Insights into the early use of oral semaglutide in routine clinical practice: The IGNITE study

被引:40
作者
Aroda, Vanita R. [1 ]
Faurby, Mads [2 ]
Lophaven, Soren [3 ]
Noone, Josh [4 ]
Wolden, Michael Lyng [2 ]
Lingvay, Ildiko [5 ,6 ]
机构
[1] Harvard Med Sch, Brigham & Womens Hosp, Div Endocrinol Diabet & Hypertens, Boston, MA 02115 USA
[2] Novo Nordisk AS, Soborg, Denmark
[3] Omicron ApS, Roskilde, Denmark
[4] Novo Nordisk, Plainsboro Township, NJ USA
[5] Univ Texas Southwestern Med Ctr, Dept Internal Med Endocrinol, Dallas, TX 75390 USA
[6] Univ Texas Southwestern Med Ctr, Dept Populat & Data Sci, Dallas, TX 75390 USA
关键词
antidiabetic drug; database research; GLP-1; glycaemic control; observational study; type; 2; diabetes;
D O I
10.1111/dom.14453
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Oral semaglutide is the first oral glucagon-like peptide-1 receptor agonist for the treatment of type 2 diabetes, and showed significant benefits in glycaemic control and weight reduction versus active comparators in the PIONEER phase 3a randomized controlled trial programme. In this retrospective study, we present early data on the use of oral semaglutide in clinical practice, from the US IBM Explorys electronic health record database. In 782 patients prescribed oral semaglutide, 54.5% were women, and the mean age (SD) was 57.8 years (11.3); 66.0% of patients received their prescription from a primary care practitioner. Although prescribing information recommends increasing the dose to 7 mg after 30 days, 37.0% of patients received a prescription only for the initial 3 mg dose. Mean body mass index was 36.2 kg/m(2) (7.6); mean HbA1c was 8.4% (1.8%). Mean HbA1c change from baseline to approximately 6 months after oral semaglutide initiation was -0.9% (95% CI: -1.1%; -0.6%), with greater reductions in patients with higher baseline HbA1c. These data indicate prevalent early adoption of oral semaglutide in primary care, show real-world improvements in glycaemic control, and identify potential treatment gaps.
引用
收藏
页码:2177 / 2182
页数:6
相关论文
共 14 条
[1]   PIONEER 1: Randomized Clinical Trial of the Efficacy and Safety of Oral Semaglutide Monotherapy in Comparison With Placebo in Patients With Type 2 Diabetes [J].
Aroda, Vanita R. ;
Rosenstock, Julio ;
Terauchi, Yasuo ;
Altuntas, Yuksel ;
Lalic, Nebojsa M. ;
Morales Villegas, Enrique C. ;
Jeppesen, Ole K. ;
Christiansen, Erik ;
Hertz, Christin L. ;
Haluzik, Martin .
DIABETES CARE, 2019, 42 (09) :1724-1732
[2]  
European Medicines Agency, 2020, RYB SUMM PROD CHAR
[3]  
Food and Drug Administration, 2020, DRUG APPR PACK RYBEL
[4]  
Food and Drug Administration, 2019, HIGHL PRESCR INF RYB
[5]   Oral Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes [J].
Husain, Mansoor ;
Birkenfeld, Andreas L. ;
Donsmark, Morten ;
Dungan, Kathleen ;
Eliaschewitz, Freddy G. ;
Franco, Denise R. ;
Jeppesen, Ole K. ;
Lingvay, Ildiko ;
Mosenzon, Ofri ;
Pedersen, Sue D. ;
Tack, Cees J. ;
Thomsen, Mette ;
Vilsboll, Tina ;
Warren, Mark L. ;
Bain, Stephen C. .
NEW ENGLAND JOURNAL OF MEDICINE, 2019, 381 (09) :841-851
[6]  
IBM Explorys EHR Solutions, WHAT IBM EXPL DAT AN
[7]  
Marso SP, 2016, NEW ENGL J MED, V375, P311, DOI [10.1056/NEJMoa1603827, 10.1056/NEJMc1615712]
[8]  
Medicine Matters® Diabetes, 2020, QUICK GUID PIONEER T
[9]   Efficacy and safety of oral semaglutide with flexible dose adjustment versus sitagliptin in type 2 diabetes (PIONEER 7): a multicentre, open-label, randomised, phase 3a trial [J].
Pieber, Thomas R. ;
Bode, Bruce ;
Mertens, Ann ;
Cho, Young Min ;
Christiansen, Erik ;
Hertz, Christin L. ;
Wallenstein, Signe O. R. ;
Buse, John B. .
LANCET DIABETES & ENDOCRINOLOGY, 2019, 7 (07) :528-539
[10]  
Rodbard Helena W, 2020, Am J Manag Care, V26, pS335, DOI 10.37765/ajmc.2020.88554