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• W1909637030 abstract "Aminoglycosides presently constitute first-line antibacterial therapy, particularly in high-risk patients with serious and life-threatening aerobic Gram-negative infections. However, aminoglycosides continue to manifest undesirable side-effects such as nephrotoxicity, complicating 5–35% of therapeutic courses. The incidence of these side-effects can be reduced when appropriate attention is paid to the dose of the drug, the duration of therapy, the avoidance of dehydration and hypokalemia, and the specific aminoglycoside selected for therapy. Actually, there is continuing debate over the most appropriate administration regimen for these drugs. Aminoglycosides have been administered in twice- or thrice-daily dosing regimens since their introduction to clinical use four decades ago. Recently, increasing numbers of experimental and clinical studies have demonstrated that a once-daily dosing regimen may be at least as effective as, and possibly less toxic than multiple dosing. It seems essential to achieve high peak concentrations, since the bactericidal activity of the aminoglycosides is concentration-dependent and the ratio of the peak concentration to the MIC correlates closely with therapeutic outcome [1Blaser J Stone BB Groner MC Zinner SH Comparative study with enoxacin and netilmicin in a pharmacodynamic model to determine importance of ratio of antibiotic peak concentration to MIC for bactericidal activity and emergence of resistance.Antimicrob Agents Chemother. 1987; 31: 1054-1060Crossref PubMed Scopus (405) Google Scholar, 2Moore RD Lietman PS Smith CR Clinical response to aminoglycoside therapy: importance of the ratio of peak concentration to minimal inhibitory concentration.J Infect Dis. 1987; 155: 93-99Crossref PubMed Scopus (936) Google Scholar, 3Vogelman B Gudmundsson S Leggett J Turnidge J Ebert S Craig WA Correlation of antimicrobial pharmacokinetic parameters with therapeutic efficacy in an animal model.J Infect Dis. 1988; 158: 831-847Crossref PubMed Scopus (597) Google Scholar, 4Craig WA Redington J Ebert SC Pharmacodynamics of amikacin in vitro and in mouse thigh and lung infections.Antimicrob Agents Chemother. 1991; 27: 29-40Crossref Google Scholar]. The risk for the development of aminoglycoside-induced nephrotoxicity has been well defined with multiple dosing regimens, including dose, duration of therapy longer than 10days, dehydration, hypokalemia, severe obesity with incorrect dosage calculations, elderly patients, concurrent nephrotoxic agents, prior aminoglycoside therapy (particularly within 6 weeks), underlying disease, pre-existing renal failure and the type of aminoglycoside used [5Whelton A Solez K Aminoglycoside nephrotoxicity a tale of two transports.J Lab Clin Med. 1982; 99: 148-155PubMed Google Scholar, 6Kourilsky O Solez K Morel-Maroger L et al.The pathology of acute renal failure due to interstitial nephritis in man with comments on the role of interstitial inflammation and sex in gentamicin nephrotoxicity.Medicine. 1982; 61: 258-268Crossref PubMed Scopus (45) Google Scholar, 7Moench TR Smith CR Risk factors for aminoglycoside nephrotoxicity.in: Whelton A Neu HC The aminoglycosides. Marcel Dekker, Inc, New York1982: 401-415Google Scholar, 8Whelton A Aminoglycoside kinetics and clinical use in renal insufficiency.in: Whelton A Neu HC The aminoglycosides. Marcel Dekker, Inc, New York1982: 585-609Google Scholar, 9Moore RD Smith CR Lipsky JJ Mellits ED Lietman PS Risk factors for nephrotoxicity in patients treated with aminoglycosides.Ann Intern Med. 1984; 100: 352-357Crossref PubMed Scopus (301) Google Scholar]. Most of these risk factors need to be re-evaluated with a once-daily regimen. The duration of aminoglycoside therapy, with a cut-off point at 6 or 7days, and the cumulative dose are recognized in both uni- and multivariate analysis as strong and well documented toxicity factors even if individualized pharmacokinetic monitoring is used [10Bertino JS Booker LA Franck PA Jenkins PL Franck KR Nafziger AN Incidence of and significant risk factors for aminoglycoside-associated nephrotoxicity in patients dosed by using individualized pharmacokinetic monitoring.J Infect Dis. 1993; 167: 173-179Crossref PubMed Scopus (150) Google Scholar, 11Maller R Ahrne H Holmen C Lausen I Nilsson LE the Scandinavian Amikacin Once Daily Study Group.Once? versus twice-daily amikacin regimen: efficacy and safety in systemic Gram-negative infections.J Antimicrob Chemother. 