POLITICHE DEL FARMACO

 

Vengono presentate, in questo articolo, le schede di valutazione relative ai sartani contributo tecnico frutto del lavoro della Commissione Interaziendale Farmaci (gruppo di lavoro "Farmaci Cardiovascolari") delle Aziende Sanitarie della Area Vasta Emilia Nord. Vengono presi in esame le indicazioni d'impiego ed i dosaggi studiati/registrati ed illustrati i criteri che hanno condotto alla formulazione delle valutazioni conclusive. 


 Schede di valutazione dei sartani 
(indicazioni e dosaggi presenti in commercio e studiati, dosi medie utilizzate negli studi, sicurezza, cinetica, valutazioni conclusive) 


Bibliografia
1. Dickstein K, Chang P, Willenheimer R, et al. Comparison of the effects of losartan and enalapril on clinical status and exercise performance in patients with moderate or severe chronic heart failure. J Am Coll Cardiol1995;26:438-45.
2. McKelvie R, Yusuf S, Pericak D, Lindgren E, Held P, for the RESOLVD Investigators. Comparison of candesartan, enalapril, and their combination in congestive heart failure: randomized evaluation of strategies for left ventricular dysfunction (RESOLVD pilot study). Circulation 1999;100:1056-1064.
3. Lang RM, Elkayam U, Yellen LG, Krauss D, McKelvie R, Vaugahn DE, et al. Comparative Effects of Losartan and Enalapril on Exercise Capacity and Clinical Status in Patients With Heart Failure. J Am Coll Cardiol 1997;30:983-91.
4. Cohn JN, Tognoni G, Valsartan Heart Failure Trial Investigators. A randomized Trial of the angiotensin-receptor blocker valsartan in chronic heart Failure. N Engl J Med 2001;345:1667-75.
5. Pitt B, Poole-Wilson PA, Segal R, et al, on behalf of the ELITE II investigators. Effect of losartan compared with captopril on mortality in patients with symptomatic heart failure: randomised trial. Lancet 2000;355:1582-1587.
6. Murdoch DR, McDonagh TA, Farmer R, Morton JJ, McMurray JJ, Dargie HJ. ADEPT: Addition of the AT1 receptor antagonist eprosartan to ACE inhibitor therapy in chronic heart failure trial: hemodynamic and neurohormonal effects. Am Heart J 2001;141:800-7.
7. Gremmler B, Kunert M, Schleiting H, Ulbricht LJ. Improvement of cardiac output in patients with severe heart failure by use of ACE-inhibitors combine with the AT1-antagonist eprosartan. Eur Heart Failure 2000;2:183-7.
8. Tonkon M, Awan N, Niazi I et al. A study of the efficacy and safety of irbesartan in combination with conventional therapy, including ACE inhibitors in heart failure: irbesartan heart failure group. Int J Clin Pract2000;54:11-8.
9. Marc A Pfeffer, Karl Swedberg, Christopher B Granger, Peter Held, John J V McMurray, Eric L Michelson, Bertil Olofsson, Jan Östergren, Salim Yusuf, for the CHARM Investigators and Committees. Effects of candesartan on mortality and morbidity in patients with chronic heart failure: the CHARM-Overall programme Lancet 2003; 362: 759-66.
10. Pfeffer MA et al. Valsartan, captopril, or both in myocardial infarction complicated by heart failure, left ventricular dysfunction or both. N Engl J Med 2003;349:1893-906.
11. Jong P, Demers C, McKelvie RS, Liu PP. Angiotensin Receptor Blockers in heart failure: meta-analisi of randomized controlled trials. J Am Coll Cardiol 2002;39:463-70.
12. Kenneth Dickstein, John Kjekshus, and the OPTIMAAL Steering Committee,* for the OPTIMAAL Study Group*. Effects of losartan and captopril on mortality and morbidity in high-risk patients after acute myocardial infarction: the OPTIMAAL randomised trial. Lancet 2002; 360: 752-60.
13. Sharma D, Buyse M, Pitt B, Rucinska EJ, the Losartan Heart Failure Mortality Meta-analysis Study Group. Meta-analysis of observed mortality data from all-controlled, double-blind, multiple-dose studies of losartan in heart failure. Am J Cardiol 2000;85:187-192.
14. Martineau P & Goulet J. New competition in the realm of renin-angiotensin axis inhibition; the angiotensin II receptor antagonists in congestive heart failure. Ann Pharmacotherapy 2001;35:71-84.
15. Crozier I, Ikram H, Awan N, Cleland J, Stephen N, Dickstein K et al. Losartan in heart failure; hemodynamic effects and tolerability. Circulation 1995;91:691-7.
