Physician adjudication of angioedema diagnosis codes in a population of patients with heart failure prescribed angiotensin-converting enzyme inhibitor therapy.

Purpose: Our objective was to calculate the positive predictive value (PPV) of the ICD-9 diagnosis code for angioedema when physicians adjudicate the events by electronic health record review. Our secondary objective was to evaluate the inter-rater reliability of physician adjudication.

Methods: Patients from the Cardiovascular Research Network previously diagnosed with heart failure who were started on angiotensin-converting enzyme inhibitors (ACEI) during the study period (July 1, 2006 through September 30, 2015) were included.

Characteristics of early sacubitril/valsartan patients and considerations for studies in electronic health record data.

Aim: We examined characteristics of early sacubitril/valsartan users in a large US electronic health records database.

Patients & Methods: We identified three cohorts of patients with heart failure (HF): sacubitril/valsartan patients with a prior HF diagnosis; patients with HF with reduced ejection fraction; and patients with HF treated with an angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker and a β-blocker.

Results: Sacubitril/valsartan patients were younger than patients in the other cohorts; the mean age of sacubitril/valsartan patients increased by 2 years in the first 15 months of marketing.

A Database Cohort Study to Assess the Risk of Angioedema Among Patients with Heart Failure Initiating Angiotensin-Converting Enzyme Inhibitors in the USA.

Introduction: Real-world evidence on the risk of angioedema associated with angiotensin-converting enzyme inhibitors (ACEIs) in patients with heart failure (HF) is scarce.

Objective: This non-interventional study aimed to estimate the incidence of and risk factors for angioedema in patients with HF initiating an ACEI in real-world practice.

Methods: This was a retrospective cohort study using claims data from the PharMetrics Plus database, supplemented with consumer health data, from 1 January 2007 to 31 March 2015.

Angioedema Among Hypertensive Patients Treated with Aliskiren or Other Antihypertensive Medications in the United States.

Background: A non-interventional study suggested that use of angiotensin-converting enzyme inhibitors (ACEIs) or aliskiren was associated with an angioedema risk three times that of beta-blockers (BBs).

Objective: The aim was to assess angioedema incidence rates (IRs) and the relative angioedema risk of aliskiren compared to other antihypertensive drugs (AHDs).

Methods: A cohort study in hypertensive patients with an AHD prescription between 2007 and 2012 was conducted using data from the US PharMetrics Plus™ claims database.

Multi-centre, multi-database studies with common protocols: lessons learnt from the IMI PROTECT project.

Purpose: To assess the impact of a variety of methodological parameters on the association between six drug classes and five key adverse events in multiple databases.

Methods: The selection of Drug-Adverse Event pairs was based on public health impact, regulatory relevance, and the possibility to study a broad range of methodological issues. Common protocols and data analytical specifications were jointly developed and independently and blindly executed in different databases in Europe with replications in the same and different databases.

Case-only designs for studying the association of antidepressants and hip or femur fracture.

Purpose: The purpose of this study is to evaluate the performance and validity of the case-crossover (CCO) and self-controlled case-series (SCCS) designs when studying the association between hip/femur fracture (HF) and antidepressant (AD) use in general practitioner databases. In addition, comparability with cohort and case-control designs is discussed.

Methods: Adult patients with HF and who received an AD prescription during 2001-2009 were identified from UK's The Health Improvement Network (THIN) and the Dutch Mondriaan databases.

Understanding inconsistency in the results from observational pharmacoepidemiological studies: the case of antidepressant use and risk of hip/femur fractures.

Purpose: Results from observational studies on the same exposure-outcome association may be inconsistent because of variations in methodological factors, clinical factors or health care systems. We evaluated the consistency of results assessing the association between antidepressant use and the risk of hip/femur fractures in three European primary care databases using two different study designs.

Methods: Cohort and nested case control studies were conducted in three European primary care databases (Spanish BIFAP, Dutch Mondriaan and UK THIN) to assess the association between use of antidepressants and hip/femur fracture.

The IMI PROTECT project: purpose, organizational structure, and procedures.

