185 defined daily doses (DDDs) per observed patient-year; "yellow" if patients received at least two prescriptions of at least one of the recommended medications; and "red" if patients did not receive at least two prescriptions of at least one of the recommended medications. The impact of the assignment of a patient to one of these three levels on all-cause mortality and CV risk was analyzed based on multivariable Cox regression analyses and reported as adjusted hazard ratios (HRs).RESULTS: We identified 32,916 patients with T2DM with an incident CV comorbidity (mean age 75.0 years, 54.2% female, Charlson Comorbidity Index [CCI]: 5.5). Observed patients received at least 185 DDDs of the following medication classes in the 12 months before/after the index date: vitamin K antagonists (6%/6%); antiplatelet drugs (9%/27%); novel oral anticoagulants (3%/13%); diuretics (48%/54%); beta blockers (31%/35%); calcium-channel blockers (34%/32%); renin-angiotensin-aldosterone system inhibitors (69%/68%); and lipid-modifying agents (19%/37%). When post-index therapy was compared to guideline recommendations, the level of "guideline adherence" was classified as "green" for 14.4% of the patients, "yellow" for 75.2% and "red" for 10.5%. An assignment of "red" was associated with worse CV outcomes in all analyses. Regarding mortality, in addition to one additional year of age (hazard ratio [HR] 1.04), CCI (HR 1.17), use of insulins (HR 1.25), digitalis glycosides (HR 1.52) and diuretics (HR 1.32), non-adherence to guideline recommendations ("red": HR 6.79; "yellow": HR: 1.30) was a significant predictor for early death, while female gender (HR 0.79), the participation in a disease management program (HR 0.69) and the use of antidiabetics other than insulin (HR 0.74) were generally associated with a reduced risk.CONCLUSION: Only a minority of patients with T2DM and an incident CV comorbidity receive a treatment fully adherent with guideline recommendations. This may contribute to high mortality rates in this population in clinical practice." />
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Gabler M, Picker N, Geier S, et al. Guideline Adherence and Associated Outcomes in the Treatment of Type 2 Diabetes Mellitus Patients With an Incident Cardiovascular Comorbidity: An Analysis Based on a Large German Claims Dataset. Diabetes Ther. 2021;12(4):1209-1226doi: 10.1007/s13300-021-01024-y.
Gabler, M., Picker, N., Geier, S., Ley, L., Aberle, J., Lehrke, M., Martin, S., Riedl, M., & Wilke, T. (2021). Guideline Adherence and Associated Outcomes in the Treatment of Type 2 Diabetes Mellitus Patients With an Incident Cardiovascular Comorbidity: An Analysis Based on a Large German Claims Dataset. Diabetes therapy : research, treatment and education of diabetes and related disorders, 12(4), 1209-1226. https://doi.org/10.1007/s13300-021-01024-y
Gabler, Maximilian, et al. "Guideline Adherence and Associated Outcomes in the Treatment of Type 2 Diabetes Mellitus Patients With an Incident Cardiovascular Comorbidity: An Analysis Based on a Large German Claims Dataset." Diabetes therapy : research, treatment and education of diabetes and related disorders vol. 12,4 (2021): 1209-1226. doi: https://doi.org/10.1007/s13300-021-01024-y
Gabler M, Picker N, Geier S, Ley L, Aberle J, Lehrke M, Martin S, Riedl M, Wilke T. Guideline Adherence and Associated Outcomes in the Treatment of Type 2 Diabetes Mellitus Patients With an Incident Cardiovascular Comorbidity: An Analysis Based on a Large German Claims Dataset. Diabetes Ther. 2021 Apr;12(4):1209-1226. doi: 10.1007/s13300-021-01024-y. Epub 2021 Mar 12. PMID: 33710520; PMCID: PMC7994459.
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Diabetes Ther. 2021 Apr;12(4):1209-1226. doi: 10.1007/s13300-021-01024-y. Epub 2021 Mar 12.

Guideline Adherence and Associated Outcomes in the Treatment of Type 2 Diabetes Mellitus Patients With an Incident Cardiovascular Comorbidity: An Analysis Based on a Large German Claims Dataset.

Diabetes therapy : research, treatment and education of diabetes and related disorders

Maximilian Gabler, Nils Picker, Silke Geier, Ludwin Ley, Jens Aberle, Michael Lehrke, Stephan Martin, Matthias Riedl, Thomas Wilke

Affiliations

  1. Boehringer Ingelheim Pharma GmbH & Co. KG, Binger Str. 173, 55216, Ingelheim am Rhein, Germany.
  2. Ingress-Health HWM GmbH, Alter Holzhafen 19, 23966, Wismar, Germany. [email protected].
  3. Universitätsklinikum Hamburg-Eppendorf (UKE), Martinistr. 52, 20246, Hamburg, Germany.
  4. Universitätsklinikum Aachen (RWTH), Pauwelsstraße 30, 52074, Aachen, Germany.
  5. Westdeutsches Diabetes- und Gesundheitszentrum (WDGZ), Hohensandweg 37, 40591, Düsseldorf, Germany.
  6. Medicum Hamburg MVZ GmbH, Beim Strohhause 2, 20097, Hamburg, Germany.
  7. Institut für Pharmakoökonomie und Arzneimittellogistik (IPAM), University of Wismar, Alter Holzhafen 19, 23966, Wismar, Germany.

PMID: 33710520 PMCID: PMC7994459 DOI: 10.1007/s13300-021-01024-y

Abstract

INTRODUCTION: According to current guidelines, appropriate drug treatment is the backbone of the effective management of cardiovascular (CV) comorbidities in patients with type 2 diabetes mellitus (T2DM). The main objective of this study was to assess the degree of real-world adherence to these guideline recommendations and to identify whether poor guideline adherence is associated with worse clinical outcomes.

METHODS: In this retrospective German claims data analysis (AOK PLUS dataset), patients with T2DM with an incident diagnosis (index date) of ischemic stroke, myocardial infarction, heart failure or coronary artery disease were observed for 12 months between 1 January 2014 and 31 December 2017. We assessed guideline adherence per observed CV disease combination at three levels: "green" if patients received prescriptions of all recommended medications with > 185 defined daily doses (DDDs) per observed patient-year; "yellow" if patients received at least two prescriptions of at least one of the recommended medications; and "red" if patients did not receive at least two prescriptions of at least one of the recommended medications. The impact of the assignment of a patient to one of these three levels on all-cause mortality and CV risk was analyzed based on multivariable Cox regression analyses and reported as adjusted hazard ratios (HRs).

RESULTS: We identified 32,916 patients with T2DM with an incident CV comorbidity (mean age 75.0 years, 54.2% female, Charlson Comorbidity Index [CCI]: 5.5). Observed patients received at least 185 DDDs of the following medication classes in the 12 months before/after the index date: vitamin K antagonists (6%/6%); antiplatelet drugs (9%/27%); novel oral anticoagulants (3%/13%); diuretics (48%/54%); beta blockers (31%/35%); calcium-channel blockers (34%/32%); renin-angiotensin-aldosterone system inhibitors (69%/68%); and lipid-modifying agents (19%/37%). When post-index therapy was compared to guideline recommendations, the level of "guideline adherence" was classified as "green" for 14.4% of the patients, "yellow" for 75.2% and "red" for 10.5%. An assignment of "red" was associated with worse CV outcomes in all analyses. Regarding mortality, in addition to one additional year of age (hazard ratio [HR] 1.04), CCI (HR 1.17), use of insulins (HR 1.25), digitalis glycosides (HR 1.52) and diuretics (HR 1.32), non-adherence to guideline recommendations ("red": HR 6.79; "yellow": HR: 1.30) was a significant predictor for early death, while female gender (HR 0.79), the participation in a disease management program (HR 0.69) and the use of antidiabetics other than insulin (HR 0.74) were generally associated with a reduced risk.

CONCLUSION: Only a minority of patients with T2DM and an incident CV comorbidity receive a treatment fully adherent with guideline recommendations. This may contribute to high mortality rates in this population in clinical practice.

Keywords: Cardiovascular disease; Cardiovascular drug treatment; Guideline adherence; T2DM

References

  1. Cardiovasc Diabetol. 2016 May 03;15:72 - PubMed
  2. Eur J Prev Cardiol. 2015 Jun;22(6):753-61 - PubMed
  3. Eur J Heart Fail. 2007 Dec;9(12):1205-11 - PubMed
  4. N Engl J Med. 2013 Oct 3;369(14):1317-26 - PubMed
  5. N Engl J Med. 2003 Jan 30;348(5):383-93 - PubMed
  6. Am J Manag Care. 2012 Nov;18(11):721-6 - PubMed
  7. N Engl J Med. 2015 Nov 26;373(22):2117-28 - PubMed
  8. Pharmacoepidemiol Drug Saf. 2006 Aug;15(8):565-74; discussion 575-7 - PubMed
  9. Lancet. 2010 Feb 27;375(9716):735-42 - PubMed
  10. Lancet Diabetes Endocrinol. 2019 Oct;7(10):776-785 - PubMed
  11. Circulation. 2019 Aug 13;140(7):618-620 - PubMed
  12. N Engl J Med. 2000 Jan 20;342(3):145-53 - PubMed
  13. PLoS One. 2019 Jan 17;14(1):e0201196 - PubMed
  14. Diabetes Metab Syndr Obes. 2019 Jul 24;12:1225-1237 - PubMed
  15. Lancet. 2019 Jan 5;393(10166):31-39 - PubMed
  16. Eur Heart J. 2018 Jan 7;39(2):119-177 - PubMed
  17. N Engl J Med. 2017 Apr 13;376(15):1407-1418 - PubMed
  18. BMJ Open Diabetes Res Care. 2019 Apr 8;7(1):e000639 - PubMed
  19. N Engl J Med. 2013 Oct 3;369(14):1327-35 - PubMed
  20. Ann Intern Med. 2006 Apr 4;144(7):465-74 - PubMed
  21. Diabetes Care. 2006 Jun;29(6):1220-6 - PubMed
  22. JAMA. 2003 Oct 8;290(14):1884-90 - PubMed
  23. Diabetes Res Clin Pract. 2019 Nov;157:107843 - PubMed
  24. Eur Heart J. 2016 Jan 14;37(3):267-315 - PubMed
  25. Hypertension. 1980 Nov-Dec;2(6):757-64 - PubMed
  26. Eur Heart J. 2012 Feb;33(4):505-14 - PubMed
  27. Eur Heart J. 2005 Aug;26(16):1653-9 - PubMed
  28. J Am Heart Assoc. 2021 Jan 19;10(2):e016835 - PubMed
  29. N Engl J Med. 2013 Apr 25;368(17):1613-24 - PubMed
  30. Dtsch Arztebl Int. 2014 Jan 31;111(5):69-81; quiz 82 - PubMed
  31. Eur J Heart Fail. 2013 Oct;15(10):1173-84 - PubMed
  32. Diabetes Obes Metab. 2017 Nov;19(11):1587-1593 - PubMed
  33. Diabetes Res Clin Pract. 2014 Nov;106(2):275-85 - PubMed
  34. Circulation. 2019 May 28;139(22):2528-2536 - PubMed
  35. Circulation. 2018 Jan 23;137(4):323-334 - PubMed
  36. Lancet. 2010 Nov 13;376(9753):1670-81 - PubMed
  37. J Clin Epidemiol. 1994 Nov;47(11):1245-51 - PubMed

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