Vengono presentate, in questo articolo, le schede di valutazione relative ai macrolidi, contributo tecnicofrutto del lavoro della Commissione Interaziendale Farmaci (gruppo di lavoro Antibiotici) 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.
Bibliografia (Studi clinici di confronto diretto)
1. Skerk V et al. Comparative analysis of azithromycin and clarithromycin efficacy and tolerability in the treatment of chronic prostatitis caused by Chlamydia trachomatis. J Chemother 2002; 14: 384-9.
2. Cascio A et al. Clarithromycin versus azithromycin in the treatment of Mediterranean spotted fever in children: a randomized controlled trial. Clin Infect Dis 2002; 34: 154-8.
3. Laurent J et al. A randomized comparison of four omeprazole-based triple therapy regimens for the eradication of Helicobacter pylori in patients with non-ulcer dyspepsia. Aliment Pharmacol Ther 2001; 15: 1787-93.
4. Dunne M et al. Randomized, double-blind trial comparing azithromycin and clarithromycin in the treatment of disseminated Mycobacterium avium infection in patients with human immunodeficiency virus. Clin InfectDis2000; 31: 1245-52.
5. O'Doherty B et al. Randomized, multicentre study of the efficacy and tolerance of azithromycin versus clarithromycin in the treatment of adults with mild to moderate community-acquired pneumonia. Azithromycin Study Group. Eur J Clin Microbiol Infect Dis 1998; 17: 828-33.
6. Ward TT et al. Randomized, open-label trial of azithromycin plus ethambutol vs. clarithromycin plus ethambutol as therapy for Mycobacterium avium complex bacteremia in patients with human immunodeficiency virus infection. Veterans Affairs HIV Research Consortium. Clin Infect Dis 1998; 27: 1278-85.
7. Venuta A et al. Azithromycin compared with clarithromycin for the treatment of streptococcal pharyngitis in children. J Int Med Res 1998l; 26: 152-8.
8. Sternon J et al. Azithromycin compared with clarithromycin in the treatment of adult patients with acute purulent tracheobronchitis: a cost of illness study. J Int Med Res 1995; 23: 413-22.
9. Bradbury F. Comparison of azithromycin versus clarithromycin in the treatment of patients with lower respiratory tract infection. J Antimicrob Chemother 1993; 31:153-62.
10. Muller O. Comparison of azithromycin versus clarithromycin in the treatment of patients with upper respiratory tract infections. J Antimicrob Chemother 1993; 31 Suppl E:137-46.
11. Block S. et al. Mycoplasma pneumoniae and Chlamydia pneumoniae in pediatric community-acquired pneumonia: comparative efficacy and safety of clarithromycin vs erythromycin ethylsuccinate . Pediatr InfectDis J 1995; 14: 471-7.
12. Harris JA et al. Safety and efficacy of azithromycin in the treatment of community-acquired pneumoniae in children. Pediatric Infect Dis J 1998; 17: 865-71.
13. Schonwald S et al. Comparison of Azithromycin and erythromycin in the treatment of atypical pneumoniae. J Antimicrob Chemother 1990; 25 suppl A: 123-6.
14. Roord JJ et al. Prospective open randomized study comparing efficacies an safeties of a 3-day course of azithromycin and a 10-days cours erythromycin in children with community-acquired acute low respiratory tract infections. Antimicrob Agents Chemother 1996; 40: 2765-8.
15. Rizzato G et al. Efficacy of a three day corse of azithromycin in moderately severe community-acquired pneumoniae. Eur. Respir J 1995; 8:398-402.
16. Bohte R et al. Efficacy and safety of Azithromycin vs benzylpenicillin o erythromycin in community-acquired pneumoniae. Eur J Clin Microbiol Infect Dis 1995; 14: 182-7.
17. Chien SM et al. Treatment of community-acquired pneumoniae. A multicenter, double blind, randomized study comparing clarithromycin with erythromycin. Chest 1993; 103: 697-701.
18. Aberg JA. Presence of macrolide resistance in respiratory flora of HIV-infected patients receiving either clarithromycin or azithromycin for Mycobacterium avium complex.HIV Clin Trials 2001; 2: 453-6.
(Studi clinici verso altri antibiotici)
19. Lode H et al. Sequential IV/PO moxifloxacin treatment of patients with severe community-acquired pneumoniae. Resp Med 2003; 97: 1134-42.
20. Romanelli G et al. Carbapenems in the treatment of severe community-acquired pneumoniae in hospitalized elderly patients: acomparative study against standard therapy. J Chemother 2002; 14: 609-17.
