Assessing strength of evidence for regulatory decision making in licensing: What proof do we need for observational studies of effectiveness?

abstract：PURPOSE:We review statistical methods for assessing the possible impact of bias due to unmeasured confounding in real world data analysis and provide detailed recommendations for choosing among the methods. METHODS:By updating an earlier systematic review, we summarize modern statistical best practices for evaluating ...

journal_title：Pharmacoepidemiology and drug safety

authors： Zhang X,Stamey JD,Mathur MB

更新日期：2020-10-01 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

abstract：BACKGROUND:Antiepileptic drugs (AEDs) are also prescribed for therapeutic indications other than epilepsy (EPI), namely, psychiatric disorders (PSY). Our aim was to develop an algorithm able to distinguish between EPI and PSY among childbearing age women based on differences in AED exposure in these patient groups. ME...

journal_title：Pharmacoepidemiology and drug safety

authors： Naldi I,Piccinni C,Mostacci B,Renzini J,Accetta G,Bisulli F,Tappatà M,Piazza A,Pagano P,Bianchi S,D'Alessandro R,Tinuper P,Poluzzi E,ESPEA (Emilia-Romagna Study on Pregnancy and Exposure to Antiepileptic drugs) Group.

更新日期：2016-07-01 00:00:00

abstract：PURPOSE:Proton pump inhibitor (PPI) may suppress adrenal cortical steroid synthesis and release, thereby leading to electrolyte disturbances. Both hyponatremia and hyperkalemia in the setting of PPI therapy have been documented in case reports. The objective of this study was to examine the association between serum po...

journal_title：Pharmacoepidemiology and drug safety

authors： Gau JT,Heh V,Acharya U,Yang YX,Kao TC

更新日期：2009-09-01 00:00:00

abstract：:The article is devoted to the establishment and development of the National Pharmacovigilance system in Ukraine. A drug safety centre of Ukraine started to form a pharmacovigilance system in 1996. It has been operating on a regular basis since 2000 and now provides the regulatory services that include data collection ...

journal_title：Pharmacoepidemiology and drug safety

authors： Stefanov O,Sharayeva M,Jajtchenja V

更新日期：2004-03-01 00:00:00

abstract：PURPOSE:This study examined recent trends and correlates of prescription opioid use and long-term use in the United States. METHODS:Data were from 47 356 adult participants of National Health and Nutrition Survey from 1999-2000 to 2013-2014. Participants were asked about prescription medications used in the past 30 da...

journal_title：Pharmacoepidemiology and drug safety

authors： Mojtabai R

更新日期：2018-05-01 00:00:00

abstract：PURPOSE:In Spain, a human papillomavirus (HPV) vaccine was firstly marketed in 2006 and mainly administered in primary care (PC) practices for girls/women or schools. As for all vaccines, a valid data source is required for research on observational effectiveness or safety. The objective of this study is to identify an...

journal_title：Pharmacoepidemiology and drug safety

authors： Martín-Merino E,Llorente-García A,Montero-Corominas D,Huerta C

更新日期：2019-02-01 00:00:00

abstract：:A series of case reports to the varicella vaccine Pregnancy Registry described inadvertent administrations during pregnancy of this live virus product instead of the intended Varicella zoster immune globulin. Cases continued to accrue despite an early publication about the pattern. The persistent problem warrants spec...

journal_title：Pharmacoepidemiology and drug safety

authors： Wise RP,Braun MM,Seward JF,Mootrey GT,Shields KE,Salive ME,Krause PR

更新日期：2002-12-01 00:00:00

abstract：OBJECTIVE:To identify the relevant prescribing quality domains of type 2 diabetes mellitus care as a basis for the selection of a minimal set of prescribing quality indicators from a set of previously validated indicators. METHODS:We used the principal factor analysis to identify the underlying dimensions or domains o...

journal_title：Pharmacoepidemiology and drug safety

authors： Martirosyan L,Haaijer-Ruskamp FM,Braspenning J,Denig P

更新日期：2012-10-01 00:00:00

abstract：PURPOSE:We aimed to describe time-trends in the use of NOACs among a group of ambulatory patients with nonvalvular atrial fibrillation (NVAF) in Colombia and to describe treatment patterns and user characteristics. METHODS:Using the Audifarma S.A administrative healthcare database in Colombia, we identified 10 528 pat...

journal_title：Pharmacoepidemiology and drug safety

authors： Machado-Alba JE,Gaviria-Mendoza A,Machado-Duque ME,Tovar-Yepes C,Ruigómez A,García Rodríguez LA

更新日期：2020-10-15 00:00:00

abstract：BACKGROUND:Despite numerous clinical guidelines on asthma management, patients often receive suboptimal drug therapy. This study identified patients who received suboptimal regimens according to the National Heart, Lung and Blood Institute (NHLBI) Guidelines for the Diagnosis and Management of Asthma in a complete popu...

journal_title：Pharmacoepidemiology and drug safety

authors： Zhang T,Smith MA,Camp PG,Carleton BC

更新日期：2013-07-01 00:00:00

abstract：PURPOSE:Prior event rate ratio (PERR) adjustment method has been proposed to control for unmeasured confounding. We aimed to assess the performance of the PERR method in realistic pharmacoepidemiological settings. METHODS:Simulation studies were performed with varying effects of prior events on the probability of subs...

journal_title：Pharmacoepidemiology and drug safety

authors： Uddin MJ,Groenwold RH,van Staa TP,de Boer A,Belitser SV,Hoes AW,Roes KC,Klungel OH

更新日期：2015-05-01 00:00:00

abstract：PURPOSE:To evaluate the outcomes of patients participating in a program of integrated care for osteoporosis in terms of medication supply, fracture incidence and expenses. METHODS:Outcomes were assessed from secondary data provided by the AOK PLUS health insurance for 2455 participants of the program and the same numb...

journal_title：Pharmacoepidemiology and drug safety

authors： Goltz L,Degenhardt G,Maywald U,Kirch W,Schindler C

更新日期：2013-03-01 00:00:00

abstract：PURPOSE:There is an increasing number of children with in utero exposure to opioids. Knowledge about opioid safety in pregnancy, particularly for outcomes later in childhood is scarce. It has been suggested that opioids can modulate immune system and increase the risk of infections. Our goal was to study the impact of ...

journal_title：Pharmacoepidemiology and drug safety

authors： Mahic M,Hernandez-Diaz S,Wood M,Kieler H,Odsbu I,Nørgaard M,Öztürk B,Bateman BT,Hjellvik V,Skurtveit S,Handal M

更新日期：2020-12-01 00:00:00

abstract：PURPOSE:Because preapproval clinical trials typically exclude pregnant women, the evidence on drug safety during pregnancy required to inform drug labeling must come from postapproval controlled observational studies. Common designs have included pregnancy registries and case-control studies. Recently, pregnancy cohort...

journal_title：Pharmacoepidemiology and drug safety

authors： Huybrechts KF,Bateman BT,Hernández-Díaz S

更新日期：2019-07-01 00:00:00

abstract：PURPOSE:During the past two decades, many novel immunosuppressive drugs have been approved for transplant recipients. Trends in the use of maintenance immunosuppressants after liver transplantation in Asia are unclear. Thus, we aimed to analyze the prescription trends in maintenance immunosuppressive drugs among liver ...

journal_title：Pharmacoepidemiology and drug safety

authors： Huang YY,Hsu CC,Chou CL,Loong CC,Wu MS,Chou YC

更新日期：2016-06-01 00:00:00

abstract：PURPOSE:Early detection of risky behaviors involving prescription opioids can assist prescribers in implementing safer prescribing. Patient-to-prescriber travel patterns may indicate potential opioid misuse. We introduce doctor hopping, patients bypassing nearby prescribers in favor of more distant ones, as a new spati...

journal_title：Pharmacoepidemiology and drug safety

authors： Young SG,Hayes CJ,Aram J,Tait MA

更新日期：2019-08-01 00:00:00

abstract：PURPOSE:The purpose of this study is to quantify the impact of the different outcomes and definitions of suicidality on the association between antiepileptic drugs (AEDs) and suicidality. METHODS:Retrospective cohort studies of selected AEDs (carbamazepine, gabapentin, lamotrigine, phenytoin, pregabalin, topiramate an...

journal_title：Pharmacoepidemiology and drug safety

authors： Schuerch M,Gasse C,Robinson NJ,Alvarez Y,Walls R,Mors O,Christensen J,Hesse U,de Groot M,Schlienger R,Reynolds R,Klungel O,de Vries F

更新日期：2016-03-01 00:00:00

abstract：PURPOSE:To examine the effects of analgesics on bone mineral density (BMD), which have not been examined in a longitudinal study with multiple measurements. METHODS:We investigated changes in BMD associated with new use of analgesics in a prospective longitudinal cohort of mid-life women. BMD and medication use were m...

journal_title：Pharmacoepidemiology and drug safety

authors： Yoshida K,Yu Z,Greendale GA,Ruppert K,Lian Y,Tedeschi SK,Lin TC,Haneuse S,Glynn RJ,Hernández-Díaz S,Solomon DH

更新日期：2018-02-01 00:00:00

abstract：PURPOSE:To assess the pattern of in-hospital changes in drug use in older patients from 2010 to 2016. METHODS:People aged 65 years or more acutely hospitalized in those internal medicine and geriatric wards that did continuously participate to the REgistro POliterapie Società Italiana di Medicina Interna register from...

journal_title：Pharmacoepidemiology and drug safety

authors： Franchi C,Ardoino I,Nobili A,Pasina L,Mannucci PM,Marengoni A,Perticone F,REPOSI investigators.

更新日期：2017-12-01 00:00:00

abstract：:The cost of drugs represents 10% of the National Health Service (NHS) budget in the UK and this fraction is increasing. Because the NHS is centrally funded and because there is a budgetary limit, prioritization in health care is required. The National Institute for Clinical Excellence in England and Wales and the Heal...

journal_title：Pharmacoepidemiology and drug safety

authors： Beard K

更新日期：2001-08-01 00:00:00

abstract：PURPOSE:Breast cancer is the most common cancer in women worldwide. We attempted to investigate the association between the risk of breast cancer and use of captopril and other antihypertensive medication. METHODS:We performed a cohort study with a nested case-control analysis using the General Practitioner Research D...

journal_title：Pharmacoepidemiology and drug safety

authors： González-Pérez A,Ronquist G,García Rodríguez LA

更新日期：2004-08-01 00:00:00

abstract：PURPOSE:Few studies have reported an association between proton pump inhibitor (PPI) use and tuberculosis. Tuberculosis incidence is relatively high in Asian people, and an increase in PPI prescriptions has been reported in South Korea. Thus, we investigated the association between PPI use and tuberculosis development....

journal_title：Pharmacoepidemiology and drug safety

authors： Song HJ,Park H,Park S,Kwon JW

更新日期：2019-06-01 00:00:00

abstract：PURPOSE:To describe the characteristics of new users of cilostazol in Europe with the aim to support the evaluation of its benefit/risk as used in regular clinical practice before the implementation of labeling changes recommended by the European Medicines Agency. METHODS:New users of cilostazol were identified in pop...

journal_title：Pharmacoepidemiology and drug safety

authors： Castellsague J,Perez-Gutthann S,Calingaert B,Bui C,Varas-Lorenzo C,Arana A,Prados-Torres A,Poblador-Plou B,Gonzalez-Rubio F,Giner-Soriano M,Roso-Llorach A,Linder M,Citarella A,Scholle O,Blenk T,Garbe E

更新日期：2017-06-01 00:00:00

abstract：PURPOSE:The Vaccine Safety Datalink (VSD) Project conducts near real-time vaccine safety surveillance using sequential analytic methods. Timely surveillance is critical in identifying potential safety problems and preventing additional exposure before most vaccines are administered. For vaccines that are administered d...

journal_title：Pharmacoepidemiology and drug safety

authors： Greene SK,Kulldorff M,Yin R,Yih WK,Lieu TA,Weintraub ES,Lee GM

更新日期：2011-06-01 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：PURPOSE:Little is known about the effects of drug-drug interactions between valacyclovir and non-steroidal anti-inflammatory drugs (NSAIDs). In this study, we analysed the adverse event 'acute kidney injury (AKI)' resulting from a possible interaction between loxoprofen (a non-selective NSAID) and valacyclovir in repor...

journal_title：Pharmacoepidemiology and drug safety

authors： Yue Z,Shi J,Jiang P,Sun H

更新日期：2014-11-01 00:00:00

abstract：PURPOSE:Propensity scores are used in observational studies to adjust for confounding, although they do not provide control for confounders omitted from the propensity score model. We sought to determine if tests used to evaluate logistic model fit and discrimination would be helpful in detecting the omission of an imp...

journal_title：Pharmacoepidemiology and drug safety

authors： Weitzen S,Lapane KL,Toledano AY,Hume AL,Mor V

更新日期：2005-04-01 00:00:00

abstract：PURPOSE:To assess the feasibility of using Clinical Practice Research Datalink (CPRD) data for identifying populations of patients with chronic obstructive pulmonary disease (COPD) eligible for a hypothetical pragmatic trial. METHODS:A retrospective multidatabase cohort study using CPRD primary care and linked seconda...

journal_title：Pharmacoepidemiology and drug safety

authors： Requena G,Wolf A,Williams R,Dedman D,Quint JK,Murray-Thomas T,Pimenta JM

更新日期：2020-12-27 00:00:00

abstract：PURPOSE:The objective of this study was to evaluate the level of use and therapy profile of antibacterial agents in hospitals. Further to explore whether type, size or geographical situation influenced antibacterial agents used. METHODS:Antibacterial use during 1998-1999, in 13 hospitals, including emergency, referral...

journal_title：Pharmacoepidemiology and drug safety

authors： Blix HS,Hartug S

更新日期：2005-09-01 00:00:00