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According to one clinical study which compared LODALIS® 2.0 g BID* in combination with atorvastatin 10 mg to 2 doses of atorvastatin monotherapy (10 mg and 80 mg) at 4 weeks, what respective mean reductions from baseline in LDL-C were achieved with atorvastatin 10 mg, atorvastatin 80 mg and LODALIS® 2.0 g + atorvastatin 10 mg?1,2†‡

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LDL-C mean reduction from baseline in randomized, placebo-controlled, double-blind, clinical studies

Study GTC-205 at 4 weeks:†‡

  • Atorvastatin 10 mg QD -38.5% (p<0.0001)
  • Atorvastatin 80 mg QD -56.3% (p<0.0001)
  • LODALIS® 2.0 g BID* + atorvastatin 10 mg QD -49.1% (p<0.0001)

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).

Study GTC-204 at 6 weeks:†§

  • Simvastatin 10 mg QD -25.5% (p<0.0001)
  • Simvastatin 20 mg QD -33.8% (p<0.0001)
  • LODALIS® 1.2 g BID* + simvastatin 20 mg QD -42.3% (p<0.0001)
  • LODALIS® 2.0 g BID* + simvastatin 10 mg QD -41.5% (p<0.0001)

LDL-C decreased more in each simvastatin-LODALIS® combination therapy group compared to each simvastatin group (p<0.006); there was no difference between the two simvastatin groups (p=0.0546) or between the two combination therapy groups (p=0.674).

* LODALIS® 1.2 g bid and 2.0 g bid are not authorized doses for use in Canada. The maximum recommended dose is 3 tablets bid or 6 tablets od.

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:

  • Bowel or biliary obstruction

Relevant Warnings and Precautions:

  • Caution in patients with dysphagia, swallowing disorders, severe gastrointestinal motility disorders, inflammatory bowel disease, liver failure or major gastrointestinal tract surgery
  • Risk of constipation, particular caution in patients with coronary heart disease and angina pectoris
  • Caution in patients with triglyceride levels of >3.4 mmol/L
  • Drug interaction with cyclosporine, monitoring required
  • Careful monitoring of patients on anticoagulant therapy
  • Prior to initiating therapy with LODALIS® (colesevelam), secondary causes of hypercholesterolemia should be considered, and properly treated if diagnosed
  • In patients taking oral contraceptive pills, LODALIS® must be administered ≥4 hrs later to minimise risk of interaction
  • Periodically monitor serum total-C, LDL-C and triglyceride levels during treatment
  • Monitoring the fasting plasma glucose (FPG) and HbA1c when treating hypercholesterolemic patients with type 2 diabetes should be considered
  • When used concomitantly with antidiabetic pharmacological treatment regimens, particularly metformin extended formulation, blood glucose and HbA1c levels should be monitored by periodic measurements

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.
§ GTC-48-204: LODALIS® was co-administered 1.2 g BID with simvastatin 20 mg QD (n=37) and 2.0 g BID with simvastatin 10 mg QD (n=35). Simvastatin 10 mg QD (n=36) and 20 mg QD (n=39) were used as active comparators.

References:

  1. Valeant Canada LP, LODALIS® Product Monograph. October 16, 2014.
  2. APOTEX Inc. APO-ATORVASTATIN Product Monograph. March 30, 2017.