XML Feed for RxPG News   Add RxPG News Headlines to My Yahoo!   Javascript Syndication for RxPG News

Research Health World General
 
  Home
 
 Latest Research
 Cancer
 Psychiatry
  Depression
  Neuropsychiatry
  Personality Disorders
  Bulimia
  Anxiety
  Substance Abuse
   Alcohol
   Smoking
   Amphetamine
   Opiates
   Cannabis
   Cocaine
  Suicide
  CFS
  Psychoses
  Child Psychiatry
  Learning-Disabilities
  Psychology
  Forensic Psychiatry
  Mood Disorders
  Sleep Disorders
  Peri-Natal Psychiatry
  Psychotherapy
  Anorexia Nervosa
 Genetics
 Surgery
 Aging
 Ophthalmology
 Gynaecology
 Neurosciences
 Pharmacology
 Cardiology
 Obstetrics
 Infectious Diseases
 Respiratory Medicine
 Pathology
 Endocrinology
 Immunology
 Nephrology
 Gastroenterology
 Biotechnology
 Radiology
 Dermatology
 Microbiology
 Haematology
 Dental
 ENT
 Environment
 Embryology
 Orthopedics
 Metabolism
 Anaethesia
 Paediatrics
 Public Health
 Urology
 Musculoskeletal
 Clinical Trials
 Physiology
 Biochemistry
 Cytology
 Traumatology
 Rheumatology
 
 Medical News
 Health
 Opinion
 Healthcare
 Professionals
 Launch
 Awards & Prizes
 
 Careers
 Medical
 Nursing
 Dental
 
 Special Topics
 Euthanasia
 Ethics
 Evolution
 Odd Medical News
 Feature
 
 World News
 Tsunami
 Epidemics
 Climate
 Business
Search

Last Updated: Aug 19th, 2006 - 22:18:38

Phase 3 Study

Smoking Channel
subscribe to Smoking newsletter

Latest Research : Psychiatry : Substance Abuse : Smoking

   DISCUSS   |   EMAIL   |   PRINT
Varenicline Prevents Relapse of Smoking Behaviour
Jul 5, 2006, 19:12, Reviewed by: Dr. Anita Dhanrajani

“Clearly, quitting smoking, even with pharmacological and behavioral assistance, is extremely difficult. Patients currently cannot and probably never will simply be able to ‘take a pill’ that will make them stop smoking. Smokers must want to stop smoking and must be willing to work hard to achieve the goal of smoking abstinence”

 
In a study, Serena Tonstad, M.D., Ph.D., of Ulleval University Hospital, Oslo, Norway and colleagues with the Varenicline Phase 3 Study Group conducted a randomized, double-blind, placebo-controlled trial evaluating the efficacy of an additional 12 weeks of varenicline used for relapse prevention in smokers who successfully achieved abstinence following an initial 12-week varenicline treatment.

According to background information in the article, 50 percent to 60 percent of people who are initially successful at quitting smoking go on to relapse within a year. A recent comprehensive review of existing studies concluded that currently there is no evidence-based relapse prevention intervention available.

The study was conducted at multiple medical clinics in 7 countries with follow-up to 52 weeks after study baseline. Of 1,927 cigarette smokers recruited between April 2003 and February 2004 and treated for 12 weeks with open-label varenicline twice per day, 1,236 (64.1 percent) did not smoke, use tobacco, or use nicotine replacement therapy during the last week of treatment and 62.8 percent (n = 1,210) were randomized to additional treatment or placebo. Participants were assigned to receive either varenicline, 1.0 mg twice per day (n = 603), or placebo (n = 607) for an additional 12 weeks.

The continuous abstinence rate for weeks 13 to 24 was higher for participants randomized to varenicline than for participants randomized to placebo (70.5 percent vs. 49.6 percent). The continuous abstinence rate for weeks 13 to 52 was also higher for the varenicline group than for the placebo group (43.6 percent vs. 36.9 percent). Adverse events reported in the open-label period were mostly mild; no difference in adverse events between varenicline and placebo was observed during the double-blind period.

“In the field of relapse prevention—in which there is a notable lack of positive findings—these results represent an important new development,” the authors write.

The researchers add that at the end of this trial, as in all existing literature on smoking cessation with 1 year of follow-up, more than 50 percent of participants in each group returned to smoking. “Thus, an examination of longer medication periods is warranted.”

“In conclusion, extended use of varenicline helps recent ex-smokers to maintain their abstinence and prevent relapse. Varenicline is the first smoking cessation treatment to demonstrate a significant long-term relapse prevention effect,” the authors write.

In an accompanying editorial, Robert C. Klesges, Ph.D., Karen C. Johnson, M.D., M.P.H., and Grant Somes, Ph.D., of the University of Tennessee Health Science Center, Memphis, Tenn., comment on the studies on varenicline and smoking cessation.

“It is important for clinicians to moderate some of the potential enthusiasm that is likely to occur as the result of the publication of these trials, FDA approval of the drug, and promotion by this manufacturer. On the one hand, these studies demonstrate that varenicline is associated with higher smoking cessation rates than placebo and may produce better cessation rates than bupropion, a first-line–approved smoking cessation drug. Importantly, varenicline represents a third class of drug with probably a different mechanism of action than either nicotine replacement therapy or bupropion. On the other hand, varenicline definitely is not a panacea for smoking cessation. Many participants in these trials experienced adverse events, stopped taking their study medication before they should have, and discontinued participation in the studies. Importantly, the majority of participants in these 3 studies did not quit smoking even with varenicline.”

“Clearly, quitting smoking, even with pharmacological and behavioral assistance, is extremely difficult. Patients currently cannot and probably never will simply be able to ‘take a pill’ that will make them stop smoking. Smokers must want to stop smoking and must be willing to work hard to achieve the goal of smoking abstinence,” the authors write. “Although much research needs to be conducted to establish the effectiveness of varenicline, stop smoking researchers and clinicians, as well as smokers wanting to quit smoking, now have another product available that appears to help increase the probability of smoking cessation.”
 

- July 5 issue of JAMA
 

JAMA . 2006;296:64-71

 
Subscribe to Smoking Newsletter
E-mail Address:

 

This study was sponsored by Pfizer Inc., which provided funding, study drug and placebo, and monitoring.

Related Smoking News

C. elegans provides model for the genetics of nicotine dependence
Smoking Ban Associated With Rapid Improvement In Health Of Bar Workers in Scotland
Smoking media literacy (SML) is a valuable tool in efforts to discourage teens from smoking
Hold the Hookah
Weight concerns affects women's motivations to stay smoke-free after delivery
Nicotine Withdrawal Begins Within 30 Minutes
Varenicline Appears Effective In Helping Smokers Kick The Habit
Smokers with chronic pain smoke more
Varenicline Prevents Relapse of Smoking Behaviour
Varenicline produce higher continuous smoking abstinence rates


For any corrections of factual information, to contact the editors or to send any medical news or health news press releases, use feedback form

Top of Page

 

© Copyright 2004 onwards by RxPG Medical Solutions Private Limited
Contact Us