The following report, which originally appeared on March 30, 2009, erroneously described the combination of rosuvastatin and fenofibric acid as being a fixed dose. The combination was actually administered in 2 separate products. We apologise for any inconvenience this error might have caused.
By Ed Susman
ORLANDO, Fla -- April 1, 2009 -- A combination of rosuvastatin 5 mg and fenofibric acid 135 mg corrects abnormal lipid profiles in men and women better than either of the drugs given as monotherapy, according to results of a study presented here at the American College of Cardiology (ACC) 58th Annual Scientific Session.
"This combination may be an appropriate therapeutic option for the treatment of dyslipidaemia in patients for whom a 5-mg starting dose of rosuvastatin is recommended," said Eli M. Roth, MD, Sterling Research Group, Cincinnati, Ohio, in a presentation on March 29.
"The combination therapy resulted in comprehensive improvement in the lipid profile of patients with atherogenic dyslipidaemia, without additional safety concerns," Dr. Roth said.
In the trial, researchers identified patients who exhibited mixed or atherogenic dyslipidaemia -- any combination of abnormal lipid triad characterised by high triglycerides, low high-density lipoprotein cholesterol (HDL-C), and elevated levels of low-density lipoprotein cholesterol (LDL-C).
For their study, Dr. Roth and colleagues randomly assigned 254 patients to receive fenofibric acid monotherapy, 241 patients to rosuvastatin monotherapy, and 236 patients to a combination of these drugs.
Treatment with fenofibric acid was statistically more effective in reducing triglycerides than statin therapy alone. Rosuvastatin reduced triglycerides 17.5% compared with a 40.3% reduction with fenofibric acid (P < .001).
The researchers also observed that fenofibric acid increased the HDL-C by 23% compared with a 12.4% reduction with rosuvastatin, again a significant difference (P < .001).
Combination therapy also reduced LDL-C by 28.7% compared with a 4.1% reduction with fenofibric acid alone (P < .001).
The majority of patients in the study were women. The average age of participants was about 55 years. More than 90% of the subjects were white. More than half of the study patients had a history of high blood pressure; 16% had documented coronary artery disease; about 10% had experienced a myocardial infarction; 28% had diabetes; 22% were considered to be obese; and 60% exhibited the metabolic syndrome.
Dr. Roth said that treatment with the combination did not produce any unexpected safety signals. "Treatment was well tolerated," he said, "with a safety profile that was consistent with individual monotherapy treatments."
Funding for this study was provided by Abbott.
[Presentation title: A Phase III Study Evaluating the Efficacy and Safety of 135 mg Fenofibric Acid (ABT-335) in Combination With 5 mg Rosuvastatin in Patients With Atherogenic Dyslipidemia. Abstract 1021-85]
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