Implementing the new NICE guidelines for type 2 diabetes (NG28): Focusing beyond HbA1c targets and clinically phenotyping patients to the appropriate second-line agent

Authors

  • Lakshminarayanan Varadhan Consultant Physician, Diabetes and Endocrinology, University Hospitals of North Midlands NHS trust https://orcid.org/0000-0003-1976-8071
  • Ponnusamy Saravanan Populations, Evidence and Technologies, Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, CV4 7AL Academic Department of Diabetes, Endocrinology and Metabolism, George Eliot Hospital NHS Trust, Nuneaton, CV10 7DJ
  • Sarah Ali Consultant Physician in Diabetes Department of Diabetes and Endocrinology Royal Free London NHS Foundation Trust Pond Street London NW3 2QG
  • Wasim Hanif Professor of Diabetes, University Hospitals Birmingham NHS Foundation trust Mindelsohn way, Edgbaston Birmingham B15 2GW
  • Vinod Patel Professor, Diabetes and Clinical Skills Warwick Medical School, University of Warwick Hon Consultant in Endocrinology and Diabetes, Acute Medicine, Medical Obstetrics Diabetes and Endocrinology Centre, George Eliot Hospital NHS Trust, Nuneaton

DOI:

https://doi.org/10.15277/bjd.2022.385

Keywords:

SGLT2i, clinical phenotyping, NICE

Abstract

A significant number of cardiovascular outcome trials have been published to support decision-making regarding treatment options after or alongside metformin in people with type 2 diabetes (T2DM), specifically targeting prevention of adverse cardiovascular and renal outcomes. The latest NICE guidelines recommend the use of sodium-glucose transport inhibitors (SGLT2i) in patients with cardiovascular diseases, heart failure and chronic kidney disease with diabetes and recommends the use of glucagon-like polypeptide receptor agonists (GLP-1RA) only in a selected group of patients. A comprehensive summary of the various trials, structured around patient characteristics and clinical outcomes, can help to compare the various classes of drugs and drugs within the class. Since the drug acquisition cost within a class is generally the same in the UK, the drug with the best available evidence in the class should be chosen to maximise clinical benefit for the patient. Clinical phenotyping, a process of aligning a patient to the inclusion criteria and the desired clinical outcomes of a trial, can guide the choice of the best drug within a class.

References

Basu A, Patel D, Winocour P, Ryder REJ. Cardiovascular impact of new drugs (GLP-1 and gliflozins): The ABCD position statement. Br J Diabetes 2021; 21:132-48. https://doi.org/10.15277/bjd.2021.283

NICE Guideline NG28: Type 2 diabetes in adults: management. 2022; Available at: https://www.nice.org.uk/guidance/ng28. Accessed 11/03/, 2022.

Moran GM, Bakhai C, Song SH, Agwu JC, Guideline Committee. Type 2 diabetes: summary of updated NICE guidance. BMJ 2022;377:o775. https://doi.org/10.1136/bmj.0775

Zinman B, Wanner C, Lachin JM, et al. Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. N Engl J Med 2015;373(22):2117-28. https://doi.org/10.1056/NEJMoa1504720

Wiviott SD, Raz I, Bonaca MP, et al. Dapagliflozin and Cardiovascular Outcomes in Type 2 Diabetes. N Engl J Med 2019;380(4):347-57. https://doi.org/10.1056/NEJMoa1812389

Varadhan L, Saravanan P, Ali SN, Hanif W, Patel V. Informing and Empowering Patients and Clinicians to Make Evidence-Supported Outcome-Based Decisions in Relation to SGLT2 Inhibitor Therapies: The Use of the Novel Years of Drug administration (YoDa) Concept. Clin Drug Investig 2022;42(2):113-25. https://doi.org/10.1007/s40261-021-01105-07

Hernandez AF, Green JB, Janmohamed S, et al. Albiglutide and cardiovascular outcomes in patients with type 2 diabetes and cardiovascular disease (Harmony Outcomes): a double-blind, randomised placebo-controlled trial. Lancet 2018;392(10157):1519-29. https://doi.org/10.1016/S0140-6736(18)32261-x

