Dr. Giuseppe Remuzzi, at the Mario Negri Institute for Pharmacological Research in Bergamo, and colleagues point out that trials of dual therapy with ezetimibe and a statin to date have compared the strategy to monotherapy with a different statin or to a higher dose of the same statin. The team therefore conducted a study of add-on ezetimibe or placebo with the same background statin therapy.
Specifically, the multicenter trial involved 108 type 2 diabetes patients with persistent hypercholesterolemia while on 40 mg/d simvastatin who were randomized to the addition of 10 mg/d ezetimibe or placebo for 2 months.
Lipid levels were virtually unchanged in the placebo group, but LDL cholesterol fell from 99 to 66 mg/dL in the ezetimibe group and total cholesterol dropped from 162 to 124 mg/dL. Similarly, apo B declined from 83to 64 mg/dL (p<0.0001 for all changes vs placebo).
LDL levels <70 mg/dL were achieved by 72% of patients on ezetimibe versus 17% on placebo (p<0.0001), the team reports.
The strategy “significantly ameliorated the lipid profile and, compared to placebo, increased by 4-folds the proportion of patients achieving the LDL target currently recommended for people with diabetes,” Dr. Remuzzi and associates conclude.
Furthermore the treatment was well tolerated, although four patients in the ezetimibe arm experienced transient sinus bradycardia. The authors therefore advise, “This therapeutic option should be considered with caution in subjects with brady-arrhythmias.
EFFECTS OF COMBINED EZETIMIBE AND SIMVASTATIN THERAPY AS COMPARED TO SIMVASTATIN ALONE IN PATIENTS WITH TYPE 2 DIABETES: A PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, CLINICAL TRIAL
Diabetes Care 2010.