Colesevelam, Lipids And Sugars, South Asian Canadian Trial

This is a prospective, non-controlled, open label, multicenter trial of colesevelam in Canadian South Asian adults at high cardiovascular risk.

• 15-20 clinical sites from Ontario, Quebec, Manitoba and British Columbia will be selected from CCRN's network of primary care physicians and cardiologists to identify patients having stable type 2 diabetes or documented stable CAD with metabolic syndrome who are on maximally tolerated statin therapy, with LDL >2.0 mmol/L or non-HDL > 2.6 mmol/L.
• Following informed consent, patients will be screened at baseline for HbA1c, fasting blood glucose, lipid profile, renal function and liver enzymes.
• Baseline demographics, CAD and diabetes documentation and concurrent drug therapy will be collected.
• 250 eligible patients will receive a physician prescription of colesevelam (Lodalis) 625 mg tablets (3 tablets taken twice daily) for 24 weeks.
• Physicians will be requested not to change lipid or diabetes therapy over the 24 week course of the trial.
• Patients will be contacted at 2 and 12 weeks (visit 3 and 4) via a phone call to assess adherence to the prescribed therapy, review other concurrent medications and assess for any adverse events.
• The week 24 visit (study visit 5) will include collection of fasting blood work as per screening visit, review of concurrent drug therapy and a final assessment for any adverse events.

Inclusion criteria

• Individuals of South Asian ethnicity; self-declared, at least 3 of 4 grandparents born in a South Asian country (i.e. India, Pakistan, Bangladesh, Sri Lanka, Nepal and Bhutan)
• Either Diabetes, or Coronary artery disease with metabolic syndrome
• Currently receiving maximally tolerated dose of statin therapy (at least Atorvastatin 20 mg or Rosuvastatin 10 mg)
• LDL >2.0 mmol/L or non-HDL >2.6 mmol/L
• Patient is willing to provide written consent
• Age ≥ 18 years

Exclusion criteria

• Receiving lipid-lowering agents, other than statins or ezetimibe
• Any changes made to current lipid lowering therapy in the last 12 weeks
• Uncontrolled diabetes (HbA1c >0.10)
• TG > 5.0 mmol/L
• Significant hepatic or renal disease (ALT > 2x ULN or eGFR < 30 mL/min/1.73 m²)
• Ongoing participation in any randomized clinical trial