1993; 31: 939-948Crossref PubMed Scopus (61) Google Scholar, 12Prins JM Büller HR Kuijper EJ Tange RA Speelman P Once-daily gentamicin versus once-daily netilmicin in patients with serious infections a randomized clinical trial.J Antimicrob Chemother. 1994; 33: 823-835Crossref PubMed Scopus (36) Google Scholar, 13Blaser J Konig C Once daily dosing of aminoglycosides.Eur J Clin Microbiol Infect Dis. 1995; 14: 1029-1038Crossref PubMed Scopus (64) Google Scholar, 14Galloe AM Graudal N Christensen HR Kampmann JP Aminoglycosides: single or multiple daily dosing- A meta-analysis on efficacy and safety.Eur J Clin Pharmacol. 1995; 48: 39-43Crossref PubMed Scopus (109) Google Scholar, 15Barza M Ioannidis JPA Cappelleri JC Lau J Single or multiple daily doses of aminoglycosides: a meta-analysis.Br Med J. 1996; 312: 338-345Crossref PubMed Scopus (361) Google Scholar, 16Ferriols-Lisart R Alos-Alminana M Effectiveness and safety of once-daily aminoglycosides: a meta-analysis.Am J Health Syst Pharmacol. 1996; 53: 1141-1150PubMed Google Scholar, 17Hatala R Dinh T Cook DJ Once-daily aminoglycoside dosing in immunocompetent adults: a meta-analysis.Ann Intern Med. 1996; 124: 717-725Crossref PubMed Scopus (269) Google Scholar, 18Munckhof WJ Grayson ML Tumidge JD A meta-analysis of studies on the safety and efficacy of aminoglycosides given either once daily or as divided doses.J Antimicrob Chemother. 1996; 37: 645-663Crossref PubMed Scopus (201) Google Scholar, 19Ali MZ Goetz MB A meta-analysis of the relative efficacy and toxicity of single daily dosing versus multiple daily dosing of aminoglycosides.Clin Infect Dis. 1997; 24: 796-809Crossref PubMed Scopus (212) Google Scholar, 20Bailey TC Little JR Littenberg B Reichley RM Dunagan WC A meta-analysis of extended-interval dosing versus multiple daily dosing of aminoglycosides.Clin Infect Dis. 1997; 24: 786-795Crossref PubMed Scopus (191) Google Scholar, 21Hatala R Dinh TT Cook DJ Single daily dosing of aminoglycosides in immunocompromised adults: a systematic review.Clin Infect Dis. 1997; 24: 810-815Crossref PubMed Scopus (89) Google Scholar, 22Paterson DL Robson JM Wagener MM Risk factors for toxicity in elderly patients given aminoglycosides once daily.J Gen Intern Med. 1998; 13: 735-739Crossref PubMed Scopus (85) Google Scholar]. High serum peak concentrations in the very elderly population, and administration of aminoglycosides during patients' rest periods, may also favor nephrotoxicity [23Koo J Tight R Rajkumar V Hawa Z Comparison of once-daily versus pharmacokinetic dosing of aminoglycosides in elderly patients.Am J Med. 1996; 101: 177-183Abstract Full Text PDF PubMed Scopus (51) Google Scholar, 24Peters Volleberg GW Dortant PM Speijers GJ Comparison of tobramycin nephrotoxicity in young adult and aged female rats.Pharmacol Toxicol. 1999; 84: 147-153Crossref PubMed Scopus (13) Google Scholar, 25Prins JM Van Weverling GJ Ketel RJ Speelman P Circadian variations in serum levels and the renal toxicity of aminoglycosides in patients.Clin Pharmacol Ther. 1997; 62: 106-111Crossref PubMed Scopus (43) Google Scholar]. The role of individual aminoglycoside selection has not been clearly evaluated during once-daily regimens, and thus it is not known if aminoglycoside-induced nephrotoxicity prevention by once-daily dosing applies equally to all aminoglycosides. After parenteral administration, aminoglycosides are eliminated almost entirely via the kidney by glomerular filtration. However, a fraction of aminoglycosides is reabsorbed in the proximal tubule. Rate-limiting binding of these polycationic antibiotics