For information on warnings, contraindications, and precautions, please refer to the "Drug information" page in the package insert.

The incidence of adverse reactions was 7.9% (5/63 patients) in the placebo group and 30.4% (21/69 patients) in the GOOFICE^® group.
Adverse reactions that occurred with an incidence of ≥5% in any group were as shown in the following table.
Serious adverse reactions including deaths did not occur in any group in this study. Adverse reactions leading to discontinuation of administration were observed in 0 patients in the placebo group and in 4 patients (9 events) in the GOOFICE^® group (4 events each of abdominal pain and diarrhea, and 1 event of nausea).

The serum LDL-cholesterol concentrations (mean ± SD) on the day of enrollment and at Week 2 visit (date of discontinuation) were 113.4 ± 31.5 mg/dL and 114.9 ± 31.4 mg/dL, respectively, in the placebo group and 117.9 ± 29.9 mg/dL and 104.5 ± 25.9 mg/dL, respectively, in the GOOFICE^® group.

[1] Incidence of adverse events

The incidence of adverse events was 77.6% (264/340 patients). Twenty adverse events occurred with incidences of ≥2%: Nasopharyngitis, 25.6% (87/340 patients); abdominal pain, 25.0% (85/340 patients); diarrhea, 15.9% (54/340 patients); abdominal pain lower and nausea, 5.0% each (17/340 patients ); upper respiratory tract inflammation, 3.8% (13/340 patients); influenza, abdominal distension, and liver function test abnormal, 3.5% each (12/340 patients); abdominal discomfort, 3.2% (11/340 patients); pharyngitis, 2.9% (10/340 patients); bronchitis, gastroenteritis, abdominal pain upper, and back pain, 2.6% each (9/340 patients); eczema, 2.4% (8/340 patients); dental caries, gastritis, faeces soft, and blood creatine phosphokinase increased, 2.1% each (7/340 patients).
Serious adverse events occurred in 1.5% of the patients (5/340 patients: “subarachnoid haemorrhage, subdural haematoma, skull fracture, subdural hygroma”, “pneumonia mycoplasmal”, “carpal tunnel syndrome”, “retinal detachment”, and “inguinal hernia” in 1 patient each). Inguinal hernia was classified as an adverse reaction, but it resolved.

[2] Actions taken for the investigational product and outcome for “abdominal pain” and “diarrhea” as the adverse events that occurred with high incidences

Abdominal pain was observed in 85 patients (126 events) and the actions taken for the investigational product were as follows: Dose increase for 1/126 events, no dose change for 60/126 events, dose reduction for 48/126 events, interruption for 10/126 events, and discontinuation for 7/126 events. The outcome was “resolved” in 1/1 event with dose increase, 60/60 events with no dose change, 48/48 events with dose reduction, 10/10 events with interruption, and 7/7 events with discontinuation. All events resolved.
Diarrhea was observed in 54 patients (92 events) and the actions taken for the investigational product were as follows: No dose change for 58/92 events, dose reduction for 21/92 events, interruption for 7/92 events, and discontinuation for 6/92 events. The outcome was “resolved” in 58/58 events with no dose change, 21/21 events with dose reduction, 7/7 events with interruption, and 6/6 events with discontinuation. All events resolved.

[1] Incidence of adverse reactions

The incidence of adverse reactions was 47.9% (163/340 patients). Adverse reactions that occurred with an incidence of ≥2% were as shown in the following table. No patients died in this study.
Inguinal hernia occurred in 1 patient (1 event) as a serious adverse reaction. Adverse reactions leading to discontinuation of administration occurred in 18 patients (26 events: Abdominal pain, 7 events; diarrhea, 6 events; abdominal distension, and liver function test abnormal, 2 events each; facial paralysis, abdominal discomfort, abdominal pain upper, flatulence, inguinal hernia, faeces soft, rash, urticaria, and oedema peripheral, 1 event each).

[2] Timing of onset of adverse reactions

When the timing of the first onset of adverse reactions was analyzed by determining the number of patients with adverse reactions and the incidence according to 28-day intervals (considering the day of the start of administration of the investigational product as Day 1), 4 events, i.e., abdominal pain, diarrhea, abdominal pain lower, and abdominal distension, were reported as adverse reactions occurring for the first time in any period with an incidence of ≥2%. The incidence in each period is shown in the table below. All events showed high incidences from Day 1 to Day 28.

The serum LDL cholesterol levels (mean ± SD) on the day of enrollment and at Weeks 4, 12, 24, 36, and 52 of the treatment period were 117.4 ± 31.2 mg/dL, 107.8 ± 29.4 mg/dL, 108.3 ± 30.5 mg/dL, 108.1 ± 30.0 mg/dL, 109.9 ± 30.5 mg/dL, and 111.2 ± 29.5 mg/dL, respectively.

Adverse reactions (including abnormal laboratory test values) were observed in 292 of 631 patients (46.3%) in clinical studies in Japan by the time of approval. Major adverse reactions were abdominal pain in 120 patients (19.0%) and diarrhea in 99 patients (15.7%).

MedDRA/J version 19.0

Note) The adverse drug reactions were grouped as follows in the package insert:
“Alanine aminotransferase (ALT [GPT]) increased,” “Liver function test abnormal,”
“Aspartate aminotransferase (AST [GOT]) increased” → “Liver function test abnormal (ALT [GPT] increased, AST [GOT] increased)”