New findings from ground-breaking PROVE IT-TIMI 22 clinical trial

Main Category: Cardiovascular / Cardiology
Article Date: 31 Aug 2004 - 0:00 PST

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Results from landmark PROVE IT-TIMI 22 trial suggest clinicians should use proven therapies, such as high-dose statin therapy, to reduce cardiovascular disease risk factors.

Previous studies have found Chlamydia pneumoniae, a common bacterium that causes respiratory illness, may also be a risk factor for atherosclerosis and other cardiovascular diseases. Researchers and clinicians had hoped that treating C. pneumoniae with antibiotics would kill the bacterium and therefore reduce the risk of cardiac events.

However, in the landmark PROVE IT-TIMI 22 clinical trial, researches from Brigham and Women's Hospital (BWH) and colleagues found that even a long-term regimen of antibiotics designed to kill C. pneumoniae does not reduce heart attacks or cardiovascular disease risk. Clinicians instead should continue to focus on other methods to reduce risk factors such as high-dose statins and ACE inhibitors.

Commenting from the European Society of Cardiology meeting, lead investigator of the PROVE IT - TIMI 22 trial (Pravastatin or Atorvastatin Evaluation and Infection Therapy), Christopher P. Cannon, MD of the TIMI Study Group in the Cardiovascular Division of BWH and associate professor of Medicine at Harvard Medical School (HMS) said, "This portion of the PROVE IT-TIMI 22 trial looked at the impact of full-dose, long-term use of antibiotics but found they did not prevent heart attacks. Clinicians need to use proven therapies to treat heart disease risk, including high-dose statins, found to be effective in the statin component of the PROVE IT trial."

PROVE IT enrolled 4,162 patients hospitalized within 10 days for an acute coronary syndrome. Approximately half the patient population was administered the antibiotic Gatifloxacin and the other half was administered a placebo, each for a 10-day course per month over a period of two years. Researchers found that those who participated in the antibiotic therapy had the same risk of a cardiac event as their placebo therapy counterparts.

"While there have been great strides in addressing cardiovascular diseases, a regimen of antibiotics does not appear to be effective in reducing coronary risk," said Eugene Braunwald, MD, chairman of the TIMI Study Group at BWH and HMS professor.

In addition to the antibiotic portion of the trial, PROVE IT-TIMI 22 is the first major comparison of clinical outcomes of two statin drugs. Earlier this year, researchers announced they had found a greater reduction in death or major cardiac events with more intensive lowering of cholesterol and, for patients who have recently suffered an acute coronary syndrome (ACS), they had greater protection from death and other cardiac events after treatment with a high-dose statin therapy, as compared to a standard-dose. Bristol-Myers Squibb and Sankyo funded this study.

BWH is a 735-bed nonprofit teaching affiliate of Harvard Medical School and a founding member of Partners HealthCare System, an integrated health care delivery network. Internationally recognized as a leading academic health care institution, BWH is committed to excellence in patient care, medical research, and the training and education of health care professionals. The hospital's preeminence in all aspects of clinical care is coupled with its strength in medical research. A leading recipient of research grants from the National Institutes of Health, BWH conducts internationally acclaimed clinical, basic and epidemiological studies.

CP Cannon (Boston, US)

This press release accompanies both a presentation and an ESC press conference given at the ESC Congress 2004. Written by the investigator himself/herself, this press release does not necessarily reflect the opinion of the European Society of Cardiology.

Contact: Camilla Dormer
cdormer@escardio.org
49-151-1172-5814
European Society of Cardiology

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