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PO23-758 EFFICACY AND SAFETY OF 6 MONTHS CO-ADMINISTRATION OF EZETIMIBE PLUS ROSUVASTATIN IN PATIENTS WITH MIXED DYSLIPIDEMIA
202 PO23-757
Poster Sessions PO23 Therapeutic interventions – statins and/or ezetimibe COMPARISON OF THE EFFICACY AND SAFETY OF 6 MONTHS CO-ADMINISTRATION OF ATORVASTATIN/EZETIMIBE VERSUS ROSUVASTATIN/EZETIMIBE IN MIXED DYSLIPIDEMIA
A. Boufidou, I.H. Styliadis, A. Makedou, E. Damvopoulou, G. Pechlivanidis, G.E. Parcharidis. Lipid Clinic, 1st Cardiology Department, AHEPA Hospital, Aristotle University, Thessaloniki, Greece Background and Aims: Co-administration of ezetimibe/statins has been well studied in hypercholesterolemia. Limited data are available comparing the efficacy of combination therapy with ezetimibe/atorvastatin versus ezetimibe/rosuvastatin in mixed dyslipidemia. We compared the efficacy of co-administration of ezetimibe 10mg/atorvastatin 10-20mg versus ezetimibe 10mg/rosuvastatin 10-20mg, in patients with mixed dyslipidemia. Methods: Ten patients received atorvastatin 10-20mg/ezetimibe 10mg (Group A) and 12 patients rosuvastatin 10-20mg/ezetimibe 10mg (Group B). The two groups were comparable concerning age, gender, BMI, and the baseline levels of cholesterol. Serum lipoproteins, liver enzymes and CK were measured after 12h fasting, before and 6 months after the treatment. Patients with LDL>190mg/dl and triglycerides<400mg/dl were enrolled in the study. Results: (Table 1) None of the patients experienced any adverse effects. Ten patients in Group B achieved LDL target (83%) versus 6 patients in Group A (60%).
Conclusions: LDL-C was significantly reduced in both groups. LDL-C reduction was greater in rosuvastatin/ezetimibe group (-63% vs -59.4%). Ezetimibe/atorvastatin (10-20mg) was more effective in triglycerides reduction (-47.3% vs -31%). Ezetimibe/rosuvastatin (10-20mg) led to greater increase in HDL-C levels (19% vs 8%). LDL-C target was achieved in higher percentage in the rosuvastatin/ezetimibe group (83% vs 60%). PO23-758
1) statistically significant reduction of LDL-C (-60%) 2) borderline statistically significant reduction of triglycerides (-9%) 3) borderline statistically significant increase of HDL (+8%) 4) 75% of the patients achieved LDL-C target. PO23-759
A 14-WEEK EXTENSION STUDY TO COMPARE THE EFFICACY AND SAFETY/TOLERABILITY PROFILE OF EZE/SIMVA COMBINATION TABLET VERSUS SIMVA MONOTHERAPY
L. Ose 1 , R. Reyes 2 , A. Sapre 2 , A.O. Johnson-Levonas 2 , T.A. Musliner 2 . HF, Oslo, Norway; 2 Merck Research Laboratories, Rahway, NJ, USA 1 Rikshospitalet-Radiumhospitalet
The efficacy and safety of ezetimibe/simvastatin (EZE/SIMVA) versus SIMVA alone was evaluated in a randomized, double-blind, 14-week extension study. Patients who completed the 12-week, randomized, double-blind placebo (PBO)-controlled base study received 1 of 8 daily treatments: EZE/SIMVA (10/10-, 10/20-, 10/40-, or 10/80-mg) or SIMVA (10, 20, 40, or 80-mg). Patients remained on the same regimen throughout the extension. Patients taking PBO or EZE 10-mg during the base study were re-randomized to either EZE/SIMVA 10/10mg or SIMVA 80mg. EZE/SIMVA significantly reduced LDL-C compared with SIMVA alone (incremental between-group difference: -14.9%;p<0.001). The incremental LDL-C lowering effect of EZE/SIMVA versus SIMVA alone was generally consistent at each corresponding dose of simvastatin (p<0.001 for each between-group comparison). A larger proportion of patients receiving EZE/SIMVA versus SIMVA achieved LDL-C concentrations <100mg/dL (79.2% vs. 48.0%;p<0.001) and <70 mg/dL (30.4 vs. 7.0%;p<0.001). For TG, TC, non-HDL-C, apo B, RLP-C, and CRP, percent reductions from baseline at extension study endpoint were significantly greater with EZE/SIMVA versus SIMVA. There were no significant between-group differences in the incidences of liver transaminase levels ≥3x the upper limit of normal (ULN) (1.3% for SIMVA vs. 1.5% for EZE/SIMVA) or creatine kinase levels ≥10x ULN (0.2% for SIMVA and EZE/SIMVA each).
