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Session 100
Poster Abstracts Dyslipidemias and Body Fat Abnormalities: Incidence, Risk Factors, Response to Therapy Monday, 1:30 - 3:30 pm Poster Hall |
Background: Limited comparative data are available on the lipid profiles of patients receiving ritonavir-boosted protease inhibitors.
Methods: In this planned ITT analysis of lipid changes from the MaxCmin 2 trial, fasting triglycerides (TG), total cholesterol (TC), and LDL cholesterol (LDL) were measured at baseline and at weeks 4 and 48. Use of lipid lowering agents was recorded. Median values and changes were calculated.
Results: A total of 324 patients initiated the assigned treatment, 163 randomized to LPV/r and 161 to SQV/r. Median values increased for all lipids in both arms over the first 4 weeks and persisted through 48 weeks; all median values remained in the normal ranges (TC <6.2 mmol/L, TG <2.3 mmol/L, LDL <3.2 mmol/L). There was no difference in TC but a statistically significant difference in median TG at week 4 and 48; 2.3 and 2.2 mmol/L for LPV/r, and 1.8 and 1.7 mmol/L for SQV/r, p = 0.002, p = 0.0015, respectively. The median percentage increase (IQR) in TC from baseline to week 48 was 6.7% (-4.5, +35%) for LPV/r, and 13.6%(-6.5, +33%) for SQV/r, p = 0.52, LPV/r vs SQV/r. Median percentage increases (IQR) in TG were 28.6% (-13.4, +90.5%) for LPV/r, and -5.9% (-31.9, +55.6%) for SQV/r, p <0.001. As LDL cannot be calculated for many patients. if TG >4.5 mmol/L, it is not possible to compare median values for changes in LDL given many missing data points, which were more frequent in the LPV/r group given the greater increases in TG. The values were calculated for patients. in whom both the TG and LDL values are available but may underestimate the changes in each arm and not accurately reflect the difference between arms. The median LDL at week 4 and week 48, were 2.7 and 2.8 mmol/L for LPV/r, and 3.1 and 3.1 mmol/L for SQV/r, p = 0.02, p = 0.07, respectively. The median percentage increase (IQR) from baseline to week 48 was 0% (IQR -17, +28.9%) for LPV/r, and 14.4% (-8.7,+46.7%,) for SQV/r, p = 0.07. Lipid lowering agents were used in 5 patients at baseline and initiated in 5 patients in each arm over 48 weeks. The presence of clinical lipodystrophy at baseline increased the likelihood of abnormal TC and TG at baseline and follow-up by 8- to 12-fold, but adjustment for this factor did not alter the associations with treatment arm described above.
Conclusions: Patientss randomized to LPV/r had a 29% median increase in TG levels over the study, whereas median TG levels did not increase in the SQV/r arm. As high TG levels affect the determination of LDL cholesterol, the latter cannot be reliably compared between arms. TC increased slightly in both arms without evidence of differences between arms.
Keywords: dyslipidemia; triglycerides; protease inhibitors
