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1.  Value of preapproval safety data in predicting postapproval hepatic safety and assessing the legitimacy of class warning 
Objective: The objective of this study was to systematically evaluate whether preapproval safety data for nonhepatotoxic drugs and hepatotoxic drugs can be compared to improve preapproval prediction of postapproval hepatic safety and to assess the legitimacy of applying class warnings.
Methods: Drugs within a therapeutic class that included at least one drug that had been withdrawn from the market because of liver toxicity or had a warning of potential liver toxicity issued by major regulatory agencies, and at least one drug free from such regulatory action, were identified and divided into two groups: drugs with and drugs without regulatory action. Preapproval clinical data [including the elevation rates of alanine aminotransferse (ALT) and withdrawal due to liver toxicity, the number of patients with combined elevation of ALT and bilirubin, and liver failure] and nonclinical data (including chemical structures, metabolic pathways, and other significant findings in animal studies) were compared between the two groups.
Results: Six drug classes were assessed in this study: thiazolidinediones, cyclooxygenase-2 inhibitors, fluoroquinolones, catechol-O-methyltransferase (COMT) inhibitors, leukotriene receptor inhibitors, and endothelin receptor antagonists. In two classes (COMT inhibitors and endothelin receptor antagonists), drugs with regulatory action had significantly higher rates of ALT elevation of more than threefold and greater numbers of patients with combined elevation of ALT and bilirubin than drugs without regulatory action. Drugs with regulatory action also had chemical structures or metabolic pathways associated with the toxicity. The legitimacy of class warnings was refuted in all six classes of drugs.
Conclusion: Preapproval safety data may help predict postapproval hepatic safety and can be used to assess the legitimacy of applying class warnings.
PMCID: PMC4110826  PMID: 25083222
class; liver toxicity; postapproval; preapproval; prediction
2.  Duration of dual antiplatelet therapy following percutaneous coronary intervention on re-hospitalization for acute coronary syndrome 
The optimal duration of dual antiplatelet therapy after percutaneous coronary intervention (PCI) remains uncertain. The objective of this study was to examine the association between duration of dual antiplatelet therapy and re-hospitalization for acute coronary syndrome (ACS) in ACS patients who underwent PCI.
We identified 975 newly diagnosed ACS patients who underwent PCI between July, 2007 and June, 2009, at a medical center in Taiwan. Cox proportional hazard models were used to examine the association between duration of dual antiplatelet therapy (9 months, 12 months and 15 months) and risks of re-hospitalization for ACS.
At a mean follow-up of 2.3 years, we found that use of clopidogrel for ≥ 12 months was associated with a decreased risk of re-hospitalization for ACS (adjusted HR 0.59, 95% CI 0.36-0.95; p = 0.03). However, use of clopidogrel for ≥ 15 months was not associated with a decreased risk of re-hospitalization for ACS (adjusted HR 0.57, 95% CI 0.29-1.13; p = 0.11). Similar results were found in patients who implanted drug-eluting stents (DES), for whom at least 12 months of clopidogrel therapy is especially critical.
The benefit of ≥ 12 months of clopidogrel use in reducing the risk of re-hospitalization for ACS was significant among ACS patients who underwent PCI and was especially critical for those who implanted DES.
PMCID: PMC3974105  PMID: 24533683
Acute coronary syndrome (ACS); Percutaneous coronary intervention (PCI); Clopidogrel; Dual antiplatelet therapy; Drug eluting stent (DES)
3.  Science of Safety Topic Coverage in Experiential Education in US and Taiwan Colleges and Schools of Pharmacy 
Objective. To compare the science of safety (SoS) topic coverage and associated student competencies in the experiential education curricula of colleges and schools of pharmacy in the United States and Taiwan.
Methods. The experiential education director, assistant director, or coordinator at a random sample of 34 US colleges and schools of pharmacy and all 7 Taiwan schools of pharmacy were interviewed and then asked to complete an Internet-based survey instrument.
Results. Faculty members in both countries perceived that experiential curricula were focused on the postmarketing phase of the SoS, and that there is a need for the pharmacy experiential curricula to be standardized in order to fill SoS coverage gaps. Inter-country differences in experiential SoS coverage were noted in topics included for safety biomarkers that signal potential for drug-induced problems and pharmacogenomics.
Conclusions. Experiential SoS topic coverage and student ability gaps were perceived within and between US and Taiwan colleges and schools of pharmacy.
PMCID: PMC3279028  PMID: 22345721
science of safety; experiential education; survey research; international

Results 1-3 (3)