Benefit-risk assessment of telithromycin in the treatment of community-acquired pneumonia

Drug Safety

Volumn 31, Issue 7, 2008, Pages 561-575

  Brown, Steven D ^a  

^a CLINICAL MICROBIOLOGY INSTITUTE   (United States)

Author keywords

Benefit risk assessment; Community acquired pneumonia, treatment; Telithromycin, adverse reactions; Telithromycin, therapeutic use

Indexed keywords

AMOXICILLIN; ANTICOAGULANT AGENT; ANTIINFECTIVE AGENT; ATORVASTATIN; AZITHROMYCIN; BENZODIAZEPINE DERIVATIVE; BETA LACTAM; CISAPRIDE; CLARITHROMYCIN; ERYTHROMYCIN; FLUINDOSTATIN; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; KETOCONAZOLE; LORAZEPAM; MACROLIDE; METOPROLOL; MEVINOLIN; MIDAZOLAM; NITRAZEPAM; PAROXETINE; PIMOZIDE; PRAVASTATIN; QUINOLONE DERIVATIVE; RIFAMPICIN; ROSUVASTATIN; SIMVASTATIN; TELITHROMYCIN; TEMAZEPAM; TROVAFLOXACIN; UNINDEXED DRUG;

ACUTE RESPIRATORY FAILURE; ALLERGIC REACTION; ANAPHYLAXIS; ANGIONEUROTIC EDEMA; ANTIBIOTIC RESISTANCE; BACTEREMIA; BACTERIUM ISOLATE; BLURRED VISION; CHLAMYDOPHILA PNEUMONIAE; CHOLESTATIC HEPATITIS; CHRONIC BRONCHITIS; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; COMMUNITY ACQUIRED PNEUMONIA; COMORBIDITY; CONTROLLED CLINICAL TRIAL; DIALYSIS; DIARRHEA; DIPLOPIA; DISEASE SEVERITY; DIZZINESS; DRIVING ABILITY; DRUG ANTAGONISM; DRUG BLOOD LEVEL; DRUG COST; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG FATALITY; DRUG MECHANISM; DRUG MEGADOSE; DRUG METABOLISM; DRUG POTENTIATION; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSGEUSIA; DYSPEPSIA; ELDERLY CARE; FOOD AND DRUG ADMINISTRATION; FOOD DRUG INTERACTION; GASTROINTESTINAL SYMPTOM; GRAPEFRUIT JUICE; HAEMOPHILUS INFLUENZAE; HEADACHE; HEALTH CARE COST; HEPATITIS; HOSPITALIZATION; HUMAN; JAUNDICE; KIDNEY DISEASE; LEGIONELLA PNEUMOPHILA; LIVER DYSFUNCTION; LIVER FAILURE; LIVER FUNCTION TEST; LIVER INJURY; LIVER TOXICITY; LOOSE FECES; MORAXELLA CATARRHALIS; MORBIDITY; MORTALITY; MULTIDRUG RESISTANCE; MYASTHENIA GRAVIS; MYCOPLASMA PNEUMONIAE; NAUSEA; PANCREATITIS; PATHOGENESIS; PATIENT COMPLIANCE; PRIORITY JOURNAL; PROTEIN FUNCTION; QT PROLONGATION; RANDOMIZED CONTROLLED TRIAL; REPEATED DRUG DOSE; RESPIRATORY TRACT INFECTION; REVIEW; RISK ASSESSMENT; SIDE EFFECT; SINUSITIS; STREPTOCOCCUS INFECTION; STREPTOCOCCUS PNEUMONIAE; SYNCOPE; TREATMENT CONTRAINDICATION; TREATMENT OUTCOME; UNITED STATES; UNSPECIFIED SIDE EFFECT; VISUAL DISORDER; VOMITING;

ANTI-BACTERIAL AGENTS; COMMUNITY-ACQUIRED INFECTIONS; DRUG INTERACTIONS; HUMANS; KETOLIDES; PNEUMONIA, BACTERIAL; RISK ASSESSMENT;

