PMID- 16507378
OWN - NLM
STAT- MEDLINE
DCOM- 20060411
LR  - 20091103
IS  - 0149-2918 (Print)
IS  - 0149-2918 (Linking)
VI  - 27
IP  - 12
DP  - 2005 Dec
TI  - Comparison of digitalis-related adverse events in hospitalized men and women in 
      Italy: an observational study.
PG  - 1922-9
AB  - BACKGROUND: A higher mortality rate in women than in men treated with digitalis 
      has been described. We hypothesized that this result could be due in part to an 
      increased susceptibility of women to adverse events (AEs) from digitalis. 
      OBJECTIVE: The aim of this study was to compare the incidence of AEs related to 
      digitalis in women and men. METHODS: This was an observational study conducted in 
      geriatrics and internal medicine acute-care wards located throughout Italy. We 
      used the data of the Gruppo Italiano di Farmacoepidemiologia nell'Anziano 
      (Italian Group of Pharmacoepidemiology in the Elderly), a collaborative study 
      group on drug use and adverse drug reactions in hospitalized adults that 
      performed 6 different surveys between 1988 and 1998. Adults who were taking 
      digitalis at the time of admission or during the hospital stay were studied, with 
      no other inclusion or exclusion criteria. The proportion of AEs to digitalis 
      diagnosed at the time of admission or during the hospital stay was compared in 
      men and women. Information on AEs was collected using a structured questionnaire 
      at admission and during the hospital stay. A logistic regression model was used 
      to evaluate the association between sex and AE(s) to digitalis, corrected for 
      potential confounding variables. RESULTS: The total sample size was 9626 
      patients. Women received a higher weight-adjusted dose of digitalis compared with 
      men (0.0027 mg/kg per day vs 0.0025 mg/kg per day; P < 0.001). Overall, 199 AEs 
      to digitalis were diagnosed. Women were more likely than men to suffer from an AE 
      to digitalis (odds ratio, 1.51; 95% CI, 1.12-2.02). This finding was confirmed 
      after correction for dose of digitalis, age, physical and cognitive impairment, 
      atrial fibrillation, chronic obstructive pulmonary disease, glomerular filtration 
      rate, and use of amiodarone, beta-blockers, nondihydropyridine calcium channel 
      blockers, and potassium-sparing diuretics (odds ratio, 1.58; 95% CI, 1.01-2.48). 
      CONCLUSIONS: In this sample of hospitalized adults in Italy, we found a higher 
      incidence of AEs to digitalis in women than in men.
FAU - Pedone, Claudio
AU  - Pedone C
AD  - Cattedra di Geriatria, Universita Campus Bio-Medico, Rome, Italy. 
      c.pedone@unicampus.it
FAU - Corsonello, Andrea
AU  - Corsonello A
FAU - Carosella, Luciana
AU  - Carosella L
FAU - Antonelli-Incalzi, Raffaele
AU  - Antonelli-Incalzi R
CN  - GIFA Investigators
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Clin Ther
JT  - Clinical therapeutics
JID - 7706726
RN  - 0 (Cardiotonic Agents)
RN  - 0 (Digitalis Glycosides)
SB  - IM
MH  - Aged
MH  - Cardiotonic Agents/administration & dosage/*adverse effects
MH  - Digitalis Glycosides/administration & dosage/*adverse effects
MH  - Dose-Response Relationship, Drug
MH  - Female
MH  - Health Surveys
MH  - Hospitalization
MH  - Humans
MH  - Italy
MH  - Logistic Models
MH  - Male
MH  - Sex Factors
EDAT- 2006/03/02 09:00
MHDA- 2006/04/12 09:00
CRDT- 2006/03/02 09:00
PHST- 2005/10/19 00:00 [accepted]
PHST- 2006/03/02 09:00 [pubmed]
PHST- 2006/04/12 09:00 [medline]
PHST- 2006/03/02 09:00 [entrez]
AID - S0149-2918(05)00321-8 [pii]
AID - 10.1016/j.clinthera.2005.12.009 [doi]
PST - ppublish
SO  - Clin Ther. 2005 Dec;27(12):1922-9. doi: 10.1016/j.clinthera.2005.12.009.