2010; Volume 1; Issue 2 (May - August)
Editorial: In this issue: PK of posaconazole, aspirin resistance, psychotropic medications in Spain and J
Clin Pharmacol Pharmacoepidemiol 2010; 1 (2): 27-28

Alejandro A. NAVA-OCAMPO(a,b)
(a)PharmaReasons, Toronto, Canada
(b)Department of Pharmacology & Toxicology, Faculty of Medicine, University of Toronto, Toronto, Canada
Correspondence: editor.jccpe@premiumreasons.com
REVIEW ARTICLE: Pharmacokinetic profile of the antifungal agent posaconazole
J Clin Pharmacol Pharmacoepidemiol 2010; 1 (2): 29-38

Dominique LEVEQUE(a,b*), Yasmine NIVOIX(a), François JEHL(b), Geneviève UBEAUD-SEQUIER(a),
(a)Pharmacy-Pharmacology, Hôpital Hautepierre, (b)Institute of Bacteriology,  and (c)Department of
Oncology and Hematology, Hôpital Hautepierre; Strasbourg, France
*Corresponding author: dominique.leveque@chru-strasbourg.fr

Posaconazole is a recent triazole antifungal agent currently available in an oral suspension. It is approved
in the treatment of various refractory invasive fungal dis-eases and for prophylaxis in high-risk patients.
This review presents the published clinical pharmacokinetic data of posaconazole. Aspects regarding
absorption, distribution, elimination, and pharmacokinetic interactions are also discussed.
REVIEW ARTICLE: Aspirin resistance: a nebulous concept
J Clin Pharmacol Pharmacoepidemiol 2010; 1 (2): 39-47

Dermot COX
Molecular and Cellular Therapeutics, Royal College of Surgeons in Ireland, Dublin, Ireland
Corresponding author: dcox@rcsi.ie

Recently there has been great interest regarding aspirin resistance in both the scientific and lay media,
yet it has proven to be a nebulous concept. The lack of an approved assay makes it difficult to agree on a
definition of aspirin resistance. Not only can we not define aspirin resistance, we cannot identify the
cause. There are three types of aspirin non-response: treatment failure, and pharmacokinetic and
pharmacodynamic resistance. Treatment failure is when a clinical event occurs despite aspirin therapy
and is due to a COX-independent process. Pharmacokinetic resistance occurs when the patient does not
receive adequate exposure to the drug and is due to many factors including non-compliance, inadequate
dosing, poor bioavailability of some preparations, and drug interaction with NSAID’s. Pharmacodynamic
resistance is defined as not being treatment failure or pharmacokinetic resistance and is the only true
aspirin resistance. However, it would appear to be rare and to have multiple causes that may be patient-
dependent. Whatever its cause or how it is identified, aspirin non-response is associated with poor
outcome. This paper reviews the types of aspirin non-response, the methods for detection, the causes of
aspirin non-response, and the clinical consequences.
ORIGINAL RESEARCH: Psychotropic medication consumption in Spain: influence of gender and
perception of health status
J Clin Pharmacol Pharmacoepidemiol 2010; 1 (2): 48-57

(a)Unit of Preventive Medicine and Public Health, Universidad Rey Juan Carlos, and (b)Department of
Preventive Medicine, Public Health & History Science, Faculty of Medicine, Universidad Complutense;
Madrid, Spain
*Corresponding author: pilar.carrasco@urjc.es

This study aimed to identify the factors associated with psychotropic medication
consumption in the Spanish adult population.
Methods: Descriptive, cross-sectional study covering the
Spanish adult population aged 16 years and over, using data drawn from the 2001 Spanish National
Health Survey. A total of 21,067 interviews were analyzed. The independent variables were
socio-demographic and health-related, and the dependent variable was total consumption of
psychotropic medication. To estimate the effect of each of the independent variables on consumption of
such medications, we also obtained the corresponding Odds Ratio (ORs) adjusted by means of a
significantly higher in women than in men (11.5% vs. 5.0%; P <0.001). Multivariate analysis, based on
logistic regression, showed an association between increased psychoactive drug intake and age.
Anxiety, depressive and sleep disorders displayed a strong association with consumption of
psychoactive drugs across the sexes, as did negative perception of health and medical visits.
Conclusions: In Spain, the prevalence of psychoactive drug consumption is higher in women than in
men, and increases with age and negative perception of health outcomes.
ORIGINAL RESEARCH: No association between inadvertent exposure to ribostamycin during early
pregnancy and fetal ototoxicity
J Clin Pharmacol Pharmacoepidemiol 2010; 1 (2): 58-61

Si Won LEE(a,b), Jung Yeol HAN(a,b,*), Hyun Jung LEE(a,b), June Seek CHOI(a,b), Hyun Kyong AHN(a,
b), Min Hyoung KIM(b), Hyun Mee RYU(b), Alejandro A. NAVA-OCAMPO(c,d,e), Gideon KOREN(c)
(a)The Korean Motherisk Program, (b)Department of Obstetrics and Gynecology, Cheil General Hospital
& Women’s Healthcare Center, Kwandong University College of Medicine, Seoul, South Korea; (c)The
Motherisk Program, Hospital for Sick Children, (d)Department of Pharmacology & Toxicology, University
of Toronto, and (e)PharmaReasons, Toronto, Canada
*Corresponding author: hanjungyeol@yahoo.com

Our goal was to evaluate a potential association between exposure to ribostamycin in early
pregnancy and ototoxicity in the offspring.
Methods: In a prospective cohort study, 85 women
inadvertently exposed to ribostamycin during the first trimester of pregnancy and 170 age- and gravidity-
matched control women, were voluntarily enrolled. Newborns were clinically examined at birth by a
neonatologist and by imaging studies if any suspicious abnormalities were noted. Hearing was assessed
directly by auditory brainstem response.
Results: No newborn had neonatal ototoxicity in the exposed
group (0/70) whereas 1/160 (0.6%) had evidence of ototoxicity in the control group (P =0.5).
Exposure to ribostamycin during the first-trimester of pregnancy does not appear to be associated with
the inner ear was not yet developed, our findings may be valuable when counseling women inadvertently
exposed to this aminoglycoside in early pregnancy.
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