Trial reportEuropean journal of clinical pharmacology2013
Intensive monitoring of duloxetine: results of a web-based intensive monitoring study.
Trial report in European journal of clinical pharmacology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
14 citing papers in PubMed, 2 syntheses or guidelines pooled it, 25 citations in OpenAlex.
- Intensive Monitoring Studies for Assessing Medicines: A Systematic Review.Frontiers in medicine · 2019Pooled it
- The value of patient reporting to the pharmacovigilance system: a systematic review.British journal of clinical pharmacology · 2017Pooled it
- Sociodemographic Characteristics of Adverse Event Reporting in the USA: An Ecologic Study.Drug safety · 2024Article
- Enhanced safety surveillance of GSK's quadrivalent seasonal influenza vaccine in Germany and Spain (2021/2022 season) using an electronic patient-reported outcome system for vaccine safety remote monitoring.Influenza and other respiratory viruses · 2023Article
- Article
- Sex Differences in Adverse Drug Reactions of Metformin: A Longitudinal Survey Study.Drug safety · 2020Article
- Evaluation of Facebook and Twitter Monitoring to Detect Safety Signals for Medical Products: An Analysis of Recent FDA Safety Alerts.Drug safety · 2017Article
- Patient-Reported Safety Information: A Renaissance of Pharmacovigilance?Drug safety · 2016Article
- Time course, outcome and management of adverse drug reactions associated with metformin from patient's perspective: a prospective, observational cohort study in the Netherlands.European journal of clinical pharmacology · 2016Observational
- Social Media Listening for Routine Post-Marketing Safety Surveillance.Drug safety · 2016Article
- Patient Participation and the Use of Ehealth Tools for Pharmacoviligance.Frontiers in pharmacology · 2016Review
- Adverse Drug Reaction Identification and Extraction in Social Media: A Scoping Review.Journal of medical Internet research · 2015Article
- The interactive web-based program MSmonitor for self-management and multidisciplinary care in multiple sclerosis: concept, content, and pilot results.Patient preference and adherence · 2015Article
- Experiences with the use of varenicline in daily practice in the Netherlands: a prospective, observational cohort study.Drug safety · 2014Observational
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeDuloxetine (Cymbalta(®)) is a serotonin (5-HT) and norepinephrine (NE) re-uptake inhibitor indicated for the treatment of depression, diabetic peripheral neuropathic pain and general anxiety disorder. The aim of this study is to gain insight in the user and safety profile of duloxetine in daily practice, reported by patients via a web-based intensive monitoring system during their first 6 months of use.
methodsFirst-time users of duloxetine were identified through the first dispensing signal in the pharmacy. Patient demographics and information about drug use and adverse drug reactions, ADRs, were collected through electronic questionnaires sent 2 and 6 weeks, 3 and 6 months after the start of duloxetine administration. ADRs were quantified and signal detection was performed on a case by case basis.
resultsThree hundred and ninety-eight patients registered for the study; 69.1 % were female. Depression was the main indication. Three hundred and three patients (76.1 %) filled in at least one questionnaire and 78.9 % of these reported an ADR. Serious ADRs were reported by 4 patients. Three new signals were identified, amenorrhea, shock-like paraesthesias and micturition problems.
conclusionsWeb-based intensive monitoring is an observational prospective cohort study mirroring the use and ADRs of duloxetine in daily practice. This study indicates that duloxetine is a relatively safe drug as used by patients for six months in daily practice, but the aforementioned signals need to be evaluated in more detail.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.