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Biomedical subjects

Jackie Bosch

Publications and source records attributed to Jackie Bosch.

15 recordsLinked to original sources
PubMed2006

Effect of ramipril on the incidence of diabetes.

BACKGROUND: Previous studies have suggested that blockade of the renin-angiotensin system may prevent diabetes in people with cardiovascular disease or hypertension. METHODS: In a double-blind, randomized clinical trial with a 2-by-2 factorial design, we randomly assigned 5269 participants without cardiovascular disease but with impaired fasting glucose levels (after an 8-hour fast) or impaired glucose tolerance to receive ramipril (up to 15 mg per day) or placebo (and rosiglitazone or placebo) and followed them for a median of 3 years. We studied the effects of ramipril on the development of diabetes or death, whichever came first (the primary outcome), and on secondary outcomes, including regression to normoglycemia. RESULTS: The incidence of the primary outcome did not differ significantly between the ramipril group (18.1%) and the placebo group (19.5%; hazard ratio for the ramipril group, 0.91; 95% confidence interval [CI], 0.81 to 1.03; P=0.15). Participants receiving ramipril were more likely to have regression to normoglycemia than those receiving placebo (hazard ratio, 1.16; 95% CI, 1.07 to 1.27; P=0.001). At the end of the study, the median fasting plasma glucose level was not significantly lower in the ramipril group (102.7 mg per deciliter [5.70 mmol per liter]) than in the placebo group (103.4 mg per deciliter [5.74 mmol per liter], P=0.07), though plasma glucose levels 2 hours after an oral glucose load were significantly lower in the ramipril group (135.1 mg per deciliter [7.50 mmol per liter] vs. 140.5 mg per deciliter [7.80 mmol per liter], P=0.01). CONCLUSIONS: Among persons with impaired fasting glucose levels or impaired glucose tolerance, the use of ramipril for 3 years does not significantly reduce the incidence of diabetes or death but does significantly increase regression to normoglycemia. (ClinicalTrials.gov number, NCT00095654 [ClinicalTrials.gov].).

Adult↗
PubMed2006

Independent design and conduct of clinical trials.

Randomized clinical trials (RCTs) have justifiably become the cornerstone for the evaluation of virtually any kind of intervention: drugs, surgical or diagnostic procedures, behavioural modifications, health policies and even systems of care. This commentary focuses on two issues related to independence in clinical trials: first, the independence to ask important questions, and second, independence from bias in the conduct, analysis and reporting of trials, which can lead to misleading conclusions. The most frequent type of RCT are those evaluating therapies, and much of this commentary will be focused on issues relevant to such trials, although the principles apply generally.

Bias↗
PubMed2005

Long-term effects of ramipril on cardiovascular events and on diabetes: results of the HOPE study extension.

BACKGROUND: We have previously demonstrated that ramipril reduces vascular events and new diagnoses of diabetes when given for a 4.5-year period. However, it is not known whether the benefits are observed in subgroups of patients at varying risk or on other proven therapies and whether the benefits are sustained beyond the current trial. The 2 aims of this investigation were to assess whether the benefits observed during the HOPE trial were (1) maintained after trial cessation during an additional 2.6 years of follow-up and (2) observed in subgroups based on risk and ancillary treatments. METHODS AND RESULTS: Of the initial 267 study centers and 9297 patients, 174 centers and 4528 patients agreed to further follow-up. The rates of use of angiotensin-converting-enzyme inhibitors (ACEIs) in the 2 groups (72% ramipril versus 68% placebo) were similar after the end of the trial. During the posttrial follow-up, patients allocated to ramipril had a 19% further lower relative risk (RR) of myocardial infarction (95% confidence interval [CI], 0.65 to 1.01), a 16% lower RR (95% CI, 0.70 to 0.99) of revascularization, and a 34% lower RR of a new diagnosis of diabetes (95% CI, 0.46 to 0.95). Similar RR reductions in vascular events were observed during and after the active phase of the trial, regardless of baseline risk (RR of 0.76, 0.89, and 0.83 for low-, medium-, and high-risk patients, respectively) or ancillary treatments (RR of 0.90 for aspirin, 0.76 for beta-blockers, and 0.84 for lipid-lowering medication). CONCLUSIONS: The benefits of ramipril observed during the active period of the HOPE trial were maintained during posttrial follow-up for cardiovascular death, stroke, and hospitalization for heart failure. Additional reductions in myocardial infarction, revascularization, and the development of diabetes were observed during the follow-up phase despite similar rates of ACEI use in the 2 randomized groups. These benefits were consistent regardless of patient risk or ancillary treatments.

Aged↗
PubMed2005

Effects of long-term vitamin E supplementation on cardiovascular events and cancer: a randomized controlled trial.

CONTEXT: Experimental and epidemiological data suggest that vitamin E supplementation may prevent cancer and cardiovascular events. Clinical trials have generally failed to confirm benefits, possibly due to their relatively short duration. OBJECTIVE: To evaluate whether long-term supplementation with vitamin E decreases the risk of cancer, cancer death, and major cardiovascular events. DESIGN, SETTING, AND PATIENTS: A randomized, double-blind, placebo-controlled international trial (the initial Heart Outcomes Prevention Evaluation [HOPE] trial conducted between December 21, 1993, and April 15, 1999) of patients at least 55 years old with vascular disease or diabetes mellitus was extended (HOPE-The Ongoing Outcomes [HOPE-TOO]) between April 16, 1999, and May 26, 2003. Of the initial 267 HOPE centers that had enrolled 9541 patients, 174 centers participated in the HOPE-TOO trial. Of 7030 patients enrolled at these centers, 916 were deceased at the beginning of the extension, 1382 refused participation, 3994 continued to take the study intervention, and 738 agreed to passive follow-up. Median duration of follow-up was 7.0 years. INTERVENTION: Daily dose of natural source vitamin E (400 IU) or matching placebo. MAIN OUTCOME MEASURES: Primary outcomes included cancer incidence, cancer deaths, and major cardiovascular events (myocardial infarction, stroke, and cardiovascular death). Secondary outcomes included heart failure, unstable angina, and revascularizations. RESULTS: Among all HOPE patients, there were no significant differences in the primary analysis: for cancer incidence, there were 552 patients (11.6%) in the vitamin E group vs 586 (12.3%) in the placebo group (relative risk [RR], 0.94; 95% confidence interval [CI], 0.84-1.06; P = .30); for cancer deaths, 156 (3.3%) vs 178 (3.7%), respectively (RR, 0.88; 95% CI, 0.71-1.09; P = .24); and for major cardiovascular events, 1022 (21.5%) vs 985 (20.6%), respectively (RR, 1.04; 95% CI, 0.96-1.14; P = .34). Patients in the vitamin E group had a higher risk of heart failure (RR, 1.13; 95% CI, 1.01-1.26; P = .03) and hospitalization for heart failure (RR, 1.21; 95% CI, 1.00-1.47; P = .045). Similarly, among patients enrolled at the centers participating in the HOPE-TOO trial, there were no differences in cancer incidence, cancer deaths, and major cardiovascular events, but higher rates of heart failure and hospitalizations for heart failure. CONCLUSION: In patients with vascular disease or diabetes mellitus, long-term vitamin E supplementation does not prevent cancer or major cardiovascular events and may increase the risk for heart failure.

Aged↗
PubMed2005

Prognostic impact of body weight and abdominal obesity in women and men with cardiovascular disease.

