Download the Free Unbound MEDLINE PubMed App to your smartphone or tablet.
Available for iPhone, iPad, iPod touch, and Android.
- Family history of cardiovascular disease and influence on statin therapy persistence. [JOURNAL ARTICLE]
- Eur J Clin Pharmacol 2014 Mar 8.
Persistence to statins is low, presumably due to lack of perception of risk. Having a close relative suffering from cardiovascular disease (CVD) might increase persistence to statins. We investigated whether family history of CVD influences the discontinuation of statin treatment.A population-based cohort study was performed. Swedish registers on dispensed drugs, hospitalization and cause of death were linked to the Multi-generation Register. Incident statin users 20-72 years of age were identified between 2006 and 2007 and followed until 30 June 2009. Family history of CVD was defined as the presence of relatives with a previous cardiovascular event. Cox regression was used to study discontinuation and estimate the effect of the family history of CVD, adjusting for gender, age, education, income, healthcare provider, prevention's type, birth's country and residence's county. Stratified analysis by type and severity of cardiovascular event was performed.A total of 86,002 patients were enrolled; 61.5 % had a family history of CVD. Discontinuation of statin therapy was not associated with family history of CVD (HR: 0.98; 95 % CI:0.96-1.01), except for patients with a family history of death from myocardial infarction (MI) (HR: 0.95 95 % CI:0.92-0.98). Young age, foreign background, low income, and statin for primary prevention and for secondary prevention when prescribed by a general practitioner were associated with higher risk of statin discontinuation.Having relatives suffering from CVD did not consistently influence the persistence to statin treatment. A family history of death from MI had a slight significant positive effect on statin persistence, though not clinically relevant.
- A detection algorithm for drug-induced liver injury in medical information databases using the Japanese diagnostic scale and its comparison with the Council for International Organizations of Medical Sciences/the Roussel Uclaf Causality Assessment Method scale. [JOURNAL ARTICLE]
- Pharmacoepidemiol Drug Saf 2014 Mar 5.
Drug-induced liver injury (DILI) is one of the primary targets for pharmacovigilance using medical information databases (MIDs). Because of diagnostic complexity, a standardized method for identifying DILI using MIDs has not yet been established. We applied the Digestive Disease Week Japan 2004 (DDW-J) scale, a Japanese clinical diagnostic criteria for DILI, to a DILI detection algorithm, and compared it with the Council for International Organizations of Medical Sciences/the Roussel Uclaf Causality Assessment Method (CIOMS/RUCAM) scale to confirm its consistency. Characteristics of DILI cases identified by the DDW-J algorithm were examined in two Japanese MIDs.Using an MID from the Hamamatsu University Hospital, we constructed a DILI detection algorithm on the basis of the DDW-J scale. We then compared the findings between the DDW-J and CIOMS/RUCAM scales. We examined the characteristics of DILI after antibiotic treatment in the Hamamatsu population and a second population that included data from 124 hospitals, which was derived from an MID from the Medical Data Vision Co., Ltd. We performed a multivariate logistic regression analysis to assess the possible DILI risk factors.The concordance rate was 79.4% between DILI patients identified by the DDW-J and CIOMS/RUCAM; the Spearman rank correlation coefficient was 0.952 (P < 0.0001). Men showed a significantly higher risk for DILI after antibiotic treatments in both MID populations.The DDW-J and CIOMS/RUCAM algorithms were equivalent for identifying the DILI cases, confirming the utility of our DILI detection method using MIDs. This study provides evidence supporting the use of MID analyses to improve pharmacovigilance. Copyright © 2014 John Wiley & Sons, Ltd.
- Estimating the effects of time-varying exposures in observational studies using Cox models with stabilized weights adjustment. [JOURNAL ARTICLE]
- Pharmacoepidemiol Drug Saf 2014 Mar 4.
