Projections of incident atherosclerotic cardiovascular disease and incident type 2 diabetes across evolving statin treatment guidelines and recommendations: A modelling study
Autoři:
Joseph C. Engeda aff001; Stefan K. Lhachimi aff003; Wayne D. Rosamond aff001; Jennifer L. Lund aff001; Thomas C. Keyserling aff005; Monika M. Safford aff006; Lisandro D. Colantonio aff007; Paul Muntner aff007; Christy L. Avery aff001
Působiště autorů:
Department of Epidemiology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America
aff001; Department of Epidemiology and Biostatistics, University of California, San Francisco, California, United States of America
aff002; Research Group Evidence-Based Public Health, Leibniz Institute for Epidemiology and Prevention Research (BIPS), Bremen, Germany
aff003; Department for Health Services Research, Institute for Public Health and Nursing, University of Bremen, Bremen, Germany
aff004; Division of General Medicine and Clinical Epidemiology, University of North Carolina, Chapel Hill, North Carolina, United States of America
aff005; Division of General Internal Medicine, Weill Cornell Medical College, New York, New York, United States of America
aff006; Department of Epidemiology, University of Alabama at Birmingham, Birmingham, Alabama, United States of America
aff007
Vyšlo v časopise:
Projections of incident atherosclerotic cardiovascular disease and incident type 2 diabetes across evolving statin treatment guidelines and recommendations: A modelling study. PLoS Med 17(8): e32767. doi:10.1371/journal.pmed.1003280
Kategorie:
Research Article
doi:
https://doi.org/10.1371/journal.pmed.1003280
Souhrn
Background
Experimental and observational research has suggested the potential for increased type 2 diabetes (T2D) risk among populations taking statins for the primary prevention of atherosclerotic cardiovascular disease (ASCVD). However, few studies have directly compared statin-associated benefits and harms or examined heterogeneity by population subgroups or assumed treatment effect. Thus, we compared ASCVD risk reduction and T2D incidence increases across 3 statin treatment guidelines or recommendations among adults without a history of ASCVD or T2D who were eligible for statin treatment initiation.
Methods and findings
Simulations were conducted using Markov models that integrated data from contemporary population-based studies of non-Hispanic African American and white adults aged 40–75 years with published meta-analyses. Statin treatment eligibility was determined by predicted 10-year ASCVD risk (5%, 7.5%, or 10%). We calculated the number needed to treat (NNT) to prevent one ASCVD event and the number needed to harm (NNH) to incur one incident case of T2D. The likelihood to be helped or harmed (LHH) was calculated as ratio of NNH to NNT. Heterogeneity in statin-associated benefit was examined by sex, age, and statin-associated T2D relative risk (RR) (range: 1.11–1.55). A total of 61,125,042 U.S. adults (58.5% female; 89.4% white; mean age = 54.7 years) composed our primary prevention population, among whom 13–28 million adults were eligible for statin initiation. Overall, the number of ASCVD events prevented was at least twice as large as the number of incident cases of T2D incurred (LHH range: 2.26–2.90). However, the number of T2D cases incurred surpassed the number of ASCVD events prevented when higher statin-associated T2D RRs were assumed (LHH range: 0.72–0.94). In addition, females (LHH range: 1.74–2.40) and adults aged 40–50 years (LHH range: 1.00–1.14) received lower absolute benefits of statin treatment compared with males (LHH range: 2.55–3.00) and adults aged 70–75 years (LHH range: 3.95–3.96). Projected differences in LHH by age and sex became more pronounced as statin-associated T2D RR increased, with a majority of scenarios projecting LHHs < 1 for females and adults aged 40–50 years. This study’s primary limitation was uncertainty in estimates of statin-associated T2D risk, highlighting areas in which additional clinical and public health research is needed.
Conclusions
Our projections suggest that females and younger adult populations shoulder the highest relative burden of statin-associated T2D risk.
Klíčová slova:
African American people – Cardiovascular disease risk – Epidemiology – Medical risk factors – Statins – Treatment guidelines – Type 2 diabetes – Type 2 diabetes risk
Zdroje
1. Shah RV, Goldfine AB. Statins and risk of new-onset diabetes mellitus. Circulation. 2012;126(18):e282–e4. doi: 10.1161/CIRCULATIONAHA.112.122135 23109518
2. Gu Q, Paulose-Ram R, Burt V, Kit B. Prescription cholesterol-lowering medication use in adults aged 40 and over: United States, 2003–2012. NCHS data brief, no 177. Hyattsville, MD: National Center for Health Statistics, US Department of Health and Human Services, CDC; 2014. 2015.
3. Stone NJ, Robinson JG, Lichtenstein AH, Bairey Merz CN, Blum CB, Eckel RH, et al. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Journal of the American College of Cardiology. 2014;63(25 Pt B):2889–934. doi: 10.1016/j.jacc.2013.11.002 24239923
4. Grundy SM, Stone NJ, Bailey AL, Beam C, Birtcher KK, Blumenthal RS, et al. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA guideline on the management of blood cholesterol: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Journal of the American College of Cardiology. 2019;73(24):e285–e350. doi: 10.1016/j.jacc.2018.11.003 30423393
5. National Cholesterol Education Program Expert Panel on Detection E, Treatment of High Blood Cholesterol in A. Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) final report. Circulation. 2002;106(25):3143–421. 12485966
6. Pencina MJ, Navar-Boggan AM, D'Agostino RB Sr, Williams K, Neely B, Sniderman AD, et al. Application of new cholesterol guidelines to a population-based sample. New England Journal of Medicine. 2014;370(15):1422–31. doi: 10.1056/NEJMoa1315665 24645848
7. Ridker PM, Rose L, Cook NR. A proposal to incorporate trial data into a hybrid ACC/AHA algorithm for the allocation of statin therapy in primary prevention. Journal of the American College of Cardiology. 2015;65(9):942–8. doi: 10.1016/j.jacc.2014.12.028 25744012
8. Waters DD. Cholesterol Lowering Guidelines: From Whence We Came and Where We Are Now. Canadian Journal of Cardiology. 2018.
9. Rajpathak SN, Kumbhani DJ, Crandall J, Barzilai N, Alderman M, Ridker PM. Statin therapy and risk of developing type 2 diabetes: a meta-analysis. Diabetes care. 2009;32(10):1924–9. doi: 10.2337/dc09-0738 19794004
10. Sattar N, Preiss D, Murray HM, Welsh P, Buckley BM, de Craen AJ, et al. Statins and risk of incident diabetes: a collaborative meta-analysis of randomised statin trials. The Lancet. 2010;375(9716):735–42.
11. Mills E, Wu P, Chong G, Ghement I, Singh S, Akl E, et al. Efficacy and safety of statin treatment for cardiovascular disease: a network meta-analysis of 170 255 patients from 76 randomized trials. QJM: An International Journal of Medicine. 2011;104(2):109–24.
12. Taylor F, Huffman MD, Macedo AF, Moore TH, Burke M, Davey Smith G, et al. Statins for the primary prevention of cardiovascular disease. The Cochrane Library. 2013.
13. Chou R, Tracy Dana M, Blazina I, Daeges M, Jeanne TL. Statins for Prevention of Cardiovascular Disease in Adults Evidence Report and Systematic Review for the US Preventive Services Task Force. JAMA: the journal of the American Medical Association. 2016;316(19):2008–24.
14. Casula M, Mozzanica F, Scotti L, Tragni E, Pirillo A, Corrao G, et al. Statin use and risk of new-onset diabetes: A meta-analysis of observational studies. Nutrition, Metabolism and Cardiovascular Diseases. 2017;27(5):396–406. doi: 10.1016/j.numecd.2017.03.001 28416099
15. Engeda JC, Stackhouse A, White M, Rosamond WD, Lhachimi SK, Lund JL, et al. Evidence of heterogeneity in statin-associated type 2 diabetes mellitus risk: A meta-analysis of randomized controlled trials and observational studies. Diabetes research and clinical practice. 2019;151:96–105. doi: 10.1016/j.diabres.2019.04.005 30954511
16. Mora S, Glynn RJ, Hsia J, MacFadyen JG, Genest J, Ridker PM. Statins for the primary prevention of cardiovascular events in women with elevated high-sensitivity C-reactive protein or dyslipidemia: results from the Justification for the Use of Statins in Prevention: An Intervention Trial Evaluating Rosuvastatin (JUPITER) and meta-analysis of women from primary prevention trials. Circulation. 2010;121(9):1069–77. doi: 10.1161/CIRCULATIONAHA.109.906479 20176986
17. Robinson JG. Starting primary prevention earlier with statins. The American Journal of Cardiology. 2014;114(9):1437–42. doi: 10.1016/j.amjcard.2014.07.076 25205631
18. Bibbins-Domingo K, Grossman DC, Curry SJ, Davidson KW, Epling JW, García FA, et al. Statin use for the primary prevention of cardiovascular disease in adults: US Preventive Services Task Force recommendation statement. JAMA: the journal of the American Medical Association. 2016;316(19):1997–2007.
19. Wald NJ, Simmonds M, Morris JK. Screening for future cardiovascular disease using age alone compared with multiple risk factors and age. PLoS ONE. 2011;6(5):e18742. doi: 10.1371/journal.pone.0018742 21573224
20. Knottnerus A, Tugwell P. STROBE—a checklist to Strengthen the Reporting of Observational Studies in Epidemiology. Journal of clinical epidemiology. 2008;61(4):323. doi: 10.1016/j.jclinepi.2007.11.006 18313555
21. Walker AM. Confounding by indication. Epidemiology. 1996;7(4):335–6. 8793355
22. US Census Bureau Population Estimates. Vintage 2012: Downloadable Data Files. [Internet]. [cited June 17, 2015]. Available from: https://www-census-gov.libproxy.lib.unc.edu/popest/data/historical/2010s/vintage_2012/datasets.html.
23. Centers for Disease Control and Prevention. National Health and Nutrition Examination Survey 2012. [cited 2018 July 1]. Available from: http://www.cdc.gov/nchs/nhanes.htm.
24. Goff DC Jr., Lloyd-Jones DM, Bennett G, Coady S, D'Agostino RB, Gibbons R, et al. 2013 ACC/AHA guideline on the assessment of cardiovascular risk: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014;129(25 Suppl 2):S49–73. doi: 10.1161/01.cir.0000437741.48606.98 24222018
25. Virani SS, Alonso A, Benjamin EJ, Bittencourt MS, Callaway CW, Carson AP, et al. Heart disease and stroke statistics-2020 update: a report from the American Heart Association. Circulation. 2020;141(9):e139–e596. doi: 10.1161/CIR.0000000000000757 31992061
26. Howard VJ, Cushman M, Pulley L, Gomez CR, Go RC, Prineas RJ, et al. The reasons for geographic and racial differences in stroke study: objectives and design. Neuroepidemiology. 2005;25(3):135–43. doi: 10.1159/000086678 15990444
27. Howard VJ, Kleindorfer DO, Judd SE, McClure LA, Safford MM, Rhodes JD, et al. Disparities in stroke incidence contributing to disparities in stroke mortality. Annals of Neurology. 2011;69(4):619–27. doi: 10.1002/ana.22385 21416498
28. Stroke W. Recommendations on stroke prevention, diagnosis, and therapy. Report of the WHO Task Force on Stroke and other Cerebrovascular Disorders. Stroke; a journal of cerebral circulation. 1989;20(10):1407–31.
29. Mortality in US 2010 [Internet]. 2010. [cited 2018 July 1]. Available from: https://www.cdc.gov/nchs/data/dvs/LCWK1_2010.pdf.
30. Mihaylova B, Emberson J, Blackwell L, Keech A, Simes J, Barnes EH, et al. The effects of lowering LDL cholesterol with statin therapy in people at low risk of vascular disease: meta-analysis of individual data from 27 randomised trials. Lancet. 2012;380(9841):581–90. doi: 10.1016/S0140-6736(12)60367-5 22607822
31. Cheung BM, Lauder IJ, Lau CP, Kumana CR. Meta‐analysis of large randomized controlled trials to evaluate the impact of statins on cardiovascular outcomes. British Journal of Clinical Pharmacology. 2004;57(5):640–51. doi: 10.1111/j.1365-2125.2003.02060.x 15089818
32. Lundh A, Lexchin J, Mintzes B, Schroll JB, Bero L. Industry sponsorship and research outcome. Cochrane Database of Systematic Reviews. 2017(2). doi: 10.1002/14651858.CD012545 28344512
33. Strom BL. Pharmacoepidemiology: John Wiley & Sons; 2006.
34. Muntner P, Colantonio LD, Cushman M, Goff DC, Howard G, Howard VJ, et al. Validation of the atherosclerotic cardiovascular disease Pooled Cohort risk equations. JAMA. 2014;311(14):1406–15. doi: 10.1001/jama.2014.2630 24682252
35. Briggs AH, Claxton K, Sculpher MJ. Decision modelling for health economic evaluation: Oxford University Press, USA; 2006.
36. Mann DM, Woodward M, Muntner P, Falzon L, Kronish I. Predictors of nonadherence to statins: a systematic review and meta-analysis. Annals of Pharmacotherapy. 2010;44(9):1410–21. doi: 10.1345/aph.1P150 20702755
37. Cook RJ, Sackett DL. The number needed to treat: a clinically useful measure of treatment effect. BMJ: British Medical Journal. 1995;310(6977):452. doi: 10.1136/bmj.310.6977.452 7873954
38. Citrome L, Ketter T. When does a difference make a difference? Interpretation of number needed to treat, number needed to harm, and likelihood to be helped or harmed. International Journal of Clinical Practice. 2013;67(5):407–11. doi: 10.1111/ijcp.12142 23574101
39. Design and estimation for the National Health Interview Survey, 1995–2004. Vital Health Stat 2. 2000(130):1–31. 11707926
40. Mosca L, Benjamin EJ, Berra K, Bezanson JL, Dolor RJ, Lloyd-Jones DM, et al. Effectiveness-based guidelines for the prevention of cardiovascular disease in women—2011 update. Circulation. 2011:CIR. 0b013e31820faaf8.
41. Grundy SM, Benjamin IJ, Burke GL, Chait A, Eckel RH, Howard BV, et al. Diabetes and cardiovascular disease: a statement for healthcare professionals from the American Heart Association. Circulation. 1999;100(10):1134–46. doi: 10.1161/01.cir.100.10.1134 10477542
42. Otto CM. Statins for primary prevention of cardiovascular disease: Patients need better tools to navigate divergent recommendations. BMJ Publishing Group Ltd and British Cardiovascular Society; 2017.
43. Leening MJ, Ferket BS, Steyerberg EW, Kavousi M, Deckers JW, Nieboer D, et al. Sex differences in lifetime risk and first manifestation of cardiovascular disease: prospective population based cohort study. BMJ. 2014;349:g5992. doi: 10.1136/bmj.g5992 25403476
44. Culver AL, Ockene IS, Balasubramanian R, Olendzki BC, Sepavich DM, Wactawski-Wende J, et al. Statin use and risk of diabetes mellitus in postmenopausal women in the Women's Health Initiative. Archives of internal medicine. 2012;172(2):144–52. doi: 10.1001/archinternmed.2011.625 22231607
45. Yebyo HG, Aschmann HE, Puhan MA. Finding the Balance Between Benefits and Harms When Using Statins for Primary Prevention of Cardiovascular Disease: A Modeling Study. Annals of Internal Medicine. 2019;170(1):1–10. doi: 10.7326/M18-1279 30508425
46. Peters SA, Colantonio LD, Zhao H, Bittner V, Dai Y, Farkouh ME, et al. Sex differences in high-intensity statin use following myocardial infarction in the United States. Journal of the American College of Cardiology. 2018;71(16):1729–37. doi: 10.1016/j.jacc.2018.02.032 29673463
47. Khan SU, Khan MZ, Raghu Subramanian C, Riaz H, Khan MU, Lone AN, et al. Participation of Women and Older Participants in Randomized Clinical Trials of Lipid-Lowering Therapies: A Systematic Review. JAMA Network Open. 2020;3(5):e205202. doi: 10.1001/jamanetworkopen.2020.5202 32437574
48. Sattar N. Gender aspects in type 2 diabetes mellitus and cardiometabolic risk. Best practice & research Clinical Endocrinology & Metabolism. 2013;27(4):501–7.
49. Sever PS, Chang CL, Gupta AK, Whitehouse A, Poulter NR. The Anglo-Scandinavian Cardiac Outcomes Trial: 11-year mortality follow-up of the lipid-lowering arm in the UK. European Heart Journal. 2011:ehr333.
50. Sever PS, Poulter NR, Dahlof B, Wedel H, Beevers G, Caulfield M, et al. The Anglo-Scandinavian Cardiac Outcomes Trial lipid lowering arm: extended observations 2 years after trial closure. European Heart Journal. 2008;29(4):499–508. doi: 10.1093/eurheartj/ehm583 18175773
51. Lloyd SM, Stott DJ, de Craen AJ, Kearney PM, Sattar N, Perry I, et al. Long-term effects of statin treatment in elderly people: extended follow-up of the PROspective Study of Pravastatin in the Elderly at Risk (PROSPER). PLoS ONE. 2013;8(9):e72642. doi: 10.1371/journal.pone.0072642 24023757
52. Seruga B, Templeton AJ, Badillo FEV, Ocana A, Amir E, Tannock IF. Under-reporting of harm in clinical trials. The Lancet Oncology. 2016;17(5):e209–e19. doi: 10.1016/S1470-2045(16)00152-2 27301048
53. Rothwell PM. External validity of randomised controlled trials:“to whom do the results of this trial apply?”. The Lancet. 2005;365(9453):82–93.
54. Westreich D, Edwards JK, Lesko CR, Cole SR, Stuart EA. Target validity and the hierarchy of study designs. American Journal of Epidemiology. 2018;188(2):438–43.
55. Preiss D, Seshasai SRK, Welsh P, Murphy SA, Ho JE, Waters DD, et al. Risk of incident diabetes with intensive-dose compared with moderate-dose statin therapy: a meta-analysis. JAMA: the journal of the American Medical Association. 2011;305(24):2556–64.
56. Antons KA, Williams CD, Baker SK, Phillips PS. Clinical perspectives of statin-induced rhabdomyolysis. The American Journal of Medicine. 2006;119(5):400–9. doi: 10.1016/j.amjmed.2006.02.007 16651050
57. Thompson PD, Clarkson P, Karas RH. Statin-associated myopathy. JAMA. 2003;289(13):1681–90. doi: 10.1001/jama.289.13.1681 12672737
58. Macedo AF, Taylor FC, Casas JP, Adler A, Prieto-Merino D, Ebrahim S. Unintended effects of statins from observational studies in the general population: systematic review and meta-analysis. BMC Medicine. 2014;12(1):51.
59. Bjarnadottir O, Romero Q, Bendahl P-O, Jirström K, Rydén L, Loman N, et al. Targeting HMG-CoA reductase with statins in a window-of-opportunity breast cancer trial. Breast Cancer Research and Treatment. 2013;138(2):499–508. doi: 10.1007/s10549-013-2473-6 23471651
60. Oesterle A, Laufs U, Liao JK. Pleiotropic effects of statins on the cardiovascular system. Circulation Research. 2017;120(1):229–43. doi: 10.1161/CIRCRESAHA.116.308537 28057795
61. McCarey DW, McInnes IB, Madhok R, Hampson R, Scherbakova O, Ford I, et al. Trial of Atorvastatin in Rheumatoid Arthritis (TARA): double-blind, randomised placebo-controlled trial. The Lancet. 2004;363(9426):2015–21.
62. Centers for Disease Control and Prevention. National diabetes statistics report, 2020. Atlanta, GA: Centers for Disease Control and Prevention, US Department of Health and Human Services [Internet]. 2020.
63. Schneider AL, Pankow JS, Heiss G, Selvin E. Validity and reliability of self-reported diabetes in the atherosclerosis risk in communities study. American Journal of Epidemiology. 2012;176(8):738–43. doi: 10.1093/aje/kws156 23013620
64. Selvin E, Wang D, Lee AK, Bergenstal RM, Coresh J. Identifying trends in undiagnosed diabetes in US adults by using a confirmatory definition: a cross-sectional study. Annals of Internal Medicine. 2017;167(11):769–76. doi: 10.7326/M17-1272 29059691
65. Carroll MD, Lacher DA, Sorlie PD, Cleeman JI, Gordon DJ, Wolz M, et al. Trends in serum lipids and lipoproteins of adults, 1960–2002. JAMA. 2005;294(14):1773–81. doi: 10.1001/jama.294.14.1773 16219880
66. Finch S, Doyle W, Lowe C, Bates C, Prentice A, Smithers G, et al. National Diet and Nutrition Survey: people aged 65 years and over: Stationery Office; 1998.
67. Rabar S, Harker M, O'flynn N, Wierzbicki AS. Lipid modification and cardiovascular risk assessment for the primary and secondary prevention of cardiovascular disease: summary of updated NICE guidance. BMJ: British Medical Journal (Online). 2014;349.
68. Anderson TJ, Gregoire J, Pearson GJ, Barry AR, Couture P, Dawes M, et al. 2016 Canadian Cardiovascular Society guidelines for the management of dyslipidemia for the prevention of cardiovascular disease in the adult. Canadian Journal of Cardiology. 2016;32(11):1263–82. doi: 10.1016/j.cjca.2016.07.510 27712954
69. Piepoli MF, Hoes AW, Agewall S, Albus C, Brotons C, Catapano AL, et al. 2016 European Guidelines on cardiovascular disease prevention in clinical practice: The Sixth Joint Task Force of the European Society of Cardiology and Other Societies on Cardiovascular Disease Prevention in Clinical Practice (constituted by representatives of 10 societies and by invited experts) Developed with the special contribution of the European Association for Cardiovascular Prevention & Rehabilitation (EACPR). European Heart Journal. 2016;37(29):2315–81. doi: 10.1093/eurheartj/ehw106 27222591
70. Mortensen MB, Nordestgaard BG. Statin Use in Primary Prevention of Atherosclerotic Cardiovascular Disease According to 5 Major Guidelines for Sensitivity, Specificity, and Number Needed to Treat. JAMA Cardiol. 2019.
71. Clough JD, Martin SS, Navar AM, Lin L, Hardy NC, Rogers U, et al. Association of Primary Care Providers' Beliefs of Statins for Primary Prevention and Statin Prescription. J Am Heart Assoc. 2019;8(3):e010241. doi: 10.1161/JAHA.118.010241 30681391
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