Simvastatin After Orthotopic Heart Transplantation
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Objective: Recent data indicate that the combination of a low cholesterol diet and simvastatin following heart transplantation is associated with significant reduction of serum cholesterol levels, lower incidence of graft vessel disease (GVD) and significantly superior 4-year survival rates than dietary treatment alone. On the basis of this first randomised long term study evaluating survival as the clinical end-point, we investigated the cost effectiveness of the above regimens as well as the long term consequences for the patient and for heart transplantation as a high-tech procedure.
Design and setting: The perspective of the economic analysis was that of the German health insurance fund. Life-years gained were calculated on the basis of the Kaplan-Meier survival curves from the 4-year clinical trial and from the International Society for Heart and Lung Transplantation (ISHLT) overall survival statistics. Incremental costs and incremental cost-effectiveness ratios were determined using various sources of data, and both costs and consequences were discounted by 3% per year. Sensitivity analyses using alternative assumptions were conducted in addition to the base-case analysis.
Patients and participants: As in the original clinical trial, the target population of the economic evaluation comprised all heart transplant recipients on standard triple immunosuppression consisting of cyclosporin, azathioprine and prednisolone, regardless of the postoperative serum lipid profile.
Interventions: The therapeutic regimens investigated in the analysis were the American Heart Association (AHA) step II diet plus simvastatin (titrated to a maximum dosage of 20 mg/day) and AHA step II diet alone.
Main outcome measures and results: Four years of treatment with simvastatin (mean dosage 8.11 mg/day) translated into an undiscounted survival benefit per patient of 2.27 life-years; 0.64 life-years within the trial period and 1.63 life-years thereafter. Discounted costs per year of life gained were $US1050 (sensitivity analyses $US800 to $US15 400) for simvastatin plus diet versus diet alone and $US18 010 (sensitivity analyses $US17 130 to $US21 090) for heart transplantation plus simvastatin versus no transplantation (all costs reflect 1997 values; $US1 = 1.747 Deutschmarks).
Conclusions: Prevention of GVD with simvastatin after heart transplantation was cost effective in all the scenarios examined with impressive prolongation of life expectancy for the heart recipient. Simvastatin also achieved an internationally robust 21% improvement in the cost effectiveness of heart transplantation compared with historical cost-effectiveness data.
KeywordsAdis International Limited Simvastatin Heart Transplantation Orthotopic Heart Transplantation Scandinavian Simvastatin Survival Study
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- 1.ISHLT 14th Annual Data Report. Available from: URL: (http://www.richmond.infi.net/~ishlt/ishlt_97/cause.html#heart_lung) [accessed 1997 Jul 8]
- 12.Evans RW. Organ transplantation and the inevitable debate as to what constitutes a basic health care benefit. In: Terasaki PI, Cecka JM, editors. Los Angeles (CA): UCLA Tissue Typing Laboratory, 1993: 359–91Google Scholar
- 13.Gold MR, Russell LB, Soegel JE, et al., editors. Cost-effectiveness in health and medicine. New York (NY): Oxford University Press, 1996Google Scholar
- 14.ISHLT 14th Annual Data Report. Available from: URL: http://www.richmond.infi.net/~~ishlt/registry/survival.htm#surv_a1 [accessed 1996 Nov 21]
- 15.Rote Liste 1997. Editio Cantor Verlag für Medizin und Naturwissenschaften GmbH. Aulendorf/Württemberg: ECV, 1997Google Scholar
- 16.GOÄ und BG-GOÄ. Gebührenordnung für Ärzte (GOÄ). 8. Auflage. Dachau: Zauner Druck und Verlags GmbH, 1997Google Scholar
- 17.Haberman S. Heart transplants: putting a price on life. Health Soc Serv J 1982; 90: 877–9Google Scholar
- 19.ISHLT 14th Annual Data Report. Available from: URL: http://www.richmond.infi.net/~ishlt/ishlt_97/surv_1.html#overall [accessed 1997 Jul 15]
- 23.Lee E. Statistical methods for survival data analysis. Belmont (CA): Wadsworth Inc., 1980: 162–7Google Scholar
- 24.1997 Drug Topics Red Book. Montvale (NJ): Medical Economics Company, Inc., 1997Google Scholar
- 25.The artificial heart: prototypes, policies, and patients. Washington, D.C.: National Academy Press, 1992: 268–9Google Scholar
- 27.Ammerman AS, Devellis RF, Keyserling TC, et al. Quality of life is not adversely affected by a dietary intervention to reduce cholesterol [abstract]. Circulation 1993; 87: 19Google Scholar
- 28.Lawrence WF, Fryback DG, Martin PA. Cholesterol and health status in the Beaver Dam Health Outcomes Study [abstract]. Med Decis Making 1994; 14: 436Google Scholar
- 29.Zimmermann R, Haverich A. Herztransplantation [editorial]. Fortschr Kardiol 1996; 1: 22Google Scholar
- 30.Anhang 1 (zu Artikel 1 Nr. 3) der Dritten Verordnung zur Änderung der Bundespflegesatzverordnung. Bundesgesetzblatt (BGBl.) I, Nr 68 vom 28. Köln: Bundesanzeiger Verlagsges mbH, 1995: 2006–12Google Scholar
- 31.Statistisches Bundesamt. Statistisches Jahrbuch für die Bundesrepublik Deutschland. Wiesbaden: Statistisches Bundesamt, 1997Google Scholar
- 32.United Network for Organ Sharing (UNOS). UNOS OPTN/Scientific Registry data. Richmond (VA): UNOS, 1997Google Scholar
- 33.Hauboldt RH. Cost implications of human organ transplantations: an update. Brookfield (CT): Milliman and Robertson, Inc., 1993Google Scholar
- 34.Poirier VL. The economic burden of artificial hearts: progress in artificial organs. Cleveland (OH): ISAO Press, 1986: 96–9Google Scholar
- 35.Discounting health care: only a matter of timing? Lancet 1992; 340: 148–9Google Scholar
- 38.The Scandinavian Simvastatin Survival Study Group. Randomized trial of cholesterol lowering in 4444 patients with coronary artery disease: the Scandinavian Simvastatin Survival Study (4S). Lancet 1994; 344: 1383–9Google Scholar
- 40.Malik IS, Anderson MH. Cost-efficacy of cholesterol lowering: West of Scotland Coronary Prevention Study versus the Scandinavian Simvastatin Survival Study [abstract]. Heart 1996; 75 Suppl. 1: 77Google Scholar
- 41.European Transplant Coordinators Organization (ETCO) Statistics. Available from: URL: http://www.kuleuven.ac.be [accessed 1997 Jul 8]
- 43.Institute of Medicine (IOM). National priorities for the assessment of clinical conditions and medical technologies. Washington, D.C.: National Academy Press, 1990Google Scholar