Assessing the safety and effectiveness of medical products with observational electronic medical record data is challenging when the treatment is time-varying. The objective of this paper is to develop a Cox model stratified by event times with stabilized weights (SWs) adjustment to examine the effect of time-varying treatment in observational studies.Time-varying SWs are calculated at unique event times and are used in a Cox model stratified by event times to estimate the effect of time-varying treatment. We applied this method in examining the effect of an antiplatelet agent, clopidogrel, on events, including bleeding, myocardial infarction, and death after a drug-eluting stent was implanted in coronary artery. Clopidogrel use may change over time on the basis of patients' behavior (e.g., non-adherence) and physicians' recommendations (e.g., end of duration of therapy). We also compared the results with those from a Cox model for counting processes adjusting for all covariates used in creating SWs.We demonstrate that the (i) results from the stratified Cox model without SWs adjustment and the Cox model for counting processes without covariate adjustment are identical in analyzing the clopidogrel data; and (ii) the effects of clopidogrel on bleeding, myocardial infarction, and death are larger in the stratified Cox model with SWs adjustment compared with those from the Cox model for counting processes with covariate adjustment.The Cox model stratified by event times with time-varying SWs adjustment is useful in estimating the effect of time-varying treatments in observational studies while balancing for known confounders. Copyright © 2014 John Wiley & Sons, Ltd.
- Underrepresentation of older adults in cancer trials. [Comment, Letter]
- JAMA 2014 Mar 5; 311(9):965-6.
- Biosimilars: In support of extrapolation of indications. [JOURNAL ARTICLE]
- J Crohns Colitis 2014 Mar 1.
Biosimilars have the potential to lead to enormous cost savings in healthcare without reducing the level of care for patients. In Europe, biosimilars have to demonstrate comparability in an extensive biosimilarity exercise including analytical, preclinical and comparative clinical studies. By successfully completing the biosimilarity exercise, the biosimilar shows that all aspects that are considered relevant for the clinical activity of the product fall within the same range as observed for the innovator. It should be carefully considered whether the benefit of additional information from more comparative clinical studies weighs up to the additional barriers such studies create for biosimilars to enter clinical practice.
- Essential medicines for COPD and asthma in low and middle-income countries. [JOURNAL ARTICLE]
- Thorax 2014 Mar 3.
Access to medications for chronic disease management is limited in many low and middle-income countries (LMICs), resulting in suboptimal care and avoidable morbidity and mortality. We performed a survey of COPD and asthma medicines that appeared on the national essential medicines lists (NEMLs) of 32 LMICs. Nearly all countries (>90%) had assigned essential medicines for treatment of exacerbations and early stable disease stages, but not for steps 4 (22%) and 5 (6%) controlled asthma management. The number of treatment options was limited, with long-acting β2-agonists (LABA) and combination dosage forms being notably absent. Suboptimal availability of chronic respiratory disease medicines suggests that implementation of NEMLs is the main problem in clinical practice.
- Use of ADHD medication during pregnancy from 1999 to 2010: a Danish register-based study. [JOURNAL ARTICLE]
- Pharmacoepidemiol Drug Saf 2014 Mar 4.
This study aimed to describe the trends in use of Attention Deficit Hyperactivity Disorders (ADHD) medication during pregnancy in Denmark from 1999 to 2010, as well as to explore characteristics of women who use ADHD medication during pregnancy and whether exposure is associated with outcome of pregnancy.A linkage between various Danish national health registries was performed to identify all recorded pregnancies from 1999 to 2010. Use of ADHD medication was defined as a redeemed prescription on methylphenidate, modafinil, or atomoxetine from 28 days prior to the first day of the last menstrual period until the end of pregnancy.Of the 1 054 494 registered pregnancies, 480 were exposed to ADHD medication. From 2003 to the first quarter of 2010, use of ADHD medication during pregnancy increased from 5 to 533 per 100 000 person-years. A similar increase was observed among Danish women of childbearing age. Compared with unexposed, women who used ADHD medication during pregnancy were more often younger, single, lower educated, received social security benefits, and used other psychopharmaca. Exposed pregnancies were more likely to result in induced abortions on maternal request (odds ratio = 4.70, 95%CI = 3.77-5.85), induced abortions on special indication (odds ratio = 2.99, 95%CI = 1.34-6.67), and miscarriage (odds ratio = 2.07, 95%CI = 1.51-2.84) compared with unexposed pregnancies.The number of pregnancies exposed to ADHD medication has increased similarly to the increase in use of ADHD medication among women of childbearing age. Use of ADHD medication in pregnancy was associated with different indicators of maternal disadvantage and with increased risk of induced abortion and miscarriage. Copyright © 2014 John Wiley & Sons, Ltd.
