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Increased dosage of Latuda safe, effective for early nonresponsive schizophrenia
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Latuda dose escalation was safe and effective among adults with acute schizophrenia and inadequate initial response to standard doses, according to recent findings.
“Treatment options for such patients include continued treatment on the current antipsychotic agent without change in dose; antipsychotic agent dose escalation; addition of adjunctive treatment (such as benzodiazepines or mood stabilizers); or switching to a different antipsychotic medication. Few studies have addressed these options using adequately controlled study designs and there is a significant need for evidence-based clinical guidance in this area,” Antony Loebel, MD, executive vice president and chief medical officer at Sunovion, told Healio.com/Psychiatry.
To assess the efficacy of dose increase among adults with schizophrenia and inadequate initial response to standard doses of Latuda (lurasidone hydrochloride, Sunovion Pharmaceuticals Inc), researchers conducted a randomized, double-blind, placebo-controlled study among hospitalized patients with acute schizophrenia. Study participants received 20 mg (n = 101) or 80 mg (n = 199) of lurasidone per day or placebo (n = 112). Participants who did not respond to 80 mg of lurasidone at 2 weeks (n = 95) were re-randomized to 80 mg or 160 mg per day for the remaining 4 weeks.
Dose increase to 160 mg per day significantly reduced Positive and Negative Symptom Scale (PANSS) total scores at week 5 among nonresponders, compared with continuing 80 mg per day (–16.6 vs. –8.9; P < .05).
Clinical Global Impression-Severity (CGI-S) scores also improved from –0.6 at week 2 to –1 at week 6 among participants who received 160 mg of lurasidone, though the difference was not statistically significant.
At week 6, PANSS (–17.6 vs. –14.5) and CGI-S (–0.93 vs. –0.73) total scores did not significantly improve among participants who received 20 mg of lurasidone, compared with placebo.
Adverse events associated with dose were not common.
“The findings of this study suggest that increasing the dose of lurasidone early in the course of treatment may be useful for those patients who do not show an adequate initial improvement, compared to maintaining a standard lower dose. Lurasidone dose escalation may now be considered a preferred treatment approach, when faced with initial nonresponse, given the strengths of the study design,” Loebel said. “Clinicians now have rigorous evidence from a double-blind, placebo-controlled, multicenter trial that increasing the dose of lurasidone (from 80 mg to 160 mg per day) may benefit patients who do not respond adequately to initial treatment, compared to maintenance of the existing dose. The increased dose of lurasidone was associated with a modest increase in certain adverse events (including akathisia, anxiety and somnolence) so clinicians should consider the overall risk vs. benefit of dose escalation and individualize treatment accordingly.” – by Amanda Oldt
Disclosure: Loebel is an employee of Sunovion Pharmaceuticals Inc. Please see the full study for a list of all authors’ relevant financial disclosures.