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S Wassertheil-Smoller

Publications and source records attributed to S Wassertheil-Smoller.

At least 37 records · Page 2Linked to original sources

Lack of effectiveness of a low-sodium/high-potassium diet in reducing antihypertensive medication requirements in overweight persons with mild hypertension. TAIM Research Group. Trial of Antihypertensive Interventions and Management.

The Trial of Antihypertensive Interventions and Management (TAIM) was a multicenter randomized drug (double-blind, placebo-controlled)-diet trial. One objective of TAIM was to assess the long-term ability of a low-sodium/high-potassium (Na+ decreases/K+ increases) diet to maintain blood pressure control in persons at 110% to 160% ideal weight with diastolic blood pressure from 90 to 100 mm Hg who were on no drugs or on low-dose monotherapy. Participants, 56% men and 33% black, were randomized to usual diet (n = 296) or to Na+ decreases/K+ increases diet (n = 291) and within each diet group to placebo, 25 mg/day chlorthalidone, or 50 mg/day atenolol. Treatment failure was defined as lack of blood pressure control requiring additional drugs according to specified criteria. At baseline, the mean value for age was 48 years; blood pressure, 143/93 mm Hg; weight, 88 kg; and 24-h urinary sodium and potassium excretion rates, 133 and 57 mmol/day, respectively. At 3 years, the net difference in 24-h urinary sodium/potassium excretion rates between the Na+ decreases/K+ increases and the usual diet groups was -30 and +11 mmol/L/day. The relative risk of treatment failure for Na+ decreases/K+ increases compared to usual diet by proportional hazards regression was 0.95 (P = .71). This study provides no support for the sole use of a low-sodium/high-potassium diet as a practical therapeutic strategy in maintaining blood pressure control in the moderately obese.

Adult↗

Plasma renin predicts success of antihypertensive drug withdrawal.

This study examined the relationship of plasma renin activity (PRA) to the likelihood of maintaining blood pressure control after discontinuation of antihypertensive medication. Patients whose blood pressure was previously treated and controlled in the Hypertension Detection and Follow-up Program were enrolled in the Dietary Intervention Study of Hypertension. After stratification by obesity, patients were randomized to discontinue medication with no dietary intervention, sodium restriction, or weight reduction for the obese. Among 496 subjects in the Dietary Intervention Study of Hypertension, 75 were randomly selected for PRA measurement at 4 months after intervention, and all had their blood pressure under control at that time. Patients were followed up for 56 weeks after randomization. The endpoint was return to antihypertensive medication due to elevated diastolic blood pressure. Kaplan-Meier survival analysis showed that subjects with PRA < or = 53.3 ng/100 mL/h, the median level, had a lower cumulative success rate for remaining off antihypertensive drug than those with PRA above the median (P = .046). In Cox regression analysis controlling for 24-h urinary sodium level, baseline diastolic blood pressure, age, sex, race, obesity, and dietary intervention group, a unit decrease in log PRA was associated with a 2.78-fold increase in risk of returning to drug (P = .006); this inverse relationship was independent of dietary intervention and change in diastolic blood pressure in the first 4 months before PRA was measured. The data indicate that patients with low PRA are less likely to maintain blood pressure control without drugs than patients with high PRA.

Age Factors↗

Reduction in long-term antihypertensive medication requirements. Effects of weight reduction by dietary intervention in overweight persons with mild hypertension.

BACKGROUND: Increasing concern over long-term drug treatment of mild hypertension has stimulated several studies of weight reduction. Phase I of the Trial of Antihypertensive Interventions and Management demonstrated a short-term effect of weight loss on blood pressure control in overweight persons with mild hypertension, who were either taking placebo or taking low-dose monotherapy. Phase II investigates the long-term benefit of weight loss on the ability to maintain blood pressure control. METHODS: From 10148 community-based screenees, 587 persons (5.8%), aged 21 to 65 years, entered a multicenter, randomized drug (double-blind, placebo-controlled) and diet trial. Participants had a diastolic blood pressure between 90 and 100 mm Hg and were at 110% to 160% of their ideal weight. They were randomized to a usual diet (n = 296) or to a weight loss diet (n = 291) and within each diet group to placebo, chlorthalidone, 25 mg/d, or atenolol, 50 mg/d. Treatment failure was defined as using additional antihypertensive medications if diastolic blood pressure rose above 90 mm Hg according to protocol-specified criteria. RESULTS: At baseline, mean diastolic blood pressure was 93 mm Hg; systolic blood pressure, 143 mm Hg; weight, 88 kg; percent ideal weight, 137%; age, 48 years; 56% were men; and 33% were black. Mean follow-up was 4.5 years. There was a net loss of 2 to 3 kg with weight loss diet compared with usual diet over most of the follow-up period. The 5-year incidence of treatment failure was 56.7 per 100 participants with usual diet and 49.8 per 100 with weight loss. Long-term weight loss decreased failure of blood pressure control for those receiving placebo or low-dose diuretic or beta-blocker by 23%. The results were similar in direction in each drug group. CONCLUSIONS: The Trial of Antihypertensive Interventions and Management demonstrated that weight reduction is an effective long-term therapy for maintaining blood pressure in the normal range when used as monotherapy or in combination with either thiazide diuretics or beta-blockers. Consequently, weight loss should be recommended for the management of obese individuals with mild hypertension.

