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Article: Characteristics and Outcomes for Recipients of NVX-CoV2373: A Real-World Retrospective Study in Germany.

Kutikova, Lucie / Brash, James T / Helme, Kawitha / Brewster, Jack / Brand, Milou / Adam, Atif / Seager, Sarah / Kostev, Karel / Schelling, Jörg

Vaccines

2024 Volume 12, Issue 4

Abstract: Real-world evidence supports SARS-CoV-2 vaccination strategies during the COVID-19 pandemic. This real-world retrospective study utilized the German Disease Analyzer database to characterize recipients of NVX-CoV2373 and explore vaccination outcomes. ... ...

Abstract	Real-world evidence supports SARS-CoV-2 vaccination strategies during the COVID-19 pandemic. This real-world retrospective study utilized the German Disease Analyzer database to characterize recipients of NVX-CoV2373 and explore vaccination outcomes. Recipients (≥12 years) of NVX-CoV2373 as a primary series or booster in Germany were vaccinated between March and December 2022. Outcomes included demographics and clinical characteristics of recipients, tolerability/reactogenicity-related events within 7 and 14 days post-vaccination, and protection from COVID-19. Overall, there were 597 recipients (mean age ~60 years) of NVX-CoV2373; 81% were vaccinated by a general practitioner, and 68% had a Standing Committee on Vaccination (STIKO) high-risk factor. The most common baseline comorbidities were chronic neurological (36%) and chronic intestinal (21%) diseases. Among recipients with metabolic disease (~11%), 65% had diabetes. Tolerability/reactogenicity-related symptoms were recorded in ~1% of recipients. There were no sick-leave notes associated with NVX-CoV2373. After 10 months (median, 7 months) of follow-up, 95% (95% CI, 93-95) of recipients were estimated to be protected from COVID-19. Outcomes were similar across the primary series, booster, and STIKO populations. Tolerability and COVID-19 protection support the use of NVX-CoV2373 as a primary/booster vaccination for all authorized populations, including high-risk.
Language	English
Publishing date	2024-04-06
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2703319-3
ISSN	2076-393X
ISSN	2076-393X
DOI	10.3390/vaccines12040387
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Article ; Online: Risk of COVID-19 Diagnosis and Hospitalisation in Patients with Osteoarthritis or Back Pain Treated with Ibuprofen Compared to Other NSAIDs or Paracetamol: A Network Cohort Study.

Xie, Junqing / Brash, James T / Turkmen, Cigdem / Driessen, Stefan / Varrassi, Giustino / Argyriou, George / Seager, Sarah / Reich, Christian / Prieto-Alhambra, Daniel

Drugs

2023 Volume 83, Issue 3, Page(s) 249–263

Abstract: Objective: We aimed to investigate whether ibuprofen use, compared with other non-selective non-steroidal anti-inflammatory drugs (ns-NSAIDs), cyclooxygenase-2 inhibitors (COX-2i) or paracetamol, increases the risk of coronavirus disease 2019 (COVID-19) ...

Abstract	Objective: We aimed to investigate whether ibuprofen use, compared with other non-selective non-steroidal anti-inflammatory drugs (ns-NSAIDs), cyclooxygenase-2 inhibitors (COX-2i) or paracetamol, increases the risk of coronavirus disease 2019 (COVID-19) diagnosis or hospitalisation. Design: A prevalent user and active comparator cohort study. Setting: Two US claims databases (Open Claims and PharMetrics Plus) mapped to the Observational Medical Outcomes Partnership Common Data Model. Participants: Insured patients with a history of osteoarthritis or back pain and receiving ibuprofen, other ns-NSAIDs, COX-2i or paracetamol between 1 November, 2019 and 31 January, 2020 (study enrolment window 1) or between 1 February, 2020 and 31 October, 2020 (study enrolment window 2). Main outcome measures: Large-scale propensity score matching and empirical calibration were used to minimise confounding. Incidence and hazard ratios of COVID-19 diagnosis and hospitalisation according to drug/s use were estimated and pooled in the same study period across data sources using a fixed-effects meta-analysis. Index treatment episode was the primary risk evaluation window, censored at the time of discontinuation. Results: A total of 633,562 and 1,063,960 participants were included in periods 1 and 2, respectively, for the ibuprofen versus ns-NSAIDs comparison, 311,669 and 524,470 for ibuprofen versus COX-2i, and 492,002 and 878,598 for ibuprofen versus paracetamol. Meta-analyses of empirically calibrated hazard ratios revealed no significantly differential risk of COVID-19 outcomes in users of ibuprofen versus any of the other studied analgesic classes: hazard ratios were 1.13 (0.96-1.33) for the ibuprofen-ns-NSAIDs comparison, 1.03 (0.83-1.28) for the ibuprofen-COX-2i comparison and 1.13 (0.74-1.73) for ibuprofen-paracetamol comparison on COVID-19 diagnosis in the February 2020-October 2020 window. Similar hazard ratios were found on COVID-19 hospitalisation and across both study periods. Conclusions: In patients with osteoarthritis or back pain, we found no differential risks of incident COVID-19 diagnosis or COVID-19 hospitalisation for ibuprofen users compared with other ns-NSAIDs, COX-2i or paracetamol. Our findings support regulatory recommendations that NSAIDs, including ibuprofen, should be prescribed as indicated in the same way as before the COVID-19 pandemic, especially for those who rely on ibuprofen or NSAIDs to manage chronic arthritis or musculoskeletal pain symptoms.
MeSH term(s)	Humans ; Anti-Inflammatory Agents, Non-Steroidal/therapeutic use ; Ibuprofen/therapeutic use ; Acetaminophen/therapeutic use ; COVID-19 Testing ; Cohort Studies ; Pandemics ; COVID-19 ; Osteoarthritis/diagnosis ; Osteoarthritis/drug therapy ; Cyclooxygenase 2 Inhibitors/adverse effects ; Back Pain/diagnosis ; Back Pain/drug therapy ; Back Pain/chemically induced
Chemical Substances	Anti-Inflammatory Agents, Non-Steroidal ; Ibuprofen (WK2XYI10QM) ; Acetaminophen (362O9ITL9D) ; Cyclooxygenase 2 Inhibitors
Language	English
Publishing date	2023-01-24
Publishing country	New Zealand
Document type	Meta-Analysis ; Journal Article
ZDB-ID	120316-2
ISSN	1179-1950 ; 0012-6667
ISSN (online)	1179-1950
ISSN	0012-6667
DOI	10.1007/s40265-022-01822-z
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Zs.A 762: Show issues

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Article ; Online: Incidence of mental health diagnoses during the COVID-19 pandemic: a multinational network study.

Epidemiology and psychiatric sciences

2024 Volume 33, Page(s) e9

Abstract: Aims: Population-wide restrictions during the COVID-19 pandemic may create barriers to mental health diagnosis. This study aims to examine changes in the number of incident cases and the incidence rates of mental health diagnoses during the COVID-19 ... ...

Abstract	Aims: Population-wide restrictions during the COVID-19 pandemic may create barriers to mental health diagnosis. This study aims to examine changes in the number of incident cases and the incidence rates of mental health diagnoses during the COVID-19 pandemic. Methods: By using electronic health records from France, Germany, Italy, South Korea and the UK and claims data from the US, this study conducted interrupted time-series analyses to compare the monthly incident cases and the incidence of depressive disorders, anxiety disorders, alcohol misuse or dependence, substance misuse or dependence, bipolar disorders, personality disorders and psychoses diagnoses before (January 2017 to February 2020) and after (April 2020 to the latest available date of each database [up to November 2021]) the introduction of COVID-related restrictions. Results: A total of 629,712,954 individuals were enrolled across nine databases. Following the introduction of restrictions, an immediate decline was observed in the number of incident cases of all mental health diagnoses in the US (rate ratios (RRs) ranged from 0.005 to 0.677) and in the incidence of all conditions in France, Germany, Italy and the US (RRs ranged from 0.002 to 0.422). In the UK, significant reductions were only observed in common mental illnesses. The number of incident cases and the incidence began to return to or exceed pre-pandemic levels in most countries from mid-2020 through 2021. Conclusions: Healthcare providers should be prepared to deliver service adaptations to mitigate burdens directly or indirectly caused by delays in the diagnosis and treatment of mental health conditions.
MeSH term(s)	Humans ; COVID-19/epidemiology ; Incidence ; Mental Health ; Pandemics ; Anxiety Disorders
Language	English
Publishing date	2024-03-04
Publishing country	England
Document type	Journal Article
ZDB-ID	2607964-1
ISSN	2045-7979 ; 2045-7960
ISSN (online)	2045-7979
ISSN	2045-7960
DOI	10.1017/S2045796024000088
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Article ; Online: Ranitidine Use and Incident Cancer in a Multinational Cohort.

