The choice of pharmacoeconomic study design during drug development--part 2.

abstract：PURPOSE:We aim to derive an internationally applicable data set to improve prescription safety of psychiatric drugs. METHODS:We performed an in-depth analysis of the concordance of prescribing information of 10 key psychiatric drugs across four major drug markets with regard to indications, warnings and precautions, a...

journal_title：Pharmacoepidemiology and drug safety

authors： Pfistermeister B,Schenk C,Kornhuber J,Bürkle T,Fromm MF,Maas R

更新日期：2013-03-01 00:00:00

abstract：PURPOSE:Determination of the incidence rate of diabetic ketoacidosis (DKA) in type 2 diabetes mellitus (T2DM) is urgent, in response to the safety issue with use of the glucose lowering drugs, sodium-glucose cotransporter-2 inhibitors, and DKA. METHODS:We extracted data of adult patients with T2DM from a medical claim...

journal_title：Pharmacoepidemiology and drug safety

authors： Takeuchi M,Kawamura T,Sato I,Kawakami K

更新日期：2018-01-01 00:00:00

abstract：:Not everything is known about a medicine when it receives its licence for marketing. The merits of a new drug, balancing its beneficial and its untoward effects, become only established after sufficient experience has been gained from its use in real practice. Part of the reason for this is that our extensive phase II...

journal_title：Pharmacoepidemiology and drug safety

authors： Amery WK,ISPE.

更新日期：1999-01-01 00:00:00

abstract：PURPOSE:In post-marketing drug safety surveillance, data mining can potentially detect rare but serious adverse events. Assessing an entire collection of drug-event pairs is traditionally performed on a predefined level of granularity. It is unknown a priori whether a drug causes a very specific or a set of related adv...

journal_title：Pharmacoepidemiology and drug safety

authors： Kulldorff M,Dashevsky I,Avery TR,Chan AK,Davis RL,Graham D,Platt R,Andrade SE,Boudreau D,Gunter MJ,Herrinton LJ,Pawloski PA,Raebel MA,Roblin D,Brown JS

更新日期：2013-05-01 00:00:00

abstract：PURPOSE:Chronic kidney disease (CKD) is a prevalent and important outcome and covariate in pharmacoepidemiology. The Health Improvement Network (THIN) in the UK represents a unique resource for population-based studies of CKD. We compiled a valid list of Read codes to identify subjects with moderate to advanced CKD. M...

journal_title：Pharmacoepidemiology and drug safety

authors： Denburg MR,Haynes K,Shults J,Lewis JD,Leonard MB

更新日期：2011-11-01 00:00:00

abstract：PURPOSE:Observational pharmacoepidemiological studies can provide valuable information on the effectiveness or safety of interventions in the real world, but one major challenge is the existence of unmeasured confounder(s). While many analytical methods have been developed for dealing with this challenge, they appear u...

journal_title：Pharmacoepidemiology and drug safety

authors： Zhang X,Faries DE,Li H,Stamey JD,Imbens GW

更新日期：2018-04-01 00:00:00

abstract：:The following article from Pharmacoepidemiology and Drug Safety, “Epidemiological evaluation of intraoperative antibiosis as a protective agent against endophthalmitis after cataract surgery” by F. Krummenauer, S. Kurz and H.B. Dick, published online on July 11 2006 inWiley Online Library (wileyonlinelibrary.com), has...

journal_title：Pharmacoepidemiology and drug safety

authors：

更新日期：2013-02-01 00:00:00

abstract：AIM:The aim of the present study was to investigate to what extent patients using prescription antiobesity drugs (orlistat, sibutramine and rimonabant) concomitantly or concurrently used psychotropic drugs and analgesics and the association between this drug use and the patients' gender and age. An additional aim was t...

journal_title：Pharmacoepidemiology and drug safety

authors： Amundsen MO,Engdahl B,Berg C,Nordeng H

更新日期：2010-03-01 00:00:00

abstract：PURPOSE:To describe a bias that can occur in the analysis of data from certain randomized trials. METHODS AND RESULTS:Although randomized trials are effective at preventing confounding, a potentially strong confounding can arise in certain therapeutic drug trials in which follow-up is extended in an open-label phase t...

journal_title：Pharmacoepidemiology and drug safety

authors： Rothman KJ

更新日期：2004-05-01 00:00:00

abstract：PURPOSE:This study aimed to examine the effect of antidepressant use on persistence with newly initiated oral antidiabetic medicines in older people. METHODS:A retrospective study of administrative claims data from the Australian Government Department of Veterans' Affairs, from 1 July 2000 to 30 June 2008 of new users...

journal_title：Pharmacoepidemiology and drug safety

authors： Caughey GE,Preiss AK,Vitry AI,Gilbert AL,Ryan P,Shakib S,Esterman A,McDermott RA,Roughead EE

