alexa Impact Of The Nocebo Effect In Clinical Studies Of Painful Diabetic Peripheral Neuropathy: Can This Effect Masquerade A Safety Signal Of A New Investigational Compound?
ISSN: 2155-6156

Journal of Diabetes & Metabolism
Open Access

Like us on:
OMICS International organises 3000+ Global Conferenceseries Events every year across USA, Europe & Asia with support from 1000 more scientific Societies and Publishes 700+ Open Access Journals which contains over 50000 eminent personalities, reputed scientists as editorial board members.

Open Access Journals gaining more Readers and Citations

700 Journals and 15,000,000 Readers Each Journal is getting 25,000+ Readers

This Readership is 10 times more when compared to other Subscription Journals (Source: Google Analytics)

Share This Page

Additional Info

Loading
Loading Please wait..
 

5th World Congress on Diabetes & Metabolism
November 03-05, 2014 Embassy Suites Las Vegas, USA

Domenico Merante
ScientificTracks Abstracts: J Diabetes Metab
DOI: 10.4172/2155-6156.S1.026
Abstract
Randomized, double blind, placebo controlled studies are `the gold standard` of Painful Diabetic Peripheral Neuropathy (DPNP). The nocebo effect represents the manifestation of side effects in clinical setting during placebo treatment. This can be considerable with side effects of any kind and severity within those in the label of an active study comparator, which is also recommended in confirmatory study designs. Accordingly to a recent analysis in 62 studies involving 5,095 patients with DPNP this effect contributed to 5.8% of subject`s discontinuations. Any attempt to mitigate the nocebo effect may improve the overall tolerability profile of placebo and ultimately the retention rate of subjects in a clinical setting. In addition and no less importantly, the nocebo effect can potentially masquerade an early safety signal from a newly tested compound. Side effects of currently available pain medications as well as newly tested molecules can be with high rate of incidence and severe by intensity. Typically the most relevant side effects are CNS-related including somnolence, dizziness, and abuse potential, gastrointestinal, cardiovascular, edema, weight gain, ophthalmological disturbances, impotence and increased risk of suicide. The danger from these side effects is considerable. It is vital to define a clinical safety plan with an Independent Safety Monitoring Committee to assess side effects of relevance in un-blinded fashion during the course of clinical studies and to ultimately establish causality relationship based on patient history and concomitant medications. This may allow the early detection of a safety signal, which otherwise might be obscured by the nocebo effect.
Biography
Domenico Merante completed his Medical degree in 1988 at the age of 25 and in 1993 became specialist of endocrinology and diabetes, both degrees obtained at Pisa University/Italy and St. Chiara Hospital, Pisa. He is currently Senior Director of Clinical Development of Daiichi Sankyo Development Ltd. in the UK. He previously worked at GSK, Eli Lilly, Novo Nordisk and Lab. Guidotti. He has dedicated over 20 years in the pharmaceutical industry mainly working in diabetes, endocrinology, hypertension and neuropathic pain areas of research. He has published 21 papers and 18 abstracts in reputed journals as main or co-author.
image PDF   |   image HTML
 

Relevant Topics

Peer Reviewed Journals
 
Make the best use of Scientific Research and information from our 700 + peer reviewed, Open Access Journals
International Conferences 2017-18
 
Meet Inspiring Speakers and Experts at our 3000+ Global Annual Meetings

Contact Us

Agri, Food, Aqua and Veterinary Science Journals

Dr. Krish

agrifoodaquavet@omicsonline.com

1-702-714-7001 Extn: 9040

Clinical and Biochemistry Journals

Datta A

clinical_biochem@omicsonline.com

1-702-714-7001Extn: 9037

Business & Management Journals

Ronald

business@omicsonline.com

1-702-714-7001Extn: 9042

Chemical Engineering and Chemistry Journals

Gabriel Shaw

chemicaleng_chemistry@omicsonline.com

1-702-714-7001 Extn: 9040

Earth & Environmental Sciences

Katie Wilson

environmentalsci@omicsonline.com

1-702-714-7001Extn: 9042

Engineering Journals

James Franklin

engineering@omicsonline.com

1-702-714-7001Extn: 9042

General Science and Health care Journals

Andrea Jason

generalsci_healthcare@omicsonline.com

1-702-714-7001Extn: 9043

Genetics and Molecular Biology Journals

Anna Melissa

genetics_molbio@omicsonline.com

1-702-714-7001 Extn: 9006

Immunology & Microbiology Journals

David Gorantl

immuno_microbio@omicsonline.com

1-702-714-7001Extn: 9014

Informatics Journals

Stephanie Skinner

omics@omicsonline.com

1-702-714-7001Extn: 9039

Material Sciences Journals

Rachle Green

materialsci@omicsonline.com

1-702-714-7001Extn: 9039

Mathematics and Physics Journals

Jim Willison

mathematics_physics@omicsonline.com

1-702-714-7001 Extn: 9042

Medical Journals

Nimmi Anna

medical@omicsonline.com

1-702-714-7001 Extn: 9038

Neuroscience & Psychology Journals

Nathan T

neuro_psychology@omicsonline.com

1-702-714-7001Extn: 9041

Pharmaceutical Sciences Journals

John Behannon

pharma@omicsonline.com

1-702-714-7001Extn: 9007

Social & Political Science Journals

Steve Harry

social_politicalsci@omicsonline.com

1-702-714-7001 Extn: 9042

 
© 2008-2017 OMICS International - Open Access Publisher. Best viewed in Mozilla Firefox | Google Chrome | Above IE 7.0 version