Acomplia (rimonabant) não foi aprovado pelo FDA. Mas, a ANVISA aprovou para uso. Esse blogue já tinha alertado baseado na experiência de endocrinologistas e, sentido a "forçada de barra" do marketing em programas televisivos. Agora, a metanálise publicada no The Lancet.
The Lancet 2007; 370:1706-1713 Efficacy and safety of the weight-loss drug rimonabant: a meta-analysis of randomised trials Robin Christensen MSc a, Pernelle Kruse Kristensen BSc a b, Else Marie Bartels DSc c, Prof Henning Bliddal MD a and Prof Arne Astrup MD b
Since the prevalence of obesity continues to increase, there is a demand for effective and safe anti-obesity agents that can produce and maintain weight loss and improve comorbidity. We did a meta-analysis of all published randomised controlled trials to assess the efficacy and safety of the newly approved anti-obesity agent rimonabant.
Methods We searched The Cochrane database and Controlled Trials Register, Medline via Pubmed, Embase via WebSpirs, Web of Science, Scopus, and reference lists up to July, 2007. We collected data from four double-blind, randomised controlled trials (including 4105 participants) that compared 20 mg per day rimonabant with placebo.
Findings Patients given rimonabant had a 4·7 kg (95% CI 4·1–5·3 kg; p<0·0001) greater weight reduction after 1 year than did those given placebo. Rimonabant caused significantly more adverse events than did placebo (OR=1·4; p=0·0007; number needed to harm=25 individuals [95% CI 17–58]), and 1·4 times more serious adverse events (OR=1·4; p=0·03; number needed to harm=59 [27–830]). Patients given rimonabant were 2·5 times more likely to discontinue the treatment because of depressive mood disorders than were those given placebo (OR=2·5; p=0·01; number needed to harm=49 [19–316]). Furthermore, anxiety caused more patients to discontinue treatment in rimonabant groups than in placebo groups (OR=3·0; p=0·03; number needed to harm=166 [47–3716]).
Interpretation Our findings suggest that 20 mg per day rimonabant increases the risk of psychiatric adverse events—ie, depressed mood disorders and anxiety—despite depressed mood being an exclusion criterion in these trials. Taken together with the recent US Food and Drug Administration finding of increased risk of suicide during treatment with rimonabant, we recommend increased alertness by physicians to these potentially severe psychiatric adverse reactions
Since the prevalence of obesity continues to increase, there is a demand for effective and safe anti-obesity agents that can produce and maintain weight loss and improve comorbidity. We did a meta-analysis of all published randomised controlled trials to assess the efficacy and safety of the newly approved anti-obesity agent rimonabant.
Methods We searched The Cochrane database and Controlled Trials Register, Medline via Pubmed, Embase via WebSpirs, Web of Science, Scopus, and reference lists up to July, 2007. We collected data from four double-blind, randomised controlled trials (including 4105 participants) that compared 20 mg per day rimonabant with placebo.
Findings Patients given rimonabant had a 4·7 kg (95% CI 4·1–5·3 kg; p<0·0001) greater weight reduction after 1 year than did those given placebo. Rimonabant caused significantly more adverse events than did placebo (OR=1·4; p=0·0007; number needed to harm=25 individuals [95% CI 17–58]), and 1·4 times more serious adverse events (OR=1·4; p=0·03; number needed to harm=59 [27–830]). Patients given rimonabant were 2·5 times more likely to discontinue the treatment because of depressive mood disorders than were those given placebo (OR=2·5; p=0·01; number needed to harm=49 [19–316]). Furthermore, anxiety caused more patients to discontinue treatment in rimonabant groups than in placebo groups (OR=3·0; p=0·03; number needed to harm=166 [47–3716]).
Interpretation Our findings suggest that 20 mg per day rimonabant increases the risk of psychiatric adverse events—ie, depressed mood disorders and anxiety—despite depressed mood being an exclusion criterion in these trials. Taken together with the recent US Food and Drug Administration finding of increased risk of suicide during treatment with rimonabant, we recommend increased alertness by physicians to these potentially severe psychiatric adverse reactions
Um comentário:
Semana passada, a Anvisa retirou do mercado o rimonabanto. Vejo aí uma triste coerência: Se as práticas de liberação, tanto do FDA quanto da Anvisa, devem sempre permanecer sob suspeita, por outro lado, também, essa brincadeira de mau gosto de liberar primeiro para depois suspender representa muito mais o jogo de interesses dos concorrentes do que qualquer processo sério. Quase sempre a questão se debruça sobre medicamentos caros e novos. Há quanto tempo se vende dipirona no Brasil sem qualquer objeção, não obstante o risco de efeitos irreversíveis ou fatais? E os vários anfetamínicos, psiquiatricamente tão ou mais problemáticos do que o rimonabanto, que continuam facilmente encontrados?
É preciso iluminar melhor esse submundo pelo qual a Anvisa tanto pode liberar por conveniências não técnicas, como também entender melhor por que a Anvisa suspende licenças por conveniências não técnicas. Caso contrário, sempre estaremos fazendo o jogo das indústrias, ou de alguma indústria (agonista ou antagonista que seja).
Um abraço.
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