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Ceftaroline Fosamil for the Treatment of Community-Acquired Bacterial Pneumonia in Elderly Patients a
b
c
George Udeani PharmD, DSc, FCCP , John Evans PharmD, MBA , Phillip Cole MD & H. David Friedland MD, c
MBA a
CHRISTUS Spohn Hospital, Corpus Christi, TX
b
CHRISTUS Spohn Hospital Alice, Alice, TX
c
Cerexa, Inc., Oakland, CA Published online: 28 May 2015.
Click for updates To cite this article: George Udeani PharmD, DSc, FCCP, John Evans PharmD, MBA, Phillip Cole MD & H. David Friedland MD, MBA (2014) Ceftaroline Fosamil for the Treatment of Community-Acquired Bacterial Pneumonia in Elderly Patients, Hospital Practice, 42:3, 109-115 To link to this article: http://dx.doi.org/10.3810/hp.2014.08.1123
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C L I N I C A L F E AT U R E S
Ceftaroline Fosamil for the Treatment of Community-Acquired Bacterial Pneumonia in Elderly Patients
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DOI: 10.3810/hp.2014.08.1123
George Udeani, PharmD, DSc, FCCP 1 John Evans, PharmD, MBA 2 Phillip Cole, MD 3 H. David Friedland, MD, MBA 3 CHRISTUS Spohn Hospital, Corpus Christi, TX; 2CHRISTUS Spohn Hospital Alice, Alice, TX; 3Cerexa, Inc., Oakland, CA 1
Abstract: The Clinical Assessment Program and Teflaro Utilization Registry (CAPTURE) is a multicenter study, assessing the contemporary use of ceftaroline fosamil in patients with community-acquired bacterial pneumonia (CABP) or acute bacterial skin and skin structure infection. This article discusses the data collected from 528 evaluable patients with CABP, from 39 sites in the United States, between August 2011 and April 2013. The majority of patients (51%) were elderly (aged $ 65 years), most of whom were treated in general hospital wards (70%). Approximately one quarter of elderly patients had $ 2 comorbidities (26%), the most common of which was structural lung disease (51%). The majority of elderly patients received ceftaroline fosamil as second-line therapy (85%), concurrently with other antibiotics (61%). Similar patterns of ceftaroline fosamil usage were noted in younger patients (aged , 65 years). Fifteen patients died (3%), 10 of whom were elderly. The overall clinical success of ceftaroline fosamil was 81% for elderly patients with CABP and 82% for younger patients. These data suggest that ceftaroline fosamil is a potentially effective treatment option for CABP in the elderly. Keywords: community-acquired bacterial pneumonia; CABP; ceftaroline fosamil; CAPTURE study; registry; elderly
Introduction
Correspondence: George Udeani, PharmD, DSc, FCCP, Corpus Christi Medical Center, Doctors Regional Hospital, Department of Pharmacy, 3315 Alameda Street, Corpus Christi, TX 78411. Tel: 361-761-1454 Fax: 361-761-1576 E-mail: [email protected]
Community-acquired bacterial pneumonia (CABP) is a major cause of morbidity and mortality. Although most CABP patients are managed as outpatients, the highest proportion of morbidity, mortality, and health care costs attributable to pneumonia occur among patients with CABP who are hospitalized.1 Approximately one third of all CABP patients are elderly (aged $ 65 years), and it is the elderly patients that account for nearly two thirds of all hospitalizations due to CABP.2 In the last 20 years, the number of patients between the ages of 65 and 84 years who are hospitalized with pneumonia has increased by 20%.3 Data on death rates in the United States during 2010 listed pneumonia as the ninth leading cause of death overall and the seventh highest cause of death among those aged 65 and over.4 Communityacquired bacterial pneumonia–related mortality is higher in elderly compared with younger patients.2 Ceftaroline is an antimicrobial of the cephalosporin class that displays in vitro activity against pathogens such as Streptococcus pneumoniae, Haemophilus influenzae, and Staphylococcus aureus,5 which commonly cause CABP.3 Sader et al5 also demonstrated that ceftaroline is active in vitro against penicillin-resistant S. pneumoniae
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Udeani et al
and methicillin-resistant S. aureus (MRSA). The in vitro activity of ceftaroline against S. aureus, S. pneumoniae, and their resistant phenotypes is due to the binding of ceftaroline to penicillin-binding proteins (PBPs) specific to these pathogens. Specifically, ceftaroline exhibits affinity to PBP1, -2, and -3 in methicillin-susceptible S. aureus (MSSA), PBP2a in MRSA, and PBP 2X, -2A, and -2B in S. pneumoniae and penicillin-resistant S. pneumoniae.6 Ceftaroline fosamil (Teflaro), the prodrug of ceftaroline, was approved by the US Food and Drug Administration (FDA) in October 2010 for the treatment of CABP and acute bacterial skin and skin structure infection in the United States,7 and by the European Medicines Agency in 2012 for similar indications. The Clinical Assessment Program and Teflaro Utilization Registry (CAPTURE) is a multicenter US chart review study evaluating the contemporary use of ceftaroline fosamil in patients with CABP or acute bacterial skin and skin structure infection. This article compares the clinical characteristics and clinical response of CABP in elderly patients (aged $ 65 years) with those in younger patients (aged , 65 years) in the CAPTURE study.
Methods Study Information
The study objectives were to describe the patient demographics, disease characteristics, characteristics of isolated pathogens, the usage of ceftaroline fosamil, and any prior, concurrent, or subsequent antibiotics; the location of care prior to, during, and following treatment; and the clinical response at discontinuation of treatment with ceftaroline fosamil. Data were collected at 39 sites in the United States between August 2011 and April 2013, from male and female patients who met all inclusion and no exclusion criteria. Patients had to be aged $ 18 years at the start of treatment with ceftaroline fosamil. All patients had to have a diagnosis of CABP, as defined by clinical signs and symptoms consistent with a lower respiratory tract infection, and chest radiography consistent with bacterial pneumonia. Patients had to receive $ 2 consecutive IV doses of ceftaroline fosamil between August 2011 and July 2012, and $ 4 consecutive IV doses thereafter, following a study protocol amendment. The final dose of ceftaroline fosamil had to be administered $ 30 days before the start of data collection. Patients were excluded from the study if information on dosing with ceftaroline fosamil or on discharge from hospital was absent from their chart. Patients were also excluded if they had 110
received previous treatment with ceftaroline fosamil and had their information extracted for the study. Elderly patients were defined as those aged $ 65 years. Locations of care included a general hospital ward, an intensive care unit (ICU), an outpatient parenteral antibiotic therapy (OPAT) unit, and the patient’s home. The ICU patients were defined as hospitalized patients who received any care in the ICU, and general hospital ward patients were hospitalized patients who received no care in the ICU. Patients treated in an OPAT unit or with home IV therapy were categorized as never being hospitalized. The CAPTURE study was approved by the institutional review board or ethics committee at each US site that provided study information. This study was conducted in accordance with the International Conference on Harmonisation E6 Good Clinical Practice guidance.8
Enrolled and Evaluable Patients
All patients included in the CAPTURE study comprised the enrolled population. Patients for whom a clinical response (success or failure) was determined were then categorized as evaluable. Clinical response was recorded as “success” if the reason for discontinuation of treatment with ceftaroline fosamil was either clinical cure, with no further need for antibiotics, or clinical improvement, with a switch to oral antibiotic. Clinical response was categorized as “failure” if treatment was discontinued due to either an adverse event or insufficient therapeutic effect and a switch to another IV antibiotic. If it was confirmed that a patient was clinically improving upon discontinuation of ceftaroline fosamil, with no evidence of failure, the clinical response was recorded as a success.