Adult↗

Trial of antihypertensive intervention and management: greater efficacy with weight reduction than with a sodium-potassium intervention.

The Trial of Antihypertensive Intervention and Management evaluated nine diet-drug combinations in 878 mildly hypertensive, moderately obese participants using a 3 x 3 factorial design. Drugs evaluated were placebo, diuretic (chlorthalidone), and beta-blocker (atenolol); diets were usual (no intervention), weight reduction, and low sodium/high potassium (Na/K). This article reports 6-month dietary changes and the effect of dietary change on blood pressure. Six-month mean weight change was -4.7 kg in the weight reduction group, -0.3 kg in the Na/K group, and -0.5 kg in the usual-diet group. At 6 months, daily electrolyte excretion had changed in the Na/K intervention group. Daily sodium excretion decreased from 138.0 to 112.0 mmol in the Na/K group and increased from 134.1 to 138.4 mmol in the weight reduction group and from 129.1 to 137.0 mmol in the usual-diet group. Daily potassium output increased from 58.7 to 71.4 mmol in the Na/K group, from 57.0 to 60.5 mmol in the weight reduction group, and from 55.3 to 59.1 mmol in the usual diet group. Analysis of 3-day food records indicated that sodium intake decreased from 141.1 to 85.8 mmol and potassium intake increased from 76.4 to 90.5 mmol. Our results indicate that the goal for weight reduction was more easily achieved than the goal for electrolyte modification.

Adult↗

Differences in precision of dietary estimates among different population subgroups.

Populations vary in consistency of diets. The precision of estimates (E) of nutrient intake depends both on the ratio (R) of intraindividual to interindividual variances, as well as on the number of days of dietary intake recorded (k). We present baseline data from 872 participants in the Trial of Antihypertensive Interventions and Management (TAIM), a randomized clinical trial of diet and drug treatment for mild hypertension. There is wide variation in R among different demographic groups and for different nutrients. This has implications for the ability to estimate the correlations between the nutrient and a physiologic variable such as blood pressure, as well as for power calculations to compare group means on nutrient intake. For example, to achieve the same degree of precision (E = 0.80) in estimating the correlation between sodium intake and blood pressure for whites in New York, 7 days of food records would be required, compared to 2 days for whites in Alabama. Tables are presented indicating within- and between-person variances for different groups and different nutrients. Methods of calculating E, determining k, and calculating samples size are provided. Investigators designing nutritional epidemiologic studies should take into account ratios of intraindividual to interindividual variances of different population subgroups and different nutrients in order to determine the number of daily food records that must be obtained and the sample size for group comparisons.

Adult↗

Effect of withdrawal of antihypertensive drug on depressive mood.

To evaluate the effects on depressive mood of withdrawal of antihypertensive medication, we conducted a randomized, multi-center study with clinical centers at the Albert Einstein College of Medicine, Bronx, NY, University of Alabama School of Medicine, Birmingham, and the University of Mississippi School of Medicine in Jackson. Patients were formerly active participants in the Hypertension Detection and Follow-Up Program (HDFP) whose blood pressure was controlled with drugs for a period of 5 years. Of 496 patients, 431 had both baseline and "1-year" mood scores. Patients, stratified by obesity, were randomized to one of three groups: continue the HDFP medication; discontinue medication with no dietary intervention, or with sodium restriction and potassium increase; or, for those overweight, to a weight reduction intervention. Depression was assessed using the CES-D scale (Center for Epidemiological Studies--Depressed Mood), administered at baseline and again approximately 1 year after randomization. Of the seven treatment groups, only those who continued their HDFP medication showed significant improvement in mood from baseline. The overweight continue-medication group showed significantly greater improvement compared to the no-drugs, no-diet intervention groups, and to the overweight sodium-restriction group. Patients who had their blood pressure successfully controlled with weight reduction had a significant improvement in mood from 11.0 scale points to 8.0, P = .006. Comparisons between those withdrawn from diuretic alone and those withdrawn from both diuretic plus reserpine were inconclusive. Dietary Intervention Study of Hypertension (DISH) shows no evidence that continued use of chlorthalidone has a negative impact on quality of life, while our results concerning reserpine were inconclusive.(ABSTRACT TRUNCATED AT 250 WORDS)

