15 results match your criteria: "Japan Institute of Pharmacovigilance[Affiliation]"
BMJ
April 2022
NPO Japan Institute of Pharmacovigilance, Tennoji-ku, Osaka, Japan 543-0043.
Expert Rev Clin Pharmacol
December 2020
Verandastigen 3, Rönninge, Sweden.
: The European Society of Cardiology and European Atherosclerosis Society (ESC/EAS) have recently published three major revisions of their guidelines for the management of chronic heart disease, blood lipids, and diabetes. : We have scrutinized these guidelines in detail and found that the authors have ignored many studies that are in conflict with their conclusions and recommendations. : The authors of the guidelines have ignored that LDL-cholesterol (LDL-C) of patients with acute myocardial infarction is lower than normal; that high cholesterol is not a risk factor for diabetics; that the degree of coronary artery calcification is not associated with LDL-C; and that 27 follow-up studies have shown that people with high total cholesterol or LDL-C live just as long or longer than people with low cholesterol.
View Article and Find Full Text PDFN Engl J Med
January 2020
Japan Institute of Pharmacovigilance, Osaka, Japan.
Expert Rev Clin Pharmacol
February 2019
p Odenvägen 44B , Lidingö , Sweden.
Expert Rev Clin Pharmacol
October 2018
q Independent Researcher , Lidingö , Sweden.
For half a century, a high level of total cholesterol (TC) or low-density lipoprotein cholesterol (LDL-C) has been considered to be the major cause of atherosclerosis and cardiovascular disease (CVD), and statin treatment has been widely promoted for cardiovascular prevention. However, there is an increasing understanding that the mechanisms are more complicated and that statin treatment, in particular when used as primary prevention, is of doubtful benefit. Areas covered: The authors of three large reviews recently published by statin advocates have attempted to validate the current dogma.
View Article and Find Full Text PDFActa Neurol Scand
February 2017
Center for Medication Safety and Efficacy, University of South Carolina, College of Pharmacy Member, Hollings National Cancer Institute, Center for Medication Safety and Efficacy, University of South Carolina, Hollings National Cancer Institute, Medical University of South Carolina, Columbia and Charleston, SC, USA.
Oseltamivir is contraindicated for people aged 10-19 in principle in Japan, due to concern about abnormal behaviours. Sudden death is another concern. This review examines growing evidence of their association and discusses underlying mechanisms of these sudden-onset type reactions to oseltamivir.
View Article and Find Full Text PDFBMJ Open
June 2016
Slottsstadens Läkarhus, Malmö, Gothenburg, Sweden.
Objective: It is well known that total cholesterol becomes less of a risk factor or not at all for all-cause and cardiovascular (CV) mortality with increasing age, but as little is known as to whether low-density lipoprotein cholesterol (LDL-C), one component of total cholesterol, is associated with mortality in the elderly, we decided to investigate this issue.
Setting, Participants And Outcome Measures: We sought PubMed for cohort studies, where LDL-C had been investigated as a risk factor for all-cause and/or CV mortality in individuals ≥60 years from the general population.
Results: We identified 19 cohort studies including 30 cohorts with a total of 68 094 elderly people, where all-cause mortality was recorded in 28 cohorts and CV mortality in 9 cohorts.
Infect Dis (Lond)
September 2016
a Non-Profit Organization, Japan Institute of Pharmacovigilance, Osaka , Japan.
Oseltamivir is recommended for the treatment and prophylaxis of influenza in persons at higher risk for influenza complications such as individuals with diabetes, neuropsychiatric illnesses, and respiratory, cardiac, renal, hepatic or haematological diseases. However, a recent Cochrane review reported that reduction of antibody production, renal disorders, hyperglycaemia, psychiatric disorders, and QT prolongation may be related to oseltamivir use. The underlying mechanisms are reviewed.
View Article and Find Full Text PDFHealth Technol Assess
May 2016
The Cochrane Collaboration, Rome, Italy.
Background: Neuraminidase inhibitors (NIs) are stockpiled and recommended by public health agencies for treating and preventing seasonal and pandemic influenza. They are used clinically worldwide.
Objectives: To (1) describe the potential benefits and harms of NIs for influenza in all age groups by reviewing all clinical study reports (CSRs) of published and unpublished randomised, placebo-controlled trials and regulatory comments; and (2) determine the effect of oseltamivir (Tamiflu(®), Roche) treatment on mortality in patients with 2009A/H1N1 influenza.
Lancet
September 2015
Centre for Research in Evidence-Based Practice (CREBP), Bond University, Gold Coast, Australia.
Drug Healthc Patient Saf
April 2015
Japan Institute of Pharmacovigilance, Osaka, Japan.
Background: Topical corticosteroid (TCS) treatment is widely prescribed for atopic dermatitis (AD). However, TCS treatment is associated with tachyphylaxis, and discontinuation after long-term use may cause exacerbation of symptoms. Some AD patients are reluctant to use TCS.
View Article and Find Full Text PDFLancet
October 2014
Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
BMJ Open
September 2014
Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
Background: The Cochrane risk of bias tool is a prominent instrument used to evaluate potential biases in clinical trials. In three updates of our Cochrane review on neuraminidase inhibitors, we assessed risk of bias on the same trials using different levels of detail: the trials in journal publications, in core reports, and in full clinical study reports. Here we analyse whether progressively greater amounts of information and detail in full clinical study reports (including trial protocols, statistical analysis plans, certificates of analyses, individual participant data listings and randomisation lists) affected our risk of bias assessments.
View Article and Find Full Text PDFInt J Risk Saf Med
October 2012
Non-profit Organization Japan Institute of Pharmacovigilance (Kusuri-no-Check), Osaka, Japan.
Objective: To examine the epidemiological association between sudden deterioration leading to death and Tamiflu use.
Design: Proportional mortality study.
Setting: Japan.