BACKGROUND: Increased body mass index (BMI) and abdominal adiposity increase the risk of cardiovascular disease (CVD) in persons free of these diseases, but their independent prognostic impact in persons with CVD has not been well defined. METHODS: BMI, waist-to-hip ratio (WHR), and waist circumference (WC) were measured in 6620 men and 2182 women with a mean age of 66 and stable CVD without congestive heart failure (CHF) participating in the Heart Outcomes Prevention Evaluation (HOPE) study. The main outcomes were CVD death, myocardial infarction, stroke, hospitalization for CHF, and all-cause mortality. RESULTS: During the 4.5-year follow-up, 658 had a CVD death, 1018 a myocardial infarction, 364 a stroke, 297 a CHF event, and 1034 died. When compared with the first tertile, the third tertile of BMI increased the adjusted relative risk (RR) of myocardial infarction by 20% (P < .02). Patients in the third tertile of WC had an increased adjusted RR of 23% for myocardial infarction (P < .01), 38% for heart failure (P < .03), and 17% for total mortality (P < .05). For WHR, there was an increased adjusted RR of 24% for CVD death (P < .03), 20% for myocardial infarction (P < .01), and 32% for total mortality (P < .001). CONCLUSIONS: Obesity, particularly abdominal adiposity, worsens the prognosis of patients with CVD; weight reduction program should be integrated in the active management of these patients.

Abdomen↗
PubMed2005

Home and community occupational therapy for children and youth: a before and after study.

BACKGROUND: There has been an increased focus on home care service provision in recent years, yet there are few data available about the provision of home and community occupational therapy for children and youth. PURPOSE: To evaluate key elements of a service provision model for home care occupational therapy in terms of occupational performance outcomes, perception of care and cost. METHODS: Eleven centres in Ontario and Quebec recruited 167 children and youth up to 18 years of age to a before and after study of occupational therapy services in the home and community. Occupational performance, quality of life and costs were measured at baseline and study end. Perception of care was measured at study completion. RESULTS: A statistically and clinically significant improvement in occupational performance was demonstrated (p < 0.001). The clients' families gave high ratings to the process of care provided by the occupational therapists. These data did not demonstrate a clear relationship between amount of service, cost and occupational performance outcome. PRACTICE IMPLICATIONS: Children receiving home and community occupational therapy services change in their occupational performance abilities. These changes are not directly related to the amount or focus of the occupational therapy services.

Adolescent↗
PubMed2004

Effect of ramipril in reducing sudden deaths and nonfatal cardiac arrests in high-risk individuals without heart failure or left ventricular dysfunction.

BACKGROUND: ACE inhibitor therapy reduces the risk of cardiovascular death, myocardial infarction, stroke, hospitalization for heart failure, and need for revascularization in high-risk patients with clinical heart failure, overt left ventricular systolic dysfunction, or vascular disease. In patients with clinical heart failure or overt left ventricular systolic dysfunction, ACE inhibitor therapy also reduces the risk of sudden or arrhythmia-related cardiac death. The objective of this study was to assess the effect of the ACE inhibitor ramipril on sudden unexpected death or resuscitated cardiac arrest among the 9297 individuals without clinical heart failure or overt left ventricular dysfunction enrolled in the Heart Outcomes Prevention Evaluation (HOPE) trial. METHODS AND RESULTS: During the median follow-up of 4.5 years, the composite outcome of unexpected death, documented arrhythmic death, or resuscitated cardiac arrest was reduced by 21% in patients randomized to ramipril therapy compared with those randomized to placebo. There were 155 (3.3%) composite outcome events in patients randomized to ramipril therapy compared with 195 (4.2%) such events in patients randomized to placebo (RR 0.79, 95% CI 0.64 to 0.98, P=0.028). There were trends toward reductions in fatal primary outcome events (unexpected death or documented arrhythmic death; RR 0.81, 95% CI 0.64 to 1.02, P=0.072) and in nonfatal primary outcome events (resuscitated cardiac arrest; RR 0.65, 95% CI 0.38 to 1.13, P=0.127) in the ramipril treatment group. CONCLUSIONS: Ramipril reduces the risk of fatal and nonfatal serious arrhythmic events in high-risk patients without clinical heart failure or overt left ventricular systolic dysfunction.

Aged↗
PubMed2004

Effects of ramipril on left ventricular mass and function in cardiovascular patients with controlled blood pressure and with preserved left ventricular ejection fraction: a substudy of the Heart Outcomes Prevention Evaluation (HOPE) Trial.

OBJECTIVES: The purpose of this study was to assess the effects of ramipril on left ventricular mass (LVM) and function in vascular disease patients with controlled blood pressure (BP) and with preserved left ventricular ejection fraction (LVEF). BACKGROUND: Increased LVM and left ventricular (LV) volume and decreased LVEF predict clinical events. Angiotensin-converting enzyme inhibitors reduce LVM and LV volume and preserve LVEF in patients with hypertension and/or LV dysfunction, but have not been studied in patients with controlled BP and preserved LVEF. METHODS: We compared the effects of two doses of ramipril (10 mg/day and 2.5 mg/day) versus placebo in 506 patients with vascular disease on echocardiographic measures of LVM and LV function. RESULTS: Baseline BP and LVEF were similar, 131/76 mm Hg and 58%, in all treatment groups. After four years, LVM index increased by 3.98 +/- 2.08 g/m2 in the placebo and by 4.16 +/- 1.86 g/m2 in the ramipril 2.5 mg/day groups and decreased by 2.02 +/- 2.25 g/m2 in the ramipril 10 mg/day group (p = 0.02). The changes in LV end-diastolic and end-systolic volumes were 4.16 +/- 2.55 ml and 5.31 +/- 1.67 ml in the placebo, -0.43 +/- 2.75 ml and 2.90 +/- 1.45 ml in the ramipril 2.5 mg/day, and -5.90 +/- 2.93 ml and -1.90 +/- 1.55 ml in the ramipril 10 mg/day groups (p = 0.02 and p = 0.001). The changes in LVEF were -2.02 +/- 0.72%, -1.54 +/- 0.74%, and -0.17 +/- 0.72%, respectively (p = 0.01). CONCLUSIONS: Ramipril has beneficial effects on LV structure and function in vascular patients with controlled BP and with preserved LVEF.

Aged↗
PubMed2004

Effects of vitamin E on cardiovascular outcomes in people with mild-to-moderate renal insufficiency: results of the HOPE study.

BACKGROUND: A controlled trial reported cardiovascular benefits of vitamin E in terminal renal insufficiency. There are no data for renal insufficiency before the stage of terminal renal failure. We evaluated effects of vitamin E supplementation on cardiovascular and renal outcomes in 993 people with a serum creatinine > or =1.4 to 2.3 mg/dL. METHODS: Post-hoc analysis of a randomized trial that compared treatment with natural source vitamin E (400 IU/day) to placebo in 9541 people, 993 of which had renal insufficiency. Participants had either known cardiovascular disease or diabetes and at least one additional coronary risk factor. Exclusion criteria included a serum creatinine > 2.3 mg/dL and dipstick-positive proteinuria. The primary study outcome after an average of 4.5 years was the composite of myocardial infarction, stroke, or cardiovascular death. Secondary outcomes included revascularizations, total mortality, and clinical proteinuria. RESULTS: In renal insufficiency, vitamin E supplementation had a neutral effect on the primary study outcome, on each component of the composite primary outcome, and on all secondary outcomes. Two hundred twenty-four primary outcomes, 23% of the vitamin E group and 22.1% of the placebo group, relative risk 1.03 (95% CI, 0.79-1.34; P= 0.82), were observed, and 585 secondary outcomes, including death in 17% and 18.8% of the vitamin E and placebo groups, respectively (RR 0.88, 95% CI, 0.66-1.18; P= 0.40). There was no effect of vitamin E on progression of proteinuria. CONCLUSION: In people with mild-to-moderate renal insufficiency at high cardiovascular risk, vitamin E at a dose of 400 IU/day had no apparent effect on cardiovascular outcomes.

Aged↗
PubMed2003

Prevention of Heart Failure in Patients in the Heart Outcomes Prevention Evaluation (HOPE) Study.

