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  AIDS 2002 Barcelona
Barcelona, Spain July 7-12 2002
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Barcelona Italian Heart Disease Study Withdrawn
  link to NATAP report from Barcelona:
The Italian randomized controlled trial that showed marked increases in the rate of coronary events has been withdrawn, according to the official Barcelona conference web site www.aids2002.com
News & Abstracts: Abstract
The Conference Scientific Committee advise all scientific community and conference delegates NOT to consider this data, due to the lack of guarantee to confirm the originality of the data presented. Code : WeOrB1307
Title: Incidence of coronary artery disease in HIV-infected patients receiving or not protease inhibitors: a randomized, multicenter study
Authors: G Barbaro1, G Di Lorenzo1, G Giancaspro1, A M Pellicelli2, B Grisorio3, G Barbarini4 1Dept.Emergency Medicine,University La Sapienza, Roma, Ital
Background: The introduction of highly antiretroviral therapy(HAART)has risulted in a decrease of opportunistic infections in HIV disease and longer surviaval rate.However, although limited to case reports,early data raised concerns about HAART regimens including protease inhibitors(PIs)being associated with increased incidence of coronary artery diseae(CAD).
Methods: We performed a 3 years prospective,randomized study assessing the incidence of CAD in 1551 previously untreated HIV-infected subjects who were assigned to receive HAART either with PIs(Group PIs+;n=776)or without PIs(Group PIs-;n=775) The cumulative incidence of CAD,in terms of recently developed angina or unstable angina,fatal and nonfatal myocardial infarction was the endpoint of the study.
RESULTS: Twenty-one percent of patients of Group PIs+ showed lipodistrophy ( with metabolic alterations in 76 percent of cases)compared to 3 percent of Group PIs- without associated metabolic alterations.The cumulative annual incidence of CAD was 9.8/1000 in Group PIs+ and 0.8/1000 in Group PIs-(P<0.001). The cumulative annual incidence of myocardial infarction was 5.1/1000 in Group PIs+ and 0.4/1000 in Group PIs-(P<0.001). Stepwise logistic regression analysis showed that the incidence of CAD was mainly related to dyslipidemia (OR:14.2; 95 percent CI:3.06-26.7),to lipodystrophy(OR:26.9; 95 percent CI:8.3-43.5) and to smoking(OR:9.7; 95 percent CI:3.5-16.7),independently of age,gender and CD4 count of the patients. CONCLUSIONS: PIs+ including HAART should be prescribed after a careful cardiologic screening of the patients,since the atherogenetic effects of PIs may sinergistically promote the acceleration of CAD and increase morbility and mortality for myocardial infarction.