Cannon CP, Pratley R, Dagogo-Jack S, et al. Cardiovascular Outcomes with Ertugliflozin in Type 2 Diabetes. N Engl J Med 2020;383(15):1425-35. https://doi.org/10.1056/NEJMoa2004967

Pfeffer MA, Claggett B, Diaz R, et al. Lixisenatide in Patients with Type 2 Diabetes and Acute Coronary Syndrome. N Engl J Med 2015;373(23):2247- 2257. https://doi.org/10.NEJMoa1509225

Neal B, Perkovic V, Mahaffey KW, et al. Canagliflozin and Cardiovascular and Renal Events in Type 2 Diabetes. N Engl J Med 2017;377(7):644-57. https://doi.org/10.1056/NEJMoa1611925

Marso SP, Daniels GH, Brown-Frandsen K, et al. Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes. N Engl J Med 2016;375(4):311-22. https://doi.org/10.1056/NEJMoa1603827

Marso SP, Bain SC, Consoli A, et al. Semaglutide and cardiovascular outcomes in patients with type 2 diabetes. N Engl J Med 2016;375(19):1834-44. https://doi.org/10.1056/NEJMoa1607141

Gerstein HC, Colhoun HM, Dagenais GR, et al. Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo- controlled trial. Lancet 2019;394(10193):121-30. https://doi.org/10.1016/S0140-6736(19)31149-3

Husain M, Birkenfeld AL, Donsmark M, et al. Oral Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes. N Engl J Med 2019; 381(9):841-51. https://doi.org/10.1056/NEJMoa1901118

Furtado RHM, Bonaca MP, Raz I, et al. Dapagliflozin and Cardiovascular Outcomes in Patients With Type 2 Diabetes Mellitus and Previous Myocardial Infarction. Circulation 2019;139(22):2516-27. https://doi.org/10.1161/CIRCULATIONAHA.119.039996

Mahaffey KW, Neal B, Perkovic V, et al. Canagliflozin for Primary and Secondary Prevention of Cardiovascular Events: Results From the CANVAS Program (Canagliflozin Cardiovascular Assessment Study). Circulation 2018;137(4):323-34. https://doi.org/10.1161/CIRCULATIONAHA.117032038

Verma S, Poulter NR, Bhatt DL, et al. Effects of Liraglutide on Cardiovascular Outcomes in Patients With Type 2 Diabetes Mellitus With or Without History of Myocardial Infarction or Stroke. Circulation 2018;138(25):2884-94. https://doi.org/10.1161/CIRCULATIONAHA.118.034516

Leiter LA, Bain SC, Hramiak I, et al. Cardiovascular risk reduction with once-weekly semaglutide in subjects with type 2 diabetes: a post hoc analysis of gender, age, and baseline CV risk profile in the SUSTAIN 6 trial. Cardiovasc Diabetol 2019;18(1):73-8. https://doi.org/10.1186/s12933-019-0871-8

White WB, Cannon CP, Heller SR, et al. Alogliptin after acute coronary syndrome in patients with type 2 diabetes. N Engl J Med 2013;369(14):1327-35. https://doi.org/10.1056/NEJMoa1305889

Rosenstock J, Perkovic V, Johansen OE, et al. Effect of Linagliptin vs Placebo on Major Cardiovascular Events in Adults With Type 2 Diabetes and High Cardiovascular and Renal Risk: The CARMELINA Randomized Clinical Trial. JAMA 2019;321(1):69-79. https://doi.org/10.1001/jama.2018.18269

Scirica BM, Bhatt DL, Braunwald E, et al. Saxagliptin and cardiovascular outcomes in patients with type 2 diabetes mellitus. N Engl J Med 2013; 369(14):1317-26. https://doi.org/10.1056/NEJMoa1307684

Green JB, Bethel MA, Armstrong PW, et al. Effect of Sitagliptin on Cardiovascular Outcomes in Type 2 Diabetes. N Engl J Med 2015;373(3):232-42. https://doi.org/10.1056/NEJMoa1501352

McMurray JJV, Solomon SD, Inzucchi SE, et al. Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction. N Engl J Med 2019; 381(21):1995-2008. https://doi.org/10.1056/NEJMoa1911303