21. Gotfried MH et al. A controlled , double blind , multicenter study comparing clarithromycin extended-release tablets in the treatment of community-acquired pneumoniae. Clin Ther 2002; 24: 736-51.
22. Sokol WN et al. A prospective, double blind , multicenter study comparing clarithromycin extended-release tablets with travofloxacin in the treatment of community-acquired pneumoniae. Clin Ther 2002; 24: 605-15.
23. Hoeffken G et al. The efficacy and safety of two oral moxifloxacin regimens compared to oral clarithromycin in the treatment of community-acquired pneumoniae. Respir Med 2001; 95: 553-64.
24. Neu HC et al. Efficacy and safety of Clarithromycin compared to cefixime as outpatient treatment of lower respiratory tract infections. Chest 1993; 104: 1393-9.
25. Chaisson RE et al. Clarithromycin therapy for bacteraemic Mycobacterium aviumcomplex disease. A randomised, double-blind, dose-ranging study in patients with AIDS. AIDS Clinical Trials Group Protocol 157 Study Team. Ann Intern Med 1994; 121: 905-911.
26. Young LS et al. Azithromycin for treatment of Mycobacterium aviumcomplex infection in patients with AIDS.Lancet 1991; 338: 1107-1109.
27. Pierce M et al. A randomised trial of clarithromycin as prophylaxis against disseminated Mycobacterium aviumcomplex infection in patients with advanced acquired immunodeficiency syndrome. N Engl J Med 1996; 335: 384-391.
28. Oldfield EC. Once weekly azithromycin therapy for prevention of Mycobacterium avium complex infection in patients with AIDS: a randomized, double-blind, placebo-controlled multicenter trial. Clin Infect Dis 1998; 26: 611-9.
29. Havlir DV et al. Prophylaxis against disseminated Mycobacterium avium complex with weekly azithromycin, daily rifabutin, or both. California Collaborative Treatment Group. N Engl J Med 1996; 335: 392-8.
30. Kogan R et al. Comparative randomized trial of azithromycin versus erythromycin and amoxicillin for treatment of community-acquired pneumonia in children. Pediatr Pulmonol 2003; 35: 91-8.
31. Frank E et al. A multicenter, open-label, randomized comparison of levofloxacin and azithromycin plus ceftriaxone in hospitalized adults with moderate to severe community-acquired pneumonia. Clin Ther 2002; 24: 1292-308.
32. Lauvau DV et al. An open, multicentre, comparative study of the efficacy and safety of azithromycin and co-amoxiclav in the treatment of upper and lower respiratory tract infections in children. The Paediatric Azithromycin Study Group. Int Med Res 1997; 25: 285-95.
33. Zachariah J. A randomized, comparative study to evaluate the efficacy and tolerability of a 3-day course of azithromycin versus a 10-day course of co-amoxiclav as treatment of adult patients with lower respiratory tract infections. J Antimicrob Chemother 1996; 37 Suppl C: 103-13.
34. Hoepelman AI et al. A single-blind comparison of three-day azithromycin and ten-day co-amoxiclav treatment of acute lower respiratory tract infections. J Antimicrob Chemother 1993; 31 Suppl E: 147-52.
35. Castaldo RS et al. A comparison of 5-day courses of dirithromycin and azithromycin in the treatment of acute exacerbations of chronic obstructive pulmonary disease. Clin Ther 2003; 25(2): 542-57.
36. DeAbate CA et al. The safety and efficacy of short course (5-day) moxifloxacin vs. azithromycin in the treatment of patients with acute exacerbation of chronic bronchitis. Respir Med 2000; 94: 1029-37.
37. Amsden GW et al. Efficacy and safety of azithromycin vs levofloxacin in the outpatient treatment of acute bacterial exacerbations of chronic bronchitis. Chest 2003; 123: 772-7.
38. Hoepelman IM et al. A short (3-day) course of azithromycin tablets versus a 10-day course of amoxycillin-clavulanic acid (co-amoxiclav) in the treatment of adults with lower respiratory tract infections and effects on long-term outcome. Int J Antimicrob Agents 1997; 9: 141-6.
39. Biebuyck XA. Comparison of azithromycin and co-amoxiclav in the treatment of acute tracheobronchitis and acute infectious exacerbations of chronic bronchitis in adults. Azithromycin Study Group. J Int Med Res 1996;24: 407-18.
40. Koletar SL et al. Azithromycin as treatment for disseminated Mycobacterium avium complex in AIDS patients.Antimicrob Agents Chemother 1999; 43: 2869-72.