EID: 45549088430     PISSN: 01145916     EISSN: None     Source Type: Journal    
DOI: 10.2165/00002018-200831070-00002     Document Type: Review

References (95)

1. Zhanel GG, Walters M, Noreddin A, et al. The ketolides: a critical review. Drugs 2002; 62: 1771-804
2. Wellington K, Noble S. Telithromycin. Drugs 2004; 64: 1683-94
3. Bonnefoy A, Girard AM, Agouridas C, et al. Ketolides lack inducibility properties of MLSB resistance phenotype. J Antimicrob Chemother 1997; 40: 85-90
4. Douthwaite S. Structure-activity relationships of ketolides vs macrolides. Clin Microbiol Infect 2001; 7 Suppl. 3: 11-7
5. Hansen LH, Mauvais P, Douthwaite S. The macrolide-ketolide antibiotic binding site is formed by structures of domain II and V of 23S ribosomal RNA. Mol Microbiol 1999; 31: 623-31
6. Douthwaite S, Champney S. Structures of ketolides and macrolides determine their mode of interaction with the ribosomal target site. J Antimicrob Chemother 2001; 48 Suppl. T1: 1-8
7. File TM. The epidemiology of respiratory tract infections. Semin Respir Infect 2000; 15: 184-94
8. Niederman MS, Mandell LA, Anzueto A, et al. Guidelines for the management of adults with community-acquired pneumonia: diagnosis, assessment of severity, antimicrobial therapy, and prevention. Am J Respir Crit Care Med 2001; 163: 1730-54
9. Blasi F. Atypical pathogens and respiratory tract infections. Eur Respir J 2004; 24: 171-81
10. Canton R. Resistance trends in Moraxella catarrhalis (PROTEKT years 1-3 [1999-2002]). J Chemother 2004; 16 Suppl. 6: 63-70
11. Dunbar LM. Current issues in the management of bacterial respiratory tract disease: the challenge of antibacterial resistance. Am J Med Sci 2003; 326: 360-8
12. Jacobs MR, Bajaksouzian S, Windau A, et al. Susceptibility of Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis to 17 oral antimicrobial agents based on pharmacodynamic parameters: 1998-2001 US Surveillance Study. Clin Lab Med 2004; 24: 503-30
13. Jenkins SG, Farrell DJ, Patel M, et al. Trends in anti-bacterial resistance among Streptococcus pneumoniae isolated in the USA, 2000-2003: PROTEKT US years 1-3. J Infect 2005; 51: 355-63
14. Mera RM, Miller RA, Daniels JJ, et al. Increasing prevalence of multidrug-resistant Streptococcus pneumoniae in the United States over a 10-year period: Alexander Project. Diagn Microbiol Infect Dis 2005; 51: 195-200
15. Low DE. Resistance trends in Haemophilus influenzae (PROTEKT years 1-3 [1999-2002]). J Chemother 2004; 16 Suppl. 6: 49-62
16. Marchese A, Schito GC. Recent findings from multinational resistance surveys: are we "PROTEKTed" from resistance? Int J Antimicrob Agents 2007; 29 Suppl. 1: S2-5
17. Reinert RR. Resistance phenotypes and multi-drug resistance in Streptococcus pneumoniae (PROTEKT years 1-3 [1999-2002]). J Chemother 2004; 16 Suppl. 6: 35-48
18. Dias R, Caniça M. Emergence of invasive erythromycin-resistant Streptococcus pneumoniae strains in Portugal: contribution and phylogenetic relatedness of serotype 14. J Antimicrob Chemother 2004; 54: 1035-9
19. Klugman KP. Clinical impact of antibiotic resistance in respiratory tract infections. Int J Antimicrob Agents 2007; 29 Suppl. 1: S6-10
20. Vanderkooi OG, Green DE, Low K, et al., for the Toronto Invasive Bacterial Disease Network. Predicting antimicrobial resistance in invasive pneumococcal infections. Clin Infect Dis 2005; 40: 1288-97