Affect↗

Renin predicts diastolic blood pressure response to nonpharmacologic and pharmacologic therapy.

OBJECTIVE: Plasma renin activity was measured at baseline and 6 months in a trial of nonpharmacologic therapy of mild hypertension to determine whether plasma renin activity predicts the diastolic blood pressure (DBP) response to nonpharmacologic therapy. DESIGN, SETTING, AND PARTICIPANTS: Randomized controlled trial of volunteers from the general community with mild hypertension (DBP between 90 and 100 mm Hg), off all antihypertensive therapy at baseline, treated in special research clinics (n = 593). INTERVENTIONS: Subjects were randomly assigned to usual, weight loss, or low sodium/high potassium diet and then randomly assigned to receive placebo, chlorthalidone, or atenolol. MAIN OUTCOME MEASURES: Renin was analyzed as plasma renin activity and as a renin index (logarithm of 24-hour urinary sodium excretion times logarithm of plasma renin activity) (593 patients at baseline and 6 months) to correct for varied sodium intakes. The DBP was measured using the random zero device. RESULTS: Change in DBP at 6 months could be predicted from baseline plasma renin activity or renin index. The DBP was decreased after 6 months of therapy by 2 mm Hg for each unit increase in baseline plasma renin activity and by 0.16 mm Hg for each unit increase in baseline renin index. Patients in the highest renin index quartile had a greater DBP response to atenolol therapy, and patients in the lowest renin index quartile had a greater DBP response to chlorthalidone therapy. Weight loss diet achieved a greater reduction in DBP in patients with higher baseline renin index and had an additive effect on DBP response in both of the drug groups. Patients on a weight loss diet receiving placebo in the highest baseline renin index quartile had a reduction in DBP of 12.4 mm Hg, compared with 4.4 mm Hg in the lowest baseline renin index quartile (P = .009). A low sodium/high potassium diet had a lesser effect than a weight loss diet on pharmacologic therapy. As with the weight loss diet, patients on a low sodium/high potassium diet in the highest baseline renin index quartile had a greater reduction in DBP than patients in the lowest baseline renin index quartile. CONCLUSIONS: These data suggest a significant relationship between baseline levels of plasma renin index and the likelihood of success of nonpharmacologic treatment of hypertension.

Adult↗

Prognosis in ischemic heart disease. Can you tell as much at the bedside as in the nuclear laboratory?

BACKGROUND--While the resting left ventricular ejection fraction (LVEF) predicts prognosis in ischemic heart disease, clinical evaluation is also useful. METHODS--To compare the prognostic value of LVEF by resting radionuclide ventriculography with that of clinical signs and symptoms of congestive heart failure (CHF), 170 patients with suspected ischemic heart disease were followed up in this prospective study. Patients had a standardized history and physical examination performed by a study cardiologist immediately before the nuclear scan. Chest roentgenography and radionuclide ventriculography were performed in a standard manner. The diagnosis of CHF was made by validated clinicoradiographic criteria based on the Framingham study. Mortality was determined by means of the National Death Index; median follow-up time was 3 years. RESULTS--There was CHF at baseline in 70 patients, and baseline LVEF was low (< or = 0.4) in 63 patients. Low LVEF was significantly associated with CHF. During follow-up, 55 of the subjects died (overall mortality, 32%). Subjects with CHF had a significantly higher risk of death than those without CHF, and subjects with low LVEF had a higher mortality than those with preserved LVEF. Both CHF and LVEF were independent predictors of mortality. In a Cox model, each percentage increase in LVEF was associated with a 2% decreased mortality, while subjects with CHF had a mortality 2.5 times higher than that of those without CHF. Also, CHF with preserved LVEF had a better prognosis than CHF with depressed LVEF, but this prognosis was worse than that in subjects without CHF. CONCLUSIONS--The clinical diagnosis of CHF, based on clinical evaluation and chest roentgenogram, is a valid predictor of mortality and provides information independent of the radionuclide LVEF in determining prognosis in patients with ischemic heart disease.

