Current and emerging pharmaceutical interventions for myopia

2019 ◽  
Vol 103 (11) ◽  
pp. 1539-1548 ◽  
Author(s):  
Kritchai Vutipongsatorn ◽  
Tae Yokoi ◽  
Kyoko Ohno-Matsui
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Side Effects ◽  
Low Dose ◽  
Ketorolac Tromethamine ◽  
Myopia Progression ◽  
Experimental Drug ◽  
Approved Drugs ◽  
Pharmaceutical Agents ◽  
Pharmaceutical Interventions

Myopia is a major cause of visual impairment. Its prevalence is growing steadily, especially in East Asia. Despite the immense disease and economic burden, there are currently no Food and Drug Administration-approved drugs for myopia. This review aims to summarise pharmaceutical interventions of myopia at clinical and preclinical stages in the last decade and discuss challenges for preclinical myopia drugs to progress to clinical trials. Atropine and oral 7-methylxanthine are shown to reduce myopia progression in human studies. The former has been extensively studied and is arguably the most successful medication. However, it has side effects and trials on low-dose atropine are ongoing. Other pharmaceutical agents being investigated at a clinical trial level include ketorolac tromethamine, oral riboflavin and BHVI2 (an experimental drug). Since the pathophysiology of myopia is not fully elucidated, numerous drugs have been tested at the preclinical stage and can be broadly categorised based on the proposed mechanisms of myopisation, namely antimuscarinic, dopaminergic, anti-inflammatory and more. However, several agents were injected intravitreally or subconjunctivally, hindering their progress to human trials. Furthermore, with atropine being the most successful medication available, future preclinical interventions should be studied in combination with atropine to optimise the treatment of myopia.

Reconsenting patients with cancer on clinical trials: Does added risk influence continued participation?

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e15610-e15610
Author(s):  
A. Elegbede ◽  
A. Andrei ◽  
A. Andrei ◽  
K. D. Holen
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Adverse Event ◽  
Side Effects ◽  
Adverse Events ◽  
Study Participant ◽  
P Value ◽  
Study Participation ◽  
Grade 5 ◽  
Study Results

e15610 Background: The general policy endorsed by multiple professional societies and cooperative groups regarding patients on cancer clinical trials states that subjects should be informed of new adverse events or significant developments during study participation and re-consented to continue on study. However, no information is known as to the effect of re-consenting on a patients’ decision to continue study participation. Our research question addresses how the severity of reported risk to other study participants will impact the subjects’ decision to continue participation in a clinical trial. Methods: We surveyed 34 patients with gastrointestinal (GI) tumors all of whom were currently enrolled in a clinical trial. The survey portrayed hypothetical adverse reactions affecting another study participant ranging from Grade 1 to Grade 5 according to the National Cancer Institutes Common Terminology Criteria for Adverse Effects v. 3.0. The survey asked about subjects’ opinions of the theoretical adverse event categorized as “would not be concerned,” “would be concerned, but would continue the study,” and “would discontinue the study.” Results: Patients willingness to continue the study was highest at Grade 1 with 97% of all participants. However, willingness to continue participation progressively declined as the severity of adverse events increased such that only 44% of participants would continue participation with a reported Grade 5 adverse event. Conclusions: Among surveyed GI cancer patients, willingness to continue participation in a clinical trial declined significantly as the severity of adverse events increased from Grade 1 to Grade 3 - 5 (p-value < 0.001. This could be due to multiple factors, including the terminal nature of the patients’ cancer, the side effects of study therapy and the patients’ response to study treatment. This data could produce a reasonable adverse event grade cut-off for re-consenting patients regarding new side effects. No significant financial relationships to disclose.

An Investigation into the Therapeutic Action of Hydroxyzine (Atarax) in the Treatment of Nervous Disorders and the Control of the Tobacco-Habit

1958 ◽  
Vol 104 (436) ◽  
pp. 826-833 ◽  
Author(s):  
G. C. Turle
Keyword(s):  
United States ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Side Effects ◽  
Young Children ◽  
Mental Hospital ◽  
The United States ◽  
Child Guidance Clinic ◽  
Therapeutic Action ◽  
Child Guidance

Hydroxyzine hydrochloride (Atarax, UCB 4492) is a tranquillizer which has attracted much interest in the United States, where it has undergone a series of clinical trials with encouraging results. In order to test the claims of American investigators a trial of hydroxyzine was made on a group of psychotic and psychoneurotic patients in a large mental hospital. The effectiveness of hydroxyzine in controlling the tobacco habit was also tested by using volunteer nurses at the hospital. Their observations provided useful information on the subjective action and side effects of the drug. A small number of young children attending a local child guidance clinic were also included in the clinical trial.

scholarly journals Is the Genie Out of the Bottle? Digital Platforms and the Future of Clinical Trials

