Long-term interviewed bipolar drug use

Newspaper says treatment in large part based on a clinical trial, imperfect
Drug originally used to treat schizophrenia and acute episodes of mania
Abilify for maintenance treatment may be leading to higher treatment costs

 the growing use of a popular drug in the treatment of bipolar long term is based largely on a single, imperfect clinical trial which may be Director doctors and patients away from drugs with a balance established, a new magazine published this week in the journal "plos Medicine" suggests.

The drug, Abilify (aripiprazole), was originally used to treat schizophrenia and acute episodes of mania, the better that good sense which characterized the bipolar disorder. In 2005, the Food and Drug Administration also approved for use in the long term in bipolar patients whose moods have stabilized (known as "maintenance" therapy).

Since then Abilify sales have more than doubled, according to studies cited in the magazine market. And 2008 physician survey has revealed that he had become the drug of first choice for the treatment of bipolar maintenance among the 23% of psychiatrists and 16% of primary care physicians.

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Medical research does not appear to justify the widespread use of Abilify for maintenance treatment, said the psychiatrist Alexander c. Tsai, M.D., one of the principal authors of the review and a researcher at Harvard University. "We have failed to find sufficient data to support its use."

Tsai insists on the fact that people taking Abilify for bipolar disorder should not abruptly stop medication. "It can actually work to some people," he said. "But it is certainly worth talking to your doctor about how it is for you."

After having noticed an increasing number of patients appears to be for Abilify by name, Tsai and colleagues performed extensive research of double-blind, randomized - both published and unpublished - on the use of Abilify for bipolar disorder long term treatment. Studies of this type are considered the gold standard of medical research.

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Their research has only one clinical trial, data that have been used in two published studies. The trial was funded by Otsuka Pharmaceutical Co., the Japanese company that developed Abilify, and Bristol-Myers Squibb, which markets the drug in the United States.

The trial had several important limitations, according to Tsai and its sponsors. For its part, they say, he could have too short to judge the real efficacy of the drug for the prevention of long-term mood swings. The first phase of the trial which lasted for 26 weeks, and less than one-fifth of participants was to complete the 48-week follow-up phase.

In addition, the population of the study was limited to persons whose mood had already stabilized on Abilify in the preliminary phase of the trial, and the placebo group was therefore of patients who have been brutally moved from Abilify to placebo. The potentially harmful effects of the rapid withdrawal of drug may have been the placebo appear artificially subject to relapse - the key finding that Abilify appear beneficial, Tsai and colleagues say.

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Psychiatrists have continued to refer to the results of the test despite these weaknesses, said Tsai. "Frankly, I think it's an embarrassment to the profession [Abilify] has been so uncritically accepted for this indication."

Gregory e. Simon, M.D., psychiatrist at the Group Health Research Institute, in Seattle, said that the perceived faults as indicated in the review are not simple. "The long-term efficacy study methods are complex, and experts agree on the best ways to study this issue," said.

The alternatives in the same class of drugs called antipsychotics atypical, include Seroquel (quetiapine) and Zyprexa (olanzapine). Older drugs, such as lithium, remain also in popular usage.

Evidence of efficiency long-term lithium is much higher that that of new medications, including Abilify, Simon said. For this reason, lithium remains its treatment of first-line maintenance treatment in bipolar disorder, despite the potentially dangerous side effects at doses too high.

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The increased use of Abilify for maintenance treatment may be leading to treatment costs higher for consumers, said Tsai. Abilify runs more than $600 a month supply and is not yet available in generic form. "But our main concern, he adds,"is that patients are diverted to more effective treatments"."

Sonia Choi, the Director of public affairs for Bristol - Myers Squibb, said in a statement, that society has conducted long-term studies five of Abilify in the maintenance of bipolar disorder, and some have been presented at medical conferences not published in journals. (Tsai and colleagues limited their analysis to peer of randomized controlled trials.)

Bristol-Myers Squibb and Otsuka committed themselves to make the data from these studies available to physicians, said Choi. "We are confident in the clinical development of Abilify program and will continue to make available information on the effectiveness and safety of Abilify of our studies in this case and other indications."

Sandy Walsh, a spokesman for the FDA, said that the Agency will examine the new study.Copyright Health Magazine 2010