21. Daneman N, McGeer A, Green K, et al. Toronto Invasive Bacterial Diseases Network. Macrolide resistance in bacteremic pneumococcal disease: implications for patient management. Clin Infect Dis 2006; 43: 432-8
22. Bell D. Promoting appropriate antimicrobial drug use: perspective from the centers for disease control and prevention. Clin Infect Dis 2001; 33 Suppl. 3: S245-50
23. Kastner U, Guggenbichler JP. Influence of macrolide antibiotics on promotion of resistance in the oral flora of children. Infection 2001; 29: 251-6
24. Nicolau DP. Treatment with appropriate antibiotic therapy in community-acquired respiratory tract infections. Am J Manag Care 2004; 10 Suppl.: S381-8
25. Brixner DL. Clinical and economic outcomes in the treatment of lower respiratory tract infections. Am J Manag Care 2004; 10 12 Suppl.: S400-7
26. Zhanel GG, Dueck M, Hoban DJ, et al. Review of macrolides and ketolides: focus on respiratory tract infections. Drugs 2001; 61: 443-98
27. Felmingham D, Farrell DJ. In vitro activity of telithromycin against gram-negative bacterial pathogens. J Infect 2006; 52: 178-80
28. Weisblum B. Insights into erythromycin action from studies of its activity as inducer of resistance. Antimicrob Agents Chemother 1995; 39: 797-805
29. Farrell DJ, Jenkins SG. Distribution across the USA of macrolide resistance and macrolide resistance mechanisms among Streptococcus pneumoniae isolates collected from patients with respiratory tract infections: PROTEKT US 2001-2002. J Antimicrob Chemother 2004; 54 Suppl. 1: i17-22
30. Farrell DJ, Jenkins SG, Brown SD, et al. Emergence and spread of Streptococcus pneumoniae with erm(B) and mef(A) resistance. Emerg Infect Dis 2005; 11: 851-8
31. Namour F, Wessels DH, Pascual MH, et al. Pharmacokinetics of the new ketolide telithromycin (HMR 3647) administered in ascending single and multiple doses. Antimicrob Agents Chemother 2001; 45: 170-5
32. Shi J, Montay G, Bhargava VO. Clinical pharmacokinetics of telithromycin, a new ketolide antibacterial. Clin Pharmacokinet 2005; 44: 915-34
33. Cantalloube C, Bhargava V, Sultan E, et al. Pharmacokinetics of the ketolide telithromycin after single and repeated doses in patients with hepatic impairment. Int J Antimicrob Agents 2003; 22: 112-21
34. Ciervo CA, Shi J. Pharmacokinetics of telithromycin: application to dosing in the treatment of community-acquired respiratory tract infections. Curr Med Res Opin 2005; 21: 1641-50
35. Ketek® (telithromycin) tablets. Sanofi-aventis, 2007 [online]. Available from URL: http://www.fda.gov/cder/foi/label/2007/021144s012lbl.pdf [Accessed 2007 Oct 12]
36. Kardas P, Devine S, Golembesky A, et al. A systematic review and meta-analysis of misuse of antibiotic therapies in the community. Int J Antimicrob Agents 2005; 26: 106-13
37. Nicolau DP. Clinical use of antimicrobial pharmacodynamic profiles to optimize treatment outcomes in community-acquired bacterial respiratory tract infections: application to telithromycin. Expert Opin Pharmacother 2004; 5: 229-35
38. Muller-Serieys C, Andrews J, Vacheron F, et al. Tissue kinetics of telithromycin, the first ketolide antibacterial. J Antimicrob Chemother 2004; 53: 149-57
39. Khair OA, Andrews JM, Honeybourne D, et al. Lung concentrations of telithromycin after oral dosing. J Antimicrob Chemother 2001; 47: 837-40
40. Farrell DJ, Canton R, Hryniewicz W. Trends in antibacterial resistance of Streptococcus pneumoniae: PROTEKT global years 1-5. Clin Microbiol Infect 2006; 12 Suppl. 4: P1279
41. Nord CE, Farrell DJ, Leclercq R. Impact of ketolides on resistance selection and ecologic effects during treatment for respiratory tract infections. Microb Drug Resist 2004; 10: 255-63
42. Capobianco JO, Cao Z, Shortridge VD, et al. Studies of the novel ketolide ABT-773: transport, binding to ribosomes and inhibition of protein synthesis in Streptococcus pneumoniae. Antimicrob Agents Chemother 2000; 44: 1562-7
43. Lorenz J. Telithromycin: the first ketolide antibacterial for the treatment of community-acquired respiratory tract infections. Int J Clin Pract 2003; 57: 519-29
44. Stratton CW. Dead bugs don't mutate: susceptibility issues in the emergence of bacterial resistance. Emerg Infect Dis 2003; 9: 10-6
45. Farrell DJ, Felmingham D. The PROTEKT study year 4 demonstrates a continued lack of resistance development to telithromycin in Streptococcus pneumoniae. J Antimicrob Chemother 2005; 56: 795-7
46. Goldstein F, Vidal B, Kitzis MD. Telithromycin-resistant Streptococcus pneumoniae. Emerg Infect Dis 2005; 11: 1489-90
47. Rantala M, Haanpera-Heikkinen M, Lindgren M, et al. Streptococcus pneumoniae isolates resistant to telithromycin. Antimicrob Agents Chemother 2006; 50: 1855-8
48. Hagberg L, Torres A, van Rensburg D, et al. Efficacy and tolerability of once-daily telithromycin compared with high-dose amoxicillin for treatment of community-acquired pneumonia. Infection 2002; 30: 378-86
49. Mathers Dunbar L, Hassman J, Tellier G. Efficacy and tolerability of once-daily oral telithromycin compared with clarithromycin for the treatment of community-acquired pneumoniae in adults. Clin Ther 2004; 26: 48-62
50. Tellier G, Niederman MS, Nusrat R, et al. Clinical and bacteriological efficacy and safety of 5 and 7 day regimens of telithromycin once daily compared with a 10 day regimen of clarithromycin twice daily in patients with mild to moderate community-acquired pneumonia. J Antimicrob Chemother 2004; 54: 515-23
51. Pullman J, Champlin J, Vrooman Jr PS. Efficacy and tolerability of once-daily oral therapy with telithromycin compared with trovafloxacin for the treatment of community-acquired pneumonia in adults. Int J Clin Pract 2003; 57: 377-84
52. Mouton Y, Thamlikitkul V, Nieman RB, et al. Telithromycin versus other first-line single-agent antibiotics in the treatment of community-acquired pneumonia: a randomized superiority trial [abstract no. P883]. Abstracts of the 15th European Congress of Clinical Microbiology and Infectious Diseases; 2005 Apr 2-5; Copenhagen
53. Carbon C, Moola S, Velancsics I, et al. Telithromycin 800mg once daily for seven to ten days is an effective and well-tolerated treatment for community-acquired pneumonia. Clin Microbiol Infect 2003; 9: 691-703
54. Fogarty CM, Patel TC, Dunbar LM, et al. Efficacy and safety of telithromycin 800mg once daily for 7 days in community-acquired pneumonia: an open-label, multicenter study. BMC Infect Dis 2005; 5: 43
55. van Rensburg DJ, Fogarty C, Kohno S, et al. Efficacy of telithromycin in community-acquired pneumonia caused by pneumococci with reduced susceptibility to penicillin and/or erythromycin. Chemotherapy 2005; 51: 186-92
56. Carbon C, van Rensburg D, Hagberg L, et al. Clinical and bacteriologic efficacy of telithromycin in patients with bacteremic community-acquired pneumonia. Respir Med 2006; 100: 577-85
57. Buchanan PP, Stephens TA, Leroy B. A comparison of the efficacy of telithromycin versus cefuroxime axetil in the treatment of acute bacterial maxillary sinusitis. Am J Rhinol 2003; 17: 369-77
