| Literature DB >> 27536508 |
Dhara N Shah1, Fay S Chan1, Nandita Kachru2, Krutina P Garcia1, Holly E Balcer3, April P Dyer4, John E Emanuel5, Michelle D Jordan6, Katherine T Lusardi7, Geri Naymick8, Radhika S Polisetty9, Lanny Sieman10, Ashley M Tyler11, Michael L Johnson2, Kevin W Garey1.
Abstract
PURPOSE: Fidaxomicin use in real-world clinical practice, especially for severe Clostridium difficile infection (CDI), is mainly based on single-center observational studies. The purpose of this pharmacoepidemiology study was to assess outcomes of patients given fidaxomicin based on episode number and use of concomitant antibiotics.Entities:
Keywords: Anaerobe infections; Clinical practice; Pharmacoepidemiology; Real-world study; Treatment
Year: 2016 PMID: 27536508 PMCID: PMC4970984 DOI: 10.1186/s40064-016-2825-x
Source DB: PubMed Journal: Springerplus ISSN: 2193-1801
Fidaxomicin utilization rates
| 2011 | 2012 | 2012 | 2013 | Overall time period | |
|---|---|---|---|---|---|
| Fidaxomicin utilization from third quarter of 2011 to second quarter of 2013 | |||||
| Number of CDI patients | 5098 | 5582 | 5160 | 6084 | 21,924 |
| Number of patients who received FDX | 11 | 119 | 126 | 218 | 474 |
| FDX use rate | 0.22 % | 2.1 % | 2.4 % | 3.6 % | 2.16 % |
CDI Clostridium difficile infection, FDX fidaxomicin
* Combined data for the entire time period; ** p value = 0.01 rural hospitals versus urban hospitals; ^ p value = 0.18 teaching versus non-teaching hospitals
Fidaxomicin utilization stratified by CDI episodes
| Early episodes | Later episodes | Overall (n = 102) | |||
|---|---|---|---|---|---|
| Episode 1 | Episode 2 | Total | Episode ≥ 3 | ||
| Mild-moderate CDI; n(%) | 10 (27 %) | 12 (37.5 %) | 22 (32 %) | Not applicable | 22/69 (32 %) |
| Severe CDI; n(%) | 27 (73 %) | 20 (62.5 %) | 47 (68 %) | Not applicable | 47/69 (68 %) |
| 1. FDX monotherapy; n (%) | 3 (8 %) | 4 (12.5 %)a | 7 (10 %) | 6 (18 %) | 13 (13 %) |
| 2. Other CDI therapy; n (%) | 34 (92 %) | 27 (84 %) | 61 (88 %) | 27 (82 %) | 88 (86 %) |
| I. Subsequent; n | 18 | 14 | 32 | 16 | 48 |
| II. Subsequent and combination; n | 8 | 6 | 14 | 2 | 16 |
| III. Combination; n | 2 | 1 | 3 | 1 | 4 |
| IV. Unable to categorize; n | 6 | 6 | 12 | 8 | 20 |
| Concomitant non-CDI antibiotics; n (%) | 25 (68 %) | 10 (31 %) | 35 (51 %) | 13 (39 %) | 48 (47 %) |
CDI = Clostridium difficile infection; FDX = fidaxomicin
aFor one patient: unknown if received fidaxomicin as monotherapy or with other CDI therapy
Clinical outcomes stratified by CDI episodes
| n | Early episodes | Later episodes | Overall | |
|---|---|---|---|---|
| Episode 1 | Episode 2 | Episode ≥ 3 | ||
| Clinical cure | 25 | 25 | 29 | 79 (77 %) |
| Recurrent CDI | 6 | 7 | 8 | 21 (21 %) |
| Re-hospitalizationa | 9 | 13 | 10 | 32 (31 %) |
| Mortality | 4 | 4 | 0 | 8 (8 %) |
aOut of 32 re-hospitalizations, 14 patients had documented CDI recurrence during that re-hospitalization