16. Riegger GAJ, Bouzo H, Petr P, et al, for the Symptom, Tolerability, Response to Exercise Trial of Candesartan Cilexetil in Heart Failure (STRETCH) Investigators. Improvement in exercise tolerance and symptoms of congestive heart failure during treatment with candesartan cilexetil. Circulation 1999;100:2224-2230.
17. Havranek EP, Thomas I, Smith WB Ponce GA, Bilsker M, Munger MA et al. Dose-related beneficial long-term hemodynaci and clinical efficacy of irbesartan in heart failure. J Am Coll Cardiol 1999;33:1174-81.
18. Dunselman PHJM. Effects of the replacement of the angiotensin converting enzyme inhibitor enalapril by the angiotensin receptor blocker telmisartan in patients with congestive heart failure. The replacement of angiotensin converting enzyme inhibition (REPLACE) investigators. International Journal of Cardiology 2001;77:131-138.
19. Brenner BM; Cooper ME; De-Zeeuw D; Keane WF; Mitch WE; Parving HH; Remuzzi G; Snapinn Sm; Zhang Z; Shahinfar S. Effects of losartan on renal and cardiovascular outcomes in patients with type 2 diabetes and nephropathy. N Engl J Med 2001; 345: 861-869.
20. 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: 851-60.
21. Parving HH, Lehnert H et al. The effect of irbesartan on the development of diabetic nephropathy in patients with type 2 diabetes. N Engl J Med 2001; 345: 870-8.
22. Carl Erik Mogensen, Steen Neldam, Ilkka Tikkanen, Shmuel Oren, Reuven Viskoper, Richard W Watts, Mark E Cooper for the CALM study group. Randomised controlled trial of dual blockade of renin­angiotensin system in patients with hypertension, microalbuminuria, and non­insulin dependent diabetes: the candesartan and lisinopril microalbuminuria (CALM) study. BMJ 2000;321:1440-4.
23. Scottish Intercollegiate Guidelines Network. Diagnosis and treatment of heart failure due to left ventricular systolic dysfunction. February 1999; No. 35. Available from: www.sign.ac.uk.
24. Dahlof B, et al. Cardiovascular morbidity and mortality in the Losartan Intervention For Endpoint reduction in hypertension study (LIFE): a randomised trial against atenolol. Lancet 2002;359:995-1003.
25. Lindholm LH, Ibsen H, Dahlof B, et al. Cardiovascular morbidity and mortality in patients with diabetes in the Losartan Intervention For Endpoint reduction in hypertension study (LIFE): a randomised trial against atenolol.Lancet 2002;359:1004-10.
26. Paul R. Conlin, J. David Spence, Bryan Williams, Arthur B. Ribeiro, Ikuo Saito, Claude Benedict, and Antonius M.G. Bunt. Angiotensin II Antagonists for Hypertension: Are There Differences in Efficacy? Am J Hypertens2000;13:418-42.
27. Schede tecniche.
28. The Medical Letter 15 aprile 2001; 8:29-34.
29. Guida all'uso dei farmaci anno 2003 n°2.
30. Renin Angiotensin System Antagonists. Drug Facts and Comparisons Jan 2000.
31. Benz J, Oshrain C, Henry D et al. Valsartan, a new angiotensin II receptor antagonist: a double-blind study comparing the incidence of cough with lisinopril and hydrochlorothiazide. J Clin Pharmacol 1997;37:101-107.
32. Chan P, Tomlinson B, Huang TY et al. Double-blind comparison of losartan, lisinopril, and metolazone in elderly hypertensive patients with previous angiotensin-converting enzyme inhibitor-induced cough.J Clin Pharmacol1997;37:253-257.
33. Colin PR et al. Effect of indomethacin on blood pressure lowering by captopril and losartan in hypertensive patients. Hypertension 2000; 36:461.
34. Hallberg P, Karlsson J, Kurland L, Lind L, Kahan T, Malmqvist K, Ohman KP, Nystrom F, Melhus H. The CYP2C9 genotype predicts the blood pressure response to irbesartan: results from the Swedish Irbesartan Left Ventricular Hypertrophy Investigation vs Atenolol (SILVHIA) trial. J Hypertens2002; 20:2089-93.
35. Marino MR, Vachharajani NN. Drug interactions with irbesartan. Clin Pharmacokinet. 2001;40:605-14.
36. Taavitsainen P, Kiukaanniemi K, Pelkonen O. In vitro inhibition screening of human hepatic P450 enzymes by five angiotensin-II receptor antagonists. Eur J Clin Pharmacol 2000;56:135-40.

Informazioni sui Farmaci, Anno 2005, n. 5