Rosiglitazone maleate in combination with metformin hydrochloride (Avandamet drug, GlaxoSmithKline) has been approved for long-term control of glucose levels in patients with type 2 diabetes. The additive effect of the two drugs has been found to reduce hemoglobin A1c levels more than the action of tablet metformin alone. (A high hemoglobin A1c score is associated with the risk of diabetes.) Intended for use as an adjunct to exercise and diet, this “two-in-one” therapy offers cost savings and simplified dosing.
For a full description of this drug, see the Pharmaceutical-Approval Update feature in this issue.
In clinical tests, involving more than 6,000 patients with type 2 diabetes who took rosiglitazone throughout North America and Europe, researchers found no hepatotoxic effects.
Researchers wondered whether rosiglitazone (Avandia tablet, GlaxoSmithKline) would act similar to another thiazolidine-dione, troglitazone (Rezulin, Warner-Lambert), which has been associated with idiosyncratic hepatic reactions leading to liver failure and death. They analyzed data from 13 double-blind clinical trials of rosiglitazone monotherapy and two ongoing, active-comparator clinical trials. No evidence of liver toxicity was observed either in monotherapy or in combination therapy for 5,006 patients.
The results aren’t unexpected, the researchers say, because rosiglitazone and troglitazone are markedly different in their biochemical and metabolic features and hepatic effects. Rosiglitazone is a PPAR-y agonist that is 100 times more effective than troglitazone. Both compounds have a thiazolinedione core, but they have different side chains. Unlike troglitazone, which has been shown to be directly toxic to cultured rat hepatocytes, rosiglitazone does not concentrate significantly in the liver, nor does it recirculate through the biliary system. The kidneys excrete 65% of the rosiglitazone generic. The researchers note that liver toxicity is unlikely to be a thiazoline-dione or PPAR-y agonist class effect.
People with type-2 diabetes mellitus (non-insulin-dependent diabetes) and coronary artery disease (CAD), as well as patients with diabetes and any other risk for cardiovascular disease, should be taking cholesterol-lowering drugs (statins), according to new guidelines published by the American College of Physicians (ACP).
Approximately 80% of people with type-2 diabetes experience or die of complications of heart and vascular disease, and about 65% of deaths among people with diabetes are a result of heart disease and stroke, according to the American Diabetes Association. Diabetes is itself a major risk factor for heart disease.
The ACP recommends that:
- All adults with type-2 diabetes and known CAD take statins, regardless of cholesterol levels.
- All type-2 diabetic patients with another risk factor for CAD take statins or the non-statin drug gemfibrozil (Lopid tablet, Parke-Davis) regardless of cholesterol levels.
- Routine monitoring of liver function or muscle enzymes is probably not needed for patients with type-2 diabetes who are taking statins unless they also have a liver abnormality or muscle pain or are taking drugs that interact with statins.
Sigma Medical, a division of Sigma Global Corporation, plans to offer a comprehensive health maintenance program for diabetic patients at only 99 cents a day ($.99). The program is designed to aid elderly patients and uninsured Americans with diabetes who might be managing their condition improperly because of the cost or a lack of information.
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The FDA has granted tentative approval for Mylan Laboratories’ Abbreviated New Drug Application for canadian pioglitazone HCl tablets in strengths of 15, 30, and 45 mg. This product is the generic version of Actos Tablets (Takeda).
Better glycemic control leads to weight loss, which leads to better gly-cemic control—the primary goal in diabetes. A study from Mexico City suggests that patients are helped by an appetite suppressant, sibutramine HCl monohydrate (Meridia®, Abbott).
Forty-four patients with type-2 (non-insulin-dependent) diabetes had been taking glibenclamide monotherapy for at least two weeks. They were randomly assigned to receive sibutramine 10 mg or a placebo once daily. After 12 months of treatment with sibutramine and gliben-clamide, the diabetic patients lost 4 kg (11 pounds), their body mass index (BMI) decreased from 29.9 to 28.2 kg/m2, and they lost 4 cm (1.5 inches) around the waist. Plasma fasting glucose concentrations declined from 140.4 to 114.2 mg/dl, and glycosylated hemoglobin (Hb A1c) fell from 8.9% to 8.3%.
The placebo patients experienced similar but smaller changes. They lost 1.4 kg (3.1 pounds); 0.6 kg/m2 in BMI; and 1.3 cm (0.5 inch) in waist circumference. Fasting glucose levels fell from 140.7 to 123.9 mg/dl, but Hb A1c values rose from 9.0% to 9.1%.
Teva Pharmaceuticals USA has introduced Generic Metformin HCl Extended-Release Tablets, 750 mg. This product is “AB-rated” and bioequivalent to Canadian Glucophage XR Tablets (Lipha/Bristol-Myers Squibb). The AB rating generally applies if a study has demonstrated bioequivalence.