takes place at various phosphoinositol-binding sites on the proximal tubular cell brush border. An additional fraction of drug enters proximal tubular cells through a basolateral cell transport system. Aminoglycosides accumulate within lysosomes. During repetitive dosing with aminoglycosides, lysosomes continuously take drugs up with a progressive size increase. The loss of their restricting membrane integrity, their disruption and the liberation of proteolytic enzymes and aminoglycosides into the cell cytosol lead to cell necrosis and renal failure. Under conventional dosing, the kidney is unable to totally excrete the aminoglycoside dose within the dosing interval related to impaired function. This point has led to the evaluation of once-daily dosing of aminoglycosides, which would take advantage of minimizing repeated exposure and therefore potential nephrotoxicity. The impact of dose scheduling on renal toxicity can be explained by non-linear drug accumulation. Uptake of aminoglycosides into renal tissue is not proportional to the concentration over the entire range of serum levels encountered during once-daily dosing, and is limited by a saturation mechanism. The penetration velocity into tubular cells becomes slower when serum concentration reaches 10–15mg/L [26Giuliano RA Verpooten GA Verbist L Wedeen RP De Broe ME In vivo uptake kinetics of aminoglycosides in the kidney cortex of rats.J Pharmacol Exp Ther. 1986; 236: 470-475PubMed Google Scholar], values regularly exceeded when aminoglycosides are used once daily, especially with netilmicin, amikacin and isepamicin. Due to drug-specific saturable uptake, high peak levels are not critical for renal accumulation [26Giuliano RA Verpooten GA Verbist L Wedeen RP De Broe ME In vivo uptake kinetics of aminoglycosides in the kidney cortex of rats.J Pharmacol Exp Ther. 1986; 236: 470-475PubMed Google Scholar, 27Giuliano RA Paulus GJ Verpooten GA et al.Recovery of cortical phospholipidoses and necrosis after acute gentamicin loading in rats.Kidney Int. 1984; 26: 838-847Crossref PubMed Scopus (80) Google Scholar, 28De Broe ME Giuliano RA Verpooten GA Choice of drug and dosage regimen: two important risk factors for aminoglycoside nephrotoxicity.Am J Med. 1986; 80: 115-118Abstract Full Text PDF PubMed Scopus (53) Google Scholar]. According to these data, aminoglycoside-induced nephrotoxicity is not primarily associated with high peak levels present for a limited period of time. Conversely, elevated trough concentrations, over 2mg/L for gentamicin and tobramycin, have been associated with nephrotoxicity [29Wenk M Vozeh S Follath F Serum level monitoring of antimicrobial drugs. A review.Clin Pharmacokinet. 1984; 9: 475-492Crossref PubMed Scopus (43) Google Scholar, 30Parker SE Davey PG Practicalities of once-daily aminoglycoside dosing.J Antimicrob Chemother. 1993; 31: 4-8Crossref PubMed Scopus (58) Google Scholar, 31Prins JM Buller HR Kuijper EJ Tange RA Speelman P Once versus thrice daily gentamicin in patients with serious infections.Lancet. 1993; 341: 335-339Abstract PubMed Scopus (359) Google Scholar]. The prolonged time period with low serum concentrations and the lower trough values achieved with once-daily dosing may therefore result in a lower total amount of accumulated drug compared to fractionated dosing. Toxicologic studies in animals have clearly demonstrated that dividing the total daily dose into several smaller doses causes more frequent and severe renal toxicity compared to once-daily administration [32Frame PT Phair JP Watanakunakorn C Bannister TWP Pharmacologic factors associated with gentamicin nephrotoxicity in rabbits.J Infect Dis. 1977; 135: 952-957Crossref PubMed Scopus (63) Google Scholar, 33Reiner NE Bloxham DD Thompson WL Nephrotoxicity of gentamicin and tobramycin given once daily or continuously in dogs.J Antimicrob Chemother. 