Journal of Pharmacy Technology

Includes bibliographical references.

Early Experience With Interleukin-6 Receptor Antagonists in Patients With COVID-19 Admitted to a Community Hospital -- Medication Use Among Patients Reporting Xerostomia of an Academic Dental Clinic -- The Role of Clinical Pharmacist in Pediatrics’ Adherence to Antiepileptic Drugs -- Effect of Antidepressants on Glucagon-Like Peptide-1 Receptor Agonist-Related Weight Loss -- Efficacy and Safety of Biologics for Chronic Rhinosinusitis With Nasal Polyps -- Daridorexant: A New Dual Orexin Receptor Antagonist for Insomnia -- Olanzapine/Samidorphan: A New Option for the Treatment of Adults With Schizophrenia or Bipolar I Disorder.

[Article Title: Early Experience With Interleukin-6 Receptor Antagonists in Patients With COVID-19 Admitted to a Community Hospital/ Kyle Manning, Chris Whitman, Lindsey Hohmann, Jessica Tubbs, Darrell Childress and Jose A. Leon de la Rocha, p. 255–263]

Abstract:

Background/objective: The efficacy of interleukin-6 (IL-6) inhibitors in hospitalized patients with severe coronavirus disease 2019 (COVID-19) pneumonitis is unclear.

Method: This retrospective, observational cohort study included patients hospitalized at a community hospital with COVID-19 pneumonia from March 2020 to May 2020. All patients were treated with standard of care (SOC), and a nonrandomly selected subset of patients also received an IL-6 inhibitor. The primary outcome was clinical response, defined as an improvement of at least 2 categories relative to baseline on a 7-category ordinal scale up to hospital discharge or 30 days. In adjusted analyses, logistic and linear regression models were conducted, controlling for covariates of hospital length of stay (LOS), intensive care unit (ICU) care, ICU LOS, gender, age, race, and Charlson Comorbidity Index.

Results: A total of 133 patients met inclusion criteria. In all, 30 patients received an IL-6 inhibitor plus SOC. There was no statistical difference in clinical outcome between groups as 76.7% in the SOC alone group and 70.0% in the IL-6 inhibitor group met the defined endpoints for clinical response (P = 0.477). In the adjusted analysis, patients treated with IL-6 inhibitors were approximately 4 times more likely to meet the primary endpoint compared with patients with SOC alone (adj. odds ratio = 4.325; P = 0.038, 95% confidence interval = [1.09-17.18]).

Conclusions: Compared with SOC alone, IL-6 inhibitors were not associated with a significant clinical response. However, after adjusting for covariates, this study suggests that the initiation of IL-6 inhibitors in patients with early COVID-19 pneumonitis before progression to the ICU may be associated with improved clinical status.

https://doi.org/10.1177/87551225221104323

[Article Title: Medication Use Among Patients Reporting Xerostomia of an Academic Dental Clinic/ Michael P. Krajewski, QingXiang Mo, Chi-Hua Lu, Albert Cantos, Steve Feuerstein, Michael J. Brandt and Robert G. Wahler, Jr., p. 264–271]

Abstract:

Background:
Global prevalence of xerostomia has been reported at 22% (range 0.01%-45%), negatively impacting oral health, nutrition intake, and quality of life. The causal relationship between xerostomia and medications remains uncertain but greater understanding could guide interventions.

Objective:
To describe the demographic characteristics and medication regimens in patients with xerostomia of an academic dental clinic.

Method:
This is a retrospective academic dental clinic record review from July 1, 2018 to October 27, 2020. Patient records were obtained from the University at Buffalo, School of Dental Medicine. Xerostomia status was determined via query of electronic health records and validated by manual review. Pharmacologic class and xerostomic potential of medications were identified by the Veterans Affairs Drug Classification System and drug compendia, respectively. Predictors of medication use were assessed using a multiple logistic regression model.

Results:
Of 37 403 examined records, 366 (0.98%) were identified as xerostomic. After excluding confounding factors (Sjogren’s and radiation), 275 of 317 patients received at least one xerostomic medication, majority were female (240, 66%) versus male (126, 34%). Mean ± (SD) age was 64.9 ± 15.11 years. A total of 208 (57%) patients were aged ≥65. The median number of total and xerostomic medications were 8 (interquartile range [IQR], 4-12) and 4 (IQR, 2-7), respectively. The 3 most prevalent xerostomic pharmacologic classes were antidepressants (131, 35%), gastric medications (101, 28%), and vitamin D (87, 24%).

