FDA отказало в регистрации тикагрелора...

[LupusDoc]

... по крайней мере, до получения результатов дополнительных анализов проведенных РКИ.

Довольно неожиданно FDA сообщило об отказе в регистрации тикагрелора, несмотря на то, что панель экспертов в июле рекомендовала одобрить препарат [Ссылки доступны только зарегистрированным пользователям ].

Компания-производитель не сообщает какие именно дополнительные данные были затребованы FDA, но известно, что требования провести новые РКИ предъявлено не было [Ссылки доступны только зарегистрированным пользователям ].

[dmblok]

Скорее всего из-за того что в Северной Америке, результаты PLATO были не очень. В частности, валят на повышенную дозу аспирина.

Why were effects of ticagrelor not as strong in North America?

There was also discussion about geographic regions: the patients enrolled in North America in PLATO, around 1800 of the total 18 000 patients, "came down on the wrong side when it comes to hazard ratios overall, although the difference was not statistically significant in PLATO STEMI," Steg said during a panel discussion after the late-breaking clinical-trial presentation.

North America is the one region in PLATO in which higher doses of aspirin were used in the study, at 325 mg per day, so there have been suggestions that this might be an explanation for this finding, he said, or it could be attributable to different body weights or body-mass indexes (BMIs) among North American patients. But, Steg added, "Personally I view this as mostly related to chance."

Dr Robert Harrington (Duke University Medical Center, Durham, NC), a PLATO investigator, said this is "very complicated" and "we are going to have to approach this in three different ways: one will be further analytical work on PLATO, which is under way. Second is mechanistic work at the bench to see whether there is some kind of biologic plausible explanation for this, and finally, in future clinical studies of ticagrelor there is a lot of enthusiasm for increased enrollment of patients in North America to better understand how it does relative to other regions."

[Pakhomov]

повокационное объяснение геторогенности результатов эффективности тикагрелора в PLATO по странам
[Ссылки доступны только зарегистрированным пользователям ]

Results: The wide distribution of outcomes differing from country to country, and inconsistency in European data despite identical aspirin doses, preclude the acceptance of the hypothesis that aspirin affects PLATO outcomes in general or adversely impacts the benefit of ticagrelor in the US cohort in particular. Differences in primary site monitoring by the study sponsor in most countries versus a third-party CRO in the USA represent an alternative explanation and deserve further attention. Conclusions: There is no solid evidence that aspirin dose affects outcomes after ticagrelor. Reevaluation of the overall endpoint differences, especially focusing on mortality, driven from sponsor-monitored sites versus outcomes observed by independent CROs is neccessary. The practice of self-monitoring in pivotal indication-seeking clinical trials should be avoided in the future.

[rsp]

тем, кто следит за "североамериканской аномалией" с тикагрелором, наверно, будет интересно данное [Ссылки доступны только зарегистрированным пользователям ]