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Biomedical subjects

W B Applegate

Publications and source records attributed to W B Applegate.

At least 73 records · Page 4Linked to original sources
PubMed1995

Trial of Nonpharmacologic Intervention in the Elderly (TONE). Design and rationale of a blood pressure control trial.

National and international policy-making organizations advocate nonpharmacologic therapies to reduce blood pressure (BP). However, data to support such recommendations in older persons are virtually nonexistent. The Trials of Nonpharmacologic Intervention in the Elderly (TONE) is a randomized, controlled trial that will test whether weight loss or a reduced sodium (Na) intake or both can maintain satisfactory BP control, without unacceptable side effects, after withdrawal of antihypertensive drug therapy. Medication-treated hypertensives (aged 60 to 80 years) with a systolic BP less than 145 mm Hg and a diastolic BP less than 85 mm Hg who are taking one antihypertensive medication are randomly assigned to one of four groups: (1) weight loss alone, (2) reduced Na intake alone, (3) combined weight loss and reduced Na intake, or (4) usual life-style (control group). Overweight participants are randomized to one of these four groups, while nonoverweight individuals are assigned to either the reduced Na intake or the usual life-style group. The interventions, tailored to the needs of older persons, use behavioral approaches to accomplish intervention-specific goals (weight loss > or = 10 lb, daily Na intake < or = 80 mEqa). Three months after the start of intervention, antihypertensive drug therapy is withdrawn. The primary trial end point is a BP of 150/90 mm Hg or higher, resumption of antihypertensive drug therapy, or the occurrence of a BP-related clinical complication during 2 to 3 years of follow-up. It is anticipated that TONE findings may identify an effective and acceptable nonpharmacologic approach to control hypertension in the increasingly large number of older persons treated with antihypertensive drug therapy.

Aged↗
PubMed1994

Impact of the treatment of isolated systolic hypertension on behavioral variables. Results from the systolic hypertension in the elderly program.

BACKGROUND: Little information has been published on the impact of antihypertensive medications on quality of life in older persons. Particular concern has existed that lowering systolic blood pressure in older persons might have adverse consequences on cognition, mood, or leisure activities. METHODS: A multicenter double-blind randomized controlled trial was conducted over an average of 5 years' followup involving 16 academic clinical trial clinics. Participants consisted of 4736 persons (1.06%) selected from 447,921 screenees aged 60 years and older. Systolic blood pressure at baseline ranged from 160 to 219 mm Hg, while diastolic blood pressure was less than 90 mm Hg. Participants were randomized to active antihypertensive drug therapy or matching placebo. Active treatment consisted of 12.5 to 25 mg of chlorthalidone for step 1, while step 2 consisted of 25 to 50 mg of atenolol. If atenolol was contraindicated, 0.05 to 0.10 mg of reserpine could be used for the second-step drug. The impact of drug treatment on measures of cognitive, emotional, and physical function and leisure activities was assessed. RESULTS: Our analyses demonstrate that active treatment of isolated systolic hypertension in the Systolic Hypertension in the Elderly Program cohort had no measured negative effects and, for some measures, a slight positive effect on cognitive, physical, and leisure function. The positive findings in favor of the treatment group were small. There was no effect on measures related to emotional state. Measures of cognitive and emotional function were stable in both groups for the duration of the study. Both treatment groups showed a modest trend toward deterioration of some measures of physical and leisure function over the study period. CONCLUSIONS: The overall study cohort exhibited decline over time in activities of daily living, particularly the more strenuous ones, and some decline in certain leisure activities. However, mood, cognitive function, basic self-care, and moderate leisure activity were remarkably stable for both the active and the placebo groups throughout the entire study. Results of this study support the inference that medical treatment of isolated systolic hypertension does not cause deterioration in measures of cognition, emotional state, physical function, or leisure activities.

Activities of Daily Living↗
PubMed1994

Double-blind comparison of amlodipine and hydrochlorothiazide in patients with mild to moderate hypertension.

