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- Alberto Garcia-Rodriguez, Luis, et al.
(författare)
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Rationale and design of a European epidemiological post-authorization safety study (PASS) program : rivaroxaban use in routine clinical practice
- 2020
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Ingår i: Expert Opinion on Drug Safety. - : TAYLOR & FRANCIS LTD. - 1474-0338 .- 1744-764X. ; 19:11, s. 1513-1520
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Tidskriftsartikel (refereegranskat)abstract
- Background Rivaroxaban is a highly selective factor Xa inhibitor approved for use in Europe for multiple indications. Study design and methods The European rivaroxaban epidemiological post-authorization safety study (PASS) program consists of seven complementary observational studies. For four of the studies, data are obtained from health-care databases in the UK, the Netherlands, Germany, and Sweden. These database studies describe patterns of rivaroxaban use and patient characteristics over time, and investigate safety and effectiveness outcomes in new users of rivaroxaban using a cohort analysis and nested case-control analysis. To put these results in context, safety outcomes are also analyzed in new users of standard of care. In addition, a modified prescription event monitoring study conducted in the early post-launch phase in primary care, and two specialist cohort event monitoring studies that investigated rivaroxaban use in the secondary care hospital setting, systematically collected drug utilization and safety data via questionnaires completed by health-care professionals in the UK. Discussion The European rivaroxaban epidemiological PASS is a comprehensive program of complementary studies generating evidence from patients treated in routine clinical practice that will expand our understanding of the risk-benefit profile of rivaroxaban.
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- Aspenberg, Per, 1949-
(författare)
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Editorial: Osteonecrosis of the jaw : What do bisphosphonates do?
- 2006
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Ingår i: Expert Opinion on Drug Safety. - : Informa Healthcare. - 1474-0338 .- 1744-764X. ; 5:6, s. 743-745
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Tidskriftsartikel (övrigt vetenskapligt/konstnärligt)abstract
- Osteonecrosis of the jaw is a new disease, partly caused by bisphosphonates. It is commonly assumed that the bisphosphonates somehow cause cell death (osteocyte necrosis) within the jawbone, which makes it prone to chronic infection. In this article, an alternative pathogenetic theory is suggested, based on the normal effect of bisphosphonates. According to the new theory, the bone is alive until it is injured and infected, and the reduced resorptive ability due to bisphosphonates hinders the formation of a fresh bone surface for re-establishment of bone cell coverage. The theories are compared, based on the recent, very scarce literature. None of them can be completely refuted, but the demonstration of living osteocytes within the lesion and the number of necessary assumptions speak against the theory of a primary, bisphosphonate-induced necrosis.
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- Blomström-Lundqvist, Carina, et al.
(författare)
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Safety and efficacy of pharmacological cardioversion of atrial fibrillation using intravenous vernakalant, a new antiarrhythmic drug with atrial selectivity
- 2012
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Ingår i: Expert Opinion on Drug Safety. - : Informa Healthcare. - 1474-0338 .- 1744-764X. ; 11:4, s. 671-679
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Tidskriftsartikel (refereegranskat)abstract
- Introduction:Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia that due to its frequent hospitalizations and increased complication rates imposes a significant health economic burden. Many patients with recurrent AF are admitted to the hospital for cardioversion to restore sinus rhythm. Given this knowledge, it is clearly important to identify a feasible and effective approach for cardioversion of these patients. Cardioversion always requires careful assessment of potential complications, which apart from thromboembolic risks, include proarrhythmias and those related to the deep sedation required for electrical cardioversion. Even though electrical cardioversion is proven to be safe and effective, the need for anesthesia makes alternative strategies more attractive.Areas covered:The research discussed is the alternative strategies for cardioversion, including electrical cardioversion and the new relatively atrial-selective antiarrhythmic drug, vernakalant. The literature search methodology undertaken included search in PubMed (cardioversion, vernakalant, conversion as key words).Expert opinion:Vernakalant is shown to have good conversion rates, an apparently safe antiarrhythmic profile and is well tolerated in patients with a history of ischemic heart disease. In most cases of recent-onset AF, pharmacological cardioversion can provide a probably more cost-effective and safer alternative to electrical cardioversion, which can then be used as a second option for those who failed the first attempt of cardioversion.
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- Buccheri, Sergio, et al.
