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Background Perennial allergic rhinitis ( PAR) represents a global and public health problem, due to its prevalence, morbidity, and impact on the quality of life. PAR is frequently associated with allergic asthma ( AA). Costs of PAR with or without AA are poorly documented. Objective Our study aimed to detail medical resource utilization ( MRU) and related direct cost for PAR, with or without concomitant AA, in France. Methods Using Electronic Health Records ( EHRs), we identified in 2010 two cohorts of PAR patients, based on General Practitioners' diagnoses and prescribing data, with and without concomitant AA. For each patient, the EHRs were linked to corresponding claims data with MRU and costs during years 2011 to 2013. Predefined subgroup analyses were performed according to severity of PAR and level of AA control. Results The median annual cost reimbursed by social security system for a patient with PAR, and no AA was 159€ in 2013. This varied from 111€ to 188€ depending on PAR severity. For patients with PAR and concomitant AA, the median annual cost varied between 266€ and 375€, and drug treatment accounted for 42-55% of the costs, depending on asthma control. Conclusion This study linking diagnoses from EHRs to claims data collected valid information on PAR management, with or without concomitant AA, and on related costs. There was a clear increase in costs with severity of PAR and control of AA. [ABSTRACT FROM AUTHOR]

Background: In sensitive patients, aspirin is associated with nasal and bronchial inflammation, eliciting local symptoms. Although the disease is clinically well characterized, its physiopathology is incompletely understood and noninvasive procedures, allowing an effective distinction between aspirin-induced asthma (AIA) and aspirin-tolerant asthma (ATA) are missing. Objectives: The aims of the study were to compare AIA and ATA cohorts for clinical characteristics and to screen peripheral blood for differential mRNA expression. Methods: Patients experiencing symptoms following aspirin ingestion were considered as aspirin sensitive. Peripheral blood was collected to quantify mRNA expression, using microarray technology and quantitative RT-PCR. Results: Data indicated that AIA and ATA share large number of similarities for clinical phenotype. Screening of mRNA expression using microarray showed an overexpression of galectin-10 mRNA in AIA (AIA/ATA ratio = 1.9, P < 0.05). Results were confirmed using qRT-PCR. A positive correlation was established between microarray and qRT-PCR results for galectin-10 mRNA expression ( r = 0.92, P < 0.0001). Finally, qRT-PCR results were validated on a subset of asthmatics and controls, showing an increased expression of galectin-10 mRNA in AIA vs ATA ( P < 0.001) and vs controls ( P < 0.01). Conclusions: Our results demonstrate that AIA and ATA remain difficult to distinguish using clinical criteria. Employing two molecular biological methods, we demonstrate that galectin-10 mRNA is overexpressed in AIA, suggesting a novel candidate gene and a potentially innovative pathway for mucosal inflammation in aspirin intolerance. [ABSTRACT FROM AUTHOR]

The characteristics of patients who report adverse events (AEs) attributed to asthma therapy have been little investigated. Asthma patients aged 18–50 years were surveyed in pharmacies. Patients completed a questionnaire linked to computerized records of dispensed medications. Patients reported all AEs that they attributed to asthma therapy. The correlates of reporting 2+ AEs were identified. Almost 59% of the 1,351 patients (mean age: 37, 56% females) attributed AEs to asthma therapy, and 35% at least two. Most common AEs included tiredness (21.8%) and palpitations (21.1%). Poor asthma control and perception of asthma as a handicap were the major correlates of reporting 2+ AEs (odds ratio (OR)=2.5, 95% confidence interval (CI)=[1.7–3.7] and OR=1.9, 95% CI=[1.4–2.5]). Other significant correlates included age >30 years, female gender, and receiving psychotropic therapy. Inadequate control may partly account for AEs attributed by patients to asthma therapy. Improving patients' education may help to improve acceptability of asthma therapy.Clinical Pharmacology & Therapeutics (2007) 82, 167–172. doi:10.1038/sj.clpt.6100224; published online 9 May 2007 [ABSTRACT FROM AUTHOR]

