Еще данные и вопрос о побочке по абилифаю

2 ответов6 568 просмотров

Еще данные и вопрос о побочке по абилифаю

#1

Скажите пожалуйста, а как скоро должно быть заметно улучшение от действия абилифая. Хотябы примерно. Это неделя, месяц, месяцы? Я имею в виду прием 30 мг/сутки.
И еще вопрос - реально изучена ли опасность его приема? Скандал с компанией pfizer очень настораживает по поводу приема новых лекарств. Методы же у всех этих компаний одинаковые.

Недавно прочитал, что абилифай включен в число 43 самых опасных препаратов. Не знаете ли, это правда или утка? А как из вашей практики? Он реально опасен.

С уважением.

Re: Еще данные и вопрос о побочке по абилифаю

#2

Смотря, что лечим абилифаем. Обычно он относительно быстрый. Эффект на продуктивную, обычно можно отмечать после 10-15 дня приема, например если брать депрессивно-параноидный синдром. Но это всё УСЛОВНО, у каждого по разному. Развертывание можно ожидать до 3 месяцев. Из проблемных мест, часто встречаю акатизию, тошноту, (тошнота обычно в течении 5 дней проходит, но этот период не забываем также корректировать, например осетроном по 5нт). Акатизию корректим обзиданом, лирикой или габапентином.
Контроль крови, биохимия, ЭКГ. А там по ситуации…

