Espen Jimenez-Solem

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Verified

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• MD, PhD
• Professor (Full) at University of Copenhagen

Introduction: Elexacaftor/tezacaftor/ivacaftor (ETI) has been shown to substantially improve clinical outcomes among people living with cystic fibrosis (pwCF). The impact of ETI on health care resource utilization in the context of universal health care is largely unknown. We aimed to assess the impact of ETI on hospital and non-hospital health ca...

Background Opioid treatment in postoperative pain management is crucial, but the impact of administration practices on outcomes is unclear. The hypothesis was that prescription trends remained stable over recent years, and that no difference in mortality and readmission risks is associated with prescription strategies. Method Electronic health rec...

Background Dyslipidemia is a known risk factor for cardiovascular disease. While statins are the primary treatment, some individuals require additional lipid-lowering therapies, such as proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors. Alirocumab and evolocumab have shown efficacy in reducing low-density lipoprotein cholesterol (LDL...

Introduction Baricitinib received European Medicines Agency (EMA) approval for the treatment of moderate‐to‐severe active rheumatoid arthritis (RA) in 2017. Due to risks including serious infections, increased blood lipid parameters, and missing information regarding safety in pregnancy, additional risk minimization measures (aRMM) including health...

OBJECTIVE Developments in pharmacotherapy and management of type 2 diabetes may have shifted the balance of treatment benefits versus harms and costs over the past decades. This study aimed to describe the trends in this balance. RESEARCH DESIGN AND METHODS We followed the Danish population with type 2 diabetes between 2002 and 2020, analyzing the...

Background People living with cystic fibrosis in Denmark had early, universal access to triple modulator treatment with elexacaftor/tezacaftor/ivacaftor. Close monitoring allowed us to assess the impact of treatment on lung function and progression of lung disease in an unselected nationwide cystic fibrosis population from 6 years of age. Methods...

Introduction Drug trials in neonates are scarce, and the neonates may consequently be at risk of adverse drug reactions (ADRs). Spontaneous ADR reporting is an important tool for expanding the knowledge on drug safety in neonates. This study explores the quality of current neonatal ADR reports and the ADR reports of the most common drugs used in ne...

OBJECTIVE Type 2 diabetes often coexists with other conditions that are amenable to pharmacological treatment. We hypothesized that polypharmacy among individuals with type 2 diabetes has increased since 2000. RESEARCH DESIGN AND METHODS Using Danish national registries, we established a cohort of all Danish individuals (aged ≥18 years) with type...

Importance Becoming a first-time parent is a major life-changing event and can be challenging regardless of the pregnancy outcome. However, little is known how different adverse pregnancy outcomes affect the father’s risk of psychiatric treatment post partum. Objective To examine the associations of adverse pregnancy outcomes with first-time psych...

Cerebral microbleeds (CMB) are frequent incidental findings on brain magnetic resonance imaging (MRI) and have previously been shown to occur in Coronavirus Disease 2019 (COVID-19) cohorts of critically ill patients. We aimed to determine the risk of having microbleeds on medically indicated brain MRI and compare non-hospitalized COVID-19 infected...

Objective This study aims to evaluate the developments in the testing of Kirsten Rat Sarcoma viral oncogene homolog (KRAS) and v‐Raf murine sarcoma viral oncogene homolog B1 (BRAF) mutations across different cancer types and regions in Denmark from 2010 to 2022. Study design and setting Using comprehensive data from the Danish health registries, w...

Aim To explore the impact of type 2 diabetes (T2D), glycaemic control and use of glucose‐lowering medication on clinical outcomes in hospitalized patients with COVID‐19. Materials and Methods For all patients admitted to a hospital in the Capital Region of Denmark (1 March 2020 to 1 December 2021) with confirmed COVID‐19, we extracted data on mort...

Introduction A feared complication after total hip arthroplasty (THA) is prosthetic joint infection (PJI), associated with high morbidity and mortality. Prophylactic antibiotics can reduce the risk of PJI. However, there is no consensus on the dosages and current recommendations are based on a low evidence level. The objective is to compare the eff...

Addressing dyslipidaemia, a condition involving abnormal amounts of lipids in the blood, is crucial due to its strong association with cardiovascular disease. Anti-proprotein convertase subtilisin/kexin type 9 (PCSK9) drugs like alirocumab and evolocumab offer promising therapeutic solutions. Here we show, from our register-based cohort study in th...

