Abstract:
PURPOSE:To assess the prevalence and potential indications of PDE5 inhibitor use among pregnant and reproductive-age women in the United States. METHODS:We identified women 15 to 50 years with a livebirth from January 2001 through March 2018 in Sentinel Database. We assessed the prevalence of PDE5 inhibitor use prior to and during pregnancy by trimester, identified potential on- and off-label indications using predefined diagnosis codes recorded within 90 days before the estimated last menstrual period through delivery. Separately, we used data from IQVIA's National Prescription Audit and Total Patient Tracker to estimate the dispensed prescriptions for PDE5 inhibitors and the number of patients with PDE5 inhibitor prescriptions. RESULTS:We identified approximately 3.3 million pregnancies during 2001 to 2018, 96 of which had PDE5 inhibitor use during pregnancy. Prevalence of PDE5 inhibitor use was 2.61, 0.62, and 0.62 per 100, 000 live-born pregnancies during the first, second, or third trimesters, respectively. Among women exposed to a PDE5 inhibitor from 90 days before conception to the end of pregnancy, 25.0%, 31.1%, and 15.5% had a diagnosis code for fetal growth restriction, preeclampsia, and pulmonary arterial hypertension. In IQVIA data, an estimated 223, 000 prescriptions from July 2015 through June 2018 and 58, 000 women received prescriptions for PDE5 inhibitors in 2017, of whom approximately 15, 000 (26%) were aged 15 to 50 years. CONCLUSION:We found a low prevalence of PDE5 inhibitor use in pregnant and reproductive-age women. Given the very low prevalence of use and the inconsistency of neonatal mortality data across STRIDER centers, the risk to public health is low at present.
journal_name
Pharmacoepidemiol Drug Safjournal_title
Pharmacoepidemiology and drug safetyauthors
Liu W,Menzin TJ,Woods CM,Haug NR,Li J,Mathew JA,Nguyen CP,Chai GP,Moeny DG,Shinde Mdoi
10.1002/pds.5112subject
Has Abstractpub_date
2021-02-01 00:00:00pages
126-134issue
2eissn
1053-8569issn
1099-1557journal_volume
30pub_type
杂志文章abstract:PURPOSE:To provide an up-to-date account of drug prescription during pregnancy in France from 2011 to 2014 using the permanent sample of the French national computerized healthcare database and with a focus on recommended supplementations, fetotoxic drugs and teratogenic drugs. METHODS:All pregnancies identified by th...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4265
更新日期:2017-09-01 00:00:00
abstract:PURPOSE:To evaluate the internet way of feedback to prescribing physicians, providing data on antimicrobial use and to assess the applicability of the DU90% (i.e. Drug Utilisation 90%--the number of drugs accounting for 90% of the volume of usage in defined daily doses, (DDDs)) methodology in the hospital setting. MET...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.898
更新日期:2004-07-01 00:00:00
abstract:PURPOSE:To evaluate the impact of 2 policy changes on quetiapine dispensing in Australia: removal of prior authorisation for prescribing (policy 1: July 2007) and removal of repeat prescriptions for 25-mg quetiapine (policy 2: January 2014). METHODS:We performed an interrupted time series analysis using Pharmaceutical...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4408
更新日期:2018-04-01 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
pub_type: 杂志文章
doi:10.1002/pds.1970
更新日期:2010-07-01 00:00:00
abstract:PURPOSE:We aimed to quantify the extent of over-the-counter (OTC) low-dose aspirin use among patients in The Health Improvement Network (THIN) in the UK. METHODS:In September 2013, a random sample of low-dose aspirin users (75 past users and 75 never users) was identified based on prescriptions recorded in THIN. Prima...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3926
更新日期:2016-04-01 00:00:00
abstract::Rosiglitazone has previously been widely used to treat patients with type 2 diabetes mellitus, but its safety in terms of cardiovascular morbidity and mortality had been called into question. Recently, there have been doubts raised about the meta-analytic evidence with the regulatory authorities relaxing its restricti...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章,meta分析
doi:10.1002/pds.3736
更新日期:2015-03-01 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
pub_type: 杂志文章
doi:10.1002/pds.5088
更新日期:2020-12-01 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
pub_type: 杂志文章
doi:10.1002/pds.3984
更新日期:2016-07-01 00:00:00
abstract:PURPOSE:To assess the reason for the relative high risk of local complications for women following cardiac catheterization by evaluating the associations between gender, sheath size, and local adverse outcomes following cardiac catheterization. METHODS:The data used in this study were obtained from a portion of the Am...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章,多中心研究
doi:10.1002/pds.1307
更新日期:2007-02-01 00:00:00
abstract:PURPOSE:Although a series of serious adverse events have continually raised concerns about the potential toxicity of traditional Chinese medicine injections (TCM injections), studies on this subject are still sparse. We conducted a descriptive analysis of a spontaneous reporting system in China to describe the safety p...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4805
更新日期:2019-07-01 00:00:00
abstract:PURPOSE:Although sales of prescribed and over-the-counter (OTC) medication are rising, little is known about individual drug intake. This study was aimed to obtain complementary information about drug intake. METHOD:Information on drug utilization was obtained in a female cohort for five different time points (TP): 36...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3943
更新日期:2016-04-01 00:00:00
abstract:PURPOSE:Determining the nature of the relationship between cumulative duration of exposure to an agent and the hazard of an adverse outcome is an important issue in environmental and occupational epidemiology, public health and clinical medicine. The Cox proportional hazards regression model can incorporate time-depend...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3607
更新日期:2014-08-01 00:00:00