Вот по побочкам:
The safety and tolerability of antipsychotic therapy are important aspects of schizophrenia management,
as they have an impact on treatment adherence and so on patients’ risk of relapse and quality of life.
Specific side effects seen with some antipsychotics, such as weight gain and hyperprolactinemia, may
also have long-term implications for patient health.
A pooled analysis of safety and tolerability data from the five short-term studies (Marder et al. 2003; Stock
et al. 2002) showed that aripiprazole treatment was well tolerated. The most commonly reported adverse
events with aripiprazole were headache, insomnia, agitation, and anxiety; these were also the most
frequently reported events in the placebo, haloperidol, and risperidone groups. The incidence of adverse
events was similar in the aripiprazole and placebo groups. Akathisia, somnolence, and EPS were more
common among patients receiving haloperidol than those receiving aripiprazole, while akathisia,
somnolence, and tachycardia were more frequent in the risperidone group than in the aripiprazole group.
The adverse-event profile of aripiprazole did not vary according to patient characteristics of age, gender,
and race, and no deaths were reported during the short-term studies. Data from the four fixed-dose
studies showed that somnolence was the only adverse event seen with aripiprazole that was possibly
dose-related. The overall incidence of somnolence with aripiprazole, however, was similar to that seen
with placebo and lower than that seen with other active treatments. Objective rating scale assessments
were used to assess changes in parkinsonian symptoms (Simpson-Angus Scale [SAS]), dyskinesias
(Abnormal Involuntary Movement Scale [AIMS]), and akathisia (Barnes Akathisia Rating Scale [BAS]).
SAS scores with aripiprazole did not differ significantly from those with placebo, whereas AIMS scores
improved significantly from baseline with aripiprazole compared with placebo. Aripiprazole did not
produce consistent dose-dependent changes in BAS scores. Haloperidol produced significant increases in
SAS and BAS scores over placebo. Rates of discontinuation due to adverse events were similar among the
groups: 9.4% with placebo, 8.0% with haloperidol, and 7.3% with aripiprazole (Otsuka Pharmaceutical
2006). According to the product labeling for aripiprazole in the United States, treatment-emergent
adverse events reported with aripiprazole in short-term trials of patients with schizophrenia (up to 6
weeks) or bipolar disorder (up to 3 weeks) that occurred at an incidence greater than or equal to 10% and
greater than placebo, respectively, included headache (30% vs. 25%), anxiety (20% vs. 17%), insomnia
(19% vs. 14%), nausea (16% vs. 12%), vomiting (12% vs. 6%), dizziness (11% vs. 8%), constipation
(11% vs. 7%), dyspepsia (10% vs. 8%), and akathisia (10% vs. 4%). A similar adverse-event profile
was observed in a 26-week trial in schizophrenia except for a higher incidence of tremor (aripiprazole 8%
vs. placebo 2%).
The most frequently reported adverse events with aripiprazole injection were headache (aripiprazole 12%
vs. placebo 7%), nausea (aripiprazole 9% vs. placebo 3%), dizziness (aripiprazole 8% vs. placebo 5%),
and somnolence (aripiprazole 7% vs. placebo 4%). In the three aripiprazole injection trials, the safety
profile was comparable to that of placebo regarding the incidence of EPS, akathisia, or dystonia. The
incidence of akathisia-related adverse events with aripiprazole injection was 2% (vs. 0% for placebo),
while the incidence of dystonia with aripiprazole injection was less than 1% (vs. 0% for placebo). In
addition, the incidence of QTc prolongation was also comparable between aripiprazole injection and
placebo.
Weight gain is another adverse event of concern seen with some antipsychotic treatments, as it is
associated with noncompliance (Allison et al. 1999), and excessive weight gain and obesity are linked to
an increased risk of morbidity and mortality from heart disease, hypertension, and diabetes (Aronne
2001). Minimal changes in mean body weight were observed with aripiprazole treatment in short-term
studies (pooled data, +0.71 kg) (Marder et al. 2003) and long-term studies (26-week: –1.26 kg; 52-week:
+1.05 kg) (Kasper et al. 2003; Pigott et al. 2003).
Olanzapine and aripiprazole were compared on their propensity to cause weight gain and other metabolic
disturbances in a 26-week randomized, double-blind multicenter trial in patients with DSM-IV
schizophrenia who were in acute relapse and required hospitalization (McQuade et al. 2004). Significant
weight gain was defined as more than 7% increase in body weight from baseline. Three hundred
seventeen patients were randomly assigned to aripiprazole (n = 156) or olanzapine (n = 161). By week
26, 37% of olanzapine-treated patients had experienced significant weight gain, compared with 14% of
aripiprazole-treated patients (P<.001). Statistically significant differences in mean weight change were
observed between treatments beginning at week 1 and sustained throughout the study. At week 26, there
was a mean weight loss of 1.37 kg (3.04 lb) with aripiprazole compared with a mean increase of 4.23 kg
(9.40 lb) with olanzapine among patients who remained on therapy (P0.001). Changes in fasting plasma
levels of total cholesterol, high-density lipoprotein cholesterol, and triglycerides were significantly
different in the two treatment groups, with worsening of the lipid profile among patients treated with
olanzapine.
Aripiprazole treatment was not associated with increases in prolactin levels during short- or long-term
studies (in fact, prolactin levels were shown to be slightly decreased by aripiprazole). Patients receiving
aripiprazole treatment also showed decreases in mean QTc interval that were similar to those seen in
patients who were receiving placebo in short-term studies (4.4 msec vs. 3.5 msec), as well as a low
incidence of QTc increase ≥30 msec (aripiprazole: 4.3%; placebo: 5.5%). Aripiprazole was not associated
with significant increases in QTc interval in long-term studies. Aripiprazole treatment was not associated
with adverse changes in glucose or lipid levels during short- or long-term studies.
Overall, aripiprazole treatment is associated with a low incidence of EPS-related symptoms and with
minimal or no effects on weight gain, QTc interval, or circulating levels of cholesterol, glucose, and
prolactin. Treatment with aripiprazole may reduce the burden of antipsychotic-associated side effects,
which is expected to improve patient adherence and reduce the risk of acute relapse.

Re: Еще данные и вопрос о побочке по абилифаю

#3

FDA серьезная контора, если кто еще не понял, и как и подобает серьезной конторе, она… работает! Я понимаю, глядя на наши минздравы, росхреннадзоры и т.п. поверить в саму возможность непросто, но, вот.
Так вот, каждый день американские доктора отмечают всякие симптомы, которые они наблюдали, но не очень ожидали. Туда же поступают “стуки” от бдительных потребителей. Враг не пройдет. Все это сливается в единую базу данных, обрабатываются, выкидываются статистически не значимые, уже известные и т.п. Короче, ежеквартально, вот уже несколько лет FDA собирает отчет (у них там всякие конторы, которые живут на деньги налогоплательщиков имеют идиотскую привычку подробно рассказывать тем, кто дает деньги, т.е. всем, о том, чем они там занимаются), и вот обработанные данные из базы AERS (Adverse Event Reporting System). Вот именно один из таких отчетов за 2008 годов Вам и попался. Там, кстати, есть ВСЕ СИОЗС и СОЗСН, и лазикс, и еще дофига всего. Важно не то, что там, а то, что выявлено, и в какой частоте. Собственно, и это не очень важно, просто в новой партии засветившегося лекарства вкладыш пополнится парой - тройкой труднопроизносимых слов.