The study
ALPHEE. Kowey PR, Crijns HJ, Aliot EM, Capucci A, Kulakowski P, Radzik D, Roy D, Connolly SJ, Hohnloser SH; on behalf of the ALPHEE Study Investigators. Circulation.
2011 Nov 14. [Epub ahead of print]
This study examined the effect of 3 different dosages of celiararone antiarrhythmic (50, 100, and 300mg / day) compared to placebo with the aim of increasing ICD survival or interventions for tachycardia or ventricular fibrillation. A fifth group of patients took 200 mg of Amiodarone a day as a historical comparison. Celivarone did not show any advantage over placebo, and in fact was inferior to amodarone. The principal investigator, Dr Kowey, commented that this is a negative trial not only on the main objective, but also on the secondary ones, where Amiodarone was almost significantly better than placebo (p = 0.503), thus proving importance of an active “historical” control group. The importance of bringing studies to an unfavorable outcome is fundamental, when they are methodologically correct, because they offer us the possibility of better orienting future research.