Data Analysis
Information was extracted by random ordering and review of patient charts identified from pharmacy listings in the general hospital ward, ICU, or OPAT unit. Data collected from patient charts included location of care, patient demographics, relevant medical history, disease characteristics, pathogens isolated, and antibiotic use. For CABP patients, relevant history included congestive heart failure, stroke, lung cancer, structural lung disease, gastroesophageal reflux, chronic sinusitis, prior pneumonia, alcoholism, and smoking. For continuous variables, descriptive statistics included the mean, standard deviation (SD), median, and range. For categorical variables, descriptive statistics were frequencies (n) and percentages. Statistical analyses were performed using SAS Software Version 9.2.
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Ceftaroline Fosamil for CABP in Elderly Patients
Results Patient Populations
The total number of enrolled patients with CABP was 548, of which 528 were evaluable (96%). The evaluable population is the focus of the data presented here, unless otherwise specified.
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Patient Demographics and Location of Care
The majority of CABP patients receiving ceftaroline fosamil were elderly (51%; Table 1). Of the elderly population, 44% were aged $ 80 years. Within the elderly and younger patient populations, slightly more than half of the patients were female (53% and 51%, respectively). Elderly patients were mostly treated in general hospital wards (70%), and the remaining patients received care in the ICU. The majority of younger patients were treated in general hospital wards (60%), and 40% were admitted to the ICU. Two younger patients received treatment in an OPAT unit or at home. The mean (± SD) duration of all hospital stays (general hospital ward plus ICU) was 12.5 (± 12.1) days among elderly patients, compared with 16.3 (± 19.1) days for younger patients. Information on duration of stay was missing for 2 younger patients.
Medical History
Most elderly and younger patients had medical histories related to CABP (78% and 75%, respectively). The most frequent medical history in elderly patients was structural lung disease (51%) and in younger patients was smoking (36%; Table 2). Prior pneumonia, congestive heart failure, and gastroesophageal reflux were also common underlying comorbidities. The majority of relevant medical histories Table 1. Baseline Demographic Data and Location of Care for Evaluable CABP Patients by Age Group Demographic Category Gender, n (%) Female Age at baseline (y) Mean (SD) Median (range) Location of care,a n (%) General hospital ward ICU
Age $ 65 years (N = 268, 50.8%)
Age , 65 years (N = 260, 49.2%)
141 (52.6)
132 (50.8)
77.8 (8.3) 78.0 (65.0–99.0)
49.3 (11.4) 52.0 (19.0–64.0)
188 (70.1) 80 (29.9)
155 (59.6) 103 (39.6)
Two younger patients (aged , 65 years) received care in an outpatient parenteral antibiotic therapy unit or had IV therapy at home. a
Abbreviations: CABP, community-acquired bacterial pneumonia; ICU, intensive care unit; SD, standard deviation.
were more prevalent among elderly than among younger patients, with the exception of smoking (24% and 36%, respectively) and alcoholism (4% and 10%, respectively).
Diagnosis and Disease Characteristics
Among elderly patients, the mean (± SD) duration of diagnosis prior to treatment was 4.0 (± 5.2) days. Younger patients had a mean (± SD) duration of diagnosis of 4.3 (± 6.2) days. On the day of CABP diagnosis, the majority of elderly patients presented with dyspnea, abnormal auscultatory findings, and cough (77%, 65%, and 57%, respectively). Upon diagnosis, younger patients mostly presented with dyspnea, cough, and abnormal auscultatory findings (75%, 68%, and 55%, respectively). At the end of treatment with ceftaroline fosamil, there was a decrease in all signs and symptoms among patients of both age groups, compared with the day of diagnosis (Figure 1). The data were missing for 1 younger patient (aged , 65 years). These categories shown on the figure are not mutually exclusive and some patients may have had . 1 sign or symptom.
Pathogens Isolated
Pathogens were identified from respiratory specimens (for example, sputum or bronchoalveolar lavage), blood, or a combination of both respiratory and blood specimens. Pathogens were recovered from 38% of all evaluable CABP patients, of which 46% were isolated from elderly patients and the remainder from younger patients. The most common pathogens recovered among elderly patients were S. aureus (16%; comprising 12% MRSA and 4% MSSA) and
Table 2. Relevant Medical History for Evaluable CABP Patients by Age Group Medical History,a n (%)
Age $ 65 years (N = 268)
Age , 65 years (N = 260)
Patients with $ 2 medical comorbidities Structural lung disease Prior pneumonia Congestive heart failure Gastroesophageal reflux Smoking Stroke Lung cancer Alcoholism Chronic sinusitis Hemodialysis
69 (25.8)
54 (20.8)
137 (51.1) 79 (29.5) 76 (28.4) 69 (25.7) 65 (24.3) 28 (10.5) 17 (6.3) 11 (4.1) 4 (1.5) 4 (1.5)
91 (35.0) 55 (21.2) 37 (14.2) 58 (22.3) 94 (36.2) 17 (6.5) 4 (1.5) 27 (10.4) 4 (1.5) 4 (1.5)
These categories are not mutually exclusive, and some patients may have had . 1 medical history. a
Abbreviation: CABP, community-acquired bacterial pneumonia.
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Figure 1. Change in frequency of each clinical sign and symptom between the day of diagnosis and the end of treatment for evaluable community-acquired bacterial pneumonia patients by age group.
S. pneumoniae (2%). The pathogens most frequently isolated from younger patients were S. aureus (20%; comprising 15% MRSA and 5% MSSA) and S. pneumoniae (4%).
