The goal of the prove ittimi 22 trial was to evaluate the efficacy of standard lipid lowering with pravastatin compared with aggressive lipid lowering using atorvastatin in patients hospitalized for an acute coronary syndrome acs. Oct 18, 2005 the relative contributions of early or late effects to the overall clinical efficacy of intensive therapy are presently unclear. The role of intensive statin therapy specifically among patients who undergo pci for acs is unknown. Galectin3 and the development of heart failure after. Kaplanmeier estimates of the incidence of the primary end point of death from any cause or a major cardiovascular event. Losmapimod does not reduce cardiovascular events in. Prove ittimi 22 pravastatin or atorvastatin evaluation and infection therapythrombolysis in myocardial infarction 22 trial demonstrated a 22% reduction p 0. Inhospital initiation of statin therapy in acute coronary. Pleiotropic effects of statins and early benefit in the. In a nested casecontrol study among patients with acs in prove ittimi 22, we identified 100 cases with a hospitalization for new or worsening hf. Click here to download slides for prove ittimi 22 trial objective.
Prove ittimi 22 pravastatin or atorvastatin evalu ation and. The study design and the main results of the timi 11b, opustimi 16, and prove ittimi 22 trials have been previously reported. We performed this nested casecontrol study with prospectively collected samples and outcomes from the main biomarker substudy within the pravastatin or atorvastatin evaluation and infection therapythrombolysis in myocardial infarction 22 prove ittimi 22 trial. Mccabe, eugene braunwald, for the prove ittimi 22 investigators the relationship between.
Prove ittimi 22 trial overview1 a multicenter randomized treatmentcontrolled trial to determine. What is the optimal blood pressure in patients after acute. These findings indicate that such patients benefit from early and continued lowering of ldl cholesterol to levels substantially below current. Effect of intensive statin therapy on clinical outcomes. The prove it timi 22 study was a randomized controlled trial of intensive versus moderate cholesterol lowering with statins and infection therapy with gatifloxacin versus placebo in patients stabilized from an acs. Prove it demonstrated a significant benefit from intensive therapy 16% reduction. Trialthrombolysis in myocardial infarction 22 prove ittimi 22 study has been reported in detail previously 1,16. Background the prove it timi pravastatin or atorvastatin evaluation and infection therapythrombolysis in myocardial infarction 22 trial demonstrated that lowdensity lipoprotein cholesterol ldlc 70 mgdl was associated with greater chd event reduction than ldlc 100 mgdl after acs. Accordingly, the pravastatin or atorvastatin evaluation and infection therapythrombolysis in myocardial infarction 22 prove ittimi 22 trial was designed to compare the standard degree of. The pravastatin or atorvastatin evaluation and infection therapythrombolysis in myocardial infarction 22 prove ittimi 22 trial, published in 2004, randomized 4,162 patients with recent acs to highdose atorvastatin 80mg daily or moderatedose pravastatin 40mg daily. Albuminuria has been shown to be associated with mortality and cardiovascular events, independent of traditional cardiovascular risk factors. A total of 4,162 patients with acs were recruited in the prove it timi 22 trial.
It may be possible but seems unlikely that the moderate therapy, delayed for 4 months in a to z, would explain the lack of event divergence during that. A comparison of the postacute coronary syndrome lipidlowering trials a to z and prove ittimi 22. Intensive versus moderate lipid lowering with statins. Prove ittimi 22 substudy 65 pravastatin or atorvastatin evaluation and infection therapythrombolysis in myocardial infarction 22 diabetes substudy. A prove it timi 22 pravastatin or atorvastatin evaluation and infection therapythrombolysis in myocardial infarction 22 substudy. Infarction 22 prove ittimi 22 study randomized 4,162 patients, stabilized after acs, to either intensive statin therapy atorvastatin 80 mg or moderate statin therapy pravastatin 40 mg. Aug 01, 2005 read comparison of the effects of pravastatin and atorvastatin on fracture incidence in the prove ittimi 22 trialsecondary analysis of a randomized controlled trial, bone on deepdyve, the largest online rental service for scholarly research with thousands of academic publications available at your fingertips. Click here to download slides for prove it timi 22 trial objective.