EFFICACY AND SAFETY OF 6 MONTHS CO-ADMINISTRATION OF EZETIMIBE PLUS ROSUVASTATIN IN PATIENTS WITH MIXED DYSLIPIDEMIA
I.H. Styliadis, A. Boufidou, A. Makedou, E. Damvopoulou, G. Giannakoulas, H. Stefanidis, G.E. Parharidis. Lipid Clinic, 1st Cardiology Department, AHEPA Hospital, Aristotle University, Thessaloniki, Greece Background and Aims: Combination therapy with ezetimibe plus statin is used for the treatment of hypercholesterolemia. Nevertheless, published data for the treatment of mixed dyslipidemia with co-administration of ezetimibe plus rosuvastatin are limited. We assessed the efficacy and safety of ezetimibe 10mg administered with rosuvastatin 10mg in patients with mixed dyslipidemia. Methods: The study population consisted of 8 high risk patients, males, mean age 56±10 years. Serum concentration of lipoproteins, liver enzymes (ALT, AST) and creatine kinase (CK) were measured after 12h fasting, before and 6 months after the treatment. Patients with LDL>190mg/dl and triglycerides<400mg/dl were enrolled in the study. Results: The results are shown in the table. None of the patients experienced any adverse effects. Six patients (75%) achieved cholesterol targets. Conclusions: Co-administration of ezetimibe 10mg plus rosuvastatin 10mg in patients with mixed dyslipidemia, (LDL>190mg/dl and triglycerides<400mg/dl) is safe and led to:
Treatment with the EZE/SIMVA tablet for 14 weeks was more efficacious then SIMVA alone with an overall similar safety/tolerability profile. PO23-760
EFFECT OF EZETIMIBE PLUS SIMVASTATIN (EZE/SIMVA) ON ATTAINMENT OF LDL-C TREATMENT TARGETS IN HYPERCHOLESTEROLEMIC PATIENTS
L. Ose 1 , A.K. Shah 2 , M.J. Davies 2 , Y.B. Mitchel 2 . 1 Rikshospitalet-Radiumhospitalet HF, Oslo, Norway; 2 Merck
Research
Laboratories, Rahway, NJ, USA Background and Aims: Attainment of LDL-C targets was examined with EZE/SIMVA treatment versus SIMVA monotherapy in patients with primary hypercholesterolemia in a post-hoc analysis using data from three nearly identical, placebo-controlled trials.
76th Congress of the European Atherosclerosis Society, June 10–13, 2007, Helsinki, Finland
Poster Sessions PO23 Therapeutic interventions – statins and/or ezetimibe COMPARISON OF THE EFFICACY AND SAFETY OF 6 MONTHS CO-ADMINISTRATION OF ATORVASTATIN/EZETIMIBE VERSUS ROSUVASTATIN/EZETIMIBE IN MIXED DYSLIPIDEMIA
A. Boufidou, I.H. Styliadis, A. Makedou, E. Damvopoulou, G. Pechlivanidis, G.E. Parcharidis. Lipid Clinic, 1st Cardiology Department, AHEPA Hospital, Aristotle University, Thessaloniki, Greece Background and Aims: Co-administration of ezetimibe/statins has been well studied in hypercholesterolemia. Limited data are available comparing the efficacy of combination therapy with ezetimibe/atorvastatin versus ezetimibe/rosuvastatin in mixed dyslipidemia. We compared the efficacy of co-administration of ezetimibe 10mg/atorvastatin 10-20mg versus ezetimibe 10mg/rosuvastatin 10-20mg, in patients with mixed dyslipidemia. Methods: Ten patients received atorvastatin 10-20mg/ezetimibe 10mg (Group A) and 12 patients rosuvastatin 10-20mg/ezetimibe 10mg (Group B). The two groups were comparable concerning age, gender, BMI, and the baseline levels of cholesterol. Serum lipoproteins, liver enzymes and CK were measured after 12h fasting, before and 6 months after the treatment. Patients with LDL>190mg/dl and triglycerides<400mg/dl were enrolled in the study. Results: (Table 1) None of the patients experienced any adverse effects. Ten patients in Group B achieved LDL target (83%) versus 6 patients in Group A (60%).
