Dale and colleagues compared lipodystrophy-related adverse events in the START I and II trials. The trials compared AZT + 3TC + indinavir (IDV), d4T + 3TC + IDV, and d4T + ddI + IDV regimens, analyzing all adverse events, including discontinuation due to changes in body mass index, weight, and non-fasting glucose and triglycerides.

The two d4T arms (n = 202) were combined and compared against the AZT arm (n = 205). Among patients in the d4T arm, 6% showed lipodystrophy related events, 3.5% had grade 3 or 4 elevations in non-fasting glucose levels, and 4% had grade 3 or 4 non-fasting hypertriglyceridemia. Patients receiving AZT had a 7% incidence of lipodystrophy-related events, a 4.4% rate of grade 3 or 4 elevated non-fasting glucose levels, and a 2.9% incidence of grade 3 or 4 non-fasting hypertriglyceridemia. No significant difference in changes in body mass index or in the development of lipodystropy related events were reported between the two groups. However, because the investigators were not specifically asked to report changes in fat distribution, changes in these characteristics may have been underreported.