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| |  DG DISPATCH - EASD: Pioglitazone Corrects Lipid Imbalance While Lowering Plasma Glucose By Cameron Johnston Special to DG News
BRUSSELS, BELGIUM -- September 29, 1999 -- The insulin sensitizer pioglitazone (Actos, co-marketed by Lilly and Takeda) appears to do more than just help patients achieve glycemic control. It also helps re-establish a balance in lipid abnormalities by lowering triglycerides and raising high-density lipoproteins (HDL cholesterol).
Dr. Robert Sherwin, a professor of medicine at Yale University, in New Haven, CO, presented the results of a number of studies involving pioglitazone at the European Association for the Study of Diabetes meeting, being held in Brussels this week. The measurement of glycated hemoglobin (HbA1c) is a measure of glucose control throughout the day over a 24-hour period and it is the best surrogate index of the average 24-hour glucose levels over a extended period of time, he explained. Therefore, it is often used as a primary endpoint in trials involving agents to treat diabetes. "One of the striking and important findings was its favorable effect on lipid profiles. It seems to be particular good at correcting the abnormalities of the lipid metabolism seem in diabetics," Dr. Sherwin commented. In one study, those patients were divided into two groups - those who previously had used other oral agents and those who were treatment-naïve and had never taken any kind of oral diabetes therapy. Among the treatment-naïve patients, there was a 2.55 point drop in HbA1c. In the group that had used other oral agents, the reduction in HbA1c was 1.44 points versus percent placebo. There were also significant reductions in serum triglycerides (11.8 percent at the 15 mg dose; 6.6 percent at the 30 mg dose; and 9.8 percent at the 4 mg/day dose): The increase in HDL was as follows: 4.9 percent at 15 mg/day; 3.1 percent at 30 mg/day; and 9.6 percent at 45 mg/day. There were increases in low-density lipoproteins (LDL) and in total cholesterol, although these were not significant. Pioglitazone was also found to offer a synergistic effect when used in combination with other commonly available oral agents - sulfonylureas, metformin and oral insulin. At 30 mg/day, pioglitazone used with metformin resulted in a 21.2 percent reduction in triglycerides over baseline. By comparison, metformin alone resulted in a 6.7 percent reduction in triglycerides. The patients were already maintained adequately on metformin and therefore the benefit shown here is highly synergistic, Dr. Sherwin said. Similarly, when used in combination, pioglitazone (30 mg) and sulfonylurea resulted in a 27 percent reduction in triglycerides as compared with reductions of 14.7 percent with the 15 mg dose and sulfonylurea, and a one percent reduction with sulfonylurea alone. On-going studies are also showing pioglitazone to be effective and relatively free of side effects over the longer term, as well. Some patients have now been followed out to 122 weeks with their HbA1c remaining relatively stable. "I think this is the most remarkable finding with these drugs and if it holds out and we get more experience with more trials," Dr. Sherwin said. The adverse events were comparable to placebo except for weight gains, and edema, both of which also are common with other glitazones. The number of hypoglycemia reactions was slightly higher than with other drugs in the same family, but they were not unexpected and were based on self-reports rather than on clinically documented cases.
Related Links: Eli Lilly and Takeda.
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