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Pharmacokinetics --- Therapeutic Equivalency --- Guidelines as Topic --- Biological Availability --- United States Food and Drug Administration --- European Union

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Introduction : La Néviparine, communément appelé Viramune, est un médicament fréquemment utilisé lors d’une trithérapie en cas d’infection par le VIH dans les pays en voie de développement. Un de ses multiples avantages est son effet bénéfique contre la transmission mère-enfant au cours de la grossesse. Ce médicament peut aussi provoquer, dans des cas isolés, de sérieux effets secondaires tels que des problèmes hépatiques ou une hypersensibilité cutanée pouvant empirer le pronostic et évoluer vers les syndromes de Lyell ou de Stevens-Johnson. Il y a quelques années, le FDA a élaboré des recommandations de sécurité visant au bon usage de la Néviparine. Celles-ci conseillaient de ne pas administrer ce médicament aux personnes ayant un taux élevé de cellules CD4 la limite étant posée à 250 cellules/mm³ pour les femmes et 400 cellules/mm³ pour les hommes. Suite à une série d’articles contradictoires sur le sujet, une étude rétrospective a été réalisée dans le but d’examiner les facteurs influençant l’hépatotoxicité des patients VIH-1 sous Névirapine. Les résultats de cette étude avaient pour but de diminuer l’impact financier dans le système hospitalier et maximiser le prise en charge des patients.
Méthode : L’étude rétrospective précitée regroupait une cohorte de patients naïfs infectés par le VIH de type 1 soumis à une trithérapie avec Névirapine depuis au moins 5 ans. Trois groupes ont été formés : dans un premier groupe, les patients qui ont dû interrompre leur traitement suite à des anomalies biologiques hépatiques, dans le deuxième groupe, ceux qui ont dû interrompre leur traitement suite à une réaction cutanée et le troisième groupe, les patients qui ont pu continuer leur traitement sans complication. Au sein de ces groupes, différents facteurs ont été analysés et comparés, comme le nombre de cellules de CD4 par rapport au grade de toxicité. D’autres variables comme l’administration d’inhibiteur de protéase et le co-infections VHB et VHC ont également été analysées afin de mettre en évidence une relation significative entre l’une de ces variables et l’occurrence de la toxicité hépatique des patients.
Résultats La taille totale de l’échantillon était de 108 patients, dont 23 patients qui ont arrêté le traitement : 8 patients suite à une toxicité hépatique et 15 patients en raison d’une hypersensibilité cutanée. Les 85 patients restants ont pu continuer le traitement sans effets secondaires apparents. Parmi ces 85 patients, 12 ont reçu un inhibiteur de protéase en combinaison avec la Névirapine, 8 patients dans la cohorte étaient co-infectés par le virus de l’hépatite C et 37 par le virus de l’hépatite B. La combinaison des patients ayant un faible taux de CD4 avec ceux ayant un taux élevé de CD4 n’a rapporté aucune association significative entre le taux de CD4 et la toxicité hépatique.
Conclusion : Les recommandations du FDA concernant la prise en compte du taux de CD4 lors de l’administration de la Névirapine, n’ont pas pu être significativement justifiées. D’après une analyse multivariée, la co-infection VHC serait un déterminant de l’hépatotoxicité notée chez les patients VIH sous Viramune. Ces résultats doivent être interprétés avec prudence étant donné le caractère rétrospectif de l’étude – pas de contrôle sur les données à priori – et la faible taille de l’échantillon Background: Nevirapine is a drug that is commonly used among other antiretroviral medications against HIV for its multiple advantages, and often used in developing countries as a treatment regimen in combination therapy as well as in monotherapies for pregnant women to prevent mother-to-child transmission. This drug is also associated, in rare cases, with serious side effects counting liver damage and skin hypersensitivity that could evolve into life-threatening health conditions as for instance the development of Lyell and the Stevens-Johnson syndrome. The most common adverse event is the skin rash touching about 25 percent of individuals under this medication (AIDS InfoNet, New Mexico AIDS Education and Training Center; University of New Mexico Health Sciences Center). The FDA has implemented certain recommendations concerning the safety use of Neviparine, which advice the avoidanceof this drug to men and women with high CD4 cell counts, the cut-off level was set to: 250 cells/mm³ for women and 400 cells/mm for men. Following several conflicting published results in regards to the impact of the CD4 cell counts, the conduct of a retrospective study was then performed in the aim of investigating and reviewing the influence of the level of the lymphocytes cell markers as well as other factors in cause with the occurrence of hepatic toxicity in our cohort of patients under the Neviparine treatment. The greatly maximize their care and improve the safety of the patients and along the line decrease the financial fluctuation created by the expenses of the treatments of adverse events.
Methods: This retrospective cohort study included naïve HIV infected patients under Neviparine-containing regimen for at least 5 years. Three groups were formed where a first group stopped the treatment due to liver abnormalities, a second group stopped the treatment due to hypersensitivity reactions and the third group referring to the control group are those who continued on with the treatment. Onwards, within these categories multiple possible factors have been analysed; first, men and women where divided according to their CD4 cell count levels (CD4 cell cunts under 250 cells/mm³ vs CD4 cell counts above 250 cells/mm³ for women and CD4 cell counts under 400 cells/mm³ vs CD4 cell counts above 400 cells/mm³ for men) and coupled to their grade of hepatic toxicity, which was ranked according to the WHO classification. Other variables were also analysed to identify any significant relationship between liver toxicity and the usage of protease inhibitors or hepatitis B and C virus co-infection.
Results: A total of 108 patients were included in the study, where 8 patients stopped the treatment due to hepatic toxicity, 15 formed the group who stopped due to hypersensitivity reactions and 85 patients did not show any dangerous sign of side effects and carry on with the treatment. A total of 12 patients were administered a protease inhibitor in addition to Neviparine, 8 were co-infected with hepatitis C and 37 with hepatitis B. Almost equal number were affected in both groups referring to the level of CD4 cell counts as well in men as in women consequently, in the analysis, the difference between both groups were not significant regarding the levels of CD4 cell counts. Different statistical analysis as frequencies, Chi-Square, multivariate analysis and linear regression were performed.
Conclusion: The recommendation suggested by the FDA to avoid usage of Neviparine in male patients over CD4 cell counts of 400 cells/mm³ and for female patients over a level of 250 cells/mm³ did not show significant implication in our data analysis. The evidence of a plausible factor influencing the occurrence of hepatic toxicity was seen with heptatis C co-infection, where patients showed to have higher tendency in developing this condition. However, being a retrospective study, I had no control over the data, which reflected one limitation in the study and moreover, due to the small sample size, the power of this study is indubitably weak and therefore, cannot validate this outcome

