Queda na prescrição de stents farmacológicos nos EUA

Confesso que não consegui avançar na leitura de seis artigos no The New England Journal of Medicine sobre a controvérsia dos stents farmacológicos. Era tarefa para o Carnaval. Hoje, The Wall Street Journal mostra que houve queda na prescrição dos stents farmacológicos porque os médicos passaram a temer trombose tardia. Esse problema pode ser contornado com o uso de Plavix por um ano, mas o preço alto e, sempre a possibilidade de adesão baixa ao tratamento está empurrando médicos a indicar o stent simples. Vamos ver o que está acontecendo por aqui, mas meu palpite é que não haverá modificação. A seguir, trecho da matéria, onde mostra que há médicos pensado com a cabeça e com o bolso do paciente. Coisa rara!.

Compared with bare stents, drug-coated stents reduce the need for repeat stentings, but they come with a small risk of blood clots years after a stent is implanted. To reduce that risk, patients are now urged to take the blood-thinning drug Plavix for a year after implantation. The drug-coated stents cost about $2,300 each and are highly profitable for the two companies that sell them in the U.S. -- Boston Scientific and Johnson & Johnson. Several companies sell bare stents, including Abbott Laboratories and Medtronic Inc., for roughly $800 each. Some doctors say they are now more hesitant to use drug-coated stents on poorer patients who are unlikely to be able to afford the $1,500-a-year cost of Plavix. "We've been burned by patients who don't take their Plavix," said Gary L. Schaer, director of the cardiac-catheterization laboratory at Rush hospital in Chicago, describing one patient who balked at the cost and "literally wiped out her whole heart" with a blood clot. Now, "if we suspect that patients have a history of noncompliance, or we're concerned that they won't follow directions or they just can't afford it," Dr. Schaer said he typically uses a bare-metal stent instead.

Medicamento falha, Wall Street Journal noticia.

Uma proposta revolucionária para as doenças cardíacas, o AGI-1067 (quem quiser assistir um filme fantástico sobre aterosclerose e a ação desse fármaco, acesse http://www.atherogenics.com) não teve sucesso na sua tentativa de reduzir morte e reinfarto do miocárdio. Uma pena. Esse fato ocorre a todo momento na pesquisa farmacêutica, mas cada vez mais a notícia chega pela imprensa econômica. O estudo deverá ser apresentado daqui há 8 dias em Nova Orleans, no congresso do colégio americano de cardiologia, mas hoje já sabemos do resultado pelo The Wall Street Journal.(abaixo a notícia) Talvez, esteja respondendo a uma pergunta de um amigo que questiona porque assino o WSJ e, compareço a poucos congressos. Esse é um dos motivos, a notícia chega antes, outro é que as transmissões à distância pela internet estão cada vez melhores e, a baixíssimo custo.

AtheroGenics Says Heart DrugMisses Primary Trial Target
By RON WINSLOWMarch 19, 2007 7:56 a.m.
AtheroGenics Inc. said its heart drug AGI-1067 failed to reach its primary goal in a 6,127-patient clinical trial, but that it did reduce a combination of cardiovascular death, heart attack and stroke.
The Alpharetta, Ga.-based company announced the preliminary findings this morning just eight days before scientists are scheduled to present more complete data at next week's meeting of the American College of Cardiology in New Orleans. Under the college's embargo rules, the company is forbidden from disclosing further details of the study until then.
"We're obviously disappointed we didn't meet the primary endpoint," said Russell Medford, president and chief executive officer of AtheroGenics, "but we are optimistic about the results of the trial and we do look forward to continuing development of what we think is an important drug with the goal of improving patient care."
AGI-1067 is a drug with both anti-inflammatory and antioxidant activity that the company is developing to prevent serious cardiovascular events in people at risk of heart disease.
Analysts have generally been skeptical that the drug would achieve its primary target, though many viewed it as a potential blockbuster if it did. The drug's fate likely depends on further details from the study, including the statistical strength of the possible benefits the company described.
The primary endpoint, as the main goal of a clinical trial is called, included cardiovascular death, resuscitated cardiac arrest, nonfatal heart attacks, need for bypass surgery or angioplasty to clear blocked arteries, and urgent hospitalization for acute chest pain. Patients in the trial all had a history of heart disease and all were being treated with a variety of other heart drugs, including cholesterol-lowering drugs called statins.
"We have a wealth of information that we're going through," Dr. Medford said in an interview this morning. "What we've seen is encouraging and we have determined that further development of the drug is important."
Whether that will require additional clinical studies isn't clear. Decisions will involve AstraZeneca PLC, which has a joint venture with AtheroGenics, and which will have 45 days once analysis of the data is complete, to determine whether to continue the relationship. The company also plans to hold discussions with the Food and Drug Administration.