After completing the 12-week study, eligible patients were assigned to coadministered ezetimibe and atorvastatin equivalent to LIPTRUZET (10/10-10/80) or atorvastatin (10-80 mg/day) for an additional 48 weeks. The long-term coadministration of ezetimibe plus atorvastatin had an overall safety profile similar to that of atorvastatin alone.

Ezetimibe

In 10 double-blind, placebo-controlled clinical trials, 2396 patients with primary hyperlipidemia (age range 9-86 years, 50% women, 90% Caucasians, 5% Blacks, 3% Hispanics, 2% Asians) and elevated LDL-C were treated with ezetimibe 10 mg/day for a median treatment duration of 12 weeks (range 0 to 39 weeks).

Adverse reactions reported in ≥2% of patients treated with ezetimibe and at an incidence greater than placebo regardless of causality assessment are shown in Table 3.

Table 3: Clinical Adverse Reactions Occurring in ≥2% of Patients Treated with Ezetimibe and at an Incidence Greater than Placebo, Regardless of Causality  Body System/Organ ClassAdverse Reaction Ezetimibe 10 mg (%)n=2396 Placebo (%)n=1159
Gastrointestinal disorders   
Diarrhea 4.1 3.7
General disorders and administration site conditions   
Fatigue 2.4 1.5
Infections and infestations   
Influenza 2.0 1.5
Sinusitis 2.8 2.2
Upper respiratory tract infection 4.3 2.5
Musculoskeletal and connective tissue disorders   
Arthralgia 3.0 2.2
Pain in extremity 2.7 2.5
Atorvastatin

In an atorvastatin placebo-controlled clinical trial database of 16,066 patients (8755 atorvastatin vs. 7311 placebo; age range 10–93 years, 39% women, 91% Caucasians, 3% Blacks, 2% Asians, 4% other) with a median treatment duration of 53 weeks, 9.7% of patients on atorvastati