Serotonin syndrome in the acute treatment landscape of migraine: the lasmiditan experience.

Background: Serotonin syndrome (SS) symptoms overlap with adverse events associated with lasmiditan, a 5-HT (serotonin)1F receptor agonist for acute treatment of migraine. Because SS symptoms are heterogeneous, diagnosis can be challenging, and potential cases observed with lasmiditan treatment led to questions about SS pathophysiology. Here, we provide an overview of the potential risk of SS based on experience with lasmiditan. Methods: Results of eight phase 2 and phase 3 lasmiditan trials (n = 5,916) and a controlled intravenous trial of lasmiditan (n = 88) were analyzed for symptomatology consistent with SS. Post-marketing surveillance data from lasmiditan's US launch date (January 2020) until data cut-off (April 2021) were also examined. Established Sternbach and Hunter diagnostic criteria were used for formal determination of SS. Results: Of 6,004 lasmiditan-treated clinical trial patients, 15 reported ≥1 treatment-emergent adverse event consistent with signs and symptom(s) of SS. After review, one case met Sternbach and Hunter criteria, two cases potentially met Sternbach criteria, and three cases reported as SS had limited/no information to determine if either criterion was met. During post-marketing surveillance (approximately 13,400 lasmiditan prescriptions), 17 cases with symptom complexes consistent with SS were reported; 3/17 cases had adequate case descriptions to apply predefined criteria. Of these, two met Sternbach and Hunter criteria, and one met Sternbach criteria. Conclusion: Awareness of clinical symptomatology and diagnostic criteria of SS can help clinicians with recognition of rare instances of SS that may occur with lasmiditan. Clinical trial registration: NCT03670810, NCT00384774, NCT00883051, NCT02565186.

A Phase 1 Multiple Dose Study of Tirzepatide in Chinese Patients with Type 2 Diabetes.

INTRODUCTION: To investigate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of tirzepatide in Chinese patients with type 2 diabetes (T2D). METHODS: In this phase 1, double-blind, placebo-controlled, multiple dose study, patients were randomized into one of two cohorts to receive once-weekly subcutaneous tirzepatide or placebo. The initial tirzepatide dose in both cohorts was 2.5 mg, which was increased by 2.5 mg every 4 weeks to a maximum final dose of 10.0 mg at week 16 (Cohort 1) or 15.0 mg at week 24 (Cohort 2). The primary outcome was the safety and tolerability of tirzepatide. RESULTS: Twenty-four patients were randomized (tirzepatide 2.5-10.0 mg: n = 10, tirzepatide 2.5-15.0 mg: n = 10, placebo: n = 4); 22 completed the study. The most frequently reported treatment-emergent adverse events (TEAEs) among patients receiving tirzepatide were diarrhea and decreased appetite; most TEAEs were mild and resolved spontaneously with no serious adverse events reported in the tirzepatide groups and one in the placebo group. The plasma concentration half-life of tirzepatide was approximately 5-6 days. Mean glycated hemoglobin (HbA1c) decreased over time from baseline in the 2.5-10.0 mg (- 2.4%) and 2.5-15.0 mg (- 1.6%) tirzepatide groups, at week 16 and week 24, respectively, but remained steady in patients receiving placebo. Body weight decreased from baseline by - 4.2 kg at week 16 in the tirzepatide 2.5-10.0 mg group and by - 6.7 kg at week 24 in the 2.5-15.0 mg group. Mean fasting plasma glucose levels fell from baseline by - 4.6 mmol/L in the tirzepatide 2.5-10.0 mg group at week 16 and by - 3.7 mmol/L at week 24 in the tirzepatide 2.5-15.0 mg group. CONCLUSIONS: Tirzepatide was well tolerated in this population of Chinese patients with T2D. The safety, tolerability, PK, and PD profile of tirzepatide support once-weekly dosing in this population. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov: NCT04235959.

Human genome and the african personality: implications for social work.

The integration of the human genome with the African personality should be viewed as an interdependent whole. The African personality, for purposes of this article, comprises Black experiences, Negritude, and an Africa-centered axiology and epistemology. The outcome results in a spiritual focused collective consciousness. Anthropologically, historically (and with the Human Genome Project), genetically Africa has proven to be the source of all human life. Human kind wherever they exist on the planet using the African personality must be viewed as interconnected. Although racism and its progeny discrimination preexist the human genome project (HGP), the human genome provides an evidence-based rationale for the end to all policy and subsequent practice based on race and racism. Policy must be based on evidence to be competent practice. It would be remiss if not irresponsible of social work and the other behavioral scientist concerned with intervention and prevention behaviors to not infuse the findings of the HCPs. The African personality is a concept that provides a wholistic way to evaluate human behavior from an African worldview.

Human genome project and sickle cell disease.

Sickle cell disease is one of the most common genetic blood disorders in the United States that affects 1 in every 375 African Americans. Sickle cell disease is an inherited condition caused by abnormal hemoglobin in the red blood cells. The Human Genome Project has provided valuable insight and extensive research advances in the understanding of the human genome and sickle cell disease. Significant progress in genetic knowledge has led to an increase in the ability for researchers to map and sequence genes for diagnosis, treatment, and prevention of sickle cell disease and other chronic illnesses. This article explores some of the recent knowledge and advances about sickle cell disease and the Human Genome Project.

Coping resources:effects on the psychological well-being of african american grandparents raising grandchildren.

The impact that parenting responsibilities have on the psychological well-being of African American grandparents raising grandchildren is an increasing concern in American society. Contemporary research studies indicate that African American grandparents who encounter a variety of challenges in raising their grandchildren are able to cope successfully with these situations if they derive a sufficient amount of psychological rewards from raising grandchildren (Giarrusso, Silverstein, & DuFeng, 2000). These rewards include increased gratification, feelings of usefulness, and increasing pride in their own abilities to meet new challenges (Fuller-Thomason & Minkler, 2000). This article will investigate how the coping resource factors of intergenerational solidarity, informal social support and spirituality enhance the psychological well-being of African American grandparents who are raising their grandchildren. doi:10.1300/J045v22n03_09.

A study to assess patient satisfaction of transitioning from Medicaid to managed care by sickle cell patients in Hampton Roads, Virginia.

Transition issues faced by the sickle cell patient who has a significant chronic illness or disability are many and often life threatening. The problems that are faced in transitioning from Medicaid to managed care are many that could hinder the process and patient satisfaction. Such problems during the transition periods could stem from interrupted health care services; improperly coordinated services; inappropriate intervention; and inappropriate or unfounded psychologically diagnosed cases (Blum, 1993). It is not known which health care programs are cost-effective and which are not. Nor is it known which health care program best meets the needs of patients with chronic illnesses or varying levels of severity; and it is not known if health status actually improves as a result of transitioning from one program to another. What factors then impact the satisfaction levels in transitioning from Medicaid to managed care for sickle cell patients in Hampton Roads, Virginia? This study looked at patient satisfaction with the transition from Medicaid to managed care as related to the cost of care, quality of care, and access to care.