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Costo-efficacia di irbesartan in pazienti con diabete di tipo 2, ipertensione e nefropatia: prospettiva italiana

Cost-effectiveness analysis of irbesartan in patients with type 2 diabetes, hypertension and nephropathy: the Italian perspective

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PharmacoEconomics Italian Research Articles

Summary

Background

The Irbesartan in Diabetic Nephropathy Trial (IDNT) demonstrated that treatment with irbesartan reduced progression to a combined end point of doubling of serum creatinine (DSC), end-stage renal disease (ESRD), or death compared to standard blood pressure control or amlodipine treatment. An epidemiological model was developed to project long term health effects and cost consequences of the IDNT in an Italian setting.

Methods

A Markov model was constructed considering four possible disease states: overt nephropathy, DSC, ESRD, and death. Treatment-specific transition probabilities between states were derived from the IDNT. Data for Italy relating to the management and outcome of ESRD were retrieved from local sources. Outcomes for the three arms (irbesartan, amlodipine, placebo control [standard hypertension treatment alone — excluding angiotensin converting enzyme inhibitors, other angiotensin-2-receptor antagonists and dihydropyridine calcium channel blockers]) were expressed in terms of cumulative incidence (CI) of ESRD onset, life expectancy and costs over a 10 year time horizon. Future costs and life expectancy were discounted at 5% per annum. Extensive sensitivity analyses were performed.

Results

The 10-year cumulative incidences of ESRD were 36%, 49%, and 45% with irbesartan, amlodipine, and control treatment arms respectively. Projected 10 year gains in discounted life expectancy due to ESRD avoided were 0.10 years and 0.22 years versus amlodipine and control respectively. Irbesartan led to 10-year net cost savings of € 13,530 and € 8,133/patient versus amlodipine and control respectively. The results were robust under a wide range of plausible assumptions.

Conclusions

Treating type 2 diabetes patients with hypertension, and overt nephropathy using irbesartan was both cost- and life-saving compared to amlodipine and standard blood pressure treatment in an Italian setting.

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Bibliografia

  1. Bruno G, Cavallo-Perin P, Bargero G, et al. Prevalence and risk factors for micro- and microalbuminuria in an Italian population-based cohort of NIDDM subjects. Diabetes Care 1996; 19(1): 43–7

    Article  PubMed  CAS  Google Scholar 

  2. Ritz E, Rychlik I, Locatelli F, et al. End-stage renal failure in type 2 diabetes: A medical catastrophe of worldwide dimensions. Am J Kidney Dis 1999; 34(5): 795–808

    Article  PubMed  CAS  Google Scholar 

  3. Locatelli F, Pozzoni P, Del Vecchio L. Epidemiology of chronic kidney disease in Italy: possible therapeutical approaches. J Nephrol 2003; 16(1): 1–10

    PubMed  Google Scholar 

  4. Catalano C, Postorino M, Kelly PJ, et al. Diabetes mellitus and renal replacement therapy in Italy: prevalence, main characteristics and complications. Nephrol Dial Transplant 1990; 5(9): 788–96

    Article  PubMed  CAS  Google Scholar 

  5. Lewis EJ, Hunsicker LG, Clarke WR, et al. Renoprotective effect of the angiotensin-receptor antagonist irbesartan in patients with nephropathy due to type 2 diabetes. N Engl J Med 2001; 345(12): 851–60

    Article  PubMed  CAS  Google Scholar 

  6. Sonnenberg FA, Beck JR. Markov models in medical decision making: a practical guide. Med Decis Making 1993; 13(4): 322–38

    Article  PubMed  CAS  Google Scholar 

  7. Rodby RA, Chiou CF, Borenstein J, et al. The cost-effectiveness of irbesartan in the treatment of hypertensive patients with type 2 diabetic nephropathy. Clin Ther 2003; 25(7): 2103–19

    Article  Google Scholar 

  8. Palmer AJ, Annemans L, Roze S, et al. An economic evaluation of irbesartan in the treatment of patients with type 2 diabetes, hypertension and nephropathy; cost-effectiveness of Irbesartan in Diabetic Nephropathy Trial (IDNT) in the Belgian, and French settings. Nephrol Dial Transplant 2003; 18: 2059–66

    Article  PubMed  CAS  Google Scholar 

  9. Lewis EJ, Hunsicke LG, Bain RP, et al. The effect of angiotensin-converting-enzyme inhibition on diabetic nephropathy. The Collaborative Study Group. N Engl J Med 1993; 329: 1456–62

    Article  PubMed  CAS  Google Scholar 

  10. Rodby RA, Firth LM, Lewis EJ. An economic analysis of captopril in the treatment of diabetic nephropathy. The Collaborative Study Group. Diabetes Care 1996; 19(10): 1051–61

    Article  PubMed  CAS  Google Scholar 

  11. Garattini L, Brunetti M, Salvioni F, et al. Economic evaluation of ACE inhibitor treatment of nephropathy in patients with insulin-dependent diabetes mellitus in Italy. PharmacoEconomics 1997; 12(1): 67–75