1978; 4: 85-101Crossref PubMed Scopus (90) Google Scholar, 34Bennet WM Plamp CE Gilbert DN Parker RA Porter GA The influence of dosage regimen on experimental gentamicin nephrotoxicity: dissociation of peak serum levels from renal failure.J Infect Dis. 1979; 140: 576-580Crossref PubMed Scopus (138) Google Scholar, 35Wood CA Norton DR Kohlhepp SJ et al.The influence of tobramycin dosage regimens on nephrotoxicity, ototoxicity and antibacterial efficacy in a rat model of subcutaneous abscess.J Infect Dis. 1988; 158: 13-22Crossref PubMed Scopus (67) Google Scholar]. In humans, the amount of netilmicin or gentamicin accumulated in the kidneys is 30–50% higher after continuous infusion (even if this regimen is never used in humans) compared to once-daily administration of the same total dose [28De Broe ME Giuliano RA Verpooten GA Choice of drug and dosage regimen: two important risk factors for aminoglycoside nephrotoxicity.Am J Med. 1986; 80: 115-118Abstract Full Text PDF PubMed Scopus (53) Google Scholar,36Giuliano RA Verpooten GA De Broe ME The effect of dosing strategy on kidney cortical accumulation of aminoglycosides in rats.Am J Kidney Dis. 1986; 7: 297-303Abstract Full Text PDF Scopus (43) Google Scholar, 37De Broe ME Giuliano RE Verpooten GA Insights into the renal handling of aminoglycosides: a guideline for prevention of nephrotoxicity.J Drug Dev. 1988; 1: 83-92Google Scholar, 38Verpoten GA Giuliano RA Verbist L Eestermans G De Broe ME Once-daily dosing decreases renal accumulation of gentamicin and netilmicin.Clin Pharmacol Ther. 1989; 45: 22-27Crossref PubMed Scopus (192) Google Scholar]. However, no study has compared renal accumulation of aminoglycosides after single daily dosing compared to multiple daily dosing [39Bertino JS Rotschafer JC Editorial response: single daily dosing of aminoglycosides a concept whose time has not yet come.Clin Infect Dis. 1997; 24: 820-823Crossref PubMed Scopus (35) Google Scholar]. Finally, the risk of nephrotoxicity does not disappear with once-daily regimens, but this risk is delayed and appears 3 days later compared to fractionated dosing [40Cometta A Zinners S De Bock R et al.Piperacillin tazobactam plus amikacin versus ceftazidime plus amikacin as empiric therapy for fever in granulocytopenic patients with cancer.Antimicrob Agents Chemother. 1995; 39: 445-452Crossref PubMed Google Scholar]. Extensive comparative clinical trial data have been published with fractionated conventional use of aminoglycosides. Twenty-five years ago, Whelton [41Whelton A Clinical strategies for the reduction of aminoglycoside nephrotoxicity and ototoxicity.Chemotherapia. 1984; 3: 52-59Google Scholar] summarized the most important studies related to aminoglycoside-induced nephrotoxicity (Table 1). Study methodology varied from study to study and few of them followed a double-blind protocol. Nephrotoxicity was generally determined using rather non-sensitive end-points such as measurement of serum creatinine. Nevertheless, the analysis of these clinical trial data confirmed that, in conventional schedules, gentamicin and tobramycin were significantly more nephrotoxic than amikacin and netilmicin, and that amikacin and netilmicin were comparable. This has been confirmed in a human study [42De Broe ME Paulus GT Verpooten GA et al.Early effects of gentamicin, tobramycin and amikacin on the human kidney.Kidney Int. 1984; 25: 643-652Crossref PubMed Scopus (143) Google Scholar] comparing lysosomal morphology and function in proximal tubular cells 4days after amikacin, gentamicin and tobramycin administration. Gentamicin and tobramycin could not be distinguished on the basis of drug tissue accumulation, lysosomal overloading, or effect on lysosomal phospholipase A1, while amikacin induced significantly lower lysosomal overloading and no loss of phospholipase A1 activity. This difference in nephrotoxic potential among aminoglycosides could be related to their chemical structure and more precisely to their ability to bind to the brush border membranes [43Williams PD Hottendorf GH Bennett DB Inhibition of renal membrane binding and nephrotoxicity of aminoglycosides.J Pharmacol Exp Ther. 1986; 237: 919-925PubMed Google Scholar,44Neuman M Relationships between chemical structure and adverse effects of antibacterial and antifungal agents.Chemioterapia. 