NEW YORK (Reuters Health) – Patients with less-severe bipolar I disorder benefit less from olanzapine than do those with more-severe disease, but both groups experience the same side effects, according to a new meta-analysis.
“Therefore, toward the mildest end of baseline severity range, clinicians should be more careful with olanzapine treatment and start with lower doses and less side-effect-prone drugs, but should also take into account the potential prophylactic antipsychotic effects in the long term,” advise Dr. Myrto Samara of The Technical University of Munich, Germany, and colleagues.
“Clinicians and patients should carefully consider the benefit-to-risk ratio of olanzapine and its additional, prophylactic effect against relapse in the long term,” they write in The Lancet Psychiatry, online September 29.
Dr. Samara and colleagues identified double-blind randomized controlled trials in the ClinicalStudyDataRequest.com database on Feb 2, 2016, that compared olanzapine with placebo in patients with acute mania associated with bipolar I disorder.
The authors found 33 reports and ultimately analyzed individual participant data from five placebo-controlled trials involving 552 patients who received olanzapine and 387 who received placebo.
The team examined the association between baseline and change in scores up to three weeks for olanzapine versus placebo, using eight increasingly complex competing mixed-effects models for repeated measures.
The interaction between baseline severity on the Young Mania Rating Scale (YMRS; range 0 to 60) and change in scores with treatment was significant (P=0.013).
At three weeks, the mean estimated YMRS scores had dropped in both groups. However, scores were higher with olanzapine than placebo:
– by 2.56 points for patients with a baseline score of 20 to 25 (9.26 for olanzapine vs. 6.70 for placebo; effect size, 0.35)
– by 4.74 points for a baseline score of 25 to 35 (14.25 vs. 9.51; effect size, 0.58); and
– by 8.01 points for a baseline score of 35 to 60 (21.72 vs. 13.71; effect size, 0.70).
“To our knowledge, this is the first individual patient data meta-analysis to examine the association between initial symptom severity and the efficacy of olanzapine versus placebo for the treatment of manic or mixed episodes in people with bipolar I disorder,” the team writes.
Dr. Gin Malhi of the University of Sydney, Australia, who wrote an accompanying commentary, told Reuters Health by email, “This study has led the way in individualizing therapy from the outset, and the next step should be to extend this approach to other anti-manic drugs, and to determine the profile for drugs in relation to baseline severity of illness. Research should also target real-world populations as opposed to trial participants, to enhance generalizability of findings.”
“The findings of this study should also inform clinical practice guidelines for the management of mood disorders, and in so doing ensure that treatment is tailored to symptom profile, illness severity, and the phase of management,” Dr. Malhi advises in the comment.
The study did not receive outside funding, but Eli Lilly allowed the use of its participant-level data.
One of the authors declared financial relationships with Eli Lilly, the manufacturer of olanzapine.
SOURCES: http://bit.ly/2yMrfET and http://bit.ly/2xQoHHT
Lancet Psychiatry 2017.
Tidak ada komentar:
Posting Komentar