December 18, 2001
As noted by Dr. William Powderly at the outset of this session, an area of immense concern related to drug toxicity is the potential for increased cardiovascular risk. Thus far, cohort data are conflicting in this regard, but this may well be due to short-term follow-up and insufficient numbers of patients.
In order to overcome these problems, Dr. Weber presented information about an ambitious project culling data from eleven cohorts throughout Europe, North America, and Australia. Called "DAD" for "Data collection on adverse events of anti-HIV drugs" the study has collected baseline information on 20,421 patients. The baseline characteristics of this group are as follows: average age 39 years old, 25 percent women, 25 percent diagnosis of AIDS, with mean CD4 cell count 420. At baseline, 12 percent of the group had a family history of coronary disease, and slightly more than 50 percent smoked cigarettes.
Treatment was distributed approximately as follows:
When evaluating lipid profiles for these patients, the investigators found that NNRTI-based regimens conferred a higher risk of increased cholesterol than NRTI-only regimens, but that both of these were lower than protease-inhibitor-based treatment and 3-class treatment. In a multivariate analysis of associated factors for elevated cholesterol, the following risks emerged: increased age, NNRTI therapy, protease inhibitor therapy, 3-class therapy, and somewhat surprisingly, a higher CD4 cell count and lower viral load.
While many of the observations presented today from this multicenter cohort have been observed before -- for example that protease inhibitor therapy is associated with higher cholesterol levels -- the strength of this study is in its numbers, which should help provide incidence data more rapidly. In fact, Dr. Weber concluded his presentation by stating that they would be able to present incidence data as early as the 2002 Retrovirus conference which will take place in February.
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