 |
|
|
| |
Barcelona Italian Heart Disease Study Withdrawn
|
| |
| |
link to NATAP report from Barcelona:
www.natap.org/2002/barcelona/day27.htm
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increases in the rate of coronary events has been withdrawn, according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
Abstract:
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.
|
|
| |
|
|
|
|
|
