Ease: Ezetimibe Add-on to Statin for Effectiveness Trail

Results from the largest community-based clinical trial to date, involving more than 3000 patients, has shown that adding the cholesterol absorption inhibitor ezetimibe to ongoing stable statin therapy in patients with hypercholesterolemia produces a significant additional reduction in low-density lipoprotein (LDL)- cholesterol compared with adding a placebo. [1] In addition, more patients who added ezetimibe achieved their National Cholesterol Education Program Adult Treatment Panel (NCEP ATP) If LDL-cholesterol targets. The Ezetimibe Add-on to Statin for Effectiveness (EASE) trial included a total of 3030 patients on a stable dose of a statin but not yet at their NCEP ATP III LDL-cholesterel goal, [2] Patients were recruited into the study from 299 practices around the United States, including practices especially selected to encourage the involvement of African American and Hispanic patients (about 9% and 5%, respectively, of the final patient population). All patients were aged >/= 18 years, had LDL-cholesterol level above NCEP ATP III target by risk category after being on a stable dose of any statin for >/= 5 weeks, and had triglyceride level < 350 mg/dL. According to NCEP ATP III risk criteria, approximately 77% of the patients had coronary heart disease (CHD) or CHD risk, and about 17% of patients had >/= 2 CHD risk factors. About 40% of patients were taking atorvastatin 10-90 mg, 30% were taking similar doses of simvastatin, 20% were on pravastatin, and other patients were on fluvastatin or lovastatin, At the time the study was started. rosuvastatin was not commercially available. Patients on lipid-lowering therapy other than a statin were excluded from the study. Randomization on a 2 to 1, double-blind basis resulted in 2020 patients continuing with their original statin treatment (same brand and dose) with the addition of ezetimibe 10 mg, and 1010 patients with their original statin treatment plus a placebo. Treatment lasted for 6 weeks. The endpoints of EASE were percentage reduction in LDL-cholesterol level and percentage of patients not at goal level at baseline who reached their NCEP ATP III LDL-cholesterol goal

Ease: Ezetimibe Add-on to Statin for Effectiveness Trail

Linda Brokes, Msc
Results from the largest community-based clinical trial to date, involving more than 3000 patients, has shown that adding the cholesterol absorption inhibitor ezetimibe to ongoing stable statin therapy in patients with hypercholesterolemia produces a significant additional reduction in low-density lipoprotein (LDL)-cholesterol compared with adding a placebo. [1]In addition, more patients who added ezetimibe achieved their National Cholesterol Education Program Adult Treatment Panel (NCEP ATP) If LDL-cholesterol targets.The Ezetimibe Add-on to Statin for Effectiveness (EASE) trial included a total of 3030 patients on a stable dose of a statin but not yet at their NCEP ATP III LDLcholesterel goal, [2] Patients were recruited into the study from 299 practices around the United States, including practices especially selected to encourage the involvement of African American and Hispanic patients (about 9% and 5%, respectively, of the final patient population).All patients were aged >/= 18 years, had LDL-cholesterol level above NCEP ATP III target by risk category after being on a stable dose of any statin for >/= 5 weeks, and had triglyceride level < 350 mg/dL.According to NCEP ATP III risk criteria, approximately 77% of the patients had coronary heart disease (CHD) or CHD risk, and about 17% of patients had >/= 2 CHD risk factors.About 40% of patients were taking atorvastatin 10-90 mg, 30% were taking similar doses of simvastatin, 20% were on pravastatin, and other patients were on fluvastatin or lovastatin, At the time the study was started.rosuvastatin was not commercially available.Patients on lipid-lowering therapy other than a statin were excluded from the study.Randomization on a 2 to 1, double-blind basis resulted in 2020 patients continuing with their original statin treatment (same brand and dose) with the addition of ezetimibe 10 mg, and 1010 patients with their original statin treatment plus a placebo.Treatment lasted for 6 weeks.The endpoints of EASE were percentage reduction in LDL-cholesterol level and percentage of patients not at goal level at baseline who reached their NCEP ATP III LDL-cholesterol goal.In the overall population, LDL-cholesterol was further reduced in the statin plus ezetimibe group from a mean of 129 mg/dL at baseline to 95 mg/dL, a reduction of approximately 23% compared with placebo (Table 1).A similarly significant percentage reduction was seen for the CHD risk factor categories.

*P <= .0O1 vs statin + placebo CHD, coronary heart disease
These effects were consistent across a number of prespecified treatment groups, including those classified according to age, gender, race (including , Caucasian (n=2471), African-American (n=279) and Hispanic patients (n=162) [other, n= 118], diabetes (38%) or metabolic syndrome (60%), and statin brand and dose.Overall, more patients on statin plus ezetimibe reached their NCEP ATP III LDL-cholesterol goal than those on statin plus placebo (Table 2).A particularly high rate, over 90%, was seen in the patients with >/= 2 CHD risk factors.

Results
Table 1.EASE: Mean LDL-Cholesterol Levels (mg/dL) The 23% additional reduction in LDL-cholesterol seen with ezetimibe added to ongoing statin monotherapy compares favorably with the 6% to 8% reduction usually seen when the dose of the original statin is doubled.Dr. Pearson commented.The results of the EASE study suggest that the addition of ezetimibe to statin therapy should be considered in patients who have not achieved their NCEP ATP III goal on statin therapy alone.
There were no differences in liver-or muscle-related side effects between the 2 treatment groups (Table 3).