Feedback and lessons from the prescription of rimonabant, a drug to be used under strict guidelines, in southeastern France, March 2007 through June 2008.

BACKGROUND: To provide feedback on the initial market authorization of rimonabant, a drug to be used under strict guidelines, we conducted a study with information from the National health insurance reimbursements database for southeastern France. The aims of this study were to: (1) describe the characteristics of subjects who have had one rimonabant prescription reimbursed; (2) study the frequency of prescriptions that did not comply with reimbursement criteria; (3) study the frequency of prescriptions for patients simultaneously treated with antidepressants; and (4) analyse the factors associated with both types of prescription (patient and prescriber characteristics). METHODS: Using the database of drug reimbursements maintained by the southeastern France general health insurance fund, we studied the characteristics of outpatients with at least one reimbursement for rimonabant, compared them to the rest of the population, and analysed compliance with the indications, contraindications, and regulations for rimonabant prescription with multivariate logistic regressions. RESULTS: A total of 10,510 beneficiaries (0.28%) had at least one rimonabant reimbursement. Among them, 55.7% were treated for diabetes. For at least 62.4% of rimonabant beneficiaries, the reimbursement regulations were not respected: this was significantly more frequent among women less than 57 years old, subjects with no chronic diseases, and when the prescriber was not an endocrinologist; 11.4% of rimonabant beneficiaries also received an antidepressant treatment. CONCLUSION: Despite the specific status of rimonabant regarding its reimbursement modalities, these results suggest that some prescribers get around reimbursement instructions and that a significant percentage of prescriptions did not respect an important contraindication. Tools to follow up the prescriptions of new drugs with strict guidelines for use should be developed and physicians should be better informed and trained regarding specific prescription regulations.

[Determination of normal levels of urinary xanthurenic acid as a function of age and sex (author's transl)]. / L'acide xanthurenique urinaire, détermination des taux normaux en fonction de l'âge et du sexe.

A quantitative determination of xanthurenic acid in human urine has made possible a statistical study of the secretion of this substance according to age and sex.

[Individual factors and mortality associated with hormone replacement therapy in a French cohort of women from 60 to 69 years of age]. / Caractéristiques individuelles et mortalité associées au traitement hormonal substitutif de la ménopause: étude d'une cohorte française de femmes d'âge compris entre 60 et 69 ans.

OBJECTIVES: Given the specificity of French postmenopausal hormonal replacement therapy, we study the link with overall mortality. MATERIALS AND METHODS: A cohort of 1200 women from 60 to 69 years of age was followed up from 2001 to 2009. We computerized from the health care repayment database the current reimbursement of behind-the-counter hormonal therapy. We sent a questionnaire to identify their lifetime history of hormone use. We test whether current and former users have higher risk of death from all cause combined. We adjusted the survival analysis on the individuals factors associated to the hormone use. The statistical methods Kaplan-Meier curves in univariate analysis and Cox Regression Model in multivariate analysis were used. RESULTS: Current users present a reduced all-cause mortality rate while former users have a higher all-cause mortality rate. This trend suggests a "healthy estrogen user survivor effect" bias. After adjustment on confounding factors, hormonal users do not have a statistically significant increased risk of overall mortality. CONCLUSION: Postmenopausal hormone replacement therapy is not linked with mortality for women from 60 to 69 years of age covered by the self-employed workers health and retirement French insurance fund.

Cost-effectiveness analysis of treatments for phimosis: a comparison of surgical and medicinal approaches and their economic effect.

OBJECTIVE: To compare the cost-effectiveness of surgery and topical steroids as treatments for phimosis (defined as a clinically verifiable, pathological, cicatricial stenosis of the prepuce) and to evaluate the financial basis of these treatments. METHODS: Data on treatment using topical steroids was obtained from published reports and those for circumcision from claims by private hospitals for children < 13 years old registered at the health insurance department of our facility. The estimate of the French national financial cost of the treatments for 1998 was calculated from public and private institutional information. RESULTS: Treatment with topical steroids for 4-8 weeks was successful in approximately 85% of patients (mean age 5 years) and had no side-effects; the remaining 15% were treated by circumcision. Topical steroid therapy costs (in French francs) F 360 per patient. For those primarily treated by circumcision (81 boys, mean age 4.3 years) and diagnosed as having phimosis, the cost was F 3330 per patient in the private sector. The total number of circumcisions performed in France, regardless of sector (public or private) for 1998 was estimated to be 51 080, which represents an annual cost of F 195.7 million. CONCLUSION: As topical pharmacological treatment avoids the disadvantages, trauma and potential complications of penile surgery, including anaesthesia-related risks, the use of topical steroids as a primary treatment appears to be justified in boys with clinically verifiable phimosis. This treatment could reduce costs by 75%, which represents a potential annual saving of approximately F 150 million.