    Article  PubMed  CAS  Google Scholar 

  12. Rodby RA, Rohde RD, Clarke WR, et al. The Irbesartan type II diabetic nephropathy trial: study design and baseline patient characteristics. For the Collaborative Study Group. Nephrol Dial Transplant 2000; 15(4): 487–97

    Article  PubMed  CAS  Google Scholar 

  13. Mann JF, Gerstein HC, Pogue J, et al. Renal insufficiency as a predictor of cardiovascular outcomes and the impact of ramipril: the HOPE randomized trial. Ann Intern Med 2001; 134(8): 629–36

    PubMed  CAS  Google Scholar 

  14. Zanchetti A, Hansson L, Dahlöf B, et al. Effects of individual risk factors on the incidence of cardiovascular events in the treated hypertensive patients of the Hypertension Optimal Treatment Study. HOT Study Group. J Hypertens 2001; 19(6): 1149–59

    Article  PubMed  CAS  Google Scholar 

  15. Leibson CL, O’Brien PC, Atkinson E, et al. Relative contributions of incidence and survival to increasing prevalence of adult-onset diabetes mellitus: a population-based study. Am J Epidemiol 1997; 146(1): 12–22

    Article  PubMed  CAS  Google Scholar 

  16. Registro Italiano Nazionale Dialisi e Trapianto. www.sin-ridt.org. 2001

  17. Conte F, Limido A, Malberti F, et al. Registro Lombardo Dialisi e Trapianto (RLDT): 31 December 1997 update — Annual Report Regione Lombardia — Direzione Generale Sanità, Milano: 21 December 1998

  18. GioFil. Il Portale dell’Informazione Sanitaria Farmaceutica. www.giofil.it. Accessed 22.09.2003

  19. www.federfarma.it Accessed 22.09.2003

  20. Aggiornamento delle tariffe delle prestazioni di assistenza ospedaliera, di cui al D-M-14 dicembre 1994. G.U. Supp ordinario n∘ 178 8 settembre 1997

  21. Prestazioni di assistenza specialistica ambulatoriale erogabili nell’ambito del SSN e relative tariffe G.U. Supp ordinario n∘ 150 14 settembre 1996

  22. Tariffario Regione Lombardia Comune Vimercate settembre 2003

  23. Lucioni C, Garancini MP, Massi-Benedetti M, et al. Il costo sociale del diabete di tipo 2 in Italia: lo studio CODE-2. PharmacoEconomics — Italian Research Articles 2000; 2(1): 1–21

    Google Scholar 

  24. Garattini L, Grilli R, Scopelliti D, et al. A proposal for Italian guidelines in pharmacoeconomics The Mario Negri Institute Centre for Health Economics. PharmacoEconomics 1995; 7(1): 1–6

    Article  PubMed  CAS  Google Scholar 

  25. Capri S, Ceci A, Terranova L. Guidelines for economic evaluations in Italy: recommendations from the Italian Group of Pharmacoeconomic Studies. Drug Information Journal 2001; 35(1): 189–201

    Article  Google Scholar 

  26. Weinstein MC, Siegel JE, Gold MR, et al. Recommendations of the Panel on Cost-effectiveness in Health and Medicine. JAMA 1996; 276(15): 1253–8

    Article  PubMed  CAS  Google Scholar 

  27. Detsky AS, Redelmeier DA. Measuring health outcomes—putting gains into perspective. N Engl J Med 1998; 339(6): 402–4

    Article  PubMed  CAS  Google Scholar 

  28. Wright JC, Weinstein MC. Gains in life expectancy from medical interventions—standardizing data on outcomes. N Engl J Med 1998; 339(6): 380–6

    Article  PubMed  CAS  Google Scholar 

  29. Szende A, Mogyorosy Z, Muszbek N. Methodological guidelines for conducting economic evaluation of healthcare interventions in Hungary: a Hungarian proposal for methodological guidelines. Eur J Health Econom 2002; 3: 196–206

    Article  Google Scholar 

  30. Herman WH, Shahinfar S, Carides GW, et al. Losartan Reduces the Costs Associated With Diabetic End-Stage Renal Disease: The RENAAL study economic evaluation. Diabetes Care 2003; 26(3): 683–7

    Article  PubMed  Google Scholar 

  31. Palmer AJ, Annemans L, Roze S, et al. Health economic consequences of the use of irbesartan in patients in Germany with type 2 diabetes, nephropathy and hypertension. Dtsch Med Wochenschr 2004; 129(1–2): 13–18

    Article  PubMed  CAS  Google Scholar 

  32. Palmer AJ, Annemans L, Roze S, et al. An economic evaluation of the Irbesartan in Diabetic Nephropathy Trial (IDNT) in a UK setting. J Hum Hypertens 2004

    Google Scholar 

  33. Parving HH, Lehnert H, Brochner-Mortensen J, et al. The effect of irbesartan on the development of diabetic nephropathy in patients with type 2 diabetes. N Engl J Med 2001

    Google Scholar 

  34. Lacourciere Y, Nadeau A, Poirier L, et al. Captopril or conventional therapy in hypertensive type II diabetics. Three-year analysis. Hypertension 1993; 21 (6pt1): 786–94

    Article  PubMed  CAS  Google Scholar 

  35. Lebovitz HE, Wiegmann TB, Cnaan A, et al. Renal protective effects of enalapril in hypertensive NIDDM: role of baseline albuminuria. Kidney Int Suppl 1994; 45: S150–S155

    Article  PubMed  CAS  Google Scholar 

  36. Trevisan R, Tiengo A. Effect of low-dose ramipril on microalbuminuria in normotensive or mild hypertensive non-insulin-dependent diabetic patients. North-East Italy Microalbuminuria Study Group. Am J Hypertens 1995; 8(9): 876–83

    Article  PubMed  CAS  Google Scholar 

  37. Agardh CD, Garcia-Puig J, Charbonnel B, et al. Greater reduction of urinary albumin excretion in hypertensive type II diabetic patients with incipient nephropathy by lisinopril than by nifedipine. J Hum Hypertens 1996; 10(3): 185–192

    PubMed  CAS  Google Scholar 

  38. Tatti P, Pahor M, Byington RP, et al. Outcome results of the Fosinopril Versus Amlodipine Cardiovascular Events Randomized Trial (FACET) in patients with hypertension and NIDDM. Diabetes Care 1998; 21(4): 597–603

    Article  PubMed  CAS  Google Scholar 

  39. Gaede P, Vedel P, Parving H-H, et al. Intensified multifactorial intervention in patients with type 2 diabetes mellitus and microalbuminuria: the Steno type 2 randomised study. Lancet 1999; 353: 617–22

    Article  PubMed  CAS  Google Scholar 

  40. Chan JC, Ko GT, Leung DH, et al. Long-term effects of angiotensin-converting enzyme inhibition and metabolic control in hypertensive type 2 diabetic patients. Kidney Int 2000; 57(2): 590–600

    Article  PubMed  CAS  Google Scholar 

  41. Estacio RO, Jeffers BW, Gifford N, et al. Effect of blood pressure control on diabetic microvascular complications in patients with hypertension and type 2 diabetes. Diabetes Care 2000; 23Suppl 2: B54–B64

    PubMed  Google Scholar 

  42. Efficacy of atenolol and captopril in reducing risk of macrovascular and microvascular complications in type 2 diabetes: UKPDS 39. UK Prospective Diabetes Study Group. BMJ 1998; 317(7160): 713–20

    Google Scholar 

  43. Schadlich PK, Brecht JG, Brunetti M, et al. Cost-effectiveness of ramipril in patients with non-diabetic nephropathy and hypertension: economic evaluation of Ramipril Efficacy in Nephropathy (REIN) Study for Germany from the perspective of statutory health insurance. PharmacoEconomics 2001; 19 (5 Pt 1): 497–512

    Article  PubMed  CAS  Google Scholar 

  44. Ruggenenti P, Pagano E, Tammuzzo L, et al. Ramipril prolongs life and is cost effective in chronic proteinuric nephropathies. Kidney Int 2001; 59(1): 286–94

    Article  PubMed  CAS  Google Scholar 

  45. Hendry BM, Viberti GC, Hummel S, et al. Modelling and costing the consequences of using an ACE inhibitor to slow the progression of renal failure in type I diabetic patients. QJM 1997; 90(4): 277–82

    Article  PubMed  CAS  Google Scholar 

  46. Clark WF, Churchill DN, Forwell L, et al. To pay or not to pay? A decision and cost-utility analysis of angiotensin-converting-enzyme inhibitor therapy for diabetic nephropathy. CMAJ 2000; 162(2): 195–98

    PubMed  CAS  Google Scholar 

  47. Le Pen C, Petitjean P, Levy P, et al. Economic evaluation of the contribution of captopril in the treatment of diabetic nephropathy:a cost-benefit approach. Nephrologie 1996; 17(6): 321–6

    PubMed  Google Scholar 

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Authors and Affiliations

  1. CORE - Center for Outcomes Research, Basel, Svizzera

    A. J. Palmer & S. Roze

  2. HEDM - Health Economics and Disease Management, Meise, Belgio

    L. Annemans & M. Lamotte

  3. Ghent University, Ghent, Belgio

    L. Annemans

  4. pbe consulting, Via Cappello 12, 37121, Verona, Italia

    P. Berto

  5. Nefrologia, Dipartimento di Medicina Interna, Università di Genova, Genova, Italia

    M. Ravera

  6. Section of Nephrology, Rush-Presbyterian St. Luke’s Medical Center, Chicago, USA

    R. A. Rodby

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  1. A. J. Palmer
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Correspondence to P. Berto.

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Palmer, A.J., Annemans, L., Roze, S. et al. Costo-efficacia di irbesartan in pazienti con diabete di tipo 2, ipertensione e nefropatia: prospettiva italiana. Pharmacoeconomics-Ital-Res-Articles 7, 43–57 (2005). https://doi.org/10.1007/BF03320534

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