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- Tjäderborn, Micaela, et al.
(author)
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Tramadol dependence : a survey of spontaneously reported cases in Sweden.
- 2009
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In: Pharmacoepidemiology and drug safety. - : Wiley. - 1099-1557 .- 1053-8569.
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Journal article (peer-reviewed)abstract
- BACKGROUND: Tramadol is a weak opioid analgesic, which is generally considered to be safe. However, conflicting data exist on the dependence potential of tramadol. OBJECTIVE: The aim of this study was to investigate occurrence of tramadol dependence and associated risk factors using spontaneously reported adverse drug reactions. METHODS: The Swedish database for spontaneously reported adverse drug reactions, Swedish Drug Information System (SweDIS), was searched for reports on tramadol dependence from 1 January 1995 until 31 December 2006. Selection was conducted based on the DSM-IV definition of dependence. Available information was scrutinised and registered and then presented descriptively. RESULTS: A total of 104 reports of tramadol dependence were identified, of which 60 (58%) concerned women. The median age (range) was 45 (15-84) years. Information on a history of substance abuse was present in 31 patients (30%) and 41 patients (39%) had a documented past or current use of a drug of abuse. Prescribed doses of tramadol ranged between 50-800 mg/day, and ingested doses between 50-4000 mg/day. Time of onset ranged from some weeks up to 4 years. In 72 (69%) cases the reaction was classified as serious, mainly due to hospitalisations for detoxification or discontinuation of tramadol. CONCLUSIONS: There is an occurrence of tramadol dependence in association with analgesic treatment within the recommended dose range. In susceptible patients a severe and serious dependence syndrome may develop. A history of abuse or use of a drug of abuse seems to be an important risk factor. Copyright (c) 2009 John Wiley & Sons, Ltd.
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- Dahlén, Elin, et al.
(author)
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Sibship and dispensing patterns of asthma medication in young children : a population based study
- 2019
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In: Pharmacoepidemiology & Drug Safety. - Stockholm : Karolinska Institutet, Dept of Medical Epidemiology and Biostatistics. - 1053-8569 .- 1099-1557.
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Journal article (peer-reviewed)abstract
- Purpose: Our aim was to study the association between sibship and dispensing patterns of asthma medication in young children, focusing on incidence and persistence, and taking sibship status, asthma diagnoses, and siblings’ medication into account. Methods: A register-based cohort study including all children (n=50,546) born in Stockholm, Sweden 2006–2007, followed up during 2006–2014. Exposure was sibling status; outcome was incidence of dispensed asthma medication and persistence over time. A Cox-model was used to study the association between sibship and asthma medication. Persistence was defined using two different time windows (4- and 18-months) in a refill sequence model including siblings’ and unrelated control children’s medication. Results: After one year of age, the adjusted hazard ratio of dispensed asthma medication was 0.85 (95%CI 0.80–0.90) among children with siblings compared to singletons. The estimated proportion of children with persistent controller medication was 7.2% (4-month model) and 64.5% (18-month model). When including the siblings’ controller medication, the estimated proportion was 8.8% (4-months) and 7.8% for control children (relative risk, RR 0.89, 95%CI 0.81-0.98). The persistence was lower for those with siblings compared to singletons (adj. RR 0.72, 95%CI 0.62-0.85 for 4-months) with similar estimates for older, younger, and full siblings and regardless of asthma diagnoses. Conclusions: Siblings have different dispensing patterns of asthma medications compared to singletons regardless of asthma diagnoses. After including the siblings’ asthma medication and compared with control children, the proportion of children with persistent medication increased which may indicate that siblings share asthma medications.
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| 3. |
- Hedman, Anna M, et al.
(author)
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Agreement between asthma questionnaire and health care register data
- 2018
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In: Pharmacoepidemiology & Drug Safety. - Stockholm : Karolinska Institutet, Dept of Medical Epidemiology and Biostatistics. - 1053-8569 .- 1099-1557.
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Journal article (peer-reviewed)abstract
- Purpose: Risk factors and consequences of asthma can be studied using validated questionnaires. The overall objective of this study was to assess the agreement of parental-reported asthma related questions regarding their children against Swedish health care registers. Methods: We linked a population-based twin cohort of 27,055 children aged 9-12 years, to the Swedish Prescribed Drug Register, National Patient Register and the Primary care register. Parent-reported asthma was obtained from questionnaires and diagnoses and medication were retrieved from the registers. For the agreement between the questionnaire and the registers, Cohen’s kappa was estimated. Results The kappa of the ‘reported ever asthma’ against a ‘register-based ever asthma’ was 0.69 and 0.57 between the parental-‘reported doctor’s diagnosis’ and ‘register-based doctor’s diagnosis’ ’. The highest agreement between ‘reported current asthma’ and ‘register- based current asthma’ with at least one dispensed medication or a diagnosis applied to different time-windows was seen for an 18 month window (kappa=0.70). Conclusions We found that parent-reported asthma-related questions showed on average good agreement with the Swedish health care registers. This implies that in depth questionnaires with rich information on phenotypes are suitable proxies for asthma in general and can be used for health care research purposes.
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| 4. |
- Ortqvist, Anne K., et al.