(författare)
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Bleeding after antiplatelet therapy for the treatment of acute coronary syndromes : a review of the evidence and evolving paradigms
- 2019
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Ingår i: Expert Opinion on Drug Safety. - : Informa UK Limited. - 1474-0338 .- 1744-764X. ; 18:12, s. 1171-1189
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Forskningsöversikt (refereegranskat)abstract
- Introduction: Potent platelet inhibition reduces the risk of thrombotic complications including myocardial infarction and death in patients with acute coronary syndrome (ACS). Targeting different pathways involved in thrombotic processes have synergistic effects and more effectively counteract thrombosis both in the acute and long-term following an ACS. Unavoidably, more potent platelet inhibition increases the risk of bleeding. In light of the adverse prognostic implications associated with bleeding, including increased mortality, safety aspects with antiplatelet therapy have gained increased importance.Areas covered: This review aims at describing the safety of different antiplatelet agents, particularly with regards to the risk of bleeding complications, used in the management of ACS patients. New bleeding reduction strategies to enhance the safety of antiplatelet therapy are also reviewed.Expert opinion: The final goal of a well-structured antiplatelet treatment strategy is that of tackling the spectrum of ischemic risk without compromising patient safety. A simple mnemonic rule for guiding therapeutic decisions in this complex clinical scenario can be summarized with the acronym ‘ABC’, meaning the sequential process of assessing, balancing and customizing treatment strategies in individual patients on the tradeoff between bleeding and ischemic risk. This approach is recommended for maximizing the ischemic benefits, while preserving safety, with the use of antiplatelet therapy.
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| 9. |
- Hägg, Staffan, et al.
(författare)
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Risk of venous thromboembolism due to antipsychotic drug therapy.
- 2009
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Ingår i: Expert opinion on drug safety. - London, England : Ashley Publications Ltd. - 1744-764X .- 1474-0338. ; 8:5, s. 537-47
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Tidskriftsartikel (refereegranskat)abstract
- An increasing number of reports suggest a link between venous thromboembolism (VTE) and the use of antipsychotics. To better understand this association the available body of evidence has been critically scrutinised. Relevant articles were identified in the databases Scopus and PubMed. Several observational studies using different methodologies show an increased risk of VTE in psychiatric patients. This elevated risk seems to be related to the use of antipsychotic medication and in particular to the use of clozapine and low-potency first-generation drugs. Many studies investigating the association have, however, methodological limitations. The biological mechanisms involved in the pathogenesis of this possible adverse reaction are largely unknown but several hypotheses have been suggested such as drug-induced sedation, obesity, increased levels of antiphospholipid antibodies, enhanced platelet aggregation, hyperhomocysteinemia and hyperprolactinemia. The association may also be related to underlying risk factors present in psychotic patients. Physicians need to be aware of this possible adverse drug reaction. Although supporting evidence has not been published they should consider discontinuing or switching the antipsychotic treatment in patients experiencing VTE. In addition, although data is lacking, the threshold for considering prophylactic antithrombotic treatment should be low when risk situations for VTE arise, such as immobilisation, surgery and so on.
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| 10. |
- Kowalec, Kaarina, et al.
(författare)
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Characteristics associated with drug-induced liver injury from interferon beta in multiple sclerosis patients
- 2014
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Ingår i: Expert Opinion on Drug Safety. - : Informa Healthcare. - 1474-0338 .- 1744-764X. ; 13:10, s. 1305-1317
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Forskningsöversikt (refereegranskat)abstract
- Objective: To identify and characterize drug-induced liver injury (DILI) associated with IFN-beta in multiple sclerosis (MS) using recommended criteria. Methods: This retrospective, mixed methods design included a cohort of IFN-beta exposed MS patients from British Columbia (BC), Canada and a series of DILI cases from other Canadian provinces and two adverse drug reaction (ADR) networks (USA and Sweden). Associations between sex, age and IFN-beta product, and DILI were explored in BC cohort using Cox proportional hazard analyses. Characteristics, including the time to DILI, were compared between sites. Results: In BC, 18/942 (1.9%) of IFN-beta exposed MS patients met criteria for DILI, with a trend toward an increased risk for women and those exposed to IFN-beta-1a SC (44 mcg 3 x weekly) (adjusted Hazard Ratios: 3.15; 95% CI: 0.72 - 13.72, p = 0.13 and 6.26; 95% CI: 0.78 - 50.39, p = 0.08, respectively). Twenty-four additional cases were identified from other sites; the median time to DILI was comparable between BC and other Canadian cases (105 and 90 days, respectively), but longer for the ADR network cases (590 days, p = 0.006). Conclusions: Approximately 1 in 50 IFN-beta exposed patients developed DILI in BC, Canada. Identification of DILI cases from diverse sources highlighted that this reaction occurs even after years of exposure.
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