Dataset Information

Use of Health Care Databases to Support Supplemental Indications of Approved Medications.

ABSTRACT: Importance:Manufacturers of US Food and Drug Administration-approved prescription drugs often apply for additional indications based on randomized clinical trials. Real-world database analyses on a medication's use and outcomes in routine settings of care might help to inform decision making regarding such supplemental indications. Objective:To examine whether longitudinal data from a health care database can support the results of a randomized clinical trial that led to a supplemental indication for telmisartan. Design, Setting, and Participants:This cohort study of patients newly prescribed telmisartan or ramipril used insurance claims data from a nationwide health care database from January 1, 2003, through September 30, 2009, to compare patient outcomes. This study replicated the inclusion and exclusion criteria used in the Ongoing Telmisartan Alone and in Combination with Ramipril Global End-point Trial (ONTARGET) and used propensity score matching to balance 74 patient characteristics. Data analysis was performed from February 15, 2017, to May 24, 2017. Exposures:Telmisartan use vs ramipril use. Main Outcomes and Measures:The primary outcome was a composite of myocardial infarction, stroke, or hospitalization for congestive heart failure. Results:Of the 640 951 patients included in the study, 48 053 were newly prescribed ramipril (mean [SD] age, 68.29 [9.52] years; 31 940 male [66.5%]) and 4665 were newly prescribed telmisartan (mean [SD] age, 69.43 [9.60] years; 2413 male [51.7%]). After propensity score matching, a total of 4665 patients were newly prescribed telmisartan (mean [SD] age, 69.43 [9.60] years; 2413 [51.7%]), and 4665 patients were newly prescribed ramipril (mean [SD] age, 69.36 [9.67] years; 2343 male [50.2%]). As seen in ONTARGET, the composite risk of stroke, myocardial infarction, and hospitalization for congestive heart failure was similar for the 2 medications (hazard ratio, 1.0; 95% CI, 0.9-1.1). In addition, the study found that telmisartan was associated with a substantially decreased risk of angioedema (hazard ratio, 0.1; 95% CI, 0.03-0.56) compared with ramipril. Conclusions and Relevance:Real-world data analyses of patients receiving routine care provided findings similar to those found in the randomized clinical trial that established telmisartan's supplemental indication. In certain situations, database studies may support supplemental applications for effectiveness for already approved medications.

SUBMITTER: Fralick M

PROVIDER: S-EPMC5833514 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:IntroductionSome patients diagnosed with cancer use medical cannabis to self-manage undesirable symptoms, including nausea and pain. To improve patient safety and oncological care quality, the routes of administration for use of medical cannabis, patients' reasons, and prescribed indications must be better understood.MethodsBased on the Joanna Briggs Institute guidelines, a scoping review was conducted to map the current evidence regarding the use of medical cannabis in oncological settings based on the experiences of patients diagnosed with cancer and their healthcare providers. A search strategy was developed with a scientific librarian which included five databases (CINAHL, Web of Science, Medline, Embase, and PsycINFO) and two grey literature sources (Google Scholar and ProQuest). The inclusion criteria were: 1) population: adults aged 18 and over diagnosed with cancer; 2) phenomena of interest: reasons for cannabis use and/or the prescribed indications for medical cannabis; 3) context: oncological setting. French- or English-language primary empirical studies, knowledge syntheses, and grey literature published between 2000 and 2021 were included. Data were extracted by two independent reviewers and subjected to a thematic analysis. A narrative description approach was used to synthesize and present the findings.ResultsWe identified 5,283 publications, of which 163 met the eligibility criteria. Two main reasons for medical cannabis use emerged from the thematic analysis: limiting the impacts of cancer and its side effects; and staying connected to others. Our results also indicated that medical cannabis is mostly used for three approved indications: to manage refractory nausea and vomiting, to complement pain management, and to improve appetite and food intake. We highlighted 11 routes of administration for medical cannabis, with oils and oral solutions the most frequently reported.ConclusionFuture studies should consider the multiple routes of administration for medical cannabis, such as inhalation and edibles. Our review highlights that learning opportunities would support the development of healthcare providers' knowledge and skills in assessing the needs and preferences of patients diagnosed with cancer who use medical cannabis.

Project description:The most effective way to move from target identification to the clinic is to identify already approved drugs with the potential for activating or inhibiting unintended targets (repurposing or repositioning). This is usually achieved by high throughput chemical screening, transcriptome matching, or simple in silico ligand docking. We now describe a novel rapid computational proteochemometric method called "train, match, fit, streamline" (TMFS) to map new drug-target interaction space and predict new uses. The TMFS method combines shape, topology, and chemical signatures, including docking score and functional contact points of the ligand, to predict potential drug-target interactions with remarkable accuracy. Using the TMFS method, we performed extensive molecular fit computations on 3671 FDA approved drugs across 2335 human protein crystal structures. The TMFS method predicts drug-target associations with 91% accuracy for the majority of drugs. Over 58% of the known best ligands for each target were correctly predicted as top ranked, followed by 66%, 76%, 84%, and 91% for agents ranked in the top 10, 20, 30, and 40, respectively, out of all 3671 drugs. Drugs ranked in the top 1-40 that have not been experimentally validated for a particular target now become candidates for repositioning. Furthermore, we used the TMFS method to discover that mebendazole, an antiparasitic with recently discovered and unexpected anticancer properties, has the structural potential to inhibit VEGFR2. We confirmed experimentally that mebendazole inhibits VEGFR2 kinase activity and angiogenesis at doses comparable with its known effects on hookworm. TMFS also predicted, and was confirmed with surface plasmon resonance, that dimethyl celecoxib and the anti-inflammatory agent celecoxib can bind cadherin-11, an adhesion molecule important in rheumatoid arthritis and poor prognosis malignancies for which no targeted therapies exist. We anticipate that expanding our TMFS method to the >27 000 clinically active agents available worldwide across all targets will be most useful in the repositioning of existing drugs for new therapeutic targets.

