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Archive - 03 - 2008

Crestor Outcomes Study JUPITER Closes Early Due To Unequivocal Evidence Of Benefit

Posted by dlife on Mon, Mar 31, 08, 03:22 PM 0 Comment

March 31, 2008 (Press Release) - AstraZeneca today announced it has decided to stop the CRESTOR JUPITER clinical study early based on a recommendation from an Independent Data Monitoring Board and the JUPITER Steering Committee, which met on March 29, 2008. The study will be stopped early because there is unequivocal evidence of a reduction in cardiovascular morbidity and mortality amongst patients who received CRESTOR when compared to placebo.JUPITER (Justification for the Use of statins in Primary prevention: an Intervention Trial Evaluating Rosuvastatin) was designed to determine if treating patients with no evidence of pre-existing cardiovascular disease and low to normal LDL-C but elevated C-reactive protein (CRP) with CRESTOR 20mg once daily would reduce major cardiovascular events. CRP is a recognized marker of inflammation and is associated with an increased risk of atherosclerotic cardiovascular events.The JUPITER study team has initiated activities to close this large multi-centre study. Over 15,000 trial participants will be scheduled by their investigator for final assessments at over 1,200 sites in 26 countries. Data from these visits will be collected and reviewed to allow a full and complete analysis and final results of the study will be published once the analysis is complete.JUPITER is one study from the global research initiative known as the GALAXY programme, which has now recruited more than 64,000 patients from 55 countries worldwide, to investigate the impact of CRESTOR on cardiovascular risk reduction and patient outcomes.

Landmark ONTARGET(TM) Trial Demonstrates Micardis(R) is Equally Effective as Ramipril, with Fewer Discontinuations, in a Broad H

Posted by dlife on Mon, Mar 31, 08, 03:15 PM 0 Comment

March 31, 2008 (PRNewswire) -- The results of the landmark ONTARGET(TM) trial have demonstrated that MICARDIS(R) (telmisartan), a second-generation angiotensin II receptor blocker (ARB), is equally effective as the current standard, ramipril, in reducing the risk of cardiovascular death, myocardial infarction, stroke and hospitalization for congestive heart failure in a broad cross-section of high-risk cardiovascular patients with normal blood pressure or controlled high blood pressure, and resulted in fewer discontinuations.(1) These cardiovascular events occurred in 1,423 patients (16.7 percent) receiving telmisartan versus 1,412 patients (16.5 percent) receiving ramipril.(1) The relativerisk (ratio of the probability of the event occurring in the telmisartan group versus the ramipril group) was 1.01, with a 95 percent CI of 0.94 -1.09.Telmisartan is now the only ARB to have demonstrated cardio and vascular risk reduction benefits beyond lowering blood pressure in this high-risk population;(1) these benefits may be attributed to the specific pharmacological properties and mode of action of the drug. Previously, in 2000, the HOPE trial showed that the cardiovascular risk for patients treated with the angiotensin-converting enzyme (ACE) inhibitor ramipril was reduced by approximately 20 percent compared with placebo.(2) This meantthat every fifth serious cardiovascular event in a high risk group of patients was prevented.(2)"The ONTARGET trial shows that telmisartan is a well-tolerated treatment in high-risk cardiovascular patients that is as effective as ramipril in preventing heart attacks, stroke and hospitalizations for heartfailure and deaths," said Professor Salim Yusuf, lead investigator of the ONTARGET Trial Program and Director of the Population Health Research Institute at McMaster University, Hamilton, Canada. "The ONTARGET results have important implications for the management of patients with cardiovascular diseases."In this trial, which was based on the HOPE study design, the benefits of telmisartan were demonstrated in a large group (8,542) of high-risk patients who were already receiving standard care such as statins to lower cholesterol, antiplatelet therapy, beta blockers and other antihypertensives.(3) Telmisartan treatment led to fewer discontinuations than treatment with ramipril, a widely used ACE inhibitor.(1) Although patients with an ACE inhibitor intolerance had been excluded from the trial, 360 (4.2 percent) patients in the ramipril treatment arm stopped their treatment because they experienced cough, a common ACE inhibitor side effect, versus only 93 (1.1 percent) patients in the telmisartan arm. Twenty-five patients stopped their treatment in the ramipril arm because of angioedema, versus only 10 in the telmisartan arm.(1) The incidence of hypotension was higher in the telmisartan arm (229 patients, 2.7 percent) versus the ramipril (149 patients, 1.7 percent) arm.(1)"Boehringer Ingelheim is proud to have supported ONTARGET(TM), the largest cardiovascular outcomes trial of its kind and the first of a series of landmark clinical studies sponsored by our company. NTARGET is just one example of Boehringer Ingelheim's leadership in trying to address the needsof people with cardiovascular disease," commented J. Martin Carroll, president and chief executive officer of Boehringer Ingelheim Pharmaceuticals, Inc. "We are committed to pursuing further research thatevaluates ways to reduce the risk of damaging events in the heart, brain and other organs due to cardiovascular disease and to uncover new treatment strategies that may improve patient outcomes and care."ONTARGET also studied the value of combining telmisartan with ramipril, to evaluate whether combining an ACE inhibitor and an ARB, i.e. the dual renin-angiotensin system (RAS) blockade, could offer even etter risk reduction compared to single blockade, a key question for the clinical community. The results announced today indicate that there was no additional risk reduction benefit achieved and a higher discontinuation rate if telmisartan and ramipril are combined.(1)About the ONTARGET(TM) Trial ProgramThe ONTARGET Trial Program is the largest clinical trial ever undertaken with an ARB, involving more than 31,000 high-risk cardiovascular patients with either normal or controlled blood pressure. The ONTARGET Trial Program encompasses two randomized, double-blind, multi-center international outcome trials: ONTARGET, the main trial with results reported today, and TRANSCEND(TM) (Telmisartan Randomized Assessment Study in ACE-intolerant subjects with cardiovascular disease), the parallel trialwith results planned to be reported later in 2008.ONTARGET evaluated more than 25,600 high-risk cardiovascular patients with normal blood pressure or controlled high blood pressure and a history of a broad range of cardiovascular diseases. The study compared the effectiveness of the ARB telmisartan to the ACE inhibitor ramipril in reducing the combined risk of cardiovascular death, myocardial infarction, stroke and hospitalization for congestive heart failure (CHF) in patients at risk. The study also compared the efficacy of the combination of the ARBtelmisartan and the ACE inhibitor ramipril compared to ramipril alone in achieving the same combined endpoint.The combined primary endpoint in the ONTARGET trial included cardiovascular death, non-fatal myocardial infarction, non-fatal stroke and hospitalization for congestive heart failure. In addition, a broad variety of secondary and tertiary endpoints were studied, including: newly diagnosed diabetes, cognitive decline/dementia, nephropathy, atrial fibrillation and left ventricular hypertrophy.Treatment arms for the ONTARGET(TM) trial were telmisartan 80 mg, ramipril 10 mg and a combination therapy with telmisartan 80 mg and ramipril 10 mg. All treatments were applied in addition to standard care for high-risk cardiovascular patients.More than 700 sites throughout Asia, Australia, New Zealand, Europe, North/South America and South Africa participated in the ONTARGET Trial Program. The ONTARGET Steering Committee consists of scientists from McMaster University in Ontario, Canada; Oxford University in Oxford, England; the University of Auckland in Auckland, New Zealand; and Boehringer Ingelheim.The ONTARGET trial was investigational and was conducted to expand scientific knowledge of telmisartan. Note that the trial included treatment for conditions outside the approved indication for telmisartan.

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