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| |  Actos Approved By FDA For Type II Diabetes PRINCETON, NJ -- July 16, 1999 -- The United States Food and Drug Administration has approved Takeda Pharmaceuticals America, Inc.’s and Eli Lilly & Co.’s Actos(TM) (pioglitazone hydrochloride), a new oral treatment for type II diabetes. Actos is the newest addition to the class of insulin sensitising diabetes agents known as thiazolidinediones (TZDs) and is always dosed once daily without regard to meals. As an adjunct to diet and exercise, Actos has four therapy indications: monotherapy and in combination with sulfonylureas, metformin or insulin to improve glycemic control in patients with type II diabetes. In clinical research studies, Actos (45 mg) given once daily significantly lowered mean blood sugar levels (fasting blood glucose) in patients who were not previously taking anti-diabetes medications by 63.7 mg/dl as compared to baseline, which resulted in a difference of as much as 94.5 mg/dl, as compared to placebo. Actos produced statistically-significant changes from baseline fasting blood glucose after as little as two to four weeks of therapy. Patients experienced mean reductions in glycosylated hemoglobin (HbA1c) levels -- a measure of average blood sugar levels during the last three months - of up to 1.9 percentage points as compared to baseline, which resulted in a difference of up to 2.6 percentage points as compared to placebo at a 45 mg dose of Actos. HbA1c reductions were statistically significant relative to placebo. The FDA approval was based on a review of data from six U.S., double-blind, placebo-controlled studies involving more than 4,500 patients with type II diabetes. Actos was studied as monotherapy and in combination with insulin, metformin or sulfonylureas. In each trial, there was a statistically significant reduction in blood glucose levels. Patients with type II diabetes often have high triglyceride levels and low levels of HDL or good cholesterol. These two abnormalities increase the risk for heart disease, especially in patients with diabetes. Importantly, compared with placebo, Actos significantly decreased mean triglyceride levels and increased mean HDL levels in both monotherapy and in combination with sulfonylureas, metformin or insulin. In contrast, no significant change in mean total cholesterol or mean LDL or bad cholesterol levels was seen with Actos used either as monotherapy or in combination therapy. "The approval of Actos is great news for type II diabetes patients," said Daniel Einhorn, M.D., associate clinical professor of medicine, University of California at San Diego School of Medicine. "There's been a lot of talk about oral diabetes drugs lately. Actos offers more options for people because it can be used alone and in combination with metformin, sulfonylureas or insulin. “Data suggest that only 20 percent to 30 percent of patients currently taking sulfonylureas achieve sufficient glycemic control. According to data submitted to the FDA, Actos delivered additional blood glucose-lowering benefits in patients taking other agents and helped those for whom dietary changes alone were not enough to lower blood sugar levels." Type II diabetes develops when the body either does not produce enough insulin or doesn't efficiently use the insulin it does produce, a phenomenon known as insulin resistance. Most type II diabetes treatments work by either increasing insulin levels or decreasing glucose production. Actos, however, helps reduce the body's resistance to insulin, which means that the body uses its own insulin more effectively. Type II diabetes -- the most common form of the disease -- affects an estimated 15 million Americans. It most often occurs in people over age 45, but has been diagnosed even in children. Left untreated, it can lead to serious health complications including blindness, heart disease, stroke, kidney failure and limb amputation. All told, diabetes consumes $98 billion in U.S. health care costs annually. The majority of side effects reported during clinical trials were mild. The most commonly reported included symptoms of upper respiratory tract infection, headache, sinusitis, muscle pain, tooth disorder and sore throat. The number of patients who withdrew from clinical trials due to an adverse event while taking Actos was similar to or less than that taking placebo. As observed with other members of this class of drugs, weight gain has been noted. Additionally, mild to moderate edema and anemia have been reported in patients taking Actos. Patients receiving Actos in combination with insulin or sulfonylureas may be at risk for hypoglycaemia and a reduction in the dose of insulin or sulfonylureas may be necessary. Occasionally, diabetes worsened during clinical trials. This occurred less frequently with Actos than with placebo. There have been no reported cases of jaundice or liver failure associated with Actos use in U.S. placebo controlled clinical trials. However, since liver toxicity has been observed with another drug in the TZD class, it is recommended that patients obtain medical monitoring of liver enzyme levels (via a routine blood test) prior to the start of therapy, every two months for the first year of therapy and periodically thereafter. In premenopausal anovulatory patients with insulin resistance, treatment with any thiazolidinedione may result in resumption of ovulation. These patients may be at risk for pregnancy.
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