Efficacy of the Use of Genetic Markers in the Choice of the Pharmacological Treatment of Smoking (GENTSMOKE)
Status:
Recruiting
Trial end date:
2022-03-01
Target enrollment:
Participant gender:
Summary
Smoking is the leading cause of avoidable death in the world. Smoking is associated with the
development of cardiovascular and respiratory diseases, as well as being considered a leading
cause of cancer death. Data show that smokers have increased cardiovascular risk in relation
to former smokers, even in comparison with individuals who have had a long and intense
history tobacco use.
Considering this scenario, some drugs are used in tobacco cessation therapy. The first-line
anti-smoking treatments approved by the Food and drug administration ( FDA ) are nicotinic
reuptake therapy, bupropion ( norepinephrine and dopamine reuptake inhibitor) and varenicline
( partial agonist of nicotinic receptors composed of subunits alpha4Beta2 ). A metanalysis of
16 clinical studies indicated that smokers treated with bupropion had a higher abstinence
rate compared to those receiving placebo - Odds ratio (OR ) - of 1,97 for treatment success.
Varenicline is more effective compared to others smoking cessation drugs approved by the FDA,
with an OR of 2,27 ( IC 95% 2,02-2,55 ) compared to placebo. However, Varenicline is much
more expensive than bupropion.
Significant advances in genetics have made the variability of the individual response to
drugs, as far as efficacy as well as the rate of adverse effects, begin to be specifically
investigated through pharmacogenetics studies.
Phase:
Phase 4
Details
Lead Sponsor:
University of Sao Paulo General Hospital
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo