Burden of acute myocardial infarction

Burden of acute myocardial infarction

Letters to the Editor Statin treatment, especially as secondary prevention but also as primary prevention, has a tremendous support from the literatu...

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Letters to the Editor

Statin treatment, especially as secondary prevention but also as primary prevention, has a tremendous support from the literature. The risk reduction appears to be proportional to the absolute LDL cholesterol reductions. However, our treatment goals are arbitrary and we lack data from studies comparing different treatment goals. The authors of this manuscript have certified that they comply with the Principles of Ethical Publishing in the International Journal of Cardiology [24]. References [1] Scandinavian Simvastatin Survival Study Group. Randomised trial of cholesterol lowering in 4 444 patients with coronary heart disease: the Scandinavian Simvastatin Survival Study (4S). Lancet 1994;344:1383–9. [2] Heart Protection Study Collaborative Group. MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin in 20536 high-risk individuals: a randomized placebo-controlled trial. Lancet 2002;360:7–22. [3] Pedersen TR, Faergeman O, Kastelein JJ, et al. High dose atorvastatin vs usual-dose simvastatin for secondary prevention after myocardial infarction: the IDEAL study: a randomized controlled trial. JAMA 2005;294:2437–45. [4] Shepherd J, Cobbe SM, Ford I, et al. Prevention of coronary heart disease with pravastatin in men with hypercholesterolemia. West of Scotland Coronary Prevention Study Group. N Engl J Med 1995;333:1301–7. [5] Sacks FM, Pfeffer MA, Moye LA, et al. The effect of pravastatin on coronary events after myocardial infarction in patients with average cholesterol levels. Cholesterol and Recurrent Events Trial investigators. N Engl J Med 1996;335:1001–9. [6] The Long-Term Intervention with Pravastatin in Ischemic Disease (LIPID) Study Group. Prevention of cardiovascular events and death with pravastatin in patients with coronary heart disease and a broad range of initial cholesterol levels. N Engl J Med 1998;339:1349–57. [7] Shepherd J, Blauw GJ, Murphy MB, et al. PROspective Study of Pravastatin in the Elderly at Risk. Pravastatin in elderly individuals at risk of vascular disease (PROSPER): a randomised controlled trial. Lancet 2002;360:1623–30. [8] Downs JR, Clearfield M, Weis S, et al. Primary prevention of acute coronary events with lovastatin in men and women with average cholesterol levels: results of AFCAPS/TexCAPS: Air Force/Texas Coronary Atherosclerosis Prevention Study. JAMA 1998;279:1615–22. [9] Holdaas H, Fellström B, Jardine AG, et al. Effect of fluvastatin on cardiac outcomes in renal transplant recipients: a multicentre, randomised, placebo-controlled trial. Lancet 2003;361:2024–31.

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[10] Serruys PW, de Feyter P, Macaya C, et al. Fluvastatin for prevention of cardiac events following successful first percutaneous coronary intervention: a randomized controlled trial. JAMA 2002;287:3215–522. [11] Schwartz GG, Olsson AG, Ezekowitz MD, et al. Effects of atorvastatin on early recurrent ischemic events in acute coronary syndromes: the MIRACLE study: a randomized controlled trial. JAMA 2000;285:1811–8. [12] Sever PS, Dahlöf B, Poulter NR, et al. Prevention of coronary and stroke events with atorvastatin in hypertensive patients who have average or lower than-average cholesterol concentrations, in the ANGLO-Scandinavian Cardiac Outcomes TrialLipid Lowering Arm (ASCOT-LLA): a multicentre randomised controlled trial. Lancet 2003;361:1149–58. [13] Colhoun HM, Betteridge DJ, Durrington PN, et al. Primary prevention of cardiovascular disease with atorvastatin in type 2 diabetes in the Collaborative Atorvastatin Diabetes Study (CARDS): multicentre randomised placebo-controlled trial. Lancet 2004;364:685–96. [14] The Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) Investigators. High-dose atorvastatin after stroke or transient ischemic attack. N Engl J Med 2006;355:549–59. [15] Wanner C, Krane V, März W, et al. Atorvastatin in patients with type 2 diabetes mellitus undergoing hemodialysis. N Engl J Med 2005;353:238–48. [16] LaRosa JC, Grundy SM, Waters DD, et al. Intensive lipid lowering with atorvastatin in patients with stable coronary disease. N Engl J Med 2005;352:1425–35. [17] Ray KK, Cannon CP, McCabe CH, et al. Early and late benefits of high-dose atorvastatin in patients with acute coronary syndromes: results from the PROVE IT-TIMI 22 trial. J Am Coll Cardiol 2005;46:1405–10. [18] Kjekshus J, Apetrei E, Barrios V, et al. Rosuvastatin in older patients with systolic heart failure. N Engl J Med 2007;357:2248–61. [19] Gissi-HF InvestigatorsTavazzi L, Maggioni AP, et al. Effect of rosuvastatin in patients with chronic heart failure (the GISSI-HF trial): a randomised, double-blind, placebo-controlled trial. Lancet 2008;372:1231–9. [20] Ridker PM, Danielson E, Fonseca FA, et al. Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein. N Engl J Med 2008;359:2195–207. [21] Fellström BC, Jardine AG, Schmieder RE, et al. Rosuvastatin and cardiovascular events in patients undergoing hemodialysis. N Engl J Med 2009;360:1395–407. [22] Cholesterol Treatment Trialists (CTT) Collaborators. Efficacy and safety of cholesterol-lowering treatment: prospective meta-analysis of data from 90.056 participants in 14 randomised trials of statins. Lancet 2005;366:1267–78. [23] de Lemos JA, Blazing MA, Wiviott SD, et al. Early intensive vs a delayed conservative simvastatin strategy in patients with acute coronary syndromes: phase Z of the A to Z trial. JAMA 2004;292:1307–16. [24] Shewan LG, Coats AJ. Ethics in the authorship and publishing of scientific articles. Int J Cardiol 2010;144:1–2.

0167-5273/$ – see front matter © 2011 Elsevier Ireland Ltd. All rights reserved. doi:10.1016/j.ijcard.2011.04.029

Burden of acute myocardial infarction Lorenzo G. Mantovani a,b, Carla Fornari a, Fabiana Madotto a, Michele A. Riva a, Luca Merlino c, Marco M. Ferrario d, Virginio Chiodini a, Alberto Zocchetti c, Giovanni Corrao e, Giancarlo Cesana a,⁎ a

CESP, Research Centre on Public Health, University of Milano Bicocca, Monza, Italy CIRFF, Center of Pharmacoeconomics, Federico II University of Naples, Naples, Italy Regional Health Authority of Lombardia, Milan, Italy d Department of Clinical and Biological Science, University of Insubria, Varese, Italy e Department of Statistics, University of Milano Bicocca, Milan, Italy b c

a r t i c l e

i n f o

Article history: Received 22 March 2011 Accepted 25 April 2011 Available online 24 May 2011 Keywords: Economic burden Acute myocardial infarction Healthcare database

⁎ Corresponding author at: CESP, Research Centre on Public Health, University of Milano Bicocca, Villa Serena, via Pergolesi, 33; I-20052, Monza, Italy. Tel.: + 39 039 2333097; fax: + 39 039 365378. E-mail address: [email protected] (G. Cesana).

The measurement of the epidemiological and economic burden of diseases is a topic of interest to public health researchers and policy makers. Cardiovascular (CV) disease is recognized as the largest cause of morbidity and mortality in the Western countries [1]. Several American studies have done such evaluations for CV diseases through insurance administrative claims [2–4]. In this context, the aim of the present study is to determine, using regional health-related administrative databases, the economic burden of hospitalized events of incident Acute Myocardial Infarction (AMI) registered in 2003 in Lombardy, the most populated region of Italy. Data are extracted from healthcare administrative databases of the region of Lombardy, with universal healthcare coverage for more than 9 million members. Public healthcare databases have been organized in a data warehouse, called DENALI, which includes data related to vital status, hospital discharges (HDs), pharmaceutical and outpatient claims.

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Letters to the Editor

Table 1 Health services utilization and cost in the first, second and third year after the index AMI event. Cost component Index event Hospitalizations CVb NO-CV Pharmaceutical claims Outpatient claims CVc NO-CV Total health care costd a b c d

1st year

2nd and 3rd year

Annual cost per patienta (€)

Total cost (€)

Annual cost per patienta (€)

Total cost (€)

6,022.27 (51.18) 7,006.62 (117.11) 5,235.24 (85.34) 1,771.38 (78.04) 1,379.89 (21.56) 749.39(24.78) 369.73(3.44) 379.66(23.93) 9,135.90 (123.48)

72,562,331.00 69,458,874.00 51,898,589.00 17,560,285.00 13,679,325.38 7,428,966.12 3,665,289.20 3,763,676.92 90,567,165.50d

– 2,100.14 (57.935) 997.11 (32.984) 1,103.03 (44.842) 1,196.29 (10.677) 622.90 (29.517) 241.28 (2.725) 381.62 (28.602) 3,919.34 (71.169)

– 28,171,537.00 13,375,381.00 14,796,156.0 16,047,248.17 8,355,627.87 3,236,591.53 5119036.34 52,574,413.04

Mean (Standard Error). CV = hospitalizations with DRG related to cardiovascular diseases: 104–105, 478, 479, 514–518. CV = ambulatory procedure and laboratory tests concerning cardiovascular care. Costs excluding the index event.

The study population includes all subjects who had a first hospitalization for AMI during 2003 and 5 years of continuous eligibility in the area of Lombardy prior to the event. All HDs with ICD-9-CM code 410.xx in at least one of six discharge diagnosis, excluding ICD-9-CM code 410.x2 (subsequent episode of care within eight weeks of the acute event) [5], are identified. The first hospitalization during 2003 defines the index event. Subjects with an AMI HD (ICD-9-CM code 410.xx) in the 5 years prior to the first hospitalization are excluded. Age is computed at the index event. The population is followed from the date of admission of the index event (index date) until the 31st of December 2005 recording the vital status, death or emigration outside the area of Lombardy, and health care resource utilizations: HDs, pharmaceutical and outpatient claims. All healthcare events (HD, prescriptions of drugs and outpatient care) are classified CV vs. NON-CV. The use of healthcare resources is presented as frequency of drugs prescribed, average annual number per person of HDs and of outpatient claims after the index event in the first year and in the second and third year of follow-up together. The probability of having a CV-related hospitalization with a CV DRG code after the index event is analyzed using the cause specific cumulative incidence function with death as a competing event. Median times from index event at the first re-hospitalization are computed. Total and average annual costs from the perspective of the Italian National Health Service (NHS) are quantified using charges, i.e. the amount of money the Italian NHS reimbursed to providers of care, and presented by type of resource, in the first year after index event and in the second and third year together. The average cost per person per year is computed for each individual as the ratio between charges and the length of individual observation period, expressed in years. 12,049 individuals have a HD for a first AMI event during year 2003 with an age standardized rate of 131.4 events per 100,000 person–years (2001 Italian population as standard). The 63% of the patients is male and the mean age at onset is 70 years. Women are older than men at onset of first event, with a gap of ten years (age mean 77 vs. 67). Overall 3380 (28%) subjects die during an average follow-up period of 23 months. More than a half of the population (55%) has a new CV-related hospitalization after the index event, with a mean time interval of about 4 months after the index date and a median interval of one month. The most frequently prescribed drug treatments in the first year of follow-up are antithrombotic agents (78% of patients), beta-blockers (58%), ACE inhibitors (57%), anti-lipid drugs (58%) and cardiac therapy (58%) (i.e. cardiac glycosides, antiarrhythmics and cardiac

0167-5273/$ – see front matter © 2011 Elsevier Ireland Ltd. All rights reserved. doi:10.1016/j.ijcard.2011.04.030

stimulants). In the subsequent two years antithrombotic treatment is still the most frequently used (86% of patients), followed by anti-lipid drugs (70%) and beta-blockers (65%). Direct costs from the NHS perspective during the follow-up are shown in Table 1. The largest component of the cost is attributable to hospital care, which account for 77% (€70 million) of total expenditure without the index hospitalization; pharmaceuticals and outpatient claims are respectively 15% (€14 million) and 8% (€7 million). The expenditure for hospitalizations is the major component of cost also in the second and third years as it accounts for 54% of the total. This study suggests that AMI remains a disease with a high human burden for the society, even in “younger” age classes, as about 30% of incident AMIs happens to individuals in the working age. Moreover overall mortality is still high, 28% of individuals reaching the hospital with AMI died within the first 2 to 3 years after the event. According to our results, the total cost of care during the first year (€163 million) corresponds to approximately 1% of the whole healthcare budget of Lombardy, and that the major component of health expenditure is inpatient care followed by pharmaceutical expenditure and outpatient visits as already reported. Our data, systematically derived from a large administrative database, confirm previous evidence [6]. The authors of this manuscript have certified that they comply with the Principles of Ethical Publishing in the International Journal of Cardiology [7]. The authors want to thank Regione Lombardia for data provided and its financial support within the "Progetto Virgilio", sponsored by Pfizer Italia. References [1] Mackay J, Mensah G. Atlas of heart disease and stroke. Geneva: World Health Organization Press; 2004. [2] Etemad LR, McCollam PL. Total first-year costs of acute coronary syndrome in a managed care setting. J Manag Care Pharm 2005;11:300–6. [3] Menzin J, Wygant G, Hauch O, Jackel J, Friedman M. One-year costs of ischemic heart disease among patients with acute coronary syndromes: findings from a multiemployer claims database. Curr Med Res Opin 2008;24:461–8. [4] Turpie AGG. Burden of disease: medical and economic impact of acute coronary syndromes. Am J Manag Care 2006;12:S430–4. [5] Coding Clinic, volume 10, number 5, 1993, pages 18, 19, 20 and 23. [6] Leal J, Luengo-Fernández R, Gray A, Petersen S, Rayner M. Economic burden of cardiovascular diseases in the enlarged European Union. Eur Heart J 2006;27:1610–9. [7] Shewan LG, Coats AJ. Ethics in authorship and the publishing of scientific articles. Int J Cardiol 2010;144:1–2.