(author)
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Validation of asthma and eczema in population-based Swedish drug and patient registers
- 2013
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In: Pharmacoepidemiology and Drug Safety. - Stockholm : Wiley. - 1053-8569 .- 1099-1557. ; 22:8, s. 850-860
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Journal article (peer-reviewed)abstract
- Purpose Validated measures of asthma and eczema at the population level remain a challenge. Our aim was to ascertain if register-based information on asthma/eczema medication can function as a proxy for an asthma/eczema diagnosis and to validate register-based asthma diagnoses. Methods Information was requested on all 0-45-year-old individuals with reported asthma/eczema medication and/or diagnoses in the Swedish Prescribed Drug Register and National Patient Register, between July 2005 and December 2009 (N = 250 691). Medical records for 1952 randomly selected individuals were reviewed to estimate the proportion of individuals with the following: (1) asthma/eczema medication that fulfilled predefined criteria of asthma/eczema (positive predictive value (PPV)) and (2) a register-based asthma diagnosis verified as asthma by predefined criteria. Results Positive predictive value for asthma by predefined criteria ranged between 0.75 (95% CI: 0.70-0.78) to 0.94 (95% CI: 0.91-0.96), depending on age group. In pre-school children, PPV for asthma in combination with obstructive bronchitis was 0.87 (95% CI: 0.83-0.90), and PPV for eczema was estimated to 0.45 (95% CI: 0.38-0.51). Eighty percent of children 0-4.5 years and 99% of children >4.5-17 years with a register-based diagnosis of asthma were verified as asthmatics. Conclusion Asthma medication is a suitable proxy for asthma in older children and adults; the same approach is insufficient for eczema. This validation study of two Swedish registers opens for future large nation-wide register-based studies on asthma. Copyright (C) 2013 John Wiley & Sons, Ltd.
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- Attelind, Sofia, et al.
(author)
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Identification of risk factors for adverse drug reactions in a pharmacovigilance database
- 2023
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In: Pharmacoepidemiology and Drug Safety. - : John Wiley & Sons. - 1053-8569 .- 1099-1557. ; 32:12, s. 1431-1438
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Journal article (peer-reviewed)abstract
- Introduction In addition to identifying new safety signals, pharmacovigilance databases could be used to identify potential risk factors for adverse drug reactions (ADRs).Objective To evaluate whether data mining in a pharmacovigilance database can be used to identify known and possible novel risk factors for ADRs, for use in pharmacovigilance practice.Method Exploratory data mining was performed within the Swedish national database of spontaneously reported ADRs. Bleeding associated with direct oral anticoagulants (DOACs)-rivaroxaban, apixaban, edoxaban, and dabigatran-was used as a test model. We compared demographics, drug treatment, and clinical features between cases with bleeding (N = 965) and controls who had experienced other serious ADRs to DOACs (N = 511). Statistical analysis was performed by unadjusted and age adjusted logistic regression models, and the random forest based machine-learning method Boruta.Results In the logistic regression, 13 factors were significantly more common among cases of bleeding compared with controls. Eleven were labelled or previously proposed risk factors. Cardiac arrhythmia (e.g., atrial fibrillation), hypertension, mental impairment disorders (e.g., dementia), renal and urinary tract procedures, gastrointestinal ulceration and perforation, and interacting drugs remained significant after adjustment for age. In the Boruta analysis, high age, arrhythmia, hypertension, cardiac failure, thromboembolism, and pharmacodynamically interacting drugs had a larger than random association with the outcome. High age, cardiac arrhythmia, hypertension, cardiac failure, and pharmacodynamically interacting drugs had odds ratios for bleeding above one, while thromboembolism had an odds ratio below one.Conclusions We demonstrated that data mining within a pharmacovigilance database identifies known risk factors for DOAC bleeding, and potential risk factors such as dementia and atrial fibrillation. We propose that the method could be used in pharmacovigilance for identification of potential ADR risk factors that merit further evaluation.
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- Bergendal, Annica, et al.
(author)
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Non-steroidal anti-inflammatory drugs and venous thromboembolism in women
- 2013
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In: Pharmacoepidemiology and Drug Safety. - : Wiley. - 1053-8569 .- 1099-1557. ; 22:6, s. 658-666
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Journal article (peer-reviewed)abstract
- Background Non-steroidal anti-inflammatory drugs (NSAIDs) might increase the risk of venous thromboembolism (VTE), and risks might differ by type of NSAID. Compared with men, women have a higher incidence of VTE at younger age, and they more often use NSAIDs. Objectives To assess risks of VTE in young and middle-aged women in association with use of NSAIDs. Patients/Methods In a nationwide case-control study (Thrombo Embolism Hormone Study) performed in Sweden 2003-2009, we included as cases 1433 women, 18 to 64years of age with a first time VTE. Controls were 1402 randomly selected women, frequency matched by age. Information was obtained by telephone interviews and DNA analyses of blood samples. We calculated adjusted odds ratios (ORs) with 95% confidence intervals (CIs) adjusting for degree of immobilization, chronic disease, smoking, body mass index, use of hormonal contraception, hormone therapy or other NSAIDs. Results Use of NSAIDs was not associated with increased risks of VTE (OR=0.98, 95% CI 0.80-1.19). The OR was 0.88 for propionic acid derivatives (95% CI 0.72-1.10), 1.18 for acetic acid derivatives (95% CI 0.82-1.70) and 1.76 for coxibs (95% CI 0.73-4.27). For users of acetic acid derivatives and coxibs, the ORs increased by cumulative dose. Carriership of the prothrombin gene mutation or factor V Leiden had only minor effects on the results. Conclusions We found no increased risks of VTE in association with use of NSAIDs. Users of high cumulative doses of acetic acid derivatives and coxibs had the highest risks, suggesting a relationship with cyclooxygenase selectivity and dose.
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