Clinical studies of 8-14 weeks duration in which Ezetrol 10 mg daily was administered alone or with a statin in 3366 patients demonstrated: Ezetrol was generally well tolerated, adverse reactions were usually mild and transient, the overall incidence of side effects reported with Ezetrol was similar to that reported with placebo and the discontinuation rate due to adverse experiences was comparable between Ezetrol and placebo.
The following common (≥1/100, <1/10) drug-related adverse experiences were reported in patients taking Ezetrol alone (n=1691) or co-administered with a statin (n=1675).
Ezetrol Administered Alone: Headache; abdominal pain, diarrhea.
Ezetrol Co-administered With a Statin: Headache, fatigue, abdominal pain, constipation, diarrhea, flatulence, nausea, increased ALT, increased AST, myalgia.
Laboratory Values: In controlled clinical monotherapy trials, the incidence of clinically important elevations in serum transaminases (ALT and/or AST ≥3 x ULN, consecutive) was similar between Ezetrol (0.5%) and placebo (0.3%). In co-administration trials, the incidence was 1.2% for patients treated with Ezetrol co-administered with a statin and 0.4% for patients treated with a statin alone. These elevations were generally asymptomatic, not associated with cholestasis, and returned to baseline after discontinuation of therapy or with continued treatment. (See Precautions).
Clinically important elevations of CPK (≥10 x ULN) in patients treated with Ezetrol administered alone or co-administered with a statin were similar to elevations seen with placebo or statin administered alone, respectively.
Post-Marketing Experience: The following adverse reactions have been reported in post-marketing experience: Hypersensitivity reactions, including angioedema and rash.