更新日期：2013-06-01 00:00:00

abstract：PURPOSE:This study aims to examine the associations between proton pump inhibitors (PPIs), traditional nonsteroidal anti-inflammatory drugs (tNSAIDs), PPI + tNSAID co-exposure, and the development of the following: (i) acute interstitial nephritis (AIN), a specific kidney injury often attributed to these drugs, and (ii...

journal_title：Pharmacoepidemiology and drug safety

authors： Leonard CE,Freeman CP,Newcomb CW,Reese PP,Herlim M,Bilker WB,Hennessy S,Strom BL

更新日期：2012-11-01 00:00:00

abstract：:Sixteen pathologically confirmed and 14 suspected cases of a new disease entity, fibrosing colonopathy, have been described in the UK and the US in children with cystic fibrosis since 1991. The patterns of use of pancreatic enzyme supplements in cases were compared with use in controls and in the market, in the 2 year...

journal_title：Pharmacoepidemiology and drug safety

authors： Bakowski MT,Prescott P

更新日期：1997-09-01 00:00:00

abstract：PURPOSE:Gut microbiota has been postulated to serve as a significant promoter of CRC formation, and colonic dysbiosis was previously reported in CRC tissue. Our aim was to evaluate the association between the type and cumulative duration of antibiotic exposure and CRC risk. METHODS:We conducted a nested case-control s...

journal_title：Pharmacoepidemiology and drug safety

authors： Boursi B,Haynes K,Mamtani R,Yang YX

更新日期：2015-05-01 00:00:00

abstract：OBJECTIVE:This study describes the use of psychotropic drugs in a sample of eight Italian psychiatric hospitals. METHODS:A cross-sectional approach was used to collect information about sociodemographic and clinical characteristics of the inpatient population, and about medications prescribed. Prescribing behaviour in...

journal_title：Pharmacoepidemiology and drug safety

authors： Barbui C,D'Avanzo B,Frattura L,Saraceno B

更新日期：1999-08-01 00:00:00

abstract：PURPOSE:Bayesian hierarchical models (BHMs) have been used to identify adverse drug reactions, allowing information sharing amongst adverse reactions and drugs expected to have similar properties. This study evaluated the use of BHMs in the routine signal detection analyses of potential first-trimester teratogens, wher...

journal_title：Pharmacoepidemiology and drug safety

authors： Cavadino A,Prieto-Merino D,Morris JK

更新日期：2020-03-01 00:00:00

abstract：PURPOSE:This paper aimed to systematically review algorithms to identify transfusion-related ABO incompatibility reactions in administrative data, with a focus on studies that have examined the validity of the algorithms. METHODS:A literature search was conducted using PubMed, Iowa Drug Information Service database, a...

journal_title：Pharmacoepidemiology and drug safety

authors： Carnahan RM,Kee VR

更新日期：2012-01-01 00:00:00

abstract：:Recent studies have shown that modern (third generation), oral contraceptives (OC) are associated with an increased incidence of venous thromboembolic disease compared to older (second generation), OC. It is not known, however, whether this association is also true for arterial thrombosis, in particular myocardial inf...

journal_title：Pharmacoepidemiology and drug safety

authors： Dunn NR,Thorogood M,de Caestecker L,Mann RD

更新日期：1997-07-01 00:00:00

abstract：PURPOSE:This study aimed to describe incidence, risk factors, and outcomes of warfarin-associated major bleeding (WAMB) in Thai patients. METHOD:A nested case-control study was conducted in a cohort of adult patients receiving ≥6 months of warfarin therapy who were prospectively followed up at a tertiary care hospital...

journal_title：Pharmacoepidemiology and drug safety

authors： Priksri W,Rattanavipanon W,Saejear W,Tanyasaensook K,Phrommintikul A,Chulavatnatol S,Nathisuwan S

更新日期：2019-07-01 00:00:00

abstract：PURPOSE:The General Practice Research Database (GPRD) is a database of longitudinal patient records from general practices in the United Kingdom. It is an important data source for pharmacoepidemiology studies, but until now it has been tedious to calculate the daily dose and duration of exposure to drugs prescribed. T...

journal_title：Pharmacoepidemiology and drug safety

authors： Shah AD,Martinez C

更新日期：2006-03-01 00:00:00

abstract：BACKGROUND:Deferasirox (DFX) is an effective and well-tolerated oral iron chelator elevating the adherence to iron chelating therapy among patients with iron overload. However, the US Food and Drug Administration issued a warning about the potential adverse events associated with DFX in 2010. METHODS:To examine the ri...

journal_title：Pharmacoepidemiology and drug safety

authors： Huang WF,Chou HC,Tsai YW,Hsiao FY

更新日期：2014-11-01 00:00:00

abstract：PURPOSE:This study mainly aimed at describing the prevalence of psychotropic medication consumption in the Spanish elderly population between the years 1993 and 2003. METHODS:Descriptive, cross-sectional study covering the Spanish population aged 65 years and over, using data drawn from the 1993 and 2003 Spanish Natio...

