfatal myocardial infarction, acute coronary syndrome not resulting in a myocardial infarction, nonfatal stroke, nonfatal acute decompensated heart failure, and death from cardiovascular causes. All-cause mortality was a secondary outcome.
Among 2636 participants (mean age, 79.9 years; 37.9% women), 2510 (95.2%) provided complete follow-up data. At a median follow-up of 3.14 years, there was a significantly lower rate of the primary composite outcome (102 events in the intensive treatment group vs 148 events in the standard treatment group; hazard ratio HR, 0.66 95% CI, 0.51-0.85) and all-cause mortality (73 deaths vs 107 deaths, respectively; HR, 0.67 95% CI, 0.49-0.91). The overall rate of serious adverse events was not different between treatment groups (48.4% in the intensive treatment group vs 48.3% in the standard treatment group; HR, 0.99 95% CI, 0.89-1.11). Absolute rates of hypotension were 2.4% in the intensive treatment group vs 1.4% in the standard treatment group (HR, 1.71 95% CI, 0.97-3.09), 3.0% vs 2.4%, respectively, for syncope (HR, 1.23 95% CI, 0.76-2.00), 4.0% vs 2.7% for electrolyte abnormalities (HR, 1.51 95% CI, 0.99-2.33), 5.5% vs 4.0% for acute kidney injury (HR, 1.41 95% CI, 0.98-2.04), and 4.9% vs 5.5% for injurious falls (HR, 0.91 95% CI, 0.65-1.29).
Among ambulatory adults aged 75 years or older, treating to an SBP target of less than 120 mm Hg compared with an SBP target of less than 140 mm Hg resulted in significantly lower rates of fatal and nonfatal major cardiovascular events and death from any cause.
clinicaltrials.gov Identifier: NCT01206062.
There are currently no proven treatments to reduce the risk of mild cognitive impairment and dementia.
To evaluate the effect of intensive blood pressure control on risk of dementia.
Randomized ...clinical trial conducted at 102 sites in the United States and Puerto Rico among adults aged 50 years or older with hypertension but without diabetes or history of stroke. Randomization began on November 8, 2010. The trial was stopped early for benefit on its primary outcome (a composite of cardiovascular events) and all-cause mortality on August 20, 2015. The final date for follow-up of cognitive outcomes was July 22, 2018.
Participants were randomized to a systolic blood pressure goal of either less than 120 mm Hg (intensive treatment group; n = 4678) or less than 140 mm Hg (standard treatment group; n = 4683).
The primary cognitive outcome was occurrence of adjudicated probable dementia. Secondary cognitive outcomes included adjudicated mild cognitive impairment and a composite outcome of mild cognitive impairment or probable dementia.
Among 9361 randomized participants (mean age, 67.9 years; 3332 women 35.6%), 8563 (91.5%) completed at least 1 follow-up cognitive assessment. The median intervention period was 3.34 years. During a total median follow-up of 5.11 years, adjudicated probable dementia occurred in 149 participants in the intensive treatment group vs 176 in the standard treatment group (7.2 vs 8.6 cases per 1000 person-years; hazard ratio HR, 0.83; 95% CI, 0.67-1.04). Intensive BP control significantly reduced the risk of mild cognitive impairment (14.6 vs 18.3 cases per 1000 person-years; HR, 0.81; 95% CI, 0.69-0.95) and the combined rate of mild cognitive impairment or probable dementia (20.2 vs 24.1 cases per 1000 person-years; HR, 0.85; 95% CI, 0.74-0.97).
Among ambulatory adults with hypertension, treating to a systolic blood pressure goal of less than 120 mm Hg compared with a goal of less than 140 mm Hg did not result in a significant reduction in the risk of probable dementia. Because of early study termination and fewer than expected cases of dementia, the study may have been underpowered for this end point.
ClinicalTrials.gov Identifier: NCT01206062.
The effect of intensive blood pressure lowering on brain health remains uncertain.
To evaluate the association of intensive blood pressure treatment with cerebral white matter lesion and brain ...volumes.
A substudy of a multicenter randomized clinical trial of hypertensive adults 50 years or older without a history of diabetes or stroke at 27 sites in the United States. Randomization began on November 8, 2010. The overall trial was stopped early because of benefit for its primary outcome (a composite of cardiovascular events) and all-cause mortality on August 20, 2015. Brain magnetic resonance imaging (MRI) was performed on a subset of participants at baseline (n = 670) and at 4 years of follow-up (n = 449); final follow-up date was July 1, 2016.
Participants were randomized to a systolic blood pressure (SBP) goal of either less than 120 mm Hg (intensive treatment, n = 355) or less than 140 mm Hg (standard treatment, n = 315).
The primary outcome was change in total white matter lesion volume from baseline. Change in total brain volume was a secondary outcome.
Among 670 recruited patients who had baseline MRI (mean age, 67.3 SD, 8.2 years; 40.4% women), 449 (67.0%) completed the follow-up MRI at a median of 3.97 years after randomization, after a median intervention period of 3.40 years. In the intensive treatment group, based on a robust linear mixed model, mean white matter lesion volume increased from 4.57 to 5.49 cm3 (difference, 0.92 cm3 95% CI, 0.69 to 1.14) vs an increase from 4.40 to 5.85 cm3 (difference, 1.45 cm3 95% CI, 1.21 to 1.70) in the standard treatment group (between-group difference in change, -0.54 cm3 95% CI, -0.87 to -0.20). Mean total brain volume decreased from 1134.5 to 1104.0 cm3 (difference, -30.6 cm3 95% CI, -32.3 to -28.8) in the intensive treatment group vs a decrease from 1134.0 to 1107.1 cm3 (difference, -26.9 cm3 95% CI, 24.8 to 28.8) in the standard treatment group (between-group difference in change, -3.7 cm3 95% CI, -6.3 to -1.1).
Among hypertensive adults, targeting an SBP of less than 120 mm Hg, compared with less than 140 mm Hg, was significantly associated with a smaller increase in cerebral white matter lesion volume and a greater decrease in total brain volume, although the differences were small.
ClinicalTrials.gov Identifier: NCT01206062.
Greater Than the Sum Fine, Jared I.; Amanzadeh, Bahar; Platt, Larry J.
Journal of the California Dental Association,
12/2024, Letnik:
52, Številka:
1
Journal Article
OBJECTIVES
To evaluate the effect of intensive systolic blood pressure (SBP) control in older adults with hypertension, considering cognitive and physical function.
DESIGN
Secondary analysis.
SETTING
...Systolic Blood Pressure Intervention Trial (SPRINT)
PARTICIPANTS
Adults 80 years or older.
INTERVENTION
Participants with hypertension but without diabetes (N = 1167) were randomized to an SBP target below 120 mm Hg (intensive treatment) vs a target below 140 mm Hg (standard treatment).
MEASUREMENTS
We measured the incidence of cardiovascular disease (CVD), mortality, changes in renal function, mild cognitive impairment (MCI), probable dementia, and serious adverse events. Gait speed was assessed via a 4‐m walk test, and the Montreal Cognitive Assessment (MoCA) was used to quantify baseline cognitive function.
RESULTS
Intensive treatment led to significant reductions in cardiovascular events (hazard ratio HR = .66; 95% confidence interval CI = .49‐.90), mortality (HR = .67; 95% CI = .48‐.93), and MCI (HR = .70; 95% CI = .51‐.96). There was a significant interaction (P < .001) whereby participants with higher baseline scores on the MoCA derived strong benefit from intensive treatment for a composite of CVD and mortality (HR = .40; 95% CI = .28‐.57), with no appreciable benefit in participants with lower scores on the MoCA (HR = 1.33 = 95% CI = .87‐2.03). There was no evidence of heterogeneity of treatment effects with respect to gait speed. Rates of acute kidney injury and declines of at least 30% in estimated glomerular filtration rate were increased in the intensive treatment group with no between‐group differences in the rate of injurious falls.
CONCLUSION
In adults aged 80 years or older, intensive SBP control lowers the risk of major cardiovascular events, MCI, and death, with increased risk of changes to kidney function. The cardiovascular and mortality benefits of intensive SBP control may not extend to older adults with lower baseline cognitive function.
Trial Registration
Clinicaltrials.gov identifier: NCT01206062. J Am Geriatr Soc 68:496–504, 2020
ABSTRACTOn November 8, 2016, the citizens of Oakland enacted an initiative imposing a tax on sugar-sweetened beverages (SSBs). The passage was the culmination of interdisciplinary efforts, including ...critical support from the local dental society, as well as individual dentists. Supporters were motivated by the impact of the consumption of soda and other SSBs on children’s health, the long-standing epidemic of dental caries, and the emerging epidemics of obesity and Type 2 diabetes. This article details how the critical support and advocacy of dentistry in collaboration with a wider health professional network and the broader community led to the successful passing of the sugar-sweetened-beverage tax.
•A randomized, double blind clinical trial of vitamin D in non-remitted depression.•Despite protocol amendments, recruitment was too slow and futility declared.•Vitamin D supplementation is common ...and poses a challenge for intervention studies.•Challenges and recommendations for the design of further studies are described.
Many patients with depression fail to achieve remission after several consecutive treatments. Vitamin D deficiency is prevalent and new research suggests that it may have an impact on mood, primarily through an effect on neurotransmitters. Numerous observational studies suggest a relationship between low levels of vitamin D and increased incidence and severity of mood disorders. A small number of pilot studies have been undertaken but lack rigorous methodology required to draw conclusions about a clinical role for this nutrient in treatment resistant depression.
