Immunotherapy with grass pollen tablets reduces medication dispensing for allergic rhinitis and asthma: A retrospective database study in France.

BACKGROUND: Moderate-to-severe allergic rhinitis (AR) may increase the risk of developing or worsening asthma, whereas treatment of AR with subcutaneously or sublingual allergen immunotherapy (SLIT) may slow this progression. METHODS: In a retrospective real-world analysis, prescription fulfilment data were gathered from French retail pharmacies between 1 March 2012 and 31 December 2016. Using linear regression analyses, patients having received at least two prescriptions of grass pollen SLIT tablets over at least 2 successive years were compared with control patients having received symptomatic medications only. RESULTS: A total of 1099 SLIT patients and 27 475 control patients were included in the main analysis. With regard to symptomatic AR medication dispensing, we observed a 50% decrease in the pre-index/follow-up ratio in the SLIT group, a 30% increase in the control group without age matching (P < 0.0001 vs SLIT) and a 20% increase in the control group with age matching (P < 0.0001 vs SLIT). During the follow-up, 11 (1.8%) and 782 (5.3%) patients initiated asthma treatment in the SLIT and control groups, respectively. The relative risk of medication dispensing for new asthma was lower in the SLIT group (by 62.5% [29.1%-80.1%] without age matching (P = 0.0025) and by 63.7% [31.5%-80.7%] with age matching; P = 0.0018). SLIT was also associated with slower progression of asthma medication dispensing during the follow-up period, relative to the control group (regression coefficient: -0.58 [-0.74 to 0.42] without age matching (P < 0.0001) and -0.61 [-0.76 to -0.46] with age matching; P < 0.0001). CONCLUSION: Prescription of grass pollen SLIT tablets reduced the dispensing of AR and asthma medications in real life.

Real life patterns of care and progression free survival in metastatic renal cell carcinoma patients: retrospective analysis of cross-sectional data.

BACKGROUND: Patient characteristics and survival outcomes in randomized trials may be different from those in real-life clinical practice. The objective of this study was to describe treatment pathways, safety, drug costs and survival in patients with metastatic Renal Cell Carcinoma (mRCC) in a real world setting. METHODS: A retrospective analysis was performed using IQVIA real world oncology cross-sectional survey data, a retrospective treatment database collecting anonymized patient-level data in Europe. Data on treatment naïve patients with mRCC who received a first-line targeted therapy in France were extracted for the period 2005-2015. Descriptive analyses were performed on treatment patterns, patient characteristics and safety profiles. Progression Free Survival (PFS) was determined using Kaplan-Meier survival analysis. RESULTS: One thousand three hundred thirty-one patients with mRCC who received a first-line targeted therapy were included. The male/female sex ratio was 2.5 and 66% of patients were aged > 60 years. 83% of patients had clear cell adenocarcinoma. 83% of patients underwent a surgical procedure, 10% had radiotherapy. In patients who received a first-line targeted therapy, 73% received sunitinib. The mean time from diagnosis to first-line treatment by targeted therapies in patients initially diagnosed with metastatic disease was 3.3 months [95% CI:2.5-4.1]. In patients who received second-line targeted therapy n = 257 (19%), the most frequently observed treatment sequences were sunitinib-everolimus (33%) and sunitinib-sorafenib (27%). Adverse events data were available for 501 patients and adverse events were documented in 70% of patients, most frequently diarrhoea. The overall median PFS was 13 months [95% CI:11.5-16]. CONCLUSION: Patient characteristics were consistent with the literature. Treatment patterns appeared to follow current practice guidelines. Despite some variations, PFS in our study seems to be consistent with findings from other real world studies. Nevertheless, PFS results were higher than those observed in clinical trials. Due to the use of cross-sectional data, PFS in our study should be interpreted with caution.

Asthma patients' self-reported behaviours toward inhaled corticosteroids.