Patients were enrolled within 10 days of presentation for acute myocardial infarction mi or nonstsegment elevation acs after. Prove it timi 22 compared the efficacy of atorvastatin vs. Prove it timi 22 trial overview1 a multicenter randomized treatmentcontrolled trial to determine lipid lowering effects of high dose atorvastatin vs. Intensive statin therapy most effective in elderly. Methodsoutcomes were compared in 2,868 patients who underwent pci for acs just prior to enrollment in the prove ittimi 22 pravastatin or atorvastatin evaluation and infection therapythrombolysis in myocardial infarction 22 trial, which. A total of 4162 patients were enrolled in the prove ittimi 22 trial at 349 sites in 8 countries in australia, europe, and north america between november 2000 and december 2001. In brief, the timi 11b trial enrolled 3910 patients from 1996 to 1998 to determine whether treatment with enoxaparin sodium was superior to treatment with. Read comparison of the effects of pravastatin and atorvastatin on fracture incidence in the prove ittimi 22 trialsecondary analysis of a randomized controlled trial, bone on deepdyve, the largest online rental service for scholarly research with thousands of academic publications available at your fingertips. Patients were randomized to intensive statin therapy atorvastatin, 80 mg or standard therapy pravastatin, 40 mg.
Intensive statin treatment produced a bigger benefit in elderly patients at high risk for coronary artery disease than in younger patients, based on an analysis from the prove ittimi 22 study. The design and results of prove ittimi 22 have been reported previously. The latitudetimi 60 trial attempts to identify if losmapimod can mitigate the maladaptive component of the inflammatory response in the setting of acute coronary. An overview of prove ittimi 22 a comparison of intensive. The effect of statin versus placebo or highintensity versus moderateintensity statin in the case of prove it timi 22 was assessed, and the number of events and event rates in the statin and placebo groups were analysed on the basis of the genetic risk score quintiles and aforementioned categories. Baseline lowdensity lipoprotein cholesterol is an important predictor of the benefit of intensive lipidlowering therapy. Accordingly, the pravastatin or atorvastatin evaluation and infection therapythrombolysis in myocardial infarction 22 prove ittimi 22 trial was. Infarction 22 prove ittimi 22 trial was designed to compare the standard degree of ldl cholesterol lowering to approximately 100 mg per deciliter with the use of 40 mg of pravastatin daily 2,3. Early and late benefits of highdose atorvastatin in patients with.
Early and late benefits of highdose atorvastatin in. Pleiotropic effects of statins and early benefit in the prove. To determine whether intensive ldlc lowering with atorvastatin 80 mgday was more efficacious than standard ldlc lowering with pravastatin 40 mgday in reducing the incidence of cardiovascular events in patients hospitalized with acute coronary syndrome. The effect of fasting status on lipids, lipoproteins, and. Request pdf on sep 1, 2006, andrea poli and others published pleiotropic effects of statins and early benefit in the prove it timi 22 study find, read and cite all the research you need on. Intensive lipid lowering with the 80mg dose of atorvastatin, as compared with moderate lipid lowering with the 40mg dose of pravastatin, reduced the hazard ratio for death or a major. We investigated the relationship between urinary albumin levels after an acute.
