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| |  Lithium Plus Valproate More Likely to Prevent Bipolar Relapse Than Valproate Monotherapy NEW YORK -- December 22, 2009 -- For people with bipolar I disorder, for whom long-term therapy is clinically indicated, both combination therapy with lithium plus valproate and lithium monotherapy are more likely to prevent relapse, compared with valproate monotherapy. This benefit seems to be irrespective of baseline severity of illness and is maintained for up to 2 years, according to a study published online first and appearing in an upcoming issue of The Lancet. However, the study could not confirm or refute an advantage of combined therapy over lithium monotherapy. In the international, multicentre, randomised Bipolar Affective disorder: Lithium/Anti-Convulsant Evaluation (BALANCE trial), 330 patients aged 16 years and older with bipolar I disorder were allocated to lithium monotherapy, valproate monotherapy, or both agents in combination after an active run-in of 4 to 8 weeks on the combination. Patients were followed for up to 24 months, and the primary outcome was initiation of new intervention for an emergent mood episode. John R Geddes, Clinical Trials Unit for Mental Illness, University of Oxford, UK, and colleagues found that 54% of people in the combination therapy group, 59% in the lithium group, and 69% in valproate group had a primary outcome event during follow-up. In terms of relative risk, those given combination therapy were 41% less likely to have a primary outcome event versus those given valproate; while those given lithium were 29% less likely to have an event than those given valproate. Patients given combination therapy were also 18% less likely to have an event versus those given lithium monotherapy, but this finding was not statistically significant. A total of 16 participants had serious adverse events after randomisation, that were judged not to be related to the trial treatments: seven receiving valproate monotherapy (3 deaths); five lithium monotherapy (2 deaths); and 4 combination therapy (1 death). “The results of BALANCE show that for people with bipolar I disorder for whom long-term therapy is clinically indicated, combination therapy with lithium plus valproate is more likely to prevent relapse than is monotherapy with valproate,” the authors wrote. “The 41% relative benefit is irrespective of baseline severity of illness, is maintained for up to 2 years, and is most apparent in prevention of manic relapse.” “The main BALANCE findings have important implications for clinical decisions about long-term therapy for bipolar disorder,” they continued. “First, valproate monotherapy is recommended by clinical practice guidelines as a first-line option for long-term therapy. Our results suggest that patients should be advised that a better outcome would be likely with combination therapy with lithium plus valproate semisodium or lithium alone. Second, guidelines suggest that patients who have frequent relapses during treatment with lithium monotherapy could switch to valproate monotherapy. The results of BALANCE suggest that these patients would fare better if they changed to combination therapy.”
SOURCE: The Lancet
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