Objective: To identify PaCO2 trajectories and assess their associations with mortality in critically ill patients with coronavirus disease 2019 (COVID-19) during the first and second waves of the pandemic in Denmark. Design: A population-based cohort study with retrospective data collection. Patients: All COVID-19 patients treated in eight int...

Objectives: We aimed to characterize the advanced NSCLC population in terms of KRAS G12C prevalence, patient characteristics, and survival outcomes after the introduction of immunotherapies. Materials and methods: We identified adult patients diagnosed with advanced NSCLC between January 1, 2018 and June 30, 2021 using the Danish health registri...

Objectives : There are no international guidelines on how the requirements for added clinical value (endpoints) should be prepared in terms of drug safety in health technology assessments (HTAs). The study aimed to review the Danish Medicines Council's drug safety endpoints Methods : Safety endpoints for 50 treatments were reviewed, of which 25 we...

Background Depression or depressive symptoms are common among pregnant women. The use of antidepressants during pregnancy has grown steadily. The risk of offspring being born small for gestational age or prematurely when exposed to duloxetine during pregnancy is not established.Objective We aimed to investigate the association between duloxetine ex...

The current report briefly summarizes the experiences and statistics of the Adverse Drug Event Manager (ADEM) covering the Capital Region of Denmark, Denmark, during the period 1 January 2013 to 31 December 2020. During this 8-year period, the ADEM function has reported a total of 4262 adverse drug reactions (ADRs) to the Danish Medicines Agency, a...

Objectives To investigate healthcare resource utilization (HRU) and associated costs by depression severity and year of diagnosis among patients with treatment-resistant depression (TRD) in Denmark. Methods Including all adult patients with a first-time hospital contact for major depressive disorder (MDD) in 1996–2015, TRD patients were defined at...

Background Discontinuation of antipsychotic medication may be linked to high risk of relapse, hospitalization and mortality. This study investigated the use and discontinuation of antipsychotics in individuals with first-episode schizophrenia in relation to cohabitation, living with children, employment, hospital admission and death. Methods Danis...

Background The chronic systemic inflammation associated with psoriasis supposedly creates an undesirable milieu for a pregnancy, resulting in an increased risk of adverse pregnancy outcomes (APOs). Objective To investigate the association between psoriasis and APOs as well as how the association differs according to psoriasis severity (mild and mo...

During the COVID-pandemic, patients diagnosed with diabetes have been overrepresented among patients admitted to hospital with COVID-19. We explored the impact of diabetes on mortality and clinical outcomes in hospitalized patients with COVID-in the Capital Region of Denmark. All patients from the Capital Region of Denmark admitted to hospital with...

Tramadol is a commonly used opioid with a potential of addiction and abuse. Using Danish nationwide registers, we aimed to (1) characterise opioid poisonings; (2) assess the 30‐day mortality following morphine, oxycodone, and mixed poisonings compared to tramadol poisonings; and (3) assess the development in tramadol poisonings during a 12‐year per...

Introduction: In patients with short bowel syndrome (SBS), severe malabsorption may cause a need for parenteral support and, by definition, these patients suffer from SBS intestinal failure. Absorption of oral medications is likely diminished in patients with SBS intestinal failure and higher than normal doses may be required to achieve sufficient...

Introduction: In Denmark, physicians are legally obliged to report serious adverse drug reactions (ADRs), such as intracranial hemorrhage (ICH) following anticoagulant (AC) treatment, to the Danish Medicines Agency. We were therefore puzzled to discover a high number of reports concerning ICHs following treatment with the direct oral anticoagulant...

Objective: To investigate whether exposure to tramadol during early pregnancy is associated with an increased risk of spontaneous abortion or major congenital malformations. Methods: The study is a nationwide cohort study including all registered pregnancies in Denmark between January 1, 1997, and December 31, 2016. The Danish National Prescript...

Introduction The antipsychotic drug clozapine remains underutilized partly because of the risk of life-threatening adverse effects, such as neutropenia. Therefore, an extensive hematological monitoring program was set up to detect neutropenia. Methods In this retrospective cohort study, we used registry-based data from the Capital Region of Denmar...

