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According to one clinical study, what was the mean reduction from baseline in LDL-C at 4 weeks when LODALIS® was added to atorvastatin 10 mg?1,2†‡

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When treating hypercholesterolemic patients with type 2 diabetes mellitus who initiate or are currently on antidiabetic pharmacologic treatment regimen, the fasting plasma glucose (FPG) lowering effect of colesevelam as well as subsequent HbA1c monitoring should be considered, since this effect has been observed with colesevelam when administered with some antidiabetic agents.

LODALIS® efficacy data

Mean reductions in LDL-C from baseline at 4 weeks in a randomized, placebo-controlled, double-blind, clinical study*

Study GTC-205:†‡

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

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.

Reference:

  1. Valeant Canada LP, LODALIS® Product Monograph. October 16, 2014.