Abstract
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Newsworthy
Diet and exercise better than metformin in preventing metabolic syndrome
The metabolic syndrome is a high-risk state for diabetes and cardiovascular disease. Weight loss and exercise are usually recommended in people who are at risk, but the efficacy of these interventions in the prevention of the metabolic syndrome is not well known. In a a randomized, controlled clinical trial involving 3234 men and women with impaired glucose tolerance, 1523 men and women without the metabolic syndrome at baseline were studied separately. Interventions were either standard lifestyle recommendations plus metformin, 850 mg twice per day, standard lifestyle recommendations plus placebo, or an intensive programme of lifestyle intervention. The goals of the lifestyle programme were to achieve and maintain a weight reduction of at least 7% of body weight through a healthy low-calorie, low-fat diet and to engage in physical activity of moderate intensity, such as brisk walking, for at least 150 min per week. By 3 years, 53% of the participants in the placebo group (260 of 490) had acquired the metabolic syndrome compared with 47% (236 of 503) in the metformin group and 38% (201 of 530) in the lifestyle group. The cumulative incidence overall (per 100 person-years) was 61% for the placebo group, 50% for the metformin group, and 38% for the lifestyle group. In a proportional hazards analysis, lifestyle intervention yielded a reduction of 41% [95% confidence interval (CI) 28–52%] in incidence of the metabolic syndrome compared with placebo (P < 0.001) and a significant 29% (95% CI 13–42%) reduction compared with metformin (P < 0.001), which itself yielded a 17% (95% CI 0–31%) lower incidence than placebo (P = 0.03). Lifestyle change was also more efficient in reversing the metabolic syndrome. Among those who had the syndrome at baseline, 18% of the placebo group, 23% of the metformin group, and 38% of the lifestyle group no longer had the syndrome after 3 years. With increasing prevalence in the population of metabolic disturbances, this study highlights the value of lifestyle interventions in the prevention and treatment of the metabolic syndrome.
Orchard TJ, et al. The effect of metformin and intensive lifestyle intervention on the metabolic syndrome: the Diabetes Prevention Program randomized trial. Ann Intern Med 2005;
High prevalence of risk factors in the Norwegian population – European guidelines challenged
In a cross-sectional population study comprising 62 104 adult Norwegians aged 20–79 years who participated in The Nord-Trondelag Health Study in 1995 to 1997 total, age and sex-specific point prevalences of individuals with total cholesterol of 5 mmol/l or greater or systolic blood pressure of 140 mmHg or greater or diastolic blood pressure of 90 mmHg or greater, or taking antihypertensive medication were assessed. In total, 76% were found to have an ‘unfavourable’ cardiovascular disease risk profile, according to guideline definitions. The point prevalence of individuals with cholesterol or blood pressure above the recommended cut-off points increased with age, reaching 90% by age 49 years. Men below 50 years of age have a higher combined risk prevalence than women. The authors remark that the 2003 European guidelines on cardiovascular disease prevention would label a large majority of Norwegian adults as having unfavourably high cholesterol or blood pressure levels, and that the current biomedical standards appear to invalidate demographic health statistics, in ‘one of the world's longest-living and healthiest-living populations’. They argue that the ‘Implementation of the European guidelines on cardiovascular disease prevention in clinical practice will label three out of four Norwegian adults aged 20 years and older as in need of medical counselling and follow-up due to unfavourably high levels of cholesterol and/or blood pressure’. First, the authors do not seem to have read the priority list in the guidelines, which do not specify that all men and women above these cut-points be identified or seen by a doctor. Second, this type of reasoning implies that cardiovascular disease is a natural phenomenon, not amenable to intervention. Third, it is precisely because levels of risk factors are so high that half the population die from cardiovascular disease, and not all of them at a ripe old age either….
Getz L, et al. Ethical dilemmas arising from implementation of the European guidelines on cardiovascular disease prevention in clinical practice. A descriptive epidemiological study. Scand J Prim Health Care 2004;
Non-pharmacological treatment of hypertension among the elderly
Lifestyle recommendations in hypertension include increased physical activity, but it is uncertain whether current exercise guidelines for reducing blood pressure are applicable to older persons. In a 6-month randomized controlled trial of combined aerobic and resistance training compared with usual care physical activity and diet advice 51 exercisers and 53 controls were evaluated. Exercisers significantly improved aerobic and strength fitness, increased lean mass, and reduced general and abdominal obesity. Mean decreases in systolic blood pressure (SBP) and diastolic blood pressure (DBP), respectively, were 5.3 and 3.7 mmHg among exercisers and 4.5 and 1.5 mmHg among controls (P < 0.001). There were no significant group differences in mean SBP change from baseline (−0.8 mmHg; P = 0.67). The mean DBP reduction was greater among exercisers (−2.2 mmHg; P = 0.02). Aortic stiffness, indexed by aortofemoral pulsewave velocity, was unchanged in both groups. Body composition improvements explained 8% of the SBP reduction (P = 0.006) and 17% of the DBP reduction (P < 0.001). The lack of improvement in aortic stiffness in exercisers suggests that older persons may be resistant to exercise-induced reductions in SBP. Body composition improvements were associated with blood pressure reductions and may be a pathway by which exercise training improves cardiovascular health in older men and women.
