The randomized controlled trial has been designed to gather additional data on the effects of Glybera on lipid metabolism and the mechanisms underlying the prevention of pancreatitis attacks. The trial is being performed under a Clinical Trial Application approved by Health Canada.

The new clinical trial builds on positive data obtained from two previous clinical trials in which a total of 22 LPLD patients were treated. These data indicate that a single treatment with Glybera results in a long-term, statistically significant and clinically important reduction in the incidence of acute pancreatitis in LPLD patients. The longest follow-up of individual patients is well over three years, and the cumulative follow-up of all patients is more than 45 years. The therapy was well tolerated and no drug-related severe adverse events or unexpected side-effects have been observed.

AMT will include the data from the new trial in the Marketing Authorization Application for Glybera. The submission of the dossier to the European Medicines Agency is planned for the second half of 2009.

LPLD is an orphan disease, for which no treatment exists today. The disease is caused by mutations in the LPL gene, resulting in highly decreased or absent activity of LPL protein in patients. This protein is needed in order to break down large fat-carrying particles that circulate in the blood after each meal. When such particles, called chylomicrons, accumulate in the blood, they may obstruct small blood vessels. This results in recurrent and severe acute inflammation of the pancreas, called pancreatitis, the most debilitating complication of LPLD. The disease can result in difficult-to-treat diabetes and is associated with significant morbidity and mortality.

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Analysis included information from 243,222 individuals cared for at the Veterans Health Administration. The incidence of hypoglycemia was higher in patients with CKD versus without, both among patients with diabetes and among those without. The risk of hypoglycemia was highest in individuals with both CKD and diabetes.

Hypoglycemia increased patients' risk of dying in the near term. According to the authors, there was a reduced risk of near term death in individuals with CKD relative to those without and this attenuation in the risk of death might relate to an increased quality of care in these patients with CKD relative to diabetic patients without CKD.

"The association of hypoglycemia with one-day mortality underscores the significance of this metabolic disturbance in patients with diabetes and chronic kidney disease," said Dr. Fink. While details on therapy were not included in this study, the findings are consistent with others that have shown that putting patients on intensive glucose-lowering medications can lead to an increased incidence of hypoglycemia and does not prolong their survival.

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