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Efficacy and safety of dabigatran etexilate and warfarin in "real-world" patients with atrial fibrillation: a prospective nationwide cohort study.

https://arctichealth.org/en/permalink/ahliterature114936
Source
J Am Coll Cardiol. 2013 Jun 4;61(22):2264-73
Publication Type
Article
Date
Jun-4-2013
Author
Torben Bjerregaard Larsen
Lars Hvilsted Rasmussen
Flemming Skjøth
Karen Margrete Due
Torbjörn Callréus
Mary Rosenzweig
Gregory Y H Lip
Author Affiliation
Department of Cardiology, Cardiovascular Research Centre, Aalborg University Hospital, Aalborg, Denmark.
Source
J Am Coll Cardiol. 2013 Jun 4;61(22):2264-73
Date
Jun-4-2013
Language
English
Publication Type
Article
Keywords
Aged
Aged, 80 and over
Anticoagulants - therapeutic use
Antithrombins - therapeutic use
Atrial Fibrillation - drug therapy - epidemiology
Benzimidazoles - therapeutic use
Denmark - epidemiology
Dose-Response Relationship, Drug
Drug Prescriptions - statistics & numerical data
Female
Follow-Up Studies
Gastrointestinal Hemorrhage - epidemiology
Hospitalization - statistics & numerical data
Humans
Incidence
Intracranial Hemorrhages - epidemiology
Logistic Models
Male
Myocardial Infarction - epidemiology
Propensity Score
Proportional Hazards Models
Prospective Studies
Pulmonary Embolism - epidemiology
Pyridines - therapeutic use
Registries
Stroke - epidemiology
Warfarin - therapeutic use
Abstract
The aim of this study was to assess the efficacy and safety in an "everyday clinical practice" population of anticoagulant-na?ve patients with atrial fibrillation (AF) treated with dabigatran etexilate after its post-approval availability in Denmark, compared with warfarin.
Concerns have been raised about an excess of bleeding events or myocardial infarction (MI) among patients treated with the new oral direct thrombin inhibitor, dabigatran etexilate.
From the Danish Registry of Medicinal Product Statistics, we identified a dabigatran-treated group and a 1:2 propensity-matched warfarin-treated group of 4,978 and 8,936, respectively. Comparisons on efficacy and safety?outcomes were made on the basis of Cox-proportional hazards models stratified on propensity-matched groups.
Stroke and systemic embolism were not significantly different between warfarin- and dabigatran-treated patients. Adjusted mortality was significantly lower with both dabigatran doses (110 mg b.i.d., propensity-match group stratified hazard ratio [aHR]: 0.79, 95% confidence interval [CI]: 0.65 to 0.95; 150 mg b.i.d., aHR: 0.57, 95% CI: 0.40 to 0.80), when compared with warfarin. Pulmonary embolism was lower compared with warfarin for both doses of dabigatran. Less intracranial bleeding was seen with both dabigatran doses (110 mg b.i.d., aHR: 0.24, 95% CI: 0.08 to 0.56; 150 mg b.i.d., aHR: 0.08, 95% CI: 0.01 to 0.40). The incidence of MI was lower with both dabigatran doses (110 mg b.i.d., aHR: 0.30, 95% CI: 0.18 to 0.49; 150 mg b.i.d., aHR: 0.40, 95% CI: 0.21 to 0.70). Gastrointestinal bleeding was lower with dabigatran 110 mg b.i.d. (aHR: 0.60, 95% CI: 0.37 to 0.93) compared with warfarin but not dabigatran 150 mg b.i.d. The main findings were broadly consistent in a subgroup analysis of dabigatran users with?=1-year follow-up (median follow-up 13.9 months [interquartile range: 12.6 to 15.3 months]).
In this "everyday clinical practice" post-approval nationwide clinical cohort, there were similar stroke/systemic embolism and major bleeding rates with dabigatran (both doses) compared with warfarin. Mortality, intracranial bleeding, pulmonary embolism, and MI were lower with dabigatran, compared with warfarin. We found no evidence of an excess of bleeding events or MI among dabigatran-treated patients in this propensity-matched comparison against warfarin, even in the subgroup with?=1-year follow-up.
Notes
Comment In: J Am Coll Cardiol. 2013 Sep 3;62(10):946-723810887
Comment In: J Am Coll Cardiol. 2013 Sep 3;62(10):945-623810890
PubMed ID
23562920 View in PubMed
Less detail

