Tolerance, pharmacokinetics and efficacy of once daily amikacin for treatment of Pseudomonas aeruginosa pulmonary exacerbations in cystic fibrosis patients

Vic, P.; Ategbo, S; Turck, Dominique; Husson, Marie; Tassin, E.; Loeuille, G. A.; Deschildre, A.; Druon, D; Elian, J C; Arrouet-Lagandre, C.; Farriaux, J. P.

doi:10.1007/bf02282885

Cited by 33 publications

(38 citation statements)

References 15 publications

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“…The serum pharmacokinetics of tobramycin did not change between day 1 and day 14, indicating that there was no accumulation of the drug during treatment. In contrast with our previous study with once daily amikacin,11 we observed a large interindividual variation in serum peak tobramycin, not only in the thrice daily group but also in the once daily group. There was a high sputum concentration of tobramycin early after the end of the infusion.…”

Section: Discussioncontrasting

confidence: 99%

“…We previously showed in an open study that 35 mg/kg amikacin given as a once daily infusion, combined with 200 mg/kg/day of ceftazidime in three daily injections, was a well tolerated and effective treatment of Ps aeruginosa exacerbations in cystic fibrosis 11. This study aimed to compare efficacy, tolerance, and serum and sputum pharmacokinetics of once daily versus thrice daily tobramycin, combined with ceftazidime, in a population of young cystic fibrosis patients.…”

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confidence: 99%

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Efficacy, tolerance, and pharmacokinetics of once daily tobramycin for pseudomonas exacerbations in cystic fibrosis

Vic¹,

Ategbo²,

Turck

et al. 1998

Archives of Disease in Childhood

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Objective-To compare once daily with thrice daily tobramycin for treatment of Pseudomonas aeruginosa infection in patients with cystic fibrosis. Design-22 patients with cystic fibrosis, mean (SD) age 11 (3.4) years (range 5.6-19.3), with pulmonary pseudomonas exacerbations were randomly assigned to receive a 14 day course of tobramycin (15 mg/kg/day) either in three infusions (group A) (n = 10) or a single daily infusion (group B) (n = 12), combined with ceftazidime (200 mg/kg/day as three intravenous injections). EYcacy was assessed by comparison of pulmonary, nutritional, and inflammatory indices on days 1 and 14. Cochlear and renal tolerance were assessed on days 1 and 14. Tobramycin concentration was measured in serum and sputum 1, 2, 3, 4, 8, and 24 hours after the start of the infusion. Analysis was by non-parametric Wilcoxon test. Results-Variables improving (p < 0.05) in both groups A and B were, respectively: weight/height (+4% and +3.1%), plasma prealbumin (+66 and +63 mg/l), forced vital capacity (FVC) (+14% and +11%), forced expiratory volume in one second (+15% and +14%), and forced expiratory flow between 25% and 75% of FVC (+13% and +21%). Improvement was not significantly diVerent between groups. Renal and cochlear indices remained within the normal range. Serum peak concentration of tobramycin on day 1 was 13.2 (7.1) mg/l in group A and 42.5 (11.2) mg/l in group B (p < 0.001); serum trough was 1.1 (0.8) mg/l in group A and 0.3 (0.2) mg/l in group B (p < 0.01). Tobramycin concentrations in sputum were two to three times higher in group B than group A. Conclusions-Once daily tobramycin combined with three injections of ceftazidime is safe and eVective for the treatment of pseudomonas exacerbations in cystic fibrosis patients. (Arch Dis Child 1998;78:536-539)

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Section: Discussioncontrasting

confidence: 99%

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confidence: 99%

Efficacy, tolerance, and pharmacokinetics of once daily tobramycin for pseudomonas exacerbations in cystic fibrosis

Vic¹,

Ategbo²,

Turck

et al. 1998

Archives of Disease in Childhood

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“…No aminoglycosides in CF that describes nephrotoxicity [16][17][18][19][20][21][22][23][24]. There was no significant change in serum creatinine or magnesium with treatment in either group in this study.…”

Section: Resultsmentioning

confidence: 85%

Once-daily tobramycin in the treatment of adult patients with cystic fibrosis

Whitehead¹,

Conway²,

Etherington³

et al. 2002

Eur Respir J

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Once-daily tobramycin in the treatment of adult patients with cystic fibrosis. A. Whitehead, S.P. Conway, C. Etherington, N.A. Caldwell, N. Setchfield, S. Bogle. #ERS Journals Ltd 2002. ABSTRACT: The aim of this study was to test the equivalence of once-and thrice-daily dosing with tobramycin by comparing efficacy and safety in adult patients with cystic fibrosis.Sixty adult patients with an acute respiratory exacerbation were randomized to receive either 10 mg?kg -1 tobramycin once-daily or 3.3 mg?kg -1 tobramycin thricedaily. Primary efficacy and safety endpoints were defined as changes in respiratory function and changes in renal function and hearing.Both groups showed a significant increase in respiratory function without a clinically significant change in renal function. For changes in forced vital capacity % predicted and serum potassium and magnesium levels, equivalence was demonstrated. For the variables forced expiratory volume in one second and forced mid-expiratory flow % pred and serum creatinine levels, there was insufficient power to demonstrate equivalence. One patient in each group showed bilateral impairment in pure tone audiogram after treatment.This study demonstrated significant clinical improvement with both once-and thricedaily tobramycin dosing. Equivalence between the two regimens was shown for some, but not all primary endpoints. Once-daily dosing should be used with careful monitoring of safety and efficacy until large multicentre studies confirm these encouraging results.

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“…This likely reflects the availability of well-designed safety and efficacy studies and meta-analyses evaluating tobramycin EID in this population, and the lack of published research studies assessing the use of gentamicin and amikacin EID in those with CF. 10,11,[13][14][15][16][17][18] As in the pediatric CF population, empiric dosing of tobramycin was most commonly prescribed at 10 mg/kg/d. 19 This practice is consistent with the dose used in a large, randomized, controlled, noninferiority study published in 2005.…”

Section: Discussionmentioning

confidence: 99%

“…8 In light of the emergence of safety and efficacy data in the CF population, the Cystic Fibrosis Foundation deemed once-daily aminoglycoside dosing as acceptable for Pseudomonas aeruginosa (grade C recommendation) in its September 2009 pulmonary exacerbation guidelines. [9][10][11][12][13][14][15][16][17][18] A 2009 survey of United States pediatric CF centers and affiliate programs distributed after the publication of these guidelines reported the use of EID (with once-daily or twice-daily dosing) in the pediatric CF population to be 94%, a significant increase from previous reports. 19 While empiric evidence suggests the use of EID of aminoglycosides to be increasingly common in the United States CF population, the prevalence of EID use across United States adult CF centers as well as the dosing and monitoring practices associated with this regimen following publication of the CF pulmonary exacerbation guidelines remain to be elicited.…”

Section: Introductionmentioning

confidence: 99%

A Survey of Extended-Interval Aminoglycoside Dosing Practices in United States Adult Cystic Fibrosis Programs

Prescott

2014

Respir Care

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Tolerance, pharmacokinetics and efficacy of once daily amikacin for treatment of Pseudomonas aeruginosa pulmonary exacerbations in cystic fibrosis patients

Abstract: Once daily amikacin administration associated with ceftazidime is well tolerated for the treatment of Pseudomonas aeruginosa pulmonary exacerbations in cystic fibrosis patients. Serum peak levels and diffusion in sputum are higher than with a conventional schedule.

Cited by 33 publications

References 15 publications

Efficacy, tolerance, and pharmacokinetics of once daily tobramycin for pseudomonas exacerbations in cystic fibrosis

Efficacy, tolerance, and pharmacokinetics of once daily tobramycin for pseudomonas exacerbations in cystic fibrosis

Once-daily tobramycin in the treatment of adult patients with cystic fibrosis

A Survey of Extended-Interval Aminoglycoside Dosing Practices in United States Adult Cystic Fibrosis Programs

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