41. Gordin FM et al. A randomized , placebo controlled study of rifabutina added to a regimen of clarithromycin and ethambutol for treatment of disseminated infection with Mycobacterium avium. Clin Infect Dis 1999; 28: 1080-5.
42. Cohn DL et al. Prospective randomized trial of four three-drug regimens in the treatment of disseminatedMycobacterium avium complex disease in AIDS Patients:excess mortality associated with high-dose clarithromycin. Clin Infect Dis 1999; 29: 125-33.
43. Chaisson RE et al. Clarithromycin and etambutol with or without clofazimine for the treatment of bacteremicMycobacterium avium complex disease in patients with HIV infection. AIDS 1997;11: 311-7.
44. Adair CD et al. Chlamydia in pregnancy: a randomized trial of azithromycin and erythromycin. Obstet Gynecol1998; 91: 165-8.
45. Weiss K et al. An open-label, randomized, multicenter, comparative study of the efficacy andsafety of 7 days of treatment with clarithromycin extended-release tablets versus clarithromycin immediate-release tablets for the treatment of patients with acute bacterial exacerbation of chronic bronchitis. Clin Ther 2002; 24: 2105-22.
46. Wilson R et al. A comparison of gemifloxacin and clarithromycin in acute exacerbations of chronic bronchitis and long-term clinical outcomes. Clin Ther 2002; 24: 639-52.
47. Weiss LR. An open-label, randomized comparison of the efficacy and tolerability of clarithromycin, levofloxacin , and cefuroxime axetil in the treatment of adult with acute bacterial exacerbation of chronic bronchitis. Clin Ther2002; 24: 1414-25.
48. McCarty JM et al. Five days of cefprozil versus 10 days of clarithromycin in the treatment of an acute exacerbation of chronic bronchitis. Ann Allergy Asthma Immunol 2001; 87: 327-34.
49. Martinot JB. A comparative study of clarithromycin modified release and amoxicillin/clavulanic acid in the treatment of acute exacerbation of chronic bronchitis. Adv Ther 2001; 18: 1-11.
50. Anzueto A. Comparison of the efficacy of extended-release clarithromycin tablets and amoxicillin/clavulanate tablets in the treatment of acute exacerbation of chronic bronchitis. Clin Ther 2001; 23: 72-86.
51. Adler JL. Phase III, randomized, double-blind study of clarithromycin extended-release and immediate-release formulations in the treatment of patients with acute exacerbation of chronic bronchitis. Clin Ther 2000; 22: 1410-20.
52. Ziering W et al. Randomized comparison of once-daily ceftibuten and twice-daily clarithromycin in the treatment of acute exacerbation of chronic bronchitis. Infection 1998; 26: 68-75.
53. Anzueto A et al. Efficacy of ciprofloxacin and clarithromycin in acute bacterial exacerbations of complicated chronic bronchitis:interim analysis. Clin Ther 1997; 19: 989-1001.
54. Neu HC et al. Efficacy and safety of clarithromycin compared to cefixime as outpatient treatment of lower respiratory tract infections. Chest 1993; 104: 1393-9.
55. Paladino JA et al. Cost-effectiveness of IV-to-oral switch therapy: azithromycin vs cefuroxime with or without erythromycin for the treatment of community-acquired pneumonia. Chest 2002; 122: 1271-9.
56. Plouffe J et al. Clinical efficacy of intravenous followed by oral azithromycin monotherapy in hospitalized patients with community-acquired pneumonia. The Azithromycin Intravenous Clinical Trials Group. Antimicrob Agents Chemother 2000; 44: 1796-802.
57. Finch R et al. Randomized controlled trial of sequential intravenous (i.v.) and oral moxifloxacin compared with sequential i.v. and oral co-amoxiclav with or without clarithromycin in patients with community-acquired pneumonia requiring initial parenteral treatment. Antimicrob Agents Chemother 2002; 46: 1746-54.
58. Niederman MS et al. Guidelines for the initial management of adults with community-acquired pneumoniae: diagnosis, assessment of severity, and initial antimicrobial therapy. American Thoracic Society. Am Rev Respir Dis1993; 148: 1418-1426.
59. BTS Guidelines for the management of Community Acquired Pneumonia in adult. Thorax 2001; 56 (suppl IV): IV1-IV58.
60. Kimberly A. et al. U.S. Centers for disease control and prevention guidelines for the treatment of sexually trasmitted disease: an opportunity to unify clinical and public health practice. Ann Inten. Med 2002; 137: 255-262.
