Seroquel For Maintenance?

Yesterday, AstraZeneca released results of a long-term study using Seroquel plus Lithium or Depakote as a maintenance drug. In a press release the company claimed:

"A large-scale, international, double-blind study (Study 126) investigated the time to recurrence of a mood event (manic, mixed, or depressed) in 1461 patients with bipolar I disorder initially stabilised with SEROQUEL (400-800 mg/day) plus lithium or divalproex.1 After stabilisation for a minimum of 12 weeks, 703 patients were randomised to maintenance treatment with SEROQUEL in combination with lithium or divalproex, or placebo in combination with lithium or divalproex for up to 104 weeks. Compared with placebo, fewer patients in the SEROQUEL group had a mood event, defined as a manic, mixed or depressed episode (49.0% versus 18.5%). SEROQUEL combination treatment also significantly reduced the risk of recurrence of a mood event in comparison with placebo plus lithium or divalproex (hazard ratio 0.28; p<0.0001). When examined according to mood event type, this reduction in risk was similar for both manic and depressed events."

The study itself is not yet available, so it's a bit hard to pick at this data especially since I don't know how many patients in the Seroquel arm of the study made it to the end of two years. One thing makes me a bit skeptical of this study, however:

"Long-term treatment with SEROQUEL was generally well tolerated - the most commonly reported (³5%) adverse events in patients treated with SEROQUEL plus a mood stabilizer during the randomized treatment phase were somnolence (5.7%), nasopharyngititis (5.4%) and headache (5.1%). Additional tolerability results were presented which included combined results from Study 126 and a second similarly designed, large-scale, double-blind study (Study 127). Pooled data showed a greater incidence of blood glucose increases to hyperglycemic levels in patients randomised to Seroquel and mood stabiliser (10.7%, 18.0 patients per 100 patient-years) than in patients randomised to placebo and mood stabiliser (4.6%, 9.5 patients per 100-patient years)."

The hyperglycemia data speaks for itself. But only 5 percent of patients reported somnolence? Based upon what I've seen in the real world, I don't trust that number at all. And weight gain? None reported. That ought to make everyone suspicious. Has anyone ever seen a Seroquel patient who hasn't packed on the pounds? I've met none during the three or four years that Seroquel has been the hot new drug in the psych world.

Although the press release doesn't mention it, it's clear to me that AstraZeneca will likely file with the FDA to have Seroquel approved as a long-term maintenance drug used in conjunction with either Lithium or Depakote. Otherwise, they would have no incentive to do a very costly study with 1,461 patients. What's interesting is that this study comes as AstraZeneca is in the midst of facing legal action by about 10,000 plaintiffs in a federal class action lawsuit along with lawsuits by several states and a Congressional investigation.

Ah, what a tangled world we live in. Stay tuned.