Objectives To evaluate safety and effectiveness of prophylactic anticoagulation with low molecular weight heparin (LMWH) in individuals hospitalised for COVID-19. Methods Using healthcare records from the capital region of Denmark (March 2020-February 2021) and Karolinska University Hospital in Sweden (February 2020-September 2021), we conducted a...

Background Women with certain inflammatory diseases have increased risk of giving birth to infants who are small for gestational age (SGA) or preterm birth (PTB), with maternal disease activity being the most important risk factor. However, studies investigation psoriasis and SGA are scarce, and with conflicting results. Objective To investigate t...

Background The prevalence of depression and the exposure to antidepressants are high among women of reproductive age and during pregnancy. Duloxetine is a selective serotonin-norepinephrine reuptake inhibitor (SNRI) approved in the United States and Europe in 2004 for the treatment of depression. Fetal safety of duloxetine is not well established....

Aims: The aim of this study is to compare the effectiveness and safety of thromboprophylactic treatments in patients undergoing primary total knee arthroplasty (TKA). Methods: Using nationwide medical registries, we identified patients with a primary TKA performed in Denmark between 1 January 2013 and 31 December 2018 who received thromboprophyl...

The COVID-19 pandemic has put massive strains on hospitals, and tools to guide hospital planners in resource allocation during the ebbs and flows of the pandemic are urgently needed. We investigate whether machine learning (ML) can be used for predictions of intensive care requirements a fixed number of days into the future. Retrospective design wh...

Previous studies on the prevalence of drug-drug interactions (DDIs) have largely been restricted to specific hospital departments. We identified common drug combinations and potential drug-drug interactions (pDDIs) in an entire hospital population throughout 1 year. Frequently administered drug combinations involved analgesics, cardiovascular medic...

Background With increasing demand for total hip arthroplasty (THA) and total knee arthroplasty (TKA), a higher percentage of patients are identified with comorbidities that might increase the risk of complications. We aimed to elucidate the preoperative characteristics of patients with a fatal outcome or admission to the Intensive Care Unit (ICU) w...

Randomised controlled trials have shown a neutral or even unfavourable risk–benefit balance of aspirin for primary prevention of cardiovascular events. Using Danish nationwide registries, we investigated aspirin use and associated risks during the past two decades (1998–2018). We linked individual patient data on repeated aspirin redemptions with r...

Background The disease course of inflammatory bowel disease (IBD) following treatment with glucagon-like peptide (GLP)-1 based therapies is unclear. The aim of this study was to examine the disease course of IBD in patients treated with GLP-1 based therapies compared with treatment with other antidiabetics. Methods Using nationwide Danish registri...

We aimed to characterise the in-hospital analgesic use among total hip or knee arthroplasty (THA or TKA) patients, and to identify possible drug-related challenges. We identified 15,263 patients operated with a THA or TKA between 1 January 2012 and 30 April 2016. The prevalence of analgesic users and patients with potential clinically relevant drug...

Background Depression and antidepressant treatment are widespread among women of childbearing age.Objective This study evaluates the association between duloxetine exposure during pregnancy and spontaneous and elective abortions.Patients and Methods The nationwide, observational study based on register data from Denmark included women with a record...

Purpose To describe the use of tramadol and other analgesics in Denmark focusing on the impact of media attention (June and December 2017) and regulatory actions (September 2017 and January 2018) on the use of tramadol. Methods Using nationwide registries, we identified all adults who filled a prescription for tramadol and other analgesics from 20...

Importance: The COVID-19 pandemic has put massive strains on hospitals, and tools to guide hospital planners in resource allocation during the ebbs and flows of the pandemic are urgently needed. Objective: We investigate whether Machine Learning (ML) can be used for predictions of intensive care requirements 5 and 10 days into the future. Design: R...

Objective : To describe treatment patterns in patients with treatment-resistant depression (TRD) and major depressive disorder (MDD) stratified by depression severity and year of diagnosis. Patterns of treatment were also compared to country-specific guidelines. Methods : All adults registered first time with a hospital contact due to MDD from 199...

Patients with severe COVID-19 have overwhelmed healthcare systems worldwide. We hypothesized that machine learning (ML) models could be used to predict risks at different stages of management and thereby provide insights into drivers and prognostic markers of disease progression and death. From a cohort of approx. 2.6 million citizens in Denmark, S...

