Cost-effectiveness of extended-release niacin/laropiprant added to a stable simvastatin dose in secondary prevention patients not at cholesterol goal in Germany

European Journal of Health Economics

Volumn 13, Issue 3, 2012, Pages 365-374

  Michailov, Galin V ^a   Davies, Glenn M ^b   Krobot, Karl J ^a  

^a MSD Sharp and Dohme GmbH   (Germany)

^b MERCK RESEARCH LABORATORIES   (United States)

Author keywords

Cost effectiveness; Dyslipidaemia; Extended release niacin; Hypercholesterolaemia; Laropiprant; Simvastatin

Indexed keywords

HIGH DENSITY LIPOPROTEIN CHOLESTEROL; LAROPIPRANT PLUS NICOTINIC ACID; LOW DENSITY LIPOPROTEIN CHOLESTEROL; SIMVASTATIN; TRIACYLGLYCEROL;

ADD ON THERAPY; ADULT; AGED; ARTICLE; CARDIOVASCULAR RISK; CHOLESTEROL BLOOD LEVEL; CONTROLLED DRUG RELEASE; CONTROLLED STUDY; COST EFFECTIVENESS ANALYSIS; DIABETES MELLITUS; DRUG COST; DRUG DOSE TITRATION; FEMALE; GERMANY; HUMAN; ISCHEMIC HEART DISEASE; MAJOR CLINICAL STUDY; MALE; PRIORITY JOURNAL; TRIACYLGLYCEROL BLOOD LEVEL;

AGED; AGED, 80 AND OVER; ANTICHOLESTEREMIC AGENTS; COST-BENEFIT ANALYSIS; DRUG THERAPY, COMBINATION; DYSLIPIDEMIAS; FEMALE; GERMANY; HEALTH CARE COSTS; HUMANS; HYPOLIPIDEMIC AGENTS; INDOLES; LIFE EXPECTANCY; MALE; MIDDLE AGED; MODELS, ECONOMIC; NIACIN; RISK ASSESSMENT; SECONDARY PREVENTION; SIMVASTATIN;

EID: 84861183524     PISSN: 16187598     EISSN: 16187601     Source Type: Journal    
DOI: 10.1007/s10198-011-0309-z     Document Type: Article

References (49)