In the final analysis of this study at Week 26, 26% of the patients randomized to receive amlodipine attained blood pressure control with amlodipine alone compared with 33% of the patients allocated to hydrochlorothiazide (HCTZ). Neither amlodipine nor HCTZ produced clinically significant changes in pulse rate or in the electrocardiogram. Amlodipine treatment did not appear to produce clinically significant changes in blood lipids; HCTZ, however, produced an increase in total plasma cholesterol (delta 22.9 +/- 8.6 mg/dl). The incidence of side effects and the rate of patient withdrawal in the amlodipine and HCTZ groups were comparable. As expected, HCTZ therapy caused well-recognized biochemical alterations in cholesterol and potassium levels, whereas amlodipine was metabolically neutral.

Adolescent↗
PubMed1994

Influence of diagnostic classification on outcomes and charges in geriatric assessment and rehabilitation.

OBJECTIVE: To determine if diagnostic classification is associated with different outcomes from treatment on a geriatric assessment unit (GAU) compared with usual care for elderly patients with acute illnesses. STUDY DESIGN: Reanalysis after post-hoc diagnostic classification of a randomized clinical trial with one year follow up. SETTING: Community hospital with rehabilitation facility. SUBJECTS: A total of 155 subjects, mean age 78 years and 78% female, of whom 58 subjects had a rehabilitation classification of their diagnoses and 97 had a medical or surgical classification. OUTCOME MEASURES: Mortality, nursing home use, activities of daily living, and charges for subsequent medical services. RESULTS: Mortality was decreased in persons with a rehabilitation classification who had received the GAU intervention. The GAU increased point-prevalence residence in the community for persons with a rehabilitation classification. For persons with a medical-surgical classification, the GAU intervention was associated with decreased cumulative use of nursing homes. However, GAU intervention was also associated with trends for increased charges in both diagnostic classification groups, even when adjusted for differential survival. CONCLUSION: Greater benefit from the GAU intervention on mortality and maintenance of residence in the community was observed in a group with a rehabilitation classification when compared with a group with a medical-surgical classification. These improved outcomes in the rehabilitation group were not accompanied by decreased charges for later medical services that could compensate for initial rehabilitation charges.

Activities of Daily Living↗
PubMed1994

Effect of lovastatin on early carotid atherosclerosis and cardiovascular events. Asymptomatic Carotid Artery Progression Study (ACAPS) Research Group.

BACKGROUND: HMG CoA reductase inhibitors (or statins), a new class of lipid-lowering compounds, have raised expectations for more widespread use than that of the older lipid-lowering drugs. Not only are they more effective in lowering LDL cholesterol, but they are better tolerated as well. No data exist concerning the effect of statins on early carotid atherosclerosis and clinical events in men and women who have moderately elevated LDL cholesterol levels but are free of symptomatic cardiovascular disease. METHODS AND RESULTS: Lovastatin (20 to 40 mg/d) or its placebo was evaluated in a double-blind, randomized clinical trial with factorial design along with warfarin (1 mg/d) or its placebo. This report is limited to the lovastatin component of the trial. Daily aspirin (81 mg/d) was recommended for everyone. Enrollment included 919 asymptomatic men and women, 40 to 79 years old, with early carotid atherosclerosis as defined by B-mode ultrasonography and LDL cholesterol between the 60th and 90th percentiles. The 3-year change in mean maximum intimal-medial thickness (IMT) in 12 walls of the carotid arteries was the primary outcome; change in single maximum IMT and incidence of major cardiovascular events were secondary outcomes. LDL cholesterol fell 28%, from 156.6 mg/dL at baseline to 113.1 mg/dL at 6 months (P < .0001), in the lovastatin groups and was largely unchanged in the lovastatin-placebo groups. Among participants not on warfarin, regression of the mean maximum IMT was seen after 12 months in the lovastatin group compared with the placebo group; the 3-year difference was statistically significant (P = .001). A larger favorable effect of lovastatin was observed for the change in single maximum IMT but was not statistically significant (P = .12). Five lovastatin-treated participants suffered major cardiovascular events--coronary heart disease mortality, nonfatal myocardial infarction, or stroke--versus 14 in the lovastatin-placebo groups (P = .04). One lovastatin-treated participant died, compared with eight on lovastatin-placebo (P = .02). CONCLUSIONS: In men and women with moderately elevated LDL cholesterol, lovastatin reverses progression of IMT in the carotid arteries and appears to reduce the risk of major cardiovascular events and mortality. Results from ongoing large-scale clinical trials may further establish the clinical benefit of statins.

