Results of three studies show the oral anti-diabetic agent ACTOS (R) (pioglitazone HCl), in combination with a sulfonylurea, metformin or insulin, resulted in triglyceride decreases and high-density lipoprotein (HDL) cholesterol increases that demonstrated statistically significant improvements from baseline.
These studies also showed that, in addition to increasing low-density lipoprotein (LDL) cholesterol particle size, ACTOS can significantly increase the size and buoyancy of HDL particles. The findings were presented today at the 13th Annual Meeting and Clinical Congress of the American Association of Clinical Endocrinologists (AACE) in Boston.
"The data are important because they underscore the additional lipid benefits of ACTOS beyond its ability to effectively manage glucose levels and positively affect triglyceride and HDL cholesterol levels," said Mehmood Khan, M.D., F.A.C.E., senior vice president for medical and scientific affairs, Takeda Pharmaceuticals North America. "While it's well-established that increases in LDL cholesterol particle size are associated with ACTOS therapy, these new data show that HDL or 'good' cholesterol particles are similarly affected, which may further expand the lipid benefits of ACTOS."
People with diabetes are about twice as likely as those without diabetes to have high triglyceride and low HDL cholesterol levels, a condition commonly referred to as diabetic dyslipidemia. Studies have shown that the presence of large, buoyant HDL particles instead of small, dense particles may be associated with reduced cardiovascular risks.
In addition, people with diabetes tend to have a higher proportion of small, dense LDL particles, which may lead to an increase in cardiovascular risk. Smaller, more dense LDL particles are thought to more easily penetrate arterial walls to form atherosclerotic plaque.
These studies were conducted to evaluate the effects of ACTOS, an insulin sensitizer belonging to the thiazolidinedione (TZD) class of oral anti-diabetic medications, on the lipid subspecies and subparticle profiles of patients with diabetic dyslipidemia when administered in conjunction with other diabetes therapies.
Three randomized, double-blind, multi-center trials studied the effect of ACTOS 30 mg or 45 mg plus either a sulfonylurea, metformin or insulin on HDL and LDL levels and subclass particle size profile in patients with type 2 diabetes over a 24-week period. More than 250 patients in the three studies were randomized to one of the following treatment arms: