A New Era for Treating Enterococcus faecalis Endocarditis
2013; Lippincott Williams & Wilkins; Volume: 127; Issue: 17 Linguagem: Inglês
10.1161/circulationaha.113.002431
ISSN1524-4539
AutoresJosé M. Miró, Juan M. Pericàs, Ana del Rı́o,
Tópico(s)Streptococcal Infections and Treatments
ResumoHomeCirculationVol. 127, No. 17A New Era for Treating Enterococcus faecalis Endocarditis Free AccessEditorialPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessEditorialPDF/EPUBA New Era for Treating Enterococcus faecalis EndocarditisAmpicillin Plus Short-Course Gentamicin or Ampicillin Plus Ceftriaxone: That Is the Question! Jose M. Miro, MD, PhD, Juan M. Pericas, MD and Ana del Rio, MD, PhDon behalf of the Hospital Clinic Endocarditis Study Group* Jose M. MiroJose M. Miro From the Infectious Diseases Service, Hospital Clinic–IDIBAPS, University of Barcelona, Barcelona, Spain. , Juan M. PericasJuan M. Pericas From the Infectious Diseases Service, Hospital Clinic–IDIBAPS, University of Barcelona, Barcelona, Spain. and Ana del RioAna del Rio From the Infectious Diseases Service, Hospital Clinic–IDIBAPS, University of Barcelona, Barcelona, Spain. and on behalf of the Hospital Clinic Endocarditis Study Group Originally published29 Mar 2013https://doi.org/10.1161/CIRCULATIONAHA.113.002431Circulation. 2013;127:1763–1766Other version(s) of this articleYou are viewing the most recent version of this article. Previous versions: April 30, 2013: Previous Version 1 Enterococci are the third most common etiologic agent of infective endocarditis worldwide after staphylococci and streptococci and cause 10% to 15% of cases.1 Enterococcal infections are increasingly relevant, especially among the elderly and patients with comorbid conditions in the healthcare setting.2,3 Approximately 90% of cases of enterococcal endocarditis are caused by Enterococcus faecalis, with 3-month history of symptoms before diagnosis.4 The gentamicin dose schedule (3 mg/kg per 24 hours IV or IM in 3 equally spaced doses) has also remained unchanged for 2 decades.In this issue of Circulation, Dahl et al8 report on the efficacy and safety of ampicillin plus short-course gentamicin for treating non-HLAR EFIE in Denmark.8 The rationale of the study relies on the good results reported in 2002 in Sweden by Olaison and Schadewitz,9 who performed a 5-year prospective study including 93 cases of EFIE. Clinical cure was achieved in 75 episodes (81%) that had been treated with a median 2-week course of aminoglycosides. Mortality was 16%, and the relapse rate 3%, although neither was associated with the shortened course of therapy. These results led to a change in the Danish Society of Cardiology guidelines in 2007,10 when the course of gentamicin was reduced from 4 to 6 weeks to 2 weeks to reduce nephrotoxicity caused by prolonged treatment with aminoglycosides. However, the study by Olaison and Schadewitz is limited by the lack of microbiological data (ie, percentage of HLAR), the omission of the type of aminoglycosides used, the low percentage of patients with symptoms for >3 months (only 5%), the short follow-up (53% at 3 months), and the fact that no analysis of antimicrobial-associated adverse events was provided. The study by Dahl et al8 overcame these limitations. Hypothesizing that outcomes would not differ between short- and standard-course gentamicin in EFIE, the authors performed a pilot prospective cohort study with a historical control group (Table). Furthermore, given that almost all patients had been treated with a short course of gentamicin since the national guidelines were modified in 2007, the authors were able to compare 41 cases of left-sided non-HLAR EFIE treated during the 5 years before and 43 cases treated during the 5 years after the modifications. Baseline characteristics (including Charlson comorbidity index, duration of symptoms, and rates of prosthetic valve endocarditis) were similar in both groups. Mean duration of treatment with gentamicin was 28 and 14days, respectively. Notably, renal function, expressed as glomerular filtration rate, was also similar in both groups before initiation of treatment. All patients received gentamicin 3 mg/kg; trough levels were monitored in all cases; and the dose schedule did not differ significantly between the 2 groups (daily in 82% and 93%, respectively). No statistically significant differences were detected in the primary end point, event-free 1-year survival (66% versus 69%; P=0.75), even after stratification by prosthetic valve endocarditis. No differences were found in heart failure, stroke or other embolisms, in-hospital surgery, in-hospital mortality, or relapses. Nonetheless, loss of renal function was less frequent in the group receiving short-course gentamicin (P=0.008). No analysis of other adverse events secondary to antimicrobial treatment was performed.Table. Main Clinical Characteristics and Outcomes of the Studies by Dahl et al8 and Fernndez-Hidalgo et al14Dahl et al8Fernández-Hidalgo et al14Country (n sites)Denmark (2)Spain (17) and Italy (1)Study period2002–20062007–20112005–2011Antibiotic regimenAmpicillin plus gentamicin*Ampicillin plus short-course gentamicin*Ampicillin plus ceftriaxone†Ampicillin plus gentamicin*Patients, n414315987Age, median (IQR), y70 (12)‡70 (11)‡70 (63–77)70 (58–75)Male sex, n (%)32 (78)38 (88)114 (72)62 (71)Charlson comorbidity score, median (IQR)1.8 (1.9)‡2.1 (1.7)‡2 (2–4)2 (1–4)Chronic renal impairment, n (%)7 (17)8 (19)53 (33)14 (16)Hemodialysis, n (%)ExcludedExcluded12 (8)3 (3)Duration of symptoms, median (IQR), d20 (14–32)30 (16–48)17 (5–44)19 (7–36)Type of valve, n (%)Native valve27 (66)27 (63)98 (62)57 (66)Prosthetic valve14 (34)16 (37)59 (37)30 (34)Pacemaker……2 (1)…Perivalvular abscess, n (%)8 (20)8 (19)36 (23)22 (25)HLAR EFIE, n (%)ExcludedExcluded51 (32)ExcludedDuration of antimicrobial treatment (in survivors), median (IQR), dNDND42 (39–46)42 (35–44)Duration of gentamicin, median (IQR), d28 (18–42)14 (7–15)NANDGentamicin once daily, n (%)32 (80)40 (93)NA37 (43)Duration of hospital stay, median (IQR), d42 (35–51)41 (36–44)NDNDAdverse events leading to treatment discontinuation, n (%)Renal failure2 (5)1 (2)020 (23)Other§NDND2 (1)2 (2)In-hospital surgery, n (%)15 (37)14 (33)53 (33)35 (40)In-hospital mortality, n (%)4 (10)2 (5)42 (26)22 (25)Relapses (in survivors), n (%)3/37 (8)2/41 (5)3/117 (3)3/65 (5)EFIE indicates Enterococcus faecalisinfective endocarditis; HLAR, high-level aminoglycoside-resistant; IQR, interquartile range; NA, not applicable; and ND, no data.All patients were treated with gentamicin 3 mg/kg (up to 240 mg/d) administered intravenously 1 to 3 times daily at the discretion of the treating physician and adjusted according to renal function when necessary.*Ceftriaxone was given at 2 g/12 h IV with ampicillin 2 g/4h IV (adjusted according to renal function when necessary) for 6 weeks.†Mean (SD).‡Rash/fever and leukopenia in 1 case each in the ampicillin plus ceftriaxone group; vestibular toxicity in 2 cases in the ampicillin plus gentamicin group.§This study provides novel data on non-HLAR EFIE and aminoglycoside use. First, it demonstrates that 2 weeks of gentamicin was as efficacious as and less nephrotoxic than 4 to 6 weeks. Remarkably, short-course gentamicin was also safe and efficacious for E. faecalis prosthetic valve endocarditis. Second, it shows that daily gentamicin was clinically efficacious. AHA guidelines recommend a schedule comprising 3 equally spaced doses of gentamicin,4 and European Society of Cardiology (ESC) guidelines (based on experimental data) recommend a twice- or thrice-daily regimen.11 However, these findings are open to debate. The study by Hessen et al12 showed that the postantibiotic effect of QD gentamicin did not achieve bactericidal concentrations in vegetations of rats with EFIE treated with penicillin and gentamicin; the authors suggested shortening the dosing interval to maintain antibiotic levels over the minimum inhibitory concentration. Subsequent results are consistent with these findings. However, using a human-like pharmacokinetic model, Gavaldà et al13 found that the therapeutic efficacy of ampicillin plus gentamicin was not significantly affected by the gentamicin dosing interval, with once-daily dosing similar to thrice-daily dosing.13 The study by Dahl et al8 is the first to provide data from a large number of patients treated with a daily gentamicin schedule. Seventy-two of the 84 patients (86%) received a daily regimen, only 10 received a thrice-daily regimen, and 2 received a twice-daily regimen, with no association between poor outcome and dosing interval. Third, the authors provide evidence that nephrotoxicity was associated with the duration of gentamicin therapy because at 2 weeks the decrease in glomerular filtration rate was very small and similar in both cohorts (P=0.65). However, at discharge, patients who received the standard gentamicin course had a significantly greater decrease in glomerular filtration rate (11 versus 1 mL/min; P=0.008). Therefore, this finding is especially relevant because the typical EFIE patient is older with high rates of chronic renal failure and a high risk of rapid renal impairment. The use of glomerular filtration rate as a measure of renal function is a wise choice because it accurately reflects the impact of treatment on kidney integrity, unlike the widely used creatinine value, which can be easily misinterpreted depending on age, muscle mass, and other factors. Moreover, avoiding the bias of selecting the duration of the course of gentamicin according to individual baseline renal function yielded more robust results and led to clear conclusions, namely that the course of gentamicin in non-HLAR EFIE should be shortened to avoid nephrotoxicity, especially in elderly patients with chronic renal failure, who are the main target when treating EFIE and the most susceptible to developing aminoglycoside-induced toxicity. On the other hand, this new antibiotic regimen cannot be extended to EFIE caused by HLAR strains, which have a current prevalence of 22% in North America and 38% in the rest of the world.3In a study carried out in Spain and Italy, Fernández-Hidalgo et al14 investigated the efficacy and safety of ampicillin plus ceftriaxone to treat EFIE. This study was inspired by the revealing finding that a double β-lactam combination was synergistic in vitro through partial saturation of penicillin-binding proteins 4 and 5 by amoxicillin and total saturation of penicillin-binding proteins 2 and 3 by cefotaxime.15 The results prompted animal models that demonstrated synergy of ampicillin plus ceftriaxone in experimental EFIE for both HLAR strains16 and non-HLAR strains.17 Shortly afterwards, Gavaldà et al18 proved the preliminary efficacy of the combination in a multicenter, open-label study that evaluated 43 patients with EFIE (49% with HLAR strains and 51% non-HLAR strains) treated with ampicillin (2 g/4 h) and ceftriaxone (2 g/12 h).18 Clinical cure rates were 71% and 73%, respectively, with 5% relapses. The study by Fernández-Hidalgo et al14 was an observational, nonrandomized, comparative, multicenter cohort study including 159 patients treated with ampicillin plus ceftriaxone (32% HLAR strains) and 87 patients treated with ampicillin plus gentamicin (all non-HLAR strains; Table). Gentamicin was administered for as long as ampicillin in 31 patients (36%); it was stopped after a median of 23 days (interquartile range, 14–34 days) in 34 patients with no adverse events. In 20 of the 22 patients in whom gentamicin was withdrawn because of adverse events (20 patients experienced renal failure), the median length of treatment was 14 to 15 days. The gentamicin schedule was 1, 2, or 3 times daily or was unknown in 43%, 7%, 43%, and 7%, respectively. Overall, no differences were found between the 2 groups in terms of treatment failure, mortality during treatment or at 3 months of follow-up, and relapses. However, a higher proportion of patients receiving ampicillin plus gentamicin switched or stopped gentamicin owing to renal failure (0% versus 23%; P 3 months of symptoms might also be considered a limitation, although this might only reflect a higher clinical suspicion of IE, resulting in an earlier diagnosis. Finally, the potential risk of colonization or superinfection by drug-resistant bacteria was not assessed. It is well known that prolonged therapy with cephalosporin is a risk factor for infection by vancomycin-resistant enterococci or Clostridium difficile.19In conclusion, both publications make an enormous contribution to improving the efficacy and safety of treatment of EFIE. In patients with EFIE that is highly resistant to both streptomycin and gentamicin, ampicillin plus ceftriaxone for 6 weeks should be the regimen of choice. In patients with non-HLAR EFIE, there are 2 options: If treatment with ampicillin plus gentamicin is chosen, gentamicin can be shortened to 2 weeks and simplified to once-daily dosing to avoid nephrotoxicity; conversely, ampicillin plus ceftriaxone is also very safe and effective. Unfortunately, efforts to perform a multinational, randomized, controlled trial comparing ampicillin plus short-course gentamicin with ampicillin plus ceftriaxone in Europe through different 7th Framework Program (FP7)-HEALTH-2011/2012 calls (AMPICEF, OCEPEE, and TOTEM proposals) have failed 3 times (Pierre Tattevin, personal communication, April 2013). Maybe it is time for American physicians to address this problem and resolve the dilemma: short-course gentamicin or ceftriaxone?AcknowledgmentsMembers of the Hospital Clínic Endocarditis Study Group, Hospital Clínic–IDIBAPS, University of Barcelona School of Medicine, Barcelona, Spain: José M. Miró, Ana del Río, Asuncion Moreno, Juan M. Pericas, Ximena Castañeda, Carlos Cervera, Jose M. Gatell (Infectious Diseases Service); Cristina Garcia de la Mària, Yolanda Armero, (Experimental Endocarditis Laboratory); Manel Almela, Francesc Marco, Jordi Vila, (Microbiology Service); Carlos A. Mestres, Juan C. Paré, Carlos Falces, Ramón Cartañá, Salvador Ninot, Manel Azqueta, Marta Sitges, Magda Heras, José L. Pomar (Cardiovascular Institute); Jose Ramírez, Teresa Ribalta (Pathology Department); Guillermina Fita, Irene Rovira (Anesthesiology Service); Merce Brunet (Toxicology Service); Dolors Soy (Pharmacy Service); and Jaume Llopis (Statistician). We thank Dr Pierre Tattevin (Rennes University Hospital, France) for the information provided regarding the clinical trials in Europe. Dr Tattevin was the Principal Investigator of the AMPICEF ('Optimizing the treatment of Enterococcus faecalis endocarditis in Europe'), OCEPEE ('Optimizing Care of Elderly Patients with Enterococcus faecalis Endocarditis'), and TOTEM ('To Optimize the Treatment of Enterococcal bacteremia, and Minimize the emergence of antimicrobial drug resistance') trials.Sources of FundingThis work was supported in part by the Ministerio de Sanidad y Consumo, Instituto de Salud Carlos III (Madrid, Spain), the Spanish Network for Research in Infectious Diseases (REIPI RD06/0008, Madrid, Spain), and Fundación Máximo Soriano Jiménez (Barcelona, Spain).DisclosuresNone.FootnotesThe opinions expressed in this article are not necessarily those of the editors or of the American Heart Association.*Members of the Hospital Clínic Endocarditis Study Group are listed in the Acknowledgments.Correspondence to Jose M. 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