1. Hockley, T., Gemmill, M.: European Cholesterol Guidelines Report. www.policy-centre.com/downloads/European-Cholesterol- Guidelines07.pdf (2007). Accessed 20 November 2009
2. World Health Organization. Mortality country fact sheet 2006 (Germany). http://www.who.int/whosis/mort/profiles/mort-euro- deu-germany.pdf (2006). Accessed 18 November 2009
3. British Heart Foundation Statistics Website. Health care costs of CHD by country, 2006, EU. http://www.heartstats.org/temp/ESspTabsp12.2spweb08.xls (2006). Accessed 20 November 2009
4. Austin, M.A., Hokanson, J.E., Edwards, K.L.: Hypertriglyceridemia as a cardiovascular risk factor. Am. J. Cardiol. 81, 7B-12B (1998) (Pubitemid 28113939)
5. McBride, P.: Triglycerides and risk for coronary artery disease. Curr. Atheroscler. Rep. 10, 386-390 (2008)
6. Assmann, G., Schulte, H., von Eckardstein, A., Huang, Y.: Highdensity lipoprotein cholesterol as a predictor of coronary heart disease risk. The PROCAM experience and pathophysiological implications for reverse cholesterol transport. Atherosclerosis 124(Suppl), S11-S20 (1996)
7. Drexel, H., Aczel, S., Marte, T., Benzer, W., Langer, P., Moll, W., Saely, C.H.: Is atherosclerosis in diabetes and impaired fasting glucose driven by elevated LDL cholesterol or by decreased HDL cholesterol? Diabetes Care 28, 101-107 (2005) (Pubitemid 40095790)
8. Jafri, H., Alsheikh-Ali, A.A., Karas, R.H.: Statin therapy does not reduce the increased cardiovascular risk associated with low levels of high-density lipoprotein cholesterol: evidence from randomized controlled trials. Circulation 120, S500 (2009). (Abstract 1423)
9. Gitt, A.K., Kastelein, J.P.P.: Predominant types of dyslipidemia in patients with coronary heart disease treated with statins in Europe and Canada: data from the dyslipidemia international study. Eur. Heart. J. 30(Suppl 1), 591 (2009). (Abstract 3543)
10. Gitt, A.K., Kastelein, J.P.P.: High prevalence of dyslipidemia in 18, 574 patients treated with statins in Europe and Canada: Results of the dyslipidemia international study. Eur. Heart. J. 30(Suppl 1), 303 (2009). (Abstract 1796)
11. NCEP. 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 106, 3143-3421 (2002)
12. The coronary drug project. JAMA 221, 918 (1972)
13. Clofibrate and niacin in coronary heart disease. JAMA 231, 360-381 (1975)
14. Brown, B.G., Hillger, L., Zhao, X.Q., Poulin, D., Albers, J.J.: Types of change in coronary stenosis severity and their relative importance in overall progression and regression of coronary disease. Observations from the FATS Trial. Familial Atherosclerosis Treatment Study. Ann. N. Y. Acad. Sci.748, 407-417 (1995). (discussion 417-418)
15. Brown, B.G., Zhao, X.Q., Chait, A., Fisher, L.D., Cheung, M.C., Morse, J.S., Dowdy, A.A., Marino, E.K., Bolson, E.L., Alaupovic, P., Frohlich, J., Albers, J.J.: Simvastatin and niacin, antioxidant vitamins, or the combination for the prevention of coronary disease. N. Engl. J. Med. 345, 1583-1592 (2001) (Pubitemid 33126837)
16. Canner, P.L., Berge, K.G., Wenger, N.K., Stamler, J., Friedman, L., Prineas, R.J., Friedewald, W.: Fifteen year mortality in Coronary Drug Project patients: long-term benefit with niacin. J. Am. Coll. Cardiol. 8, 1245-1255 (1986) (Pubitemid 17208898)
17. Knopp, R.H., Ginsberg, J., Albers, J.J., Hoff, C., Ogilvie, J.T., Warnick, G.R., Burrows, E., Retzlaff, B., Poole, M.: Contrasting effects of unmodified and time-release forms of niacin on lipoproteins in hyperlipidemic subjects: clues to mechanism of action of niacin. Metabolism 34, 642-650 (1985) (Pubitemid 15036921)
18. Illingworth, D.R., Stein, E.A., Mitchel, Y.B., Dujovne, C.A., Frost, P.H., Knopp, R.H., Tun, P., Zupkis, R.V., Greguski, R.A.: Comparative effects of lovastatin and niacin in primary hypercholesterolemia. A prospective trial. Arch. Intern. Med. 154, 1586-1595 (1994) (Pubitemid 24242345)
19. Mills, E., Prousky, J., Raskin, G., Gagnier, J., Rachlis, B., Montori, V.M., Juurlink, D.: The safety of over-the-counter niacin. A randomized placebo-controlled trial [ISRCTN18054903]. BMC. Clin. Pharmacol. 3, 4 (2003)
20. Birjmohun, R.S., Hutten, B.A., Kastelein, J.J., Stroes, E.S.: Increasing HDL cholesterol with extended-release nicotinic acid: from promise to practice. Neth. J. Med. 62, 229-234 (2004) (Pubitemid 39193956)
