By Lexa W. Lee
Atorvastatin (Lipitor, Pfizer) 20 mg a day significantly increased levels of fasting plasma glucose (FPG) in patients with Type 2 diabetes (T2DM) and combined dyslipidemia, while FPG was not affected following 12 weeks of therapy with pitavastatin (Livalo, Kowa Pharmaceuticals) 4 mg a day, according to a study presented at the 2011 American College of Cardiology meeting.
Several studies have reported that statin therapy is associated with the deterioration of glucose metabolism and a 9 percent increase in the incidence of T2DM. However, current guidelines recommend statin therapy for existing diabetics because there is about a 40 percent chance of reducing major cardiovascular events in diabetics.
“We launched [Livalo] in June of last year here in the US, but the product has been well-used in Asia since 2003,” said Craig Sponseller, MD, vice president of medical affairs at Kowa Pharmaceuticals America in Montgomery, Alabama.
The purpose of this retrospective study of patients who participated in a multinational Phase 3 trial (NK-104-305) was to evaluate changes in FPG associated with atorvastatin (ATOR) and pitavastatin (PITA) in patients with existing T2DM and combined dyslipidemia, over a 12-week period from baseline. The randomized, multicenter, double-blind Phase 3 clinical trial showed no statistical difference in LDL cholesterol reduction between PITA compared to ATOR.
The researchers compared records of 401 patients with T2DM and combined dyslipidemia taking a daily dose of PITA 4 mg versus ATOR 20 mg and assessed mean changes in FPG levels from baseline to the end of the trial, a period of 12 weeks. Baseline values like glucose levels, of diabetes, age, BMI, gender, insulin, diuretic and beta-blocker use showed no significant differences. The investigators compared 269 patients taking PITA to 132 taking ATOR. There were 174 women and 227 men.
After 12 weeks, there was a mean increase of 2.6 mg/dL (p = .1033) in FPG in the PITA group when compared with baseline versus an increase of 9.2 mg/dL (p = .0062) in the ATOR group. When differences based on gender were assessed, there was a mean increase of 3.5 mg/dL for the 117 women in the PITA group versus 17.0 mg/dL for the 57 women in the ATOR group (p = .0071), compared to an increase of 2.0 mg/dL for the 152 men in the PITA group versus 3.2 mg/dL for the 75 men in the ATOR group (p = .3872).
“I don’t know what that means from a gender standpoint,” said Dr. Sponseller. “Piecing it together is a bit of a task. Limitations exist for post hoc analyses, variations of FPG may exist in patients with different comorbidities and concomitant medication use, and this was a short-term study. I think there are some nuances within its [PITA] chemical structure and its metabolism, but there’s more characterization that has to happen before we go on and say there’s any specific difference with this stuff versus another. There’s not enough data.”
The researchers concluded that there were no significant changes in fasting plasma glucose after 12 weeks of therapy in patients with T2DM and combined dyslipidemia with pitavastatin 4 mg, while atorvastatin 20 mg significantly increased fasting plasma glucose. In addition, there was a significantly greater FBG increase between women after taking ATOR and women after taking PITA. There were no statistical differences in the men, however. Further investigation is needed to confirm the findings and their relevance to clinical outcomes.
Author Disclosures: Dr. Sponseller is an employee of Kowa Pharmaceuticals America. This study was sponsored by Kowa and Eli Lilly.