The application of the STOPP/START criteria in the elderly patients with type 2 diabetes mellitus and essential hypertension at the endocrinology department of a multidisciplinary hospital

Objective. To assess the polypharmacy and the appropriateness of prescribed drugs according to the STOPP/START criteria of elderly patients with type 2 diabetes mellitus (T2DM) аnd essential arterial hypertension (HTN) at the endocrinology department of a multidisciplinary hospital.

Design and methods. Medical records of 260 patients ≥ 65 years old (65-93 years old, average age — 75,2 ± 6,8 years, 219 women) with T2DM and HTN admitted to the endocrinology department of the multidisciplinary hospital (Moscow, Russia) were analyzed according to the “STOPP/START” criteria.

Results. Five and more medications (polypharmacy) were simultaneously prescribed in 211 people (81,2 %). We identified that potentially not recommended (which should be avoided in certain cases) drugs were prescribed to 58 patients (22,3 %). At the same time 178 patients (65,4 %) did not get prescription for the recommended medications. The most frequent identified STOPP criteria included: 1) glibenclamide or chlorpropamide or glimepiride in patients with T2DM (29,5 %); 2) loop diuretics in the absence of clinical signs of heart failure (17,9 %); 3) glibenclamide in T2DM (15,4 %). The most frequent START criteria included: 1) statin therapy in patients with the documented history of coronary, cerebral or peripheral vascular disease, where the patient’s functional status remains independent for daily activities and life expectancy is more than 5 years (30,5 %); 2) aspirin with the documented history of atherosclerotic coronary disease in patients with sinus rhythm (16,3 %); 3) clopidogrel with a documented history of cerebral or peripheral vascular disease (15,1 %).

Conclusions. According to our data, in patients aged 65 years and older with T2DM and HTN, polypharmacy occurs in more than 80 % of cases. In patients ≥ 65 years old with T2DM potentially not recommended drugs are often administrated, while recommended medications are not prescribed. Our findings demonstrate the need for optimization of pharmacotherapy in elderly and senile patients with T2DM and HTN.

1. Surinov AE, Baranov EF, Bezborodova TS, Bobylev SN, Bugakova NS, Gokhberg LM et al. Russia in numbers 2018. A brief statistical compilation. M.: Rosstat, 2018. 255 p. In Russian.

2. Dedov II, Shestakova MV, Vikulova OK, Zheleznyakova AV, Isakov MA. Diabetes mellitus in the Russian Federation: prevalence, incidence, mortality, parameters of glycaemic control and structure of glucose lowering therapy according to the Federal Diabetes Register, status 2017. Diabetes Mellitus. 2018;21(3): 144-159. doi:10.14341/DM9686. In Russian.

3. Oganov RG, Simanenkov VI, Bakulin IG, Bakulina NV, Barbarash OL, Boytsov SA et al. Comorbidities in clinical practice. Algorithms for diagnostics and treatment. Cardiovascular Therapy and Prevention. 2019;18 (1):5-66. https://doi.org/10.15829/1728-8800-2019-1-5-66. In Russian.

4. Sychev DA. Polypharmacy in clinical practice: a problem and solutions. 2nd edition. St. Petersburg: CSC “Professya”, 2018. 272 p. In Russian.

5. Payne R, Avery A, Duerden M, Saunders C, Simpson C, Abel G. Prevalence of polypharmacy in a Scottish primary care population. Eur J Clin Pharmacol. 2014;70(5):575-581. doi:10.1007/s00228-013-1639-9

6. O’Connor MN. Adverse drug reactions in older people during hospitalisation: prevalence, risk factors and recognition. Unpublished MD thesis. University College Cork. Cork: 2013.

7. Garfinkel D, Zur-Gil S, Ben-Israel J. The war against polypharmacy: a new cost-effective geriatric-palliative approach for improving drug therapy in disabled elderly people. Isr Med Assoc J. 2007;9(6):430-434.

8. On the order of the medical care within the specialty “clinical pharmacology” #575n. URL: https://www.rosminzdrav.ru/documents/9146-prikaz-ministerstva-zdravoohraneniya-rossiyskoy-federatsii-ot-2-noyabrya-2012-g-575n-ob-utverzhdenii-poryadka-okazaniya-meditsinskoy-pomoschi-po-profilyu-klinicheskaya-farmakologiya. In Russian.

9. On the order of the administration and prescription of medications, order of the prescription format, recording and storing: order of the Ministry of Health ofthe Russian Federation dated by 20.12.2012 #1175n. URL: https://www.rosminzdrav.ru/documents/9171-prikaz-ministerstva-zdravoohraneniya-rossiyskoy-federatsii-ot-20-dekabrya-2012-g-1175n. In Russian.

10. Hovstadius B, Hovstadius K, Astrand B, Petersson G. Increasing polypharmacy — an individual-based study of the Swedish population 2005-2008. BMC Clin Pharmacol. 2012;10:16. doi:10.1186/1472-6904-10-16

11. Hajjar ER, Gray SL, Slattum PW, Starner CI et al. Geriatrics. In: DiPiro JT, Talbert RL, Yee GC, Matzke GR et al. Pharmacotherapy: a pathophysiologic approach. 9th ed. McGraw-Hill Education. 2014;107-118.

12. Hamilton H, Gallagher P, Ryan C, Byrne S, O'Mahony D. Potentially inappropriate medications defined by STOPP criteria and the risk of adverse drug events in older hospitalized patients. Arch Intern Med. 2011;171(11):1013-1019. doi:10.1001/archin-ternmed.2011.215

13. Barry P, Gallagher P, Ryan C, O’Mahony D. START (screening tool to alert doctors to the right treatment) — an evidence-based screening tool to detect prescribing omissions in elderly patients. Age and Ageing. 2007;36(6):632-638. doi:10.1093/ageing/afm118

14. O’Mahony D, Gallagher P, Ryan C, Byrne S, Hamilton H, Barry P et al. STOPP & START criteria: a new approach to detecting potentially inappropriate prescribing in old age. European Geriatric Medicine. 2010;1(1):45-51. doi:10.1016/j.eurger.2010.01.007

15. Dedov II, Shestakova MV, Mayorov AY, Vikulova OK, Galstyan GR, Kuraeva TL et al. Standards of specialized diabetes care. Ed. by Dedov II, Shestakova MV, Mayorov AY 8th edition. Diabetes mellitus. 2017;20(1S):1-121. https://doi.org/10.14341/DM20171S8 In Russian.

16. Gangji AS, Cukierman T, Gerstein HC, Goldsmith CH, Clase CM. A systematic review and meta-analysis of hypoglycemia and cardiovascular events: a comparison of glyburide with other secretagogues and with insulin. Diabetes Care. 2007;30(2):389—394. doi:10.2337/dc06-1789

17. Abdelhafiz AH, Rodriguez-Manas L, Morley JE, Sinclair AJ. Hypoglycemia in older people — a less well recognized risk factor for frailty. Aging and Disease. 2015;6(2):156—167. http://dx.doi.org/10.14336/AD.2014.0330

18. Goto А, Arah ОА, Goto М, Terauchi Y, Noda M. Severe hypoglycaemia and cardiovascular disease: systematic review and meta-analysis with bias analysis. Br Med J. 2013;347:f4533. https://doi.org/10.n36/bmj.f4533

19. Shorr RI, Ray WA, Daugherty JR, Griffin MR. Incidence and risk factors for serious hypoglycemia in older persons using insulin or sulfonylureas. Arch Intern Med. 1997;157(15): 1681—1686. https://doi.org/10.1001/archinte.1997.00440360095010

20. Noale M, Veronese N, Cavallo Perin P, Pilotto A, Tiengo A, Crepaldi G et al. Polypharmacy in elderly patients with type 2 diabetes receiving oral antidiabetic treatment. Acta Diabetol. 2016;53 (2):323-330. https://doi.org/10.1007/s00592-015-0790-4

21. Sharonova LA, Verbovoy AF, Kosareva OV. The role of sulfonylures in the treatment of type 2 diabetes. Diabetes Mellitus. 2016;19(3):221—228. doi:10.14341/DM2003422-27. In Russian.

22. RLS: Pharmacological group — Hypoglycemic synthetic and other drugs. [Internet]. Available from: https://www.rlsnet.ru/fg_index_id_292.htm [cited 2019 May 3. In Russian].

23. Кукес В. Г. Клиническая фармакология. М.: ГЭОТАР-Медиа, 2006. 944 с. [Kukes VG. Clinical pharmacology. M.: GEOTAR-Media, 2006. 944 p. In Russian].

24. Cianfrone G, Pentangelo D, Cianfrone F, Mazzei F, Turchetta R, Orlando MP et al. Pharmacological drugs inducing ototoxicity, vestibular symptoms and tinnitus: a reasoned and updated guide. Eur Rev Med Pharmacol Sci. 2011;15(6):601-636.

25. Williams B, Mancia G, Spiering W, Agabiti Rosei E, Azizi M, Burnier M et al; Authors/Task Force Members. 2018 ESC/ESH Guidelines for the management of arterial hypertension: The Task Force for the management of arterial hypertension of the European Society of Cardiology and the European Society of Hypertension: The Task Force for the management of arterial hypertension of the European Society of Cardiology and the European Society of Hypertension. J Hypertens. 2018;36(10):1953-2041. doi:10.1097/HJH.0000000000001940

26. Taylor RJ, Lemtouni S, Weiss K, Pergolizzi JV. Pain management in the elderly: an FDA safe use initiative expert panel’s view on preventable harm associated with NSAID. Curr Gerontol Geriatr Res. 2012; article ID 196159:9 р. doi:10.1155/2012/196159

27. Wehling M. Non-steroidal anti-inflammatory drug use in chronic pain conditions with special emphasis on the elderly and patients with relevant comorbidities: management and mitigation of risks and adverse effects. Eur J Clin Pharmacol. 2014;70(10):1159— 1172. doi:10.1007/s00228-014-1734-6

28. Antman EM, Bennett JS, Daugherty A, Furberg C, Roberts H, Taubert KA. AHA scientific statements use of nosteroidal antiflammotory drugs. Circulation. 2007;115(12):1634-1642. doi:10.1161/CIRCULATIONAHA.106.181424

29. The Scandinavian Simvastatin Survival Study group. Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease: the Scandinavian Simvastatin Survival Study (4S). Lancet. 1994;344 (8934):1383-1389. doi.org/10.1016/S0140-6736(94)90566-5. doi:10.1016/S0140-6736(02)09327-3

30. Catapano AL, Graham I, De Backer G, Wiklund O, Chapman MJ, Drexel H et al; ESC Scientific Document Group. 2016 ESC/EAS Guidelines for the management of dyslipidaemias. Eur Heart J. 2016;37(39):2999-3058. doi:10.1093/eurheartj/ehw272

31. Harker LA, Boissel IP, Pilgrim AJ, Gent M. Comparative safety and tolerability of clopidogrel and aspirin: results from CAPRIE. CAPRIE Steering Committee and Investigators. Clopidogrel versus aspirin in patients at risk of ischaemic events. Drug Saf. 1999;21(4):325-335.

32. Bhatt DL, Flather MD, Hacke W, Berger PB, Black HR, Boden WE et al; CHARISMA Investigators. Patients with prior myocardial infarction, stroke, or symptomatic peripheral arterial disease in the CHARISMA trial. J Am Coll Cardiol. 2007;49 (19):1982—1988. doi:10.1016/j.jacc.2007.03.025

33. Task Force Members, Montalescot G, Sechtem U, Achenbach S, Andreotti F, Arden C, Budaj A et al. 2013 ESC guidelines on the management of stable coronary artery disease: the Task Force on the management of stable coronary artery disease of the European Society of Cardiology. Eur Heart J. 2013;34 (38):2949—3003. doi:10.1093/eurheartj/eht296