1987; 6: 299-305PubMed Google Scholar].Table 1Nephrotoxic potential of aminoglycosides with conventional use [41Whelton A Clinical strategies for the reduction of aminoglycoside nephrotoxicity and ototoxicity.Chemotherapia. 1984; 3: 52-59Google Scholar]AminoglycosidePatients nNephrotoxicity n% mean (range)Amikacin (A)733638.6 (0–27.6)Gentamicin (G)105516315.5 (2.0–55.2)Netilmicin (N)256197.4 (1.0–38.2)Tobramycin (T)7099813.8 (5.8–58.0)G versus A: P=0.00002; RR=1.26 (CI 95:1.15–1.38). G versus T: P=0.34. G versus N: P=0.0009; RR=1.13 (CI 95:1.07–1.20). T versus A: P=0.002; RR=1.28 (CI 95:1.11–1.46). T versus N: P=0.007; RR=1.16 (CI 95 1.06–1.27). A versus N: P=0.55. Open table in a new tab G versus A: P=0.00002; RR=1.26 (CI 95:1.15–1.38). G versus T: P=0.34. G versus N: P=0.0009; RR=1.13 (CI 95:1.07–1.20). T versus A: P=0.002; RR=1.28 (CI 95:1.11–1.46). T versus N: P=0.007; RR=1.16 (CI 95 1.06–1.27). A versus N: P=0.55. In the last 10years, the effects of the single daily dosing of aminoglycosides on toxicity and efficacy have been evaluated in many randomized comparative clinical studies. The majority of them failed to demonstrate clearly a real benefit of this regimen. Since 1994, several meta-analyses [13Blaser J Konig C Once daily dosing of aminoglycosides.Eur J Clin Microbiol Infect Dis. 1995; 14: 1029-1038Crossref PubMed Scopus (64) Google Scholar, 14Galloe AM Graudal N Christensen HR Kampmann JP Aminoglycosides: single or multiple daily dosing- A meta-analysis on efficacy and safety.Eur J Clin Pharmacol. 1995; 48: 39-43Crossref PubMed Scopus (109) Google Scholar, 15Barza M Ioannidis JPA Cappelleri JC Lau J Single or multiple daily doses of aminoglycosides: a meta-analysis.Br Med J. 1996; 312: 338-345Crossref PubMed Scopus (361) Google Scholar, 16Ferriols-Lisart R Alos-Alminana M Effectiveness and safety of once-daily aminoglycosides: a meta-analysis.Am J Health Syst Pharmacol. 1996; 53: 1141-1150PubMed Google Scholar, 17Hatala R Dinh T Cook DJ Once-daily aminoglycoside dosing in immunocompetent adults: a meta-analysis.Ann Intern Med. 1996; 124: 717-725Crossref PubMed Scopus (269) Google Scholar, 18Munckhof WJ Grayson ML Tumidge JD A meta-analysis of studies on the safety and efficacy of aminoglycosides given either once daily or as divided doses.J Antimicrob Chemother. 1996; 37: 645-663Crossref PubMed Scopus (201) Google Scholar, 19Ali MZ Goetz MB A meta-analysis of the relative efficacy and toxicity of single daily dosing versus multiple daily dosing of aminoglycosides.Clin Infect Dis. 1997; 24: 796-809Crossref PubMed Scopus (212) Google Scholar, 20Bailey TC Little JR Littenberg B Reichley RM Dunagan WC A meta-analysis of extended-interval dosing versus multiple daily dosing of aminoglycosides.Clin Infect Dis. 1997; 24: 786-795Crossref PubMed Scopus (191) Google Scholar, 21Hatala R Dinh TT Cook DJ Single daily dosing of aminoglycosides in immunocompromised adults: a systematic review.Clin Infect Dis. 1997; 24: 810-815Crossref PubMed Scopus (89) Google Scholar] have been published, providing information on the evaluation of single daily dosing of aminoglycosides. This regimen appears to be clearly associated with a decrease in the nephrotoxicity incidence. These apparent good results may have been minimized by a relatively prolonged duration of treatment with aminoglycosides performed in all these studies (generally from 7 to 10days). Actually, it has been pointed out that the nephrotoxic risk was higher when the treatment with aminoglycosides was prolonged above 6–7days [11Maller R Ahrne H Holmen C Lausen I Nilsson LE the Scandinavian Amikacin Once Daily Study Group.Once? versus twice-daily amikacin regimen: efficacy and safety in systemic Gram-negative infections.J Antimicrob Chemother. 1993; 31: 939-948Crossref PubMed Scopus (61) Google Scholar,12Prins JM Büller HR Kuijper EJ Tange RA Speelman P Once-daily gentamicin versus once-daily netilmicin in patients with serious infections a randomized clinical trial.J Antimicrob Chemother. 1994; 33: 823-835Crossref PubMed Scopus (36) Google Scholar]. In addition, most of these meta-analyses did not evaluate the benefit of the single daily dosing according to the nephrotoxic potential of the different aminoglycosides. Only two meta-analyses emphasized aminoglycoside nephrotoxic risk on a family basis. In the meta-analyses published by Blaser and Konig [13Blaser J Konig C Once daily dosing of aminoglycosides.Eur J Clin Microbiol Infect Dis. 1995; 14: 1029-1038Crossref PubMed Scopus (64) Google Scholar], a total of 24 randomized prospective clinical trials comparing multiple and single daily dosing of amikacin, gentamicin, netilmicin, or tobramycin were pooled. In these trials, the definition of a potentially significant change in the serum creatinine value ranged from ≥20% to ≥50%, or from ≥30 to ≥45μmol/L increase from baseline. In most trials, no significant difference between the regimens was detected. The overall analysis of the 3181 patients enrolled in this meta-analysis (Table 2) revealed no significant difference between single and multiple daily dosing. However, there was a trend towards less nephrotoxicity in the once-daily treatment groups (4.5% versus 5.5%). More precisely, the authors confirmed that the renal tolerance of gentamicin was significantly improved when it was used once-daily (P=0.02; RR=0.51). But when the data from this meta-analysis are carefully analyzed, some results need to be pointed out: (1) gentamicin delivered in multiple daily doses was significantly more nephrotoxic than amikacin (P=0.0002; RR=2.53), but no difference was observed compared to netilmicin, as opposed to the analysis of Whelton [34Bennet WM Plamp CE Gilbert DN Parker RA Porter GA The influence of dosage regimen on experimental gentamicin nephrotoxicity: dissociation of peak serum levels from renal failure.J Infect Dis. 1979; 140: 576-580Crossref PubMed Scopus (138) Google Scholar]; (2) when delivered in multiple daily doses, amikacin appeared significantly less nephrotoxic than netilmicin (P=0.00008; RR=0.60), as well as netilmicin when delivered once daily (P=0.02; RR=0.75); (3) neither netilmicin nor amikacin showed significant benefit of single daily dosing regarding renal toxicity; (4) when delivered once daily, gentamicin and amikacin renal tolerance was similar (P=0.9), and relatively low (3.5%). Finally, only gentamicin, because of an important nephrotoxic potential, exhibits a benefit from being used once daily. G MDD versus A MDD: P=0.0002; RR=2.53 (CI 95:1.65–3.88). G MDD versus N MDD: P=0.69. A MDD versus N MDD: P=0.00008; RR=0.60 (CI 95:0.43–0.82). G SDD versus G MDD: P=0.02; RR=0.51 (CI 95:0.26–1.01). A SDD versus A MDD: P=0.3. N SDD versus N MDD: P=0.9. G SDD versus A SDD: P=0.9. G SDD versus N SDD: P=0.2. A SDD versus N SDD: P=0.02; RR=0.75 (CI 95:0.57–0.98). Munckhof et al [18Munckhof WJ Grayson ML Tumidge JD A meta-analysis of studies on the safety and efficacy of aminoglycosides given either once daily or as divided doses.J Antimicrob Chemother. 1996; 37: 645-663Crossref PubMed Scopus (201) Google Scholar] have described similar results. The pooled data of 15 studies involving 2295 evaluable patients showed an overall rate of nephrotoxicity of 4.7% and 5.9% after, respectively, once and multiple daily dosing. When both studies involving gentamicin were pooled, with a total of only 111 patients, a marked decrease in the rate of nephrotoxicity was demonstrated when the drug was given once daily. On the contrary, among the larger groups of 788 and 1396 patients who received, respectively, netilmicin or amikacin, there was no significant difference in the rate of nephrotoxicity between once and multiple daily dosing. Some studies have confirmed that preservation of renal function was better in gentamicin once-a-day patients than in gentamicin three-times-a-day patients [31Prins JM Buller HR Kuijper EJ Tange RA Speelman P Once versus thrice daily gentamicin in patients with serious infections.Lancet. 