According to the study, funded by the NHS and published in the Archives of General Psychiatry, patients with schizophrenia whose medication is being changed gain little benefit from being put on the newer drugs - despite their much larger market share. This runs contrary to the widely-held view that second-generation anti-psychotics are safer and more effective than the less expensive first-generation.
Antipsychotic medication is the main method of treating schizophrenia, with most UK patients currently receiving second-generation drugs through the NHS which cost at least 10 times more than their predecessors. Previous, industry-sponsored trials reported these newer drugs to be more effective and better tolerated, leading most experts to currently recommend using them first despite their additional cost.
Study leader Professor Shôn Lewis said: “The development of second-generation anti-psychotics was thought to be a major advance, as the first trials seemed to show they reduced side effects. Claims that they were also more effective than first-generation drugs shifted treatment patterns away from these medications, even though previous research comparing the drug classes has had mixed results.”
The NHS commissioned the study – the first ever to compare treatment results in this area – to assess whether the additional costs of second-generation anti-psychotics were off-set by improvements in patients’ quality of life or reductions in the use of health and social care services.“We undertook the study thinking that we would show the NHS that their misgivings about the previous data were unfounded,” Professor Lewis said.
The team, which includes colleagues at the University of Cambridge, Institute of Psychiatry and Imperial College London, studied 227 schizophrenia patients for whom a change in drug treatment was being considered (because of ineffectiveness or harmful side effects). The participants were randomly assigned to receive one class of drug or the other, with doctors determining which of the first- or second-generation medications would be best for each patient.
They were assessed before and 12, 26 and 52 weeks after the change in treatment using a quality of life scale, and symptoms, side effects, treatment costs and satisfaction with the drug were also measured.
The results failed to reveal the advantage in side effects or effectiveness predicted for the second generation drugs; instead there was a trend towards the older drugs working better.
Professor Lewis said: “We estimated that the second-generation anti-psychotics would produce a five-point improvement in quality of life scores, compared with first-generation anti-psychotics. But after 12 weeks, the quality of life scores averaged 49.2 for the first-generation group and 46.6 for the second-generation group.”
After 26 weeks, the first-generation group score averaged 49.2, compared with and 50.4 for second-generation, but after a year it was 53.2 for first-generation users and 51.3 for second-generation. Participants in the first-generation group also showed a trend toward greater improvements in symptoms.
“We were so certain we would find exactly the opposite that we went back and checked the data,” Professor Lewis continued. “But it all suggested that careful prescribing of first-generation anti-psychotics, at least in the context of a trial, is not associated with poorer efficacy or a greater adverse effect.
A parallel trial, also funded by the NHS, did confirm previous reports that the second generation drug clozapine stood out from the others in terms of effectiveness for people with severe schizophrenia. “This drug improved quality of life and symptoms better than the other newer drugs, and patients preferred it,” Professor Lewis said.
“However, our research suggests that, despite modern prescribing patterns, second-generation anti-psychotics are not the great breakthrough they were once thought to be – and certainly may not justify their ten-times higher price tag. Further trials to evaluate both the role of second-generation anti-psychotics in the management of schizophrenia and the usefulness of cheaper, older drugs could save the NHS millions of pounds.”
Jon Keighren | alfa
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