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Prevalence of diabetes, impaired fasting glucose, and impaired glucose tolerance in U.S adults. Rationale for the use of insulin therapy alone as the pharmacological treatment of type 2 diabetes. A study of the effects of hypoglycemic agents on vascular complications in patients with adult-onset diabetes.
This continues to pose a real challenge to physicians as the prevalence of this disease in the United States continues to rise.
The focus of this review will be the management of patients with type 2 diabetes using one or more of the five available classes of oral hypoglycemic agents: sulfonylureas, meglitinides, biguanides, thiazolidinediones and alphaglucosidase inhibitors (Table 1). Metformin (Glucophage) is currently the only agent in this antidiabetic class available in this country. Food and Drug Administration (FDA) included troglitazone (Rezulin), rosiglitazone (Avandia) and pioglitazone (Actos). Alpha-glucosidase inhibitors act by inhibiting the enzyme alpha-glucosidase found in the brush border cells that line the small intestine, which cleaves more complex carbohydrates into sugars.
Reasonable combinations of agents include a sulfonylurea plus metformin, a sulfonylurea plus an alpha-glucosidase inhibitor, a sulfonylurea plus a thiazolidinedione, metformin plus repaglinide, biguanide plus alpha-glucosidase inhibitor, and metformin plus a thiazolidinedione. Type 2 diabetes is defined as a syndrome characterized by insulin deficiency, insulin resistance and increased hepatic glucose output.
Metformin works by reducing hepatic glucose output and, to a lesser extent, enhancing insulin sensitivity in hepatic and peripheral tissues. Subsequently, in March 2000, the FDA asked the manufacturer (Parke-Davis, Warner-Lambert) of troglitazone, the first agent in this class to receive labeling approval, to remove the product from the market. Because they inhibit the breakdown and subsequent absorption of carbohydrates (dextrins, maltose, sucrose and starch; no effect on glucose) from the gut following meals, the largest impact of these drugs is on postprandial hyperglycemia. Medications used to treat type 2 diabetes are designed to correct one or more of these metabolic abnormalities. It is of particular concern with agents that are metabolized to an active metabolite with significant renal excretion. Currently, there are five distinct classes of hypoglycemic agents available, each class displaying unique pharmacologic properties.
These agents include chlorpropamide (Diabinese) and glyburide, both of which should be avoided in the setting of impaired renal function and used with caution in elderly patients.


Most of the related side effects (including metallic taste, gastrointestinal discomfort and nausea) are transient and commonly reported only during initiation of therapy.
These classes are the sulfonylureas, meglitinides, biguanides, thiazolidinediones and alpha-glucosidase inhibitors.
Unlike the commonly used sulfonylureas, the meglitinides have a very short onset of action and a short half-life. Therapy with acarbose has been linked to elevations in serum transaminase levels and the use of this agent is contraindicated in patients with liver cirrhosis. In patients for whom diet and exercise do not provide adequate glucose control, therapy with a single oral agent can be tried. All sulfonylureas have been associated with weight gain and thus, may not be the optimal first choice for obese patients.Unfortunately, not all patients treated with a sulfonylurea will have an adequate response.
Taking the drug with meals may also lessen the severity of the gastrointestinal side effects.
Patients treated with pioglitazone have displayed mean decreases in triglyceride levels, mean increases in HDL cholesterol levels, and no consistent mean changes in LDL and total cholesterol levels.20,21Because these agents do not increase insulin secretion, hypoglycemia does not pose a risk when thiazolidinediones are taken as monotherapy.
When choosing an agent, it is prudent to consider both patient- and drug-specific characteristics. Treatment failure with sulfonylurea therapy can be divided into two categories: primary and secondary. If a meal is omitted throughout the day, patients should be instructed to skip the corresponding dose to prevent hypoglycemia. Because metformin does not affect insulin secretion, it is not associated with hypoglycemia when used as monotherapy, but can potentiate hypoglycemia when used in combination with a sulfonylurea or insulin.
Other contraindications include patients with inflammatory bowel disease or a history of bowel obstruction.32Therapy should be initiated with the lowest effective dose and titrated slowly over intervals of two to four weeks. If adequate blood glucose control is not attained using a single oral agent, a combination of agents with different mechanisms of action may have additive therapeutic effects and result in better glycemic control.
Primary failure results when a patient exhibits an initial poor response to sulfonylurea therapy (a decrease in FPG levels of less than 20 mg per dL [1.1 mmol per L]). Likewise, if an extra meal is added throughout the day, the patient should add a dose to cover that meal.
Repaglinide can be titrated to a dosage of 4 mg before each meal (maximum dosage of 16 mg per day).


The use of thiazolidinediones should be avoided in these patients.As referred to earlier, of greatest concern are the reports of an idiosyncratic drug reaction with troglitazone.
Although hypoglycemia is not typically associated with monotherapy with the alpha-glucosidase inhibitors, it can occur in combination with other drugs. Most of the hypoglycemic effects of the sulfonylureas will be observed at one half of the maximum dose recommended for a specific agent. At least one week should be allowed between dosage adjustments to adequately assess blood glucose response. This reaction is initially characterized by increased serum transaminase levels, which in some cases progressed to hepatitis, hepatic failure and death. In patients undergoing contrast studies, metformin therapy should be withheld for approximately 48 hours following the procedure or until it has been determined that renal function has returned to baseline. Preliminary attempts (before troglitazone was withdrawn from the market in March 2000) to prevent such incidents included a request by the FDA that Parke-Davis strengthen the drug's labeling and require stringent monitoring of transaminase levels in patients taking this agent.
In March 1999, the FDA's Endocrine and Metabolic Drugs Advisory Committee reviewed the status of troglitazone and the potential toxicities and recommended continued availability in a select group of patients: those who are not well controlled with other antidiabetic agents. Since then, it has been determined that patients requiring the use of an insulin sensitizer should be treated with one of the alternative agents. Although results from pre-marketing trials revealed no evidence of hepatotoxicity with the newer agents (rosiglitazone and pioglitazone), two recent case reports demonstrated that rosiglitazone may be associated with hepatic failure following just 14 days of therapy, although a true cause-and-effect relationship has not been established.26,27The FDA recommends that serum transaminase levels be monitored every other month for the first year in all patients receiving a thiazolidinedione. Following one year of therapy with the newer agents, the incidence of serum transaminase elevations has been reported to be similar to placebo.The time to achieve a desired effect with the thiazolidinediones is somewhat longer than the other classes of hypoglycemic agents discussed thus far. Intervals of at least three to four weeks should be allowed before increasing the dosage of these agents.
Smaller dosages can be initiated if used as part of a combination regimen with a sulfonylurea or a sulfonylurea plus metformin.



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