21. Abbott Pharmaceuticals. Niaspan (Niacin extended-release tablets) US prescribing information. http://www.rxabbott.com/pdf/niaspan.pdf (2005). Accessed 9 November 2009
22. Krobot, K.J., Michailov, G.V., Wagner, A.: Four-year treatment practice with extended-release niacin in Germany: adherence, treatment gaps and daily maintenance dose. Eur. Heart. J. 30(Suppl 1), 590 (2009). (Abstract 3541)
23. Dunn, R.T., Ford, M.A., Rindone, J.P., Kwiecinski, F.A.: Lowdose aspirin and ibuprofen reduce the cutaneous reactions following niacin administration. Am. J. Ther. 2, 478-480 (1995)
24. Whelan, A.M., Price, S.O., Fowler, S.F., Hainer, B.L.: The effect of aspirin on niacin-induced cutaneous reactions. J. Fam. Pract. 34, 165-168 (1992)
25. Trovato, A.T., Norquist, J.M., Rhodes, T., McQuarrie, K., Miller, T.B., Paolini, J.F., Watson, D.J.: The impact of niacin-induced flushing during the first week of therapy in a real world setting. J. Am. Coll. Cardiol. 51, A255 (2008). (Abstract 1019-1150)
26. Kamal-Bahl, S., Watson, D.J., Ambegaonkar, B.M.: Patients' experiences of niacin-induced flushing in clinical practice: a structured telephone interview. Clin. Ther. 31, 130-140 (2009)
27. Cheng, K., Wu, T.J., Wu, K.K., Sturino, C., Metters, K., Gottesdiener, K., Wright, S.D., Wang, Z., O'Neill, G., Lai, E., Waters, M.G.: Antagonism of the prostaglandin D2 receptor 1 suppresses nicotinic acid-induced vasodilation in mice and humans. Proc. Natl. Acad. Sci. U S A 103, 6682-6687 (2006)
28. Sturino, C.F., O'Neill, G., Lachance, N., Boyd, M., Berthelette, C., Labelle, M., Li, L., Roy, B., Scheigetz, J., Tsou, N., Aubin, Y., Bateman, K.P., Chauret, N., Day, S.H., Levesque, J.F., Seto, C., Silva, J.H., Trimble, L.A., Carriere, M.C., Denis, D., Greig, G., Kargman, S., Lamontagne, S., Mathieu, M.C., Sawyer, N., Slipetz, D., Abraham, W.M., Jones, T., McAuliffe, M., Piechuta, H., Nicoll-Griffith, D.A., Wang, Z., Zamboni, R., Young, R.N., Metters, K.M.: Discovery of a potent and selective prostaglandin D2 receptor antagonist, [(3R)-4-(4-chloro-benzyl)-7-fluoro-5- (methylsulfonyl)-1,2,3,4- tetrahydrocyclopenta[b]indol-3-yl]-acetic acid (MK-0524). J. Med. Chem. 50, 794-806 (2007) (Pubitemid 46332991)
29. Paolini, J.F., Mitchel, Y.B., Reyes, R., Kher, U., Lai, E., Watson, D.J., Norquist, J.M., Meehan, A.G., Bays, H.E., Davidson, M., Ballantyne, C.M.: Effects of laropiprant on nicotinic acid-induced flushing in patients with dyslipidemia. Am. J. Cardiol. 101, 625-630 (2008)
30. Maccubbin, D., Bays, H.E., Olsson, A.G., Elinoff, V., Elis, A., Mitchel, Y., Sirah, W., Betteridge, A., Reyes, R., Yu, Q., Kuznetsova, O., Sisk, C.M., Pasternak, R.C., Paolini, J.F.: Lipidmodifying efficacy and tolerability of extended-release niacin/laropiprant in patients with primary hypercholesterolaemia or mixed dyslipidaemia. Int. J. Clin. Pract. 62, 1959-1970 (2008)
31. Cook, J.R., Yin, D., Alemao, E., Davies, G., Krobot, K.J., Veltri, E., Lipka, L., Badia, X.: Cost-effectiveness of ezetimibe coadministration in statin-treated patients not at cholesterol goal: application to Germany, Spain and Norway. Pharmacoeconomics 22(Suppl 3), 49-61 (2004) (Pubitemid 39481912)
32. Cook, J.R., Yin, D., Alemao, E., Drummond, M.: Development and validation of a model to project the long-term benefit and cost of alternative lipid-lowering strategies in patients with hypercholesterolaemia. Pharmacoeconomics 22(Suppl 3), 37-48 (2004) (Pubitemid 39481911)
33. D'Agostino, R.B., Russell, M.W., Huse, D.M., Ellison, R.C., Silbershatz, H., Wilson, P.W., Hartz, S.C.: Primary and subsequent coronary risk appraisal: new results from the Framingham study. Am. Heart J. 139, 272-281 (2000) (Pubitemid 30090804)
34. Anderson, K.M., Odell, P.M., Wilson, P.W., Kannel, W.B.: Cardiovascular disease risk profiles. Am. Heart J. 121, 293-298 (1991)
35. Das Informationssystem der Gesundheitsberichterstattung des Bundes. http://www.gbe-bund.de/(2007). Accessed 12 March 2009
36. Statistisches Bundesamt Deutschland. http://www.destatis.de/jetspeed/ portal/cms/(2007). Accessed 12 March 2009
37. Roeters van Lennep, H.W., Liem, A.H., Dunselman, P.H., Dallinga- Thie, G.M., Zwinderman, A.H., Jukema, J.W.: The efficacy of statin monotherapy uptitration versus switching to ezetimibe/simvastatin: results of the EASEGO study. Curr. Med. Res. Opin. 24, 685-694 (2008) (Pubitemid 351428979)