A total of 4,162 patients with acs were recruited in the prove ittimi 22 trial. Similarly, reducing serum lowdensity lipoprotein cholesterol to 1. Another secondary prevention trial, prove ittimi 22, investigated the clinical benefit of moderate statin therapy pravastatin 40 mg daily versus intensive statin therapy atorvastatin 80 mg daily in 4162 patients after an acute coronary syndrome who had total cholesterol level of. The publication of the prove ittimi 22 and reversal trials was associated with a sustained and statistically significant increase in the number of prescriptions dispensed for atorvastatin 80 mg range, 272 to 635 additional prescriptions per month, whereas the number of prescriptions filled for pravastatin 40 mg did not change. Early and late benefits of highdose atorvastatin in patients with acute coronary syndromes. Prove ittimi 22 6466 pravastatin or atorvastatin evaluation and infection therapythrombolysis in myocardial infarction 22 bristolmyers squibb. Lipoproteinassociated phospholipase a2 and its association. To determine whether intensive ldlc lowering with atorvastatin 80 mgday was more efficacious than standard ldlc lowering with pravastatin 40 mgday in reducing the incidence of cardiovascular events in patients hospitalized with acute coronary syndrome acs within the. Prove ittimi 22, provided they were stable for at least 24 h. Outcomes were compared in 2,868 patients who underwent pci for acs just prior to enrollment in the prove ittimi 22 pravastatin or atorvastatin evaluation and infection therapythrombolysis in myocardial infarction 22 trial, which randomized patients to either atorvastatin 80 mg or pravastatin 40 mg daily.
Prove ittimi 22 compared the efficacy of atorvastatin vs. This suggests that albuminuria may not just represent glomerular damage, but may be a marker of more diffuse endothelial dysfunction. Betablockade during and after myocardial infarction. By contrast, in prove it, there was a significant 22 % relative risk reduction from intensive therapy 80 mg atorvastatin based on the same a to z end point and a 26% reduction in deathmi.
Hospitalization for hf occurring more than 30 days after randomization was determined during a mean followup of 24 months. Mccabe, eugene braunwald, for the prove ittimi 22 investigators the relationship between intensive statin therapy and the. Pravastatin or atorvastatin evaluation and infection therapy. Aims the impact of intensive lipid lowering therapy with statins in acute coronary syndrome acs patients with diabetes mellitus dm is not well characterized methods and results we explored this question in data from the pravastatin or atorvastatin evaluation and infection therapy prove it timi 22 trial, which tested standard pravastatin 40 mg vs. Sep 29, 2006 giraldez rr, giugliano rp, mohanavelu s, murphy sa, mccabe ch, cannon cp, braunwald e. Serum galectin3 was measured at baseline within 7 days postacs. The pravastatin or atorvastatin evaluation and infection therapythrombolysis in myocardial infarction 22 prove ittimi 22 trial showed that.
At the same time, health funders are grappling with meeting the costs of everwidening indications for statin therapy. An overview of prove it timi 22 a comparison of intensive statin therapy and moderate statin therapy in acute coronary syndrome patients. Using noninferiority analysis at a mean followup of 2 years, the high. This was a prespecified subgroup analysis of data from prove ittimi 22, a 2. Direct comparison of the a to z and prove it trials circulation. Early and late benefits of highdose atorvastatin in patients. Myocardial infarction 22 trial presented by ridker et al. The prove ittimi 22 study was a randomized controlled trial of intensive versus moderate cholesterol lowering with statins and infection therapy with gatifloxacin versus placebo in patients stabilized from an acs. A number of explanations have been proposed to explain why the clinical benefit observed with intensive statin therapy in the miracl and prove ittimi 22 trials was not mirrored in the a to z trial.
Volume 46, issue 8, 18 october 2005, pages 14051410. Intensive versus moderate lipid lowering with statins after. The pravastatin or atorvastatin evaluation and infection therapy thrombolysis in myocardial infarction 22, also known as proveit timi 22, was a randomized, doubleblind, clinical trial that recruited 4,162 people admitted within 10 days of an acute coronary event and randomised them to the lipidlowering drugs pravastatin 40mg or atorvastatin 80mg and a 10 day course of. Intensive statin therapy and the risk of hospitalization for heart failure after an acute coronary syndrome in the prove ittimi 22 study benjamin m. Impact of the pravastatin or atorvastatin evaluation and. In a nested casecontrol study among patients with acs in prove it timi 22, we identified 100 cases with a hospitalization for new or worsening hf.