Acquired Immunodeficiency Syndrome --- HIV Infections --- Antiretroviral Therapy, Highly Active --- Anti-Retroviral Agents --- United States Food and Drug Administration --- Nevirapine

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Tobacco products --- Tobacco use --- Government policy --- Prevention --- Center for Tobacco Products (United States. Food and Drug Administration) --- Management.

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Tobacco products --- User charges --- Government policy --- Evaluation. --- Center for Tobacco Products (United States. Food and Drug Administration) --- Rules and practice.

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A controversial and provocative look at the way pharmaceutical companies are helping to create and market illness.Using their dominating influence in the world of medical science, drug companies are working to widen the very boundaries that define illness. Mild problems are redefined as serious illness, and common complaints are labeled as medical conditions requiring drug treatments. Runny noses are now allergic rhinitis, pms has become a psychiatric disorder, and hyperactive children have add.Selling Sickness reveals how expanding the boundaries of illness and lowering the threshold for treatments is creating millions of new patients and billions in new profits, in turn threatening to bankrupt national healthcare systems all over the world. This Canadian edition includes an introduction placing the issue in a Canadian context and describing why Canadians should be concerned about the problem.

QV 736 Drug industry. Economics of pharmacy. Advertising --- United States --- Drug Industry --- Sociology, Medical --- Health Services Misuse --- United States Food and Drug Administration --- Marketing --- Health Care --- Public Health