Conclusion:
Despite observed prevalence of xerostomia lower than global prevalence, xerostomic medication burden for patients experiencing xerostomia was high. Pharmacist-led interprofessional collaborations should be investigated to reduce xerostomic burden.

https://doi.org/10.1177/87551225221108599

[Article Title: The Role of Clinical Pharmacist in Pediatrics’ Adherence to Antiepileptic Drugs/ Suha Jarad, Amal Akour, Wael H. Khreisat, Afrah K. Elshammari and Saba Madae’en p. 272–282]

Abstract:

Background:
Rate of nonadherence to antiepileptic drugs (AEDs) in children is about 33%. Engaging clinical pharmacists in the management of patients has proved to increase adherence to medications which will improve the outcomes of treatment.

Objectives:
To investigate the effect of a clinical pharmacist-led education on the adherence to AEDs in pediatric patients with epilepsy. Secondary outcomes include effectiveness and safety of AEDs, satisfaction with information about AEDs provided to the caregivers, and patients quality of life (QoL).

Methods:
This was an interventional study where pediatric patients were randomly assigned to the intervention (n = 41) or the control (n = 40) group. A 30-minute clinical pharmacist-led educational interview to the parent/caregiver was provided to the first group as add-on to standard medical care received by latter. Outcomes were measured at baseline and after 8-week follow-up.

Results:
The intervention group had an increase in mean adherence score from 6 ± 1.09 at baseline to 7.6 ± 0.9 at follow-up (P value < 0.001), while the control group had no significant change (P value > 0.05), the difference between the 2 groups at follow-up was significant (P value < 0.0001). No significant difference was observed between groups at follow-up with regard to effectiveness (P value > 0.05), and safety (P value = 0.08). While higher satisfaction with information (P value < 0.0001), and higher QoL (P value < 0.05) was observed in the intervention group.

Conclusion and relevance:
Clinical pharmacist-led education had a positive outcome on pediatric patients with epilepsy with regard to adherence, effectiveness, safety, satisfaction with information about AEDs, and QoL.

https://doi.org/10.1177/87551225221097619

[Article Title: Effect of Antidepressants on Glucagon-Like Peptide-1 Receptor Agonist-Related Weight Loss/ Natalie Durell, Rachel Franks, Scott Coon, Kevin Cowart and Nicholas W. Carris, p. 283–288]

Abstract:

Background:
Depression and obesity have a bidirectional relationship making the management of one, without the other, problematic. Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are a preferred medication class for diabetes and obesity treatment given their weight loss effect; however, it is not known how antidepressants impact this effect.

Objective:
To assess the impact of antidepressant use on GLP-1 RA-associated weight loss in patients with or without type 2 diabetes mellitus.

Methods:
This was a retrospective, propensity matched, cohort study conducted using TriNetX. The study identified patients initiating a GLP-1 RA being treated with citalopram/escitalopram, bupropion, or no antidepressant. Cohorts were propensity score matched to analyze the primary outcome of mean end-of-study (77-371 days) body weight.

Results:
An initial query identified 31 273 patients eligible for analysis (30 160 receiving no antidepressant, 311 receiving bupropion, and 802 receiving citalopram/escitalopram). After propensity score matching, the study found patients receiving citalopram/escitalopram were taking more antidiabetic therapies at baseline compared with patients not treated with an antidepressant. Patients in the antidepressant cohorts experienced less weight loss compared with their respective matched cohorts not receiving antidepressants (citalopram/escitalopram −0.73 kg versus −1.74 kg; bupropion −0.84 kg versus −3.46 kg). Only the bupropion cohort was significantly heavier at end-of-study versus the non-antidepressant cohort (108 kg versus 103 kg, P = 0.018).

Conclusion and Relevance:
Antidepressants may diminish the weight loss effect of GLP-1 RAs. Additional research is needed to assess whether all GLP-1 RAs are affected similarly and the optimal weight loss strategies in patients receiving antidiabetic therapy with comorbid depression.

https://doi.org/10.1177/87551225221110850

[Article Title: Efficacy and Safety of Biologics for Chronic Rhinosinusitis With Nasal Polyps/ Renee R. Koski, Luke Hill and Kylee Taavola, p.289–296]

Abstract:

Objective: To review published literature for biologic treatment of nasal polyps.

Data Sources: PubMed search performed on February 16, 2022, using search terms: biologics, benralizumab, dupilumab, mepolizumab, omalizumab, or reslizumab AND nasal polyps, nasal polyposis, or chronic rhinosinusitis with nasal polyposis (CRSwNP). Inclusion criteria were English language, published randomized controlled trials, post hoc analyses, and meta-analyses evaluating biologics for nasal polyposis, with or without comorbid asthma, and no date limits. Additional studies were found through references of primary and tertiary literature.

Study Selection and Data Extraction: Nineteen studies, including 8 randomized controlled trials, 2 meta-analyses, and 9 post hoc analyses, examined the efficacy and safety of biologics for nasal polyposis. Agents studied included benralizumab, dupilumab, mepolizumab, omalizumab, and reslizumab. Studies had similar inclusion (refractory and recurrent CRSwNP) and exclusion criteria. All studies included the use of an intranasal corticosteroid (mometasone or fluticasone) in addition to the biologic or placebo. The most commonly studied primary endpoint was change in endoscopic nasal polyp score.