Aged↗

The Trial of Antihypertensive Interventions and Management (TAIM) Study. Final results with regard to blood pressure, cardiovascular risk, and quality of life.

The Trial of Antihypertensives Interventions and Management (TAIM) was a multicenter double-blind placebo-controlled clinical trial of drug and diet combinations for the treatment of mild hypertension among 878 participants, ages 21 to 65, 110% to 160% ideal weight, and with baseline diastolic blood pressure 90 to 100 mm Hg. The drugs used were placebo, chlorthalidone (25 mg/daily) or atenolol (50 mg/daily). The diets studied were usual, weight loss, sodium reduction/potassium increase. Trial end points were 6-month diastolic blood pressure change, cardiovascular risk change, and quality of life change. Either drug combined with weight loss produced the greatest blood pressure reduction of 15 mm Hg, compared to 8 mm Hg on placebo/usual diet. Adding sodium restriction to either drug did not enhance blood pressure lowering effect. Drugs outperformed diet in terms of antihypertensive effect. However, those on placebo and assigned to weight reduction who lost more than 4.5 kg and those on sodium restriction who reduced sodium to less than 70 mEq daily lowered blood pressure to a similar extent as those on either of the two drugs alone. Cardiovascular risk at 6 months relative to baseline ranged from 0.85 in weight loss/atenolol subgroup to 1.04 in the usual diet/chlorthalidone subgroup. Blacks were more responsive to chlorthalidone plus weight loss and whites to atenolol plus weight loss. Quality of life, as measured by scales of distress and well-being, was favorably affected by weight reduction. Although there were few side effects of the drugs and most patients improved on most parameters, sexual complaints were worsened among those on chlorthalidone and usual diet compared to placebo.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗

Effect of antihypertensive therapy on weight loss. The Trial of Antihypertensive Interventions and Management Research Group.

We report the effect of weight changes of the type of antihypertensive medication prescribed in a trial of the relative efficacy of drug and dietary measures in mild hypertension. The Trial of Antihypertensive Interventions and Management studied 878 mildly hypertensive individuals randomly assigned, in a 3 x 3 design, to no diet change, weight loss, or a low sodium-high potassium diet and to placebo, 25 mg chlorthalidone, or 50 mg atenolol. The type of drug prescribed affected weight change with all diets. The drug effect on weight change, present in all groups at 6 months, was most pronounced in those randomly assigned to the weight loss diet, where the placebo group lost 4.4 kg, the atenolol group lost 3.0 kg, and the chlorthalidone group lost 6.9 kg. The group differences were attenuated but persisted at 24 months. We suggest that the antihypertensive drug prescribed affects the success of a conjoint weight loss program and speculate that the difference between the drugs may be due to their intrinsic effects on the sympathetic nervous system and related metabolic changes.

Atenolol↗

The Trial of Antihypertensive Interventions and Management (TAIM) study. Adequate weight loss, alone and combined with drug therapy in the treatment of mild hypertension.

This report examines the effect of weight loss, alone and in combination with drugs, on diastolic blood pressure change in the Trial of Antihypertensive Interventions and Management (TAIM), which is a randomized, multicenter, placebo-controlled clinical trial of drug and diet combinations in the treatment of mild hypertension among 787 patients. Diastolic blood pressure drop (11.6 mm Hg) at 6 months among those patients who were randomized to weight reduction and placebo drug treatment was greater among those who lost 4.5 kg or more, than the 7-mm Hg drop for those who lost less than 2.25 kg or for the placebo-treated control group, and it was statistically equivalent to the reduction achieved by 25 mg of chlorthalidone or 50 mg of atenolol (11.1- and 12.4-mm Hg drop, respectively). Weight loss potentiated effects of drugs, with reductions of 18.4 mm Hg, for those patients who were taking atenolol and had a 4.5-kg or more weight loss, and of 15.4 mm Hg, for those patients who were taking chlorthalidone and had at least a 2.25-kg weight loss. We concluded that effective weight loss (greater than or equal to 4.5 kg) lowers blood pressure similarly to low-dose drug therapy and potentiates drug effects, with the apparent 4.5-kg threshold being lowered to 2.25 kg for those patients who receive chlorthalidone.