Background: Optimal control is a major objective of disease management of asthma. The aim of the present study was to provide descriptive data on disease management in asthma patients, including medical resource utilization. Methods: Asthma patients (age 18–50 years) were consecutively recruited in 348 dispensing pharmacies. They completed a questionnaire which collected data on personal characteristics, asthma management, including medical resource utilization, including asthma management. Asthma control was measured with the Asthma Control Test. Data from computerized pharmacy records of medications, dispensed before inclusion, were also collected. Results: In 1791 eligible patients, 1559 accepted to participate in the study (mean age = 36.5, 56.1% of females). During the previous 4 weeks, the asthma control was satisfactory for only 28% of the patients, despite extensive provision of anti-inflammatory asthma control treatments (89%). Combinations of long acting beta agonists (LABA) and inhaled corticosteroids (ICS) were commonly used (59%), while fewer patients received LABA and ICS as two separate medications (15%). In addition, short-acting beta agonists, were frequently dispensed (71%). A substantial number of patients consulted their GPs on a monthly basis. Patients commonly reported daily shortness of breath (30%), daily use of rescue medication (29%) and weekly nocturnal symptoms (32%). Surprisingly, most patients considered their asthma as completely or well controlled (76%). Conclusions: Our results clearly identify a need to improve the management of asthma. Education programmes would be beneficial to improve asthma control. [ABSTRACT FROM AUTHOR]

Aims To describe trends in utilization and prescribing of statins and other lipid lowering drugs across Europe from data in routine administrative databases. Methods Observational study in EU member states and Norway. Comparison of annual utilization data for lipid lowering agents by class and drug from national administrative databases for reimbursement over the period 1997–2003, measured in DDDs per 1000 inhabitants/day. Prescribed daily doses (PDD) of statins obtained from a commercial database (IMS Health) for 2000 and 2003, and used to calculate numbers of ‘patient treatment days’ (PTD) in each country in each year. Analysis of PTD to explain increased utilization of statins. Results Use of lipid lowering agents varied among countries (in 2003, highest in Ireland and Norway, and lowest in Italy), but increased in all countries studied (between 2000 and 2003 by 274% in Ireland and by 56% in France). This increase was entirely due to increases in statin use. Prescribed daily doses of statins increased in all countries for which data was available between 2000 and 2003, but still usually fell below the doses used in the major trials of statins. As a result, the numbers of PTDs increased to a lesser extent than suggested by utilization (e.g. by 192% in Ireland and by 35% in France). One-third of the total rise in utilization was explained by increased PDD, and two-thirds by an increase in numbers of PTDs. Statins dominated the markets in all countries, although fibrates remained strong in France and Belgium (approximately 25% of all lipid lowering agents) and to a lesser extent Germany (10%). Conclusions Use of statins across Europe has increased hugely over the study period. Some of the increase in use is due to higher prescribed daily doses, but two-thirds is due to increases in numbers of patient days of treatment, either due to more patients treated or less likely to better compliance. [ABSTRACT FROM AUTHOR]

Allergic rhinitis was recently classified by the ARIA guidelines as persistent or intermittent. Levocetirizine was shown to improve symptoms and health-related quality of life of patients with persistent allergic rhinitis in the XPERTTM study, a 6-month randomized double blind placebo-controlled trial.To assess the total costs of persistent allergic rhinitis, and the effect of long-term treatment with levocetirizine on these costs from several perspectives (societal, social security system, and employers).Direct medical cost parameters (medications, physician visits and hospitalizations) and time lost parameters (workdays and Usual Daily Activities (UDA) lost) related to persistent allergic rhinitis and its comorbidities (asthma, sinusitis, otitis and upper respiratory infection) were measured. A cost analysis was performed using 2002 French costing data.From a societal perspective, the total cost of persistent allergic rhinitis without long-term treatment was estimated at€355.06/patient/month. From a social security perspective, levocetirizine treatment yielded an additional cost of€2.78/patient/month, compared to no-treatment. However, levocetirizine reduced the total cost of persistent allergic rhinitis and its comorbidities by€152.93/patient/month from a societal perspective and by€64.70/patient/month from an employer perspective. Most gains resulted from a decrease in the lost workdays and UDA in the levocetirizine group.The cost of persistent allergic rhinitis is substantial. Treatment with levocetirizine reduces the cost of persistent allergic rhinitis and its comorbidities to the society by€152.93/patient/month while improving symptoms and health-related quality of life. [ABSTRACT FROM AUTHOR]