- Safety analysis of Epzicom® (lamivudine/abacavir sulfate) in post-marketing surveillance in Japan. [JOURNAL ARTICLE]
- Pharmacoepidemiol Drug Saf 2014 Mar 3.
To obtain safety and effectiveness data on a combined anti-HIV drug, Epzicom (abacavir 600 mg/lamivudine 300 mg), a post-marketing surveillance on Epzicom that was required by the Japanese regulatory authority was conducted between January 2005 and December 2010.A joint survey (HIV-related drug [HRD] survey) has been conducted involving manufacturers of drugs for treatment of HIV infection in Japan. Safety and effectiveness data from total 624 cases (1107.3 person-years) registered to the HRD surveys and received Epzicom were obtained. Adverse drug reactions (ADRs) were defined as adverse events (AE) of which association with Epzicom could not be 'ruled out'.It was found that the incidence of ADR was 32.4% (202/624 cases) on the case basis. In addition, the frequently reported ADR included hyperlipidaemia (59 cases), hypertriglyceridaemia (21 cases), blood bilirubin increased (19 cases), gamma-glutamyltransferase increase (14 cases), blood triglyceride increase (14 cases) and rash (14 cases). Serious AEs were seen in 19 patients (30 events), including one death (no evident association with Epzicom). There were four cases (0.6%) of survey-defined 'hypersensitivity', and the incidence was 0.9% (4/445) among abacavir naïve patients; none of which was reported as serious. No case of myocardial infarction was reported. One pregnant case who delivered a normal baby by caesarean section was reported to have experienced aggravation of anaemia and nausea.The post-marketing surveillance indicated that the incidence of both ischaemic heart disease and hypersensitivity associated with Epzicom was considerably low, suggesting that this drug can be safely used in the Japanese population. © 2014 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons, Ltd.
- Utilization of psychotropic drugs prescribed to persons with and without HIV infection: a Danish nationwide population-based cohort study. [JOURNAL ARTICLE]
- HIV Med 2014 Mar 3.
The objective was to estimate the utilization of psychotropic drugs in HIV-infected individuals compared with that in the background population.Using data obtained from the Danish HIV Cohort Study and the Danish National Prescription Registry, we analysed aggregated data on redeemed prescription of psychotropic drugs during 1995-2009. We primarily focused our analyses on HIV-infected individuals with no history of injecting drug use (IDU) or hepatitis C virus (HCV) infection. Drug utilization was expressed as defined daily doses per 1000 person-days (DDD/1000PD). The utilization rate ratio (URR) was calculated as utilization in the HIV-infected cohort compared with that in the comparison cohort. We estimated longitudinal trends in utilization and potential associations with HIV and exposure to highly active antiretroviral therapy (HAART), especially efavirenz.During 1995-2009, 54.5% of the HIV-infected cohort (3615 non-IDU/non-HCV-infected HIV-infected individuals) and 29.2% of the comparison cohort (32 535 individuals) had at least one prescription of a psychotropic drug. HIV infection was associated with a URR of 1.13 for antipsychotics, 1.76 for anxiolytics, 4.42 for hypnotics and sedatives, and 2.28 for antidepressants. Antidepressants were confined primarily to men who have sex with men (MSM). Older age, more recent calendar time, and increased time after HIV diagnosis were associated with increased drug utilization. However, no association with exposure to HAART or efavirenz was found.HIV-infected individuals had a higher utilization of psychotropic drugs than the background population, which was not confined to individuals with a history of IDU or HCV infection. This emphasizes the need to focus on diagnosis of, and appropriate psychopharmacological interventions for, mental disorders in this population.