PMID- 21925846
OWN - NLM
STAT- MEDLINE
DCOM- 20120301
LR  - 20181201
IS  - 1872-7913 (Electronic)
IS  - 0924-8579 (Linking)
VI  - 38
IP  - 6
DP  - 2011 Dec
TI  - Overview of safety experience with caspofungin in clinical trials conducted over 
      the first 15 years: a brief report.
PG  - 540-4
LID - 10.1016/j.ijantimicag.2011.07.008 [doi]
AB  - Safety experience is available from 32 completed clinical studies (17 Phase I and 
      15 Phase II-III) of caspofungin (CAS) conducted between 1995 and 2010 in adult 
      and paediatric patients. Clinical and laboratory adverse events (AEs) were 
      collected from all enrolled subjects and patients. Investigators identified the 
      seriousness, causality and result of all AEs noted during study therapy and for 
      up to 28 days post therapy. Up to 31 December 2010, full safety data are 
      available from 1951 individuals who have received at least one dose of CAS in 
      Phase I-III clinical studies, including 171 paediatric patients, 394 volunteer 
      adult subjects and 1386 adult patients (276 with oropharyngeal/oesophageal 
      candidiasis, 366 with invasive candidiasis, 180 with invasive aspergillosis and 
      564 with persistent fever and neutropenia). CAS was administered for up to 196 
      days at daily doses ranging from 5mg to 210 mg. Overall, 41.8% of CAS recipients 
      had an AE that was classified as drug-related. The most frequently reported 
      drug-related AEs were fever (9.3%), chills (5.2%), increased alanine 
      aminotransferase (6.5%), increased aspartate aminotransferase (6.0%) and 
      increased alkaline phosphatase (5.2%). Serious AEs were reported in 27.3% of CAS 
      recipients overall but were attributed to CAS in only 0.8%, and discontinuation 
      of CAS due to a drug-related AE was infrequent (2.7%). Dose-related CAS toxicity 
      was not observed. In conclusion, CAS has demonstrated a favourable safety profile 
      in 1951 adult and paediatric patients enrolled in clinical trials.
CI  - Copyright (c) 2011 Elsevier B.V. and the International Society of Chemotherapy. All 
      rights reserved.
FAU - Ngai, Angela L
AU  - Ngai AL
AD  - Merck Research Laboratories, North Wales, PA 19454, USA.
FAU - Bourque, Michael R
AU  - Bourque MR
FAU - Lupinacci, Robert J
AU  - Lupinacci RJ
FAU - Strohmaier, Kim M
AU  - Strohmaier KM
FAU - Kartsonis, Nicholas A
AU  - Kartsonis NA
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PT  - Review
DEP - 20110916
PL  - Netherlands
TA  - Int J Antimicrob Agents
JT  - International journal of antimicrobial agents
JID - 9111860
RN  - 0 (Antifungal Agents)
RN  - 0 (Echinocandins)
RN  - 0 (Lipopeptides)
RN  - F0XDI6ZL63 (Caspofungin)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Antifungal Agents/*adverse effects/therapeutic use
MH  - Aspergillosis/*drug therapy
MH  - Candidiasis/*drug therapy
MH  - Caspofungin
MH  - Child
MH  - Child, Preschool
MH  - Clinical Trials as Topic
MH  - Echinocandins/*adverse effects/therapeutic use
MH  - Humans
MH  - Infant
MH  - Lipopeptides
MH  - Treatment Outcome
MH  - Young Adult
EDAT- 2011/09/20 06:00
MHDA- 2012/03/02 06:00
CRDT- 2011/09/20 06:00
PHST- 2011/06/07 00:00 [received]
PHST- 2011/07/20 00:00 [revised]
PHST- 2011/07/20 00:00 [accepted]
PHST- 2011/09/20 06:00 [entrez]
PHST- 2011/09/20 06:00 [pubmed]
PHST- 2012/03/02 06:00 [medline]
AID - S0924-8579(11)00317-7 [pii]
AID - 10.1016/j.ijantimicag.2011.07.008 [doi]
PST - ppublish
SO  - Int J Antimicrob Agents. 2011 Dec;38(6):540-4. doi: 
      10.1016/j.ijantimicag.2011.07.008. Epub 2011 Sep 16.