PMID- 23394685
OWN - NLM
STAT- MEDLINE
DCOM- 20130930
LR  - 20131121
IS  - 1872-7913 (Electronic)
IS  - 0924-8579 (Linking)
VI  - 41
IP  - 5
DP  - 2013 May
TI  - Safety of daptomycin in patients completing more than 14 days of therapy: results 
      from the Cubicin(R) Outcomes Registry and experience.
PG  - 421-5
LID - S0924-8579(13)00004-6 [pii]
LID - 10.1016/j.ijantimicag.2012.12.008 [doi]
AB  - Patients with complicated infections may receive daptomycin for extended periods. 
      This retrospective analysis was conducted to describe the safety profile of 
      daptomycin in patients completing >14 days of therapy. In the Cubicin((R)) Outcomes 
      Registry and Experience (CORE((R))) 2005-2009, a retrospective, multicentre, 
      observational registry, patients completing >14 days of daptomycin were studied. 
      Investigators assessed adverse events (AEs) using ICH-E2A definitions of 
      seriousness/severity </=30 days after completing daptomycin. AEs were grouped by 
      onset at </=14, 15-28 and >28 days after starting daptomycin. In total, 2263 
      patients received >14 days of daptomycin. The most common indications were 
      complicated skin and skin-structure infection (25.5%) and osteomyelitis (21.7%). 
      Regarding AEs, 205 patients (9.1%) experienced AEs with an onset </=14 days of 
      therapy, 168 (7.4%) between 15-28 days and 108 (4.8%) >28 days; a total of 
      389/2263 patients experienced 814 AEs. The most common AE was increased blood 
      creatine phosphokinase (CPK), occurring in 49 patients (2.2%) during </=14 days of 
      therapy, 32 (1.4%) between 15-28 days and 10 (0.4%) >28 days. In 183/2263 
      patients (8.1%), 264 AEs were possibly related to daptomycin. Serious AEs 
      occurred in 153/2263 patients (6.8%). Eighty-nine (3.9%) of 2263 patients had 
      daptomycin discontinued due to AEs, with 36 discontinued due to increased CPK. 
      The overall mortality rate was 63/2263 (2.8%); 4 patients died of a possibly 
      related AE. The most common AEs with onset <14 days were similar to those 
      occurring between 15-28 days and >28 days. Daptomycin appears to be safe in 
      patients treated for >14 days.
CI  - Copyright (c) 2013 Elsevier B.V. and the International Society of Chemotherapy. All 
      rights reserved.
FAU - Rege, Shruta
AU  - Rege S
AD  - Cubist Pharmaceuticals, Inc., Lexington, MA 02421, USA. shruta.rege@cubist.com
FAU - Mohr, John
AU  - Mohr J
FAU - Lamp, Kenneth C
AU  - Lamp KC
FAU - Yoon, Min
AU  - Yoon M
FAU - Lindfield, Kimberly C
AU  - Lindfield KC
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20130205
PL  - Netherlands
TA  - Int J Antimicrob Agents
JT  - International journal of antimicrobial agents
JID - 9111860
RN  - 0 (Anti-Bacterial Agents)
RN  - NWQ5N31VKK (Daptomycin)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Anti-Bacterial Agents/*adverse effects/*therapeutic use
MH  - Bacterial Infections/*drug therapy
MH  - Child
MH  - Daptomycin/*adverse effects/*therapeutic use
MH  - Drug-Related Side Effects and Adverse Reactions/*epidemiology/pathology
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Retrospective Studies
MH  - Survival Analysis
MH  - Time Factors
MH  - Treatment Outcome
MH  - Withholding Treatment/statistics & numerical data
MH  - Young Adult
EDAT- 2013/02/12 06:00
MHDA- 2013/10/01 06:00
CRDT- 2013/02/12 06:00
PHST- 2012/07/25 00:00 [received]
PHST- 2012/12/11 00:00 [revised]
PHST- 2012/12/13 00:00 [accepted]
PHST- 2013/02/12 06:00 [entrez]
PHST- 2013/02/12 06:00 [pubmed]
PHST- 2013/10/01 06:00 [medline]
AID - S0924-8579(13)00004-6 [pii]
AID - 10.1016/j.ijantimicag.2012.12.008 [doi]
PST - ppublish
SO  - Int J Antimicrob Agents. 2013 May;41(5):421-5. doi: 
      10.1016/j.ijantimicag.2012.12.008. Epub 2013 Feb 5.