Stewart KJ, et al. Effect of exercise on blood pressure in older persons. A randomized controlled trial. Arch Intern Med 2005;
The effect of cardiac resynchronization on morbidity and mortality in heart failure
Cardiac resynchronization reduces symptoms and improves left ventricular function in many patients with heart failure due to left ventricular systolic dysfunction and cardiac dyssynchrony. The effects on morbidity and mortality have been evaluated in this study.
Patients with New York Heart Association class III or IV heart failure as a result of left ventricular systolic dysfunction and cardiac dyssynchrony who were receiving standard pharmacological therapy were randomly assigned to receive medical therapy alone or with cardiac resynchronization. The primary endpoint was the time to death from any cause or an unplanned hospitalization for a major cardiovascular event. The principal secondary endpoint was death from any cause.
A total of 813 patients were enrolled and followed for a mean of 29.4 months. The primary endpoint was reached by 159 patients in the cardiac resynchronization group, compared with 224 patients in the medical therapy group [39 vs. 55%; hazard ratio (HR) 0.63; 95% confidence interval (CI) 0.51–0.77; P < 0.001]. There were 82 deaths in the cardiac resynchronization group, compared with 120 in the medical therapy group (20 vs. 30%; HR 0.64; 95% CI 0.48–0.85; P < 0.002). Compared with medical therapy, cardiac resynchronization reduced the interventricular mechanical delay, the end-systolic volume index, and the area of the mitral regurgitant jet; increased the left ventricular ejection fraction; and improved symptoms and quality of life (P < 0.01 for all comparisons).
Therefore, in patients with heart failure and cardiac dyssynchrony, cardiac resynchronization improves symptoms and quality of life and reduces complications and the risk of death. These benefits are in addition to those afforded by standard pharmacological therapy. The implantation of a cardiac resynchronization device should routinely be considered in such patients.
Cleland JGF, et al. The effect of cardiac resynchronization on morbidity and mortality in heart failure. N Engl J Med 2005;
Standard antibiotics do not work for the secondary prevention of cardiovascular heart disease
Epidemiological, laboratory, animal, and clinical studies suggest that there is an association between Chlamydia pneumoniae infection and atherogenesis. The efficacy of one year of azithromycin treatment has been evaluated for the secondary prevention of coronary events.
In this randomized, prospective trial, 4012 patients with documented stable coronary artery disease were assigned to receive either 600 mg azithromycin or placebo weekly for one year. The participants were followed for a mean of 3.9 years at 28 clinical centers throughout the United States.
The primary endpoint, a composite of death as a result of coronary heart disease, non-fatal myocardial infarction, coronary revascularization, or hospitalization for unstable angina, occurred in 446 of the participants who had been randomly assigned to receive azithromycin and 449 of those who had been randomly assigned to receive placebo.
There was no significant risk reduction in the azithromycin group compared with the placebo group with regard to the primary endpoint (risk reduction 1%; 95% confidence interval −13–13%). There were also no significant risk reductions with regard to any of the components of the primary endpoint, death from any cause, or stroke. The results did not differ when the participants were stratified according to sex, age, smoking status, the presence or absence of diabetes mellitus, or C. pneumoniae serological status at baseline.
In conclusion, a 1-year course of weekly azithromycin did not alter the risk of cardiac events among patients with stable coronary artery disease.
Grayston JT, et al. Azithromycin for the secondary prevention of coronary events. N Engl J Med 2005;
Chlamydia pneumoniae has been found within atherosclerotic plaques, and elevated titres of antibody to this organism have been linked to a higher risk of coronary events. Pilot studies have suggested that antibiotic treatment may reduce the risk of cardiovascular events.
The authors enrolled 4162 patients who had been hospitalized for an acute coronary syndrome within the preceding 10 days, and evaluated the efficacy of long-term treatment with gatifloxacin, a bactericidal antibiotic known to be effective against C. pneumoniae, in a double-blind, randomized, placebo-controlled trial. Subjects received 400 mg of gatifloxacin daily during an initial 2-week course of therapy that began 2 weeks after randomization, followed by a 10-day course every month for the duration of the trial (mean duration 2 years) or placebo. The primary endpoint was a composite of death from all causes, myocardial infarction, documented unstable angina requiring rehospitalization, revascularization (performed at least 30 days after randomization) and stroke.
A Kaplan–Meier analysis revealed that the rates of primary endpoint events at 2 years were 23.7% in the gatifloxacin group and 25.1% in the placebo group (hazard ratio 0.95; 95% confidence interval 0.84–1.08; P = 0.41). No benefit was seen in any of the prespecified secondary endpoints or in any of the prespecified subgroups, including patients with elevated titres to C. pneumoniae or C-reactive protein.
Therefore, despite long-term treatment with a bactericidal antibiotic effective against C. pneumoniae, no reduction in the rate of cardiovascular events was observed.
Cannon CP, et al. Antibiotic treatment of chlamydia pneumoniae after acute coronary syndrome. N Engl J Med 2005;