{"id":37814,"date":"2013-06-21T23:02:51","date_gmt":"2013-06-22T03:02:51","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=37814"},"modified":"2013-06-21T23:02:51","modified_gmt":"2013-06-22T03:02:51","slug":"seroquel-good-to-the-last-drop","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2013\/06\/21\/seroquel-good-to-the-last-drop\/","title":{"rendered":"seroquel: good to the last drop…"},"content":{"rendered":"
The life of a Key Opinion Leader can be hectic at times, and Dr. Madhukar Trivedi has certainly been busy of late. At the end of March, he was hawking Viibryd® for Forest Laboratories in a syndicated newspaper article in small papers all over the country [Viibryd® – coming to a hamlet near you…<\/a>]. In April, he published yet another STAR*D article in the American Journal of Psychiatry [beyond my understanding…<\/a>] and in May, he was a spokesperson for Vortioxetine, a new antidepressant introduced by Lundbeck at the APA Meeting [way past time<\/a>] and the AstraZeneca article below came out. Then in June, the STAR*D piece appeared in the print version of the AJP as the cover article [objectively…<\/a>]. Busy busy busy…<\/div>\n
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Evaluation of the effects of extended release quetiapine fumarate monotherapy on sleep disturbance in patients with major depressive disorder: a pooled analysis of four randomized acute studies.<\/a><\/div>\n
by Trivedi MH, Bandelow B, Demyttenaere K, Papakosts GI, Szamosi J<\/font><\/strong>, Earley W<\/font><\/strong>, and Eriksson H<\/font><\/strong>.<\/div>\n
International Journal of Neuropsychopharmacology.<\/font><\/strong> 2013 14:1-12.<\/div>\n

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Effects of once-daily extended-release quetiapine fumarate [quetiapine XR] monotherapy on sleep quality and disturbance in patients with major depressive disorder [MDD] were evaluated. Pooled data from four 6- or 8-wk placebo-controlled quetiapine XR [50-300 mg\/d] monotherapy studies [StudyD1448C00001; D1448C00002; D1448C00003; D1448C00004] were analysed. Primary efficacy end-point was change from randomization in Montgomery Åsberg Depression Rating Scale [MADRS] score. Post hoc analyses of secondary end-points were conducted for change from randomization in: MADRS item 4 [reduced sleep]; Hamilton Rating Scale for Depression [HAMD] items 4 [insomnia-early], 5 [insomnia-middle], 6 [insomnia-late] and sleep disturbance factor [items 4 + 5+6] scores; Pittsburgh Sleep Quality Index [PSQI] global scores. MADRS total score change was also evaluated in patients experiencing high and low baseline sleep disturbance [HAMD sleep disturbance factor scores >4 and <4, respectively]. In total, 1808 patients were randomized to quetiapine XR or placebo across four studies. At last assessment, quetiapine XR reduced MADRS item 4, HAMD items 4, 5 and 6, HAMD sleep disturbance factor score and PSQI global scores from baseline vs. placebo [p < 0.001]. For those experiencing high sleep disturbance [n = 865, quetiapine XR; n = 514, placebo], quetiapine XR improved MADRS total score vs. placebo at all visits [p < 0.001]. For those with low sleep disturbance [n = 252, quetiapine XR; n = 121, placebo], quetiapine XR improved MADRS total score vs. placebo at weeks 2 [p < 0.001], 4 and 6 [both p < 0.05]. In conclusion, quetiapine XR [50-300 mg\/d] monotherapy improved symptoms of sleep disturbance vs. placebo in patients with MDD, including those with either high or low baseline sleep disturbance levels.<\/div>\n<\/blockquote>\n
Let’s get the standard KOL stuff out of the way first. This is an reanalysis of four AstraZeneca Trials with three AstraZeneca employees as authors, funded by AstraZeneca, who paid writer Jocelyn Woodcock of Complete Medical Communications to write it. And since I doubt you read that abstract, let me summarize it quickly: Quetiapine XR [Seroquel XR®] is a sleeping pill just like regular Quetiapine [Seroquel®] was a sleeping pill [whether you’re having trouble with sleep or not]. <\/div>\n

I know that my reviews of these lightweight, experimercials are boring, boring, boring. I persevere undeterred because we slept through the 1990s and most of the 2000s and let this kind of thing happen. Now here we sit in the 2010s, and my contention is that we shouldn’t let a little thing like terminal boredom stand between us and cleaning up this mess<\/font><\/strong> – and it is an unholy mess. This is an article about the pooled results from four studies AstraZeneca did on Seroquel XR® in MDD six or so years ago – the Moonstone Study Group. Here’s a summary of those four earlier studies:<\/p>\n

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They were all published [though the failed study, D1448C00004, was buried in an abstract and not indexed in PubMed]. I could access two of the others and they were both written by Complete Medical Communications. The authors were people from the various clinical research centers or AstraZeneca employees. This was hardly the extent of AstraZeneca’s Seroquel XR® in MDD effort. They got it FDA approved as an adjunctive therapy in MDD. This Moonstone Group effort was their shot at getting it approved as a monotherapy [which didn’t fly]. After just-plain Seroquel® went off patent, AstraZeneca flooded us with ads about Seroquel XR® as an adjunct in MDD. And now we have three latter-day<\/em> articles generated from pooled results of these Moonstone papers:<\/div>\n