BACKGROUND AND OBJECTIVES: Long-term (>1 year) safety and efficacy studies of combination lipid therapy are lacking. This year 2 study evaluated fenofibric acid 135 mg in combination with moderate-dose statin (rosuvastatin 20 mg, simvastatin 40 mg or atorvastatin 40 mg) in patients with mixed dyslipidaemia. METHODS: This was a phase 3, open-label, year 2 extension study in patients who had completed one of three double-blind, 12-week, controlled studies and the subsequent open-label, year 1 extension study. Patients in this study had mixed dyslipidaemia (high-density lipoprotein cholesterol [HDL-C] <40 mg/dL [<1.02 mmol/L] for men or <50 mg/dL [<1.28 mmol/L] for women, triglycerides [TG] > or =150 mg/dL [> or =1.69 mmol/L], and low-density lipoprotein cholesterol [LDL-C] > or =130 mg/dL [> or =3.37 mmol/L]) at the start of the controlled study, and had completed the year 1 extension study. Treatment was once-daily oral coadministration of fenofibric acid 135 mg and moderate-dose statin (rosuvastatin 20 mg, simvastatin 40 mg or atorvastatin 40 mg), and was identical to the treatment received in the year 1 study. The year 2 population safety data were summarized for the entire duration of fenofibric acid + statin therapy. Efficacy data were summarized by combination therapy group, as well as pooled across combination therapies, and summarized across the controlled and open-label studies. RESULTS: Of the 310 patients enrolled into the year 2 study, 287 (93%) completed therapy. The mean cumulative exposure to combination therapy was 743 days across the studies. Adverse event rates were similar for all three combination therapy groups. No deaths or treatment-related serious adverse events occurred. The incidence of discontinuation due to adverse events was 2.9% overall. Rhabdomyolysis was not reported in any group. Overall, fenofibric acid + moderate-dose statin for > or =2 years resulted in sustained improvements in HDL-C (+17.4%), TG (-46.4%) and LDL-C (-40.4%). CONCLUSIONS: This long-term study demonstrated that fenofibric acid + moderate-dose statin was generally well tolerated with no new or unexpected safety concerns, and resulted in comprehensive and sustained lipid improvements in patients with mixed dyslipidaemia.
RCT Entities:
BACKGROUND AND OBJECTIVES: Long-term (>1 year) safety and efficacy studies of combination lipid therapy are lacking. This year 2 study evaluated fenofibric acid 135 mg in combination with moderate-dose statin (rosuvastatin 20 mg, simvastatin 40 mg or atorvastatin 40 mg) in patients with mixed dyslipidaemia. METHODS: This was a phase 3, open-label, year 2 extension study in patients who had completed one of three double-blind, 12-week, controlled studies and the subsequent open-label, year 1 extension study. Patients in this study had mixed dyslipidaemia (high-density lipoprotein cholesterol [HDL-C] <40 mg/dL [<1.02 mmol/L] for men or <50 mg/dL [<1.28 mmol/L] for women, triglycerides [TG] > or =150 mg/dL [> or =1.69 mmol/L], and low-density lipoprotein cholesterol [LDL-C] > or =130 mg/dL [> or =3.37 mmol/L]) at the start of the controlled study, and had completed the year 1 extension study. Treatment was once-daily oral coadministration of fenofibric acid 135 mg and moderate-dose statin (rosuvastatin 20 mg, simvastatin 40 mg or atorvastatin 40 mg), and was identical to the treatment received in the year 1 study. The year 2 population safety data were summarized for the entire duration of fenofibric acid + statin therapy. Efficacy data were summarized by combination therapy group, as well as pooled across combination therapies, and summarized across the controlled and open-label studies. RESULTS: Of the 310 patients enrolled into the year 2 study, 287 (93%) completed therapy. The mean cumulative exposure to combination therapy was 743 days across the studies. Adverse event rates were similar for all three combination therapy groups. No deaths or treatment-related serious adverse events occurred. The incidence of discontinuation due to adverse events was 2.9% overall. Rhabdomyolysis was not reported in any group. Overall, fenofibric acid + moderate-dose statin for > or =2 years resulted in sustained improvements in HDL-C (+17.4%), TG (-46.4%) and LDL-C (-40.4%). CONCLUSIONS: This long-term study demonstrated that fenofibric acid + moderate-dose statin was generally well tolerated with no new or unexpected safety concerns, and resulted in comprehensive and sustained lipid improvements in patients with mixed dyslipidaemia.
Authors: Harold E Bays; Peter H Jones; Syed M Mohiuddin; Maureen T Kelly; Hsiaoming Sun; Carolyn M Setze; Susan M Buttler; Darryl J Sleep; James C Stolzenbach Journal: J Clin Lipidol Date: 2008-11-12 Impact factor: 4.766
Authors: Peter H Jones; Michael H Davidson; Moti L Kashyap; Maureen T Kelly; Susan M Buttler; Carolyn M Setze; Darryl J Sleep; James C Stolzenbach Journal: Atherosclerosis Date: 2008-10-05 Impact factor: 5.162
Authors: Peter H Jones; Harold E Bays; Michael H Davidson; Maureen T Kelly; Susan M Buttler; Carolyn M Setze; Darryl J Sleep; James C Stolzenbach Journal: Clin Drug Investig Date: 2008 Impact factor: 2.859
Authors: Vasilios G Athyros; Athanasios A Papageorgiou; Valasia V Athyrou; Dimokritos S Demitriadis; Athanasios G Kontopoulos Journal: Diabetes Care Date: 2002-07 Impact factor: 19.112
Authors: Anne C Goldberg; Harold E Bays; Christie M Ballantyne; Maureen T Kelly; Susan M Buttler; Carolyn M Setze; Darryl J Sleep; James C Stolzenbach Journal: Am J Cardiol Date: 2008-12-26 Impact factor: 2.778
Authors: Michel Farnier; David Marcereuil; Sophie De Niet; Jean Ducobu; Armin Steinmetz; Kjetil Retterstøl; Leszek Bryniarski; Albert Császár; Francis Vanderbist Journal: Clin Drug Investig Date: 2012-04-01 Impact factor: 2.859
Authors: Michael Davidson; Robert S Rosenson; Kevin C Maki; Stephen J Nicholls; Christie M Ballantyne; Carolyn Setze; Dawn M Carlson; James Stolzenbach Journal: Cardiovasc Drugs Ther Date: 2012-08 Impact factor: 3.727