BACKGROUND: Previous trials in the prevention of heart failure have been restricted to patients with low ejection fraction or hypertension. We assessed an angiotensin-converting enzyme (ACE) inhibitor, ramipril, to prevent the development of heart failure in high-risk patients without known low ejection fraction or heart failure. METHODS AND RESULTS: We randomly assigned 9297 patients to receive double-blind ramipril (10 mg daily) or matching placebo for 4.5 years. Death attributable to heart failure, hospitalization for heart failure, initiation of open-label ACE inhibitor for heart failure, or development of typical signs or symptoms of heart failure developed in 951 patients and was associated with a 4.01-fold increase in the risk of death (P<0.0001). The rate of developing heart failure was significantly increased with coronary disease (risk ratio, 2.17), microalbuminuria (1.82), left ventricular hypertrophy (1.47), increasing age (by decade, 1.37), and diabetes (1.36). Ramipril reduced new-onset heart failure rate from 11.5% to 9.0% (relative risk, 0.77; 95% CI, 0.68 to 0.87; P<0.0001). Ramipril consistently reduced heart failure rate both in those with (relative risk, 0.87) and those without an interim myocardial infarction (relative risk, 0.78). Ramipril also reduced the heart failure rate more in patients with baseline systolic pressure above the median (139 mm Hg) (relative risk, 0.67) compared with those below the median (relative risk, 0.91; P=0.024 for interaction of group by treatment). CONCLUSION: Ramipril significantly reduces the rate of development of heart failure in patients at high risk of cardiovascular events.

Angiotensin-Converting Enzyme Inhibitors↗
PubMed2003

Relationship of electrocardiographic left ventricular hypertrophy to mortality and cardiovascular morbidity in high-risk patients.

BACKGROUND: The prognostic significance of left ventricular hypertrophy (LVH) identified by simple electrocardiographic (ECG) criteria in high-risk patients with established cardiovascular (CV) diseases is not clearly understood. DESIGN AND METHODS: The Heart Outcomes Prevention Evaluation (HOPE) trial was a randomized trial, which evaluated the effects of ramipril and of vitamin E on major CV outcomes in 9541 men and women aged 55 years or older with a history of coronary artery disease, stroke, peripheral vascular disease or diabetes mellitus with at least one additional CV risk factor. Patients were followed for an average of 4.5 years. We evaluated the association between simple ECG criteria for LVH and the risk for major vascular events, for CV and all-cause mortality and for heart failure. RESULTS: Electrocardiographic LVH was present in 793 (8.3%) HOPE study participants. Of these, 19.0% sustained a major CV event (MI, stroke or CV death), 15.6% died and 6.1% developed heart failure compared with 15.6%, 10.8% and 2.9% respectively of those without ECG-LVH (P = 0.0023; P < 0.0001 and P < 0.0001). In multivariate analysis ECG-LVH was an independent predictor of CV and all-cause death and of heart failure. CONCLUSIONS: In patients with CV disease simple, easily applicable ECG criteria for LVH identify a subset of individuals at particularly high risk for death and for heart failure.

Aged↗
PubMed2002

Effect of long-term therapy with ramipril in high-risk women.

OBJECTIVES: We evaluated the effects of long-term therapy with the angiotensin-converting enzyme (ACE) inhibitor ramipril on major cardiovascular (CV) outcomes in high-risk women. BACKGROUND: The effect of long-term ACE inhibitor therapy in high-risk women without heart failure and with preserved left ventricular (LV) systolic function has not been previously reported. METHODS: The Heart Outcomes Prevention Evaluation (HOPE) trial is a large, randomized clinical trial that evaluated ramipril and vitamin E in high-risk patients. We present the preplanned analysis of the effects of ramipril in women in the HOPE study. The study randomized 2,480 women aged >or=55 years with vascular disease or diabetes and at least one additional CV risk factor and without heart failure or a known low LV ejection fraction to ramipril (10 mg/day) or placebo. The primary outcome was the composite of myocardial infarction, stroke or CV death. Average follow-up was 4.5 years. RESULTS: Treatment with ramipril resulted in reduced primary end point rates (11.3% vs. 14.9% in the placebo arm; relative risk [RR] 0.77, 95% confidence interval [CI] 0.62 to 0.96; p = 0.019), fewer strokes (3.1% vs. 4.8%; RR 0.64, 95% CI 0.43 to 0.96; p = 0.029) and fewer CV deaths (4.2% vs. 6.9%; RR 0.62, 95% CI 0.44 to 0.88; p = 0.0068). There were trends toward reduced rates of myocardial infarction, heart failure and all-cause death. The beneficial effect of ramipril was similar in women and men. CONCLUSIONS: Treatment with ramipril reduces the CV risk in high-risk women without heart failure and with preserved LV systolic function.