2018 ◽  
Author(s):  
Niccolò Tempini ◽  
David Teira
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Safe Alternative ◽  
Digital Platforms ◽  
Industrial Grade ◽  
Experimental Drug ◽  
The Status ◽  
Als Patients ◽  
A Company ◽  
Social Media Network

Is it possible to conduct impartial clinical trials in a world full of digital networking tools that patients can use to coordinate themselves and act against research protocols? This paper builds on an ethnography of PatientsLikeMe, a company running an Internet social media network where patients with different conditions share their clinical data with standardised questionnaires. The company faced a serious dilemma in 2011 when some ALS patients, members of the site, started sharing data about a phase II clinical trial of an experimental drug (NP001) in which some of them were participating, to anticipate the experiment’s outcomes and understand each one’s allocation over trial arms. In parallel, some other patients were using the site and other web tools to coordinate and run their own replication of the trial with homebrew mixes of industrial grade chemicals. PatientsLikeMe researchers reflected on their position as networks managers and eventually decided to use the collected data to develop their own analysis of the efficacy of the original compound, and of the homebrewers’ compound. They presented the NP001 events as a case in point for articulating a new social contract for clinical research. This paper analyses these events, first, by understanding the clinical trial as an experiment organisation form that can succeed only as long as its protocol can be enforced; second, we observe how web networks make it dramatically easier for the trial protocol to be violated; finally, we point out how a potentially dangerous confluence of interests over web networks could incubate developments that disrupt the status quo without creating a robust and safe alternative for experimentation. We conclude by warning about the interests of the pharmaceutical industry in exploiting patients’ methodological requests to its own advantage.

scholarly journals A review on pharmacokinetics, pharmacodynamics and clinical aspects of remdesivir and favipiravir for the treatment of coronavirus disease

2021 ◽  
Vol 11 (1) ◽  
pp. 121-129
Author(s):  
Inder Kumar
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Influenza Virus ◽  
Clinical Aspects ◽  
Preclinical Research ◽  
Chemical Agents ◽  
The World ◽  
The Status ◽  
Adenosine Analogue ◽  
Approved Drugs

The coronavirus disease has spread all over the world. Till now no medicine, vaccine, and any other monoclonal antibodies have been approved for the diagnosis or prevention of COVID-19. In many countries, doctors are considering “repurposing” different approved drugs like interferon-ɑ, lopinavir/ ritonavir, ribavirin, and chloroquine phosphate, etc. to treat COVID-19. Remedesivir (GS-5734) is a prodrug of monophosphoramidate of adenosine analogue. Remedesivir block the viral RNA dependent RNA polymerease (RdRp). Favipiravir (T-705) is also a prodrug and was revealed during evaluating the antiviral activity of chemical agents concerning the influenza virus. This review summarizes the status, mechanisms, preclinical research, and clinical trial progress of remedesivir and favipiravir for the treatment of COVID-19. Keywords: coronavirus disease, favipiravir, remdesivir, clinical trials, pharmacodynamics

The impact of newly approved drugs on clinical and operational strategies for multiple myeloma clinical trials.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e19511-e19511
Author(s):  
Bhavani Krishnan ◽  
Bernadette Collins ◽  
Michael Jeffrey Cho ◽  
Tanya Partridge ◽  
Durga Vighnay ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Multiple Myeloma ◽  
Clinical Trials ◽  
Real World ◽  
Operational Strategies ◽  
Clinical Trial Enrollment ◽  
Near Term ◽  
Approved Drugs ◽  
The Impact ◽  
The U.S

e19511 Background: The global burden of multiple myeloma (MM) has increased steadily in last 3 decades. The IARC reports there were ~160,000 new cases worldwide in 2018. There has been an increase in the development and approval of more effective targeted therapy options (new immunomodulatory agents, proteasome inhibitors, and monoclonal antibodies); this, coupled with high adoption of these therapies presents a major challenge in enrollment of current ongoing clinical trials. We assessed the impact of near-term regulatory approvals on clinical trial enrollment. Methods: Public domain clinical trial enrollment data from MM studies (Phase I, I/II, II) closed/completed between 2011-2018 were used to determine enrollment trends pre and post 2014. We leveraged real-world medical claims data to project/model adoption of recently approved drugs in the U.S.; additionally, drug sales volume data was used to evaluate ex-US national adoption trends. The utilization rates of 5 recently approved drugs by regimen and line of treatment was determined. Results: In the U.S., there is a 13% increase in median enrollment duration with a corresponding 25% decrease in median p/s/m enrollment in MM studies, irrespective of phase, where enrollment was completed between 2015 -2018 compared to 2011-2014. We hypothesize that one of the factors for this increase in enrollment timeline is the approval and adoption of newly approved therapies post 2014. Two of the five recently approved drugs show a steady increase in the number of patients treated over 2016, 2017 and 2018, while one of the drugs plateaus over the same period. Outside of the U.S., our analysis confirms the existence of gaps in time to approval /adoption of recently approved drugs; for example, we observe a two-year delay in approval/adoption for one of the drugs in France compared to the other countries in Western Europe. Conclusions: There are over 10 investigational MM drugs currently in development which are anticipated to be granted approval between 2019-2021. Factoring the real-world adoption of near-term drug approval into global clinical and operational strategies offers insights into mitigating potential future enrollment challenges.

