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French to English: CLINICAL TRIALS General field: Medical
Source text - French SOURCE : FRENCH
Tridural: Avis de refus – Valeur thérapeutique
Description du médicament
Le tramadol est un analgésique à action centrale doté d’un double mécanisme d’action. Il a une faible activité sur les récepteurs μ des opiacés et il inhibe le recaptage neuronal de la norépinéphrine et de la sérotonine. Les comprimés à prise uniquotidienne sont conçus pour libérer le tramadol en deux phases : l’une rapide, dans les heures suivant son administration, et l’autre lente, sur une période de 24 heures. TriduralMC est indiqué pour la prise en charge de la douleur d’intensité modérée chez les adultes qui ont besoin du traitement pendant plusieurs jours ou plus.
Valeur thérapeutique
L’efficacité analgésique de TriduralMCest documentée par les résultats d’un essai randomisé et contrôlé avec placebo (Burch 2007) portant sur des individus souffrant de douleur causée par de l’arthrose du genou et qui répondent au TriduralMC. Ainsi, comparativement au placebo, TriduralMC apporte une amélioration de 0,7 point seulement sur l’échelle numérique de douleur en 11 points. Habituellement, pour cette échelle, une réponse est jugée cliniquement significative lorsqu’on remarque une différence absolue de 2 points environ.
Au regard de l’innocuité, environ 60 % des individus traités avec TriduralMC éprouvent au moins un effet indésirable. Environ 10 % des sujets se désistent pour cette raison. Les effets indésirables les plus fréquents sont les étourdissements, la nausée et les vomissements ainsi que les céphalées. Par ailleurs, une récente étude de cohorte rétrospective (Torring 2008) sème un doute quant à l’innocuité digestive du tramadol. Il s’agit d’une analyse de dossiers médicaux et d’ordonnances d’environ 1 300 individus hospitalisés pour un ulcère gastrique perforé. On observe qu’une plus forte proportion de personnes recevant le tramadol décèdent dans les 30 jours suivant leur admission, comparativement aux personnes traitées avec des anti-inflammatoires non-stéroïdiens. De plus, un avis des autorités américaines publié en juillet 2004 fait état de nombreux rapports d’abus et de dépendance liés à l’utilisation du tramadol. À cet effet, Santé Canada évalue présentement la possibilité de l’inscrire à l’annexe 1 du Règlement sur les stupéfiants.
Ainsi, les résultats d’un essai clinique contre placebo témoignent d’une efficacité faible qui s’accompagne de nombreux effets indésirables. Une méta-analyse de Cochrane (Cepeda 2006) fait le même constat, à savoir que tramadol peut diminuer l’intensité de la douleur, mais que ce bénéfice est faible. En outre, son utilisation est limitée par une forte incidence d’effets indésirables, lesquels peuvent mener à l’abandon du traitement. De plus, la possibilité d’une reclassification du tramadol à l’annexe 1 du Règlement sur les stupéfiants, en raison de son potentiel d’abus, ainsi que les résultats d’une étude de cohorte rétrospective portant sur la mortalité associée à des ulcères gastriques perforés suggèrent que ce produit pourrait présenter des risques qui, jusqu’ici, ont été ignorés. Pour ces raisons, le Conseil juge que la valeur thérapeutique de TriduralMC n’est pas démontrée.
Ainsi, le Conseil est d’avis que TriduralMC ne rencontre pas le critère de la valeur thérapeutique et a recommandé de ne pas l’inscrire sur les listes de médicaments.
Translation - English TARGET : ENGLISH
Tridural: Non-Acceptance Report (Refusal notice) - Therapeutic Value
Description of the drug
Tramadol is a centrally acting analgesic with a dual mechanism of action. It has low activity on μ opioid receptors (MOR1) and inhibits the neuronal reuptake of norepinephrine and serotonin (SNRIS2). The once-daily tablets are designed to release the tramadol into two phases: a rapid one, within hours of its administration, and the other slow, over a period of 24 hours. Tridural ™ recommended for handling moderate pain in adults who require treatment for several days or even longer.
Therapeutic value
The analgesic efficacy of TRIDURALTM is documented by the results of a randomized controlled trial with placebo (Burch 2007) on individuals suffering from pain caused by osteoarthritis of the knee and responding to TRIDURALTM. Thus, compared to placebo, Tridural ™ provides an improvement of 0.7 points only on the11 point numerical scale of pain. Usually, for this scale, a response is considered clinically significant when we notice an absolute difference of about 2 points.
In view of safety, approximately 60% of individuals treated with TRIDURALTM are experiencing at least one adverse event (side effect). For this reason about 10% of patients have withdrawn from the study. The most common side effects are dizziness, nausea and vomiting and headache. Moreover, a recent retrospective cohort study (Torring 2008) casts doubt about the gastrointestinal safety of tramadol. It is an analysis of medical records and prescriptions for about 1 300 individuals hospitalized for a perforated gastric ulcer4. We observe that a higher proportion of people receiving tramadol die within 30 days after admission, compared to those treated with anti-inflammatory non-steroid drugs. In addition, a notice issued by the U.S. authorities in July 2004 reported numerous reports of abuse and dependence associated with the use of tramadol. To this end, Health Canada is currently assessing the possibility of its inclusion in Annex 1 of the Narcotic Control Regulations.
Thus, the results of a clinical trial against placebo show a low efficiency that comes with many side effects. A Cochrane meta-analysis (Cepeda 2006) made the same point, namely that tramadol may decrease the intensity of pain, but this benefit is quite low. In addition, its use is limited by a high incidence of side effects, which can lead to discontinuation of the treatment. Moreover, the possibility of a reclassification of tramadol in Annex 1 of the Narcotic Control Regulations, based on its abuse potential and the results of a retrospective cohort study on mortality rate associated with perforated gastric ulcer, suggest that this product may present risks that have hitherto been ignored. For these reasons, the Commission finds that the therapeutic value of TRIDURALTM is not established.
Thus the Council believes that Tridural ™ does not meet the criterion of therapeutic value and has recommended for not including it in the lists of drugs.
Note:
1. The μ-opioid receptors (MOR) are a class of opioid receptors with high affinity for enkephalins and beta-endorphin but low affinity for dynorphins. They are also referred to as μ opioid peptide (MOP) receptors. The prototypical μ receptor agonist is the opium alkaloid morphine; μ (mu) refers to morphine.
2 (SNRIS).Serotonin-norepinephrine reuptake inhibitors in the … - Dell'Osso - Cited by 39
http://cat.inist.fr/?aModele=afficheN&cpsidt=17763459
3.A retrospective cohort study, also called a historic cohort study, is a medical research study in which the medical records of groups of individuals who are alike in many ways but differ by a certain characteristic (for example, female nurses who smoke and those who do not smoke) are compared for a particular outcome (such as lung cancer).[1] In retrospective cohort studies, the odds ratio gives an assessment of relative risk.[2]
4.Perforated gastric ulcer.
J. Wilson-Macdonald, N. J. Mortensen, and R. C. Williamson
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2418177/
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