(23%), glycopeptides (11%), tetracyclines (5%), penicillins (4%), and oxazolidinones (3%) concurrently with ceftaroline fosamil.
Antibiotic Treatment
Clinical Success and Adverse Events
The mean (± SD) duration of therapy with ceftaroline fosamil was 6.0 (± 3.5) days among elderly patients and 6.3 (± 4.5) days among younger patients. The mean (± SD) number of ceftaroline fosamil doses administered to elderly and younger patients were 10.5 (± 6.8) and 11.1 (± 8.9), respectively. Overall, the majority of elderly patients were given ceftaroline fosamil as second-line therapy (85%), and most elderly patients received ceftaroline fosamil concurrently with other antibiotics (61%). Similar patterns of administration were noted in younger patients: ceftaroline fosamil was given as a second-line agent in 84%, and the majority of younger patients were administered ceftaroline fosamil as concurrent therapy (68%). When ceftaroline fosamil was used as second-line therapy, the prior antibiotics most frequently administered to elderly patients were quinolones (30%), followed by glycopeptides (28%), macrolides (26%), penicillins (20%), and oxazolidinones and tetracyclines (each 4%). Prior antibiotics administered to younger patients were quinolones and glycopeptides (each 35%), macrolides (27%), penicillins (22%), oxazolidinones (5%), and tetracyclines (2%). Ceftaroline fosamil was given as concurrent therapy to elderly patients most commonly with macrolides (22%), followed by quinolones (18%), penicillins (7%), glycopeptides (6%), tetracyclines (3%), and oxazolidinones (1%). Younger patients received macrolides (24%), quinolones 112
The overall clinical success was 81% among elderly patients and 82% for younger patients treated with ceftaroline fosamil (Table 3). For patients with $ 2 comorbidities, the rates of clinical success were 84% among elderly patients and 82% among younger patients. Among elderly patients with a pathogen isolated, clinical success was 67% to 100%, compared with 80% to 91% for younger patients. There were similar rates of clinical success for elderly patients whether they received ceftaroline fosamil as firstline therapy (78%) or as second-line therapy (82%). Among younger patients, the clinical success rate was 86% when ceftaroline fosamil was used as first-line therapy and 82% when it was used as second-line therapy. Clinical success was comparable among elderly patients treated with ceftaroline fosamil as monotherapy or concurrently with other antibiotics (81% and 82%, respectively). For younger patients, the rates of clinical success were also similar when comparing administration of ceftaroline fosamil as monotherapy or concurrent therapy (82% and 83%, respectively). Serious adverse events (SAEs) were reported for 14 patients (3%)—9 elderly patients and 5 younger patients. The SAEs reported for patients who died (8 elderly patients and 3 younger patients) included B-cell lymphoma, cardiac arrest, cardiopulmonary arrest, respiratory failure, renal failure, and sepsis. The 3 SAEs that were not associated with patient death were drug exposure during pregnancy (1 younger patient),
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Ceftaroline Fosamil for CABP in Elderly Patients
Table 3. Rates of Clinical Success for Evaluable CABP Patients by Age Group Category, n/N (%)
Age $ 65 years
Age , 65 years
Overall Patients with $ 2 medical comorbidities Pathogen isolated Staphylococcus aureus MRSA MSSA Streptococcus pneumoniae Ceftaroline fosamil usage First-line use Second-line use Monotherapy Concurrent therapy
218/268 (81.3) 58/69 (84.1)
214/260 (82.3) 44/54 (81.5)
30/43 (69.8) 22/33 (66.7) 8/10 (80.0) 6/6 (100)
43/53 (81.1) 32/40 (80.0) 11/13 (84.6) 10/11 (90.9)
32/41 (78.0) 186/227 (81.9) 83/103 (80.6) 135/165 (81.8)
36/42 (85.7) 178/218 (81.7) 68/83 (81.9) 146/177 (82.5)
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Abbreviations: CABP, community-acquired bacterial pneumonia; MRSA, methicillin-resistant Staphylococcus aureus; MSSA, methicillin-susceptible Staphylococcus aureus.
empyema (1 elderly patient), and enterococcal meningitis (1 younger patient). None of the SAEs reported for this subset of patients were thought to be related to ceftaroline fosamil therapy. Discontinuation of treatment with ceftaroline fosamil due to an adverse event was reported in a total of 7 patients (1%)—3 elderly and 4 younger.
Discharge Destinations
After treatment with ceftaroline fosamil, 47% of elderly patients were discharged to home and the same proportion was transferred to another care facility (including hospital, nursing home, rehabilitation facility, or skilled nursing facility). The majority of younger patients were discharged to home after receiving ceftaroline fosamil (70%), and 27% were referred to another care facility. In addition to those patients discharged to home or to another care facility, 15 patients died (3%)—10 elderly and 5 younger. The 4 additional deaths that are reported here, compared with those that were reported due to SAEs, occurred after the time interval required for SAE reporting in the study (. 24 hours after discontinuation of ceftaroline fosamil). Discharge destinations were missing from the remaining 11 patients (2%)—7 elderly and 4 younger.
