PMID- 28664412 OWN - NLM STAT- MEDLINE DCOM- 20180601 LR - 20231213 IS - 1179-1950 (Electronic) IS - 0012-6667 (Print) IS - 0012-6667 (Linking) VI - 77 IP - 12 DP - 2017 Aug TI - Early Use of Ceftaroline Fosamil in the United States Veterans Health Care System. PG - 1345-1351 LID - 10.1007/s40265-017-0785-2 [doi] AB - BACKGROUND: Ceftaroline fosamil is US Food and Drug Administration-approved for acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia, but it is not known how ceftaroline is being used in real-world settings or how adverse effects (AEs) and mortality compare to clinical trials. OBJECTIVE: This study describes ceftaroline use, AEs, and mortality in US Veterans Health Administration (VHA) hospital patients. METHODS: This phase IV, population-based, epidemiologic study analyzed patients >/=18 years old who received one or more ceftaroline doses within 14 days of admission to 69 VHA hospitals in 41 US states/territories from 1 October 2010 to 30 September 2014. VHA repository data were linked using unique patient identifiers. Diagnoses and AEs were determined using ICD9-CM and CSS codes. Demographics, AEs within 30 days of therapy initiation, and all-cause in-hospital mortality were summarized using descriptive statistics. RESULTS: 764 Patients met study criteria. Patients were 97% male and 56% White, with a median age of 61 years and a Charlson score of 6. Diagnoses included skin (40%), sepsis (30%), osteomyelitis (25%), diabetic foot (22%), pneumonia (16%), bacteremia (11%), endocarditis (6%), meningitis (2%), and device (2%) infections. Ceftaroline was used first-line (37%), second-line (56%), and third-line or greater (7%). Patients received ceftaroline a median of 3 days after hospital admission. All-cause in-hospital mortality rates were: overall (5%), skin (2%), sepsis (9%), osteomyelitis (3%), diabetic foot (1%), pneumonia (13%), bacteremia (6%), endocarditis (11%), meningitis (6%), and device (13%). Eosinophilia, leukopenia, leukocytosis, fibromyalgia, myalgia and myositis, and polymyalgia rates were <1% each. CONCLUSIONS: Ceftaroline is used in VHA hospitals for various diagnoses. Mortality was low and comparable with rates from clinical trials. Additional studies comparing ceftaroline to other drugs used in similar situations are needed. FAU - Britt, Rachel S AU - Britt RS AD - Pharmacotherapy Division, College of Pharmacy, The University of Texas at Austin, San Antonio, TX, USA. AD - Pharmacotherapy Education and Research Center, School of Medicine, University of Texas Health Science Center at San Antonio, 7703 Floyd Curl Dr., MSC-6220, San Antonio, TX, 78229, USA. FAU - Evoy, Kirk E AU - Evoy KE AD - Pharmacotherapy Division, College of Pharmacy, The University of Texas at Austin, San Antonio, TX, USA. AD - Pharmacotherapy Education and Research Center, School of Medicine, University of Texas Health Science Center at San Antonio, 7703 Floyd Curl Dr., MSC-6220, San Antonio, TX, 78229, USA. AD - University Health System, San Antonio, TX, USA. FAU - Lee, Grace C AU - Lee GC AD - Pharmacotherapy Division, College of Pharmacy, The University of Texas at Austin, San Antonio, TX, USA. AD - Pharmacotherapy Education and Research Center, School of Medicine, University of Texas Health Science Center at San Antonio, 7703 Floyd Curl Dr., MSC-6220, San Antonio, TX, 78229, USA. FAU - Reveles, Kelly R AU - Reveles KR AD - Pharmacotherapy Division, College of Pharmacy, The University of Texas at Austin, San Antonio, TX, USA. AD - Pharmacotherapy Education and Research Center, School of Medicine, University of Texas Health Science Center at San Antonio, 7703 Floyd Curl Dr., MSC-6220, San Antonio, TX, 78229, USA. FAU - Sorensen, Kimberly M AU - Sorensen KM AD - Pharmacotherapy Division, College of Pharmacy, The University of Texas at Austin, San Antonio, TX, USA. AD - Pharmacotherapy Education and Research Center, School of Medicine, University of Texas Health Science Center at San Antonio, 7703 Floyd Curl Dr., MSC-6220, San Antonio, TX, 78229, USA. FAU - Jones, Xavier AU - Jones X AD - Pharmacotherapy Division, College of Pharmacy, The University of Texas at Austin, San Antonio, TX, USA. AD - South Texas Veterans Health Care System, San Antonio, TX, USA. FAU - Bollinger, Mary AU - Bollinger M AD - Pharmacotherapy Education and Research Center, School of Medicine, University of Texas Health Science Center at San Antonio, 7703 Floyd Curl Dr., MSC-6220, San Antonio, TX, 78229, USA. AD - South Texas Veterans Health Care System, San Antonio, TX, USA. FAU - Frei, Christopher R AU - Frei CR AD - Pharmacotherapy Division, College of Pharmacy, The University of Texas at Austin, San Antonio, TX, USA. freic@uthscsa.edu. AD - Pharmacotherapy Education and Research Center, School of Medicine, University of Texas Health Science Center at San Antonio, 7703 Floyd Curl Dr., MSC-6220, San Antonio, TX, 78229, USA. freic@uthscsa.edu. AD - University Health System, San Antonio, TX, USA. freic@uthscsa.edu. AD - South Texas Veterans Health Care System, San Antonio, TX, USA. freic@uthscsa.edu. LA - eng GR - KL2 TR001118/TR/NCATS NIH HHS/United States GR - P30 AG044271/AG/NIA NIH HHS/United States GR - TL1 TR001119/TR/NCATS NIH HHS/United States GR - UL1 TR001120/TR/NCATS NIH HHS/United States PT - Journal Article PL - New Zealand TA - Drugs JT - Drugs JID - 7600076 RN - 0 (Anti-Bacterial Agents) RN - 0 (Cephalosporins) SB - IM MH - Aged MH - Anti-Bacterial Agents/administration & dosage/adverse effects/*therapeutic use MH - Cephalosporins/administration & dosage/adverse effects/*therapeutic use MH - Community-Acquired Infections/drug therapy MH - Epidemiologic Studies MH - Female MH - Humans MH - Male MH - Middle Aged MH - United States MH - Veterans Health MH - Ceftaroline PMC - PMC5553123 MID - NIHMS889472 EDAT- 2017/07/01 06:00 MHDA- 2018/06/02 06:00 PMCR- 2018/08/01 CRDT- 2017/07/01 06:00 PHST- 2017/07/01 06:00 [pubmed] PHST- 2018/06/02 06:00 [medline] PHST- 2017/07/01 06:00 [entrez] PHST- 2018/08/01 00:00 [pmc-release] AID - 10.1007/s40265-017-0785-2 [pii] AID - 10.1007/s40265-017-0785-2 [doi] PST - ppublish SO - Drugs. 2017 Aug;77(12):1345-1351. doi: 10.1007/s40265-017-0785-2.