Goal achievement of HbA1c and LDL‐ cholesterol in a randomized trial comparing colesevelam with ezetimibe: GOAL‐RCT
- Resource Type
- Authors
- Oren Steen; Dishay Jiandani; Karri Venn; Hani Al‐Asaad; Suzan Abdel-Salam; Hasnain Khandwala; Harpreet S. Bajaj; Ronnie Aronson; Ruth E. Brown
- Source
- Diabetes, Obesity and Metabolism. 22:1722-1728
- Subject
- medicine.medical_specialty
Endocrinology, Diabetes and Metabolism
Hypercholesterolemia
Colesevelam Hydrochloride
030209 endocrinology & metabolism
030204 cardiovascular system & hematology
Gastroenterology
law.invention
03 medical and health sciences
0302 clinical medicine
Endocrinology
Randomized controlled trial
Ezetimibe
law
Internal medicine
Internal Medicine
medicine
Humans
Adverse effect
Aged
Glycated Hemoglobin
Intention-to-treat analysis
Colesevelam
business.industry
Anticholesteremic Agents
Cholesterol, LDL
Middle Aged
Discontinuation
Clinical trial
Treatment Outcome
Diabetes Mellitus, Type 2
Tolerability
Drug Therapy, Combination
Hydroxymethylglutaryl-CoA Reductase Inhibitors
business
Goals
medicine.drug
- Language
- ISSN
- 1463-1326
1462-8902
AIM To compare the efficacy and safety of colesevelam and ezetimibe as second-line low density lipoprotein-cholesterol (LDL-c)-lowering options in type 2 diabetes (T2D). MATERIALS AND METHODS GOAL-RCT is a 24-week, open-label, randomized, pragmatic clinical trial. Subjects with T2D with uncontrolled HbA1c (7.1%-10%) and LDL-c (>2.0 mmol/L) were randomized 1:1 to colesevelam 3.75 g or ezetimibe 10 mg daily. The primary composite outcome was the proportion of participants achieving an LDL-c target of ≤2.0 mmol/L and HbA1c target of ≤7.0%. Intention to treat analysis was performed. RESULTS Two hundred subjects were enrolled: mean age 59 ± 10 years; mean HbA1c 8.0%; mean LDL-c 2.5 mmol/L; 97% on statin therapy. The primary composite outcome was achieved by similar proportions of participants with colesevelam (14.6%) and ezetimibe (10.5%) (Pnon-inferiority