This study was designed as a randomized, double-blind, placebo controlled intervention study administering a weekly (bolus) dose of 28 000IU of Vitamin D3 or placebo to 125 patients with non-remitted depression adjunct to current antidepressant medication. Patients were followed weekly for eight weeks plus a one month follow up. Outcomes measured included depression severity, serum vitamin D levels and safety. Due to slow recruitment during the first season, amendments were made. These included extending the age range to 18–75 and removing the requirement for failing to respond to one pharmacologic antidepressant agent. The protocol was amended to reduce the burden on participants by changing the in-office visits to bi-weekly. Three additional tertiary psychiatric clinics were also added as trial sites.
Over three recruitment period years (fall/winter), a total of 148 participants completed screening, 24 (16.2%) of whom qualified to participate in the study. Use of too many or no psychiatric medications, comorbid exclusionary psychiatric conditions, current use of a vitamin D supplement, and lack of participant compensation were the predominant reasons for ineligibility or unwillingness to participate. 9 participants were successfully enrolled in the study, 7 (77.8%) of whom completed the trial as per the protocol. After the third season, futility was declared based on inability to enroll participants. The sample size of enrolled participants (7/125, 5.6%) lacks power to conduct a full assessment of findings.
High accessibility of vitamin D, as well as a growing lack of equipoise in patients and clinicians about the potential ubiquitous benefits of vitamin D for Canadians, not just for mood disorders, resulted in a large proportion of ineligible potential participants. Limited funding provided to studies on natural health products hampered recruitment. The labile and fluctuating nature of non-remitted depression as well as frequent co-morbid conditions creates additional challenges for conducting trials in this population. Future studies assessing vitamin D in depression should consider our experiences in design and conduct of research. Innovations in clinical trial design such as preference trials or accepting patients already using vitamin D but not achieving an optimal target value are potential solutions to some of these challenges.
Improper electrocardiogram (ECG) lead placement resulting in suboptimal gating may lead to reduced image quality in cardiac magnetic resonance imaging (CMR). A patientspecific systematic technique ...for rapid optimization of lead placement may improve CMR image quality. A rapid 3 dimensional image of the thorax was used to guide the realignment of ECG leads relative to the cardiac axis of the patient in forty consecutive adult patients. Using our novel approach and consensus reading of pre- and post-correction ECG traces, seventy-three percent of patients had a qualitative improvement in their ECG tracings, and no patient had a decrease in quality of their ECG tracing following the correction technique. Statistically significant improvement was observed independent of gender, body mass index, and cardiac rhythm. This technique provides an efficient option to improve the quality of the ECG tracing in patients who have a poor quality ECG with standard techniques.
OBJECTIVESTo evaluate the effect of intensive systolic blood pressure (SBP) control in older adults with hypertension, considering cognitive and physical function.DESIGNSecondary ...analysis.SETTINGSystolic Blood Pressure Intervention Trial (SPRINT)PARTICIPANTSAdults 80 years or older.INTERVENTIONParticipants with hypertension but without diabetes (N = 1167) were randomized to an SBP target below 120 mm Hg (intensive treatment) vs a target below 140 mm Hg (standard treatment).MEASUREMENTSWe measured the incidence of cardiovascular disease (CVD), mortality, changes in renal function, mild cognitive impairment (MCI), probable dementia, and serious adverse events. Gait speed was assessed via a 4‐m walk test, and the Montreal Cognitive Assessment (MoCA) was used to quantify baseline cognitive function.RESULTSIntensive treatment led to significant reductions in cardiovascular events (hazard ratio HR = .66; 95% confidence interval CI = .49‐.90), mortality (HR = .67; 95% CI = .48‐.93), and MCI (HR = .70; 95% CI = .51‐.96). There was a significant interaction (P < .001) whereby participants with higher baseline scores on the MoCA derived strong benefit from intensive treatment for a composite of CVD and mortality (HR = .40; 95% CI = .28‐.57), with no appreciable benefit in participants with lower scores on the MoCA (HR = 1.33 = 95% CI = .87‐2.03). There was no evidence of heterogeneity of treatment effects with respect to gait speed. Rates of acute kidney injury and declines of at least 30% in estimated glomerular filtration rate were increased in the intensive treatment group with no between‐group differences in the rate of injurious falls.CONCLUSIONIn adults aged 80 years or older, intensive SBP control lowers the risk of major cardiovascular events, MCI, and death, with increased risk of changes to kidney function. The cardiovascular and mortality benefits of intensive SBP control may not extend to older adults with lower baseline cognitive function.Trial RegistrationClinicaltrials.gov identifier: NCT01206062. J Am Geriatr Soc 68:496–504, 2020
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