Discussion
According to the 2010 US National Hospital Discharge Survey of short-stay hospitals, approximately 1.1 million patients were hospitalized with pneumonia, of whom 55% were elderly and 45% were aged , 65 years.9 Studies have found that there was an association with higher mortality in elderly patients with CABP.10–16 Although mortality among
the elderly in the CAPTURE study was low (2%), it was higher than that of younger patients (1%), which is consistent with the published reports for CABP as previously mentioned. In the CAPTURE study, patient deaths were not related to treatment with ceftaroline fosamil. One reason for the increased mortality among elderly CABP patients may be the presence of multiple comorbidities and the increased severity of these comorbidities among elderly patients12,15,17; however, age and comorbidity were independent risk factors for CABP mortality, according to Kothe et al.15 In the CAPTURE study, 56% of patients with $ 2 comorbidities were elderly, and a higher proportion of elderly than younger patients had comorbidities, including structural lung disease, prior pneumonia, congestive heart failure, gastroesophageal reflux, and lung cancer. Published data show that underlying lung disease, congestive heart failure, and lung cancer are all independently associated with higher mortality in patients with CABP.12,15,18,19 Although advanced age and the presence of comorbidities can be predictors of CABP requiring ICU admission, as noted in the Pneumonia Patient Outcomes Research Team CABP scoring system,20 fewer elderly patients in the CAPTURE study were treated in an ICU compared with younger patients (30% and 40%, respectively). The results of pneumonia severity scoring systems were not collected in CAPTURE as a means of comparison between elderly and younger patients, but the difference in location of care may be explained, in part, by different attitudes for advanced directives among elderly and younger patients, such as their wishes regarding invasive procedures such as endotracheal intubation.21 Furthermore, clinicians may be disinclined to admit elderly patients to the ICU due to concerns that invasive procedures may worsen the condition of the patient.22 Age $ 60 years does not have a notable impact on the microbial etiology of CABP,23 although S. pneumoniae appears to be the pathogen most commonly isolated from elderly CABP patients.24 In the CAPTURE study, similar percents of elderly and younger patients had pathogens isolated; however, S. aureus (MSSA and MRSA) was identified more often than S. pneumoniae. This is likely to be related to a change of antimicrobial administration to ceftaroline fosamil once S. aureus was confirmed as the causative pathogen of CABP. In addition, S. aureus, being a nonfastidious organism, is relatively easier to detect in culture than S. pneumoniae.25 The current Infectious Diseases Society of America/ American Thoracic Society joint committee guidelines on the management of CABP specify antibiotic treatment by disease
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severity, rather than by age group.26 In the CAPTURE study, there were similar patterns of ceftaroline fosamil administration among elderly and younger CABP patients, with the majority of both age groups receiving ceftaroline fosamil as second-line therapy, and concurrently with other antibiotics. There were also similar rates of clinical success among elderly and younger CABP patients who received ceftaroline fosamil as second-line therapy or as concurrent therapy (81%–83%). These rates were comparable to the overall clinical success in elderly and younger patients with CABP (81% and 82%, respectively), and the success observed for elderly and younger patients with $ 2 comorbidities (84% and 82%, respectively). The CAPTURE data found lower rates of clinical success among elderly than younger patients with MRSA isolated (67% and 80%, respectively). Vancomycin is one agent recommended by the current Infectious Diseases Society of America/American Thoracic Society joint committee guidelines to treat CABP suspected or confirmed to be caused by MRSA.26 Fewer elderly than younger patients received glycopeptides prior to ceftaroline fosamil (28% and 35%, respectively), which may reflect a reluctance to use a potentially nephrotoxic agent until the etiologic agent of CABP had been identified. Likewise, waiting for culture results to return in these cases would have led to a delay in empiric antibiotic treatment and would likely contribute to worse clinical outcomes. Limitations of the CAPTURE study include those inherent to a retrospective study in which information is extracted from clinical charts. These include the reporting of microbiology data without confirmation of results from a central laboratory, the extraction of information from nonstandardized patient charts, and the lack of randomization or blinding to control for potential bias. This leads to an increased risk of certain types of bias, including, but not limited to, ascertainment bias. Furthermore, the results of standardized pneumonia scoring systems (for example, the Pneumonia Patient Outcomes Research Team) were not collected as part of CAPTURE, as mentioned previously, because they are intended for use at admission, and the majority of ceftaroline fosamil usage described occurred subsequent to the time of admission. The CAPTURE study collected information on the use of ceftaroline fosamil, as well as prior, concurrent, and subsequent antimicrobial treatment, to reflect the contemporary clinical usage patterns of ceftaroline fosamil. Prior to an amendment to the study protocol, some patients were eligible for abstraction if they had received $ 2 doses of ceftaroline fosamil; however, this was subsequently amended 114
to $ 4 doses to better assess a potential treatment effect of ceftaroline fosamil. Nevertheless, the clinical success rates of ceftaroline fosamil reported here for both elderly and younger patients are encouraging. The elderly are an ever-growing segment of the population, and it is estimated that the proportion of people aged $ 65 years in the United States would increase from 13% in 2010 to 20% in 2050.27 With the increasing incidence of CABP in the last 20 years,17 it is important that CABP in the elderly be treated effectively to diminish the present and future health care impact of CABP in the United States. The findings presented here further support the administration of ceftaroline fosamil as an effective treatment for CABP in the elderly.
Conclusion
Community-acquired bacterial pneumonia is a continuing health care burden among elderly patients. One reason for the increased mortality among elderly CABP patients may be the presence of multiple comorbidities, as observed in the CAPTURE study and other studies. The clinical success rates of ceftaroline fosamil reported here for elderly CABP patients are encouraging. Despite a few limitations, the results of the CAPTURE study show that ceftaroline fosamil is a viable option for treating CABP in the elderly.
Acknowledgements
We thank the participating sites, investigators, and their staff for their contribution to this study. Micron Research Limited assisted in the preparation of this manuscript.
Conflict of Interest Statement
George Udeani, PharmD, DSc, FCCP, and John Evans, PharmD, MBA, are study investigators for CAPTURE, the ceftaroline fosamil study funded by Forest Laboratories, Inc. Dr Udeani is also a consultant for Cerexa, Inc. Phillip Cole, MD, is an employee of Cerexa, Inc., a wholly owned subsidiary of Forest Laboratories, Inc., and a shareholder of Forest Laboratories, Inc. H. David Friedland, MD, MBA, is an employee of Cerexa, Inc., a wholly owned subsidiary of Forest Laboratories, Inc.
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15. Kothe H, Bauer T, Marre R, et al. Outcome of community-acquired pneumonia: influence of age, residence status and antimicrobial treatment. Eur Respir J. 2008;32(1):139–146. 16. Lee JS, Primack BA, Mor MK, et al. Processes of care and outcomes for community-acquired pneumonia. Am J Med. 2011;124(12):1175. e9–e17. 17. Fry AM, Shay DK, Holman RC, Curns AT, Anderson LJ. Trends in hospitalizations for pneumonia among persons aged 65 years or older in the United States, 1988–2002. JAMA. 2005;294(21):2712–2719. 18. Jackson ML, Neuzil KM, Thompson WW, et al. The burden of community-acquired pneumonia in seniors: results of a population-based study. Clin Infect Dis. 2004;39(11):1642–1650. 19. Neupane B, Walter SD, Krueger P, Marrie T, Loeb M. Predictors of inhospital mortality and re-hospitalization in older adults with community-acquired pneumonia: a prospective cohort study. BMC Geriatr. 2010;10:22. 20. Fine MJ, Auble TE, Yealy DM, et al. A prediction rule to identify lowrisk patients with community-acquired pneumonia. N Engl J Med. 1997;336(4):243–250. 21. Dales RE, O’Connor A, Hebert P, et al. Intubation and mechanical ventilation for COPD: development of an instrument to elicit patient preferences. Chest. 1999;116(3):792–800. 22. Nguyen YL, Angus DC, Boumendil A, Guidet B. The challenge of admitting the very elderly to intensive care. Ann Intensive Care. 2011;1(1):29. 23. Ruiz M, Ewig S, Marcos MA, et al. Etiology of community-acquired pneumonia: impact of age, comorbidity, and severity. Am J Respir Crit Care Med. 1999;160(2):397–405. 24. Simonetti AF, Viasus D, Garcia-Vidal C, Carratalà J. Management of community-acquired pneumonia in older adults. Ther Adv Infect Dis. 2014;2(1):3–16. 25. Bartlett JG. Diagnostic tests for agents of community-acquired pneumonia. Clin Infect Dis. 2011;52(Suppl 4):S296–S304. 26. Mandell LA, Wunderink RG, Anzueto A, et al. Infectious Diseases Society of America/American Thoracic Society consensus guidelines on the management of community-acquired pneumonia in adults. Clin Infect Dis. 2007;44(Suppl 2):S27–S72. 27. Vincent GK, Velkoff VA; US Census Bureau. The next four decades, the older population in the United States: 2010 to 2050. Curr Population Rep. 2010;25–1138. http://www.census.gov/prod/2010pubs/p25–1138. pdf. Accessed January 30, 2014.
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Hospital Practice Publication details, including instructions for authors and subscription information: http://www.tandfonline.com/loi/ihop20
Ceftaroline Fosamil for the Treatment of Community-Acquired Bacterial Pneumonia in Elderly Patients a
b
c
George Udeani PharmD, DSc, FCCP , John Evans PharmD, MBA , Phillip Cole MD & H. David Friedland MD, c
MBA a
CHRISTUS Spohn Hospital, Corpus Christi, TX
b
CHRISTUS Spohn Hospital Alice, Alice, TX
c
Cerexa, Inc., Oakland, CA Published online: 28 May 2015.
Click for updates To cite this article: George Udeani PharmD, DSc, FCCP, John Evans PharmD, MBA, Phillip Cole MD & H. David Friedland MD, MBA (2014) Ceftaroline Fosamil for the Treatment of Community-Acquired Bacterial Pneumonia in Elderly Patients, Hospital Practice, 42:3, 109-115 To link to this article: http://dx.doi.org/10.3810/hp.2014.08.1123
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C L I N I C A L F E AT U R E S
Ceftaroline Fosamil for the Treatment of Community-Acquired Bacterial Pneumonia in Elderly Patients
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DOI: 10.3810/hp.2014.08.1123
George Udeani, PharmD, DSc, FCCP 1 John Evans, PharmD, MBA 2 Phillip Cole, MD 3 H. David Friedland, MD, MBA 3 CHRISTUS Spohn Hospital, Corpus Christi, TX; 2CHRISTUS Spohn Hospital Alice, Alice, TX; 3Cerexa, Inc., Oakland, CA 1
Abstract: The Clinical Assessment Program and Teflaro Utilization Registry (CAPTURE) is a multicenter study, assessing the contemporary use of ceftaroline fosamil in patients with community-acquired bacterial pneumonia (CABP) or acute bacterial skin and skin structure infection. This article discusses the data collected from 528 evaluable patients with CABP, from 39 sites in the United States, between August 2011 and April 2013. The majority of patients (51%) were elderly (aged $ 65 years), most of whom were treated in general hospital wards (70%). Approximately one quarter of elderly patients had $ 2 comorbidities (26%), the most common of which was structural lung disease (51%). The majority of elderly patients received ceftaroline fosamil as second-line therapy (85%), concurrently with other antibiotics (61%). Similar patterns of ceftaroline fosamil usage were noted in younger patients (aged , 65 years). Fifteen patients died (3%), 10 of whom were elderly. The overall clinical success of ceftaroline fosamil was 81% for elderly patients with CABP and 82% for younger patients. These data suggest that ceftaroline fosamil is a potentially effective treatment option for CABP in the elderly. Keywords: community-acquired bacterial pneumonia; CABP; ceftaroline fosamil; CAPTURE study; registry; elderly
Introduction
Correspondence: George Udeani, PharmD, DSc, FCCP, Corpus Christi Medical Center, Doctors Regional Hospital, Department of Pharmacy, 3315 Alameda Street, Corpus Christi, TX 78411. Tel: 361-761-1454 Fax: 361-761-1576 E-mail: [email protected]
Community-acquired bacterial pneumonia (CABP) is a major cause of morbidity and mortality. Although most CABP patients are managed as outpatients, the highest proportion of morbidity, mortality, and health care costs attributable to pneumonia occur among patients with CABP who are hospitalized.1 Approximately one third of all CABP patients are elderly (aged $ 65 years), and it is the elderly patients that account for nearly two thirds of all hospitalizations due to CABP.2 In the last 20 years, the number of patients between the ages of 65 and 84 years who are hospitalized with pneumonia has increased by 20%.3 Data on death rates in the United States during 2010 listed pneumonia as the ninth leading cause of death overall and the seventh highest cause of death among those aged 65 and over.4 Communityacquired bacterial pneumonia–related mortality is higher in elderly compared with younger patients.2 Ceftaroline is an antimicrobial of the cephalosporin class that displays in vitro activity against pathogens such as Streptococcus pneumoniae, Haemophilus influenzae, and Staphylococcus aureus,5 which commonly cause CABP.3 Sader et al5 also demonstrated that ceftaroline is active in vitro against penicillin-resistant S. pneumoniae
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Udeani et al
and methicillin-resistant S. aureus (MRSA). The in vitro activity of ceftaroline against S. aureus, S. pneumoniae, and their resistant phenotypes is due to the binding of ceftaroline to penicillin-binding proteins (PBPs) specific to these pathogens. Specifically, ceftaroline exhibits affinity to PBP1, -2, and -3 in methicillin-susceptible S. aureus (MSSA), PBP2a in MRSA, and PBP 2X, -2A, and -2B in S. pneumoniae and penicillin-resistant S. pneumoniae.6 Ceftaroline fosamil (Teflaro), the prodrug of ceftaroline, was approved by the US Food and Drug Administration (FDA) in October 2010 for the treatment of CABP and acute bacterial skin and skin structure infection in the United States,7 and by the European Medicines Agency in 2012 for similar indications. The Clinical Assessment Program and Teflaro Utilization Registry (CAPTURE) is a multicenter US chart review study evaluating the contemporary use of ceftaroline fosamil in patients with CABP or acute bacterial skin and skin structure infection. This article compares the clinical characteristics and clinical response of CABP in elderly patients (aged $ 65 years) with those in younger patients (aged , 65 years) in the CAPTURE study.
Methods Study Information
The study objectives were to describe the patient demographics, disease characteristics, characteristics of isolated pathogens, the usage of ceftaroline fosamil, and any prior, concurrent, or subsequent antibiotics; the location of care prior to, during, and following treatment; and the clinical response at discontinuation of treatment with ceftaroline fosamil. Data were collected at 39 sites in the United States between August 2011 and April 2013, from male and female patients who met all inclusion and no exclusion criteria. Patients had to be aged $ 18 years at the start of treatment with ceftaroline fosamil. All patients had to have a diagnosis of CABP, as defined by clinical signs and symptoms consistent with a lower respiratory tract infection, and chest radiography consistent with bacterial pneumonia. Patients had to receive $ 2 consecutive IV doses of ceftaroline fosamil between August 2011 and July 2012, and $ 4 consecutive IV doses thereafter, following a study protocol amendment. The final dose of ceftaroline fosamil had to be administered $ 30 days before the start of data collection. Patients were excluded from the study if information on dosing with ceftaroline fosamil or on discharge from hospital was absent from their chart. Patients were also excluded if they had 110
received previous treatment with ceftaroline fosamil and had their information extracted for the study. Elderly patients were defined as those aged $ 65 years. Locations of care included a general hospital ward, an intensive care unit (ICU), an outpatient parenteral antibiotic therapy (OPAT) unit, and the patient’s home. The ICU patients were defined as hospitalized patients who received any care in the ICU, and general hospital ward patients were hospitalized patients who received no care in the ICU. Patients treated in an OPAT unit or with home IV therapy were categorized as never being hospitalized. The CAPTURE study was approved by the institutional review board or ethics committee at each US site that provided study information. This study was conducted in accordance with the International Conference on Harmonisation E6 Good Clinical Practice guidance.8
Enrolled and Evaluable Patients
All patients included in the CAPTURE study comprised the enrolled population. Patients for whom a clinical response (success or failure) was determined were then categorized as evaluable. Clinical response was recorded as “success” if the reason for discontinuation of treatment with ceftaroline fosamil was either clinical cure, with no further need for antibiotics, or clinical improvement, with a switch to oral antibiotic. Clinical response was categorized as “failure” if treatment was discontinued due to either an adverse event or insufficient therapeutic effect and a switch to another IV antibiotic. If it was confirmed that a patient was clinically improving upon discontinuation of ceftaroline fosamil, with no evidence of failure, the clinical response was recorded as a success.
Data Analysis
Information was extracted by random ordering and review of patient charts identified from pharmacy listings in the general hospital ward, ICU, or OPAT unit. Data collected from patient charts included location of care, patient demographics, relevant medical history, disease characteristics, pathogens isolated, and antibiotic use. For CABP patients, relevant history included congestive heart failure, stroke, lung cancer, structural lung disease, gastroesophageal reflux, chronic sinusitis, prior pneumonia, alcoholism, and smoking. For continuous variables, descriptive statistics included the mean, standard deviation (SD), median, and range. For categorical variables, descriptive statistics were frequencies (n) and percentages. Statistical analyses were performed using SAS Software Version 9.2.
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Ceftaroline Fosamil for CABP in Elderly Patients
Results Patient Populations
The total number of enrolled patients with CABP was 548, of which 528 were evaluable (96%). The evaluable population is the focus of the data presented here, unless otherwise specified.
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Patient Demographics and Location of Care
The majority of CABP patients receiving ceftaroline fosamil were elderly (51%; Table 1). Of the elderly population, 44% were aged $ 80 years. Within the elderly and younger patient populations, slightly more than half of the patients were female (53% and 51%, respectively). Elderly patients were mostly treated in general hospital wards (70%), and the remaining patients received care in the ICU. The majority of younger patients were treated in general hospital wards (60%), and 40% were admitted to the ICU. Two younger patients received treatment in an OPAT unit or at home. The mean (± SD) duration of all hospital stays (general hospital ward plus ICU) was 12.5 (± 12.1) days among elderly patients, compared with 16.3 (± 19.1) days for younger patients. Information on duration of stay was missing for 2 younger patients.
Medical History
Most elderly and younger patients had medical histories related to CABP (78% and 75%, respectively). The most frequent medical history in elderly patients was structural lung disease (51%) and in younger patients was smoking (36%; Table 2). Prior pneumonia, congestive heart failure, and gastroesophageal reflux were also common underlying comorbidities. The majority of relevant medical histories Table 1. Baseline Demographic Data and Location of Care for Evaluable CABP Patients by Age Group Demographic Category Gender, n (%) Female Age at baseline (y) Mean (SD) Median (range) Location of care,a n (%) General hospital ward ICU
Age $ 65 years (N = 268, 50.8%)
Age , 65 years (N = 260, 49.2%)
141 (52.6)
132 (50.8)
77.8 (8.3) 78.0 (65.0–99.0)
49.3 (11.4) 52.0 (19.0–64.0)
188 (70.1) 80 (29.9)
155 (59.6) 103 (39.6)
Two younger patients (aged , 65 years) received care in an outpatient parenteral antibiotic therapy unit or had IV therapy at home. a
Abbreviations: CABP, community-acquired bacterial pneumonia; ICU, intensive care unit; SD, standard deviation.
were more prevalent among elderly than among younger patients, with the exception of smoking (24% and 36%, respectively) and alcoholism (4% and 10%, respectively).
Diagnosis and Disease Characteristics
Among elderly patients, the mean (± SD) duration of diagnosis prior to treatment was 4.0 (± 5.2) days. Younger patients had a mean (± SD) duration of diagnosis of 4.3 (± 6.2) days. On the day of CABP diagnosis, the majority of elderly patients presented with dyspnea, abnormal auscultatory findings, and cough (77%, 65%, and 57%, respectively). Upon diagnosis, younger patients mostly presented with dyspnea, cough, and abnormal auscultatory findings (75%, 68%, and 55%, respectively). At the end of treatment with ceftaroline fosamil, there was a decrease in all signs and symptoms among patients of both age groups, compared with the day of diagnosis (Figure 1). The data were missing for 1 younger patient (aged , 65 years). These categories shown on the figure are not mutually exclusive and some patients may have had . 1 sign or symptom.
