Significant LDL-C level reduction in patients treated with LODALIS® and atorvastatin versus atorvastatin 10 mg1†‡
Demonstrated at 4 weeks, in a randomized, placebo-controlled, double-blind, parallel-group clinical study‡
The decrease in LDL-C was greater after treatment with the combination atorvastatin-LODALIS® than after treatment with atorvastatin 10 mg alone (p=0.007), but not different from atorvastatin 80 mg alone (p=0.070).
Clinical Use:
LODALIS® has not been studied in Fredrickson Type I, IIb, III, IV and V
dyslipidemias.
Safety and efficacy in pediatric patients (≤18 years of age) have not been established.
Contraindications:
Relevant Warnings and Precautions:
For more information:
Please consult the product monograph at https://pdf.hres.ca/dpd_pm/00027744.PDF for important information relating
to adverse reactions, drug interactions, and dosing information which
have not been discussed in this piece.
The product monograph is also available by calling 1 800 361-4261.
† Randomized, placebo-controlled, double-blind, parallel-group efficacy studies were conducted in patients 18 years of age or older with primary hypercholesterolemia. Patients had a serum LDL-C of at least 3.36 mmol/L. All patients followed a low-fat, low-cholesterol diet, avoided fasting or binge eating, and ate at least 2 meals on most days.
‡ GTC-48-205: LODALIS® was co-administered with atorvastatin 10 mg QD (n=19). Atorvastatin 80 mg QD (n=20) was used as an active comparator.
Reference: