scholarly journals Baloxavir Marboxil: A New Antiviral for Acute Influenza

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.

Ethics in Clinical Studies: The Dilemma of very Young and Old

2021 ◽  
Vol 3 (2) ◽  
Author(s):  
Avisek Dutta ◽  
Avisek Dutta ◽  
Avisek Dutta
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Human Physiology ◽  
Informed Consent ◽  
Adverse Effects ◽  
Age Groups ◽  
The Elderly ◽  
Infantile Spasms ◽  
Care Givers ◽  
Improve Health

The objectives of the research are to percolate knowledge which can improve health and improve understanding of human physiology. Pervasive exclusion of children and elderly in clinical trials as is happening today is not justified. Children have different physiology and pharmacology from adults; often adverse effects are also different and specific. Diseases like neonatal hyperbilirubinemia, infantile spasms are very age specific. Elderly too, have age specific issues like dementias, malignancies, weakened systems and polypharmacy that make them a special cohort. Clinical trials in these age groups are essential so as to gather comprehensive data about a medication across all age groups. Informed consent is a challenge in both these groups. It can be remedied by obtaining consent from parents, or legally acceptable representative in case of children and care givers and/or LARs in case of the elderly. Oral assent from 7 to 11 years, and written assent from 12 to 18 years and in the elderly, along with consent from the LAR, parents, care givers as the case may be, forms the bedrock of good clinical trial ethics.

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

Animals ◽  
2019 ◽  
Vol 9 (10) ◽  
pp. 832 ◽  
Author(s):  
Kelly A. Deabold ◽  
Wayne S. Schwark ◽  
Lisa Wolf ◽  
Joseph J. Wakshlag
Keyword(s):  
Single Dose ◽  
Adverse Effects ◽  
Safety Data ◽  
Area Under The Curve ◽  
Pet Owners ◽  
Dose Oral ◽  
Oral Pharmacokinetics ◽  
Healthy Dogs ◽  
Clinically Significant

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.

Baloxavir: A Novel Single-Dose Oral Antiviral for the Treatment of Influenza

2019 ◽  
Vol 34 (4) ◽  
pp. 243-252
Author(s):  
Nicole A. Dziewiatkowski ◽  
Elizabeth N. Osmon ◽  
Elias B. Chahine ◽  
Krisy-Ann Thornby
Keyword(s):  
Single Dose ◽  
Symptom Onset ◽  
Adverse Reactions ◽  
Dosage Adjustment ◽  
Data Extraction ◽  
Relevant Information ◽  
Data Synthesis ◽  
Study Selection ◽  
Dependent Endonuclease ◽  
Dose Oral

OBJECTIVE: To review the pharmacology, pharmacokinetics, pharmacodynamics, clinical efficacy, tolerability, dosing, and administration of baloxavir marboxil (BXM), as well as its place in the treatment of influenza.<br/> DATA SOURCES: A search of PubMed and Google Scholar using the terms "baloxavir" and "S-033188" was performed. The manufacturer's website was also reviewed to further identify relevant information.<br/> STUDY SELECTION/DATA EXTRACTION: All Englishlanguage articles from January 2008 to December 2018 appearing in these searches were reviewed for relevance to this paper. In addition, their bibliographies were reviewed to identify any articles not identified in the searches.<br/> DATA SYNTHESIS: BXM is a selective cap-dependent endonuclease inhibitor approved by the Food and Drug Administration for the treatment of acute uncomplicated influenza in adults and adolescents 12 years of age and older who weigh at least 40 kg. Clinical trials demonstrated that BXM was associated with a significantly shorter time to alleviation of influenza symptoms compared with placebo when taken within 48 hours of symptom onset. The time to alleviation of symptoms was similar with BXM and oseltamivir. The most common adverse reactions associated with BXM were diarrhea, bronchitis, nausea, nasopharyngitis, and headache. BXM is administered orally as a single-dose of 40 mg or 80 mg, depending on body weight. No dosage adjustment is needed in patients with mild-to-moderate hepatic or renal impairment.<br/> CONCLUSION: BXM has been proven safe and effective in the treatment of acute uncomplicated influenza in patients 12 years of age and older when administered within 48 hours of symptom onset.

scholarly journals Emergence of Ketamine as a Rapid Acting Antidepressant: Mechanistic Insights and Future Directions

2021 ◽  
Author(s):  
Atamjit Singh ◽  
Preet Mohinder Singh Bedi
Keyword(s):  
Clinical Trials ◽  
Adverse Effects ◽  
Receptor Antagonist ◽  
Mechanism Of Action ◽  
Antidepressant Activity ◽  
Future Directions ◽  
Aspartate Receptor ◽  
Resistant Depression ◽  
Significant Attention ◽  
Shed Light

Ketamine is a phencyclidine derivative and N-methyl-D-aspartate receptor antagonist, widely popular as a dissociative anesthetic. Its use as an anesthetic in humans was progressively fallen out due to its associated adverse effects and the emergence of newer and safer anesthetics. In recent few decades, various reports related to its efficacy in the treatment of resistant depression with anti-suicidal potential draw significant attention from researchers around the globe. The rapid clinical effect of ketamine within hours as compared to traditional antidepressants that take several weeks makes it a hot topic in antidepressant research. Studies conducted in the recent past suggest its mechanism of action through glutamate modulation via receptors like NMDA, AMPA as well as downregulation of BDNF etc. This chapter will shed light on the various mechanisms of ketamine related to antidepressant activity. Along with that its pharmacokinetics, toxicology and ongoing clinical trials will also be discussed.

Atovaquone: A Review with Emphasis on its Role in the Treatment of Pneumocystis Carinii Pneumonia

1994 ◽  
Vol 10 (4) ◽  
pp. 151-155
Author(s):  
Daniel S. Maddix
Keyword(s):  
Clinical Trials ◽  
Adverse Effects ◽  
Mechanism Of Action ◽  
Pneumocystis Carinii Pneumonia ◽  
Pneumocystis Carinii ◽  
Plasmodium Species ◽  
Double Blind ◽  
Medline Search

Objective: To discuss the mechanism of action, in vitro and in vivo activity, pharmacokinetics, clinical trials, adverse effects, drug interactions, and dosage guidelines of atovaquone. Data Sources: Pertinent literature published since 1988 was identified via a MEDLINE search. Published proceedings of selected conferences were also used. Study Selection: All basic science, microbiologic, and pharmacokinetic articles were evaluated. Since only limited data regarding atovaquone are available in the literature, all clinical trials involving the use of atovaquone in the treatment of Pneumocystis carinii pneumonia were reviewed. Data Synthesis: Atovaquone is an antiprotozoal agent that was recently approved for the treatment of mild to moderate P. carinii pneumonia (PCP) in patients who are intolerant of trimethoprim/sulfamethoxazole (TMP/SMX). The exact mechanism of action of atovaquone against P. carinii has not been determined. The drug has in vitro and in vivo activity against P. carinii, Toxoplasma gondii, and Plasmodium species. The bioavailability of oral atovaquone is highly variable. The drug must be administered with food to enhance absorption. In a double-blind comparative trial in AIDS patients with mild to moderate PCP, those who were treated with atovaquone had a significantly higher mortality rate than those treated with TMP/SMX. More patients who received TMP/SMX experienced adverse effects that resulted in discontinuation of therapy. Conclusions: Because of concerns of increased mortality in atovaquone recipients, the drug should be reserved for the treatment of mild to moderate PCP in patients who are unable to tolerate TMP/SMX and trimethoprim-dapsone.

scholarly journals Drugs used in viral diseases – their mechanism of action, selected adverse effects and safety during pregnancy and lactation

2019 ◽  
Vol 73 ◽  
pp. 491-507
Author(s):  
Kamil Dyrka ◽  
Miłosz Miedziaszczyk ◽  
Edyta Szałek ◽  
Katarzyna Łącka
Keyword(s):  
Clinical Trials ◽  
Adverse Effects ◽  
Mechanism Of Action ◽  
Antiviral Drugs ◽  
Patient Treatment ◽  
Viral Diseases ◽  
Efficacy And Safety ◽  
Treatment Results ◽  
Pregnancy And Lactation

Viruses cause many diseases in humans, from self-resolving diseases to acute fatal diseases. New antiviral drugs are registered and the efficacy and safety of other medicines are evaluated in clinical trials. Antiviral therapy significantly reduces the morbidity and mortality of patients, but may cause numerous adverse effects. The aim of this study is to discuss the mechanism, selected adverse effects of available antivirals and their safety during pregnancy and lactation. The authors refer to the classification of drugs used during pregnancy and recommendations for breastfeeding, which, for example, definitely prohibit the use of ribavirin. The authors also pay attention to the monitoring of selected diagnostic parameters to improve the treatment results. Clinicians should limit adverse effects through an individual, specific to the patient treatment regimen. Physicians should pay special attention to the use of antiviral drugs in pregnant and breast-feeding women. Clinical trials should be continued to increase knowledge about the adverse effects of antiviral medicines.

Ongoing randomized clinical trials for the treatment of thrombosis in the antiphospholipid syndrome

2001 ◽  
Vol 21 (02) ◽  
pp. 77-81 ◽  
Author(s):  
G. Finazzi
Keyword(s):  
Clinical Trials ◽  
Large Scale ◽  
Low Dose ◽  
Randomized Clinical Trials ◽  
Oral Anticoagulants ◽  
Collaborative Study ◽  
Clinical Problem ◽  
Vascular Events ◽  
Dose Oral ◽  
Adverse Pregnancy

SummaryThrombotic events are a major clinical problem for patients with antiphospholipid antibodies (APA). However, current recommendations for their prevention and treatment are still based on retrospective studies. Data from large scale, prospective clinical trials are required to ultimately identify the optimal management of these patients. To date, at least four randomized studies are underway. The WAPS and PAPRE clinical trials are aimed to establish the correct duration and intensity of oral anticoagulation in APA patients with major arterial or venous thrombosis. The WARSS-APASS is a collaborative study to evaluate the efficacy and safety of aspirin or low-dose oral anticoagulants in preventing the recurrence of ischemic stroke. The recently announced UK Trial compares low-dose aspirin with or without low-intensity anticoagulation for the primary prevention of vascular events in APA-positive patients with SLE or adverse pregnancy history, but still thrombosis-free. It is hoped that the results of these trials will be available soon since clinicians urgently need more powerful data to treat their patients with the APA syndrome.

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