The cost-effectiveness of this product, which is much cheaper than the leading stop smoking products in many countries, means that this could offer a new practical way for people to stop smoking.
The trial, which involved 740 patients, showed that people trying to stop smoking were 3.4 times more likely succeed than those who took a placebo tablet instead.
Tabex® has been available for more than 15 years in some parts of Central and Eastern Europe. However, there had been a lack of robust clinical evidence to prove whether the drug was effective, until now. Of the participants who were given Tabex®, 8.4 per cent were able to abstain from smoking for a year, compared with 2.4 per cent from the group who were given a placebo. The low overall quit rates for both groups reflect the difficulty that even highly motivated people have in stopping long term.
The study was led by researchers based at the Cancer Research UK Health Behaviour Research Centre at UCL (University College London) and the Cancer Centre and Institute of Oncology in Warsaw, Poland.
In countries such as Russia, a four week course of treatment costs the equivalent of £1.50 a week. This makes the tablet particularly suited to low and middle income countries where the cost of effective drugs to help them give up could deter many would-be ex smokers. Recent studies have suggested that 70 per cent of smokers would like to stop.
Professor Robert West from the UCL Department of Epidemiology and Public Health who led the study team said:
“With more than a billion smokers worldwide and lung cancer still as one of the top killers, we’re extremely encouraged that the benefits of Tabex are comparable with those of other smoking cessation treatments, but at a fraction of the cost. We recognise that stopping smoking can be extremely difficult and we hope that by using cytisine as a substitute for nicotine, the results of this trial could help transform the health of nations around the globe by offering a practical option even for the poorest smokers.”
Jean King, Cancer Research UK’s director of tobacco control, said:
“It is great news that smokers around the world may have access to a new way to help them beat their addiction. When so many smokers are trying so hard to give up it is ridiculous that tobacco companies are still able to market their deadly products in ways that draw young people into smoking. We hope that cytisine will help low and middle-income countries meet their obligations to help treat nicotine dependence under the World Health Organization’s treaty on tobacco.”
Science Minister David Willetts said:
“Smoking is a major global public health issue, and it’s great that UK researchers have provided new scientific evidence on such a cost-effective treatment. This study will provide governments, health organisations and charities with reliable research that could increase access to a potentially life-changing drug for millions of people.”
Tabex is a tablet containing cytisine, a nicotine substitute naturally found in laburnum seeds. It will now go onto the next round of approvals for use in the UK and elsewhere. The results of the clinical trial are published online today in the New England Journal of Medicine.
Notes to editors:
For a copy of the paper or to arrange an interview please contact the MRC Press Office on 0207 395 2345 or email [email protected]
The National Prevention Research Initiative (NPRI) is a partnership of public and charity sector organisations in the UK. The Funding Partners relevant to this award are: Medical Research Council; British Heart Foundation; Cancer Research UK; Chief Scientist Office of the Scottish Government Health Directorate; Department of Health; Diabetes UK; Economic and Social Research Council; Health & Social Care Research Division, Public Health Agency for Northern Ireland; The Stroke Association; and the Welsh Assembly Government.
The article Placebo-Controlled Trial of Cytisine for Smoking Cessation will appear in the New England Journal of Medicine on 29 September.
Please note that the active ingredient tested in this trial is cytisine, not cytosine.
Tabex, developed and marketed by Sopharma of Bulgaria, is licenced globally to Extab Corporation. Tabex is produced and marketed in Central and Eastern Europe by Sopharma of Bulgaria. Sopharma is the leading pharmaceutical company in Bulgaria with extensive exports to all leading markets globally. Extab Corporation has licenced global rights (excluding Central and Eastern Europe) to Tabex from Sopharma. Extab is undertaking clinical trials of Tabex to obtain marketing approval in the UK, US, EU, Japan and developing markets.