Adult↗
PubMed1994

The effect of fish oil on blood pressure and high-density lipoprotein-cholesterol levels in phase I of the Trials of Hypertension Prevention. Trials of Hypertension Prevention Collaborative Research Group.

OBJECTIVE: To study the effects of moderate doses of fish oil on blood pressure and high-density lipoprotein (HDL)-cholesterol. METHODS: The participants were 350 normotensive men and women aged 30-54 years who were enrolled from seven academic medical centers in phase I of the Trials of Hypertension Prevention. They were randomly assigned to receive placebo or 6 g purified fish oil once a day, which supplied 3 g n-3 polyunsaturated fatty acids for 6 months. RESULTS: Baseline blood pressure was (mean +/- SD) 123 +/- 9/81 +/- 5 mmHg. The mean differences in the blood pressure changes between the fish oil and placebo groups were not statistically significant. There was no tendency for fish oil to reduce blood pressure more in subjects with baseline blood pressures in the upper versus the lower quartile (132/87 versus 114/75 mmHg), low habitual fish consumption (0.4 versus 2.9 times a week) or low baseline plasma levels of n-3 fatty acids. Fish oil increased HDL2-cholesterol significantly compared with the placebo group. Subgroup analysis showed this effect to be significant in the women but not in the men. Increases in serum phospholipid n-3 fatty acids were significantly correlated with increases in HDL2-cholesterol and decreases in systolic blood pressure. CONCLUSION: Moderate amounts of fish oil (6 g/day) are unlikely to lower blood pressure in normotensive persons, but may increase HDL2-cholesterol, particularly in women.

Adult↗
PubMed1994

Short report: the effect of fish oil on blood pressure and high-density lipoprotein-cholesterol levels in phase I of the Trials of Hypertension Prevention.

OBJECTIVE: To study the effects of moderate doses of fish oil on blood pressure and high-density lipoprotein (HDL)-cholesterol. METHODS: The participants were 350 normotensive men and women aged 30-54 years who were enrolled from seven academic medical centers in phase I of the Trials of Hypertension Prevention. They were randomly assigned to receive placebo or 6 g purified fish oil once a day, which supplied 3 g n-3 polyunsaturated fatty acids for 6 months. RESULTS: Baseline blood pressure was (mean +/- SD) 123 +/- 9/81 +/- 5 mmHg. The mean differences in the blood pressure changes between the fish oil and placebo groups were not statistically significant. There was no tendency for fish oil to reduce blood pressure more in subjects with baseline blood pressure in the upper versus the lower quartile (132/87 versus 114/75 mmHg), low habitual fish consumption (0.4 versus 2.9 times a week) or low baseline plasma levels of n-3 fatty acids. Fish oil increased HDL2-cholesterol significantly compared with the placebo group. Subgroup analysis showed this effect to be significant in the women but not in the men. Increases in serum phospholipid n-3 fatty acids were significantly correlated with increases in HDL2-cholesterol and decreases in systolic blood pressure. CONCLUSION: Moderate amounts of fish oil (6 g/day) are unlikely to lower blood pressure in normotensive persons, but may increase HDL2-cholesterol, particularly in women.

Adult↗
PubMed1993

Managing the older patient with hypertension.

