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PROVE IT-TIMI 22
Pravastatin or atorvastatin Evaluation and Infection Therapy Thrombolysis In Myocardial Infarction 22
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Author(s) |
(a) Cannon CP, McCabe CH, Belder R, Breen J, Braunwald E
(b) Cannon CP, Braunwald E, McCabe CH, Rader DJ, Rouleau JL, Belder R, Joyal SV, Hill KA, Pfeffer MA, Skene AM
(c) Cannon CP, Braunwald E, McCabe CH, Grayston JT, Muhlestein B, Giugliano RP, Cairns R, Skene AM |
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Title(s) |
(a) Design of the Pravastatin or Atorvastatin Evaluation and Infection Therapy (PROVE IT)–TIMI 22 trial
(b) Intensive versus moderate lipid lowering with statins after acute coronary syndromes
(c) Antibiotic treatment of Chlamydia pneumoniae after acute coronary syndrome |
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Reference(s) |
(a) Am J Cardiol 2002;89:860–1
(b) N Engl J Med 2004;350:1495–504
(c) N Engl J Med 2005;352:1646–54 |
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Disease |
Acute coronary syndromes |
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Purpose |
To compare the effects of standard vs intensive statin therapy on the incidence of cardiovascular events in patients with an acute coronary syndrome. Secondary, to evaluate the effectiveness of gatifloxacin in reducing the incidence of cardiovascular events in these patients |
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Study design |
Randomised, double-blind, placebo-controlled, parallel-group, 2 x 2 factorial |
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Follow-up |
Mean 2 years |
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Patients |
4162 patients (statin arm: 2063 pravastatin, 2099 atorvastatin; antibiotic arm: 2076 gatifloxacin, 2086 placebo), mean age 58 years, hospitalised for AMI or high-risk unstable angina pectoris within the previous 10 days, with total cholesterol ≤ 240 mg/dl (6.21 mmo/l) |
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Treatment regimen |
Pravastatin, 40 mg/day, or atorvastatin, 80 mg/day, plus gatifloxacin, 400 mg/day, for 2 weeks initially, then for a 10-day course every month, or placebo. The dose of pravastatin could be increased to 80 mg/day if LDL cholesterol > 125 mg/dl on 2 consecutive visits |
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Results |
The composite primary endpoint of all-cause mortality, MI, documented unstable angina requiring rehospitalisation, revascularisation (CABG or PCI), and stroke was reached by 26.3% of patients in the pravastatin group and 22.4% of those in the atorvastatin group (p = 0.005). In the antibiotic component of the trial, there was no significant difference between the gatifloxacin and placebo groups in the incidence of the primary endpoint (23.7% vs 25.1%; p = 0.41) |
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Comments |
This study has been the basis for a number of publications. A selection of references:
C-reactive protein levels
– Ridker PM et al, N Engl J Med 2005;352:20–8
Hospitalisation for heart failure
– Scirica BM et al, J Am Coll Cardiol 2006;47:2326–31
Intracellular adhesion molecule-1
– Ray KK et al, Am J Cardiol 2006;98:861–5
Recurrent cardiovascular events
– Murphy SA et al, J Am Coll Cardiol 2009;54:2358–62
Seasonal variation in cholesterol levels
– Tung P et al, Am J Cardiol 2009;103:1056–60
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