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Primary care practitioner guide to the International Working Group on the Diabetic Foot “This article provides the recommendations on prevention of foot amputation in at-risk individuals with diabetes, and applies them to the Australian context.” evidence based on high-quality research is still lacking in many areas; however, people with diabetes are presenting to primary care providers for immediate intervention and need care. This article provides the recommendations on prevention of amputation in at-risk individuals with diabetes, and applies them to the Australian context. Further work is underway to support the generation of evidence to better prevent and manage people with diabetes, to work towards reaching the aim of significantly reducing foot ulcerations and amputations in people with diabetes. n Harris M (2009) The role of primary health care in preventing the onset of chronic disease, with a particular focus on the lifestyle risk factors of obesity, tobacco and alcohol. Centre for Primary Health Care and Equity, UNSW Hinchliffe RJ, Brownrigg JRW, Apelqvist J et al (2016) IWGDF guidance on the diagnosis, prognosis and management of peripheral artery disease in patients with foot ulcers in diabetes. Diabetes Metab Res Rev 32: 37–44 Iversen MM, Tell GS, Riise T et al (2009) History of foot ulcer increases mortality among individuals with diabetes: tenyear follow-up of the Nord-Trondelag Health Study, Norway. Diabetes Care 32: 2193–9 Lavery LA, Peters EJ, Williams JR et al (2008) Reevaluating the way we classify the diabetic foot: restructuring the diabetic foot risk classification system of the International Working Group on the Diabetic Foot. Diabetes Care 31: 154–6 Armstrong DG, Lavery LA (1997) Monitoring healing of acute Charcot’s arthropathy with infrared dermal thermometry. J Rehabil Res Dev 34: 317–21 Australian Commission on Safety and Quality in Health Care (2015) Australian Atlas of Healthcare Variation. Australian Commission on Safety and Quality in Health Care, Sydney, NSW. Available at: https://safetyandquality.gov.au/wp-content/uploads/2015/11/ SAQ201_07_Chapter6_v7_FILM_tagged_merged_6-8.pdf (accessed 19.05.17) Baker IDI Heart & Diabetes Institute (2011) National Evidencebased guideline. Prevention, identification and management of foot complications in diabetes (part of the guidelines on management of type 2 diabetes). Melbourne, Vic. Available at: www.baker.edu.au/Assets/Files/Foot_FullGuideline_23062011. pdf (accessed 16.05.17) Bakker K, Apelqvist J, Lipsky BA et al (2016) The 2015 IWGDF guidance documents on prevention and management of foot problems in diabetes: development of an evidence–based global consensus. Diabetes Metab Res Rev 32: 2–6 Bus SA, van Netten JJ, Lavery LA et al (2016a) IWGDF guidance on the prevention of foot ulcers in at–risk patients with diabetes. Diabetes Metab Res Rev 32: 16–24 Bus SA, Armstrong DG, van Deursen RW et al (2016b) IWGDF guidance on footwear and offloading interventions to prevent and heal foot ulcers in patients with diabetes. Diabetes Metab Res Rev 32: 25–36 Cathcart S, Cantrell W, Elewski BE (2009) Onychomycosis and diabetes. J Eur Acad Dermatol Venereol 23: 1119–22 Diabetic Foot Australia (2016) DFA Guides You Through: Australian and International Guidelines on Diabetic Foot Disease. Diabetic Foot Australia, West End, Qld. Available at: https://www. diabeticfootaustralia.org//wp-content/uploads/2016/07/DFA- Guides-you-through-guidelines.pdf (accessed 15.05.17) Faglia E, Favales F, Morabito A (2001) New ulceration, new major amputation, and survival rates in diabetic subjects hospitalized for foot ulceration from 1990 to 1993: a 6.5-year follow-up. Diabetes Care 24: 78–83 Game FL, Apelqvist J, Attinger C et al (2016) IWGDF guidance on use of interventions to enhance the healing of chronic ulcers of the foot in diabetes. Diabetes Metab Res Rev 32: 75–83 Gupta AK, Paquet M, Simpson FC (2013) Therapies for the treatment of onychomycosis. Clin Dermatol 31: 544–54 Guyatt GH, Oxman AD, Vist GE et al (2008) GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ 336: 924–6 Lipsky BA, Aragón–Sánchez J, Diggle M et al (2016) IWGDF guidance on the diagnosis and management of foot infections in persons with diabetes. Diabetes Metab Res Rev 32: 45–74 Magliano D, Peeters A, Vos T et al (2009) Projecting the burden of diabetes in Australia – what is the size of the matter? Aust N Z J Public Health 33: 540–3 McAra S, Trevethan R, Wang L, Tinley P (2016) Clinical vascular screening of the foot: For life and limb. Diabetes & Primary Care Australia 2: 16–23 National Diabetes Strategy Advisory Group (2015) A Strategic Framework for Action: Advice to Government on the Development of the Australian National Diabetes Strategy 2016–2020. Commonwealth of Australia, Canberra, ACT Ogrin R, Forgione N (2016) Prevention, screening and referral of people with diabetes related foot complications in primary care. Diabetes & Primary Care Australia 1: 86–93 Price P (2016) How can we improve adherence? Diabetes Metab Res Rev 32(Suppl 1): 201–5 Reiber GE, Vileikyte L, Boyko EJ et al (1999) Causal pathways for incident lower–extremity ulcers in patients with diabetes from two settings. Diabetes Care 22: 157–62 Ribu L, Hanestad BR, Moum T et al (2007) A comparison of the health–related quality of life in patients with diabetic foot ulcers, with a diabetes group and a nondiabetes group from the general population. Qual Life Res 16: 179–89 Schaper NC, Van Netten JJ, Apelqvist J et al (2016) Prevention and management of foot problems in diabetes: a Summary Guidance for Daily Practice 2015, based on the IWGDF Guidance Documents. Diabetes Metab Res Rev 32: 7–15 Scott JE, Hendry GJ, Locke J (2016) Effectiveness of percutaneous flexor tenotomies for the management and prevention of recurrence of diabetic toe ulcers: a systematic review. J Foot Ankle Res 9: 25 Singh N, Armstrong DG, Lipsky BA (2005) Preventing foot ulcers in patients with diabetes. JAMA 293: 217–28 Tennant J, McClelland M, Miller J (2015) Identifying nocturia as a contributor to diabetic foot ulcer healing delays. The Diabetic Foot Journal 18: 186–9 118 Diabetes & Primary Care Australia Vol 2 No 3 2017
Article The new class war: SGLT2 inhibitors versus DPP-4 inhibitors Merlin Thomas Over 90% of people with type 2 diabetes will need more than metformin monotherapy to achieve their targets for optimal glucose levels. There are many second-line options for glucose management in type 2 diabetes, including the sodium–glucose cotransporter 2 (SGLT2) inhibitor and dipeptidyl peptidase-4 (DPP-4) inhibitor classes. This article provides a framework for Australian general practices to compare the associated benefits and risks of SGLT2 inhibitors and DPP-4 inhibitors when added to metformin for the management of type 2 diabetes. Over 90% of people with type 2 diabetes will need more than metformin monotherapy to achieve their targets for optimal glucose levels. Dual therapy may begin early in their management, when it is clear that metformin is insufficient (primary failure) or later as the efficacy of metformin gradually wanes (secondary failure). The Royal Australian College of General Practitioners (RACGP) and Diabetes Australia (2014) guidelines recommend that when optimal glycaemic levels are not met, no more than 3–6 months should pass before a secondline agent is added. Of course, earlier initiation of combination therapy may be appropriate in some cases, especially when diabetes is clearly managed suboptimally. There are many second-line options for glucose management of type 2 diabetes, including the sodium–glucose cotransporter 2 (SGLT2) inhibitor and dipeptidyl peptidase-4 (DPP-4) inhibitor classes. These newer classes have a number of advantages compared to older classes, including reduced risk of hypoglycaemia and weight gain, and no need for dose-titration. So the question, rather than whether to use them, is which agent will be best for the patient you have in front of you? This article provides a framework to compare the associated benefits and risks of SGLT2 inhibitors and DPP-4 inhibitors, when added to metformin for the management of type 2 diabetes in Australian general practice. Question #1: efficacy The most obvious first question when deciding between an SGLT2 and a DPP-4 inhibitor is how well does each class lower glucose? Across clinical trials, SGLT2 inhibitors have been shown to lower HbA 1c by 7.2 mmol/mol (−0.66%; 95% confidence interval [CI], −0.73%, −0.58%; Vasilakou et al, 2013). Very similar results have also been reported for DPP-4 inhibitors in participants who were not achieving their glycaemic target on metformin alone (7.2 mmol/mol [−0.69%] 95% CI, −0.79%, −0.61%; Liu et al, 2012). It has been considered that there is no significant difference in glucose lowering achieved by either drug class (Goring et al, 2014). However, recent head-to-head studies have suggested that SGLT2 inhibitors may result in a greater glucose-lowering effect than DPP-4 inhibitors in people with type 2 diabetes very suboptimally managed diabetes at baseline (HbA 1c >75 mmol/mol [9%]; Rosenstock et al, 2014; DeFronzo et al, 2015). In contrast, for people with type 2 diabetes who have an HbA 1c around 53 mmol/mol (7%), a DPP-4 inhibitor may achieve a greater glucose-lowering effect. The effect of DPP-4 inhibitors on fasting plasma glucose may be modestly greater than with SGLT2 inhibitors in combination with metformin, while the converse may be true for post-prandial glucose levels (Rosenstock et al, 2014; DeFronzo et al, 2015). In people with type 2 diabetes who have renal impairment, there may be a reduction in SGLT2 inhibitor efficacy. The glucose-lowering effects of DPP-4 inhibitors are unaffected or Citation: Thomas M (2017) The new class war: SGLT2 inhibitors versus DPP-4 inhibitors. Diabetes & Primary Care Australia 2: 119–23 Article points 1. Over 90% of people with type 2 diabetes will require additional medication after metformin. 2. Dipeptidyl peptidase-4 inhibitors and sodium–glucose cotransporter 2 inhibitors provide an alternative to the older glucoselowering medications. 3. Drug regimens should be individualised and patient-centred. Key words – DPP-4 inhibitors – Dual therapy – SGLT2 inhibitors Author Merlin Thomas is Professor, Department of Diabetes, Central Clinical School, Monash University, Melbourne. Diabetes & Primary Care Australia Vol 2 No 3 2017 119
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