Single-Dose Pharmacokinetics and Preliminary Safety Assessment with Use of CBD-Rich Hemp Nutraceutical in Healthy Dogs and Cats

The use of CBD-rich hemp products is becoming popular among pet owners with no long-term safety data related to consumption in adult dogs and cats. The purpose of this study was to determine the single-dose oral pharmacokinetics of CBD, and to provide a preliminary assessment of safety and adverse effects during 12-week administration using a hemp-based product in healthy dogs and cats. Eight of each species were provided a 2 mg/kg total CBD concentration orally twice daily for 12 weeks with screening of single-dose pharmacokinetics in six of each species. Pharmacokinetics revealed a mean maximum concentration (Cmax) of 301 ng/mL and 43 ng/mL, area under the curve (AUC) of 1297 ng-h/mL and 164 ng-h/mL, and time to maximal concentration (Tmax) of 1.4 h and 2 h, for dogs and cats, respectively. Serum chemistry and CBC results showed no clinically significant alterations, however one cat showed a persistent rise in alanine aminotransferase (ALT) above the reference range for the duration of the trial. In healthy dogs and cats, an oral CBD-rich hemp supplement administered every 12 h was not detrimental based on CBC or biochemistry values. Cats do appear to absorb or eliminate CBD differently than dogs, showing lower serum concentrations and adverse effects of excessive licking and head-shaking during oil administration.

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Long-term efficacy of single-dose oral treatment in schistosomiasis haematobium

Transactions of the Royal Society of Tropical Medicine and Hygiene ◽

10.1016/0035-9203(84)90172-x ◽

1984 ◽

Vol 78 (1) ◽

pp. 55-59 ◽

Cited By ~ 10

Author(s):

R.N.N. Pugh ◽

C.H. Teesdale

Keyword(s):

Single Dose ◽

Oral Treatment ◽

Term Efficacy ◽

Dose Oral

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Eltrombopag for use in children with immune thrombocytopenia

Blood Advances ◽

10.1182/bloodadvances.2017010660 ◽

2018 ◽

Vol 2 (4) ◽

pp. 454-461 ◽

Cited By ~ 28

Author(s):

Taylor Olmsted Kim ◽

Jenny Despotovic ◽

Michele P. Lambert

Keyword(s):

Adverse Effects ◽

Immune Thrombocytopenia ◽

Safety Data ◽

The Body ◽

Double Blind ◽

Platelet Counts ◽

Blood Disorder ◽

Thrombopoietin Receptor ◽

Clinically Significant ◽

Chronic Immune Thrombocytopenia

Abstract Eltrombopag is currently the only US Food and Drug Administration–approved thrombopoietin receptor agonist for the treatment of chronic immune thrombocytopenia (ITP) in children. This oral, once-per-day therapy has shown favorable efficacy and adverse effect profiles in children. Two multicenter, double-blind, placebo controlled clinical trials (PETIT [Efficacy and Safety Study of Eltrombopag in Pediatric Patients With Thrombocytopenia From Chronic Idiopathic Thrombocytopenic Purpura (ITP)] and PETIT2 [Study of a New Medication for Childhood Chronic Immune Thrombocytopenia (ITP), a Blood Disorder of Low Platelet Counts That Can Lead to Bruising Easily, Bleeding Gums, and/or Bleeding Inside the Body]) demonstrated efficacy in raising platelet counts, reducing bleeding, and reducing the need for concomitant ITP therapies with relatively few adverse effects. The most commonly reported drug-related adverse effects include headache, nausea, and hepatobiliary laboratory abnormalities. Long-term safety data in children are limited, and studies in adults have not revealed a clinically significant increased incidence of thrombosis, marrow fibrosis, or cataract formation. Eltrombopag has also been approved for treating refractory severe aplastic anemia (AA) and has potential for expanded use in ITP and severe AA as well as in other conditions associated with thrombocytopenia.

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Safety assessment of spine MRI in deep brain stimulation patients

Journal of Neurosurgery Spine ◽

10.3171/2019.12.spine191241 ◽

2020 ◽

Vol 32 (6) ◽

pp. 973-983

Author(s):

Alexandre Boutet ◽

Gavin J. B. Elias ◽

Robert Gramer ◽

Clemens Neudorfer ◽

Jürgen Germann ◽

...

Keyword(s):

Deep Brain Stimulation ◽

Adverse Effects ◽

Brain Stimulation ◽

Brain Mri ◽

Safety Data ◽

Clinical Effects ◽

Clinical Trial Registration ◽

Spine Mri ◽

Deep Brain

OBJECTIVEMany centers are hesitant to perform clinically indicated MRI in patients who have undergone deep brain stimulation (DBS). Highly restrictive guidelines prohibit the use of most routine clinical MRI protocols in these patients. The authors’ goals were to assess the safety of spine MRI in patients with implanted DBS devices, first through phantom model testing and subsequently through validation in a DBS patient cohort.METHODSA phantom was used to assess DBS device heating during 1.5-T spine MRI. To establish a safe spine protocol, routinely used clinical sequences deemed unsafe (a rise in temperature > 2°C) were modified to decrease the rise in temperature. This safe phantom-based protocol was then used to prospectively run 67 spine MRI sequences in 9 DBS participants requiring clinical imaging. The primary outcome was acute adverse effects; secondary outcomes included long-term adverse clinical effects, acute findings on brain MRI, and device impedance stability.RESULTSThe increases in temperature were highest when scanning the cervical spine and lowest when scanning the lumbar spine. A temperature rise < 2°C was achieved when 3D sequences were modified to 2D and when the number of slices was decreased by the minimum amount compared to routine spine MRI protocols (but there were still more slices than allowed by vendor guidelines). Following spine MRI, no acute or long-term adverse effects or acute findings on brain MR images were detected. Device impedances remained stable.CONCLUSIONSPatients with DBS devices may safely undergo spine MRI with a fewer number of slices compared to those used in routine clinical protocols. Safety data acquisition may allow protocols outside vendor guidelines with a maximized number of slices, reducing the need for radiologist supervision.Clinical trial registration no.: NCT03753945 (ClinicalTrials.gov).

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Baloxavir Marboxil: A New Antiviral for Acute Influenza

Journal of Contemporary Pharmacy Practice ◽

10.37901/jcphp19-00004 ◽

2020 ◽

Vol 66 (4) ◽

pp. 33-38

Author(s):

Stephen Selvanayagam ◽

Amy Kang ◽

David Ha

Keyword(s):

Clinical Trials ◽

Single Dose ◽

Adverse Effects ◽

Mechanism Of Action ◽

Age Groups ◽

Viral Titer ◽

Dependent Endonuclease ◽

Dose Oral ◽

Endonuclease Enzyme ◽

Viable Treatment

Baloxavir is a newly approved, single-dose, oral influenza antiviral indicated for acute uncomplicated influenza in patients 12 years and older if symptomatic for less than 48 hours. The purpose of this article is to review currently available literature on the mechanism of action, pharmacokinetics, safety, and clinical and virologic efficacy of baloxavir. Its novel mechanism of action prevents influenza replication by targeting the viral cap-dependent endonuclease enzyme. In clinical trials baloxavir was shown to be superior to placebo and comparable to oseltamivir with regard to time to alleviation of symptoms and viral titer reduction and was well tolerated with minimal adverse effects. Baloxavir is a viable treatment option for acute uncomplicated influenza in certain age groups.

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Is breastfeeding safe with azathioprine?

Obstetric Medicine ◽

10.1258/om.2011.110013 ◽

2011 ◽

Vol 4 (3) ◽

pp. 104-107 ◽

Cited By ~ 2

Author(s):

Mandeep Singh ◽

Jan Qualie ◽

Andrew Currie ◽

Edmund S Howarth ◽

Manjiri M Khare

Keyword(s):

Safety Data ◽

Organ Transplant ◽

Clinical Signs ◽

Case Series ◽

Short Term ◽

Tertiary Teaching ◽

Pregnancy And Postpartum ◽

Haematological Profile ◽

Clinically Significant

Background Azathioprine is commonly used as an immunosuppressant during pregnancy in the management of various conditions such as connective tissue disorders, inflammatory bowel disease and pregnant women with organ transplant. Continuation of azathioprine through pregnancy and postpartum is vital for maternal reasons. However, there is limited evidence regarding safety of use of azathioprine with breastfeeding. Methods and results We report an observational case series of 10 mother–baby pairs managed at a tertiary teaching hospital. Mothers on azathioprine who were keen to breastfeed were counselled antenatally regarding limited short-term and long-term safety data for the babies. Mothers participating in this study completed a questionnaire at every visit. At follow-up visits, babies were examined by a neonatologist for clinical signs of infection and checked for adverse effects on haematological profile. Conclusion There was no clinically significant adverse effect on haematological profile or immunosuppression in these babies. Our case series supports safety of azathioprine in the short term. However, large numbers are needed to determine long-term safety of azathioprine and breastfeeding.

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Long-term follow-up of psilocybin-assisted psychotherapy for psychiatric and existential distress in patients with life-threatening cancer

Journal of Psychopharmacology ◽

10.1177/0269881119897615 ◽

2020 ◽

Vol 34 (2) ◽

pp. 155-166 ◽

Cited By ~ 10

Author(s):

Gabrielle I Agin-Liebes ◽

Tara Malone ◽

Matthew M Yalch ◽

Sarah E Mennenga ◽

K Linnae Ponté ◽

...

Keyword(s):

Single Dose ◽

Controlled Trial ◽

Well Being ◽

Psychiatric Distress ◽

Existential Distress ◽

Spiritual Well Being ◽

Life Threatening ◽

Clinically Significant

Background: A recently published randomized controlled trial compared single-dose psilocybin with single-dose niacin in conjunction with psychotherapy in participants with cancer-related psychiatric distress. Results suggested that psilocybin-assisted psychotherapy facilitated improvements in psychiatric and existential distress, quality of life, and spiritual well-being up to seven weeks prior to the crossover. At the 6.5-month follow-up, after the crossover, 60–80% of participants continued to meet criteria for clinically significant antidepressant or anxiolytic responses. Methods: The present study is a long-term within-subjects follow-up analysis of self-reported symptomatology involving a subset of participants that completed the parent trial. All 16 participants who were still alive were contacted, and 15 participants agreed to participate at an average of 3.2 and 4.5 years following psilocybin administration. Results: Reductions in anxiety, depression, hopelessness, demoralization, and death anxiety were sustained at the first and second follow-ups. Within-group effect sizes were large. At the second (4.5 year) follow-up approximately 60–80% of participants met criteria for clinically significant antidepressant or anxiolytic responses. Participants overwhelmingly (71–100%) attributed positive life changes to the psilocybin-assisted therapy experience and rated it among the most personally meaningful and spiritually significant experiences of their lives. Conclusion: These findings suggest that psilocybin-assisted psychotherapy holds promise in promoting long-term relief from cancer-related psychiatric distress. Limited conclusions, however, can be drawn regarding the efficacy of this therapy due to the crossover design of the parent study. Nonetheless, the present study adds to the emerging literature base suggesting that psilocybin-facilitated therapy may enhance the psychological, emotional, and spiritual well-being of patients with life-threatening cancer.

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