The rough road for rosiglitazone.

PURPOSE OF REVIEW

Rosiglitazone is effective in lowering blood sugars in patients with type 2 diabetes and may be expected to reduce microvascular complications associated with hyperglycemia. Whereas preliminary studies using surrogate outcomes for cardiovascular disease have suggested the potential for cardioprotective effects, the drug is associated with fluid retention and increased risk of congestive heart failure. Long-term cardiovascular safety remains incompletely understood. In this review the potential for increased ischemic cardiovascular risk associated with rosiglitazone use is discussed.

RECENT FINDINGS

Meta-analysis of patients participating in controlled clinical trials suggests increased risk of cardiovascular events for patients using rosiglitazone. Considering only clinical trials in patients with type 2 diabetes with patient-level data, a double-masked, randomized design, and using approved doses of rosiglitazone, independent meta-analysis shows that cardiovascular event rates are low, and suggests that increased ischemic cardiovascular risk may be particularly manifest in subgroups of patients with type 2 diabetes who are using nitrates or insulin.

SUMMARY

There continues to be uncertainty about the risk of ischemic heart disease in patients with type 2 diabetes associated with the use of rosiglitazone. Caution should be used in patients with underlying heart disease using nitrates, and when added to ongoing insulin-based therapy.