Data Synthesis: All studies, post hoc analyses, and meta-analyses found improvement in endoscopic, clinical, and/or radiographic endpoints with benralizumab, dupilumab, mepolizumab, omalizumab, or reslizumab in patients with CRSwNP with or without comorbid asthma. Dupilumab has the most published data. Dupilumab, mepolizumab, and omalizumab are the only biologics currently Food and Drug Administration–approved for CRSwNP.

Conclusion: Biologics are beneficial for treating nasal polyps with or without comorbid asthma. The choice depends on patient and provider preference and insurance coverage.

https://doi.org/10.1177/87551225221105749

[Article Title: Daridorexant: A New Dual Orexin Receptor Antagonist for Insomnia/ Erin St. Onge, Bradley Phillips and Casey Rowe, p. 297–303]

Abstract:

Objective: To review the safety, efficacy, and tolerability of daridorexant in treating insomnia characterized by difficulties with sleep onset and/or sleep maintenance in adult patients.

Data Sources: A literature search was performed through PubMed using the following key terms: daridorexant, ACT-541468, orexin, insomnia, and sleep.

Study Selection and Data Extraction: Selected articles included those which described clinical studies of the pharmacokinetics, efficacy, safety, or tolerability of daridorexant.

Data Synthesis: Daridorexant works through antagonism of the dual orexin receptor. It is the third agent in this class of medications approved by the U.S. Food and Drug Administration (FDA). Daridorexant, at a dose of 25 mg to 50 mg, was shown to be effective in improving sleep parameters in phase 3 clinical studies and was well tolerated. Adverse event rates from phase 2 and 3 clinical trials were low with fatigue, nasopharyngitis, gait disturbance, somnolence, diarrhea, and headache most commonly reported.

Conclusions: All currently available agents for treating insomnia have received a “weak” recommendation in the clinical practice guidelines, including the dual orexin receptor antagonist class of medications. Initial data suggest that with routine use daridorexant does not impair next day functioning, a common issue with other agents used to treat insomnia. In addition, daridorexant appears to be as safe and effective in treating insomnia in patients of all ages including those ≥65 years of age.

https://doi.org/10.1177/87551225221112546

[Article Title: Olanzapine/Samidorphan: A New Option for the Treatment of Adults With Schizophrenia or Bipolar I Disorder/ Huy Pham, Halford Warlick, Ricardo Bermudez, Quan Nguyen, and Jose A. Rey, p. 304–313]

Abstract:

Objective:
To review the pharmacology, pharmacokinetics, and efficacy and safety data of a combination of olanzapine and samidorphan (OLZ/SAM) for the treatment of schizophrenia and bipolar I disorder, which mitigates the possible unwanted side effects of weight gain associated with olanzapine (OLZ).

Data Sources:
The review was done with a bibliographic survey of studies using MEDLINE/PubMed (January 1999-May 2021) database using the keywords olanzapine and samidorphan. Abstracts, scientific posters, and information from the manufacturer’s product labeling were evaluated for inclusion. Inclusion criteria: phase 2, phase 3, and open-labeled studies that evaluated the use of OLZ/SAM for the treatment of schizophrenia and bipolar I disorder.

Data Synthesis:
We have included one phase 2 dose-ranging exploratory study, two phase 3 efficacy and safety studies, and several open-label extension studies without a comparator. For the treatment of schizophrenia, OLZ/SAM and OLZ alone were analyzed in 2 randomized, double-blind comparison studies of approximately 960 patients. Analysis indicated that OLZ (5-20 mg)/SAM (10 mg) significantly mitigated the side effect of weight gain compared with OLZ alone (control) while maintaining antipsychotic efficacy. For bipolar I disorder, OLZ/SAM was approved as an acute treatment for manic or mixed episodes, as well as an adjunct to valproate or lithium for manic/mixed episodes based on bridging strategy allowed by the Food and Drug Administration.

Relevance to Patient Care and Clinical Practice:
The combination of olanzapine and samidorphan demonstrated efficacy for the treatment of schizophrenia with a dosage range of 5 to 20 mg OLZ to a 10-mg fixed dose of samidorphan. Advantages of this drug combination include once-daily dosing, favorable tolerability, and most importantly, mitigation of weight gain, which may encourage adherence, when compared with OLZ alone.

Conclusion:
The new combination treatment of OLZ/SAM is a unique antipsychotic formulation to provide the recognized efficacious treatment of OLZ, while mitigating the weight gain and possibly the weight-related adverse effects secondary to OLZ monotherapy.

https://doi.org/10.1177/87551225221114281