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1.
Medical Letter on Drugs and Therapeutics ; 64(1654):105-112b, 2022.
Article in English | EMBASE | ID: covidwho-2057513

ABSTRACT

The FDA has approved tirzepatide (Mounjaro - Lilly), a peptide hormone with activity at both glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptors, to improve glycemic control in adults with type 2 diabetes. Tirzepatide, which is injected subcutaneously once weekly, is the fi rst dual GIP/GLP-1 receptor agonist to become available in the US. Selective GIP receptor agonists are not available in the US;GLP-1 receptor agonists have been available for years. Copyright © 2022, Medical Letter Inc.. All rights reserved.

2.
European Journal of Clinical Pharmacology ; 78:S130, 2022.
Article in English | EMBASE | ID: covidwho-1955961

ABSTRACT

Introduction: Zolpidem and zopiclone are widely used for sleep disorders, yet their abuse and dependence potential has been underestimated. The electronic prescription of zolpidem/zopiclone became mandatory on 17.07.2019 in Greece. Objectives: To investigate descriptive characteristics of zolpidem/ zopiclone prescriptions and the impact of the mandatory electronic prescription mandate. Methods: Anonymized prescriptions of zopiclone (ATC: N05CF01) and/or zolpidem (ATC: NC05CF02) that were executed in pharmacies between 01.10.2018 and 01.10.2021 were obtained from the Greek nationwide prescription database. The database covers almost the entire Greek population and it is administrated by IDIKA of the Greek Ministry of Health. We investigated descriptive characteristics of prescriptions, and calculated themonthly number of prescriptions taking into consideration dates with potential impact, i.e., the date of the mandatory electronic prescription mandate (on 17.07.2019) and the date of the first case of COVID-19 in Greece (on 26.02.2020). Results and Conclusion: During the investigated period of three years, there were 1229842 executed prescriptions of zolpidem (89.4%), zopiclone (10.4%) or both (0.3%), considering 156554 unique patients. The patients weremainly elderly (73.1%were ≥ 65 years old) andwomen (64.5%). The majority of the prescription physicians (69.9%) were general practitioners or internists, followed by 17% psychiatrists or neurologists, 5.3% cardiologists, 4.5% physicians in specialty training, 1% nephrologists and 2.4% of physicians with another specialty. After the mandatory electronic prescription mandate and before COVID- 19 in Greece, i.e., between 08.2019 to 03.2020, there was a notable increase of prescriptions in comparison to the previous period from 10.2018 to 07.2019 (median 37267 vs median 34106;Mann-Whitney U=9, p-value=0.009). After COVID-19, the median monthly number of prescriptions was 36363, yet there were variations ranging from 16963 to 39956. In conclusion, the mandatory electronic prescription system could increase the surveillance of drugs with abuse potential such as zolpidem and zopiclone. Nevertheless, the large number of prescriptions in elderly patients and prescribed by primary care physicians is worrisome and warrants further investigation.

3.
Sleep ; 45(SUPPL 1):A370, 2022.
Article in English | EMBASE | ID: covidwho-1927447

ABSTRACT

Introduction: The COVID-19 vaccines have documented transient side effects, including injection site soreness, redness, headache, fatigue, and fever. In addition, there have been few reported long-term side effects, including Guillain-Barre, pericarditis, and cerebral venous sinus thrombosis. We present a rare case of severe insomnia as a long-term side effect following COVID-19 vaccination. Report of Cases: A 59-year-old female with a past medical history of well-controlled hypothyroidism and migraine presented to the sleep center with four months of insomnia. She had a history of COVID infection in November 2020 with only mild symptoms of sore throat and fatigue. The patient finished her two-shot series of the Moderna COVID-19 vaccine in April 2021. Immediately following the vaccination, the patient had severe trouble falling and staying asleep. Her insomnia was resistant to multiple medications including zolpidem Immediate-release(IR), Controlledrelease( CR) formulas, zaleplon, eszopiclone, trazodone, melatonin, clonazepam, suvorexant, and lemborexant. However, magnetic resonance imaging (MRI) brain imaging only showed nonspecific white matter disease. She had no mood disorders or psychosocial stressors, and the patient had excellent sleep hygiene measures. However, insomnia caused severe impairment of her daily life activities to a point where she was almost seeking inpatient admission for her insomnia. During the COVID-19 pandemic, the effects on sleep have been significant, particularly insomnia. Prescriptions for sleep medications have increased. Many have attributed the rise of insomnia to pandemic-related stress, disturbance of circadian rhythm from home confinement, and worsening mental health. Conclusion: To our knowledge, there have not been documented side effects of insomnia on the COVID-19 vaccines, with some studies suggesting sleep deprivation reducing their effectiveness. As vaccination efforts continue worldwide, awareness of side effects from vaccines is paramount for clinicians facing the challenges in patient care.This case demonstrates that chronic insomnia can be a side effect of the COVID-19 vaccines. Therefore, further surveillance of patients and side effects from COVID-19 vaccination is warranted as insomnia can have significant clinical and psychosocial consequences.

