LA SER Europe Ltd

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Grimaldi-Bensouda L.,Paris West University Nanterre La Défense | Grimaldi-Bensouda L.,French National Conservatory of Arts and Crafts | Grimaldi-Bensouda L.,Pasteur Institute | Rossignol M.,Center for Risk Research | And 14 more authors.
International Journal of Cardiology | Year: 2013

Background Evidence on the real effectiveness of statins on acute coronary syndrome (ACS) incidence is scarce. We assessed the effectiveness of real-life statins on the risk of first non-fatal ACS in a low-cardiovascular-risk country. Methods Systematic case-control study was conducted in 60 cardiology centres and 371 general practices from across France. A total of 2238 cases with first ACS within 1 month from recruitment and 2238 controls without history of ACS were included; controls were matched to ACS cases on sex, age, frequency of visits to GPs, date of recruitment and personal history of chronic diseases. Statin exposure and risk factors were documented through patient telephone interviews and validated against medical records. The index date was the date of ACS for cases. Adjusted odds ratios (OR) of first ACS and statin use were estimated by multiple conditional logistic regression models controlled for risk factors and propensity score for statin exposure. Results Statin use was associated with lower ACS risk, with an adjusted matched OR of 0.67; 95% confidence interval (CI): 0.56 to 0.79 for current use (within 2 months) and 0.73; 95% CI: 0.62 to 0.86 for any use within 24 months [atorvastatin: 0.83 (0.63-1.10), fluvastatin: 0.75 (0.43-1.30), pravastatin: 0.98 (0.72-1.34), rosuvastatin: 0.49 (0.35-0.68) and simvastatin: 0.62 (0.46-0.84)]. The preventive effect of statins on non-fatal ACS reached its maximum after one to four years of use. Conclusion A similar magnitude of effect for statin use was observed in real life, as compared to randomised clinical trials in France. © 2013 Elsevier Ireland Ltd.


Aiassa E.,Assessment and Methodological Support Unit | Higgins J.P.T.,University of Bristol | Frampton G.K.,University of Southampton | Greiner M.,Leibniz University of Hanover | And 11 more authors.
Critical Reviews in Food Science and Nutrition | Year: 2015

Food and feed safety risk assessment uses multi-parameter models to evaluate the likelihood of adverse events associated with exposure to hazards in human health, plant health, animal health, animal welfare, and the environment. Systematic review and meta-analysis are established methods for answering questions in health care, and can be implemented to minimize biases in food and feed safety risk assessment. However, no methodological frameworks exist for refining risk assessment multi-parameter models into questions suitable for systematic review, and use of meta-analysis to estimate all parameters required by a risk model may not be always feasible. This paper describes novel approaches for determining question suitability and for prioritizing questions for systematic review in this area. Risk assessment questions that aim to estimate a parameter are likely to be suitable for systematic review. Such questions can be structured by their “key elements” [e.g., for intervention questions, the population(s), intervention(s), comparator(s), and outcome(s)]. Prioritization of questions to be addressed by systematic review relies on the likely impact and related uncertainty of individual parameters in the risk model. This approach to planning and prioritizing systematic review seems to have useful implications for producing evidence-based food and feed safety risk assessment. © 2015, Copyright © Taylor & Francis Group, LLC.


Grimaldi-Bensouda L.,LA SER and National Conservatory of Arts and Crafts | Cameron D.,University of Edinburgh | Marty M.,Center for Therapeutic Innovation in Oncology and Hematology | Barnett A.H.,University of Birmingham | And 13 more authors.
Diabetes Care | Year: 2014

Objective Several studies have been published in 2009 suggesting a possible association between insulin glargine and increased risk of malignancies, including breast cancer. The objective of this study was to assess the relation between the individual insulins (glargine, aspart, lispro, and human insulin) and development of breast cancer. Research Design And Methods Seven hundred seventy-five incident cases of primary invasive or in situ carcinoma breast cancer occurring in women with diabetes from 92 centers in the U.K., Canada, and France were matched to a mean of 3.9 diabetic community control subjects (n = 3,050; recruited from 580 general practices) by country, age, recruitment date, and diabetes type and management. The main risk model was a multivariate conditional logistic regression model with case/control status as the dependent variable and individual insulin use, 8 years preceding the index date, as the independent variable, controlling for past use of any insulin, oral antidiabetes drugs, reproductive factors, lifestyle, education, hormone replacement therapy and history of contraceptive use, BMI, comorbidities, diabetes duration, and annual number of physician visits. Glargine was also compared with every other insulin by computing all ratios using the variance-covariance matrix of logistic model parameters. Results Adjusted odds ratios of breast cancer for each type of insulin versus no use of that insulin were 1.04 (95% CI 0.76-1.44) for glargine, 1.23 (0.79-1.92) for lispro, 0.95 (0.64-1.40) for aspart, and 0.81 (0.55-1.20) for human insulin. Two-by-two comparisons found no difference between glargine and the different types of insulins. Insulin dosage or duration of use and tumor stage did not change the results. Conclusions This international study found no difference in the risk of developing breast cancer in patients with diabetes among the different types of insulin with short- to midterm duration of use. Longer-term studies would be of interest. © 2014 by the American Diabetes Association.


Udo R.,University Utrecht | Tcherny-Lessenot S.,Sanofi S.A. | Brauer R.,London School of Hygiene and Tropical Medicine | Dolin P.,Takeda Development Center Europe | And 8 more authors.
Pharmacoepidemiology and Drug Safety | Year: 2016

Purpose: To examine the robustness of findings of case-control studies on the association between acute liver injury (ALI) and antibiotic use in the following different situations: (i) Replication of a protocol in different databases, with different data types, as well as replication in the same database, but performed by a different research team. (ii) Varying algorithms to identify cases, with and without manual case validation. (iii) Different exposure windows for time at risk. Methods: Five case-control studies in four different databases were performed with a common study protocol as starting point to harmonize study outcome definitions, exposure definitions and statistical analyses. Results: All five studies showed an increased risk of ALI associated with antibiotic use ranging from OR 2.6 (95% CI 1.3-5.4) to 7.7 (95% CI 2.0-29.3). Comparable trends could be observed in the five studies: (i) without manual validation the use of the narrowest definition for ALI showed higher risk estimates, (ii) narrow and broad algorithm definitions followed by manual validation of cases resulted in similar risk estimates, and (iii) the use of a larger window (30days vs 14days) to define time at risk led to a decrease in risk estimates. Conclusions: Reproduction of a study using a predefined protocol in different database settings is feasible, although assumptions had to be made and amendments in the protocol were inevitable. Despite differences, the strength of association was comparable between the studies. In addition, the impact of varying outcome definitions and time windows showed similar trends within the data sources. © 2015 John Wiley & Sons, Ltd.


Rossignol M.,McGill University | Rossignol M.,Center for Risk Research | Begaud B.,University of Bordeaux Segalen | Engel P.,LA SER | And 14 more authors.
Pharmacoepidemiology and Drug Safety | Year: 2012

Objective: The objective of this study was to assess the effect of physician practicing preferences (PPP) in primary care for homeopathy (Ho), CAM (Complementary and alternative medicines) with conventional medicine (Mx) or exclusively conventional medicine (CM) on patients with musculoskeletal disorders (MSDs), with reference to clinical progression, drug consumption, side effects and loss of therapeutic opportunity. Methods: The EPI3-MSD study was a nationwide observational cohort of a representative sample of general practitioners (GP) and their patients in France. Recruitment of GP was stratified by PPP, which was self-declared. Diagnoses and comorbidities were recorded by GP at inclusion. Patients completed a standardized telephone interview at inclusion, one, three and twelve months, including MSD-functional scales and medication consumption. Results: 1153 MSD patients were included in the three PPP groups. Patients did not differ between groups except for chronicity of MSDs (>12 weeks), which was higher in the Ho group (62.1%) than in the CM (48.6%) and Mx groups (50.3%). The twelve-month development of specific functional scores was identical across the three groups after controlling for baseline score (p>0.05). After adjusting for propensity scores, NSAID use over 12 months was almost half in the Ho group (OR, 0.54; 95%CI, 0.38-0.78) as compared to the CM group; no difference was found in the Mx group (OR, 0.81; 95% CI: 0.59-1.15). Conclusion: MSD patients seen by homeopathic physicians showed a similar clinical progression when less exposed to NSAID in comparison to patients seen in CM practice, with fewer NSAID-related adverse events and no loss of therapeutic opportunity. © 2012 John Wiley & Sons, Ltd.


Grimaldi-Bensouda L.,LA SER | Rossignol M.,Center for Risk Research Inc. | Rossignol M.,McGill University | Aubrun E.,LA SER | And 4 more authors.
Pharmacoepidemiology and Drug Safety | Year: 2012

Purpose: The use of prescription records for the assessment of exposure to nonsteroidal anti-inflammatory drugs (NSAIDs) does not capture over-the-counter drug use. This study compared patients' self-reported use to physician's prescriptions for NSAIDs and other drugs used to treat musculoskeletal disorders (MSDs). Methods: The international Pharmacoepidemiologic General Research eXtension database includes a network of general practitioners recruiting patients without reference to diagnoses or prescriptions. Data on all drug use across France within the 2 years preceding the date of inclusion (index date) were obtained from both patients' self-reports (PSRs) and physicians' prescription reports (PPRs). Patients' reports were obtained using a structured telephone interview combined with an interview guide containing a list of drugs commonly used. Comparisons were made on exposure to four categories of MSD drugs and three time windows up to 24months before the index date. Results: Agreement between physician and patient reports was assessed on 4152 patient-physician pairs. Bias- and prevalence-adjusted kappa values showed fair agreement for nonaspirin NSAIDs, moderate to fair for nonnarcotic analgesics, high for osteoarthritis and moderate to substantial for muscle relaxants. Over-the-counter drug use was associated with greater disagreement (OR=2.21, 95%CI=1.05-1.38). Age was not associated with disagreement. Conclusion: Differences between PSR and PPR in estimating the prevalence of MSD drug use varied by the type of drug and the elapsed time from the index date. The patient-assisted interview method used in this study showed better agreement with PPR compared with standard interviews, especially for long time windows and patients older than 65years. © 2012 John Wiley & Sons, Ltd.


Grimaldi-Bensouda L.,LA SER | Grimaldi-Bensouda L.,Institute Pasteur Paris | Aubrun E.,LA SER | Leighton P.,LA SER Europe Ltd | And 6 more authors.
Pharmacoepidemiology and Drug Safety | Year: 2013

Purpose: Patients' self-reported vaccine exposure (PS) may be subject to memory errors and other biases. Physicians' prescription records and other medical records (MR) do not capture noncompliance with vaccination. This study compared PS with MR for influenza, 23-valent pneumococcal, and human papillomavirus (HPV) vaccines. Methods: The Pharmacoepidemiologic General Research Extension (PGRx) database uses a network of over 300 general practitioners across France, who systematically recruit an age- and sex-stratified sample of patients (≥ 14years old), without reference to their diagnoses or prescriptions. Patients received a structured telephone interview, combined with an interview guide listing vaccines commonly given. Patients' self-reported vaccination in the 3 years before their recruitment was compared with medical records kept by the physician or the patient. Results: Concordance between PS and MR was assessed for 7613 patients for whom both sources of information were available. Agreement within 3 years before the recruitment date was substantial for influenza vaccines (prevalence and bias-adjusted kappa [PABAK]=0.74, sensitivity PS relative to MR 81.5%) and high for 23-valent pneumococcal vaccines (PABAK=0.98, sensitivity PS 49.6) and HPV vaccines (PABAK=0.92, sensitivity PS 91.6). In adjusted analyses, agreement varied with sociodemographic and health-related factors, particularly for influenza and 23-valent pneumococcal vaccines. Conclusions: The PGRx method for drug exposure assessment is a new tool in pharmacoepidemiology that shows substantial to high agreement between PS and MR for exposure to various vaccines. Our finding of high agreement between PS and MR for HPV vaccination status in young women is a significant addition to the literature. © 2013 John Wiley & Sons, Ltd.


PubMed | University Utrecht, Sanofi S.A., London School of Hygiene and Tropical Medicine, European Medicines Agency EMA and 2 more.
Type: | Journal: Pharmacoepidemiology and drug safety | Year: 2016

To examine the robustness of findings of case-control studies on the association between acute liver injury (ALI) and antibiotic use in the following different situations: (i) Replication of a protocol in different databases, with different data types, as well as replication in the same database, but performed by a different research team. (ii) Varying algorithms to identify cases, with and without manual case validation. (iii) Different exposure windows for time at risk.Five case-control studies in four different databases were performed with a common study protocol as starting point to harmonize study outcome definitions, exposure definitions and statistical analyses.All five studies showed an increased risk of ALI associated with antibiotic use ranging from OR 2.6 (95% CI 1.3-5.4) to 7.7 (95% CI 2.0-29.3). Comparable trends could be observed in the five studies: (i) without manual validation the use of the narrowest definition for ALI showed higher risk estimates, (ii) narrow and broad algorithm definitions followed by manual validation of cases resulted in similar risk estimates, and (iii) the use of a larger window (30 days vs 14 days) to define time at risk led to a decrease in risk estimates.Reproduction of a study using a predefined protocol in different database settings is feasible, although assumptions had to be made and amendments in the protocol were inevitable. Despite differences, the strength of association was comparable between the studies. In addition, the impact of varying outcome definitions and time windows showed similar trends within the data sources.


PubMed | McGill University, University of Franche Comte, Cyklad group, Institute Pasteur Paris and 5 more.
Type: | Journal: BMC complementary and alternative medicine | Year: 2016

The purpose of the study was to compare utilization of conventional psychotropic drugs among patients seeking care for anxiety and depression disorders (ADDs) from general practitioners (GPs) who strictly prescribe conventional medicines (GP-CM), regularly prescribe homeopathy in a mixed practice (GP-Mx), or are certified homeopathic GPs (GP-Ho).This was one of three epidemiological cohort studies (EPI3) on general practice in France, which included GPs and their patients consulting for ADDs (scoring 9 or more in the Hospital Anxiety and Depression Scale, HADS). Information on all medication utilization was obtained by a standardised telephone interview at inclusion, 1, 3 and 12 months.Of 1562 eligible patients consulting for ADDs, 710 (45.5 %) agreed to participate. Adjusted multivariate analyses showed that GP-Ho and GP-Mx patients were less likely to use psychotropic drugs over 12 months, with Odds ratio (OR) = 0.29; 95 % confidence interval (CI): 0.19 to 0.44, and OR = 0.62; 95 % CI: 0.41 to 0.94 respectively, compared to GP-CM patients. The rate of clinical improvement (HADS <9) was marginally superior for the GP-Ho group as compared to the GP-CM group (OR = 1.70; 95 % CI: 1.00 to 2.87), but not for the GP-Mx group (OR = 1.49; 95 % CI: 0.89 to 2.50).Patients with ADD, who chose to consult GPs prescribing homeopathy reported less use of psychotropic drugs, and were marginally more likely to experience clinical improvement, than patients managed with conventional care. Results may reflect differences in physicians management and patients preferences as well as statistical regression to the mean.


Julin B.,Karolinska Institutet | Vahter M.,Karolinska Institutet | Amzal B.,LA SER Europe Ltd. | Wolk A.,Karolinska Institutet | And 2 more authors.
Environmental Health: A Global Access Science Source | Year: 2011

Background: Cadmium is a widespread environmental pollutant with adverse effects on kidneys and bone, but with insufficiently elucidated public health consequences such as risk of end-stage renal diseases, fractures and cancer. Urinary cadmium is considered a valid biomarker of lifetime kidney accumulation from overall cadmium exposure and thus used in the assessment of cadmium-induced health effects. We aimed to assess the relationship between dietary cadmium intake assessed by analyses of duplicate food portions and cadmium concentrations in urine and blood, taking the toxicokinetics of cadmium into consideration. Methods. In a sample of 57 non-smoking Swedish women aged 20-50 years, we assessed Pearson's correlation coefficients between: 1) Dietary intake of cadmium assessed by analyses of cadmium in duplicate food portions collected during four consecutive days and cadmium concentrations in urine, 2) Partial correlations between the duplicate food portions and urinary and blood cadmium concentrations, respectively, and 3) Model-predicted urinary cadmium concentration predicted from the dietary intake using a one-compartment toxicokinetic model (with individual data on age, weight and gastrointestinal cadmium absorption) and urinary cadmium concentration. Results: The mean concentration of cadmium in urine was 0.18 (+/- s.d.0.12) g/g creatinine and the model-predicted urinary cadmium concentration was 0.19 (+/- s.d.0.15) g/g creatinine. The partial Pearson correlations between analyzed dietary cadmium intake and urinary cadmium or blood concentrations were r = 0.43 and 0.42, respectively. The correlation between diet and urinary cadmium increased to r = 0.54 when using a one-compartment model with individual gastrointestinal cadmium absorption coefficients based on the women's iron status. Conclusions: Our results indicate that measured dietary cadmium intake can reasonably well predict biomarkers of both long-term kidney accumulation (urine) and short-term exposure (blood). The predictions are improved when taking data on the iron status into account. © 2011 Julin et al; licensee BioMed Central Ltd.

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