PMID- 17694280
OWN - NLM
STAT- MEDLINE
DCOM- 20071130
LR  - 20070813
IS  - 0723-5003 (Print)
IS  - 0723-5003 (Linking)
VI  - 102
IP  - 8
DP  - 2007 Aug 15
TI  - [Analysis of hospital admissions associated with digitalis glycosides].
PG  - 603-11
AB  - BACKGROUND: Although the value of digitalis glycosides in the treatment of heart 
      failure is limited, approximately 255 million DDDs of digitalis glycosides (DGs) 
      were prescribed in Germany in 2004. METHOD: The authors analyzed data from 
      adverse drug reactions (ADRs) resulting in hospitalization in the four German 
      Pharmacovigilance Centers (PVCs) associated with DGs between 2000 and 2004. All 
      patients with an at least "probable" ADR were included. RESULTS: Out of 3,092 ADR 
      patients, in 314 patients (10.2%, 244 women) admission was caused by a DG-related 
      ADR. Patients with DG-related ADR had a significantly lower body weight and were 
      significantly older than patients with other ADRs. Per 1,000 patients exposed to 
      DGs the incidence [95% CI] was calculated to 1.9 [1.0; 3.3] ADRs per 3 months 
      exposition. Oral digitoxin was involved in 296 patients (228 women). 70.6% of 
      women but only 29.3% of men were overdosed (> 1 mug/kg body weight per day). 
      Women received significantly higher body weight-related digitoxin doses and had 
      significantly higher digitoxin plasma levels than men. ADRs in patients with 
      nonelevated digitoxin serum level were mainly caused by pharmacodynamic drug-drug 
      interactions (e.g., beta-blockers). Overall, 42.4% of the ADRs were supposed to 
      be preventable. CONCLUSION: Body weight-adapted dosing of digitoxin is essential 
      for preventing DG-ADRs, particularly in elderly women with low body weight. 
      Beyond giving attention to pharmacodynamic and pharmakokinetic drug-drug 
      interactions, regular measurements of digitoxin plasma concentrations are crucial 
      accounting for the increased half-life of digitoxin in the very old.
FAU - Schmiedl, Sven
AU  - Schmiedl S
AD  - HELIOS Klinikum Wuppertal, Philipp Klee-Institut fur Klinische Pharmakologie, 
      Universitat Witten/Herdecke, Witten/Herdecke.
FAU - Szymanski, Jacek
AU  - Szymanski J
FAU - Rottenkolber, Marietta
AU  - Rottenkolber M
FAU - Drewelow, Bernd
AU  - Drewelow B
FAU - Haase, Grit
AU  - Haase G
FAU - Hippius, Marion
AU  - Hippius M
FAU - Reimann, Ilselore R
AU  - Reimann IR
FAU - Siegmund, Werner
AU  - Siegmund W
FAU - May, Karen
AU  - May K
FAU - Haack, Sara
AU  - Haack S
FAU - Hasford, Jorg
AU  - Hasford J
FAU - Thurmann, Petra A
AU  - Thurmann PA
CN  - Deutsche Pharmakovigilanz-Studiengruppe
LA  - ger
PT  - English Abstract
PT  - Journal Article
TT  - Fingerhut--ein alter Hut?: Eine Analyse stationarer Aufnahmen durch 
      digitalisassoziierte unerwunschte Arzneimittelwirkungen.
PL  - Germany
TA  - Med Klin (Munich)
JT  - Medizinische Klinik (Munich, Germany : 1983)
JID - 8303501
RN  - 0 (Cardiotonic Agents)
RN  - 0 (Digitalis Glycosides)
SB  - IM
MH  - Adverse Drug Reaction Reporting Systems
MH  - Aged
MH  - Aged, 80 and over
MH  - Arrhythmias, Cardiac/blood/*drug therapy/epidemiology
MH  - Cardiotonic Agents/administration & dosage/pharmacokinetics/*toxicity
MH  - Digitalis Glycosides/administration & dosage/pharmacokinetics/*toxicity
MH  - Dose-Response Relationship, Drug
MH  - Drug Interactions
MH  - Drug Monitoring
MH  - Female
MH  - Germany
MH  - Heart Failure/blood/*drug therapy/epidemiology
MH  - Humans
MH  - Incidence
MH  - Male
MH  - Middle Aged
MH  - Patient Admission/*statistics & numerical data
EDAT- 2007/08/19 09:00
MHDA- 2007/12/06 09:00
CRDT- 2007/08/19 09:00
PHST- 2007/02/19 00:00 [received]
PHST- 2007/05/18 00:00 [accepted]
PHST- 2007/08/19 09:00 [pubmed]
PHST- 2007/12/06 09:00 [medline]
PHST- 2007/08/19 09:00 [entrez]
AID - 10.1007/s00063-007-1064-x [doi]
PST - ppublish
SO  - Med Klin (Munich). 2007 Aug 15;102(8):603-11. doi: 10.1007/s00063-007-1064-x.