4.
Drug Topics ; 165(4):24-26, 2021.
Article in English | EMBASE | ID: covidwho-1865973
5.
Blood ; 138:4023, 2021.
Article in English | EMBASE | ID: covidwho-1582390

ABSTRACT

BACKGROUND: Autologous stem cell transplantation (ASCT) for multiple myeloma (MM) entails sudden life changes including acute symptom burden, changes in physical function, and shifting caregiver dynamics. Several studies have shown that anxiety, insomnia, and distress rise in the initial weeks following ASCT before slowly recovering. Long-term consequences of these acute exacerbations include persistent quality of life (QOL) impairments (El-Jawahri 2016), post-traumatic stress disorder (Griffith 2020), and the usage of potentially inappropriate medications (PIMs) for symptom management (Banerjee 2021). We have recently completed a pilot study of digital life coaching (DLC), whereby life coaches work with patients via phone calls and text messages to provide longitudinal support, education, and accountability to meet wellbeing-related goals. Our pilot study of 15 patients demonstrated the feasibility of DLC during this period, with bidirectional patient-coach engagement occurring every 5-7 days even during index hospitalizations for ASCT (Banerjee 2021). Based on these positive results, we have now launched a randomized Phase 2 study of DLC versus usual care among patients with MM undergoing ASCT. STUDY DESIGN: Our study is registered at clinicaltrials.gov as NCT04589286. We plan to enroll 60 adult patients with MM undergoing first ASCT at our institution. Inclusion criteria include English language proficiency and ownership of a personal cellphone. However, neither smartphones nor specific mobile apps are required for study participation. All patients, including those in the control arm, receive brief wellness-related tips with each request for PRO data as outlined below. As shown in the Figure, patients in the DLC arm are paired with a trained life coach beginning at Day -10 before ASCT. Coaches use structured frameworks to assist patients longitudinally with identifying and accomplishing wellbeing-related goals. Specific coaching topics can vary from week to week and are set by each patient. In addition to weekly coach-led phone calls, patients are encouraged to maintain bidirectional communication via phone/text/email as often as desired. Patients in the control arm do not receive access to DLC. Our primary endpoint is the total usage of sedative-class PIMs - including lorazepam, temazepam, zolpidem, and other similar medications - prescribed for anxiety or insomnia during each of 4 four-week study subperiods identified in the Figure. Secondary endpoints include patient-reported outcome (PRO) assessments of QOL (PROMIS Global Health), distress (NCCN Distress Thermometer), and insomnia (PROMIS Sleep Disturbances 4A). PRO assessments are collected exclusively using automated REDCap emails every 1-2 weeks as shown in the Figure. PROGRESS TO DATE: As of the data cutoff (7/31/21), 19 patients have enrolled onto our study and 5 have completed all follow-up. The median age of enrolled patients is 62 (range: 31-77), with 26% of patients aged 70 or older. As shown in our pilot study (Banerjee 2021), PRO collection via automated REDCap emails is feasible. Specifically, of 93 email-based requests for PRO assessments as of the data cutoff, 92 (99%) have been completed. Analyses of PRO assessment responses and PIM usage will be conducted after study completion. DISCUSSION: Improving patient wellbeing during the acute peri-ASCT period is an unmet need in multiple myeloma. Published supportive strategies during this time include music therapy (Bates 2017), acupuncture (Deng 2018), palliative care (El-Jawahri 2017), and programmed hospital room lighting (Valdimarsdottir 2018). DLC may offer unique advantages given its easy accessibility and unified patient-facing interface across hospital/clinic/home transitions. These strengths may be particularly relevant in light of the COVID-19 pandemic, where home-based follow-up after ASCT has become more common. That being said, broadening the accessibility of DLC to include patients with limited English proficiency or patients without personal cell phones are important priorities for fu ure studies. In summary, our randomized Phase 2 study of DLC versus usual care is ongoing. If shown to reduce PIM prescription rates while improving wellbeing-related PRO trajectories longitudinally, DLC may become a standard of care for patients with hematologic malignancies undergoing ASCT. [Formula presented] Disclosures: Banerjee: Pack Health: Research Funding;SparkCures: Consultancy;Sanofi: Consultancy. Knoche: Amgen: Honoraria. Brassil: Abbvie: Research Funding;Astellas: Research Funding;BMS: Research Funding;Daiichi Sankyo: Research Funding;Genentech: Research Funding;GSK: Research Funding;Sanofi: Research Funding;Pack Health: Current Employment. Jackson: Pack Health: Current Employment. Patel: Pack Health: Current Employment. Lo: Oncopeptides: Consultancy;EUSA Pharma: Consultancy. Chung: Caelum: Research Funding. Wong: Amgen: Consultancy;Genentech: Research Funding;Fortis: Research Funding;Janssen: Research Funding;GloxoSmithKlein: Research Funding;Dren Biosciences: Consultancy;Caelum: Research Funding;BMS: Research Funding;Sanofi: Membership on an entity's Board of Directors or advisory committees. Wolf: Adaptive Biotechnologies: Consultancy;Teneobio: Consultancy;Sanofi: Consultancy;Amgen: Consultancy. Martin: Oncopeptides: Consultancy;Sanofi: Research Funding;Amgen: Research Funding;Janssen: Research Funding;GlaxoSmithKline: Consultancy. Shah: Bluebird Bio: Research Funding;GSK: Consultancy;Janssen: Research Funding;Indapta Therapeutics: Consultancy;BMS/Celgene: Research Funding;CareDx: Consultancy;CSL Behring: Consultancy;Kite: Consultancy;Nektar: Research Funding;Karyopharm: Consultancy;Amgen: Consultancy;Oncopeptides: Consultancy;Poseida: Research Funding;Precision Biosciences: Research Funding;Sanofi: Consultancy;Sutro Biopharma: Research Funding;Teneobio: Research Funding.

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