Current antiplatelet options for NSTE-ACS patients. (33/105)

Non-ST elevation (NSTE) myocardial infarction and unstable angina are the most common clinical presentations of acute coronary syndrome (ACS). Platelet activation is central to the pathogenesis of NSTE-ACS and consensus guidelines that advocate early revascularization supported by intensive antiplatelet therapy. This review examines the drugs used concurrently with aspirin as dual antiplatelet therapy in the NSTE-ACS setting. Clopidogrel represented an important therapeutic advance. However, variations in platelet response and a relatively slow onset of action compromise outcomes with clopidogrel. Evidence reviewed in this article shows that in NSTE-ACS patients, ticagrelor and prasugrel are more effective than clopidogrel and are relatively well tolerated, with an acceptable and manageable bleeding risk. The literature suggests several differences between ticagrelor and prasugrel that should allow clinicians to better tailor treatment to the patient. Head-to-head comparisons are now needed to compare directly the risks and benefits of ticagrelor and prasugrel in NSTE-ACS. Further studies also need to address other outstanding issues such as the benefits and risks of prasugrel pre-treatment and to stratify efficacy and tolerability according to diabetes mellitus (DM) and other co-morbidities. In the meantime, the issues discussed in this review should enhance clinicians' ability to optimize and individualize NSTE-ACS treatment, thereby further reducing the morbidity and mortality associated with this common cardiovascular condition.  (+info)

Novel data-mining methodologies for adverse drug event discovery and analysis. (34/105)

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Monitoring medicines use: the role of the clinical pharmacologist. (35/105)

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A pharmacovigilance study of adults on highly active antiretroviral therapy, South Africa: 2007 - 2011. (36/105)

BACKGROUND: Of the 1.6 million South African people infected with human immunodeficiency virus (HIV), approximately 970,000 (55%) have been initiated on HAART. Despite these numbers, very little has been published about the safety profile of antiretroviral (ARV) medicines in the country. This study was performed at the Medunsa National Pharmacovigilance Centre and aimed to describe the demographic characteristics of patients enrolled in the pharmacovigilance surveillance study; highly active antiretroviral therapy (HAART) initiation regimen patterns; reasons for regimen changes; and adverse effects of ARV medicines. METHODS: A cohort study of HIV-infected individuals aged 15 years or older who were on ARV medicines was conducted at four sentinel sites. RESULTS: After HAART initiation, with an average lapse of 17.8 months (range: 0 - 83.8 months), 2,815 patients were enrolled into the study. Results show that patients were observed for 1,606.2 person-years for pharmacy visits (collection of ARV medicines) and 817.1 person-years for clinical visits (consultation with the doctor). Females constituted 69.6% (1,958/2,815) of the study population. Almost all patients initiated HAART on first-line regimens (2,801/2,815). Some patients (6.7%, 190/2,815) dropped out of the study after HAART initiation. Reasons for regimen changes were not recorded for 2.5% (22/891) of the patients who changed regimens. The primary reason for regimen changes was drug-related toxicity (76.1%, 678/891), mostly evident in patients taking first-line regimens. Adverse effects experienced by patients were polyneuropathy (24.0%, 163/678); lipodystrophy (23.9%, 162/678); neuropathy (10.6%, 72/678); and suspected lactic acidosis (3.8%, 26/678). CONCLUSION: The majority of prescribers complied with the HAART guidelines and initiated most patients on first-line regimens. However, adverse effects are evident in patients taking first-line regimens. We recommend that the Department of Health should introduce less toxic first-line ARV regimens. Future efforts will aim to initiate patients on HAART and enrol them into the study simultaneously to determine early risk profiles of ARV medicines.  (+info)

Novel approach to utilizing electronic health records for dermatologic research: developing a multi-institutional federated data network for clinical and translational research in psoriasis and psoriatic arthritis. (37/105)

The implementation of Electronic Health Records (EHR) in the United States has created new opportunities for research using automated data extraction methods. A large amount of information from the EHR can be utilized for clinical and translational research. To date, a number of institutions have the capability of extracting clinical data from EHR to create local repositories of de-identified data amenable to research queries through the Informatics for Integrated Biology and the Bedside (i2b2) platform. Collaborations among institutions sharing a common i2b2 platform hold exciting opportunities for research in psoriasis and psoriatic arthritis. With the automated extraction of patient-level data from multiple institutions, this novel informatics network has the ability to address high-priority research questions. With commitment to high-quality data through applied algorithms for cohort identification and validation of outcomes, the creation of Psoriasis and Psoriatic Arthritis Integrated Research Data Network (PIONEER) will make a significant contribution to psoriasis and psoriatic arthritis research.  (+info)

Drug-drug interaction through molecular structure similarity analysis. (38/105)

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[Risk communication efforts regarding drug safety in the US and EU, and Japan]. (39/105)

In pharmacovigilance, it has been recognized that it is essential to share the information regarding the risk of drugs among stakeholders and to have risk communication (RC) which enables consumers to make their own judgments regarding the risk. In particular, RC between the governmental agencies and consumers is given a high priority. Hence, its provisions and initiatives should be considered thoroughly. I present a brief overview of current proactive approaches for RC to protect the patient's rights, to increase openness and transparency and to share information in the US and EU. Following the Food and Drug Administration Amendment Act (FDAAA), Institute of Medicine of the National Academies (IOM) recommended that FDA makes efforts for RC. The RC Advisory Committee was established and consumers are involved as its members. FDA published "Guidance Drug Safety Information" in 2007 and "Strategic Plan for RC" in 2009. Thus, its framework has been developed. European Medicines Agency (EMA) issued "Work programme 2010" and "EMA Communication on safety related issues", which indicated its policies and measures. EMA is promoting development of the framework for Patient Involvement (e.g., members of scientific committees). Regarding the direct patient reporting of adverse drug reactions, FDA began that in 2003 and EMA recommends to encourage it for EU Member States, and it has already started in some countries. RC has important roles to take safety measures for drugs and to protect patient's rights, therefore such an approach for it be implemented is expected in Japan.  (+info)

Detection of pharmacovigilance-related adverse events using electronic health records and automated methods. (40/105)

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