Pathogens Isolated
Pathogens were identified from respiratory specimens (for example, sputum or bronchoalveolar lavage), blood, or a combination of both respiratory and blood specimens. Pathogens were recovered from 38% of all evaluable CABP patients, of which 46% were isolated from elderly patients and the remainder from younger patients. The most common pathogens recovered among elderly patients were S. aureus (16%; comprising 12% MRSA and 4% MSSA) and
Table 2. Relevant Medical History for Evaluable CABP Patients by Age Group Medical History,a n (%)
Age $ 65 years (N = 268)
Age , 65 years (N = 260)
Patients with $ 2 medical comorbidities Structural lung disease Prior pneumonia Congestive heart failure Gastroesophageal reflux Smoking Stroke Lung cancer Alcoholism Chronic sinusitis Hemodialysis
69 (25.8)
54 (20.8)
137 (51.1) 79 (29.5) 76 (28.4) 69 (25.7) 65 (24.3) 28 (10.5) 17 (6.3) 11 (4.1) 4 (1.5) 4 (1.5)
91 (35.0) 55 (21.2) 37 (14.2) 58 (22.3) 94 (36.2) 17 (6.5) 4 (1.5) 27 (10.4) 4 (1.5) 4 (1.5)
These categories are not mutually exclusive, and some patients may have had . 1 medical history. a
Abbreviation: CABP, community-acquired bacterial pneumonia.
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Udeani et al
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Figure 1. Change in frequency of each clinical sign and symptom between the day of diagnosis and the end of treatment for evaluable community-acquired bacterial pneumonia patients by age group.
S. pneumoniae (2%). The pathogens most frequently isolated from younger patients were S. aureus (20%; comprising 15% MRSA and 5% MSSA) and S. pneumoniae (4%).
(23%), glycopeptides (11%), tetracyclines (5%), penicillins (4%), and oxazolidinones (3%) concurrently with ceftaroline fosamil.
Antibiotic Treatment
Clinical Success and Adverse Events
The mean (± SD) duration of therapy with ceftaroline fosamil was 6.0 (± 3.5) days among elderly patients and 6.3 (± 4.5) days among younger patients. The mean (± SD) number of ceftaroline fosamil doses administered to elderly and younger patients were 10.5 (± 6.8) and 11.1 (± 8.9), respectively. Overall, the majority of elderly patients were given ceftaroline fosamil as second-line therapy (85%), and most elderly patients received ceftaroline fosamil concurrently with other antibiotics (61%). Similar patterns of administration were noted in younger patients: ceftaroline fosamil was given as a second-line agent in 84%, and the majority of younger patients were administered ceftaroline fosamil as concurrent therapy (68%). When ceftaroline fosamil was used as second-line therapy, the prior antibiotics most frequently administered to elderly patients were quinolones (30%), followed by glycopeptides (28%), macrolides (26%), penicillins (20%), and oxazolidinones and tetracyclines (each 4%). Prior antibiotics administered to younger patients were quinolones and glycopeptides (each 35%), macrolides (27%), penicillins (22%), oxazolidinones (5%), and tetracyclines (2%). Ceftaroline fosamil was given as concurrent therapy to elderly patients most commonly with macrolides (22%), followed by quinolones (18%), penicillins (7%), glycopeptides (6%), tetracyclines (3%), and oxazolidinones (1%). Younger patients received macrolides (24%), quinolones 112
The overall clinical success was 81% among elderly patients and 82% for younger patients treated with ceftaroline fosamil (Table 3). For patients with $ 2 comorbidities, the rates of clinical success were 84% among elderly patients and 82% among younger patients. Among elderly patients with a pathogen isolated, clinical success was 67% to 100%, compared with 80% to 91% for younger patients. There were similar rates of clinical success for elderly patients whether they received ceftaroline fosamil as firstline therapy (78%) or as second-line therapy (82%). Among younger patients, the clinical success rate was 86% when ceftaroline fosamil was used as first-line therapy and 82% when it was used as second-line therapy. Clinical success was comparable among elderly patients treated with ceftaroline fosamil as monotherapy or concurrently with other antibiotics (81% and 82%, respectively). For younger patients, the rates of clinical success were also similar when comparing administration of ceftaroline fosamil as monotherapy or concurrent therapy (82% and 83%, respectively). Serious adverse events (SAEs) were reported for 14 patients (3%)—9 elderly patients and 5 younger patients. The SAEs reported for patients who died (8 elderly patients and 3 younger patients) included B-cell lymphoma, cardiac arrest, cardiopulmonary arrest, respiratory failure, renal failure, and sepsis. The 3 SAEs that were not associated with patient death were drug exposure during pregnancy (1 younger patient),
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Ceftaroline Fosamil for CABP in Elderly Patients
Table 3. Rates of Clinical Success for Evaluable CABP Patients by Age Group Category, n/N (%)
Age $ 65 years
Age , 65 years
Overall Patients with $ 2 medical comorbidities Pathogen isolated Staphylococcus aureus MRSA MSSA Streptococcus pneumoniae Ceftaroline fosamil usage First-line use Second-line use Monotherapy Concurrent therapy
218/268 (81.3) 58/69 (84.1)
214/260 (82.3) 44/54 (81.5)
30/43 (69.8) 22/33 (66.7) 8/10 (80.0) 6/6 (100)
43/53 (81.1) 32/40 (80.0) 11/13 (84.6) 10/11 (90.9)
32/41 (78.0) 186/227 (81.9) 83/103 (80.6) 135/165 (81.8)
36/42 (85.7) 178/218 (81.7) 68/83 (81.9) 146/177 (82.5)
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Abbreviations: CABP, community-acquired bacterial pneumonia; MRSA, methicillin-resistant Staphylococcus aureus; MSSA, methicillin-susceptible Staphylococcus aureus.
empyema (1 elderly patient), and enterococcal meningitis (1 younger patient). None of the SAEs reported for this subset of patients were thought to be related to ceftaroline fosamil therapy. Discontinuation of treatment with ceftaroline fosamil due to an adverse event was reported in a total of 7 patients (1%)—3 elderly and 4 younger.
Discharge Destinations
After treatment with ceftaroline fosamil, 47% of elderly patients were discharged to home and the same proportion was transferred to another care facility (including hospital, nursing home, rehabilitation facility, or skilled nursing facility). The majority of younger patients were discharged to home after receiving ceftaroline fosamil (70%), and 27% were referred to another care facility. In addition to those patients discharged to home or to another care facility, 15 patients died (3%)—10 elderly and 5 younger. The 4 additional deaths that are reported here, compared with those that were reported due to SAEs, occurred after the time interval required for SAE reporting in the study (. 24 hours after discontinuation of ceftaroline fosamil). Discharge destinations were missing from the remaining 11 patients (2%)—7 elderly and 4 younger.
Discussion
According to the 2010 US National Hospital Discharge Survey of short-stay hospitals, approximately 1.1 million patients were hospitalized with pneumonia, of whom 55% were elderly and 45% were aged , 65 years.9 Studies have found that there was an association with higher mortality in elderly patients with CABP.10–16 Although mortality among
the elderly in the CAPTURE study was low (2%), it was higher than that of younger patients (1%), which is consistent with the published reports for CABP as previously mentioned. In the CAPTURE study, patient deaths were not related to treatment with ceftaroline fosamil. One reason for the increased mortality among elderly CABP patients may be the presence of multiple comorbidities and the increased severity of these comorbidities among elderly patients12,15,17; however, age and comorbidity were independent risk factors for CABP mortality, according to Kothe et al.15 In the CAPTURE study, 56% of patients with $ 2 comorbidities were elderly, and a higher proportion of elderly than younger patients had comorbidities, including structural lung disease, prior pneumonia, congestive heart failure, gastroesophageal reflux, and lung cancer. Published data show that underlying lung disease, congestive heart failure, and lung cancer are all independently associated with higher mortality in patients with CABP.12,15,18,19 Although advanced age and the presence of comorbidities can be predictors of CABP requiring ICU admission, as noted in the Pneumonia Patient Outcomes Research Team CABP scoring system,20 fewer elderly patients in the CAPTURE study were treated in an ICU compared with younger patients (30% and 40%, respectively). The results of pneumonia severity scoring systems were not collected in CAPTURE as a means of comparison between elderly and younger patients, but the difference in location of care may be explained, in part, by different attitudes for advanced directives among elderly and younger patients, such as their wishes regarding invasive procedures such as endotracheal intubation.21 Furthermore, clinicians may be disinclined to admit elderly patients to the ICU due to concerns that invasive procedures may worsen the condition of the patient.22 Age $ 60 years does not have a notable impact on the microbial etiology of CABP,23 although S. pneumoniae appears to be the pathogen most commonly isolated from elderly CABP patients.24 In the CAPTURE study, similar percents of elderly and younger patients had pathogens isolated; however, S. aureus (MSSA and MRSA) was identified more often than S. pneumoniae. This is likely to be related to a change of antimicrobial administration to ceftaroline fosamil once S. aureus was confirmed as the causative pathogen of CABP. In addition, S. aureus, being a nonfastidious organism, is relatively easier to detect in culture than S. pneumoniae.25 The current Infectious Diseases Society of America/ American Thoracic Society joint committee guidelines on the management of CABP specify antibiotic treatment by disease
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Udeani et al
severity, rather than by age group.26 In the CAPTURE study, there were similar patterns of ceftaroline fosamil administration among elderly and younger CABP patients, with the majority of both age groups receiving ceftaroline fosamil as second-line therapy, and concurrently with other antibiotics. There were also similar rates of clinical success among elderly and younger CABP patients who received ceftaroline fosamil as second-line therapy or as concurrent therapy (81%–83%). These rates were comparable to the overall clinical success in elderly and younger patients with CABP (81% and 82%, respectively), and the success observed for elderly and younger patients with $ 2 comorbidities (84% and 82%, respectively). The CAPTURE data found lower rates of clinical success among elderly than younger patients with MRSA isolated (67% and 80%, respectively). Vancomycin is one agent recommended by the current Infectious Diseases Society of America/American Thoracic Society joint committee guidelines to treat CABP suspected or confirmed to be caused by MRSA.26 Fewer elderly than younger patients received glycopeptides prior to ceftaroline fosamil (28% and 35%, respectively), which may reflect a reluctance to use a potentially nephrotoxic agent until the etiologic agent of CABP had been identified. Likewise, waiting for culture results to return in these cases would have led to a delay in empiric antibiotic treatment and would likely contribute to worse clinical outcomes. Limitations of the CAPTURE study include those inherent to a retrospective study in which information is extracted from clinical charts. These include the reporting of microbiology data without confirmation of results from a central laboratory, the extraction of information from nonstandardized patient charts, and the lack of randomization or blinding to control for potential bias. This leads to an increased risk of certain types of bias, including, but not limited to, ascertainment bias. Furthermore, the results of standardized pneumonia scoring systems (for example, the Pneumonia Patient Outcomes Research Team) were not collected as part of CAPTURE, as mentioned previously, because they are intended for use at admission, and the majority of ceftaroline fosamil usage described occurred subsequent to the time of admission. The CAPTURE study collected information on the use of ceftaroline fosamil, as well as prior, concurrent, and subsequent antimicrobial treatment, to reflect the contemporary clinical usage patterns of ceftaroline fosamil. Prior to an amendment to the study protocol, some patients were eligible for abstraction if they had received $ 2 doses of ceftaroline fosamil; however, this was subsequently amended 114
to $ 4 doses to better assess a potential treatment effect of ceftaroline fosamil. Nevertheless, the clinical success rates of ceftaroline fosamil reported here for both elderly and younger patients are encouraging. The elderly are an ever-growing segment of the population, and it is estimated that the proportion of people aged $ 65 years in the United States would increase from 13% in 2010 to 20% in 2050.27 With the increasing incidence of CABP in the last 20 years,17 it is important that CABP in the elderly be treated effectively to diminish the present and future health care impact of CABP in the United States. The findings presented here further support the administration of ceftaroline fosamil as an effective treatment for CABP in the elderly.
Conclusion
Community-acquired bacterial pneumonia is a continuing health care burden among elderly patients. One reason for the increased mortality among elderly CABP patients may be the presence of multiple comorbidities, as observed in the CAPTURE study and other studies. The clinical success rates of ceftaroline fosamil reported here for elderly CABP patients are encouraging. Despite a few limitations, the results of the CAPTURE study show that ceftaroline fosamil is a viable option for treating CABP in the elderly.
Acknowledgements
We thank the participating sites, investigators, and their staff for their contribution to this study. Micron Research Limited assisted in the preparation of this manuscript.
Conflict of Interest Statement
George Udeani, PharmD, DSc, FCCP, and John Evans, PharmD, MBA, are study investigators for CAPTURE, the ceftaroline fosamil study funded by Forest Laboratories, Inc. Dr Udeani is also a consultant for Cerexa, Inc. Phillip Cole, MD, is an employee of Cerexa, Inc., a wholly owned subsidiary of Forest Laboratories, Inc., and a shareholder of Forest Laboratories, Inc. H. David Friedland, MD, MBA, is an employee of Cerexa, Inc., a wholly owned subsidiary of Forest Laboratories, Inc.
© Hospital Practice, Volume 42, Issue 3, August 2014, ISSN – 2154-8331 ResearchSHARE®: www.research-share.com • Permissions: [email protected] • Reprints: [email protected] Warning: No duplication rights exist for this journal. Only JTE Multimedia, LLC holds rights to this publication. Please contact the publisher directly with any queries.
Ceftaroline Fosamil for CABP in Elderly Patients
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