Goal achievement of HbA1c and LDL‐cholesterol in a randomized trial comparing colesevelam with ezetimibe: GOAL‐RCT. Issue 10 (18th June 2020)

• Record Type: Journal Article
• Authors: Bajaj, Harpreet S.; Brown, Ruth E.; Jiandani, Dishay; Venn, Karri; Al‐Asaad, Hani; Khandwala, Hasnain; Steen, Oren; Abdel‐Salam, Suzan; Aronson, Ronnie
• Is Part Of: Diabetes, obesity & metabolism. Volume 22:Issue 10(2020)
• Page Start: 1722
• Page End: 1728
• Publication Date: 2020-06-18
• Subjects: cardiovascular prevention, cholesterol, HbA1c, LDL‐c, lipid, randomized trial; Diabetes -- Periodicals; Obesity -- Periodicals; Metabolism -- Disorders -- Periodicals; Clinical pharmacology -- Periodicals; 616.462
• DOI: 10.1111/dom.14084
• Languages: English
• ISSNs: 1462-8902

Abstract

Abstract: 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%) ( P non‐inferiority < .001, P superiority = .41). LDL‐c reduction from baseline was less with colesevelam compared with ezetimibe (14.0% vs. 23.2%, P < .01), as was the proportion of subjects achieving an LDL‐c target of ≤2.0 mmol/L (47.6% and 67.0%, respectively; P = .007). Mean HbA1c was reduced with colesevelam (−0.26 ± 0.10%), while no change was observed with ezetimibe (difference P = .06). Adverse events and discontinuation rates were higher for colesevelam (20.2% and 31.1%) compared with ezetimibe (7.2% and 6.2%), respectively. Conclusions: Among subjects with T2D, the initiation of colesevelam or ezetimibe led to similar achievement of primary composite outcome (LDL‐c and HbA1c within target), with ezetimibe recording a greater LDL‐c reduction and better tolerability than colesevelam.