February 16, 2012
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 added.
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):535-539).
Reuters Health Medical News
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