Hyponatremia in elderly patients treated with desmopressin for nocturia: a review of a case series.

https://arctichealth.org/en/permalink/ahliterature29732
Source
Eur J Clin Pharmacol. 2005 Jun;61(4):281-4
Publication Type
Article
Date
Jun-2005
Author
Torbjörn Callréus
Elisabet Ekman
Morten Andersen
Author Affiliation
Research Unit of Clinical Pharmacology, Institute of Public Health, IPH, University of Southern Denmark, Winslowparken 19, 3rd floor, 5000 Odense C, Denmark. tcallreus@health.sdu.dk
Source
Eur J Clin Pharmacol. 2005 Jun;61(4):281-4
Date
Jun-2005
Language
English
Publication Type
Article
Abstract
OBJECTIVE: Lately, desmopressin (dDAVP) administered orally has been demonstrated to be an effective alternative in the management of nocturia in adults. Although the safety profile of dDAVP is well known, much of the experience originates from studies in enuretic children and younger adults, and it may not be readily extrapolated to elderly patients. In order to identify factors associated with an increased risk of hyponatremia in elderly patients treated with dDAVP for nocturia, we analysed spontaneous reports accrued from clinical practice in Denmark and Sweden. METHOD: Following a selection procedure, the study base comprised 15 case reports. From the included reports, information was sought on concurrent diseases, concomitant medications and other factors that may predispose elderly patients to hyponatremia when treated with desmopressin. RESULTS: The median age amongst the cases was 81 years (range 61-93 years) and 80% were females. For seven of the patients, the hyponatremia occurred during the first 3 weeks of treatment. The symptoms presented by the patients led to hospitalisation in all but one case. Among patients with information available on concomitant medication, half of them were treated with cyclooxygenase inhibitors. An excessive fluid intake could only be ascertained in one case; all 15 patients eventually recovered. CONCLUSION: In elderly patients treated with dDAVP for nocturia, an increased risk of hyponatremia exists in the first weeks of treatment. Compared with younger subjects, risk factors other than excessive intake of fluid appear to contribute to this adverse drug reaction.
PubMed ID
15875172 View in PubMed
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Spontaneous reporting of adverse events following immunisation against pandemic influenza in Denmark November 2009-March 2010.

https://arctichealth.org/en/permalink/ahliterature99811
Source
Vaccine. 2010 Dec 18;
Publication Type
Article
Date
Dec-18-2010
Author
Maja Folkenberg
Torbjörn Callréus
Henrik Svanström
Palle Valentiner-Branth
Anders Hviid
Author Affiliation
Consumer Safety Division, Danish Medicines Agency, Copenhagen, Denmark.
Source
Vaccine. 2010 Dec 18;
Date
Dec-18-2010
Language
English
Publication Type
Article
Abstract
Our study reviews the spontaneous reports of adverse events following immunisation submitted to the Danish Medicines Agency during the 2009-2010 influenza A/H1N1v season. During the study period (4 November 2009-31 March 2010), 607 reports comprising 1885 adverse events were reported among 339,507 influenza A/H1N1v vaccinated individuals (reporting rate, 179 per 100,000 vaccinated). The majority of individual case safety reports (85%) were submitted by physicians and other health care professionals and concerned known and non-serious reactions occurring within 1 day of vaccination (82%). Events of special interest as defined by EMA prior to vaccination campaign start, comprised 1% of all events. In conclusion, we did not observe any strong signals of any unknown or serious adverse events associated with influenza A/H1N1v vaccination in Denmark. Our experience also demonstrates the well-known limitations of spontaneous reports with respect to evaluation of a casual relationship and highlights the importance for a timely availability of background events rates and the need for new approaches to study late adverse effects following immunisation.
PubMed ID
21172382 View in PubMed
Less detail

Temporal data mining for adverse events following immunization in nationwide Danish healthcare databases.