Packer M, Anker SD, Butler J, et al. Cardiovascular and Renal Outcomes with Empagliflozin in Heart Failure. N Engl J Med 2020;383(15):1413-24. https://doi.org/10.1056/NEJMoa2022190

Radholm K, Figtree G, Perkovic V, et al. Canagliflozin and Heart Failure in Type 2 Diabetes Mellitus: Results From the CANVAS Program. Circulation 2018; 138(5):458-68. https://doi.org/10.1161/CIRCULATIONAHA.118.04222

Anker SD, Butler J, Filippatos G, et al. Empagliflozin in Heart Failure with a Preserved Ejection Fraction. N Engl J Med 2021;385(16):1451-61. https://doi.org/10.1056/NEJM0a2107038

Perkovic V, Jardine MJ, Neal B, et al. Canagliflozin and Renal Outcomes in Type 2 Diabetes and Nephropathy. N Engl J Med 2019;380(24):2295-306. https://doi.org/10.1056/NEJMoa1811744

Heerspink HJL, Stefansson BV, Correa-Rotter R, et al. Dapagliflozin in Patients with Chronic Kidney Disease. N Engl J Med 2020;383(15):1436-46. https://doi.org/10.1056/NEJMoa2024816

Wanner C, Inzucchi SE, Lachin JM, et al. Empagliflozin and Progression of Kidney Disease in Type 2 Diabetes. N Engl J Med 2016;375(4):323-34. https://doi.org/10.1056/NEJMoa1515920

Neuen BL, Ohkuma T, Neal B, et al. Cardiovascular and Renal Outcomes With Canagliflozin According to Baseline Kidney Function. Circulation 2018; 138(15):1537-50. https://doi.org/10.1161/CIRCULATIONAHA.118.035901

Mann JFE, Orsted DD, Brown-Frandsen K, et al. Liraglutide and Renal Outcomes in Type 2 Diabetes. N Engl J Med 2017;377(9):839-48. https://doi.org/10.1056/NEJMoa1616011

Hippisley-Cox J, Coupland C, Vinogradova Y, et al. Performance of the QRISK cardiovascular risk prediction algorithm in an independent UK sample of patients from general practice: a validation study. Heart 2008;94(1):34-39. https://doi.org/10.1136/hrt.2007.134890

Cahn A, Raz I, Leiter LA, et al. Cardiovascular, Renal and Metabolic Outcomes of Dapagliflozin versus Placebo in a primary cardiovascular Prevention Cohort: Analyses from DECLARE-TIMI 58. Emerging Therapies: Drugs and Regimens 2021;44(5):1159-67. https://doi.org/10.2337/dc20-2492

Palmer SC, Tendal B, Mustafa RA, et al. Sodium-glucose cotransporter protein-2 (SGLT-2) inhibitors and glucagon-like peptide-1 (GLP-1) receptor agonists for type 2 diabetes: systematic review and network meta-analysis of randomised controlled trials. BMJ 2021;372:m4573. https://doi.org/10.1136/bmj.m4573

Patorno E, Pawar A, Franklin JM, et al. Empagliflozin and the Risk of Heart Failure Hospitalization in Routine Clinical Care. Circulation 2019; 139(25):2822-30. https://doi.org/10.1161/CIRCULATIONAHA.118.039177

Kosiborod M, Lam CSP, Kohsaka S, et al. Cardiovascular Events Associated With SGLT-2 Inhibitors Versus Other Glucose-Lowering Drugs: The CVD-REAL 2 Study. J Am Coll Cardiol 2018;71(23):2628-39. https://doi.org/10.1016/j/jacc.2018.03.009

Kosiborod M, Cavender MA, Fu AZ, et al. Lower Risk of Heart Failure and Death in Patients Initiated on Sodium-Glucose Cotransporter-2 Inhibitors Versus Other Glucose-Lowering Drugs: The CVD-REAL Study (Comparative Effectiveness of Cardiovascular Outcomes in New Users of Sodium-Glucose Cotransporter-2 Inhibitors). Circulation 2017;136(3):249-59. https://doi.org/10.1161/CIRCULATIONAHA.117.029190

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Published

2022-12-21

Issue

Vol. 22 No. 2 (2022): December 2022

Section

Learning from practice

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