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Case-non case studies belongs to the methods assessing drug safety by analyzing the disproportionality of notifications of adverse drug reactions in pharmacovigilance databases. Used for the first time in the 1980s, the last few decades have seen a significant increase in the use of this design. The principle of the case-non case study is to compare drug exposure in cases of a studied adverse reaction with that of cases of other reported adverse reactions and called "non cases". Results are presented in the form of a reporting odds ratio (ROR), the interpretation of which makes it possible to identify drug safety signals. This article describes the principle of the case-non case study, the method of calculating the ROR and its confidence interval, the different modalities of analysis and how to interpret its results with regard to the advantages and limitations of this design., (Copyright © 2017 Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. All rights reserved.)

Background: In February 2013, a retired French professor of medicine published a book denying the benefits of statins for cardiovascular prevention. The book was the subject of extensive media coverage and multiple public discussions and debate., Aims: To investigate the impact of this media event on use of statins among regular users., Methods: This repeated cohort study used the French claims database sample Échantillon généraliste des bénéficiaires to identify regular statin users and quantify the number who discontinued statins after February 2013, compared to discontinuation patterns in previous years (2011 and 2012). Discontinuation was defined as a gap of at least 2months without statin exposure., Results: In 2013, 30,725 regular statin users were identified; 29,517 in 2012 and 28,272 in 2011. Statin discontinuation at 9-month follow-up in 2013 was 11.9% (95% confidence interval [CI] 11.5-12.2), compared with 8.5% (95% CI 8.2-8.8) in 2012 and 8.5% (95% CI 8.2-8.8) in 2011. Discontinuation varied according to cardiovascular risk: 19.4% (95% CI 18.2-20.6) in low risk, 11.6% (95% CI 11.1-12.0) in moderate risk, and 7.4% (95% CI 6.8-8.1) in high risk for the 2013 cohort. These discontinuation rates were, respectively, 1.53 (95% CI 1.36-1.72), 1.40 (95% CI 1.31-1.49), and 1.25 (95% CI 1.08-1.46) times higher in 2013 than in 2012 for low risk, moderate risk, or high risk patients., Conclusions: The rate of statin discontinuation, overall and in each cardiovascular risk group, was greater in 2013 after the media event than in previous years. The clinical impact of the increased discontinuation could be important., (Copyright © 2016 Elsevier Masson SAS. All rights reserved.)

Aim: The objective of the study is to describe the characteristics of subjects under opiate maintenance treatment by general practionners (GPs)., Method: Data analysis from observatory for pharmacodependency in ambulatory medicine survey (observation des pharmacodépendances en médecine ambulatoire [OPEMA]) program in 2013 of the subjects under high dosage buprenorphine (HDB) and methadone prescribed or obtained illegally reported by GPs in France., Results: Survey concerned consumers with 862, 433 and 429 of high dosage buprenorphine and respectively methadone. The average age is 39±9 years respectively, and 36±8 years; over 70% are male; 55% have paid employment and over 30% report social benefits; 9% are in temporary housing. In both groups, more than 50% have anxiety and depression; over 25% have associated somatic disorders and digestive diseases, respiratory, pain is the most common. Almost 99% use oral route; nearly 100% have a daily consumption and about 20% of the alcohol concomitantly; 24% of HDB use benzodiazepines and 18% of the methadone group (P=0.06); 33% of the population using methadone consume illicit psychoactive substances and 21% for HDB population (P<0.0001), in particular cannabis (P<0.0001). Heroin and cocaine are also consumed., Conclusion: The population consuming opiate maintenance treatments shows social, somatic and psychiatric vulnerability. Misuse associated forms and consumption of other psychoactive substances and illegal drugs are observed. Despite the complexity of management of these patients, general practitioners have a major role to play., (Copyright © 2016 Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. All rights reserved.)