Goal achievement ofHbA1candLDL-cholesterol in a randomized trial comparing colesevelam with ezetimibe:GOAL-RCT

被引:7
作者
Bajaj, Harpreet S. [1 ,2 ]
Brown, Ruth E. [1 ]
Jiandani, Dishay [1 ]
Venn, Karri [1 ]
Al-Asaad, Hani [1 ]
Khandwala, Hasnain [1 ]
Steen, Oren [1 ]
Abdel-Salam, Suzan [1 ]
Aronson, Ronnie [1 ]
机构
[1] LMC Diabet & Endocrinol, Toronto, ON, Canada
[2] Mt Sinai Hosp, Leadership Sinai Ctr Diabet, Toronto, ON, Canada
关键词
cardiovascular prevention; cholesterol; HbA1c; LDL-c; lipid; randomized trial; BILE-ACID SEQUESTRANTS; LDL-CHOLESTEROL; GLYCEMIC CONTROL; STATIN THERAPY; CARDIOVASCULAR-DISEASE; PRIMARY-CARE; ADD-ON; MANAGEMENT; EFFICACY; SAFETY;
D O I
10.1111/dom.14084
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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 < .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 (differenceP= .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.
引用
收藏
页码:1722 / 1728
页数:7
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