Protected: Qi11 – Lipid-lowering medications in diabetes v0.2

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Operationalisation

Denominator

Individuals aged ≥40 years with at least one ATC A10 (Drugs used in diabetes) dispensation during the examined year, and at least one ATC A10BA or A10BB or A10BD or A10BG or A10BH or A10BX  class medication dispensation during the examined year, or within two years (730 days) preceding the first dispensation during the examined year.  

Numerator

All defined in the denominator who were dispensed statins, ezetimibe, or PCSK9-inhibitors (ATC C10AA , C10AX09/13/14/16 or C10BA/BX, or combination product including a statin component A10BH5*) at least once during the examined year.

Exclusions (Numerator, denominator)

  • Individuals aged <40 years at the end of the year.
  • Individuals who die or emigrate during the year.

Notes

  • Diabetes patients are identified using blood glucose lowering medication dispensations as a proxy.
  • A dispensation of another diabetes medication except SGLT2-inhibitors, GLP1-analogues or insulin within three years is required to minimise the risk of including individuals with type 1 diabetes, or other indication for pharmacotherapy than diabetes. 

Sources of Data

  • Population register
  • Outpatient medication dispensations register

Information about the indicator set

Purpose

  • The quality indicator set is intended for comparison of effectiveness and/or safety aspects of prescribing across Nordic countries and subnational regions.
  • Further comparisons across population subgroups (e.g., socioeconomic position, immigration background) can inform equity considerations.
  • Further comparisons in relation to expenditures can inform efficiency considerations

Limitations

  • The indicators in the set use medication dispensings and/or sales data as a proxy for appropriate prescribing and medication use. This is to allow comparisons using register data, which have the advantage of being readily available and comprehensive in terms of population coverage and over time (5–7).
  • Register data are not without limitations. Medications may have been prescribed, but not collected from the pharmacy by the user. Collected medications may not have been (appropriately) used by the patient. Sales data may not be fully comparable across countries.
  • Register data are collected primarily for other purposes than quality assessment. Thus, discontinuities over time due to, e.g., legislative changes and administrative reforms need to be acknowledged in the interpretation of the results.
  • Indicators need to be updated regularly because clinical guidelines and the range of available medications change over time.
  • ATC-codes are based on WHO Collaborating Centre for Drug Statistics Methodology ATC/DDD Index version 2024

Background and literature related to the proposed indicator

Clinical guidelines

2023 European Society of Cardiology (ESC) Guidelines for the management of cardiovascular disease in patients with diabetes (5)

  • Statins recommended as first-choice (LDL-C)-lowering treatment in patients with diabetes and above targeg LDL-C-levels.
  • Combination of statin with ezetimibe recommended if target is not reached with statins.
  • A PCSK9 inhibitor recommended in patients at very high cardiovascular risk who do not achieve targets despite maximum tolerated statin dose in combination with ezetimibe or who are statin intolerant.
  • If patient is intolerant to statins, ezetimibe with or without PCSK9 inhibitor should be considered.

Finnish Current Care guideline on dyslipidemias (10)

  • Patients with diabetes are considered at risk for arterial disease.
  • Patients with diabetes duration >10 years or one risk factor (e.g., smoking, dyslipidemia, hypertension) are considered at high risk
  • Patients with diabetes and clinical arterial disease, target-organ damage, or three risk factors, or type 1 diabetes duration >20 years are considered at very high risk
  • Patients at high risk generally require lipid-lowering medications.
  • Statin is fist-choice medication. Ezetimibe or PCSK9 inhibitor may be added if targets are not reached with statin alone. PCSK9 inhibitor may be considered if statins cannot be used.

Similar or related indicators in Nordic or European quality assessment guidelines or databases

2022 ESC Quality Indicators for Cardiovascular Disease Prevention (11)

  • Proportion of patients 40–70 years of age with very high risk for ASCVD and a baseline LDL-C ≥ 1.8 mmol/L (≥70 mg/dL) who are prescribed lipid lowering therapy.

OECD Healthcare quality indicators, prescribing in primary care (12)

  • Diabetic patients with at least one prescription of cholesterol lowering medication

Swedish Association of Local Authorities and Regions quality indicators (Vården i siffror) & The Swedish National Diabetes Register (13)

  • Proportion of patients (≥18 years) with diabetes in primary care who are treated with lipid-lowering medications (14)
  • Proportion of patients (≥18 years) with type 1 diabetes in specialis care who are treated with lipid-lowering medications (15)

Similar or related indicators in international scientific literature

  • Patients treated with antidiabetics and statins divided by no. of patients treated with antidiabetics x 100% (higher score desirable, based on guidelines) (16)
  • A high rate of prescribing of statins and aspirin in patients with non-insulin-dependent diabetes mellitus (17)
  • Appropriate & necessary: Statins in patients at high risk of cardiovascular events (& dosing of statins simvastatin ≥40 mg/d (or equivalent): previous vascular event, peripheral vascular disease, or age >40 with diabetes mellitus without established vascular disease (18)
  • Percentage of patients with diabetes treated with lipid-lowering medications (19)
  • Guideline-based prescribing in diabetes – Use statin. Diabetes patients identified based on use of oral or non-oral diabetes medications during the analysis year (20)
  • Potentially drug-related preventable hospitalisation: Hospitalisation due to cardiovascular disease in patient with history of diabetes and not on lipid lowering drug (21)
  • Hierarchic register data algorithm to distinguish statin users by indication (evidence strongly supports statin use for patients with myocardial infarction (MI); ischaemic heart disease (IHD); peripheral arterial disease (PAD); and diabetes) (22)
  • Diabetes: Start statins in patients with a high or very high cardiovascular risk (23)
  • Start statins (first line) in patients with very high cardiovascular risk (e.g., heart disease, T2DM, T1DM with organ impairment, moderate to severe renal impairment) (23)
  • The percentage of patients with type 2 diabetes between 55 and 80 years treated with statins (24)
  • The proportion of patients at high cardiovascular risk (e.g., diabetes over age 40; or known cardiovascular disease or with 10-year coronary heart disease risk >10%) who were dispensed a statin and of those, the proportion who are using statins for at least 80% of a one-year period. (25)
  • Hospitalisation outcome to avoid: Ischaemic event, in patient with history of diabetes or ischaemic event, and no antiplatelet or lipid lowering medications (26)

References

  1. Ong KL, Stafford LK, McLaughlin SA, Boyko EJ, Vollset SE, Smith AE, et al. Global, regional, and national burden of diabetes from 1990 to 2021, with projections of prevalence to 2050: a systematic analysis for the Global Burden of Disease Study 2021. The Lancet. 2023 Jul 15;402(10397):203–34.
  2. Lancet T. Diabetes: a defining disease of the 21st century. The Lancet. 2023 Jun 24;401(10394):2087.
  3. Sun H, Saeedi P, Karuranga S, Pinkepank M, Ogurtsova K, Duncan BB, et al. IDF Diabetes Atlas: Global, regional and country-level diabetes prevalence estimates for 2021 and projections for 2045. Diabetes Res Clin Pract. 2022 Jan 1;183:109119.
  4. OECD. Health at a Glance 2023: OECD Indicators [Internet]. OECD; 2023 [cited 2024 May 3]. (Health at a Glance). Available from: https://www.oecd-ilibrary.org/social-issues-migration-health/health-at-a-glance-2023_7a7afb35-en
  5. Marx N, Federici M, Schütt K, Müller-Wieland D, Ajjan RA, Antunes MJ, et al. 2023 ESC Guidelines for the management of cardiovascular disease in patients with diabetes: Developed by the task force on the management of cardiovascular disease in patients with diabetes of the European Society of Cardiology (ESC). Eur Heart J. 2023 Oct 14;44(39):4043–140.
  6. Hill-Briggs F, Adler NE, Berkowitz SA, Chin MH, Gary-Webb TL, Navas-Acien A, et al. Social Determinants of Health and Diabetes: A Scientific Review. Diabetes Care. 2021 Jan;44(1):258–79.
  7. Laugesen K, Ludvigsson JF, Schmidt M, Gissler M, Valdimarsdottir UA, Lunde A, et al. Nordic Health Registry-Based Research: A Review of Health Care Systems and Key Registries. Clin Epidemiol. 2021 Dec 31;13:533–54.
  8. Furu K, Wettermark B, Andersen M, Martikainen JE, Almarsdottir AB, Sørensen HT. The Nordic countries as a cohort for pharmacoepidemiological research. Basic Clin Pharmacol Toxicol. 2010 Feb;106(2):86–94.
  9. Rasmussen L, Wettermark B, Steinke D, Pottegård A. Core concepts in pharmacoepidemiology: Measures of drug utilization based on individual-level drug dispensing data. Pharmacoepidemiol Drug Saf. 2022;31(10):1015–26.
  10. Dyslipidemiat [Internet]. [cited 2024 Apr 24]. Available from: https://www.kaypahoito.fi/hoi50025
  11. Aktaa S, Gencer B, Arbelo E, Davos CH, Désormais I, Hollander M, et al. European Society of Cardiology Quality Indicators for Cardiovascular Disease Prevention: developed by the Working Group for Cardiovascular Disease Prevention Quality Indicators in collaboration with the European Association for Preventive Cardiology of the European Society of Cardiology. Eur J Prev Cardiol. 2022 May 1;29(7):1060–71.
  12. Healthcare Quality and Outcomes Indicators – OECD [Internet]. [cited 2024 Feb 29]. Available from: https://www.oecd.org/health/health-care-quality-outcomes-indicators.htm
  13. The Swedish National Diabetes Register – Nationella Diabetesregistret [Internet]. [cited 2024 May 3]. Available from: https://ndr.registercentrum.se/in-english/the-swedish-national-diabetes-register/p/BJyILnupj
  14. Blodfettssänkande behandling vid diabetes – primärvård [Internet]. [cited 2024 May 3]. Available from: https://vardenisiffror.se/indikator/f1a785db-b131-4532-9a4e-130f54bb20a7?datefrom=2022-07-01&dateto=2023-12-31&gender&periodtype=quarter&relatedmeasuresbyentry=keyword&relatedmeasuresbyid=lakemedelsbehandling&showtarget=false&units=18&units=09&units=04&units=14&units=19&units=23&units=17&units=10&units=21&units=25&units=05&units=07&units=12&units=03&units=20&units=01&units=24&units=13&units=08&units=06&units=22&units=se
  15. Blodfettssänkande behandling vid diabetes typ 1 – medicinklinik [Internet]. [cited 2024 May 3]. Available from: https://vardenisiffror.se/indikator/263ce1eb-140d-43e3-a17e-c50e5dabd0e2?datefrom=2022-07-01&dateto=2023-12-31&gender&periodtype=quarter&relatedmeasuresbyentry=keyword&relatedmeasuresbyid=lakemedelsbehandling&showtarget=false&units=18&units=09&units=04&units=14&units=19&units=23&units=17&units=10&units=21&units=25&units=05&units=07&units=12&units=03&units=20&units=01&units=24&units=13&units=08&units=06&units=22&units=se
  16. Muijrers PEM, Janknegt R, Sijbrandij J, Grol RPTM, Knottnerus JA. Prescribing indicators. Eur J Clin Pharmacol. 2004 Dec 1;60(10):739–46.
  17. Okechukwu I, Bennett K, Feely J. General practitioners’ ranking of evidence-based prescribing quality indicators: a comparative study with a prescription database. Br J Clin Pharmacol. 2006;62(2):218–24.
  18. Dreischulte T, Grant AM, McCowan C, McAnaw JJ, Guthrie B. Quality and safety of medication use in primary care: consensus validation of a new set of explicit medication assessment criteria and prioritisation of topics for improvement. BMC Clin Pharmacol. 2012 Feb 8;12:5.
  19. Selim AJ, Fincke BG, Rogers WH, Qian S, Selim BJ, Kazis LE. Guideline-recommended medications: variation across medicare advantage plans and associated mortality. J Manag Care Pharm. 2013 Mar;19(2):132–8.
  20. Manteuffel M, Williams S, Chen W, Verbrugge RR, Pittman DG, Steinkellner A. Influence of Patient Sex and Gender on Medication Use, Adherence, and Prescribing Alignment with Guidelines. J Womens Health 15409996. 2014 Feb;23(2):112–9.
  21. Caughey GE, Kalisch Ellett LM, Wong TY. Development of evidence-based Australian medication-related indicators of potentially preventable hospitalisations: a modified RAND appropriateness method. BMJ Open. 2014 Apr 28;4(4):e004625.
  22. Wallach-Kildemoes H, Stovring H, Holme Hansen E, Howse K, Pétursson H. Statin prescribing according to gender, age and indication: what about the benefit–risk balance? J Eval Clin Pract. 2016;22(2):235–46.
  23. Desnoyer A, Blanc AL, Pourcher V, Besson M, Fonzo-Christe C, Desmeules J, et al. PIM-Check: development of an international prescription-screening checklist designed by a Delphi method for internal medicine patients. BMJ Open. 2017 Jul 31;7(7):e016070.
  24. Smits KPJ, Sidorenkov G, Kleefstra N, Bouma M, Meulepas M, Voorham J, et al. Development and validation of prescribing quality indicators for patients with type 2 diabetes. Int J Clin Pract. 2017 Jan;71(1).
  25. Spackman E, Clement F, Allan GM, Bell CM, Bjerre LM, Blackburn DF, et al. Developing key performance indicators for prescription medication systems. PloS One. 2019;14(1):e0210794.
  26. Spinks JM, Kalisch Ellett LM, Spurling G, Theodoros T, Williamson D, Wheeler AJ. Adaptation of potentially preventable medication-related hospitalisation indicators for indigenous populations in Australia using a modified Delphi technique. BMJ Open. 2019 Nov;9(11):e031369.