61. Scottish Intercollegiate Guidelines Network - Community Management of lower respiratory tract infection in adults 2002.
62. Bevan CD et al. Efficacy and safety of azithromycin as monotherapy or combined with metronidazole compared with two standard multidrug regimens for the treatment of acute pelvic inflammatory disease. J Int Med Res 2003; 31: 45-54.
63. Vergis EN et al.Azitromycin vs Cefuroxim plus Erythromycin for empirical treatment of CAP in Hospitalized patients. Arch Intern Med 2000;160: 1294-00.
64. Genne D et al. Clarithromycin vs amoxicillin-clavulanic acid in the treatment of community-acquired pneumoniae. Eur J Clin Microbiol Infect Dis 1997; 16: 783-8 .
(Studi di farmacocinetica e tollerabilità )
65. Chiu LM et al. Pharmacokinetics of intravenous azithromycin and ceftriaxone when administered alone and concurrently to healthy volunteers. J Antimicrob Chemother 2002; 50: 1075-9.
66. Luke DR et al. Toleration of intravenous azithromycin. Ann Pharmacother 1997; 31: 965-9.
67. Luke DR et al. G Disposition of oral azithromycin in humans. Clin Pharmacol Ther 1997; 61: 641-8.
68. Luke DR et al. Safety, toleration, and pharmacokinetics of intravenous azithromycin. Antimicrob Agents Chemother 1996; 40 : 2577-81.
69. Tschida SJ et al. QTc-interval prolongation associated with slow intravenous erythromycin lactobionate infusions in critically ill patients: a prospective evaluation and review of the literature. Pharmacotherapy 1996; 16: 663-74.
70. Waites KB et al. Serum concentrations of erythromycin after intravenous infusion in preterm neonates treated for Ureaplasma urealyticum infection. Pediatr Infect Dis J 1994; 13: 287-93.
71. Rengelshausen J et al. Contribution of increased oral bioavailability and reduced nonglomerular renal clearance of digoxin to the digoxin-clarithromycin interaction. Br J Clin Pharmacol 2003; 56: 32-8.
72. De Dios Garcia-Diaz J [Phlebitis due to intravenous administration of macrolide antibiotics. A comparative study of erythromycin versus clarithromycin] Med Clin (Barc) 2001; 116: 133-5.
73. Kevin W. Intravenous Azithromycin. The Annals of Pharmacotherapy 1999; 33: 218-228.
74. Amsden GW et al. A study of the interaction potential of azithromycin and clarithromycin with atorvastatin in healthy volunteers. J Clin Pharmacol 2002; 42: 444-9.
75. Garey KW et al. Lack of effect of zafirlukast on the pharmacokinetics of azithromycin,clarithromycin, and 14-hydroxyclarithromycin in healthy volunteers. Antimicrob Agents Chemother 1999; 43:1152-5.
76. Greenblatt DJ et al. Inhibition of triazolam clearance by macrolide antimicrobial agents: in vitro correlates and dynamic consequences. Clin Pharmacol Ther 1998; 64: 278-85.
77. Apseloff G et al. Comparison of azithromycin and clarithromycin in their interactions with rifabutin in healthy volunteers. J Clin Pharmacol 1998; 38: 830-5.
78. Rodvold KA et al. Intrapulmonary steady-state concentrations of clarithromycin and azithromycin in healthy adult volunteers. Antimicrob Agents Chemother 1997; 41: 1399-402.
79. Patel KB et al. Comparison of bronchopulmonary pharmacokinetics of clarithromycin and azithromycin.Antimicrob Agents Chemother 1996; 40: 2375-9.
80. Yeates RA et al. Interaction between midazolam and clarithromycin: comparison with azithromycin. Int J Clin Pharmacol Ther 1996; 34: 400-5.
81. Singlas E. Clinical pharmacokinetics of Azithromycin. Pathol Biol (Paris) 1995; 43: 505-11.
82. Hopkins S. Clinical safety and tolerance of azithromycin in children. J Antimicrob Chemother 1993;31 Suppl E:111-7.
83. Hafner R et al. Tolerance and pharmacokinetic interactions of rifabutin and clarithromycin in human immunodeficiency virus-infected volunteers. Antimicrob Agents Chemother 1998; 42: 631-9.
84. Zimmermann T. Comparative tolerability of intravenous azithromycin, clarithromycin and erythromycin in healthy volunteers. Clin Drug Invest 2001; 21: 527-536.