In elderly patients, elevation of systolic blood pressure represents a more serious risk than elevation of diastolic blood pressure. Major trials of antihypertensive therapy in the elderly include the Systolic Hypertension in the Elderly Program, the Swedish Trial of Older Patients with Hypertension, the Medical Research Council Trial, and the Veterans Affairs Cooperative Study Group. Results of these trails indicate that, even for very elderly patients, reducing blood pressure reduces both morbidity and mortality from stroke and cardiac disease. Diuretics and calcium antagonists stand out as particularly efficacious in elderly hypertensive patients. beta-Adrenergic blockers and angiotensin converting enzyme inhibitors may be less suitable in this patient population. Studies of the effects of antihypertensive therapy on the quality of life indicate that elderly patients can easily tolerate efficacious doses of antihypertensive drugs.

Aged↗
PubMed1993

Mortality in a public and a private hospital compared: the severity of antecedent disorders in Medicare patients.

OBJECTIVES: The objectives of this study were to determine (1) if there were significant differences between patients who died at a public hospital and those who died at a university hospital that functions as a private, community hospital, and (2) if those differences were associated with an increased risk of death. METHODS: Chart review collected variables used by the Health Care Financing Administration in mortality analyses to examine how severity of illness data contribute to accurate predictions of death in a public hospital compared with a university hospital. RESULTS: Compared with patients who died at the university hospital, public hospital patients who died had more comorbid disease, were more severely ill, more likely to be emergently admitted, and more likely to be admitted from an extended-care facility. Inclusion of severity of illness with variables previously used to predict mortality significantly improved the accuracy of mortality prediction models for the public hospital but not for the university hospital. CONCLUSIONS: The results suggest that urban public hospitals provide care to more severely ill patients. Administrative data sets may not be adequate to identify these differences between patient populations.

Adult↗
PubMed1992

Baseline characteristics of participants in phase I of the Trials of Hypertension Prevention.

Phase I of the Trials of Hypertension Prevention was designed to test the effectiveness and safety of three life-style (weight loss, sodium restriction, and stress management) and four nutrition supplement (calcium, magnesium, potassium, and fish oil) interventions in reducing diastolic blood pressure (DBP) in persons with a high-normal blood pressure. A total of 2182 persons with a DBP between 80 and 89 mm Hg met the eligibility criteria for participation in phase I and were randomized to one of the active intervention or control treatment groups. Most were white (82%), male (70%), married (76%), nonsmoking (88%), college graduate (53%), full-time employees (91%). The average blood pressure prior to entry into the trial was 124.9 mm Hg systolic and 83.8 mm Hg diastolic. A variety of baseline observations, including sociodemographic characteristics, personal and family medical history, health habits, diet, and biologic measurements, were documented before randomization and compared among the seven active intervention and control groups. As might be expected in a randomized trial of this sample size, the distribution of measured baseline characteristics was virtually identical in the treated and control groups. Based on this finding and the knowledge that randomization procedures were implemented without deviation from the phase I protocol, it is probable that unknown potential confounders were also equally distributed at entry into the study. Given the achievement of high rates of follow-up, subsequent differences in blood pressure are unlikely to have been due to baseline differences between the active treatment and control groups, and can probably be attributed to effects of the active interventions.

Adult↗
PubMed1992

The hypertensive patient. Not just a number.

Treatment of both systolic-diastolic and isolated systolic hypertension in patients over age 65 has been shown to decrease subsequent cardiovascular morbidity and mortality. In the European Working Party on High Blood Pressure in the Elderly study, the number of morbid and mortal cardiovascular events prevented in the treatment group was 29/1,000 person-years, whereas in the Systolic Hypertension in the Elderly Program, the number was 55/1,000 person-years. This magnitude of reduction is substantial, but in the case of primary prevention in the elderly, a large number of patients must be treated to benefit relatively few. Better strategies of targeting treatment based on risk over and above that of high blood pressure are needed. Certainly, patients with more than one cardiovascular risk factor or evidence of end-organ damage should be treated more aggressively.

