Current medical research and opinion
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Randomized Controlled Trial
Impact of lurasidone on health-related quality of life in adults with bipolar depression: a post-hoc analysis.
The objective of this post-hoc analysis was to assess the impact of lurasidone monotherapy on health-related quality of life (HRQoL) in adults with bipolar depression. ⋯ Treatment with lurasidone provided a significant improvement across HRQoL items including overall life satisfaction, social and family relationships, medication satisfaction, and ability to function in daily life. Improvements were sustained during the 6-month OLE.
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Randomized Controlled Trial
Oral, intranasal, and intravenous abuse potential of serdexmethylphenidate, a novel prodrug of d-methylphenidate.
Serdexmethylphenidate (SDX) chloride (Cl) is a novel prodrug of d-methylphenidate (d-MPH). These studies evaluated the abuse potential of SDX Cl when administered orally, intranasally (IN), and intravenously (IV). ⋯ These findings indicate that the novel d-MPH prodrug, SDX, has lower abuse potential than d-MPH and support its classification as a C-IV controlled substance.
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Randomized Controlled Trial
Limitations of randomized, controlled, double-blinded studies in determining safety and effectiveness of treatments.
Randomized, controlled, double-blinded studies, in which treated subjects are randomly selected from the same pool as controlled (untreated) ones and neither the caregiver nor the patient knows which is which, are widely accepted as the gold standard of experimental medicine. There are well-documented advantages of such studies. ⋯ Some limitations of them are widely known and taught, such as inadequate sample size, failure of proper randomization, et cetera; others are less well-known. We shall focus on the latter.
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Randomized Controlled Trial
Long-term treatment with galcanezumab in patients with chronic migraine: results from the open-label extension of the REGAIN study.
Galcanezumab, a monoclonal antibody to calcitonin gene-related peptide, was found to be safe and efficacious for the preventive treatment of chronic migraine based on the randomized, placebo-controlled double-blind period of the REGAIN study. Long-term safety and efficacy were assessed in an open-label extension. ⋯ Galcanezumab was effective, safe, and well-tolerated, with high adherence, for up to 12 months of treatment in patients with chronic migraine.
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Randomized Controlled Trial
Migraine history and response to lasmiditan across racial and ethnic groups.
The robust enrollment in SPARTAN and SAMURAI provided the opportunity to present post-hoc descriptive details on migraine disease characteristics and treatment outcomes after treatment with lasmiditan, a selective serotonin (5-HT1F) receptor agonist, in racial and ethnic subgroups. ⋯ There were few differences in demographic and clinical characteristics across racial and ethnic groups. Similar lasmiditan efficacy and safety outcomes were observed in AA versus W participants, and in HL versus Non-HL participants. Small observed differences may be driven by a tendency toward a more positive response observed across all treatment groups by AA and HL participants.