https://arctichealth.org/en/permalink/ahliterature140249
Source
Drug Saf. 2010 Nov 1;33(11):1015-25
Publication Type
Article
Date
Nov-1-2010
Author
Henrik Svanström
Torbjörn Callréus
Anders Hviid
Author Affiliation
Department of Epidemiology Research, Statens Serum Institut, Copenhagen, Denmark. htr@ssi.dk
Source
Drug Saf. 2010 Nov 1;33(11):1015-25
Date
Nov-1-2010
Language
English
Publication Type
Article
Keywords
Cohort Studies
Data Mining
Databases, Factual
Delivery of Health Care - statistics & numerical data
Denmark
Drug-Related Side Effects and Adverse Reactions
Exanthema - epidemiology
Hospitalization
Humans
Lymphatic Diseases - epidemiology
Measles-Mumps-Rubella Vaccine - adverse effects
Purpura, Thrombocytopenic, Idiopathic - epidemiology
Seizures, Febrile - epidemiology
Time Factors
Vaccination
Abstract
A rarely used opportunity in pharmacovigilance is data mining for adverse drug reactions (ADRs) in population-based healthcare databases.
To evaluate the potential of data mining for ADRs in the nationwide Danish healthcare databases. We specifically considered hospital contacts following measles, mumps and rubella (MMR) immunization.
We constructed a cohort consisting of all children born in Denmark from 1995 to 2007 (n?=?918,831) with individual-level linked data on childhood vaccinations and hospital contacts from the nationwide Danish healthcare databases. We applied a cohort-based data mining methodology to compare the observed versus the expected incidence of adverse event in different time periods relative to immunization. With this approach we evaluated temporal associations between MMR immunization and 5915 different diagnoses occurring in the cohort. In order to evaluate the ability of our approach to detect signals, we singled out a set of four adverse events previously recognized as being associated with the MMR vaccine.
We were able to link a total of 3,162,251 hospital contacts and 5915 different diagnoses to the children in the cohort. Previously recognized temporal associations between adverse events (febrile convulsions, idiopathic thrombocytopenic purpura, lymphadenopathy and rash) and MMR immunization were identified in the Danish databases by our method.
Data mining in the Danish population-based healthcare databases provides adequate ability to detect adverse events. Pharmacovigilance using electronic healthcare databases holds potential as an important supplement to traditional pharmacovigilance.
PubMed ID
20925439 View in PubMed
Less detail

Use of angiotensin receptor blockers and the risk of cancer.

https://arctichealth.org/en/permalink/ahliterature135379
Source
Circulation. 2011 Apr 26;123(16):1729-36
Publication Type
Article
Date
Apr-26-2011
Author
Björn Pasternak
Henrik Svanström
Torbjörn Callréus
Mads Melbye
Anders Hviid
Author Affiliation
Department of Epidemiology Research, Statens Serum Institut, Artillerivej 5, Copenhagen S, Denmark. bjp@ssi.dk
Source
Circulation. 2011 Apr 26;123(16):1729-36
Date
Apr-26-2011
Language
English
Publication Type
Article
Keywords
Aged
Angiotensin II Type 1 Receptor Blockers - adverse effects
Angiotensin-Converting Enzyme Inhibitors - adverse effects
Cardiovascular Diseases - drug therapy - mortality
Denmark - epidemiology
Female
Humans
Incidence
Lung Neoplasms - mortality
Male
Middle Aged
Product Surveillance, Postmarketing - statistics & numerical data
Registries - statistics & numerical data
Risk factors
Urogenital Neoplasms - mortality
Abstract
A recent meta-analysis of randomized trials suggested that use of angiotensin receptor blockers (ARBs) may be associated with a modestly increased risk of incident cancer, particularly lung cancer.
We linked individual-level data from Danish registries on filled drug prescriptions, diagnostic information, and covariates. In a nationwide cohort of new users of ARBs and angiotensin-converting enzyme inhibitors =35 years of age during 1998 to 2006, we compared incidence rates of all cancer, cancer subgroups by anatomic site, and cancer mortality. Among 107 466 ARB users, 3954 cases of cancer were detected during 312 753 person-years of follow-up compared with 6214 cases during 435 207 person-years of follow-up in 209 692 angiotensin-converting enzyme inhibitor users (adjusted rate ratio, 0.99; 95% confidence interval, 0.95 to 1.03). Cancer risk did not increase with increasing duration of ARB exposure (increase in rate ratio per year, 0.99; 95% confidence interval, 0.99 to 1.00,) and was similar across individual ARBs. In subgroup analyses, there was a significant association between ARB use and cancer of male genital organs (rate ratio, 1.15; 95% confidence interval, 1.02 to 1.28), but no significantly increased risk of any of the other 15 cancer subgroups, including lung cancer (rate ratio, 0.92; 95% confidence interval, 0.82 to 1.02). For cancer mortality, the rate ratio was 0.77 (95% confidence interval, 0.72 to 0.82).
In this large nationwide cohort, use of ARBs was not significantly associated with increased risk of incident cancer overall or of lung cancer.
PubMed ID
21482967 View in PubMed
Less detail