The aim of this study was to validate registration of pharmacological treatment in the Danish Hip Arthroplasty Register (DHR) and Danish Knee Arthroplasty Register (DKR). We conducted a population‐based study in the Capital Region of Denmark, January 2012 to April 2016. Positive predictive value (PPV) and sensitivity were calculated with 95% confid...

Background Psoriasis is a disease that extends beyond the skin with profound medical, social and mental health implications. To our knowledge no previous studies have specifically investigated the medical and socioeconomic characteristics of women with psoriasis compared to women without psoriasis. Objectives We investigated 1) whether women with...

Background Patients with severe COVID-19 have overwhelmed healthcare systems worldwide. We hypothesized that Machine Learning (ML) models could be used to predict risks at different stages of management (at diagnosis, hospital admission and ICU admission) and thereby provide insights into drivers and prognostic markers of disease progression and de...

The means by which patients acquire their medications differ between countries, and a knowledge of this is essential when conducting and interpreting pharmacoepidemiological studies. The aim of this paper is to provide an overview of how patients obtain medicines in Denmark, to relate these to nationwide registries available for research, and to di...

Introduction: The aim of this study was to examine the prevalence and characteristics of tramadol users in Denmark, Norway and Sweden. Methods: Data from the national prescription databases comprising the entire population of Denmark, Norway and Sweden between 2007 and 2015 were used to assess prescription medicine use and sold amount (in define...

Brand-name adalimumab (Humira, hereinafter originator) is by far the most cost-intensive pharmaceutical product in the US with global sales of $19.9 billion in 2018.¹ Five adalimumab biosimilars have been approved by the US Food and Drug Administration, but none are marketed owing to patent disputes. The first to become marketed is expected in Janu...

Treatment guidelines for type 2 diabetes (T2D) recommend avoidance of hypoglycemia and less stringent glycemic control in older patients. We examined the relation of glycemic control to glucose-lowering medications use in a cohort of patients aged>80 years with a diagnosis of T2D and a hospital admission in the Capital Region of Denmark in 2012–201...

Introduction: Pain assessment in people with dementia is difficult, and withdrawal of analgesics may allow for assessment of treatment efficacy whilst decreasing pill burden, adverse events and interactions. We aimed to describe the use of analgesics among elderly in Denmark and to compile the evidence for withdrawal of analgesics among people wit...

In this narrative review of the real-world effectiveness and safety of pharmacological thromboprophylaxis following primary total hip and knee arthroplasty, a total of 12 non-interventional observational studies were included. Pharmacological thromboprophylaxis included warfarin, heparins, dabigatran, rivaroxaban, apixaban, acetylsalicylic acid, an...

Objectives: Bisacodyl and sodium picosulfate are classified both as stimulant laxatives, approved for short-term treatment of constipation and sold without prescription (OTC). Stimulant laxatives are associated with harmful long-term colonic effects and possible carcinogenic risk – and evidence support that these agents are used for longer periods....

Background Calcium channel blockers (CCBs) are widely used drugs that have a narrow therapeutic index. Even minor overdoses must be treated in-hospital due to the risk of severe hypotension and bradycardia. We aimed to describe trends in CCB use and overdoses in Denmark. Methods Data on enquiries concerning CCBs reported to the Danish Poisons Info...

INTRODUCTION: Antimicrobial stewardship programmes recommend use of narrow-spectrum antibiotics as first-line treatment of childhood pneumonia in secondary care. The primary aim of the present study was to assess whether current guidelines are followed. A secondary aim was to assess if tracheal aspiration is a useful tool in the diagnostic process...

Purpose To investigate whether exposure to antazoline‐naphazoline eye drops in the first trimester of pregnancy was associated with an increased risk of malformations in humans. Methods All women giving live birth between 1997 and 2011 in Denmark were included in this nationwide cohort study. All women redeeming at least one prescription of antazo...

Recent research suggests that women with polycystic ovary syndrome (PCOS) have a higher risk of asthma. However, the severity of asthma, use of antiasthma medication and effect on fertility have yet to be investigated. In a case–control cross-sectional registry study using the Danish National Patient Register and other Danish registries, asthma pre...