58. Luterman M, Tellier G, Lasko B, et al. Efficacy and tolerability of telithromycin for 5 or 10 days vs amoxicillin/clavulanic acid for 10 days in acute maxillary sinusitis. Ear Nose Throat J 2003; 82: 576-86
59. Ferguson BJ, Guzzetta RV, Spector SL, et al. Efficacy and safety of oral telithromycin once daily for 5 days versus moxifloxacin once daily for 10 days in the treatment of acute bacterial rhinosinusitis. Otolaryngol Head Neck Surg 2004; 131: 207-14
60. Zervos MJ, Heyder AM, Leroy B. Oral telithromycin 800mg once daily for 5 days versus cefuroxime axetil 500mg twice daily for 10 days in adults with acute exacerbations of chronic bronchitis. J Int Med Res 2003; 31: 157-69
61. Aubier M, Aldons PM, Leak A, et al. Telithromycin is as effective as amoxicillin/clavulanate in acute exacerbations of chronic bronchitis. Respir Med 2002; 96: 862-71
62. Fogarty C, de Wet R, Mandell L, et al. Five-day telithromycin once daily is as effective as 10-day clarithromycin twice daily for the treatment of acute exacerbations of chronic bronchitis and is associated with reduced healthcare resource utilization. Chest 2005 128: 1980-8
63. Niederman MS, McCombs JS, Unger AN, et al. The cost of treating community-acquired pneumonia. Clin Ther 1998; 20: 820-37
64. Miravitlles M, Murio C, Guerrero T, et al. Pharmacoeconomic evaluation of acute exacerbations of chronic bronchitis and COPD. Chest 2002; 121: 1449-55
65. Niederman MS, Chang JR, Stewart J, et al. Comparison of hospitalization rates in patients with community-acquired pneumonia treated with 10 days of telithromycin or clarithromycin. Curr Med Res Opin 2004; 20: 749-56
66. Niederman MS, Chang JR, Stewart J, et al. Hospitalization rates among patients with community-acquired pneumonia treated with telithromycin vs clarithromycin: results from two randomized, double-blind, clinical trials. Curr Med Res Opin 2004; 20: 969-80
67. US FDA. sanofi-aventis briefing document available for public disclosure Ketek® (telithromycin). December 14-15, 2006 Anti-infective Drugs Advisory Committee/Drug Safety and Risk Management Advisory Committee meeting 2006 Dec 14-15 [online]. Available from URL: http://222.fda.gov/ohrms/ dockets/ac/06/briefing/2006-4266b1-01-03-ketek-briefing-document.pdf [Accessed 2008 Jun 5]
68. Telithromycin briefing document for the FDA anti-infective drug product advisory meeting January 2003 [online]. Available from URL: http://www.fda.gov/ ohrms/dockets/ac/03/briefing/3919B1_01_Aventis-KETEK.pdf [Accessed 2008 Jan 23]
69. Lonks JR, Goldmann DA. Telithromycin: a ketolide antibiotic for treatment of respiratory tract infections. Clin Infect Dis 2005; 40: 1657-64
70. Démolis JL, Vacheron F, Cardus S, et al. Effect of single and repeated oral doses of telithromycin on cardiac QT interval in healthy subjects. Clin Pharmacol Ther 2003; 73: 242-52
71. Clay KD, Hanson JS, Pope SD, et al. Brief communication: severe hepatotoxicity of telithromycin. Three case reports and literature review. Ann Intern Med 2006; 144: 415-20
72. Perrot X, Bernard N, Vial C, et al. Myasthenia gravis exacerbation or unmasking associated with telithromycin treatment. Neurology 2006; 67: 2256-8
73. Jennett AM, Bali D, Jasti P, et al. Telithromycin and myasthenia crisis. Clin Infect Dis 2006; 43: 1621-2
