Caroline Laurendeau

Persistence and adherence to single-tablet regimens in HIV treatment: a cohort study from the French National Healthcare Insurance Database

OBJECTIVES To compare adherence and persistence (continuous treatment with a prescribed medication) in HIV adult patients who received combination ART (cART) as a once-daily single-tablet regimen (STR) versus other administration schedules. METHODS A representative random sample of the French National Healthcare Insurance Database was used. Adherence and persistence were compared according to their administration schedules using χ(2) and survival analyses. STRs were marketed in France in 2009 and the study period was selected to allow a sufficient number of patients with an STR and a relevant duration of follow-up. RESULTS During the period covered (2006-11), 362 HIV-positive adult antiretroviral-naive patients (566 lines of treatments) were selected. The mean rates of adherence were 89.6% for the STR (tenofovir/emtricitabine/efavirenz; n = 76), 86.4% for cART with >1 pill once daily (n = 242) and 77.0% for cART with >1 daily intake (n = 248; P < 0.0001 versus STR). Kaplan-Meier estimations of persistence after 2 years of treatment were 79.1% for the STR, 53.3% for cART with >1 pill once daily and 51.8% for cART with >1 daily intake (P = 0.001; log-rank test). Sensitivity analyses confirmed these results. After excluding treatment sequences showing a switch from tenofovir/emtricitabine plus efavirenz to the similar STR, the rates of persistence were 80.3% for the STR (n = 60), 77.3% for atazanavir-containing cART (n = 96) and 68.3% for darunavir-containing cART (n = 56) at 18 months (global P = 0.006). CONCLUSIONS These results suggest that persistence is higher in HIV patients treated with an STR compared with other administration schedules. Significant benefit in terms of adherence was observed with the STR in comparison with regimens with >1 daily intake but no difference was observed when comparing with regimens involving >1 pill once daily.

Measurement of treatment compliance using a medical device for glaucoma patients associated with intraocular pressure control: a survey.

Objective: To identify and characterize treatment compliance profiles of glaucoma patients and evaluate the association with intraocular pressure (IOP). Methods: A computerized device (Travalert®) that recorded daily instillation times and eye-drop counts was given for 3 months. Patients were declared compliant when at least 2 drops were instilled per day. Compliance rates were calculated for weekdays and weekends, separately, over 8 consecutive weeks. A principal components analysis (PCA) was followed by an ascendant hierarchical classification (AHC) to identify compliance groups. Results: 140 patients were recruited (mean age 65.5 years; 51.8% female) of whom 83.6% had primary open-angle glaucoma with mean IOP 23.9 mmHg before Travalert® use. 60.7% were treated with DuoTrav® (travoprost timolol fixed combination) and 39.3% with travoprost. The PCA identified two axes (compliance and treatment weeks). The AHC identified 3 compliance groups: ‘high’ (56.6%, approx. 80% compliance), ‘medium’ (21.2%, approx. 50% compliance), and ‘low’ (22.1%, approx. 20% compliance). Demographics and glaucoma parameters did not predict low compliance. Final mean IOP was 16.1 mmHg, but higher in the low compliance group (17.7 mmHg, P = 0.02). Conclusions: Compliance measurement by a medical device showed compliance rates <80% by 50% (approx.) of patients, significantly impacting IOP control. No demographic or glaucoma variable was associated with low compliance.

Intraocular Pressure Control with Latanoprost/Timolol and Travoprost/ Timolol Fixed Combinations : A Retrospective, Multicentre, Cross-Sectional Study

Methods:Patients with ocular hypertension or primary open angle glaucoma stabilized on TT or TL were included in this retrospective cross-sectional study. Data on demographics, medical history and previous treatments were extracted from the patients’ medical records. Last treatment instillation times and IOP values were recorded at clinic visits. Treatments were compared by analyses of variance, logistic regressions and propensity scores adjusted for confounding factors.Results:Out of 316 patients included, 124 instilled TT, 192 instilled TL and 266 (84.2%) overall had instilled their eye drops within 24 hours. The patients’ mean age was 64.5 years and 51.6% were female. Treatment groups were comparable except for longer disease and treatment durations in TL recipients. Worse eye mean IOPs were 25.8 mmHg at diagnosis and 21.9 mmHg on starting their designated fixed combination treatment. The best IOP control was provided by TT instillations (mean IOP 17.1 and 19.0 mmHg in the TT and TL groups, respectively; p < 0.001). This difference was reinforced by results in the subgroup of patients who instilled treatment >24 hours prior to IOP measurement (mean IOP 17.0 and 20.3 mmHg in the TT and TL groups, respectively; p < 0.004). Also, 82.6% of TT patients satisfied their ophthalmologists’ IOP targets versus 51.1% of TL patients (p < 0.001). All significant differences persisted after adjustment for confounding factors.Conclusion:This study, conducted in routine ophthalmic practice, confirmed published clinical trial results showing that TT provides better IOP control than TL when measured in the morning, and that travoprost has longer-lasting residual effects than latanoprost when IOP is measured >24 hours after instillation. However, readers should interpret these findings in the context of a cross-sectional observational study conducted in a naturalistic setting.

Characteristics and management of rheumatoid arthritis in France: Analysis of a representative French national claims database resulting in an estimated prevalence of 0.35%

Joint Bone Spine - In Press.Proof corrected by the author Available online since mercredi 9 decembre 2015

Outcomes and management costs of peripheral arterial disease in France

Background: Little is known about the characteristics and prognosis of patients with peripheral arterial disease (PAD) and related real‐life health costs in France. Methods: A cohort of patients diagnosed with PAD between 2007 and 2011 was extracted from the French Echantillon Généraliste des Bénéficiaires (EGB) claims database. The patients were followed up from the date of PAD diagnosis. Their characteristics, incidence of death and other events, treatments, and costs were analyzed by comparison with age‐ and gender‐matched PAD‐free controls. Results: There were 5889 patients with PAD identified. Mean age was 70.8 years, and 68.1% of patients were male. Diabetes was present in 28.9% of patients (13.2% of controls), hypercholesterolemia in 52.9% (28.7%), and hypertension in 46.6% (12.3%); 4.9% of patients had a history of unstable angina or myocardial infarction (0.5%), and 6.0% had a history of stroke or transient ischemic attack (1.4%). At inclusion, 69.3% of patients were receiving antiplatelet drugs (17.3%), 52.3% statins (21.9%), 26.7% angiotensin‐converting enzyme inhibitors (13.7%), and 24.2% angiotensin receptor blockers (16.6%). Cumulative mortality rates were 13.2% at 1 year and 19.4% at 2 years (3.2% and 6.5% in controls). Cumulative incidence rates of death and major cardiovascular events (myocardial infarction and ischemic stroke) were 15.7% (95% confidence interval [CI], 14.8%‐16.6%) at 1 year and 22.9% (95% CI, 21.9%‐24.0%) at 2 years vs 3.9% (95% CI, 3.4%‐4.4%) and 7.8% (95% CI, 7.1%‐8.5%) in controls. All differences were statistically significant (P < .05). Total annual management costs were &U20AC;14,949 in the PAD group and &U20AC;3812 in the control group. Conclusions: Mortality is elevated and cardiovascular events are frequent among French PAD patients. PAD drug treatment guidelines are not fully implemented in France.

Effectiveness and cost of contraception in France (FACET study): a cohort study from the French National Healthcare Insurance Database

OBJECTIVE To assess the effectiveness and costs associated with contraceptive methods based on real-world data in France. STUDY DESIGN A cross-sectional cohort study based on data from a representative sample of the French National Healthcare Insurance Database (Echantillon Généralistes des Bénéficiaires (EGB)) was performed between January 1st 2006 and December 31st 2012. Women aged 15 years or older and users of at least one reimbursed contraceptive method between January 1st 2012 and December 31st 2012 were selected. The outcome of interest was unintended pregnancy, defined as pregnancies occurring after at least one month since the dispensation of a contraceptive method. The mean annual costs of contraceptive methods (in 2012 Euros) were collected in the database from a health system perspective. Costs were expressed for the first year of use, considering the next years of use and taking into account or not the cost of unplanned pregnancies. RESULTS A population of 48,090 women representative of the 4,664,730 French women with a reimbursed contraceptive method was identified in the EGB in 2012: 68.6% used at least one reimbursed oral contraception (OC), 30.2% used at least one intrauterine devices (IUD) (LGN-IUS 52 mg, 17.6%; copper, 13.1%) and 5.1% used at least one etonogestrel implant. Unplanned pregnancies rates ranged from 0.6% with LNG-IUS 52 mg and 0.8% with the etonogestrel implant to 4.8% with 1st and 2nd generation combined OCs. The mean annual costs of contraception for the first year of use ranged from €145 for 1st-2nd generation combined oral contraceptions (COCs) to €308 for LNG-IUS 52 mg taking into account the next years of use, the etonogestrel implant was associated with the lowest mean annual cost (€88). When costs of unplanned pregnancies were taken into account, the mean annual cost of contraception for the first year of use was lower for progestin-only OC (€251) and copper IUD (€257) compared to etonogestrel implant (€300) and LNG-IUS 52 mg(€323). CONCLUSION This real-world study suggests that Long-acting reversible contraceptives (LARCs) (i.e. implant and IUDs) should be considered for a broader use to prevent unplanned pregnancies and related abortions in France both from a public health and economic perspective.

FRI0224 Prevalence Determination of Severe Ankylosing Spondylitis and its Co-Morbidities in 2012 in France: Analysis of a National Public Health Insurance Database

Background While there is an increasing need to better understand the epidemiology of ankylosing spondylitis (AS), such data in France are limited1,2 or issued from cohorts, with the inherent risk of selection bias. Objectives To estimate the prevalence of severe AS in France and the frequency of chronic, severe co-morbidities, as compared with a control group based on a national representative claims database. Methods The EGB database is a national representative 1/97 sample of individuals covered by the 3 main French insurance schemes. This database lists all healthcare consumption and allows identification of beneficiaries eligible for full health insurance coverage due to severe conditions (list of conditions is defined by the French Sickness fund and called “ALD”). The studied population comprised adults (>18 yrs) with severe AS in 2012. Frequency of serious chronic co-morbidities, such as inflammatory bowel diseases (IBD), cardiovascular diseases and malignancies were identified based on ALD eligibility and compared with a control group without full coverage due to AS and matched by sex and age. Results Among 470,326 adults in the database, 827 patients with severe AS were identified, corresponding to a crude prevalence rate of 0.18% and a nationwide prevalence estimate of 88,275 patients in 2012 in France. Their M/F sex ratio was 1.2, mean (±SD) age was 50.4 (±14.3) years and the time since decision for full health insurance coverage due to AS was 9.7 (±7.8) years. IBD, high blood pressure (HBP), recurrent major depressive disorders and other co-morbidities taken as a whole were significantly more frequent in AS patients than controls (Table; 3.5 vs 0.24%, p<0.0001; 4.5 vs 1.8%; p<0.0001; 3.1 vs 1.5%; p=0.003 and 24.7 vs 18.8%; p=0.0003, respectively). There was no significant difference in mortality between AS and controls as measured by annual death rate. Conclusions Analysis of a national representative claim database provides up-to-date data on the current prevalence of severe AS in France. These initial results also indicate an increase in several co-morbidities, such as IBD, HBP and depression. No differences were seen regarding malignancies or mortality rates. Further research is needed to confirm these findings. References Saraux A. Ann Rheum Dis 2005;64:1431–1435. Costantino F. Ann Rheum Dis 2013 [Epub ahead of print] Acknowledgements The authors acknowledge Costello Medical Consulting for editorial assistance which was funded by UCB Pharma. Disclosure of Interest M. Breban Consultant for: UCB Pharma, P. Claudepierre Consultant for: UCB Pharma, T. de Chalus Employee of: UCB Pharma, J. M. Joubert Employee of: UCB Pharma, C. Laurendeau Employee of: CEMKA mandated by UCB Pharma for the analysis of the database, J. Gourmelen: None declared, F. Fagnani Employee of: CEMKA mandated by UCB Pharma for the analysis of the database