Efficacy and tolerability of racecadotril in acute diarrhea in children.

BACKGROUND & AIMS: Oral rehydration therapy is the only treatment recommended by the World Health Organization in acute diarrhea in children. Antisecretory drugs available could not be used because of their side effects, except for racecadotril, which is efficient in acute diarrhea in adults. METHODS: The efficacy and tolerability of racecadotril (1.5 mg/kg administered orally 3 times daily) as adjuvant therapy to oral rehydration were compared with those of placebo in 172 infants aged 3 months to 4 years (mean age, 12.8 months) who had acute diarrhea. The treatment groups were comparable in terms of age, duration of diarrhea, number of stools, and causative microorganism at inclusion. RESULTS: During the first 48 hours of treatment, patients receiving racecadotril had a significantly lower stool output (grams per hour) than those receiving placebo. The 95% confidence interval was 43%-88% for the full data set (n = 166; P = 0.009) and 33%-75% for the per-protocol population (n = 116; P = 0.001). There was no difference between treatments depending on rotavirus status. Significant differences between treatment groups were also found after 24 hours of treatment: full data set (n = 167; P = 0.026) and per-protocol population (n = 121; P = 0.015). Tolerability was good in both groups of patients. CONCLUSIONS: This study demonstrates the efficacy (up to 50% reduction in stool output) and tolerability of racecadotril as adjuvant therapy to oral rehydration solution in the treatment of severe diarrhea in infants and children.

[Major depressive episodes in patients over 70 years of age. Evaluation of the efficiency and acceptability of tianeptine and mianserin]. / Episodes dépressifs majeurs de sujets âgés de plus de 70 ans. Evaluation de l'efficacité et de l'acceptabilité de la tianeptine et de la miansérine.

OBJECTIVES: The aim of this multicenter study was to compare the efficacy, acceptability and impact on quality of life of tianeptine (T) and mianserine (M) in patients over 70 years of age with major depression. METHODS: Fulfilment of the DSM IIIR criteria for major depression with a total Montgomery and Asberg depression rating scale (MADRS) of at least 25 and a Hamilton anxiety rating scale (HARS) of at least 18 were required for inclusion. The 315 men and women enrolled in the study were given, by double blind assignment, either T: 37.5 mg/day, T: 25 mg/day or M: 30 mg/day. Treatment duration was 6 months in all three groups and follow-up continued for 3 months after withdrawal of tianeptine or mianserine. The main efficacy criterion was the MADRS score evaluated at each of 6 visits at day 15 (D15) and month 1 (M1), M2, M4, M4.5 and M6. The HARS score was another efficacy criterion. Overall assessment of efficacy and acceptability was done at each visit by the patient and the investigator. Both the patient and the physician estimated global effectiveness on a quality of life scale at M1, M3, M6 and M9. RESULTS: In the intention-to-treat population (n = 299), the antidepressant efficacy of tianeptine and mianserine was not significantly different, whether assessed as effect on anxiety or on quality of life. Scores however tended to be better in the T: 37.5 mg group. Acceptability was good as shown by the low number of adverse events in all 3 groups, but at D15, the incidence of impaired vigilance or equilibrium was significantly lower in the T: 25 mg group than in the M: 30 mg group, emphasizing the advantage of tianeptine in decreasing the risk of falling. Physician-assessed tolerance and acceptability was significantly different at M3 (p = 0.014) and at M6 (p = 0.028) in favor of T: 37.5 mg, indicating that though increasing dosage does not improve efficacy, there is no risk of poorer acceptability. CONCLUSION: These findings reconfirm the antidepressive efficacy, acceptability and safety of tianeptine. They also confirm the anxiolytic aspect associated with the antidepressive effect of tianeptine without any sedative effect. Tianeptine is particularly well indicated in the treatment of depression in elderly or very elderly subjects.

[Bone mineral density of the femoral neck, a cross-sectional study of normal values in 827 French women aged 36 to 86 years]. / Densité minérale osseuse du col du fémur, une étude transversale des valeurs normales chez 827 françaises âgées de 36 à 86 ans.

The need for determining country-specific reference bone mineral density values has been emphasized. The effects of age and time since menopause on femoral neck bone mineral density in healthy women are still insufficiently documented. The goal of this study was to determine age-specific femoral neck bone mineral density values and postmenopausal bone loss rates in French women. Dual-energy X-ray absorptiometry was used to measure lumbar spine, femoral neck, and Ward's triangle bone mineral densities in 827 women aged 36 to 86 years. Inclusion criteria included a negative history for established or suspected osteoporosis. A cross-sectional, retrospective design was used. Lumbar spine bone mineral densities were similar to reference values reported previously in healthy subjects from other countries. Consequently, we considered that the femoral neck values that we obtained were those of a healthy population. Results were as follows: 1) The annual rate of bone loss at the femur increased within one or two years after menopause (to 1.5% and 2% at the femoral neck and Ward's triangle, respectively), remained high for 12-13 years, then declined (0.8% and 1.2%, respectively). 2) Femoral bone loss was slow before the age of 55 years (0.2% and 0.5% per year) and continued at a faster rate thereafter (1.3% and 1.7% per year). Our study provides normal reference femoral bone mineral density values for French women. Our data confirm that age and time since the menopause have a substantial influence on bone mineral density, not only at the lumbar spine, but also at the femoral neck.