Reuters Health Medical News (02.02.12) - Thursday, February
Current or recent use (within a year) of HIV protease
inhibitors was not associated with a composite endpoint of
sudden death or first non-hemorrhagic stroke, a new study
suggests. However, a secondary analysis found such an
association with increasing years of PI treatment.
The analysis is based on the Data Collection on Adverse Events
of Anti-HIV Drugs (D:A:D) registry, a prospective multi-cohort
study involving people with HIV under active follow-up in
Europe, the United States, and Australia.
Case reports and Food and Drug Administration warnings over
the last few years suggest that some PIs may affect the
electrical activity of the heart, putting patients at risk of
life-threatening arrhythmias. But according to the new study,
it would be premature to recommend routine electrocardiograms
(EKGs) for PI users, according to study author Dr. S.W. Worm,
of the University of Copenhagen, and colleagues.
Of the 49,737 HIV patients followed for 234,818 person-years
in the study, 31,876 had used PIs for a median of 1.5 years.
Researchers did not study EKGs, but found 78 sudden deaths and
172 first non-hemorrhagic strokes. Rates of composite endpoint
were 1.3 per 1,000 person-years among those with current and
recent PI exposure, compared with 0.9 per 1,000 person-years
for those with no recent exposure.
Unadjusted risk for death or non-hemorrhagic stroke among
current or recent PI users was 42 percent greater than in non-
users. The risk was no longer significant after adjusting for
confounders such as cardiovascular disease risk factors (rate
ratio 1.2, p=0.12).
However, cumulative PI use was associated with a significant
risk of an event - 6 percent extra risk per year of exposure.
This finding is "more consistent with our previously reported
results indicating that [PI] exposure may lead to the
development of ischemic coronary disease which, in turn, may
result in sudden death." Larger studies are required before
routine EKGs are recommended for patients taking PIs, they
The full study, "Evaluation of HIV Protease Inhibitor Use and
the Risk of Sudden Death or Nonhemorrhagic Stroke," was
published in Journal of Infectious Diseases (2012;205(4):535-