PROVE IT-TIMI 22 Trial

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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]

Click here to download slides for PROVE IT-TIMI 22 Trial.

Objective

To determine whether intensive LDL-C lowering with atorvastatin 80 mg/day was more efficacious than standard LDL-C lowering with pravastatin 40 mg/day in reducing the incidence of cardiovascular events in patients hospitalized with acute coronary syndrome (ACS) within the preceding 10 days.

Methods

Pravastatin or Atorvastatin Evaluation and Infection Therapy-Thrombolysis in Myocardial Infarction 22 (PROVE IT-TIMI 22) trial was a randomized comparative study where in 4162 patients who had been hospitalized for an acute coronary syndrome within the preceding 10 days were enrolled and randomly assigned to treatment with either 40 mg a day pravastatin or 80 mg a day atorvastatin. The primary end point was a composite of death from any cause, myocardial infarction, documented unstable angina requiring re-hospitalization, revascularization (performed at least 30 days after randomization), and stroke.

Results

  • High-dose atorvastatin group achieved a mean LDL-C level of 62 mg per deciliter compared to 95 mg per deciliter in the standard-dose pravastatin group.
  • The composite end point at 30 days occurred in 3.0% of patients receiving atorvastatin 80 mg versus 4.2% of patients receiving pravastatin 40 mg.

Conclusion

Among patients who have recently had an acute coronary syndrome, an intensive lipid-lowering statin regimen provides greater protection against death or major cardiovascular events than does a standard regimen. These findings indicate that such patients benefit from early and continued lowering of LDL-C to levels substantially below current target levels.[1][2][3][4][5]

References

  1. Cannon CP, Braunwald E, McCabe CH; et al. (2004). "Intensive versus moderate lipid lowering with statins after acute coronary syndromes". The New England Journal of Medicine. 350 (15): 1495–504. doi:10.1056/NEJMoa040583. PMID 15007110. Unknown parameter |month= ignored (help)
  2. Rouleau J (2005). "Improved outcome after acute coronary syndromes with an intensive versus standard lipid-lowering regimen: results from the Pravastatin or Atorvastatin Evaluation and Infection Therapy-Thrombolysis in Myocardial Infarction 22 (PROVE IT-TIMI 22) trial". The American Journal of Medicine. 118 Suppl 12A: 28–35. doi:10.1016/j.amjmed.2005.09.014. PMID 16356805. Unknown parameter |month= ignored (help)
  3. Murphy SA, Cannon CP, Wiviott SD; et al. (2007). "Effect of intensive lipid-lowering therapy on mortality after acute coronary syndrome (a patient-level analysis of the Aggrastat to Zocor and Pravastatin or Atorvastatin Evaluation and Infection Therapy-Thrombolysis in Myocardial Infarction 22 trials)". The American Journal of Cardiology. 100 (7): 1047–51. doi:10.1016/j.amjcard.2007.04.053. PMID 17884359. Unknown parameter |month= ignored (help)
  4. Ray KK, Cannon CP, McCabe CH; et al. (2005). "Early and late benefits of high-dose atorvastatin in patients with acute coronary syndromes: results from the PROVE IT-TIMI 22 trial". Journal of the American College of Cardiology. 46 (8): 1405–10. doi:10.1016/j.jacc.2005.03.077. PMID 16226162. Unknown parameter |month= ignored (help)
  5. Giraldez RR, Giugliano RP, Mohanavelu S; et al. (2008). "Baseline low-density lipoprotein cholesterol is an important predictor of the benefit of intensive lipid-lowering therapy: a PROVE IT-TIMI 22 (Pravastatin or Atorvastatin Evaluation and Infection Therapy-Thrombolysis In Myocardial Infarction 22) analysis". Journal of the American College of Cardiology. 52 (11): 914–20. doi:10.1016/j.jacc.2008.05.046. PMID 18772061. Unknown parameter |month= ignored (help)