A randomized, double-blind, placebo-controlled trial of coenzyme Q10 in Huntington disease.
Обработка статьи · этапы, ошибки и управление
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
McGarry Andrew, McDermott Michael, Kieburtz Karl, de Blieck Elisabeth A, Beal Flint, Marder Karen, Ross Christopher, Shoulson Ira, Gilbert Peter, Mallonee William M, Guttman Mark, Wojcieszek Joanne, Kumar Rajeev, LeDoux Mark S, Jenkins Mary, Rosas H Diana, Nance Martha, Biglan Kevin, Como Peter, Dubinsky Richard M, Shannon Kathleen M, O'Suilleabhain Padraig, Chou Kelvin, Walker Francis, Martin Wayne, Wheelock Vicki L, McCusker Elizabeth, Jankovic Joseph, Singer Carlos, Sanchez-Ramos Juan, Scott Burton, Suchowersky Oksana, Factor Stewart A, Higgins Donald S, Molho Eric, Revilla Fredy, Caviness John N, Friedman Joseph H, Perlmutter Joel S, Feigin Andrew, Anderson Karen, Rodriguez Ramon, McFarland Nikolaus R, Margolis Russell L, Farbman Eric S, Raymond Lynn A, Suski Valerie, Kostyk Sandra, Colcher Amy, Seeberger Lauren, Epping Eric, Esmail Sherali, Diaz Nancy, Fung Wai Lun Alan, Diamond Alan, Frank Samuel, Hanna Philip, Hermanowicz Neal, Dure Leon S, Cudkowicz Merit, Huntington Study Group 2CARE Investigators and Coordinators
Аннотация
METHODS: We performed a multicenter randomized, double-blind, placebo-controlled trial. Patients with early-stage HD (n = 609) were enrolled at 48 sites in the United States, Canada, and Australia from 2008 to 2012. Patients were randomized to receive either CoQ 2,400 mg/d or matching placebo, then followed for 60 months. The primary outcome variable was the change from baseline to month 60 in Total Functional Capacity score (for patients who survived) combined with time to death (for patients who died) analyzed using a joint-rank analysis approach.
RESULTS: An interim analysis for futility revealed a conditional power of <5% for the primary analysis, prompting premature conclusion in July 2014. No statistically significant differences were seen between treatment groups for the primary or secondary outcome measures. CoQ was generally safe and well-tolerated throughout the study.
CONCLUSIONS: These data do not justify use of CoQ as a treatment to slow functional decline in HD.
CLINICALTRIALSGOV IDENTIFIER: NCT00608881.
CLASSIFICATION OF EVIDENCE: This article provides Class I evidence that CoQ does not slow the progressive functional decline of patients with HD.