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Reduction in blood pressure with statins: results from the UCSD Statin Study, a randomized trial.

ABSTRACT: Some studies have suggested reductions in blood pressure (BP)with statin treatment, particularly in persons with hypertension. Randomized trial evidence is limited.We performed a randomized, double-blind, placebo-controlled trial with equal allocation to simvastatin, 20 mg; pravastatin sodium,40 mg; or placebo for 6 months. Nine hundred seventy-three men and women without known cardiovascular disease or diabetes mellitus, with low-density lipoprotein cholesterol screening levels of 115 to 190 mg/dL, had assessment of systolic and diastolic BP (SBP and DBP, respectively). Blood pressure values were compared for placebo vs statins by intention-to-treat (ITT) analysis. Additional analyses were performed that (1) were confined to subjects with neither high baseline BP (SBP>140 mm Hg or DBP>90 mm Hg) nor receiving BP medications, to exclude groups in whom BP medications or medication changes may have influenced results, and (2) separately evaluated simvastatin and pravastatin (vs placebo). The time course of BP changes after statin initiation and the effect of stopping statins on BP were examined.Statins modestly but significantly reduced BP relative to placebo,by 2.2 mm Hg for SBP (P=.02) and 2.4 mm Hg for DBP (P<.001) in ITT analysis. Blood pressure reductions ranged from 2.4 to 2.8 mm Hg for both SBP and DBP with both simvastatin and pravastatin, in those subjects with full follow-up, and without potential for influence by BP medications (ie, neither receiving nor meriting BP medications).Reductions in SBP and DBP occurred with hydrophilic and lipophilic statins and extended to normotensive subjects. These modest effects may contribute to the reduced risk of stroke and cardiovascular events reported on statins. Trial Registration clinicaltrials.gov Identifier: NCT00330980.

SUBMITTER: Golomb BA

PROVIDER: S-EPMC4285458 | biostudies-literature | 2008 Apr

REPOSITORIES: biostudies-literature

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Reduction in blood pressure with statins: results from the UCSD Statin Study, a randomized trial.

Golomb Beatrice A BA Dimsdale Joel E JE White Halbert L HL Ritchie Janis B JB Criqui Michael H MH

Archives of internal medicine 20080401 7

<h4>Background</h4>Some studies have suggested reductions in blood pressure (BP)with statin treatment, particularly in persons with hypertension. Randomized trial evidence is limited.<h4>Methods</h4>We performed a randomized, double-blind, placebo-controlled trial with equal allocation to simvastatin, 20 mg; pravastatin sodium,40 mg; or placebo for 6 months. Nine hundred seventy-three men and women without known cardiovascular disease or diabetes mellitus, with low-density lipoprotein cholestero ...[more]

PMID: 18413554

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Project description:BackgroundLow/ered cholesterol is linked to aggression in some study designs. Cases/series have reported reproducible aggression increases on statins, but statins also bear mechanisms that could reduce aggression. Usual statin effects on aggression have not been characterized.Methods1016 adults (692 men, 324 postmenopausal women) underwent double-blind sex-stratified randomization to placebo, simvastatin 20mg, or pravastatin 40mg (6 months). The Overt-Aggression-Scale-Modified-Aggression-Subscale (OASMa) assessed behavioral aggression. A significant sex-statin interaction was deemed to dictate sex-stratified analysis. Exploratory analyses assessed the influence of baseline-aggression, testosterone-change (men), sleep and age.ResultsThe sex-statin interaction was significant (P=0.008). In men, statins tended to decrease aggression, significantly so on pravastatin: difference=-1.0(SE=0.49)P=0.038. Three marked outliers (OASMa-change ≥40 points) offset otherwise strong significance-vs-placebo: statins:-1.3(SE=0.38)P=0.0007; simvastatin:-1.4(SE=0.43)P=0.0011; pravastatin:-1.2(SE=0.45)P=0.0083. Age≤40 predicted greater aggression-decline on statins: difference=-1.4(SE=0.64)P=0.026. Aggression-protection was emphasized in those with low baseline aggression: age<40-and-low-baseline-aggression (N=40) statin-difference-vs-placebo=-2.4(SE=0.71)P=0.0016. Statins (especially simvastatin) lowered testosterone, and increased sleep problems. Testosterone-drop on statins predicted aggression-decline: β=0.64(SE=0.30)P=0.034, particularly on simvastatin: β=1.29(SE=0.49)P=0.009. Sleep-worsening on statins significantly predicted aggression-increase: β=2.2(SE=0.55)P<0.001, particularly on simvastatin (potentially explaining two of the outliers): β=3.3(SE=0.83)P<0.001. Among (postmenopausal) women, a borderline aggression-increase on statins became significant with exclusion of one younger, surgically-menopausal woman (N=310) β=0.70(SE=0.34)P=0.039. The increase was significant, without exclusions, for women of more typical postmenopausal age (≥45): (N=304) β=0.68(SE=0.34)P=0.048 - retaining significance with modified age-cutoffs (≥50 or ≥55). Significance was observed separately for simvastatin. The aggression-increase in women on statins was stronger in those with low baseline aggression (N=175) β=0.84(SE=0.30)P=0.006. No statin effect on whole blood serotonin was observed; and serotonin-change did not predict aggression-change.ConclusionStatin effects on aggression differed by sex and age: Statins generally decreased aggression in men; and generally increased aggression in women. Both findings were selectively prominent in participants with low baseline aggression - bearing lower change-variance, rendering an effect more readily evident.Trial registrationClinicaltrials.gov NCT00330980.

Project description:ImportancePractical health promotion strategies for improving cardiometabolic health in older adults are needed.ObjectiveTo examine the efficacy of a sedentary behavior reduction intervention for reducing sitting time and improving blood pressure in older adults.Design, setting, and participantsThis parallel-group randomized clinical trial was conducted in adults aged 60 to 89 years with high sitting time and body mass index of 30 to 50 from January 1, 2019, to November 31, 2022, at a health care system in Washington State.InterventionParticipants were randomized 1:1 to the sitting reduction intervention or a healthy living attention control condition for 6 months. Intervention participants received 10 health coaching contacts, sitting reduction goals, and a standing desk and fitness tracker to prompt sitting breaks. The attention control group received 10 health coaching contacts to set general healthy living goals, excluding physical activity or sedentary behavior.Main outcomes and measuresThe primary outcome, measured at baseline, 3 months, and 6 months, was sitting time assessed using accelerometers worn for 7 days at each time point. Coprimary outcomes were systolic and diastolic blood pressure measured at baseline and 6 months.ResultsA total of 283 participants (140 intervention and 143 control) were randomized (baseline mean [SD] age, 68.8 [6.2] years; 186 [65.7%] female; mean [SD] body mass index, 34.9 [4.7]). At baseline, 147 (51.9%) had a hypertension diagnosis and 97 (69.3%) took at least 1 antihypertensive medication. Sitting time was reduced, favoring the intervention arm, with a difference in the mean change of -31.44 min/d at 3 months (95% CI, -48.69 to -14.19 min/d; P < .001) and -31.85 min/d at 6 months (95% CI, -52.91 to -10.79 min/d; P = .003). Systolic blood pressure change was lower by 3.48 mm Hg, favoring the intervention arm at 6 months (95% CI, -6.68 to -0.28 mm Hg; P = .03). There were 6 serious adverse events in each arm and none were study related.Conclusions and relevanceIn this study of a 6-month sitting reduction intervention, older adults in the intervention reduced sedentary time by more than 30 min/d and reduced systolic blood pressure. Sitting reduction could be a promising approach to improve health in older adults.Trial registrationClinicalTrials.gov Identifier: NCT03739762.

Project description:Background Population-wide reduction in mean blood pressure is proposed as a key strategy for primary prevention of cardiovascular disease. We evaluated the effectiveness of a task-sharing strategy involving frontline health workers in the primary prevention of elevated blood pressure. Methods and Results We conducted DISHA (Diet and lifestyle Interventions for Hypertension Risk reduction through Anganwadi Workers and Accredited Social Health Activists) study, a cluster randomized controlled trial involving 12 villages each from 4 states in India. Frontline health workers delivered a custom-made and structured lifestyle modification intervention in the selected villages. A baseline survey was conducted in 23 and 24 clusters in the control (n=6663) and intervention (n=7150) groups, respectively. The baseline characteristics were similar between control and intervention clusters. In total 5616 participants from 23 clusters in the control area and 5699 participants from 24 clusters in the intervention area participated in a repeat cross-sectional survey conducted immediately after the intervention phase of 18-months. The mean (SD) systolic blood pressure increased from 125.7 (18.1) mm Hg to 126.1 (16.8) mm Hg in the control clusters, and it increased from 124.4 (17.8) mm Hg to 126.7 (17.5) mm Hg in the intervention clusters. The population average adjusted mean difference in difference in systolic blood pressure was 1.75 mm Hg (95% CI, -0.21 to 3.70). Conclusions Task-sharing interventions involving minimally trained nonphysician health workers are not effective in reducing population average blood pressure in India. Expanding the scope of task sharing and intensive training of health workers such as nurses, nutritionists, or health counselors in management of cardiovascular risk at the population level may be more effective in primary prevention of cardiovascular disease. Registration URL: https://www.ctri.nic.in; Unique identifier: CTRI/2013/10/004049.

Project description:BACKGROUND:Inadequate blood pressure (BP) control is a frequent challenge in general practice. The objective of this study was to determine whether a color-coded BP booklet using a traffic light scheme (red, >180 mmHg systolic BP and/or >110 mmHg diastolic BP; yellow, >140-180 mmHg systolic BP or >90-110 mmHg diastolic BP; green, ≤140 mmHg systolic BP and ≤90 mmHg diastolic BP) improves BP control and adherence with home BP measurement. METHODS:In this two-group, randomized controlled trial, general practitioners recruited adult patients with a BP >140 mmHg systolic and/or >90 mmHg diastolic. Patients in the control group received a standard BP booklet and the intervention group used a color-coded booklet for daily home BP measurement. The main outcomes were changes in BP, BP control (treatment goal <140/90 mmHg), and adherence with home BP measurement after 6 months. RESULTS:One hundred and twenty-one of 137 included patients qualified for analysis. After 6 months, a significant decrease in systolic and diastolic BP was achieved in both groups, with no significant difference between the groups (16.1/7.9 mmHg in the intervention group versus 13.1/8.6 mmHg in the control group, P=0.3/0.7). BP control (treatment target <140/90 mmHg) was achieved significantly more often in the intervention group (43% versus 25%; P=0.037; number needed to treat of 5). Adherence with home BP measurement overall was high, with a trend in favor of the intervention group (98.6% versus 96.2%; P=0.1). CONCLUSION:Color-coded BP self-monitoring significantly improved BP control (number needed to treat of 5, meaning that every fifth patient utilizing color-coded self-monitoring achieved better BP control after 6 months), but no significant between-group difference was observed in BP change. A markedly higher percentage of patients achieved BP values in the normal range. This simple, inexpensive approach of color-coded BP self-monitoring is user-friendly and applicable in primary care, and should be implemented in the care of patients with arterial hypertension.

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Reduction in blood pressure with statins: results from the UCSD Statin Study, a randomized trial.

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Reduction in blood pressure with statins: results from the UCSD Statin Study, a randomized trial.

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