Aged↗
PubMed1992

Discrepancies in recording systolic blood pressure of elderly persons by ambulatory blood pressure monitor.

Agreements between auscultatory blood pressure measurements and recordings of the Suntech Accutracker II ambulatory blood pressure monitor (ABPM) were examined in 103 participants ages 23 through 91 to estimate influence of age on accuracy of automated recordings. Simultaneous auscultation by two technicians and recording by the ABPM were compared. Technicians demonstrated close agreement in auscultation of blood pressure. Mean systolic blood pressure measured by ABPM was 5.6 mm Hg lower and mean ABPM diastolic blood pressure was 6.3 mm Hg lower than average auscultatory blood pressure measured by technicians (P less than .0001). Discrepancies in systolic blood pressure measurements between technicians and ABPM were associated with age and systolic blood pressure. The age effect, controlled for gender and race, was a 0.15 mm Hg increase in systolic blood pressure discrepancy per year of age. Discrepancies in diastolic blood pressure measurements were associated with race but not with age or body size measurements. Automated recordings of blood pressure by this ABPM may have systematic bias compared to auscultation which exceeds current standards for ABPM instrumentation. For systolic blood pressure, this bias increases with age and may affect interpretation of ABPM recordings in elderly persons.

Adult↗
PubMed1992

Advances in management of hypertension in older persons.

Recent studies have now demonstrated that it is more important to focus on the SBP level than the DBP level in older persons. In addition, recent studies indicate that persons over age 80 still derive substantial benefit from treating ISH or DH. Also, studies now show that low-dose diuretics have a more favorable impact on subsequent coronary heart disease rates than was previously demonstrated. Finally, although caution is urged, it is unlikely the J-shaped relationship between treated DBP or SBP and subsequent mortality is due to overly aggressive treatment of high blood pressure. Table 4 provides the authors' guidelines for treating older persons with high blood pressure.

Adult↗
PubMed1992

Reproducibility of noninvasive ultrasonic measurement of carotid atherosclerosis. The Asymptomatic Carotid Artery Plaque Study.

BACKGROUND AND PURPOSE: To determine the effect of a lipid-lowering agent and/or a low-dose antithrombotic agent on the progression of early-stage carotid atherosclerosis, noninvasive B-mode ultrasound was used to measure intimal-medial thickness in asymptomatic individuals with moderately elevated lipids as part of the ongoing multicenter Asymptomatic Carotid Artery Plaque Study. METHODS: Uniform ultrasonic scanning and reading protocols were implemented to obtain maximum intimal-medial thickness measurements in 12 standard segments in patients having a small to moderate wall thickness (1.5-3.5 mm) in at least one of the carotid arteries. Paired B-mode image recordings on 858 patients, performed 1 month apart and read at a core laboratory (each pair by the same reader), determined both within-sonographer (W, n = 405) and between-sonographer (B, n = 453) reproducibility. RESULTS: The primary end point (mean +/- SD), defined in each individual as the mean value of the 12 maximum intimal-medial thickness measurements, was 1.31 +/- 0.21 mm (W) and 1.32 +/- 0.22 (B) at the time of the second examination. The mean difference in the primary end point (exam 2-exam 1) was -0.01 +/- 0.13 mm (W) and 0.00 +/- 0.15 mm (B). The Pearson correlation coefficients were 0.79 (W) and 0.75 (B). In 90% of the patients, the absolute difference in the primary end point was less than 0.22 mm (W) and less than 0.24 mm (B). Variability of the secondary end point, defined as the single largest intimal-medial thickness measurement in a patient, was between three and four times larger than the variability for the primary end point. Differences in sonographer performance between clinical centers were very small. CONCLUSIONS: The results demonstrate that standardized noninvasive ultrasonic techniques yield highly reproducible measures of carotid intimal-medial thickness, which can serve as a measure of carotid atherosclerosis in clinical trials that monitor small rates of lesion progression.

Adult↗