This article is more than 5 years old. Information may no longer be current.

ABT-335 improved lipid levels in patients with mixed dyslipidemia and type 2 diabetes

Add topic to email alerts

Receive an email when new articles are posted on

Please provide your email address to receive an email when new articles are posted on .

Subscribe

Added to email alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

Back to Healio

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

Back to Healio

American Diabetes Association 68th Scientific Sessions

Use of the investigational drug ABT-335 in combination with rosuvastatin calcium demonstrated similar improvements in LDL, HDL and triglycerides, according to results of a phase-3 study.

The results of this multicenter, double blind, controlled trial were presented at the American Diabetes Association 68th Annual Scientific Sessions, held in San Francisco.

Researchers evaluated the efficacy and safety of ABT-355 (TriLipix, Abbott) in combination with rosuvastatin (Crestor, AstraZeneca) in 1,445 patients with mixed dyslipidemia. A subgroup of 276 of these patients had type 2 diabetes. Patients had a baseline LDL >130 mg/dL, HDL < 40 mg/dL (men), HDL < 50 mg/dL (women) and triglycerides >150 mg/dL.

The researchers’ randomized patients to receive ABT-335 (135 mg) combined with rosuvastatin (10 mg, 20 mg), ABT-335 alone (135 mg) or rosuvastatin alone (10 mg, 20 mg, 40 mg).

“After 12 weeks of treatment, ABT-335 in combination with rosuvastatin resulted in mean values of LDL, triglyceride and HDL that were within or close to ADA-recommended target values,” the researchers wrote in the abstract.

Findings showed that patients with diabetes treated with the combination ABT-335 and rosuvastatin 10 mg had an increase in HDL of 21% compared to a HDL increase of 6.6% with rosuvastatin 10 mg alone, and a 14.7% increase with ABT-355 alone (P=.001). Patients had a LDL decreased of 37.1% with the combination compared to a 43.6% decrease with rosuvastatin 10 mg alone, and a 6.1% decrease with ABT-335 alone (P<.001). Triglycerides decreased 44.7% in the combined group, decreased 28.8% with rosuvastatin 10 mg alone, and decreased 33.9% with ABT-355 alone (P=.002).

Additionally, those treated with the combination of ABT-335 and rosuvastatin 20 mg had an increase in HDL of 17.6% compared to a HDL increase of 12.2% with rosuvastatin 30 mg alone (P=.214). Patients had a LDL decreased of 34.7% with the combination compared to a 44.7% decrease with rosuvastatin 20 mg alone (P<.001). Triglycerides decreased 42.4% in the combined group and decreased 26.8% with rosuvastatin 20 mg alone (P=.002).

The 40 mg rosuvastatin arm was included to assess safety and adverse events, but was not included in the analysis.

“Treatment guidelines recommend aggressive treatment of lipids in patients with mixed dyslipidemia and type 2 diabetes,” Peter H. Jones, MD, FACP,one of the trial researchers, said in a press release.

“A comprehensive approach may be necessary to help these patients manage their lipids,” added Jones, of the Methodist DeBakey Heart and Vascular Center, Houston.

Jones PH, Davidson MH, Kashyap ML, et al. OR-85. Efficacy of ABT-335 in combination with rosuvastatin in patients with type 2 diabetes mellitus and mixed dyslipidemia. Presented at: American Diabetes Association 68th Scientific Sessions; June 6-10, 2008; San Francisco.