"Rosuvastatin in Older Patients with Systolic Heart Failure". The New England Journal of Medicine. 2007. 357(22):2248-2261. PubMed • Full text • PDF

Contents

1. Clinical Question
2. Bottom Line
3. Major Points
4. Guidelines
5. Design
6. Population
6.1 Inclusion Criteria
6.2 Exclusion Criteria
6.3 Baseline Characteristics
7. Interventions
8. Outcomes
8.1 Primary Outcome
8.2 Secondary Outcomes
9. Criticisms
10. Funding
11. Further Reading

Clinical Question

In older patients with systolic heart failure, does the addition of rosuvastatin to standard heart failure therapy affect cardiovascular outcomes?

Bottom Line

In older patients with systolic heart failure, rosuvastatin did not reduce the primary composite outcome of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke despite improving lipid profiles.

Major Points

This study assessed the impact of statin therapy on cardiovascular outcomes in a population with systolic heart failure, where acute coronary events are less common. The results indicated no reductions in primary composite outcome or total mortality but did show a reduction in cardiovascular hospitalizations.

Guidelines

As of the most recent guidelines, specific recommendations regarding statin therapy in systolic heart failure have not been universally established.

Design

- Multicenter, double-blind, randomized, placebo-controlled trial
- N=5,011 patients with systolic heart failure, at least 60 years old
- Rosuvastatin (10 mg daily) vs. placebo
- Median follow-up: 32.8 months

Population

Inclusion Criteria

- Age ≥60 years
- NYHA class II, III, or IV ischemic systolic heart failure
- Ejection fraction ≤40% (≤35% if NYHA class II)

Exclusion Criteria

- Previous statin-induced myopathy
- Decompensated heart failure
- Recent myocardial infarction, unstable angina, or stroke
- Recent or planned revascularization or device implantation
- Significant noncardiac comorbidity

Baseline Characteristics

- Well-matched between groups
- Mean age 73 years
- High rates of comorbid conditions such as hypertension and diabetes
- Majority on comprehensive heart failure medication regimens

Interventions

- Rosuvastatin 10 mg or matching placebo, once daily

Outcomes

Primary Outcome

- No significant reduction in the composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke with rosuvastatin

Secondary Outcomes

- No significant reduction in all-cause mortality
- Fewer hospitalizations for cardiovascular causes with rosuvastatin
- No impact on NYHA functional class or patient well-being
- Rosuvastatin demonstrated a favorable safety profile

Criticisms

- Patients were typically on extensive background heart failure therapies, which might have influenced the lack of observed benefit.
- The population may not represent all patients with systolic heart failure, such as those with nonischemic heart failure or those with a preserved ejection fraction.

Funding

- Supported by AstraZeneca.
- Multiple authors reported personal fees from AstraZeneca and other disclosures.

Further Reading

- Full article on The New England Journal of Medicine's website.