Effects of a Therapeutic Interchange Between Branded and Generic Inhaled Therapy on Chronic Obstructive Pulmonary Disease.

Objective To evaluate the difference in the occurrence of chronic obstructive pulmonary disease (COPD) exacerbations six months preconversion compared with six months postconversion from the branded inhaled corticosteroid/long-acting beta 2-agonist inhalers to the generic fluticasone/salmeterol inhalers. Design Retrospective cohort study using a six-month pre-/post-test design Setting Three primary care offices within a Management Service Organization (MSO) in South Florida. Patients, Participants Patients were included in the study if they had a diagnosis of COPD (in electronic medical record [EMR]), were at least 18 years of age, were under the care of a provider at one of the three primary care clinics within an MSO, and were switched from a branded ICS/LABA inhaler to a generic ICS/LABA inhaler between May 2019 and February 2020. This study included a total of 22 patients. Interventions Not applicable; this was a retrospective chart review. Main Outcome Measure The prevalence of COPD exacerbations leading to hospitalizations, emergency room visits, urgent care visits, or clinic visits. Results In this study, 10 (45.5%) patients experienced at least one exacerbation while on generic inhaler therapy compared with four (18.2%) patients while on branded inhaler therapy (P = 0.05). Those on a generic inhaler were 3.8 times more likely to have a COPD exacerbation. Conclusion While changing patients from branded to generic inhalers may be appealing because of the potential benefits in cost-reduction, the results of this study conclude that the inhaler switch may lead to increased exacerbations. Prescribers need to be aware of potential complications that may be related to a therapeutic interchange.

Lumateperone: A Novel Antipsychotic for Schizophrenia.

OBJECTIVE: To provide a concise review of the new Food and Drug Administration (FDA)-approved antipsychotic, lumateperone, for use in schizophrenia. DATA SOURCES: A literature search of PubMed was performed (January 2000 to May 2020) using the following key terms: lumateperone, Caplyta, and ITI-007. Abstracts from conferences, review articles, clinical trials, and drug monographs were reviewed. STUDY SELECTION AND DATA EXTRACTION: Relevant English-language monographs and studies conducted in humans were considered. DATA SYNTHESIS: Lumateperone was FDA approved for the treatment of schizophrenia in December 2019 based on 2 published randomized, double-blind, placebo-controlled trials. Lumateperone's pharmacology is consistent with that of other second-generation antipsychotics in that it has a higher affinity for the serotonin (5-HT2A) receptors compared with dopamine (D2) receptors but with lower affinities for α-1 and histaminergic receptors. In addition, it serves as a presynaptic dopamine partial agonist, serotonin reuptake inhibitor, and an indirect modulator of glutamatergic systems. Based on the 4-week clinical trials, lumateperone was well tolerated. Most common treatment-emergent adverse events were headache, somnolence, and dizziness. RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE: At this time, lumateperone had a statistically significant reduction in Positive and Negative Syndrome Scale when compared with placebo and was not significantly associated with the extrapyramidal symptoms (EPS) and metabolic adverse effects commonly seen with other antipsychotics. CONCLUSIONS: Lumateperone has the potential to benefit individuals with schizophrenia who are intolerant to the EPSs or metabolic adverse effects of other antipsychotics. However, further head-to-head trials with commercially available antipsychotics are still required to assist in establishing its role in treatment.