Impact of bisphosphonate compliance on the risk of osteoporotic fracture in France.

Limited information is available on the impact of bisphosphonate compliance levels on fracture risk in osteoporosis patients in France. The results of this nested case-control, retrospective study suggest that fracture risk did not significantly change with bisphosphonate compliance levels, except for highly compliant patients. PURPOSE/INTRODUCTION: This was the first study conducted in France to evaluate the impact of compliance levels for bisphosphonates, the most frequently prescribed first-line anti-osteoporotic treatment, on fracture risk. METHODS: This retrospective nested case-control study included patients ≥ 50 years old, who were recorded in a random sample of French claims data, did not die between 2006 and 2013, and received ≥ 1 reimbursement for anti-osteoporotic treatment between 2007 and 2013. Cases (patients hospitalised for osteoporosis-related fractures) were matched to 1-3 controls (patients hospitalised for other reasons). Patients hospitalised for fractures within 12 months preceding the first delivery of anti-osteoporotic treatment or during the first 24 months of follow-up were excluded. Bisphosphonate compliance during the 24 months preceding hospitalisation was calculated by the Continuous measure of Medication Acquisition version 7 (CMA7). We evaluated the impact of bisphosphonate compliance (CMA7 ≥ 80%) and very good compliance levels (CMA7 > 90%) on fracture risk. RESULTS: In the main analysis, the mean CMA7 values during the 24 months preceding hospitalisation were 48.4% for the 434 cases and 51.3% for the 1123 age-matched controls. An adjusted conditional logistic regression showed no significant impact (odds ratio: 0.851 [95% confidence interval: 0.668, 1.084]) of bisphosphonate compliance on fracture occurrence. In the sensitivity analysis, including one randomly selected control per case and only controls with CMA7 values > 90%, occurrence of fractures was lower (odds ratio: 0.741 [95% confidence interval: 0.608, 0.903]) among the 119 controls. CONCLUSION: In conclusion, this study suggested that very high levels of compliance with bisphosphonates are necessary to induce significant decreases in fracture risk.

Recurrent Wheezing in Infants: A Population-Based Study.

Recurrent wheezing (RW) has a significant impact on infants, caregivers, and society, but morbidity and related medical resource utilization (MRU) have not been thoroughly explored. The burden of RW needs to be documented with population-based data. The objective was to assess the characteristics, medical management, and MRU of RW infants identified from national claims data. Infants aged from 6 to 24 months, receiving ≥2 dispensations of respiratory drugs within 3 months, and presenting a marker of poor control (index date), were selected. During the 6 months after index date, MRU was described in the cohort and among 3 subgroups with more severe RW, defined as ≥4 dispensations of respiratory drugs, ≥3 dispensations of oral corticosteroids (OCS), or ≥1 hospitalization for respiratory symptoms. A total of 115,489 infants had RW, corresponding to 8.2% of subjects in this age group. During follow-up, 68.7% of infants received inhaled corticosteroids, but only 1.8 U (unit) were dispensed over 6 months, suggesting discontinuous use. Control was mostly inadequate: 61.7% of subjects received OCS, 80.2% antibiotics, and 71.2% short-acting beta-agonists, and medical/paramedical visits were numerous, particularly for physiotherapy. Severe RW concerned 39.0% of the cohort; 32.8% and 11.7% of infants had repeated use of respiratory drugs and OCS, respectively, and 5.5% were hospitalized for respiratory symptoms. In this real-life nation-wide study, RW was common and infants had poor control and high MRU. Interventions are needed to support adequate use of controller therapy, and to improve medical care.

Effectiveness of Montelukast on asthma control in infants: methodology of a French claims data study.

BACKGROUND: This pilot study, conducted on a 1/97th representative sample of French claims data, prepared a project to assess the effectiveness of Montelukast (MTL-4) as add-on therapy for asthma in infants (6-24 months) compared to inhaled corticosteroids (ICS), based on real-world data. Due to the very recent opening of French claims data for effectiveness research, and the complex structure of this data source, we first tested the feasibility of identifying infants with asthma and outcome criteria, and the ability to perform relevant comparisons. METHODS: We identified a cohort of infants with uncontrolled asthma and receiving ≥2 consecutive dispensations of any respiratory drug (R03 ATC classification) during a 6-month period. Uncontrolled asthma was identified either from exacerbations or from markers of acute loss of asthma control; date of occurrence of an event (exacerbation and/or acute loss of asthma control) was defined as index date. The study groups comprised infants receiving MTL-4 +/- ICS (MTL-4 group) or ICS without MTL-4 (ICS group) at index date. These two groups were matched on gender, age, quarter of index date, therapy before index date, past asthma-related hospitalization (ever), and were followed for 6 months. The outcome was the rate of infants with uncontrolled asthma, defined as above. RESULTS: This pilot cohort study included 1,149 infants with asthma (mean age 14.1 months, 64% boys). Of these, 51 and 768 were assigned to the MTL-4 and ICS groups, respectively. Uncontrolled asthma occurred in 78.8% and 78.4% of infants in these groups, respectively (oral corticosteroids were dispensed to 49% and 61%, respectively). Assessment of uncontrolled asthma, exposure to MTL-4 and ICS, and occurrence of outcomes were achieved. For the development of matching criteria, we defined a new marker of severity (therapeutic typologies). CONCLUSION: These data support the feasibility of the final project, to be conducted on claims data from the whole French population. We also showed that, with appropriate methodology and by using valid criteria, French claims data are an adequate resource for conducting comparative effectiveness studies in pediatric asthma. Finally, the algorithm used to identify infants with asthma could be applied to other studies using claims data.