Evidence confirms the positive effects of lipid-lowering agents on the risk of cardiovascular disease. Local guidelines in France (AFSSAPS) have defined therapeutic objectives for LDL-cholesterol. These objectives vary with the number of cardiovascular risk factors in addition to dyslipidaemia. We determined the proportions of patients at therapeutic objective in different classes of cardiovascular risk to test the hypothesis that compliance with guidelines varies across the levels of risk. Comparison with international guidelines (ANDEM) was also performed.A group of 3173 dyslipidaemic patients treated with lipid-lowering agents and managed by general practitioners was randomly selected from BKL-Thales panel, a French computerized database. For each patient, history of coronary heart disease and the number of cardiovascular risk factors were documented. Compliance with guidelines was assessed from achievement of therapeutic objective.The study population included 79% primary prevention patients (1.6, 25.5, 31.7 and 20.1%, with 1, 2, 3, and>3 risk factors, respectively) and 21.0% secondary prevention patients. Applying AFSSAPS guidelines, the proportions of primary prevention patients not at LDL-cholesterol objectives varied across risk categories (P < 0.0001), from 3.9% for patients with one risk factor to 46.5% for patients with>3 risk factors, and therapeutic failure reached 39.9% in secondary prevention. Only 26% of patients who were at high cardiovascular risk (>3 risk factors or prior coronary heart disease) and not at therapeutic objective received high doses (>standard recommended doses) of lipid-lowering agents in monotherapy. Applying ANDEM guidelines, 74% of secondary prevention patients were not at treatment goal.Compliance with guidelines varied inversely with the level of cardiovascular risk. Besides, most patients not at therapeutic objective were not up-titrated. The use of lipid-lowering agents is inadequate, depriving many patients of an effective protection against cardiovascular diseases. [ABSTRACT FROM AUTHOR]

In a double-blind randomized parallel-group study, six investigators enrolled 43 subjects to study the prophylactic effect of 10 mg cetirizine b.i.d. on grass pollen-induced asthma. The control group received 60 mg b.i.d. terfenadine, given to avoid withdrawals from the trial because of hay fever symptoms. Subjects were included in the study between the appearance of the first symptoms of hay fever and those of pollen-induced asthma. The hay fever and asthma symptoms, visual analogue scores (VAS), FEV1 and self-assessment data on complaints, salvage treatment and peak-flow values were statistically analysed, Both treatments were well tolerated, with a low and similar incidence of side-effects. During the last 3 weeks of treatment, six (32%) of the 19 subjects on cetirizine who were evaluable for efficacy remained free of asthma complaints, and another two (10%) had only a single minor attack. None had a grade 3 (incapacitating) attack. Conversely, only one (5%) of the 20 evaluable subjects on terfenadine remained complaint free, and all others (95%) had multiple attacks, which incapacitated three (15%) of them. Nasal obstruction, dyspnoea, morning peak flow, consumption of β2-mimetics and an efficacy index on asthma, combining complaints and rescue drug consumption, were significantly better on cetirizine (P<0.05). It is concluded that cetirizine is able to prevent the exacerbation of asthma induced by grass pollen. [ABSTRACT FROM AUTHOR]

Asthma, rhinitis, and atopic dermatitis (AD) are interrelated clinical phenotypes that partly overlap in the human interactome. The concept of "one-airway-one-disease," coined over 20 years ago, is a simplistic approach of the links between upper- and lower-airway allergic diseases. With new data, it is time to reassess the concept. This article reviews (i) the clinical observations that led to Allergic Rhinitis and its Impact on Asthma (ARIA), (ii) new insights into polysensitization and multimorbidity, (iii) advances in mHealth for novel phenotype definitions, (iv) confirmation in canonical epidemiologic studies, (v) genomic findings, (vi) treatment approaches, and (vii) novel concepts on the onset of rhinitis and multimorbidity. One recent concept, bringing together upper- and lower-airway allergic diseases with skin, gut, and neuropsychiatric multimorbidities, is the "Epithelial Barrier Hypothesis." This review determined that the "one-airway-one-disease" concept does not always hold true and that several phenotypes of disease can be defined. These phenotypes include an extreme "allergic" (asthma) phenotype combining asthma, rhinitis, and conjunctivitis. Rhinitis alone and rhinitis and asthma multimorbidity represent two distinct diseases with the following differences: (i) genomic and transcriptomic background (Toll-Like Receptors and IL-17 for rhinitis alone as a local disease; IL-33 and IL-5 for allergic and non-allergic multimorbidity as a systemic disease), (ii) allergen sensitization patterns (mono- or pauci-sensitization versus polysensitization), (iii) severity of symptoms, and (iv) treatment response. In conclusion, rhinitis alone (local disease) and rhinitis with asthma multimorbidity (systemic disease) should be considered as two distinct diseases, possibly modulated by the microbiome, and may be a model for understanding the epidemics of chronic and autoimmune diseases., (© 2023 The Authors. Allergy published by European Academy of Allergy and Clinical Immunology and John Wiley & Sons Ltd.)

Aim: To assess persistence with subcutaneous (SC) tumour necrosis factor (TNF) inhibitors as well as the impact of persistence on healthcare resource utilization (HCRU) and costs in patients with chronic inflammatory joint diseases., Methods: In this cohort study using population-based French claims data (from 2011 to 2014), we measured persistence with SC TNF inhibitors within 12 months (M0-12) following treatment initiation in treatment-naïve and treatment-experienced users (divided into three cohorts: rheumatoid arthritis [RA], ankylosing spondylitis [AS] and psoriatic arthritis [PsA]). Persistent patients were propensity score matched to nonpersistent patients at M12. The impact of persistence status on HCRU and costs was assessed during M12-24., Results: Of treatment-naïve (n = 3,804) and treatment-experienced (n = 2,279) users, only 56.1% and 46.8% were persistent at M12, respectively. Nonpersistent patients had more outpatient visits, computerized tomography scans, spine or joint magnetic resonance imaging procedures and disease-related hospitalizations, while persistent patients had more rheumatologist visits. Nonpersistent patients had lower drug costs but higher nondrug-related healthcare and hospitalization costs than persistent patients. In AS and PsA, overall healthcare costs were similar in persistent and nonpersistent patients. In RA, overall healthcare costs were lower in persistent patients (15,753€ vs 17,590€ in treatment-naïve and 17,622€ vs 21,177€ in treatment-experienced)., Conclusion: Persistence with SC TNF inhibitors within first 12 months following treatment initiation was low in both treatment-naïve and treatment-experienced patients. Differences were observed in distribution of costs between persistent and nonpersistent patients, showing that nonpersistence with SC TNF inhibitors can lead to increased HCRU and higher costs., (© 2020 The British Pharmacological Society.)

Nonallergic hypersensitivity and allergic reactions are part of the many different types of adverse drug reactions (ADRs). Databases exist for the collection of ADRs. Spontaneous reporting makes up the core data-generating system of pharmacovigilance, but there is a large under-estimation of allergy/hypersensitivity drug reactions. A specific database is therefore required for drug allergy and hypersensitivity using standard operating procedures (SOPs), as the diagnosis of drug allergy/hypersensitivity is difficult and current pharmacovigilance algorithms are insufficient. Although difficult, the diagnosis of drug allergy/hypersensitivity has been standardized by the European Network for Drug Allergy (ENDA) under the aegis of the European Academy of Allergology and Clinical Immunology and SOPs have been published. Based on ENDA and Global Allergy and Asthma European Network (GA(2)LEN, EU Framework Programme 6) SOPs, a Drug Allergy and Hypersensitivity Database (DAHD((R))) has been established under FileMaker((R)) Pro 9. It is already available online in many different languages and can be accessed using a personal login. GA(2)LEN is a European network of 27 partners (16 countries) and 59 collaborating centres (26 countries), which can coordinate and implement the DAHD across Europe. The GA(2)LEN-ENDA-DAHD platform interacting with a pharmacovigilance network appears to be of great interest for the reporting of allergy/hypersensitivity ADRs in conjunction with other pharmacovigilance instruments.