74. US Food and Drug Administration. Center for Drug Evaluation and Research. Telithromycin (marketed as Ketek) information [online]. Available from URL: http://www.fda.gov/cder/drμg/infopage/telithromycin/default.htm [Accessed 2007 Oct 12]
75. Ross DB. The FDA and the case of Ketek. N Engl J Med 2007; 356: 1601-4
76. Soreth J, Cox E, Kweder S, et al. Ketek: the FDA perspective. N Engl J Med 2007; 356: 1675-6
77. European Medicines Agency discussion document 30 Mar 2007 [online]. Available from URL: http://www.emea.europa.eu/humandocs/PDFs/EPAR/ketek/ 101401en6.pdf [Accessed 2008 Jan 23]
78. Pfizer. Zithromax®. Pfizer Labs, 2003 [online]. Available from URL: http://www.fda.gov/cder/foi/label/2001/50710s008lbl.pdf [Accessed 2007 Oct 12]
79. Abbott Laboratories. Biaxin® and Biaxin XL®. Abbott Laboratories, 2005 [online]. Available from URL: http://www.fda.gov/cder/foi/label/2005/ 050662s038,050698s020,050775 s008lbl.pdf [Accessed 2007 Oct 12]
80. Dore DD, DiBello JR, Lapane KL. Telithromycin use and spontaneous reports of hepatotoxicity. Drug Saf 2007; 30: 697-703
81. Shi J, Montay G, Chapel S, et al. Pharmacokinetics and safety of the ketolide telithromycin in patients with renal impairment. J Clin Pharmacol 2004; 44: 234-44
82. Perret C, Lenfant B, Weinling E, et al. Pharmacokinetics and absolute oral bioavailability of an 800-mg oral dose of telithromycin in healthy young and elderly volunteers. Chemotherapy 2002; 48: 217-23
83. Tinel M, Descatoire V, Larrey D, et al. Effects of clarithromycin on cytochrome P-450: comparison with other macrolides. J Pharmacol Exp Ther 1989; 250: 746-51
84. Michalets EL, Williams CR. Drug interactions with cisapride: clinical implications. Clin Pharmacokinet 2000; 39: 49-75
85. Bellosta S, Paoletti R, Corsini A. Safety of statins: focus on clinical pharmacokinetics and drug interactions. Circulation 2004; 109 Suppl. 1: III50-7
86. Montay G, Chevalier P, Guimart C, et al. A 12-hour dosing interval reduces the pharmacokinetic interaction between telithromycin and simvastatin [abstract A-1623]. Abstracts of the 43rd Interscience Conference on Antimicrobial Agents and Chemotherapy; 2003 Sep 14-17; Chicago (IL)
87. Boger RH. Drug interactions of the statins and consequences for drug selection. Int J Clin Pharmacol Ther 2001; 39: 369-82
88. Lee AJ, Maddix DS. Rhabdomyolysis secondary to a drug interaction between simvastatin and clarithromycin. Ann Pharmacother 2001; 35: 26-31
89. Bolt HM. Rifampicin, a keystone inducer of drug metabolism: from Herbert Remmer's pioneering ideas to modern concepts. Drug Metab Rev 2004; 36: 497-509
90. Shi J, Montay G, Leroy B, et al. Effects of itraconazole or grapefruit juice on the pharmacokinetics of telithromycin. Pharmacotherapy 2005; 25: 42-51
91. Shi J, Chapel S, Montay G, et al. Effect of ketoconazole on the pharmacokinetics and safety of telithromycin and clarithromycin in older subjects with renal impairment. Int J Clin Pharmacol Ther 2005; 43: 123-33
92. Kane GC, Lipsky JJ. Drug-grapefruit juice interactions. Mayo Clin Proc 2000; 75: 933-42
93. O'Reilly RA. Stereoselective interactions of trimethoprim- sulfamethoxazole with the separated enantiomorphs of racemic warfarin in man. N Engl J Med 1980; 302: 33-5
94. Shrader SP, Fermo JD, Dzikowski AL. Azithromycin and warfarin interaction. Pharmacotherapy 2004; 24: 945-9
95. Kolilekas L, Anagnostopoulos GK, Lampaditis I. Potential interaction between telithromycin and warfarin. Ann Pharmacother 2004; 38: 1424-7