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EZE cohort was a 48-month prospective, nationwide study conducted between 2008 and 2013 in Franceat the request of the French Haute Autorite de Sante. Its objective was to assess the real life use and impact of the drug on lipid lowering. Over 700 physicians (94% general practitioners and 4% cardiologists recruited and described 3,395 eligible adult patients who had initiated ezetimibe treatment for no longer than three months, of which 3,215 (94.7%) were entered in the analyses. Patients were naturalistically followed up to 4 years without any visits formally planned. Blood lipids were reported by physicians every twelve months and lipid lowering medicines utilization every six months with patient’s telephone interviews between each physician’s visit. 9 314 person-years of follow-up were accumulated. At inclusion, patients were 61.5 year-old on average (standard deviation (SD): 10.7) and 54.6% were males. Classified by CV risk categories were for primary prevention 29.3% low, 32.4% moderate and 11.4% high, and 26.9% secondary prevention. Type of ezetimibe exposure at inclusion was 33.1% monotherapy, 13.2% ezetimibe added to a statin, and 53.7% fixed association ezetimibe – simvastatin. Exposure to ezetimibe has been very stable during follow-up of the cohort with treatment interruption rate of 12.5 per 100 person-years of followup. LDL-C was 4.1mmol/L (SD: 1.1) at baseline and decreased by 23.8% (SD: 28.8) in the first 12 months, reaching –27.3% (SD: 28.3) at 48 months. Adjusting for baseline clinical characteristics and risk factors, interruption of lipid lowering treatment at least once during the follow-up was associated with a lower probability for the LDL-C to progress to the lower tertile (OR: 0.38, 95% confidence interval: 0.31 – 0.45). In this population with incident exposure to ezetimibe LDL-C decreased by one quarter in the first year and remained stable over the four-year follow-up.

Background Despite demonstrated positive effects in a number of clinical trials, the evidence is lacking as to the impact of statins on the risk of first myocardial infarction (MI) in real life settings. Objectives To assess the impact of real life statin utilization on the risk of first non-fatal MI Methods Case-control methodology using the pharmacoepidemiological information system PGRx. Data on comorbidities, risk factors and medications were obtained from medical records and patient telephone interviews. General practices (n=371) and cardiology centres (n=60) across France were employed in the study. Cases were patients with the first MI ≤ 1 month before the date of recruitment (n=2238). Controls were patients seen by a general practitioner (GP) with no restriction as to the reasons of consultation (n=2238), matched to MI cases on gender, age, frequency of visits to a doctor, date of recruitment and personal history of non-cardiovascular chronic disease. Statin exposure was defined as any utilisation in the two-year prior to date of MI in cases or recruitment date in controls. Adjusted odds ratios (OR) of the risk of first MI was estimated by multiple conditional logistic regression models. Comparative effectiveness and propensity to use of individual statin molecules were assessed. Results The use of statins was associated with a lower MI risk (adjusted OR 0.67 [95% CI 0.56 - 0.79] for current use (within 2 months before the index date) and 0.73 [0.62 0.86] for any use within 24 months). Among individual statins, rosuvastatin was associated with the lowest MI risk (adjusted OR 0.49 [0.35 - 0.68] for any use in 24 months preceding the index date) followed by simvastatin (0.62 [0.46 - 0.84]). Conclusions In this first major population-based observational study we reproduced the results observed in recent meta-analyses accounting for real life compliance and population variability. The results could be of interest and applicable to other industrialised countries as the observed risk reduction was constant across MI risk levels.

Background While gout is considered as a risk factor for vascular diseases, the relation of allopurinol with the risk of cardiovascular events is controversial. In some studies, drug use was associated with an increased vascular risk, while other studies described a protective effect. Objectives We conducted a case-control study to examine the relation between allopurinol use and risk of myocardial infarction (MI). Methods Cases (n=2277) were successive patients with a first-ever non-fatal MI referred to 63 cardiology centres throughout France between March 15, 2007 and November 30, 2010. They were matched to 4849 controls selected in a large (12,313) general practice patient referent population. Controls had no past history of coronary heart disease and were matched to MI cases on age, gender, number of visits to a doctor in the preceding year, date of consultation (MI) and past history of high blood pressure. Data about medication use during the two preceding years, and past medical history and life habits (smoking, physical activity, etc.) were obtained from patient's standardized interview and GP records. Odds ratios (OR) and their 95% confidence interval were computed using conditional logistic regression, adjusting for classical vascular risk factors (body mass index, smoking, diabetes, physical activity). Results MI cases and controls had a mean age of 59 years, 76% were men and 56% reported a history of high blood pressure. High body mass index, low physical activity, smoking and diabetes were more prevalent in cases than in controls. Overall, during the two preceding years, 3.8% of controls and 3.1% of MI cases had used allopurinol, and 1.1 of both cases and controls had used another hypouricemiant. Use of allopurinol was associated with a non-significant decreased risk of MI (adjusted OR (95%CI): 0.75 (0.56 - 1.01). Conclusions This study showed that allopurinol use is not a risk factor for first-ever non-fatal MI and might rather be associated with a decreased risk of MI.