Psoriasis is a chronic immune-mediated inflammatory disease affecting women of childbearing potential. Biologic agents, notably Tumor Necrosis Factor inhibitors (TNFi), are the only current non-contraindicated systemic treatment option during pregnancy. TNFi comprised of complete immunoglobulin G (IgG) antibodies antibodies (adalimumab, golimumab,...

Aims: Registries on in-hospital drug use are sparse, especially those that can be linked to nationwide registries. In this study, we present and validate the Electronic Patient Medication module (EPM)-the electronic administrative database on in-hospital drug use covering the Capital Region of Denmark. Methods: The research database (EPM-researc...

Aim Hemorrhoids are common during pregnancy. In spite of this, safety of their pharmacological treatment has not been assessed. The aim of this study is to determine the association between exposure to antihemorrhoidal agents during the first trimester and congenital malformations. Methods We identified all pregnancies resulting in a live birth bet...

Background: Recently, concern has been raised in Danish media regarding tramadol's addictive properties. To assess whether use of tramadol is of national public health concern, we examined the prevalence of tramadol users in Denmark, and compared it with Norway and Sweden. Methods: The cohort constitutes the entire population of Denmark, Norway, an...

Objective: To study the association between paternal exposure to methotrexate within the 90-day period before pregnancy and congenital malformations and stillbirth in the offspring. Methods: We conducted a nationwide register study. Our cohort consisted of all live births in Denmark between 1997 and 2011 identified from the Medical Birth Registr...

Aims: In vitro studies have demonstrated that formation of reactive oxygen species (ROS) contributes to the effect of bactericidal antibiotics. The formation of ROS is not restricted to bacteria, but also occurs in mammalian cells. Oxidative stress is linked to several diseases. This study investigates whether antibiotic drugs induce oxidative str...

Introduction: Spontaneous reporting of adverse drug reactions (ADRs) is used for continuous risk-benefit evaluation of marketed pharmaceutical products and for signal detection. The Adverse Drug Event Manager (ADEM) is a service offered to clinicians employed at hospitals in the Capital Region of Denmark. The ADEM assists healthcare professionals...

Introduction Misoprostol can be used in the prevention of gastric ulcer in treatment with diclofenac and is used in rheumatic diseases. Since misoprostol causes contractions of the uterus, it can also be used to induce abortions when administrated vaginally. The aim of the study was to investigate if early pregnancy exposure to oral diclofenac/miso...

Mebendazole and pyrvinium are anthelmintics used to treat infections with pinworms, a common infection in children. Other indications for treatment with mebendazole are infections with soil-transmitted helminths. These infections are rare in Denmark, but affect more than 1.5 billion people worldwide. Limited safety data of anthelmintics during preg...

Trimethoprim antagonize the actions of folate by inhibition of dihydrofolate reductase. This could diminish serum folate levels in humans and causes folate deficiency in some patients. We conducted a randomized, double-blind, placebo-controlled trial, to investigate the effect of trimethoprim on serum folate levels in healthy participants after a 7...

Introduction: Misoprostol can be used in the prevention of gastric ulcer in treatment with diclofenac and is used in rheumatic diseases. Since misoprostol causes contractions of the uterus, it can also be used to induce abortions when administrated vaginally. The aim of the study was to investigate if early pregnancy exposure to oral diclofenac/mi...

Background Spontaneous reporting of suspected adverse drug events (ADEs) by health professionals is a cornerstone in pharmacovigilance and an important source from which to generate new adverse drug reaction (ADR) signals. However, under-reporting is a major challenge. Objective The aim of this study was to increase the number of spontaneous ADE re...

This is a case report of an 83-year-old man in warfarin treatment with stable international normalised ratio (INR) after aortic valve replacement and atrial fibrillation. Due to back pain he took paracetamol (acetaminophen) 4 g/day, morphine 30 mg/day and diclofenac as rescue medication for two weeks. After 14 days of treatment he was admitted to a...

Aims/hypothesis We investigated whether urinary markers of nucleic acid oxidation are associated with an increased risk of cancer in type 2 diabetes patients. Methods Urine samples from 1381 newly diagnosed diabetes patients were assayed for the oxidatively modified guanine nucleosides 8-oxo-7,8-dihydro-2′-deoxyguanosine (8-oxodG) and 8-oxo-7,8-di...