Explanipedia

Post‐authorisation safety study to assess the risk of urinary tract cancer in people with type 2 diabetes initiating empagliflozin: A multi‐country European study Open

Niklas Schmedt, Ayman Alhamdow, Giorgi Tskhvarashvili, Laura Saarelainen, Xu Qiao , et al. · 2025

Aims This study aimed to assess the risk of urinary tract cancers (UTCs), including bladder and renal cancers, in people with type 2 diabetes (T2D) initiating empagliflozin compared with people initiating any dipeptidyl peptidase‐4 inhibit…

The sustained increase of cardiovascular risk following COPD exacerbations: meta-analyses of the EXACOS-CV studies Open

Clémentine Nordon, Sami O. Simons, Jonathan Marshall, Hana Müllerová, Michael Pollack , et al. · 2024

Background The EXAcerbations of COPD and their OutcomeS on CardioVascular disease (EXACOS-CV) multi-database studies have consistently shown an increased risk of serious cardiovascular event following COPD exacerbations, but with some risk…

Persistence of advanced systemic pharmacological treatment of moderate‐to‐severe psoriasis among bio‐naïve patients—A retrospective register‐based cohort study in Finland and Sweden Open

Giorgi Tskhvarashvili, Kunal Aher, I. Sveide, Urmeli Katus, Anna Westerlund , et al. · 2024

Background Plaque psoriasis (PsO) requires long‐term treatment for symptom control and remission; thus, a long‐term pharmacological intervention is necessary. Treatment persistence reflects long‐term therapeutic effectiveness and tolerance…

Long-Term Safety of Roflumilast in Patients with Chronic Obstructive Pulmonary Disease, a Multinational Observational Database Cohort Study Open

Edeltraut Garbe, Fabian Hoti, Tania Schink, Kristian Svendsen, Haydar Al-Eid , et al. · 2024

There was no observed increase in 5-year mortality risk with the use of roflumilast in Sweden or Norway. A small increase in 5-year mortality risk was observed in Germany and the US in the ever versus never comparison, likely due to residu…

Empagliflozin Use Is Associated With Lower Risk of All‐Cause Mortality, Hospitalization for Heart Failure, and End‐Stage Renal Disease Compared to DPP‐4i in Nordic Type 2 Diabetes Patients: Results From the EMPRISE (Empagliflozin Comparative Effectiveness and Safety) Study Open

Gisle Langslet, Thomas Nyström, Dorte Vistisen, Bendix Carstensen, Emilie Toresson Grip , et al. · 2024

Objective : To evaluate the effectiveness of empagliflozin in reducing all‐cause mortality (ACM), hospitalization for heart failure (HHF), myocardial infarction (MI), stroke, cardiovascular mortality (CVM), and end‐stage renal disease (ESR…

Risk of cardiovascular events after an exacerbation of chronic obstructive pulmonary disease: results from the EXACOS-CV cohort study using the PHARMO Data Network in the Netherlands Open

Karin M. A. Swart, Brenda N. Baak, Louise Lemmens, Fernie J. A. Penning‐van Beest, Camilla Bengtsson , et al. · 2023

Empagliflozin is associated with lower cardiovascular risk compared with dipeptidyl peptidase-4 inhibitors in adults with and without cardiovascular disease: EMPagliflozin compaRative effectIveness and SafEty (EMPRISE) study results from Europe and Asia Open

Dorte Vistisen, Bendix Carstensen, Patorno E Elisabetta, Stefanie Lanzinger, Elise Tan , et al. · 2023

Empagliflozin cardiovascular and renal effectiveness and safety compared to dipeptidyl peptidase-4 inhibitors across 11 countries in Europe and Asia: Results from the EMPagliflozin compaRative effectIveness and SafEty (EMPRISE) study Open

Avraham Karasik, Stefanie Lanzinger, Elise Tan, Daisuke Yabe, Dae Jung Kim , et al. · 2023

Validation of safety outcomes in routinely collected data: Lessons learned from a multinational postapproval safety study Open

Patrick J. Arena, Kui Huang, Lukas Löfling, Shahram Bahmanyar, Jingping Mo , et al. · 2022

Cardiovascular outcomes with sodium–glucose cotransporter-2 inhibitors vs other glucose-lowering drugs in 13 countries across three continents: analysis of CVD-REAL data Open

Kamlesh Khunti, Mikhail Kosiborod, Dae Jung Kim, Shun Kohsaka, Carolyn S.P. Lam , et al. · 2021

