Tumor necrosis factor inhibitors added to nonbiological immunosuppressants vs. nonbiological immunosuppressants alone: a different signal of cancer risk according to the condition. A disproportionality analysis in a nationwide pharmacovigilance database.

We aimed at detecting a signal of an increased risk of cancer in patients treated with TNF inhibitor (TNFi) and nonbiological immunosuppressant (NBIS), compared with NBIS alone for autoimmune diseases. Secondly, we aimed at comparing this risk between the different TNFis. We conducted a disproportionality analysis (case/noncase study) from the French National PharmacoVigilance Database. We selected all the reports of serious adverse drug reactions from 2000 to 2010 in patients treated with NBIS for labeled indications of TNFi. Cases were all the reports of cancer that occurred after a minimal 3-month exposure to NBIS. Noncases were all the other reports. We searched for exposure to TNFi and calculated reporting odds ratios (RORs), stratified by condition and type of cancer and adjusted by age, gender, history of cancer, type of NBIS and year of reporting. Of the 1918 reports included in the study population, 217 were cases (135 solid and 82 blood cancers). A safety signal was found in rheumatoid arthritis (RA) (ROR: 5.43, 95% CI[3.52-8.38]) particularly for nonmelanoma skin cancer (NMSC) (20.17[2.49-163.36]), and in psoriasis/psoriatic arthritis (3.45[1.09-10.92]). No signal was found in inflammatory bowel diseases (IBD) and ankylosing spondylitis, whatever the type of cancer. There was no difference between TNFis. This study puts the argument of an increased risk of cancer (particularly NMSC) in patients with rheumatoid arthritis exposed to TNFi and NBIS compared with NBIS alone, but not in IBD and ankylosing spondylitis patients. No signal was detected for melanoma potentially related to the lack of power. The signal seems similar whatever the TNFi.

[Factors Associated with Direct Oral Anticoagulants versus Vitamin K Antagonists in Patients with Non-valvular Atrial Fibrillation]. / Facteurs associés à la prescription d'anticoagulants oraux directs versus anti-vitamines K dans la fibrillation atriale non valvulaire.

OBJECTIVE: Describing the factors associated with direct oral anticoagulants (DOA) prescription in patients with atrial fibrillation (AF). METHOD: This study was performed in Toulouse on a cohort of patients received in rhythmology consultation, treated with vitamin K antagonists (VKA) or DOA for AF. A multivariate model was performed using logistic regression to describe the factors associated with DOA prescription and secondly, those associated with discontinuation of the anticoagulant. RESULTS: Among the 140 patients included, 96 (66%) were treated with VKA and 48 (34%) with DOA. Recent AF diagnosis (OR 7.52, 95% CI [2.41;23.29], p = 0.001), previous exposure to VKA (OR 17.11, 95% CI [4.48;60.91], p<0.001), and no current exposure to anti-platelet agents (APA) (OR 7.69, 95% CI [1.22; 50.00], p = 0.030) were associated to DOA prescription. Discontinuation of the anticoagulant (n=24) was associated to DOA intake (OR 2.71, 95% CI [1.21; 6.08], p = 0.016). DISCUSSION: DOA are less prescribed than VKA in patients treated with APA. DOA switch to VKA was not systematic in patients diagnosed for a long time. However, international normalized ratio (INR) values were stable in most of patients treated with VKA at the switching to DOA. A more powerful study would confirm the factors associated with DOA prescription.

[The lack of adherence to antiosteoporotic drugs: crossing methods, the key to adherence measurement?]. / Défaut d'observance aux médicaments antiostéoporotiques: croisement de deux techniques, la clef pour l'évaluation de l'observance ?

OBJECTIVE: To use two different techniques to assess adherence of patients treated with antiosteoporotic drug. METHODS: This monocentric transversal study was performed on a 6 months period, on patients of a single French pharmacy treated with antiosteoporotic drugs. Adherence was assessed crossing 2 techniques (patient autoquestionnaire and medication possession ratio measurement). Statistical analysis consisted in a description of the population study and a multivariate logistic regression to identify the factors associated with a lack of observance. RESULTS: Using the two techniques, the lack of adherence was estimated to be between 14 and 55%. Adherence was better in patients who were given dietetic advice or information about the usefulness of physical activity and worse in patients who reached menopause less than 23 years ago. CONCLUSION: A better identification of patients with a lack of observance is possible by crossing several techniques to assess adherence of the patient to his antiosteoporotic drug.