Atenolol↗

Effect of antihypertensives on sexual function and quality of life: the TAIM Study.

OBJECTIVE: To evaluate treatment of mild hypertension using combinations of diet and low-dose pharmacologic therapies. DESIGN: Multicenter, randomized, placebo-controlled clinical trial. SETTING: Three university-based tertiary care centers. PATIENTS: Patients (697) 21 to 65 years of age with diastolic blood pressure between 90 and 100 mm Hg as well as weight between 110% and 160% of ideal weight. INTERVENTION: Patients were stratified by clinical center and race and were randomly assigned to one of three diets (usual, low-sodium and high-potassium, weight loss) and one of three agents (placebo, chlorthalidone, and atenolol). MEASUREMENTS: Changes in measures of sexual problems, distress, and well-being after 6 months of therapy were analyzed. MAIN RESULTS: Low-dose chlorthalidone and atenolol produced few side effects, except in men. Erection-related problems worsened in 28% (95% CI, 15% to 41%) of men receiving chlorthalidone and usual diet compared with 3% (CI, 0% to 9%) of those receiving placebo and usual diet (P = 0.009) and 11% (CI, 2% to 20%) of those receiving atenolol and usual diet (P greater than 0.05). The weight loss diet ameliorated this effect. The low-sodium diet with placebo was associated with greater fatigue (34%; CI, 23% to 45%) than was either usual diet (18%; CI, 10% to 27%; P = 0.04) or weight reduction (15%; CI, 7% to 23%; P = 0.009). The low-sodium diet with chlorthalidone increased problems with sleep (32%; CI, 22% to 42%) compared with chlorthalidone and usual diet (16%; CI, 8% to 24%; P = 0.04). The weight loss diet benefited quality of life most, reducing total physical complaints (P less than 0.001) and increasing satisfaction with health (P less than 0.001). Total physical complaints decreased in 57% to 76% of patients depending on drug and diet group, and were markedly decreased by weight loss. CONCLUSION: In general, low-dose antihypertensive drug therapy (with chlorthalidone or atenolol) improves rather than impairs the quality of life; however, chlorthalidone with usual diet increases sexual problems in men.

Adult↗

Effect of drug and diet treatment of mild hypertension on diastolic blood pressure. The TAIM Research Group.

The Trial of Antihypertensive Interventions and Management is a multicenter randomized trial designed to examine the diastolic blood pressure response of various combinations of pharmacological and dietary interventions in the treatment of mild hypertension (diastolic blood pressure 90-100 mm Hg). Eight hundred and seventy-eight participants at 110-160% of ideal weight were randomly allocated to nine drug/diet treatment groups receiving either a placebo, chlorthalidone (25 mg), or atenolol (50 mg), combined with a usual, a weight loss, or a low sodium/high potassium diet. The primary outcome was diastolic blood pressure change from baseline to 6 months. Seven hundred and eighty-seven participants had follow-up data. The mean baseline diastolic blood pressure was 93.8 mm Hg; 55.9% of the participants were male, and the weight loss diet group lost an average of 4.7 kg. Multiple comparisons were accounted for in the analysis. A significantly greater lowering of diastolic blood pressure (12.4 mm Hg) was achieved in the atenolol group compared with either the low sodium/high potassium diet group (7.9 mm Hg, p = 0.001) or weight loss group (8.8 mm Hg, p = 0.006). Adding weight loss to chlorthalidone significantly enhanced blood pressure lowering (15.1 mm Hg) when compared with the diuretic alone (10.8 mm Hg, p = 0.002), but adding a low sodium/high potassium diet (12.2 mm Hg, p = 0.029) did not. In the short-term treatment of mild hypertension where diastolic blood pressure is the sole consideration, drugs outperform diet, and weight loss is beneficial, especially with diuretics.

Adrenergic beta-Antagonists↗

Nuclear exercise testing and the management of coronary artery disease.

Three hundred seventy-eight patients referred for nuclear exercise testing were classified using demographics and symptoms into low, intermediate, and high coronary disease likelihood categories. These likelihood groups constituted 15%, 41%, and 15% of referrals, respectively. Patients with prior infarction or disease at angiography (proven disease) made up the remaining 29% of patients. Only 2% of low likelihood patients had typical angina, but physicians diagnosed coronary disease in 64%, prescribed antianginal therapy in 50%, and were considering catheterization in 28% of these patients, all as frequently as for patients with intermediate or high likelihoods for disease. Patients with proven disease were treated differently in that 79% were receiving antianginal therapy and 56% were considered for catheterization (p less than 0.001). Nuclear exercise test results reduced the perceived need for catheterization in all groups, on average by 49%. Nuclear exercise tests are a standard by which patients are managed, sometimes substituting for the traditional role of the history in physician decision making.