journal_title：Pharmacoepidemiology and drug safety

authors： Carrasco-Garrido P,Jiménez-García R,Astasio-Arbiza P,Ortega-Molina P,de Miguel AG

更新日期：2007-04-01 00:00:00

abstract：PURPOSE:To explore associations between preterm birth and use of medications in young adulthood as a proxy for different diseases. METHODS:We linked data on birth characteristics from the Medical Birth Registry of Norway (1967-1999) and the Norwegian Prescription Database (2004-2015). Individuals born as singletons du...

journal_title：Pharmacoepidemiology and drug safety

authors： Engeland A,Bjørge T,Klungsøyr K,Skurtveit S,Furu K

更新日期：2017-07-01 00:00:00

abstract：BACKGROUND:Following approval in the EU in 2002 and the USA in 2003, an Intensive Safety Surveillance Scheme (IS(3) ) was initiated to educate prescribers on the appropriate use of miglustat for the treatment of type I Gaucher disease (GD1), and to actively solicit safety-relevant information. This report summarises da...

journal_title：Pharmacoepidemiology and drug safety

authors： Brand M,Muller A,Alsop J,van Schaik IN,Bembi B,Hughes D

更新日期：2015-03-01 00:00:00

abstract：PURPOSE:Active surveillance of population-based health networks may improve the timeliness of detection of adverse drug events (ADEs). Active monitoring requires sequential analysis methods. Our objectives were to (1) evaluate the utility of automated healthcare claims data for near real-time drug adverse event surveil...

journal_title：Pharmacoepidemiology and drug safety

authors： Brown JS,Kulldorff M,Chan KA,Davis RL,Graham D,Pettus PT,Andrade SE,Raebel MA,Herrinton L,Roblin D,Boudreau D,Smith D,Gurwitz JH,Gunter MJ,Platt R

更新日期：2007-12-01 00:00:00

abstract：PURPOSE:To evaluate the concurrent validity of three European sets of drug-specific indicators of prescribing quality METHODS:In 200 hip fracture patients (≥65 years), consecutively recruited to a randomized controlled study in Sahlgrenska University Hospital in 2009, quality of drug treatment at study entry was asses...

journal_title：Pharmacoepidemiology and drug safety

authors： Wallerstedt SM,Belfrage B,Fastbom J

更新日期：2015-09-01 00:00:00

abstract：PURPOSE:Drug induced Torsades de Pointes (TdP) is a major concern for new drugs seeking regulatory approval. Prolongation of QT intervals greater than 60 millisecond or to longer than 500 millisecond in an individual patient has been considered to be associated with a higher risk. The purpose of this study is to identi...

journal_title：Pharmacoepidemiology and drug safety

authors： Lin YL,Kung MF

更新日期：2009-03-01 00:00:00

abstract：PURPOSE:To conduct a synthesis of the literature on methods to evaluate the impacts of FDA regulatory actions and identify best practices for future evaluations. METHODS:We searched MEDLINE for manuscripts published between January 1948 and August 2011 that included terms related to FDA, regulatory actions, and empiri...

journal_title：Pharmacoepidemiology and drug safety

authors： Briesacher BA,Soumerai SB,Zhang F,Toh S,Andrade SE,Wagner JL,Shoaibi A,Gurwitz JH

更新日期：2013-09-01 00:00:00

abstract：PURPOSE:The aim of this study was to examine trends in potentially inappropriate medication (PIM) prescribing in Norwegian nursing homes. METHODS:Patients aged ≥70 years were included from three cross-sectional studies conducted in 1997, 2005 and 2011. PIMs were analyzed according to the Norwegian General Practice-Nur...

journal_title：Pharmacoepidemiology and drug safety

authors： Halvorsen KH,Selbaek G,Ruths S

更新日期：2017-02-01 00:00:00

abstract：PURPOSE:In order to assess the short-term safety and tolerability of newly prescribed antihypertensive monotherapies in Korean patients, a prospective study was carried out. METHODS:A total of 1181 patients were observed from July 1997 to August 1999. At 2, 4, 8 and 12 weeks after initiation of antihypertensive monoth...

journal_title：Pharmacoepidemiology and drug safety

authors： Kim YS,Park HS,Sunwoo S,Byeon JJ,Song YM,Seo HG,Kim CH,Cheon KS,Yoo SM,Lee JK,Korea Post-Marketing Surveillance Research Group.

更新日期：2000-12-01 00:00:00

abstract：PURPOSE:Some studies have reported reduced risks of advanced, but not early, prostate cancer among statin users, and one study found a reduced risk only among statin users who had also used non-steroidal anti-inflammatory drugs (NSAIDs). We have previously reported no association between statin use and prostate cancer ...

journal_title：Pharmacoepidemiology and drug safety

authors： Coogan PF,Kelly JP,Strom BL,Rosenberg L

更新日期：2010-07-01 00:00:00