BACKGROUND: Patient adherence to recommended use of ICS is questionable in asthma, with irregular use or interruptions occurring frequently. Factors explaining discontinuation of controller therapy could orientate interventions. The characteristics of patients with interruptions of inhaled corticosteroids (ICSs), intentional or accidental, were investigated. METHODS: Asthma patients regularly prescribed ICS by GPs (Cegedim network) were included. Patients' characteristics and behaviours toward ICS (accidental/intentional interruptions, less frequent use of ICS and change in dosing) were identified from self-report questionnaires, and linked to data prescription database. Interrelations between declared behaviours toward ICS were studied with a Multiple Component Analysis (MCA) and the correlates of ICS interruptions were identified. RESULTS: During the past 3 months, 31.6% of 204 patients (mean age: 53.8 years, females: 59.3%) intentionally interrupted ICS when feeling better, 25.4% forgot ICS and 18.3% deliberately changed the doses. A quarter of patients considered constant use of respiratory medicines as unhealthy. MCA revealed that intentional, accidental interruptions and less frequent use of ICS were closely correlated. Risk of intentional interruption was increased when patients considered constant use of respiratory therapy to be unhealthy (OR=3.36, 95%CI=[1.47-7.66]). Conversely, risk was significantly lower when ICS was associated or combined with another controller (OR=0.24, 95%CI=[0.08-0.73]), compared to ICS in monotherapy. Less frequent interruptions were observed in patients older than 65 (OR=0.35, 95%CI=[0.13-0.89]). CONCLUSIONS: Our study suggests that discontinuation of use of controllers is associated with other inadequate behaviours or beliefs about inhaled controllers. Efforts should be targeted at patients' perceptions and behaviours toward controller therapy.

Prevalence of low high-density lipoprotein cholesterol and hypertriglyceridaemia in patients treated with hypolipidaemic drugs.

AIM: To estimate the prevalence of triglyceride and/or high density lipoprotein cholesterol (HDL-C) disorders and their relationships with other cardiovascular risk factors among patients with dyslipidaemia on lipid-lowering therapy. METHODS: In this cross-sectional study in dyslipidaemic patients receiving lipid-lowering therapy, lipid disorders were defined as triglyceride greater than 1.5 g/L, HDL-C lesser than 0.4 g/L and low-density lipoprotein cholesterol (LDL-C) above the recommended concentration according to French guidelines. Based on these disorders, patients were classified into four groups: group 1, no lipid disorders; group 2, low HDL-C and/or high triglyceride concentration with normal LDL-C; group 3, isolated elevated LDL-C; and group 4, elevated LDL-C and low HDL-C and/or high triglyceride. Patients' cardiovascular risk levels were compared across groups. RESULTS: Among the 2727 patients (mean age 64.7 years, 46.7% women), 28% did not reach the target LDL-C concentration as defined by French guidelines. Prevalence rates of high triglyceride and low HDL-C were 27.2 and 10.3%, respectively. Over half (51.2%) of the patients were in group 1, 20.5% were in group 2, 16.2% in group 3 and 12.1% in group 4. Among patients meeting the target LDL-C, those with high triglyceride and/or low HDL-C exhibited a significantly higher number of risk factors (1.83 vs 1.68, p<0.001). Smoking, diabetes and hypertension were associated separately with low HDL-C and/or high triglyceride (p=0.01, p<0.0001, p=0.03, respectively). Conversely, these associations were not observed in patients who did not achieve the target LDL-C, with the exception of smoking (p<0.0001). CONCLUSION: HDL-C and triglyceride disorders are relatively frequent among treated patients, particularly when cardiovascular risk level increased.

[General practitioners' management of gastroesophageal reflux in France in 2005: a pharmacoeconomic study]. / Etude pharmaco-économique sur la prise en charge du reflux gastro-oesophagien en France en 2005 en médecine générale.

AIMS: Proton pump inhibitors (PPIs) rank third among drug classes in the amount they cost the French health care system annually (more than a billion euros, i.e., 5.7% of community pharmaceutical expenditures, 50% prescribed for gastroesophageal reflux disease (GERD)). METHODS: Data for a representative sample of patients aged 20 years and older, who visited their GP at least once in 2005 for uncomplicated symptomatic GERD came from the Thales database (1200 representative general practitioners (GP) connected to a computerized network) a. RESULTS: In 2005, 122 571 patients (mean age, 56 years, 45% male, 2.6 consultations for GERD) met the inclusion criteria. Extrapolated to the French population, this sample corresponds to 5.7 million people, i.e., 13% of the adult population who visited a GP during the year. PPIs were prescribed as first-line treatment for GERD in 84% of the consultations. Omeprazole, as a proprietary or generic drug, was prescribed most often (79%) and at a full dose (20mg), while other compounds (lansoprazole, pantoprazole, rabeprazole and esomeprazole) were prescribed at half dose in 64% of cases. The extrapolated annual cost of PPIs reimbursed for this indication was 465 million euros (Meuro) at a mean reimbursement level of 73%. Brand-name omeprazole still accounts for 11% of the total cost reimbursed. Complete replacement of brand-name omeprazole by its generic counterpart would reduce costs by 18.35Meuro (-4.3% reimbursed expenditure). The switch from generic full-dose omeprazole to a half dose of other PPIs would allow a further saving of 2.6 (with lansoprazole) to 13.2 Meuro (with pantoprazole). CONCLUSION: A substantial saving in reimbursed pharmaceutical spending in uncomplicated GERD and full compliance with clinical practice recommendations could be achieved by the substitution of less expensive PPIs.

Correlates of LDL-cholesterol goal attainment in patients under lipid lowering therapy.

BACKGROUND: LDL-cholesterol therapeutic objectives attainment under lipid lowering therapy remains inadequate. The correlates of LDL-cholesterol therapeutic objective attainment have not been thoroughly explored in an observational setting. METHODS: Patients under lipid lowering therapy and managed by general practitioners were included. LDL-cholesterol therapeutic objective was defined according to the number of cardiovascular risk factors associated with dyslipidemia (AFSSAPS-2005 guidelines). RESULTS: Most of the 2727 patients (mean age: 64.7+/-11.0) received a statin (70.0%) or a fibrate (24.3%) in monotherapy. 58.5% of patients at high cardiovascular risk did not reach therapeutic objective. Compared to simvastatin, patients receiving fibrates were less likely to be at therapeutic objective (OR=0.38, 95% CI=[0.26-0.54]). So were patients receiving fluvastatin (OR=0.41, IC95%=[0.26-0.64]) or pravastatin (OR=0.49, IC95%=[0.35-0.70]) at the dosages used by GPs. No significant difference appeared with atorvastatin (OR=0.99, 95% CI=[0.71-1.39]) or rosuvastatin (OR=1.25, CI95%=[0.77-2.02]). Patients with LDL-cholesterol levels<0.7 g/L tended to be prescribed high doses of lipid lowering therapy. CONCLUSIONS: In real conditions of lipid lowering therapy use, LDL-cholesterol therapeutic objective attainment was inadequate in high-risk patients, and TO differences were observed between drugs at prescribed doses.

Diagnostic indicators of restless legs syndrome in primary care consultations: the DESYR study.

The objective of this study is to determine whether spontaneous complaints about sleep or the legs could be used as potential indicators of restless legs syndrome (RLS) in primary care. A total of 351 general practitioners participated in the study. In a first historical patient identification phase, all patients with spontaneous complaints of sleep or leg symptoms over the previous year were identified. A control group without such complaints was identified. In a second prospective data collection phase, those who consulted a participating physician were interviewed to assess consensus diagnostic criteria of RLS. Severity was assessed with the International Restless Legs Syndrome Study Group severity rating scale. Of 1,405,823 patients consulting during the historical phase, a leg complaint was reported in 61,685 and a sleep complaint in 40,568. A total of 1,432 consulted during the prospective phase. A diagnosis of RLS was assigned to 42.6% of patients with leg complaints, 35.5% of those with sleep complaints, 54.9% of those with both complaints, and 12.9% of those with no complaints. Median RLS severity scores were 18.8 to 20.4. A total of 63.7% of patients were prescribed a venotonic, 43.7% a hypnotic, and 41.5% an anxiolytic. Complaints of sleep or leg symptoms are frequently associated with a diagnosis of RLS, and their presence should alert the physician to the possibility of a differential diagnosis of RLS.

Use of margarine enriched in phytosterols by patients at high cardiovascular risk and treated by hypolipidemic drugs.

BACKGROUND AND AIMS: The use of phytosterol-enriched margarines (PEM) in patients at cardiovascular risk has not been thoroughly explored. We determined the proportion of users of PEM in a population at high cardiovascular risk, and their characteristics. In addition, the correlates of using at least 25 g/d of PEM were identified. METHODS AND RESULTS: Patients with at least two cardiovascular risk factors in addition to dyslipidemia (primary prevention) or with past cardiovascular disease (secondary prevention) were recruited by general practitioners (GPs). Baseline characteristics were collected from a computerized GP database linked to a survey. GPs recorded patterns of PEM use. First, users were compared with non-users. Then, analyses were conducted to identify characteristics of patients using PEM at a recommended dose (>or=25 g/d). Among 1631 patients with documented consumption, a minority used PEM (15.2%), and only 36.4% of consumers used it at recommended level. Overall, PEM users did not differ from non-users as to general characteristics, nor as to the level of cardiovascular risk in primary prevention. However, PEM users reported significantly more cardiovascular events among their parents (OR=1.4; 95% CI=[1.0-1.9]). Consumers who used at least 25 g/d of PEM were more likely to be men (OR=3.1; 95% CI=[1.6-5.8]), to be aged 60-74 (OR=3.0; 95% CI=[1.4-6.4]), or 75 or older (OR=4.0; 95% CI=[1.5-10.6]). Again, no difference was observed regarding the level of cardiovascular risk. CONCLUSIONS: The level of use of PEM was low in this population of high cardiovascular risk patients. In addition, only a third of users consumed margarine at the recommended level. Our data suggest that pattern of use of PEM is not related to the level of cardiovascular risk.

Discrepancies between patient-reported outcomes and clinician-reported outcomes in chronic venous disease, irritable bowel syndrome, and peripheral arterial occlusive disease.

OBJECTIVE: To explore the degree of agreement between patient- and clinician-reported outcomes (PROs and CROs, respectively) in three chronic diseases. METHODS: Respectively, 120, 131, and 61 French general practitioners (GPs) included 291, 307, and 90 patients with chronic venous disease (CVD), irritable bowel syndrome (IBS), and peripheral arterial occlusive disease (PAOD), in a cross-sectional survey. Patients completed a specific Health-Related Quality of Life (QoL) questionnaire (Chronic Venous Insufficiency Questionnaire [CIVIQ], Functional Digestive Disorders Quality of Life [FDDQL], and Claudication Scale [CLAU-S], respectively) and scored their pain (visual analog scale, pain-free walking distance). GPs were concomitantly asked to estimate patients' pain and QoL. RESULTS: Although correlated (CVD and IBS: Kw = 0.27 and Kw = 0.31, respectively; PAOD: r = 0.64, P < 0.01), pain intensity estimated by GPs was lower than as estimated by patients with CVD and IBS (e.g., 39.0 +/- 24.9 vs. 30.4 +/- 21.0 for IBS), and pain-free walking distance was greater as estimated by GPs than by patients with PAOD. Pain estimated by patients only partially reflected their QoL (r between 0.30 and 0.78; P between 0.02 and <0.01). Global QoL scores estimated by patients and GPs were moderately correlated (Kw between 0.17 and 0.28). GPs underestimated QoL impairment in CVD (global score: 72 +/- 19 vs. 61 +/- 20) and in most dimensions of the IBS questionnaire (in six of eight dimensions), and overestimated QoL impairment in PAOD (54 +/- 21 vs. 66 +/- 23). CONCLUSIONS: Although correlated, PROs and CROs differed. In addition, their relationship was not consistent across diseases. PROs are therefore essential to take account of all the aspects of diseases.

Changes in osteoarthritis management by general practitioners in the COX2-inhibitor era-concomitant gastroprotective therapy.

OBJECTIVES: Two selective COX2 inhibitors, rofecoxib and celecoxib, were introduced on the French market in 2000. We evaluated their use in the treatment of osteoarthritis by general practitioners, with special attention to concomitant prescription of gastroprotective agents. MATERIAL AND METHODS: The Thales Epidemiology Observatory is a medical database compiled by a representative sample of 1000 general practitioners in France. We examined the data collected during the year before and the year after the introduction of rofecoxib and celecoxib on the French market (November 1999-October 2001). During each of the 2 years of the study period, about 200,000 visits for 70,000 patients were entered into the database. RESULTS: COX2 inhibitors were prescribed at a rapidly increasing rate during the second year, when they accounted for 38% of the prescription volume for nonsteroidal antiinflammatory drugs (NSAIDs) and 25% of prescribed medication costs. In some patients, COX2 inhibitors were substituted for nonselective NSAIDs, and in others they were used as first-line NSAID therapy. On average over the 2-year study period, 22.1% of prescriptions for conventional NSAIDs included a prescription for a gastroprotective agent; this proportion increased from 18.6% in November 1999 to 24.8% in October 2001. Among prescriptions for COX2 inhibitors, 17.5% included a gastroprotective agent. CONCLUSION: General practitioners have been prompt to use COX2 inhibitors in the treatment of osteoarthritis. However, they have not decreased their use of concomitant gastroprotective treatment. Thus, they seem aware that proof of a lower long-term risk of gastrointestinal toxicity with COX2 inhibitors is lacking, and that elderly patients such as those with osteoarthritis are at high risk for gastrointestinal side effects of NSAIDs.