Outcomes in patients with lung cancer treated with crizotinib and erlotinib in routine clinical practice: A post‐authorization safety cohort study conducted in Europe and in the United States Open

Véra Ehrenstein, Kui Huang, Johnny Kahlert, Shahram Bahmanyar, Pär Karlsson , et al. · 2021

Purpose We examined safety outcomes of interest (SOI) and overall survival (OS) among lung cancer patients initiating crizotinib and erlotinib in routine clinical practice. Methods This descriptive cohort study used routinely collected hea…

Evaluating the Effectiveness of an Additional Risk Minimization Measure to Reduce the Risk of Prescribing Mirabegron to Patients with Severe Uncontrolled Hypertension in Four European Countries Open

Heintjes EM, Bezemer ID, Daniel Prieto‐Alhambra, Elisabeth Smits, Booth HP , et al. · 2020

Edith M Heintjes,1 Irene D Bezemer,1 Daniel Prieto-Alhambra,2,3 Elisabeth Smits,1 Helen P Booth,4 Daniel Dedman,4 Ying He,3 Fabian Hoti,5 Minna Vehkala,5 Stefan de Vogel,6 Noah Jamie Robinson,6 Kwame Appenteng,7 Fernie JA Penning-van Beest…

Evaluating the Effectiveness of an Additional Risk Minimization Measure to Reduce the Risk of Prescribing Mirabegron to Patients with Severe Uncontrolled Hypertension in Four European Countries Open

Edith M. Heintjes, Irene D. Bezemer, Daniel Prieto‐Alhambra, Elisabeth Smits, Helen Booth , et al. · 2020

Severe uncontrolled hypertension prior to mirabegron initiation was uncommon in these four European countries even before DHPC dissemination. This suggests that other risk minimisation communications (prior to the DHPC dissemination) had w…

Health and work disability outcomes in parents of patients with schizophrenia associated with antipsychotic exposure by the offspring Open

Heidi Taipale, Syed Rahman, Antti Tanskanen, Juha Mehtälä, Fabian Hoti , et al. · 2020

Use of postmenopausal hormone therapy and risk of Alzheimer’s disease in Finland: nationwide case-control study Open

Hanna Savolainen‐Peltonen, Päivi Rahkola‐Soisalo, Fabian Hoti, Pia Vattulainen, Mika Gissler , et al. · 2019

Objectives To compare the use of hormone therapy between Finnish postmenopausal women with and without a diagnosis for Alzheimer’s disease. Design Nationwide case-control study. Setting Finnish national population and drug register, betwee…

Different patterns of second‐line treatment in type 2 diabetes after metformin monotherapy in Denmark, Finland, Norway and Sweden (D360 Nordic): A multinational observational study Open

Frederik Persson, Johan Bodegård, Jorma Lahtela, Thomas Nyström, Marit E. Jørgensen , et al. · 2018

Summary Aims The understanding of second‐line use of glucose‐lowering drugs ( GLD s) in the general population with type 2 diabetes (T2D) treatment is important as recent results have shown cardiovascular benefits with sodium‐glucose cotra…

Burden for Parents of Patients With Schizophrenia—A Nationwide Comparative Study of Parents of Offspring With Rheumatoid Arthritis, Multiple Sclerosis, Epilepsy, and Healthy Controls Open

Ellenor Mittendorfer‐Rutz, Syed Rahman, Antti Tanskanen, Maila Majak, Juha Mehtälä , et al. · 2018

Parents of patients with schizophrenia have a considerably higher risk of psychiatric health care and social welfare benefit receipt than other parents. Psychiatric health care use worsens over time and with increasing disease severity of …

Increased risk for stress urinary incontinence in women with postmenopausal hormone therapy Open

Päivi Rahkola‐Soisalo, Hanna Savolainen‐Peltonen, Mika Gissler, Fabian Hoti, Pia Vattulainen , et al. · 2018

Pioglitazone use and risk of bladder cancer: a systematic literature review and meta-analysis of observational studies Open

Juha Mehtälä, Houssem Khanfir, Dimitri Bennett, Yizhou Ye, Pasi Korhonen , et al. · 2018

Real-world Effectiveness of Pharmacologic Treatments for the Prevention of Rehospitalization in a Finnish Nationwide Cohort of Patients With Bipolar Disorder Open

Markku Lähteenvuo, Antti Tanskanen, Heidi Taipale, Fabian Hoti, Pia Vattulainen , et al. · 2018

Lithium was the most effective mood stabilizer, and long-acting injections the most effective antipsychotics, in preventing hospitalization due to mental or physical illness.

Exacerbations and healthcare resource utilization among COPD patients in a Swedish registry-based nation-wide study Open

Gunnar Johansson, Vasili Mushnikov, Tobias Bäckström, Andreas Engström, Mona Aeysha Khalid , et al. · 2018

COPD/CB patients with history of severe exacerbations and high use of COPD medication experienced a significantly increased rate of severe exacerbations and healthcare resource utilization during the one-year follow-up.

Pioglitazone and cause-specific risk of mortality in patients with type 2 diabetes: extended analysis from a European multidatabase cohort study Open

Helen Strongman, Solomon Christopher, Maila Majak, Rachael Williams, Shahram Bahmanyar , et al. · 2018

Objectives Describe and compare the risk of cardiovascular and non-cardiovascular mortality in patients whose antidiabetic therapy is modified to include pioglitazone compared with an alternative antidiabetic medication at the same stage o…

Real-World Effectiveness of Antipsychotic Treatments in a Nationwide Cohort of 29 823 Patients With Schizophrenia Open

Jari Tiihonen, Ellenor Mittendorfer‐Rutz, Maila Majak, Juha Mehtälä, Fabian Hoti , et al. · 2017

Clozapine and long-acting injectable antipsychotic medications were the pharmacologic treatments with the highest rates of prevention of relapse in schizophrenia. The risk of rehospitalization is about 20% to 30% lower during long-acting i…

Pioglitazone and risk of mortality in patients with type 2 diabetes: results from a European multidatabase cohort study Open

Helen Strongman, Pasi Korhonen, Rachael Williams, Shahram Bahmanyar, Fabian Hoti , et al. · 2017

Objectives Estimate and compare the risk of mortality in patients whose antidiabetic therapy is modified to include pioglitazone compared with an alternative antidiabetic medication at the same stage of disease progression. Design Retrospe…

Lower Death Risk for Vascular Dementia than for Alzheimer’s Disease with Postmenopausal Hormone Therapy Users Open

Tomi S. Mikkola, Hanna Savolainen‐Peltonen, Pauliina Tuomikoski, Fabian Hoti, Pia Vattulainen , et al. · 2016

Estradiol-based HT use is associated with a reduced risk of death from both VD and AD, but the risk reduction is larger and appears sooner in VD than AD.

Pioglitazone use and risk of bladder cancer in patients with type 2 diabetes: retrospective cohort study using datasets from four European countries Open

Pasi Korhonen, Edith M. Heintjes, Rachael Williams, Fabian Hoti, Solomon Christopher , et al. · 2016

Registered to the European Union electronic register of post-authorisation studies (EU PAS register no EUPAS3626).

Cardiac Death Risk in Relation to the Age at Initiation or the Progestin Component of Hormone Therapies Open

Hanna Savolainen‐Peltonen, Pauliina Tuomikoski, Pasi Korhonen, Fabian Hoti, Pia Vattulainen , et al. · 2016

Estradiol-based hormone therapies are accompanied with larger CHD mortality risk reductions the earlier the therapies are initiated. The progestin component of EPT does not modify this "timing effect."

All-Cause and Cause-Specific Mortality among Users of Basal Insulins NPH, Detemir, and Glargine Open

Arto Y. Strandberg, Fabian Hoti, Timo Strandberg, Solomon Christopher, Jari Haukka , et al. · 2016

In real clinical practice, mortality was substantially higher among users of NPH insulin as compared to insulins detemir or glargine. Considering the large number of patients who require insulin therapy, this difference in risk may have ma…

Vaginal estradiol use and the risk for cardiovascular mortality Open

Tomi S. Mikkola, Pauliina Tuomikoski, Heli Lyytinen, Pasi Korhonen, Fabian Hoti , et al. · 2016

This work was supported by unrestricted grants from the Päivikki and Sakari Sohlberg Foundation, the Emil Aaltonen Foundation, the Finnish Medical Foundation, Finska Läkaresällskapet, the Orion Farmos Research Foundation, the Paavo Nurmi F…

Increased Cardiovascular Mortality Risk in Women Discontinuing Postmenopausal Hormone Therapy Open

Tomi S. Mikkola, Pauliina Tuomikoski, Heli Lyytinen, Pasi Korhonen, Fabian Hoti , et al. · 2015

Increased cardiovascular death risks question the safety of annual HT discontinuation practice to evaluate whether a woman could manage without HT.

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