1993; 341: 335-339Abstract PubMed Scopus (359) Google Scholar,45Gilbert DN Lee BL Dworkin RJ et al.A randomized comparison of the safety and efficacy of once-daily gentamicin or thrice-daily gentamicin in combination with ticarcillin clavulanate.Am J Med. 1998; 105 (DOI: 10.1016/s0002-9343(98)00244-7): 182-191Abstract Full Text Full Text PDF PubMed Scopus (29) Google Scholar,46Rybak MJ Abate BJ Kang SL Ruffing MJ Lerner SA Drusano GL Prospective evaluation of the effect of an aminoglycoside dosing regimen on rates of observed nephrotoxicity and ototoxicity.Antimicrob Agents Chemother. 1999; 43: 1549-1555PubMed Google Scholar]. When delivered once daily, gentamicin does not appear more nephrotoxic than netilmicin [12Prins JM Büller HR Kuijper EJ Tange RA Speelman P Once-daily gentamicin versus once-daily netilmicin in patients with serious infections a randomized clinical trial.J Antimicrob Chemother. 1994; 33: 823-835Crossref PubMed Scopus (36) Google Scholar,47Tange RA Dreschler WA Prins JM Büller HR Kuijper EJ Speelman P Ototoxicity and nephrotoxicity of gentamicin vs netilmicin in patients with serious infections. A randomized clinical trial.Clin Otolaryngol. 1995; 20: 118-123Crossref PubMed Scopus (18) Google Scholar]. In the experience of the Hartford Hospital, more than 2000 patients have been treated with gentamicin once daily with a fixed 7mg/kg intravenous dose. The incidence of nephrotoxicity was reduced from about 4% with conventional dosing to 1.2% [48Nicolau DP Freeman CD Belliveau PP et al.Experience with a once-daily aminoglycoside program administered to 2,184 adult patients.Antimicrob Agents Chemother. 1995; 39: 650-655Crossref PubMed Scopus (544) Google Scholar,49Nicolau DP Wu AH Finocchiaro S et al.Once-daily aminoglycoside dosing: impact on requests and costs for therapeutic drug monitoring.Ther Drug Monit. 1996; 18: 263-266Crossref PubMed Scopus (49) Google Scholar]. This once-a-day program reduced the incidence of nephrotoxicity, and was cost-effective, with nephrotoxicity management savings of 70% per patient [50Hitt CM Klepser ME Nightingale CH Quintiliani R Nicolau DP Pharmacoeconomic impact of once-daily aminoglycoside administration.Pharmacotherapy. 1997; 17: 810-814PubMed Google Scholar]. The chemical structure of isepamicin, a 1-N-S-α-hydroxy-β-aminopropionyl derivative of gentamicin B, is very close to that of gentamicin. The nephrotoxic potential of isepamicin delivered once and twice daily was compared with that of amikacin delivered twice daily in a few studies. In a prospective randomized trial [51Beaucaire G Evaluation of the efficacy and safety of isepamicin compared with amikacin in the treatment of nosocomial pneumonia and septicaemia.J Chemother. 1995; 7: 165-173PubMed Google Scholar], efficacy and safety of isepamicin were compared with those of amikacin in 168 ICU adult patients with nosocomial pneumonia or septicemia. Each studied aminoglycoside was administered concurrently with ceftazidime or imipenem. Patients were randomized to receive isepamicin 15mg/kg per day, once daily (n=56) or twice daily (n=55), or amikacin 15mg/kg per day, twice daily (n=57). The definition of a potentially significant change in the serum creatinine value was a ≥0.5mg/dL (44.2μmol/L) increase from baseline, and any increase above the upper limit of the normal range. The proportion of patients reporting at least one treatment-related adverse event (Table 3) was higher in the isepamicin twice-daily group than in the isepamicin once-daily group, and significantly higher than in the amikacin twice-daily group (P=0.04; RR=1.74), while there was no difference between the isepamicin once-daily group and the amikacin twice-daily group. Renal toxicity was one of the most frequently reported adverse events. An increase in serum creatinine, considered by the investigator to be treatment-related, was noted in none of the patients receiving isepamicin once-daily, three patients (8%) receiving isepamicin twice-daily and three patients (7%) receiving amikacin twice-daily. The proportion of patients reporting renal failure and renal insufficiency as a treatment-related adverse event was higher, close to the limit of significance, in the isepamicin twice-daily, compared to the isepamicin once-daily, group (P=0.056) and the amikacin twice-daily group (P=0.054), while there was no difference between the isepamicin once-daily group and the amikacin twice-daily group. Finally, in this study, it could be emphasized that the renal tolerance of isepamicin was improved when used once daily, compared to twice-daily administration. This study confirmed the real nephrotoxic potential of isepamicin. In an overview of the safety of isepamicin in adults [52Blum D An overview of the safety of isepamicin in adults.J Chemother. 1995; 7: 87-93PubMed Google Scholar], comparing different regimens of isepamicin and amikacin in 1243 and 552 patients, respectively, receiving a fixed 15mg/kg per day dose, some differences appeared concerning the renal tolerance of isepamicin when delivered once or twice daily (Table 4). When all the patients treated with isepamicin were compared with those treated with amikacin, the rate of treatment-related adverse events was similar in the two groups (11% versus 9%). An analysis stratified on the different regimens showed a significant difference favoring the twice-daily regimen of amikacin over the twice-daily regimen of isepamicin (P=0.03; RR=1.71). No difference was noted between the patients treated with isepamicin once or twice daily, or between the patients treated with isepamicin once daily or amikacin twice daily. With respect to the nephrotoxicity rate, there was a significant difference favoring the once-daily regimen of isepamicin compared to the twice-daily regimen (P=0.01; RR=0.57), and the twice-daily regimen of amikacin compared to the twice-daily regimen of isepamicin (P=0.05; RR=2.70). No difference was noted between the patients treated with isepamicin once daily or amikacin twice daily. Details concerning the serum creatinine increase in the different groups of patients were not available. Finally, in this overview of the safety of isepamicin, it should be emphasized again that the renal tolerance of isepamicin was improved when used once daily, compared to twice-daily administration. Finally, isepamicin, like gentamicin, and because of its nephrotoxic potential, benefits from once-daily dosing, appearing to be less nephrotoxic. Isepamicin delivered twice daily is significantly more nephrotoxic than amikacin delivered twice daily. No data comparing the nephrotoxicity of isepamicin and amikacin when both are delivered once daily are available. Better knowledge of the risk factors associated with the renal toxicity of aminoglycosides, a reduction in the number of daily injections of aminoglycosides, minimization of the therapy duration, and the administration of aminoglycosides at the time of the lowest toxicity of the drug in patients given an appropriate diet are the most interesting approaches to reduce the incidence of these agents' renal toxicity [53Beauchamp D Labrecque G Bergeron MG Is it still possible to reduce the incidence of nephrotoxicity of aminoglycosides-.Pathol Biol. 1995; 43: 779-787PubMed Google Scholar,54Fabrizii V Thalhammer F Hã¶rl WH Aminoglycoside-induced nephrotoxicity.Wien Klin Wochenschr. 1997; 109: 830-835PubMed Google Scholar]. Moreover, individualized dosing based on individual patient parameters and population models [55Van Lent Evers NA Mathãt RA Van Geus WP Hout BA Vinks AA Impact of goal-oriented and model-based clinical pharmacokinetic dosing of aminoglycosides on clinical outcome: a cost-effectiveness analysis.Ther Drug Monit. 1999; 21: 63-73Crossref PubMed Scopus (180) Google Scholar], and individualized pharmacokinetic monitoring, are promising to decrease the rate of aminoglycoside-related nephrotoxicity [39Bertino JS Rotschafer JC Editorial response: single daily dosing of aminoglycosides a concept whose time has not yet come.Clin Infect Dis. 1997; 24: 820-823Crossref PubMed Scopus (35) Google Scholar]." @default.
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