JAMA network open

2023 Volume 6, Issue 9, Page(s) e2333495

Abstract: Importance: Ranitidine, the most widely used histamine-2 receptor antagonist (H2RA), was withdrawn because of N-nitrosodimethylamine impurity in 2020. Given the worldwide exposure to this drug, the potential risk of cancer development associated with ... ...

Abstract	Importance: Ranitidine, the most widely used histamine-2 receptor antagonist (H2RA), was withdrawn because of N-nitrosodimethylamine impurity in 2020. Given the worldwide exposure to this drug, the potential risk of cancer development associated with the intake of known carcinogens is an important epidemiological concern. Objective: To examine the comparative risk of cancer associated with the use of ranitidine vs other H2RAs. Design, setting, and participants: This new-user active comparator international network cohort study was conducted using 3 health claims and 9 electronic health record databases from the US, the United Kingdom, Germany, Spain, France, South Korea, and Taiwan. Large-scale propensity score (PS) matching was used to minimize confounding of the observed covariates with negative control outcomes. Empirical calibration was performed to account for unobserved confounding. All databases were mapped to a common data model. Database-specific estimates were combined using random-effects meta-analysis. Participants included individuals aged at least 20 years with no history of cancer who used H2RAs for more than 30 days from January 1986 to December 2020, with a 1-year washout period. Data were analyzed from April to September 2021. Exposure: The main exposure was use of ranitidine vs other H2RAs (famotidine, lafutidine, nizatidine, and roxatidine). Main outcomes and measures: The primary outcome was incidence of any cancer, except nonmelanoma skin cancer. Secondary outcomes included all cancer except thyroid cancer, 16 cancer subtypes, and all-cause mortality. Results: Among 1 183 999 individuals in 11 databases, 909 168 individuals (mean age, 56.1 years; 507 316 [55.8%] women) were identified as new users of ranitidine, and 274 831 individuals (mean age, 58.0 years; 145 935 [53.1%] women) were identified as new users of other H2RAs. Crude incidence rates of cancer were 14.30 events per 1000 person-years (PYs) in ranitidine users and 15.03 events per 1000 PYs among other H2RA users. After PS matching, cancer risk was similar in ranitidine compared with other H2RA users (incidence, 15.92 events per 1000 PYs vs 15.65 events per 1000 PYs; calibrated meta-analytic hazard ratio, 1.04; 95% CI, 0.97-1.12). No significant associations were found between ranitidine use and any secondary outcomes after calibration. Conclusions and relevance: In this cohort study, ranitidine use was not associated with an increased risk of cancer compared with the use of other H2RAs. Further research is needed on the long-term association of ranitidine with cancer development.
MeSH term(s)	Female ; Humans ; Middle Aged ; Male ; Ranitidine/adverse effects ; Cohort Studies ; Thyroid Neoplasms ; Histamine H2 Antagonists/adverse effects ; Skin Neoplasms
Chemical Substances	Ranitidine (884KT10YB7) ; Histamine H2 Antagonists
Language	English
Publishing date	2023-09-05
Publishing country	United States
Document type	Meta-Analysis ; Journal Article ; Research Support, Non-U.S. Gov't
ISSN	2574-3805
ISSN (online)	2574-3805
DOI	10.1001/jamanetworkopen.2023.33495
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Article ; Online: Comparative Effectiveness and Safety Between Apixaban, Dabigatran, Edoxaban, and Rivaroxaban Among Patients With Atrial Fibrillation : A Multinational Population-Based Cohort Study.

Lau, Wallis C Y / Torre, Carmen Olga / Man, Kenneth K C / Stewart, Henry Morgan / Seager, Sarah / Van Zandt, Mui / Reich, Christian / Li, Jing / Brewster, Jack / Lip, Gregory Y H / Hingorani, Aroon D / Wei, Li / Wong, Ian C K

Annals of internal medicine

2022 Volume 175, Issue 11, Page(s) 1515–1524

Abstract: Background: Current guidelines recommend using direct oral anticoagulants (DOACs) over warfarin in patients with atrial fibrillation (AF), but head-to-head trial data do not exist to guide the choice of DOAC.: Objective: To do a large-scale ... ...

Abstract	Background: Current guidelines recommend using direct oral anticoagulants (DOACs) over warfarin in patients with atrial fibrillation (AF), but head-to-head trial data do not exist to guide the choice of DOAC. Objective: To do a large-scale comparison between all DOACs (apixaban, dabigatran, edoxaban, and rivaroxaban) in routine clinical practice. Design: Multinational population-based cohort study. Setting: Five standardized electronic health care databases, which covered 221 million people in France, Germany, the United Kingdom, and the United States. Participants: Patients who were newly diagnosed with AF from 2010 through 2019 and received a new DOAC prescription. Measurements: Database-specific hazard ratios (HRs) of ischemic stroke or systemic embolism, intracranial hemorrhage (ICH), gastrointestinal bleeding (GIB), and all-cause mortality between DOACs were estimated using a Cox regression model stratified by propensity score and pooled using a random-effects model. Results: A total of 527 226 new DOAC users met the inclusion criteria (apixaban, Limitation: Residual confounding is possible. Conclusion: Among patients with AF, apixaban use was associated with lower risk for GIB and similar rates of ischemic stroke or systemic embolism, ICH, and all-cause mortality compared with dabigatran, edoxaban, and rivaroxaban. This finding was consistent for patients aged 80 years or older and those with chronic kidney disease, who are often underrepresented in clinical trials. Primary funding source: None.
MeSH term(s)	Humans ; Administration, Oral ; Anticoagulants/adverse effects ; Atrial Fibrillation/drug therapy ; Cohort Studies ; Dabigatran/adverse effects ; Embolism/epidemiology ; Embolism/etiology ; Embolism/prevention & control ; Ischemic Stroke ; Renal Insufficiency, Chronic/complications ; Rivaroxaban/adverse effects ; United States ; Clinical Trials as Topic
Chemical Substances	Anticoagulants ; apixaban (3Z9Y7UWC1J) ; Dabigatran (I0VM4M70GC) ; edoxaban (NDU3J18APO) ; Rivaroxaban (9NDF7JZ4M3)
Language	English
Publishing date	2022-11-01
Publishing country	United States
Document type	Journal Article
ZDB-ID	336-0
ISSN	1539-3704 ; 0003-4819
ISSN (online)	1539-3704
ISSN	0003-4819
DOI	10.7326/M22-0511
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Article ; Online: Background rates of five thrombosis with thrombocytopenia syndromes of special interest for COVID-19 vaccine safety surveillance: Incidence between 2017 and 2019 and patient profiles from 38.6 million people in six European countries.

Burn, Edward / Li, Xintong / Kostka, Kristin / Stewart, Henry Morgan / Reich, Christian / Seager, Sarah / Duarte-Salles, Talita / Fernandez-Bertolin, Sergio / Aragón, María / Reyes, Carlen / Martinez-Hernandez, Eugenia / Marti, Edelmira / Delmestri, Antonella / Verhamme, Katia / Rijnbeek, Peter / Horban, Scott / Morales, Daniel R / Prieto-Alhambra, Daniel

Pharmacoepidemiology and drug safety

2022 Volume 31, Issue 5, Page(s) 495–510

MeSH term(s)	COVID-19/epidemiology ; COVID-19/prevention & control ; COVID-19 Vaccines/adverse effects ; Humans ; Incidence ; Syndrome ; Thrombocytopenia/chemically induced ; Thrombocytopenia/epidemiology ; Thrombosis/epidemiology
Chemical Substances	COVID-19 Vaccines
Language	English
Publishing date	2022-02-27
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	1099748-9
ISSN	1099-1557 ; 1053-8569
ISSN (online)	1099-1557
ISSN	1053-8569
DOI	10.1002/pds.5419
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Article: Risk of Arterial and Venous Thrombotic Events Among Patients with COVID-19: A Multi-National Collaboration of Regulatory Agencies from Canada, Europe, and United States.

Lo Re Iii, Vincent / Cocoros, Noelle M / Hubbard, Rebecca A / Dutcher, Sarah K / Newcomb, Craig W / Connolly, John G / Perez-Vilar, Silvia / Carbonari, Dena M / Kempner, Maria E / Hernández-Muñoz, José J / Petrone, Andrew B / Pishko, Allyson M / Rogers Driscoll, Meighan E / Brash, James T / Burnett, Sean / Cohet, Catherine / Dahl, Matthew / DeFor, Terese A / Delmestri, Antonella /

Djibo, Djeneba Audrey / Duarte-Salles, Talita / Harrington, Laura B / Kampman, Melissa / Kuntz, Jennifer L / Kurz, Xavier / Mercadé-Besora, Núria / Pawloski, Pamala A / Rijnbeek, Peter R / Seager, Sarah / Steiner, Claudia A / Verhamme, Katia / Wu, Fangyun / Zhou, Yunping / Burn, Edward / Paterson, J Michael / Prieto-Alhambra, Daniel

Clinical epidemiology

2024 Volume 16, Page(s) 71–89

Abstract: Purpose: Few studies have examined how the absolute risk of thromboembolism with COVID-19 has evolved over time across different countries. Researchers from the European Medicines Agency, Health Canada, and the United States (US) Food and Drug ... ...

Abstract	Purpose: Few studies have examined how the absolute risk of thromboembolism with COVID-19 has evolved over time across different countries. Researchers from the European Medicines Agency, Health Canada, and the United States (US) Food and Drug Administration established a collaboration to evaluate the absolute risk of arterial (ATE) and venous thromboembolism (VTE) in the 90 days after diagnosis of COVID-19 in the ambulatory (eg, outpatient, emergency department, nursing facility) setting from seven countries across North America (Canada, US) and Europe (England, Germany, Italy, Netherlands, and Spain) within periods before and during COVID-19 vaccine availability. Patients and methods: We conducted cohort studies of patients initially diagnosed with COVID-19 in the ambulatory setting from the seven specified countries. Patients were followed for 90 days after COVID-19 diagnosis. The primary outcomes were ATE and VTE over 90 days from diagnosis date. We measured country-level estimates of 90-day absolute risk (with 95% confidence intervals) of ATE and VTE. Results: The seven cohorts included 1,061,565 patients initially diagnosed with COVID-19 in the ambulatory setting before COVID-19 vaccines were available (through November 2020). The 90-day absolute risk of ATE during this period ranged from 0.11% (0.09-0.13%) in Canada to 1.01% (0.97-1.05%) in the US, and the 90-day absolute risk of VTE ranged from 0.23% (0.21-0.26%) in Canada to 0.84% (0.80-0.89%) in England. The seven cohorts included 3,544,062 patients with COVID-19 during vaccine availability (beginning December 2020). The 90-day absolute risk of ATE during this period ranged from 0.06% (0.06-0.07%) in England to 1.04% (1.01-1.06%) in the US, and the 90-day absolute risk of VTE ranged from 0.25% (0.24-0.26%) in England to 1.02% (0.99-1.04%) in the US. Conclusion: There was heterogeneity by country in 90-day absolute risk of ATE and VTE after ambulatory COVID-19 diagnosis both before and during COVID-19 vaccine availability.
Language	English
Publishing date	2024-02-10
Publishing country	New Zealand
Document type	Journal Article
ZDB-ID	2494772-6
ISSN	1179-1349
ISSN	1179-1349
DOI	10.2147/CLEP.S448980
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Article: Comparative Effectiveness of Second-line Antihyperglycemic Agents for Cardiovascular Outcomes: A Large-scale, Multinational, Federated Analysis of the LEGEND-T2DM Study.

Khera, Rohan / Aminorroaya, Arya / Dhingra, Lovedeep Singh / Thangaraj, Phyllis M / Camargos, Aline Pedroso / Bu, Fan / Ding, Xiyu / Nishimura, Akihiko / Anand, Tara V / Arshad, Faaizah / Blacketer, Clair / Chai, Yi / Chattopadhyay, Shounak / Cook, Michael / Dorr, David A / Duarte-Salles, Talita / DuVall, Scott L / Falconer, Thomas / French, Tina E /

Hanchrow, Elizabeth E / Kaur, Guneet / Lau, Wallis Cy / Li, Jing / Li, Kelly / Liu, Yuntian / Lu, Yuan / Man, Kenneth Kc / Matheny, Michael E / Mathioudakis, Nestoras / McLeggon, Jody-Ann / McLemore, Michael F / Minty, Evan / Morales, Daniel R / Nagy, Paul / Ostropolets, Anna / Pistillo, Andrea / Phan, Thanh-Phuc / Pratt, Nicole / Reyes, Carlen / Richter, Lauren / Ross, Joseph / Ruan, Elise / Seager, Sarah L / Simon, Katherine R / Viernes, Benjamin / Yang, Jianxiao / Yin, Can / You, Seng Chan / Zhou, Jin J / Ryan, Patrick B / Schuemie, Martijn J / Krumholz, Harlan M / Hripcsak, George / Suchard, Marc A

medRxiv : the preprint server for health sciences

2024

Abstract: Background: SGLT2 inhibitors (SGLT2is) and GLP-1 receptor agonists (GLP1-RAs) reduce major adverse cardiovascular events (MACE) in patients with type 2 diabetes mellitus (T2DM). However, their effectiveness relative to each other and other second-line ... ...

Abstract	Background: SGLT2 inhibitors (SGLT2is) and GLP-1 receptor agonists (GLP1-RAs) reduce major adverse cardiovascular events (MACE) in patients with type 2 diabetes mellitus (T2DM). However, their effectiveness relative to each other and other second-line antihyperglycemic agents is unknown, without any major ongoing head-to-head trials. Methods: Across the LEGEND-T2DM network, we included ten federated international data sources, spanning 1992-2021. We identified 1,492,855 patients with T2DM and established cardiovascular disease (CVD) on metformin monotherapy who initiated one of four second-line agents (SGLT2is, GLP1-RAs, dipeptidyl peptidase 4 inhibitor [DPP4is], sulfonylureas [SUs]). We used large-scale propensity score models to conduct an active comparator, target trial emulation for pairwise comparisons. After evaluating empirical equipoise and population generalizability, we fit on-treatment Cox proportional hazard models for 3-point MACE (myocardial infarction, stroke, death) and 4-point MACE (3-point MACE + heart failure hospitalization) risk, and combined hazard ratio (HR) estimates in a random-effects meta-analysis. Findings: Across cohorts, 16·4%, 8·3%, 27·7%, and 47·6% of individuals with T2DM initiated SGLT2is, GLP1-RAs, DPP4is, and SUs, respectively. Over 5·2 million patient-years of follow-up and 489 million patient-days of time at-risk, there were 25,982 3-point MACE and 41,447 4-point MACE events. SGLT2is and GLP1-RAs were associated with a lower risk for 3-point MACE compared with DPP4is (HR 0·89 [95% CI, 0·79-1·00] and 0·83 [0·70-0·98]), and SUs (HR 0·76 [0·65-0·89] and 0·71 [0·59-0·86]). DPP4is were associated with a lower 3-point MACE risk versus SUs (HR 0·87 [0·79-0·95]). The pattern was consistent for 4-point MACE for the comparisons above. There were no significant differences between SGLT2is and GLP1-RAs for 3-point or 4-point MACE (HR 1·06 [0·96-1·17] and 1·05 [0·97-1·13]). Interpretation: In patients with T2DM and established CVD, we found comparable cardiovascular risk reduction with SGLT2is and GLP1-RAs, with both agents more effective than DPP4is, which in turn were more effective than SUs. These findings suggest that the use of GLP1-RAs and SGLT2is should be prioritized as second-line agents in those with established CVD. Funding: National Institutes of Health, United States Department of Veterans Affairs.
Language	English
Publishing date	2024-02-08
Publishing country	United States
Document type	Preprint
DOI	10.1101/2024.02.05.24302354
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Book: Excuse my dust

Seager, Sarah

1994

Author's details	Sarah Seager
Language	English
Size	[87] Bl, Ill, 21 cm
Publisher	Imschoot
Publishing place	Gent
Document type	Book
ISBN	9072191749 ; 9789072191748
Database	Former special subject collection: coastal and deep sea fishing

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Article ; Online: Background rates of five thrombosis with thrombocytopenia syndromes of special interest for COVID-19 vaccine safety surveillance: incidence between 2017 and 2019 and patient profiles from 20.6 million people in six European countries

Burn, Edward / Li, Xintong / Kostka, Kristin / Morgan Stewart, Henry / Reich, Christian / Seager, Sarah / Duarte-Salles, Talita / Fernandez-Bertolin, Sergio / Aragón, María / Reyes, Carlen / Martinez-Hernandez, Eugenia / Marti, Edelmira / Delmestri, Antonella / Verhamme, Katia / Rijnbeek, Peter / PRIETO-ALHAMBRA, DANIEL

medRxiv

Abstract: Background Thrombosis with thrombocytopenia syndrome (TTS) has been reported among individuals vaccinated with adenovirus-vectored COVID-19 vaccines. In this study we describe the background incidence of TTS in 6 European countries. Methods Electronic ... ...

Abstract	Background Thrombosis with thrombocytopenia syndrome (TTS) has been reported among individuals vaccinated with adenovirus-vectored COVID-19 vaccines. In this study we describe the background incidence of TTS in 6 European countries. Methods Electronic medical records from France, Netherlands, Italy, Germany, Spain, and the United Kingdom informed the study. Incidence rates of cerebral venous sinus thrombosis (CVST), splanchnic vein thrombosis (SVT), deep vein thrombosis (DVT), pulmonary embolism (PE), and stroke, all with concurrent thrombocytopenia, were estimated among the general population between 2017 to 2019. A range of additional adverse events of special interest for COVID-19 vaccinations were also studied in a similar manner. Findings A total of 20,599,134 individuals were included. Background rates ranged from 1.0 (0.7 to 1.4) to 1.5 (1.0 to 2.0) per 100,000 person-years for DVT with thrombocytopenia, from 0.5 (0.3 to 0.6) to 1.4 (1.1 to 1.8) for PE with thrombocytopenia, from 0.1 (0.0 to 0.1) to 0.7 (0.5 to 0.9) for SVT with thrombocytopenia, and from 0.2 (0.0 to 0.4) to 4.4 (3.9 to 5.0) for stroke with thrombocytopenia. CVST with thrombocytopenia was only identified in one database, with incidence rate of 0.1 (0.0 to 0.2) per 100,000 person-years. The incidence of TTS increased with age, with those affected typically having more comorbidities and greater medication use than the general population. TTS was also more often seen in men than women. A sizeable proportion of those affected were seen to have been taking antithrombotic and anticoagulant therapies prior to their TTS event. Interpretation Although rates vary across databases, TTS has consistently been seen to be a very rare event among the general population. While still very rare, rates of TTS are typically higher among older individuals, and those affected were also seen to generally be male and have more comorbidities and greater medication use than the general population. Funding This study was funded by the European Medicines Agency (EMA/2017/09/PE Lot 3).
Keywords	covid19
Language	English
Publishing date	2021-05-13
Publisher	Cold Spring Harbor Laboratory Press
Document type	Article ; Online
DOI	10.1101/2021.05.12.21257083
Database	COVID19

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Your chosen title can be delivered directly to ZB MED Cologne location if you are registered as a user at ZB MED Cologne.

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In stock of ZB MED Cologne/Königswinter

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In stock of ZB MED Cologne/Königswinter

Order via subito

More links

Kategorien

Order via subito

Inter-library loan at ZB MED

More links

Kategorien

In stock of ZB MED Cologne/Königswinter

Order via subito

Full text online

More links

Kategorien

In stock of ZB MED Cologne/Königswinter

Order via subito

More links

Kategorien

Order via subito

More links

Kategorien

Inter-library loan at ZB MED

More links

Kategorien

Order via subito

Inter-library loan at ZB MED

Full text online

Kategorien

Inter-library loan at ZB MED