ABT AZN – These post hoc subset data on Certriad (the combination of ABT’s TriLipix and AZN’s Crestor) pertain to patients with type-2 diabetes. Certraid, which has the potential to be a very big-selling drug, has an NDA pending with a PDUFA date in 1H10.
›Abbott's TriLipix (Fenofibric Acid) in Combination With Rosuvastatin Calcium Helps Patients With Mixed Dyslipidemia and Type 2 Diabetes Meet American Diabetes Association Lipid Targets
Monday June 8, 2009, 9:00 am EDT
Post-hoc analysis of two large clinical trials showed combination therapy helped more patients reach combined targets for HDL, triglycerides and LDL than the pre-determined therapy alone
NEW ORLEANS, June 8 /PRNewswire-FirstCall/ -- Abbott's (NYSE: ABT ) TriLipix (fenofibric acid) delayed-release capsules in combination with rosuvastatin calcium achieved individual and combined lipid targets in patients with mixed dyslipidemia and type 2 diabetes. In these patients, the combination of TriLipix and rosuvastatin helped up to three times more patients simultaneously reach all three key lipid targets - HDL, triglycerides and LDL - than the pre-determined monotherapy. Results from this post-hoc analysis were presented today at the American Diabetes Association's 2009 Scientific Sessions.
TriLipix is a prescription medicine used along with diet to lower triglycerides and LDL (bad) cholesterol, and increase HDL (good) cholesterol. TriLipix is also used along with diet to lower triglycerides and increase HDL cholesterol in people who are at high risk of heart disease and are taking a statin medicine to control their LDL cholesterol. TriLipix has not been shown to prevent heart attacks or stroke more than a statin alone.
Dyslipidemia affects millions of Americans living with diabetes. These patients often have mixed dyslipidemia, a combination of two or more lipid problems including low HDL, high triglycerides and high LDL.
"Because diabetes is a risk factor for heart disease, it is particularly important that patients with diabetes and mixed dyslipidemia manage all three key lipid parameters," said Robert Rosenson, M.D., State University of New York, Brooklyn, New York. "The results of this analysis are promising for combination therapy with TriLipix and rosuvastatin."
TriLipix is the first and only fibrate to be approved for use in combination with a statin. In certain patients, treatment guidelines recommend the combination of a fibrate with a statin to improve lipid levels.
…About the Phase 3 Clinical Trials [the data in the following paragraph are as previously reported]
A total of 2,197 patients with mixed dyslipidemia were enrolled in two phase 3 clinical studies evaluating TriLipix in combination with rosuvastatin 5 mg, 10 mg, or 20 mg compared to either TriLipix alone or rosuvastatin alone. Both studies met their primary endpoints, with combination therapy significantly improving HDL and triglycerides compared to rosuvastatin alone, and significantly improving LDL compared to TriLipix alone. The combination of TriLipix with the highest dose of rosuvastatin (40 mg) has not been studied. These studies are part of the largest clinical program to date designed to evaluate the safety and efficacy of a fibrate in combination with statins.
About the Post Hoc Analysis[this is the new info]
This post-hoc analysis of two 12-week, randomized phase 3 studies of patients with mixed dyslipidemia examined a subgroup of 480 patients with type 2 diabetes. These patients were required to have an LDL greater than or equal to 130 mg/dL, triglycerides greater than or equal to 150 mg/dL and HDL less than 40 mg/dL for men and less than 50 mg/dL for women to be included in the study.
The analysis compared the proportion of patients reaching American Diabetes Association (ADA) lipid targets who received TriLipix in combination with rosuvastatin to those who received the corresponding dose of rosuvastatin alone, the pre-determined monotherapy. The ADA lipid targets included LDL less than 100 mg/dL, triglycerides less than 150 mg/dL and HDL greater than 40 mg/dL for men and greater than 50 mg/dL for women.
About the Study Results
More patients simultaneously achieved all three ADA lipid targets for HDL, triglycerides and LDL when receiving TriLipix in combination with rosuvastatin 10 mg (28.3 percent vs. 8.3 percent; p=0.012) or 20 mg (19.1 percent vs. 5.9 percent; p= 0.045) compared to rosuvastatin 10 mg or 20 mg alone, respectively. Additionally, TriLipix in combination with rosuvastatin 5 mg resulted in 21.7 percent of patients achieving all three ADA lipid targets simultaneously compared to 12.1 percent of patients receiving rosuvastatin 5 mg alone (p=0.137). TriLipix monotherapy resulted in 4.3 percent of patients obtaining simultaneous achievement of these goals.
"The clinical program continues to generate important data supporting the use of TriLipix in combination with rosuvastatin therapy in high risk patient populations," said Eugene Sun, M.D., vice president, Global Pharmaceutical Clinical Development, Abbott.
TriLipix Clinical Development Program
The TriLipix clinical program studied 3,458 patients with mixed dyslipidemia in four 12-week controlled studies where patients received TriLipix alone, TriLipix in combination with one of the three most commonly prescribed statins (atorvastatin, simvastatin or rosuvastatin) or statin alone. The clinical program also included a 52-week, long-term, open-label extension study.‹
[Certriad is a pill that combines AZN’s Crestor and ABT’s TriLipix. As is typical in cases Big Pharma companies receive a CRL, this PR provides no details on what the FDA needs in order to approve.]
WILMINGTON, Del. and ABBOTT PARK, Ill., March 30 /PRNewswire-FirstCall/ -- AstraZeneca and Abbott (NYSE: ABT ) announced today that the U.S. Food and Drug Administration (FDA) issued a complete response letter (CRL) for the New Drug Application (NDA) for CERTRIAD™ (rosuvastatin / fenofibric acid delayed release) Capsules. The companies are currently evaluating the CRL, will continue discussions with the FDA to determine next steps with respect to the CERTRIAD NDA and will respond to the agency's request for additional information.[Can’t get any more laconic than that.]‹
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