Aged↗
PubMed2002

Use of ramipril in preventing stroke: double blind randomised trial.

OBJECTIVE: To determine the effect of the angiotensin converting enzyme inhibitor ramipril on the secondary prevention of stroke. DESIGN: Randomised controlled trial with 2x2 factorial design. SETTING: 267 hospitals in 19 countries. PARTICIPANTS: 9297 patients with vascular disease or diabetes plus an additional risk factor, followed for 4.5 years as part of the HOPE study. OUTCOME MEASURES: Stroke (confirmed by computed tomography or magnetic resonance imaging when available), transient ischaemic attack, and cognitive function. Blood pressure was recorded at entry to the study, after 2 years, and at the end of the study. RESULTS: Reduction in blood pressure was modest (3.8 mm Hg systolic and 2.8 mm Hg diastolic). The relative risk of any stroke was reduced by 32% (156 v 226) in the ramipril group compared with the placebo group, and the relative risk of fatal stroke was reduced by 61% (17 v 44). Benefits were consistent across baseline blood pressures, drugs used, and subgroups defined by the presence or absence of previous stroke, coronary artery disease, peripheral arterial disease, diabetes, or hypertension. Significantly fewer patients on ramipril had cognitive or functional impairment. CONCLUSION: Ramipril reduces the incidence of stroke in patients at high risk, despite a modest reduction in blood pressure.

Aged↗
PubMed2002

Effects of vitamin E on cardiovascular and microvascular outcomes in high-risk patients with diabetes: results of the HOPE study and MICRO-HOPE substudy.

OBJECTIVES: Experimental and observational studies suggest that vitamin E may reduce the risk of cardiovascular (CV) events and of microvascular complications in people with diabetes. However, data from randomized clinical trials are limited. Therefore, we evaluated the effects of vitamin E supplementation on major CV outcomes and on the development of nephropathy in people with diabetes. RESEARCH DESIGN AND METHODS: The Heart Outcomes Prevention Evaluation (HOPE) trial is a randomized clinical trial with a 2 x 2 factorial design, which evaluated the effects of vitamin E and of ramipril in patients at high risk for CV events. Patients were eligible for the study if they were 55 years or older and if they had CV disease or diabetes with at least one additional coronary risk factor. The study was designed to recruit a large number of people with diabetes, and the analyses of the effects of vitamin E in this group were preplanned. Patients were randomly allocated to daily treatment with 400 IU vitamin E and with 10 mg ramipril or their respective placebos and were followed for an average of 4.5 years. The primary study outcome was the composite of myocardial infarction, stroke, or CV death. Secondary outcomes included total mortality, hospitalizations for heart failure, hospitalizations for unstable angina, revascularizations, and overt nephropathy. RESULTS: There were 3,654 people with diabetes. Vitamin E had a neutral effect on the primary study outcome (relative risk = 1.03, 95% CI 0.88-1.21; P = 0.70), on each component of the composite primary outcome, and on all predefined secondary outcomes. CONCLUSIONS: The daily administration of 400 IU vitamin E for an average of 4.5 years to middle-aged and elderly people with diabetes and CV disease and/or additional coronary risk factor(s) has no effect on CV outcomes or nephropathy.

Aged↗