Project description:ObjectivesEvidence-based therapies for opioid use disorder (OUD) and chronic pain, such as medications for OUD (MOUD) and complementary and integrative health (CIH; e.g., acupuncture and meditation) therapies, exist. However, their adoption has been slow, particularly in primary care, due to numerous implementation challenges. We sought to expand the use of MOUD and CIH within primary care by using an evidence-based quality improvement (EBQI) implementation strategy.MethodsWe used EBQI to engage two facilities in the Veterans Health Administration (VHA) from June 2018 to September 2019. EBQI included multilevel stakeholder engagement, with external facilitators providing technical support, practice facilitation, and routine data feedback. We established a quality improvement (QI) team at each facility with diverse stakeholders (e.g., primary care, addiction, pain, nursing, pharmacy). We met monthly with regional stakeholders to address implementation barriers. We also convened an advisory board to ensure alignment with national priorities.ResultsPre-implementation interviews indicated facility-level and provider-level barriers to prescribing buprenorphine, including strong primary care provider resistance. Both facilities developed action plans. They both conducted educational meetings (e.g., Grand Rounds, MOUD waiver trainings). Facility A also offered clinical preceptorships for newly trained primary care prescribers. Facility B used mass media and mailings to educate patients about MOUD and CIH options and dashboards to identify potential candidates for MOUD. After 15 months, both facilities increased their OUD treatment rates to the ≥ 90th percentile of VHA medical centers nationally. Exit interviews indicated an attitudinal shift in MOUD delivery in primary care. Stakeholders valued the EBQI process, particularly cross-site collaboration.ImplicationsDespite initial implementation barriers, we effectively engaged stakeholders using EBQI strategies. Local QI teams used an assortment of QI interventions and developed tools to catapult their facilities to among the highest performers in VHA OUD treatment.ImpactsEBQI is an effective strategy to partner with stakeholders to implement MOUD and CIH therapies.

Project description:IntroductionIn African countries, respiratory infections and severe sepsis are common causes of respiratory failure and mortality in children under five years of age. Mortality and morbidity in these children could be reduced with adequate respiratory support in the emergency care setting. The purpose of this review is to describe management priorities in the emergency care of critically ill children presenting with respiratory problems. Basic and advanced respiratory support measures are described for implementation according to available resources, work load and skill-levels.MethodsWe did a focused search of respiratory support for critically ill children in resource-limited settings over the past ten years, using the search tools PubMed and Google Scholar, the latest WHO guidelines, international 'Advanced Paediatric Life Support' guidelines and paediatric critical care textbooks.ResultsThe implementation of triage and rapid recognition of respiratory distress and hypoxia with pulse oximetry is important to correctly identify critically ill children with increased risk of mortality in all health facilities in resource constrained settings. Basic, effective airway management and respiratory support are essential elements of emergency care. Correct provision of supplemental oxygen is safe and its application alone can significantly improve the outcome of critically ill children. Non-invasive ventilatory support is cost-effective and feasible, with the potential to improve emergency care packages for children with respiratory failure and other organ dysfunctions. Non-invasive ventilation is particularly important in severely under-resourced regions unable to provide intubation and invasive mechanical ventilation support. Malnutrition and HIV-infection are important co-morbid conditions, associated with increased mortality in children with respiratory dysfunction.DiscussionA multi-disciplinary approach is required to optimise emergency care for critically ill children in low-resource settings. In this context, it is important to consider aspects of training of staff, technical support and pragmatic research.

Project description:ObjectiveUnderstanding public discourse on emergency use of unproven therapeutics is essential to monitor safe use and combat misinformation. We developed a natural language processing-based pipeline to understand public perceptions of and stances on coronavirus disease 2019 (COVID-19)-related drugs on Twitter across time.MethodsThis retrospective study included 609 189 US-based tweets between January 29, 2020 and November 30, 2021 on 4 drugs that gained wide public attention during the COVID-19 pandemic: (1) Hydroxychloroquine and Ivermectin, drug therapies with anecdotal evidence; and (2) Molnupiravir and Remdesivir, FDA-approved treatment options for eligible patients. Time-trend analysis was used to understand the popularity and related events. Content and demographic analyses were conducted to explore potential rationales of people's stances on each drug.ResultsTime-trend analysis revealed that Hydroxychloroquine and Ivermectin received much more discussion than Molnupiravir and Remdesivir, particularly during COVID-19 surges. Hydroxychloroquine and Ivermectin were highly politicized, related to conspiracy theories, hearsay, celebrity effects, etc. The distribution of stance between the 2 major US political parties was significantly different (P < .001); Republicans were much more likely to support Hydroxychloroquine (+55%) and Ivermectin (+30%) than Democrats. People with healthcare backgrounds tended to oppose Hydroxychloroquine (+7%) more than the general population; in contrast, the general population was more likely to support Ivermectin (+14%).ConclusionOur study found that social media users with have different perceptions and stances on off-label versus FDA-authorized drug use across different stages of COVID-19, indicating that health systems, regulatory agencies, and policymakers should design tailored strategies to monitor and reduce misinformation for promoting safe drug use. Our analysis pipeline and stance detection models are made public at https://github.com/ningkko/COVID-drug.

Dataset Information

Use of Health Care Databases to Support Supplemental Indications of Approved Medications.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets