The cardiovascular safety of the thiazolidinedione rosiglitazone (Avandia – GlaxoSmithKline) is in the news again, with some authorities calling for its removal from the market (New York Times, February 19, 2010).

The FDA has removed prescribing and dispensing restrictions placed on rosiglitazone (Avandia, and others) in 2010 because of concerns about its cardiovascular safety.1 The removal of restrictions was based on the results of an independent reevaluation of the RECORD trial, which found no significant difference between rosiglitazone and metformin/sulfonylurea in the risk of cardiovascular (or unknown cause) death, myocardial infarction, or stroke.21. FDA Drug Safety Communication: FDA requires removal of some prescribing and dispensing restrictions for rosiglitazone-containing diabetes...

Pioglitazone is the third thiazolidinedione ("glitazone") to be marketed in the USA for treatment of type 2 diabetes. Thiazolidinediones decrease resistance to insulin.

Full-page advertisements in newspapers are urging patients with type 2 diabetes coming off Rezulin to ask their doctors to switch to Avandia or Actos. Troglitazone was withdrawn from the market on March 21 because of rare but severe hepatic toxicity.

Rosiglitazone, the second thiazolidinedione derivative to be marketed in the USA for treatment of type 2 diabetes, has been approved by the FDA for use either alone or combined with meformin.

Polycystic ovary syndrome (PCOS), an endocrine abnormality characterized by hyperandrogenism and anovulation, affects 5-10% of women of reproductive age in the US. It is often accompanied by obesity and insulin resistance. In recent years, antidiabetic drugs, although not approved for such use by the FDA, have been tried for treatment of this disorder. This review describes the effectiveness of metformin and the thiazolidinediones in women with PCOS. Also included is a dosage and cost table for some insulin-sensitizing drugs.

The goal for drug therapy of type 2 diabetes is achieving and maintaining a near-normal glycated hemoglobin (HbA1C) concentration without inducing hypoglycemia; the target has generally been an HbA1C of 6.5-7.0% or lower. Whether treating to this level prevents macrovascular (cardiovascular) events has been unclear. Now, 2 large randomized, double-blind trials in patients with long-standing diabetes and at high risk for cardiovascular disease have found no decrease in macrovascular events with intensive glucose control.The ACCORD trial in about 10,000 patients found that patients intensively...

The thiazolidinediones rosiglitazone (Avandia) and pioglitazone (Actos) are peripheral insulin sensitizing agents used to treat hyperglycemia in patients with type 2 diabetes; one or the other is often used as a second or third agent with metformin (Glucophage, and others) and/or a sulfonylurea such as glimepiride (Amaryl, and others). A recent report suggested that rosiglitazone may increase the incidence of myocardial infarction (MI) and cardiovascular mortality.

Avandaryl, a new fixed-dose tablet combining the thiazolidinedione rosiglitazone (Avandia) and the sulfonylurea glimepiride (Amaryl, and others), was recently approved by the FDA for treatment of type 2 diabetes. It is approved for patients already taking a combination of rosiglitazone and a sulfonylurea or those not adequately controlled on rosiglitazone or sulfonylurea monotherapy. Rosiglitazone is also available in a fixed-dose combination with metformin (Avandamet). Most patients with type 2 diabetes eventually require 2 drugs with different mechanisms to control...

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