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Уважаемый коллега, читайте первоисточники и никому не верьте на слово! Один очень известный человек, которого я лично глубоко уважаю, кинул ссылку на What`s What. Там Вы найдёте некоторую часть информации о протоколах. Рекомендую!
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Например:
1. CAST (Cardiac Arrhythmia Suppression Trial)
Purpose:
To determine whether the suppression of asymptomatic or mildly symptomatic ventricular arrhythmias after MI reduces the mortality rate in arrhythmia
Patients
1727 patients (730 encainide or flecainide, 272 moricizine and 725 placebo) with 6 or more ventricular premature depolarisations/h on 24-h Holter recording and a left ventricular ejection fraction ≤ 0.55, if ≤ 90 days after MI, and ≤ 0.40 if > 90 days. Time since MI: 6 days to 2 years
Comments
The CAST Data and Safety Monitoring Board, after reviewing the data in April 1989, recommended that encainide and flecainide be discontinued and the study be continued with moricizine. The continuing study design was slightly changed and called CAST II
Комментарий: Вы где-нибудь видели упоминание о пропафеноне?
2. CAST II
Cardiac Arrhythmia Suppression Trial II
Author(s)
(a) The Cardiac Arrhythmia Suppression Trial II investigators
(b) Brooks MM, Gorkin L, Schron EB, Wiklund I, Campion J, Ledingham RB
Title(s)
(a) Effect of the antiarrhythmic agent moricizine on survival after myocardial infarction
(b) Moricizine and quality of life in the cardiac arrhythmia suppression trial II
Reference(s)
(a) N Engl J Med 1992;327:227-33
(b) Control Clin Trials 1994;15:437-49
Disease
Ventricular arrhythmia after AMI
Purpose
To determine whether the suppression of asymptomatic or mildly symptomatic arrhythmias after MI, by moricizine, reduces the mortality rate in arrhythmia
Study design
Randomised, double-blind, placebo-controlled
Follow-up
2 weeks (initial trial), mean 18 months (long-term trial)
Patients
1325 patients in the initial trial (665 moricizine, 660 placebo), 1155 patients in the long-term trial (581 moricizine, 574 placebo). Time since MI: < 90 days. The long-term trial included 1374 patients
Treatment regimen
Moricizine, 200 mg tid (initial trial), up to 900 mg tid (long-term trial), or placebo (both trials)
Concomitant therapy
Results
During the initial 2-week trial, 17 patients (2.3%) died compared to 3 (0.3%) in the placebo group. The relative risk was 5.6 (95% Cl 1.7-19.1). Adverse effects were also more common in the patients treated with moricizine. For the long-term trial there were 49 deaths (15%) as well as more frequent adverse events in the moricizine group compared to placebo (42 deaths, 12%). The differences were not significant for the long-term trial.
The prospectively designed quality of life outcome measure was found to be sensitive for assessing pharmacological therapies in the treatment of heart disease, and showed that quality of life improved significantly in both the moricizine and placebo groups after entry into the trial
Comments
CAST II was stopped early because the first 2-week treatment period with moricizine was associated with excess mortality and morbidity. The likelihood of observing a significant benefit as calculated from the main study was only 0.078
Комментарий: пропафенон, ау?
3. CASH (Cardiac Arrest Study Hamburg)
Title(s)
(a) Implantable cardioverter defibrillator compared with antiarrhythmic drug treatment in cardiac arrest survivors (the Cardiac Arrest Study Hamburg)
(b) Value of programmed electrical stimulation to predict clinical outcome in survivors of cardiac arrest: subgroup analysis from the Cardiac Arrest Study Hamburg (CASH)
(c) Randomized comparison of antiarrhythmic drug therapy with implantable defibrillators in patients resuscitated from cardiac arrest
Disease
Cardiac arrest
Purpose
To compare the incidence of cardiac arrest, sudden cardiac death, cardiac mortality and total mortality among patients treated with antiarrhythmic drugs or an implantable cardioverter/defibrillator (ICD)
Study design
Randomised, placebo-controlled
Follow-up
Mean 57 months (range 2–9 years). Mean 11.3 months for the propafenone arm
Patients
346 patients (propafenone 58, amiodarone 92, metoprolol 97, ICD 99) £ 3 months following cardiac arrest
Treatment regimen
Amiodarone, loading dose 1000 mg/day for 7 days followed by 200–600 mg/day, or metoprolol, titrated from 12.5–25 mg/day to maximally 200 mg/day over 7–14 days, or propafenone, titrated from 450 mg/day to maximally 900 mg/day over 8–14 days, or implantation of an ICD
Concomitant therapy
Results
Over a mean follow-up of 57 months, the death rate was 36.4% in the ICD arm compared to 44.4% in the antiarrhythmic arm. In the ICD arm the rate of sudden death was 13.0% and that of nonfatal cardiac arrest was 11.1% compared to 33.0% and 19.5%, respectively, in the antiarrhythmic arm. Overall survival was higher in the ICD arm but not significantly different from that in the antiarrhythmic arm (1-sided p = 0.081)
Comments
The propafenone arm was stopped after 11.3 months because total mortality and recurrence of cardiac arrest differed significantly from those of ICD-treated patients
Комментарий: а вот и наш герой - пропафенон! НО, во-первых, у больных после cardiac arrest, а, во-вторых, по сравнению с кардиовертером-дефибриллятором. Внимание, вопрос! При чём здесь ЖЭС? Минута пошла...