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All sulfonylurea drugs are capable of producing severe hypoglycemia. Proper patient selection, dosage, and instructions are important to avoid hypoglycemic episodes. At such times, it may be necessary to withhold Avandaryl and temporarily administer insulin. In a clinical study in healthy volunteers who received 8 mg of rosiglitazone once daily for 8 weeks, there was a statistically significant increase in median plasma volume compared to placebo. Since thiazolidinediones, including rosiglitazone, can cause fluid retention, which can exacerbate or lead to congestive heart failure, Avandaryl should be used with caution in patients at risk for heart failure. Patients should be monitored for signs and symptoms of heart failure In controlled clinical trials of patients with type 2 diabetes, mild to moderate edema was reported in patients treated with rosiglitazone, and may be dose related.

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Precautions

Patients in this trial were started on Avandaryl 4 mg/1 mg, rosiglitazone 4 mg, or glimepiride 1 mg. Doses could be increased at 4-week intervals to reach a maximum total daily dose of either 4 mg/4 mg or 8 mg/4 mg for Avandaryl, 8 mg for rosiglitazone monotherapy or 4 mg for glimepiride monotherapy. Few patients were withdrawn for hypoglycemia (less than 1%) and few episodes of hypoglycemia were considered to be severe (less than 1%). Events of anemia and edema tended to be reported more frequently at higher doses, and were generally mild to moderate in severity and usually did not require discontinuation of treatment with rosiglitazone.

Adverse Reactions

Adverse events occurring at a frequency of greater than 5% in any treatment group in the 28-week double-blind trial of Avandaryl in drug-naive patients with type 2 diabetes mellitus are presented in Table 6. Edema was reported by 4.8% of patients receiving rosiglitazone compared to 1.3% on placebo, and 1.0% on sulfonylurea monotherapy. The reporting rate of edema was higher for rosiglitazone 8 mg added to a sulfonylurea (12.4%) compared to other combinations, with the exception of insulin. Anemia was reported by 1.9% of patients receiving rosiglitazone compared to 0.7% on placebo, 0.6% on sulfonylurea monotherapy, and 2.3% on rosiglitazone in combination with a sulfonylurea. The incidence of hypoglycemia with glimepiride, as documented by blood glucose values less than 60 mg/dL, ranged from 0.9% to 1.7% in 2 large, well-controlled, 1-year studies.

Drug Interactions

Hepatic porphyria reactions and disulfiram-like reactions have been reported with sulfonylureas, including glimepiride. Ophthalmic examinations were carried out in more than 500 subjects during long-term studies of glimepiride using the methodology of Taylor and West and Laties et al. No significant differences were seen between glimepiride and glyburide in the number of subjects with clinically important changes in visual acuity, intraocular tension, or in any of the 5 lens-related variables examined. Cases of hyponatremia have been reported with glimepiride and all other sulfonylureas, most often in patients who are on other medications or have medical conditions known to cause hyponatremia or increaserelease of antidiuretic hormone.

Overdosage

Changes in accommodation and/or blurred vision may occur with the use of glimepiride. This is thought to be due to changes in blood glucose, and may be more pronounced when treatment is initiated. This condition is also seen in untreated diabetic patients, and may actually be reduced by treatment. In clinical studies in volunteers, rosiglitazone has been administered at single oral doses of up to 20 mg and was well tolerated. Ophthalmic examinations were carried out during long-term studies using the method of Chylack et al.