Two similar clinical trials in patients presenting with acute coronary syndromes acs, the aggrastat to zocor a to z 1 and pravastatin or atorvastatin evaluation and infection therapy prove ittimi 22 2 trials, each compared intensive versus moderate statin therapies for 2 years. Prove ittimi 22 trial overview1 a multicenter randomized treatmentcontrolled trial to determine lipid lowering effects of high dose atorvastatin vs. The design and results of the main trial have been described. Urinary albumin concentration and longterm cardiovascular. The pravastatin or atorvastatin evaluation and infection therapythrombolysis in myocardial infarction 22 prove ittimi 22 trial showed that the use of. Request pdf on sep 1, 2006, andrea poli and others published pleiotropic effects of statins and early benefit in the prove ittimi22 study find, read and cite all the research you need on. The pravastatin or atorvastatin evaluation and infection therapy thrombolysis in myocardial infarction 22, also known as prove it timi 22, was a randomized, doubleblind, clinical trial that recruited 4,162 people admitted within 10 days of an acute coronary event and randomised them to the lipidlowering drugs pravastatin 40mg or atorvastatin 80mg and a 10 day course of the antibiotic.
An overview of prove ittimi 22 a comparison of intensive statin therapy and moderate statin therapy in acute coronary syndrome patients. Sankyo prove ittimi 22 substudy 65 pravastatin or atorvastatin evaluation and infection therapythrombolysis in myocardial infarction 22 diabetes substudy bristolmyers squibb. Effect of intensive statin therapy on clinical outcomes among. Paul ridker and colleagues showed in the prove ittimi 22 trial that a posttreatment reduction in crp levels to below 2 mg per litre is associated with a. Pravastatin or atorvastatin evaluation and infection. Impact of triglyceride levels beyond lowdensity lipoprotein. This trial enrolled 4,162 patients hospitalized for acseither acute myocardial infarction with or without stsegment elevation or highrisk unstable anginain the preceding 10 days. Highdose atorvastatin in acute coronary and cerebrovascular. Prove it timi 22, 2004 trial summary pdf trial summary a randomised clinical trial investigating the effect of atorvastatin versus pravastatin in patients who had been hospitalized for an acute coronary syndrome within the preceding 10 days. Request pdf the effect of fasting status on lipids, lipoproteins, and inflammatory biomarkers assessed after hospitalization for an acute coronary syndrome. Publications home of jama and the specialty journals of.
Gibson cm1, pride yb, hochberg cp, sloan s, sabatine ms, cannon cp. The study population was derived from the pravastatin or atorvastatin evaluation and infection therapythrombolysis in myocardial infarction 22 prove ittimi 22 study, a randomized trial. Publications home of jama and the specialty journals of the. Jzzjzk 0521861241pre cb996velleman october 19, 2005 23. Galectin3 and the development of heart failure after acute. Background the prove ittimi pravastatin or atorvastatin evaluation and infection therapythrombolysis in myocardial infarction 22 trial demonstrated that lowdensity lipoprotein cholesterol ldlc 70 mgdl was associated with greater chd event reduction than ldlc 100 mgdl after acs. Intensive statin therapy and the risk of hospitalization.
The relative contributions of early or late effects to the overall clinical efficacy of intensive therapy are presently unclear. Patients stabilized post acs prove it timi 22 trial, stable patients who were free of clinical events at six months showed a similar benefit in favor of intensive statin therapy atorvastatin, 80 mg compared with standarddose statin therapy pravastatin, 40 mg for both the primary and the composite triple end points. Intensive statin therapy and the risk of hospitalization for. Creactive protein levels and outcomes after statin therapy. A total of 4162 patients were enrolled in the prove it timi 22 trial at 349 sites in 8 countries in australia, europe, and north america between november 2000 and december 2001. Which drugs should postmi patients routinely receive. Methods study population and design the design and results of prove ittimi 22 have been reported previously. The pravastatin or atorvastatin evaluation and infection therapythrombolysis in myocardial infarction 22 prove it timi 22 trial, published in 2004, randomized 4,162 patients with recent acs to highdose atorvastatin 80mg daily or moderatedose pravastatin 40mg daily. This relationship was not materially affected by their by ldl, hdl or nonhdl. Intensive versus moderate lipid lowering with statins after acute.
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