Benzodiazepines, Amphetamines, Testosterone and Sildenafil as New Candidates Drugs for Sexual Interest, Desire and/or Arousal Disorder

2021 ◽  
Vol 10 ◽  
Author(s):  
Richard Joseph Wix ◽  
Ezequiel Uribe
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Side Effects ◽  
Sexual Interest ◽  
New Drugs ◽  
Hypoactive Sexual Desire Disorder ◽  
Arousal Disorder ◽  
Approved Drugs ◽  
Fda Approved Drugs ◽  
Desire Disorder

Background: The FDA approved drugs for female sexual interest, desidere and/or arousal disorder (FSIAD), and hypoactive sexual desire disorder (HSDD), however this have low tolerability for patients because its multiple side effects and does not show real therapeutic efficacy. Hypoactive Sexaul Desire affects from 750.000.000 to 1.400.000.000 people worldwide. Methods: In this paper we analyze therapeutic candidate in clinical practice as well as the methodologies clinical trials of possible therapeutic targets of different systems related to the dysfunction. Results: Therefore New Drugs (Benzodiazepines, Amphetamines, Testosterone, Sildenafil or New Compound) Clinical Trials to treat this disorder are necessary.

scholarly journals Homo-harringtonine (HHT) – A highly effective drug against coronaviruses and the potential for large-scale clinical applications

2021 ◽  
Author(s):  
Hai-Jun Wen ◽  
Pei Lin ◽  
Gong-Xun Zhong ◽  
Zhi-Chao Xu ◽  
Lei Shuai ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Large Scale ◽  
Clinical Applications ◽  
Structural Proteins ◽  
Specific Mechanism ◽  
General Weakness ◽  
Medical Facilities ◽  
Approved Drugs ◽  
Protein Elongation

In the search for treatment schemes of COVID-19, we start by examining the general weakness of coronaviruses and then identify approved drugs attacking that weakness. The approach, if successful, should identify drugs with a specific mechanism that is at least as effective as the best drugs proposed and are ready for clinical trials. All coronaviruses translate their non-structural proteins (~16) in concatenation, resulting in a very large super-protein. Homo-harringtonine (HHT), which has been approved for the treatment of leukemia, blocks protein elongation very effectively. Hence, HHT can repress the replication of many coronaviruses at the nano-molar concentration. In two mouse models, HHT clears SARS-CoV-2 in 3 days, especially by nasal dripping of 40 ug per day. We also use dogs to confirm the safety of HHT delivered by nebulization. The nebulization scheme could be ready for large-scale applications at the onset of the next epidemics. For the current COVID-19, a clinical trial has been approved by the Ditan hospital of Beijing but could not be implemented for want of patients. The protocol is available to qualified medical facilities.

scholarly journals Adherence and side effects of three ferrous sulfate treatment regimens on anemic pregnant women in clinical trials

2009 ◽  
Vol 25 (6) ◽  
pp. 1225-1233 ◽  
Author(s):  
Ariani Impieri de Souza ◽  
Malaquias Batista Filho ◽  
Cristiane Campello Bresani ◽  
Luiz Oscar Cardoso Ferreira ◽  
José Natal Figueiroa
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Side Effects ◽  
Pregnant Women ◽  
Patient Information ◽  
Ferrous Sulfate ◽  
Epigastric Pain ◽  
Hemoglobin Concentration ◽  
Iron Supplement ◽  
Treatment Regimens

The objective of this study was to analyze adherence and side effects of three iron supplement regimens (ferrous sulfate) on anemic pregnant women. The clinical trial involved 150 women between the 16th and 20th gestational weeks, at low obstetric risk and with hemoglobin concentration of between 8.0 and 11.0g/dL. Treatment was provided by ferrous sulfate with 60mg of elemental iron during 16 (± 1) weeks, in three regimens: single tablet a week (n = 48); single tablet twice a week (n = 53) or single tablet a day (n = 49). The outcomes were adherence, assessed through interviews and by counting tablets, and side effects, according to patient information. The adherence showed a declining trend (92%, 83% and 71%; p = 0.010) and the side effects revealed a growing trend (40%, 45% and 71%; p = 0.002) as the dosage increased. Diarrhea and epigastric pain were significantly associated with the dose administered (p = 0.002). These results suggest that in anemic pregnant women, complaints are directly proportional and the compliance is inversely proportional to the amount of medicinal iron.

Sign in / Sign up

Export Citation Format

Share Document