The Pharmacoepidemiological Research on Outcomes of Therapeutics by a European ConsorTium (PROTECT) initiative was a collaborative European project that sought to address limitations of current methods in the field of pharmacoepidemiology and pharmacovigilance. Initiated in 2009 and ending in 2015, PROTECT was part of the Innovative Medicines Initiative, a joint undertaking by the European Union and pharmaceutical industry. Thirty-five partners including academics, regulators, small and medium enterprises, and European Federation of Pharmaceuticals Industries and Associations companies contributed to PROTECT.

Exposure to benzodiazepines (anxiolytics, hypnotics and related drugs) in seven European electronic healthcare databases: a cross-national descriptive study from the PROTECT-EU Project.

Purpose: Studies on drug utilization usually do not allow direct cross-national comparisons because of differences in the respective applied methods. This study aimed to compare time trends in BZDs prescribing by applying a common protocol and analyses plan in seven European electronic healthcare databases.

Methods: Crude and standardized prevalence rates of drug prescribing from 2001-2009 were calculated in databases from Spain, United Kingdon (UK), The Netherlands, Germany and Denmark.

Incidence of ischemic colitis in treated, commercially insured hypertensive adults: a cohort study of US health claims data.

Background: Ischemic colitis (IC) incidence rates (IRs) among treated hypertensive patients are poorly understood, and existing literature on the subject is sparse. Antihypertensive drugs may raise the risk of developing IC. Novel antihypertensive agents—such as the direct renin inhibitor aliskiren—have not been assessed for IC risk.

Antiepileptic drug use in seven electronic health record databases in Europe: a methodologic comparison.

Objective: The annual prevalence of antiepileptic drug (AED) prescribing reported in the literature differs considerably among European countries due to use of different type of data sources, time periods, population distribution, and methodologic differences. This study aimed to measure prevalence of AED prescribing across seven European routine health care databases in Spain, Denmark, The Netherlands, the United Kingdom, and Germany using a standardized methodology and to investigate sources of variation.

Methods: Analyses on the annual prevalence of AEDs were stratified by sex, age, and AED.

Acute pancreatitis in association with type 2 diabetes and antidiabetic drugs: a population-based cohort study.

Objective: Previous observational studies have found an increased risk of acute pancreatitis among type 2 diabetic patients. However, limited information is available on this association and specifically on the role of antidiabetic treatment. Our aim, therefore, was to further assess the risk of acute pancreatitis in adult patients with type 2 diabetes.

Lymphoma among patients with atopic dermatitis and/or treated with topical immunosuppressants in the United Kingdom.

Background: Atopic dermatitis (AD) has been associated with an increased risk of lymphoma.

Objectives: To assess the risk of lymphoma associated with AD and use of topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) in a database allowing medical record validation.

Methods: We conducted a nested-case control study using the United Kingdom-based The Health Improvement Network (THIN) database.

Topical treatments with pimecrolimus, tacrolimus and medium- to high-potency corticosteroids, and risk of lymphoma.

Background/aims: A potential risk of lymphoma associated with the use of topical calcineurin inhibitors is debated. We assessed the risk of lymphoma among patients treated with topical pimecrolimus, tacrolimus or corticosteroids.

Methods: We conducted a cohort study using health insurance claims data.

Age-related differences in the prevalence of potential drug-drug interactions in ambulatory dyslipidaemic patients treated with statins.

Background And Objective: Elderly patients may be at higher risk of drug-drug interactions (DDIs) because of polypharmacy. This study evaluated age-specific differences in the prevalence of clinically relevant potential DDIs (pDDIs) in ambulatory dyslipidaemic patients treated with an HMG-CoA reductase inhibitor (statin). We hypothesised that elderly patients are at higher risk for pDDIs because of the presence of more drugs and drugs with a higher potential for DDIs in this age group.

Statins and the risk of pneumonia: a population-based, nested case-control study.

Study Objective: To determine if the use of statins affects pneumonia-related outpatient visits, hospitalizations with survival, and deaths.

Design: Population-based, retrospective, nested case-control analysis.

Data Source: United Kingdom-based General Practice Research Database.

Prevalence of potentially inappropriate medication use in elderly patients: comparison between general medical and geriatric wards.

Background And Objective: Inappropriate drug use is one of the risk factors for adverse drug reactions in the elderly. We hypothesised that, in elderly patients, geriatricians are more aware of potentially inappropriate medications (PIMs) and may replace or stop PIMs more frequently compared with internists. We therefore evaluated and compared the prevalence of PIMs as well as anticholinergic drug use throughout hospital stay in elderly patients admitted to a medical or geriatric ward.

The prevalence of potential drug-drug interactions in patients with heart failure at hospital discharge.

Background/objective: Pharmacotherapy for heart failure is complex and, due to polypharmacy, is associated with a large risk of potential drug-drug interactions (DDIs). The objective of the present study was to assess the prevalence of potential DDIs in the medication of hospitalised heart failure patients and to evaluate their clinical relevance.

Study Design/methods: The medication of 400 patients was retrospectively analysed for potential DDIs at hospital admission and discharge using a computerised drug interaction program.

[Dealing with adverse drug reactions in dentistry. Procedures on encountering adverse drug reactions and goal of the Swiss Pharmacovigilance system].

Dentists may be confronted with adverse drug reactions (ADRs) in their dental practice, and are--like other health professionals--obliged to report certain ADRs. The aim of this article is to sensitise dentists for this topic, to show how to proceed in case of a supposed ADR, and to emphasise the importance of spontaneous reporting of ADRs. ADRs may not always be clearly distinguished from symptoms of underlying diseases, and in cases of polypharmacy multiple drugs may be responsible for the reaction.

Current use of nonsteroidal antiinflammatory drugs and the risk of acute myocardial infarction.

Study Objective: To evaluate the risk of acute myocardial infarction during current exposure to nonsteroidal antiinflammatory drugs (NSAIDs).

Design: Retrospective case-control analysis.

Setting: General practice offices.

Corticosteroid-associated tendinopathies: an analysis of the published literature and spontaneous pharmacovigilance data.

Introduction And Objective: Corticosteroids may cause tendinopathies, an adverse effect that is not well known and characterised, although it was initially described more than 40 years ago. This study was conducted in order to characterise the important aspects of this adverse reaction, such as the role played by routes of corticosteroid administration, therapy duration, comedication, cumulative corticosteroid dose and underlying disease.

Study Design And Methods: Published case reports of tendinopathies that were associated with corticosteroid use were identified by a comprehensive literature search using the databases MEDLINE, Pharm-line, EMBASE, ToxFile, Adis Inpharma, International Pharmaceutical Abstracts, Drug Information Fulltext and PASCAL.

Prevalence of potentially severe drug-drug interactions in ambulatory patients with dyslipidaemia receiving HMG-CoA reductase inhibitor therapy.

Background: Drug-drug interactions (DDIs) are a well known risk factor for adverse drug reactions. HMG-CoA reductase inhibitors ('statins') are a cornerstone in the treatment of dyslipidaemia and patients with dyslipidaemia are concomitantly treated with a variety of additional drugs. Since DDIs are associated with adverse reactions, we performed a cross-sectional study to assess the prevalence of potentially critical drug-drug and drug-statin interactions in an outpatient adult population with dyslipidaemia.

Hepatotoxicity during rapid intravenous loading with amiodarone: Description of three cases and review of the literature.

Objective: Atrial fibrillation is the most common arrhythmia after cardiac surgery. Amiodarone can effectively prevent and control postoperative atrial and ventricular fibrillation. Acute hepatic damage after intravenous amiodarone, which can be fatal, is not well recognized.

Discontinuation of nonsteroidal anti-inflammatory drug therapy and risk of acute myocardial infarction.

Background: Systemic inflammation has been shown to be associated with an increased risk of acute myocardial infarction (AMI). However, the effect of the use of nonsteroidal anti-inflammatory drugs (NSAIDs) on the risk of AMI has not yet been well defined. We therefore studied the risk of AMI during NSAID exposure and after the cessation of NSAID therapy.

Current use of selective serotonin reuptake inhibitors and risk of acute myocardial infarction.

Background: It has been suggested that increased platelet activation increases the risk of acute myocardial infarction (AMI) in patients with depression. Selective serotonin reuptake inhibitors (SSRIs) may attenuate platelet activation by serotonin depletion in platelets. Observational studies have shown discrepant results of AMI risk associated with the use of SSRIs.