abstract:OBJECTIVES:The aim of this study was to examine epidemiologic characteristics of Adverse Drug Events (ADEs) among children and adolescents presenting to an Emergency Department (ED) in Newfoundland and Labrador (NL), Canada. MATERIALS AND METHODS:This study was conducted in three phases and included an ED chart review...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1900
更新日期:2010-02-01 00:00:00
abstract:PURPOSE:The use of granulocyte colony-stimulating factor (G-CSF) in the treatment of non-chemotherapy drug- induced agranulocytosis is controversial. We aimed at assessing the effect of G-CSF on the duration of agranulocytosis. METHODS:To assess the effect of G-CSF on the duration of agranulocytosis, a Cox proportiona...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1542
更新日期:2008-03-01 00:00:00
abstract:PURPOSE:We describe the design, implementation, and use of a large, multiorganizational distributed database developed to support the Mini-Sentinel Pilot Program of the US Food and Drug Administration (FDA). As envisioned by the US FDA, this implementation will inform and facilitate the development of an active surveil...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.2336
更新日期:2012-01-01 00:00:00
abstract::There is an increasing reliance on databases of healthcare records for pharmacoepidemiology and other medical research, and such resources are often accessed over a long period of time so it is vital to consider the impact of changes in data, access methodology and the environment. The authors discuss change in commun...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章,评审
doi:10.1002/pds.4004
更新日期:2016-07-01 00:00:00
abstract:PURPOSE:To evaluate the frequency, severity and preventability of warfarin-induced cerebral haemorrhages due to warfarin and warfarin-drug interactions in patients living in the county of Ostergötland, Sweden. METHODS:All patients with a diagnosed cerebral haemorrhage at three hospitals during the period 2000-2002 wer...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1291
更新日期:2007-03-01 00:00:00
abstract:PURPOSE:Our aim was to describe and assess the medicinal products and doses used for euthanasia in a series of cases, identified within an epidemiological death certificate study in Belgium, where euthanasia was until recently legally forbidden and where guidelines for euthanasia are not available. METHODS:In a random...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.863
更新日期:2004-02-01 00:00:00
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
pub_type: 杂志文章
doi:10.1002/pds.3389
更新日期:2013-03-01 00:00:00
abstract::Erythromycin is commonly used to treat simple community-acquired pneumonia. We measured the prolongation in QT(c) intervals in EKGs associated with intravenous erythromycin administration among patients hospitalized for simple pneumonia (DRGs 89 and 90). We reviewed the medical records of 50 patients who received at l...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/(SICI)1099-1557(199701)6:1<13::AID-PDS251>
更新日期:1997-01-01 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
pub_type: 杂志文章
doi:10.1002/pds.986
更新日期:2005-04-01 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
pub_type: 杂志文章
doi:10.1002/pds.3724
更新日期:2015-05-01 00:00:00
abstract:PURPOSE:We developed a computerized system for signal detection in spontaneous reporting system (SRS) of Shanghai. Data acquisition, data mining could be carried out automatically and the process of data preprocessing and cleaning could be facilitated. This system was expected to detect signals from SRS after drug lice...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1695
更新日期:2009-02-01 00:00:00
abstract:PURPOSE:Drug-induced liver injury (DILI) is one of the primary targets for pharmacovigilance using medical information databases (MIDs). Because of diagnostic complexity, a standardized method for identifying DILI using MIDs has not yet been established. We applied the Digestive Disease Week Japan 2004 (DDW-J) scale, a...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.3603
更新日期:2014-09-01 00:00:00
abstract::The General Practice Research Database (GPRD) is the world's largest computerized database of anonymized longitudinal patient records from general practice and is a unique public health research tool. Several issues have threatened the viability of the database in recent years; in April 1999 responsibility for its man...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.608
更新日期:2001-08-01 00:00:00
abstract:PURPOSE:Discontinuing low-dose acetylsalicylic acid (ASA) therapy after upper gastrointestinal bleeding (UGIB) may increase the risk of cardiovascular-related death. Our aim was to compare mortality in UK primary care patients who discontinue ASA after UGIB with that in patients who continue therapy. METHODS:ASA users...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.4140
更新日期:2017-02-01 00:00:00
abstract:AIM:To determine the appropriate size of risk windows in both exposed and unexposed sub-cohorts. METHOD:Data was taken from a previous study of upper gastrointestinal haemorrhage and perforation. The length of each prescription for NSAIDs was estimated. The risk was calculated for the duration of a prescription plus i...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/(SICI)1099-1557(199807/08)7:4<275::AID-PDS
更新日期:1998-07-01 00:00:00
abstract:OBJECTIVE:To update United States steroidal contraceptive use data for the period 1989 to 1994. STUDY DESIGN:Pharmaceutical marketing data were used to examine trends in the utilization and distribution of oral contraceptives, Norplant, and Depo-Provera. RESULTS:There were 56.8 million prescriptions for oral contrace...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/(SICI)1099-1557(199605)5:3<141::AID-PDS221
更新日期:1996-05-01 00:00:00
abstract::Dr. Walker asserts that a hypothesis always can be tested using the same data source that generated the data if the test data are independent of the data generating the hypothesis. One way to do this is to use part of the totality of data to generate the hypothesis and the other to test the hypothesis. The validity of...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 评论,杂志文章
doi:10.1002/pds.1928
更新日期:2010-05-01 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
pub_type: 杂志文章
doi:10.1002/pds.2133
更新日期:2011-06-01 00:00:00