Bayes Theorem↗

Pharmacologic and nutritional treatment of mild hypertension: changes in cardiovascular risk status.

OBJECTIVE: To evaluate the 6-month change in cardiovascular (coronary heart disease) risk as a function of diet and drug therapy for mild hypertension. DESIGN: Collaborative randomized, controlled clinical trial to assess the efficacy of alternative regimens in treating mild hypertension. SETTING: Three university-based tertiary care centers-the Trial of Antihypertensive Interventions and Management (TAIM). PATIENTS: Six hundred and ninety-two men and women ages 21 to 65 years with diastolic blood pressure between 90 and 100 mm Hg and weight between 110% and 160% of ideal weight. MEASUREMENTS AND MAIN RESULTS: Patients stratified by clinical center and race were randomized into diet (usual, low sodium-high potassium, weight loss) and drug (placebo, chlorthalidone, and atenolol) groups resulting in nine diet plus drug combinations. The cardiovascular risk at 6-month follow-up was estimated relative to baseline in 692 participants using the Framingham Study model. Due to the blood pressure reduction, cardiovascular risk declined from baseline for all treatment groups (except the usual diet plus chlorthalidone group because of increased cholesterol levels). The relative cardiovascular risk at 6 months compared to baseline ranged from 0.83 in the weight loss plus atenolol subgroup to 1.03 in the usual diet plus chlorthalidone subgroup. The active drug plus weight loss groups showed the lowest relative cardiovascular risk at 6 months. CONCLUSIONS: Mild hypertension was generally reduced to desirable levels within 6 months by monotherapy. Evaluating blood pressure changes together with the risk factors indicated a differential effect on overall cardiovascular risk depending on the diet and drug used. Dietary therapy, particularly weight reduction, was important adjunctive treatment in reducing overall cardiovascular risk.

Adrenergic beta-Antagonists↗

Estimation of protein intake: comparison of dietary assessment and urinary excretion.

Estimates of dietary intake of nutrients have many problems, and confirmation of these estimates by chemical measurements of excretory products helps to establish their validity. The correlation between urinary amino acid excretion and dietary history of protein intake are reported herein. Diet diaries were kept by and 24-h urine collected from participants in the Trial of Antihypertensive Therapy and Management, a multicenter cooperative trial comparing the effects of drugs and diet on blood pressure control, side effects, and quality of life. The nutritional information was coded and the data stored by the nutritional analyses facility at Albert Einstein College of Medicine. The chemical determinations were done in the laboratories of the Department of Pathology, Izumo, Japan. The correlation between total protein and 3-methylhistidine was r = 0.42 (n = 96). The correlation was similar for animal protein (r = 0.4). These correlations are of the same order of magnitude as those between dietary sodium and urine sodium, and dietary potassium and urine potassium. We conclude that measurement of urinary protein excretion products may be a useful way to estimate dietary protein intake.

Adult↗

Effect of weight loss on thiazide produced erectile problems in men.

Thiazide-type diuretics frequently produce erectile dysfunction in men on a regular diet. However, men on a weight-loss diet have much less erectile dysfunction. Thiazide-type diuretics also produce erectile dysfunction in rats and interfere with normal copulation. The mechanism of the dysfunction and the favorable response to weight loss is unknown.

Animals↗

Trial of antihypertensive interventions and management. Design, methods, and selected baseline results.

The Trial of Antihypertensive Interventions and Management was a multicenter randomized, placebo-controlled trial designed to assess the effectiveness of various combinations of pharmacologic and dietary interventions in the treatment of mild hypertension (diastolic blood pressure 90-100 mmHg). The primary outcome was blood pressure change between baseline and 6 months. The study consisted of a 3 X 3 factorial design wherein participants were randomly allocated to nine drug-diet treatment groups. Drugs included placebo, diuretic, and beta-blocker. Diets were usual, weight loss, and low sodium/high potassium. The basic strategy was to address clinical questions of interest by comparing mean blood pressure changes of selected drug-diet combinations. This paper describes the study including experimental design, sample size considerations, statistical analysis, organizational structure, and baseline findings.

Adult↗