38. Gleim, G., Ballantyne, C.M., Liu, N., Thompson-Bell, S., McCrary Sisk, C., Pasternak, R.C., Mitchel, Y., Paolini, J.F.: Efficacy and safety profile of co-administered ER niacin/laropiprant and simvastatin in dyslipidaemia. Br. J. Cardiol. 16, 90-97 (2009)
39. Lauer-Fischer. Lauer-Taxe Online. http://www.lauer-fischer. de/LF/Seiten/Produkte/Lauer-Taxe?online/Lauer-Taxe?online. aspx (2009). Accessed October 2009
40. Roze, S., Ferrieres, J., Bruckert, E., Van Ganse, E., Chapman, M.J., Liens, D., Renaudin, C.: Cost-effectiveness of raising HDL cholesterol by adding prolonged-release nicotinic acid to statin therapy in the secondary prevention setting: a French perspective. Int. J. Clin. Pract. 61, 1805-1811 (2007) (Pubitemid 47573092)
41. Botteman, M.F., Meijboom, M., Foley, I., Stephens, J.M., Chen, Y.M., Kaura, S.: Cost-effectiveness of zoledronic acid in the prevention of skeletal-related events in patients with bone metastases secondary to advanced renal cell carcinoma: application to France, Germany, and the United Kingdom. Eur. J. Health. Econ. (2010). doi:10.1007/s10198-010-0272-0
42. Maccubbin, D., Koren, M.J., Davidson, M., Gavish, D., Pasternak, R.C., Macdonell, G., Mallick, M., Sisk, C.M., Paolini, J.F., Mitchel, Y.: Flushing profile of extended-release niacin/laropiprant versus gradually titrated niacin extended-release in patients with dyslipidemia with and without ischemic cardiovascular disease. Am. J. Cardiol. 104, 74-81 (2009)
43. Graham, I., Atar, D., Borch-Johnsen, K., Boysen, G., Burell, G., Cifkova, R., Dallongeville, J., De Backer, G., Ebrahim, S., Gjelsvik, B., Herrmann-Lingen, C., Hoes, A., Humphries, S., Knapton, M., Perk, J., Priori, S.G., Pyorala, K., Reiner, Z., Ruilope, L., Sans-Menendez, S., Scholte op Reimer, W., Weissberg, P., Wood, D., Yarnell, J., Zamorano, J.L., Walma, E., Fitzgerald, T., Cooney, M.T., Dudina, A., Vahanian, A., Camm, J., De Caterina, R., Dean, V., Dickstein, K., Funck-Brentano, C., Filippatos, G., Hellemans, I., Kristensen, S.D., McGregor, K., Sechtem, U., Silber, S., Tendera, M., Widimsky, P., Altiner, A., Bonora, E., Durrington, P.N., Fagard, R., Giampaoli, S., Hemingway, H., Hakansson, J., Kjeldsen, S.E., Larsen, M.L., Mancia, G., Manolis, A.J., Orth-Gomer, K., Pedersen, T., Rayner, M., Ryden, L., Sammut, M., Schneiderman, N., Stalenhoef, A.F., Tokgozoglu, L., Wiklund, O., Zampelas, A.: European guidelines on cardiovascular disease prevention in clinical practice: executive summary. Eur. Heart J. 28, 2375-2414 (2007)
44. Cooper, A., Nherera, L., Calvert, N., O'Flynn, N., Turnbull, N., Robson, J., Camosso-Stefinovic, J., Rule, C., Browne, N., Ritchie, G., Stokes, T., Mannan, R., Bath, P., Brindle, P., Gill, P., Gujral, R., Hogg, M., Marshall, T., Minhas, R., Pavitt, L., Reckless, J., Rutherford, A., Thorogood, M., Wood, D.: Clinical guidelines and evidence review for lipid modification: cardiovascular risk assessment and the primary and secondary prevention of cardiovascular disease. http://www.guidance.nice.org.uk/CG67/Guidance/pdf/English (2008). Accessed 22 November 2009
45. Todd, P.A., Goa, K.L.: Simvastatin. A review of its pharmacological properties and therapeutic potential in hypercholesterolaemia. Drugs 40, 583-607 (1990)
46. Jones, P.H., Davidson, M.H., Stein, E.A., Bays, H.E., McKenney, J.M., Miller, E., Cain, V.A., Blasetto, J.W.: Comparison of the efficacy and safety of rosuvastatin versus atorvastatin, simvastatin, and pravastatin across doses (STELLAR* Trial). Am. J. Cardiol. 92, 152-160 (2003) (Pubitemid 36835963)
47. Michailov, G.V., Davies, G.M., Buono, J., Sazonov, V., Krobot, K.J.: Lipid goal attainment in German CHD patients receiving ER-Niacin/Laropiprant added to statin therapy. Clin. Res. Cardiol. 99(Suppl 2), P159 (2010). doi:10.1007/s00392-010-1200-0
48. Clinicaltrials.gov. NCT00461630: Treatment of HDL to reduce the incidence of vascular events HPS2-THRIVE. http://www. clinicaltrials.gov/ct2/show/ NCT00461630 Accessed 22 November 2009
49. Prevention of coronary heart disease in clinical practice. Recommendations of the Second Joint Task Force of European and other Societies on coronary prevention. Eur. Heart. J. 19, 1434-1503 (1998)