What question did this study set out to answer?

To determine whether early initiation of low-dose pravastatin therapy reduces the risk of recurrent major adverse cardiac events in patients after acute myocardial infarction.

December 25, 2007Circulation JournalOpen Access

Effect of Early Use of Low-Dose Pravastatin on Major Adverse Cardiac Events in Patients With Acute Myocardial Infarction

Q: What is the clinical evidence from this study?

Study design: RCT. Population: Acute Myocardial Infarction (n=353). Intervention: Pravastatin vs. Standard AMI therapy without pravastatin. Primary outcome: Composite of death, nonfatal myocardial infarction, unstable angina, stroke, revascularization, and rehospitalization because of other cardiovascular disease (RR 0.56, 95% CI 0.36-0.87, p=0.006).

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Key result

Early treatment with low-dose pravastatin (10 mg/daily) reduced the risk of recurrent major adverse cardiac events by 44% compared to standard therapy in patients with acute myocardial infarction.

Why the study?

Does early use of low-dose pravastatin reduce major adverse cardiac events in patients with acute myocardial infarction?

Population

n=353 patients with acute myocardial infarction presenting within 1 week after onset, mean age ~63, ~77%…

Comparison

Pravastatin 10 mg/daily initiated in the week… vs Standard AMI therapy without pravastatin, plus…

Design

RCT, randomly assigned, open-labeled, blinded-endpoint evaluation

Follow-up

9 months

Authors

HSHiroshi SatoGeneral / Preventive / Lipids KKKunihiro KinjoThe University of Osaka HIHiroshi ItoKanazawa University

Discussion

Member takes

Implication

Supports early low-dose pravastatin post-AMI; extends statin evidence to lower doses in acute settings.

Key Points

To determine whether early initiation of low-dose pravastatin therapy reduces the risk of recurrent major adverse cardiac events in patients after acute myocardial infarction.
Conducted a randomized trial in 353 patients with acute myocardial infarction who had plasma total cholesterol levels of 200–250 mg/dL and triglyceride levels <300 mg/dL.
Patients were randomly assigned to receive pravastatin (10 mg/daily, n=176) or no pravastatin (n=177) with a follow-up period of 9 months.
Monitored a composite primary endpoint comprising death, nonfatal myocardial infarction, unstable angina, stroke, revascularization, and cardiovascular rehospitalization.
The primary endpoint occurred in 17.9% of patients (31/176) in the pravastatin group versus 31.4% (55/177) in the non-pravastatin group (relative risk, 0.56; 95% confidence interval, 0.36–0.87).
No significant differences occurred between groups for death, nonfatal myocardial infarction, unstable angina, or stroke, but the pravastatin group experienced a lower risk of needing revascularization.

Study Design

Type

RCT (n=353)

Blinding

Open-label, blinded-endpoint

Randomization

Randomized

Multicenter

Yes

Structured PICO

Does early use of low-dose pravastatin reduce major adverse cardiac events in patients with acute myocardial infarction?

Population

n=353 patients with acute myocardial infarction (AMI) presenting within 1 week after onset, mean age ~63, ~77% male, in Japan. Key inclusion: plasma total cholesterol 200-250 mg/dl and triglycerides <300 mg/dl. Key exclusion: concurrent statin therapy, life-threatening arrhythmia, severe CHF (NYHA III-IV), hepatic dysfunction, renal failure, cerebrovascular disease, poorly controlled diabetes.

Intervention

Pravastatin 10 mg/daily initiated in the week after onset of AMI, plus dietary counseling.

Comparator

Standard AMI therapy without pravastatin (physicians allowed to use non-statin lipid-lowering drugs), plus dietary counseling.

Outcome

Composite of death, nonfatal myocardial infarction (MI), unstable angina (UA), stroke, revascularization, and rehospitalization because of other cardiovascular disease at 9 months follow-up, evaluated by blinded Endpoint Classification Committee.composite

Main Result

Effect estimate: RR 0.56 (95% CI 0.36-0.87)

Absolute Event Rate: 17.9% vs 31.4%

p-value: p=0.006

Early initiation of low-dose pravastatin (10 mg/day) in Japanese patients with acute myocardial infarction significantly reduced the 9-month risk of major adverse cardiac events, driven primarily by a reduction in the need for revascularization.

Limitations

Open-label design may introduce bias, especially since the majority of events were revascularizations, which are partially based on subjective factors.
Relatively small sample size.
Open-label design may have introduced bias in the decision to perform coronary interventions (revascularization)

Cite This Study

Sato et al. (2007) conducted an RCT in Acute Myocardial Infarction (n=353). Pravastatin vs. Standard AMI therapy without pravastatin was evaluated on Composite of death, nonfatal myocardial infarction, unstable angina, stroke, revascularization, and rehospitalization because of other cardiovascular disease (RR 0.56, 95% CI 0.36-0.87, p=0.006). Early treatment with low-dose pravastatin (10 mg/daily) reduced the risk of recurrent major adverse cardiac events by 44% compared to standard therapy in patients with acute myocardial infarction.

synapsesocial.com/papers/6a0ec54653f874f2b222bfba https://doi.org/10.1253/circj.72.17

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