Lettre aux prescripteurs

Informations importantes sur le bon usage du RIVOTRIL® et sur la réduction du conditionnement des comprimés
 
A la suite d’une enquête nationale réalisée par le Centre d’Evaluation et d’Information sur la Pharmacodépendance (CEIP) de Marseille entre 1998 et 2006 et révélant une augmentation importante des cas d’abus, de pharmacodépendance et d’usage détourné, les laboratoires Roche, en accord avec l’Afssaps, rappellent que RIVOTRIL® est uniquement indiqué dans la prise en charge de l’épilepsie.
Le conditionnement de RIVOTRIL® 2 mg en boîte de 40 comprimés est remplacé par un conditionnement en boîte de 28 comprimés.

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Le Centre National Hospitalier d'Information sur le Médicament (CNHIM), association loi 1901, a été créé en décembre 1979, par la volonté des trois syndicats de Pharmaciens Hospitaliers (SYNPREFH, SNPHPU et SNPGH) et à la demande de la Direction de la Pharmacie et du Médicament au Ministère de la Santé.

L’objectif du CNHIM est de diffuser des informations indépendantes, scientifiques, validées, mises à jour quotidiennement, sur tous les médicaments disponibles en France via différents supports informatiques et télématiques, adaptés aux besoins des praticiens de santé.

Susman E. A Prospective Study to Determine the Prevalence of Hypovitaminosis D in Women With Early Stage Breast Cancer Treated With an Aromatase Inhibitor and the Benefit of Vitamin D Supplementation on Musculoskeletal Symptoms and Overall QOL. 2007. Abstract 6075

SAN ANTONIO, TX -- December 17, 2007
Treatment of low levels of vitamin D in women with early-stage breast cancer appears to reduce fatigue and muscle pain associated with aromatase inhibitor therapy, researchers reported here at the 30th San Antonio Breast Cancer Symposium (SABCS).
The preliminary results involving 40 women out of planned enrollment of 60 women were presented in a poster presentation here on December 16 by Qaram Khan, MD, Assistant Professor of Hematology/Oncology, University of Kansas Medical Center, Kansas City, Kansas.
Although the study showed that vitamin D insufficiency was already present in 75% of women at the start of adjuvant aromatase inhibitor therapy, when vitamin D supplementation was added to treatment, there was a decrease in fatigue and muscle pain, Dr. Khan reported.
For the 16-week study, postmenopausal women with early-stage invasive breast cancer were started on the aromatase inhibitor letrozole in addition to 1,200 mg/day of calcium and 600 IU/day of vitamin D. Vitamin D levels were recorded at baseline and at weeks 4, 10, and 16.
Four weeks later, the women who still had vitamin D serum levels of less than 40 ng/mL were given 50,000 units of oral vitamin D once every week for 12 weeks.
At the start of the study, women were assessed for fatigue and musculoskeletal pain. The fatigue scores on the Brief Fatigue Inventory rose from about 1.7 to about 2.5 during the first 4 weeks of treatment, and then decreased to near baseline levels after beginning the extra supplementation. Similarly, muscular pain remained constant from baseline to 4 weeks and then decreased dramatically from 0.4 to 0.2 on the Health Assessment Questionnaire.
At the start of the study 17 of 40 women were found to be deficient in vitamin D (serum levels <20 ng/mL); 32 of the 40 women had insufficient levels of vitamin D (<36 ng/mL); and 36 of the 40 women had less than optimal levels of vitamin D for breast health (<40 ng/mL).
After week 16, there were no women among the 36 who finished the trial who were deficient in vitamin D. One woman was judged to have insufficient levels of vitamin D, and two of the 36 women had less serum vitamin D than is optimal for breast health.
Dr. Khan said a randomized, controlled trial is being planned to confirm the pilot study results. He said that supplementation appears safe and effective.

Conclusion
Bien qu'il s'agisse d'une étude prospective sur un petit nombre de cas, cette étude mérite confirmation de l'efficacité de la supplémentation en vitamine D pour lutter contre l'asthénie et les douleurs musculaires fréquentes chez les femmes traitées par un inhibiteur de l'aromatase en cas de cancer du sein.