Conclusions: LDL-C was significantly reduced in both groups. LDL-C reduction was greater in rosuvastatin/ezetimibe group (-63% vs -59.4%). Ezetimibe/atorvastatin (10-20mg) was more effective in triglycerides reduction (-47.3% vs -31%). Ezetimibe/rosuvastatin (10-20mg) led to greater increase in HDL-C levels (19% vs 8%). LDL-C target was achieved in higher percentage in the rosuvastatin/ezetimibe group (83% vs 60%). PO23-758
1) statistically significant reduction of LDL-C (-60%) 2) borderline statistically significant reduction of triglycerides (-9%) 3) borderline statistically significant increase of HDL (+8%) 4) 75% of the patients achieved LDL-C target. PO23-759
A 14-WEEK EXTENSION STUDY TO COMPARE THE EFFICACY AND SAFETY/TOLERABILITY PROFILE OF EZE/SIMVA COMBINATION TABLET VERSUS SIMVA MONOTHERAPY
L. Ose 1 , R. Reyes 2 , A. Sapre 2 , A.O. Johnson-Levonas 2 , T.A. Musliner 2 . HF, Oslo, Norway; 2 Merck Research Laboratories, Rahway, NJ, USA 1 Rikshospitalet-Radiumhospitalet
The efficacy and safety of ezetimibe/simvastatin (EZE/SIMVA) versus SIMVA alone was evaluated in a randomized, double-blind, 14-week extension study. Patients who completed the 12-week, randomized, double-blind placebo (PBO)-controlled base study received 1 of 8 daily treatments: EZE/SIMVA (10/10-, 10/20-, 10/40-, or 10/80-mg) or SIMVA (10, 20, 40, or 80-mg). Patients remained on the same regimen throughout the extension. Patients taking PBO or EZE 10-mg during the base study were re-randomized to either EZE/SIMVA 10/10mg or SIMVA 80mg. EZE/SIMVA significantly reduced LDL-C compared with SIMVA alone (incremental between-group difference: -14.9%;p<0.001). The incremental LDL-C lowering effect of EZE/SIMVA versus SIMVA alone was generally consistent at each corresponding dose of simvastatin (p<0.001 for each between-group comparison). A larger proportion of patients receiving EZE/SIMVA versus SIMVA achieved LDL-C concentrations <100mg/dL (79.2% vs. 48.0%;p<0.001) and <70 mg/dL (30.4 vs. 7.0%;p<0.001). For TG, TC, non-HDL-C, apo B, RLP-C, and CRP, percent reductions from baseline at extension study endpoint were significantly greater with EZE/SIMVA versus SIMVA. There were no significant between-group differences in the incidences of liver transaminase levels ≥3x the upper limit of normal (ULN) (1.3% for SIMVA vs. 1.5% for EZE/SIMVA) or creatine kinase levels ≥10x ULN (0.2% for SIMVA and EZE/SIMVA each).
EFFICACY AND SAFETY OF 6 MONTHS CO-ADMINISTRATION OF EZETIMIBE PLUS ROSUVASTATIN IN PATIENTS WITH MIXED DYSLIPIDEMIA
I.H. Styliadis, A. Boufidou, A. Makedou, E. Damvopoulou, G. Giannakoulas, H. Stefanidis, G.E. Parharidis. Lipid Clinic, 1st Cardiology Department, AHEPA Hospital, Aristotle University, Thessaloniki, Greece Background and Aims: Combination therapy with ezetimibe plus statin is used for the treatment of hypercholesterolemia. Nevertheless, published data for the treatment of mixed dyslipidemia with co-administration of ezetimibe plus rosuvastatin are limited. We assessed the efficacy and safety of ezetimibe 10mg administered with rosuvastatin 10mg in patients with mixed dyslipidemia. Methods: The study population consisted of 8 high risk patients, males, mean age 56±10 years. Serum concentration of lipoproteins, liver enzymes (ALT, AST) and creatine kinase (CK) were measured after 12h fasting, before and 6 months after the treatment. Patients with LDL>190mg/dl and triglycerides<400mg/dl were enrolled in the study. Results: The results are shown in the table. None of the patients experienced any adverse effects. Six patients (75%) achieved cholesterol targets. Conclusions: Co-administration of ezetimibe 10mg plus rosuvastatin 10mg in patients with mixed dyslipidemia, (LDL>190mg/dl and triglycerides<400mg/dl) is safe and led to:
Treatment with the EZE/SIMVA tablet for 14 weeks was more efficacious then SIMVA alone with an overall similar safety/tolerability profile. PO23-760
EFFECT OF EZETIMIBE PLUS SIMVASTATIN (EZE/SIMVA) ON ATTAINMENT OF LDL-C TREATMENT TARGETS IN HYPERCHOLESTEROLEMIC PATIENTS
L. Ose 1 , A.K. Shah 2 , M.J. Davies 2 , Y.B. Mitchel 2 . 1 Rikshospitalet-Radiumhospitalet HF, Oslo, Norway; 2 Merck
Research
Laboratories, Rahway, NJ, USA Background and Aims: Attainment of LDL-C targets was examined with EZE/SIMVA treatment versus SIMVA monotherapy in patients with primary hypercholesterolemia in a post-hoc analysis using data from three nearly identical, placebo-controlled trials.
76th Congress of the European Atherosclerosis Society, June 10–13, 2007, Helsinki, Finland