Original Title: État des connaissances: stratégies de cessation tabagique

Authors' objectives: The efficacy and safety profile of nicotine replacement therapies (NRTs) at the usual doses is well known. On the other hand, the efficacy and safety of higher doses used in patches, the long-acting form of NRT, although utilized in certain settings for smokers who previously experienced smoking-cessation failures or who have greater nicotine dependence problems , are poorly documented. It was against this background that the Ministère de la Santé et des Services sociaux (MSSS) asked the Institut national d’excellence en santé et en services sociaux (INESSS) to prepare a state-of-knowledge report on the efficacy of NRTs, in particular, high nicotine doses administered via smoking cessation patches. This request ties in with the MSSS's desire and goals to improve access to pharmacological smoking cessation aids as part of the revision of the Plan québécois de lutte contre le tabagisme (Tobacco Control Plan).

Authors' results and conclusions: RESULTS: The scientific data search yielded 1629 items, including a good-quality SR of 63 trials involving 41,509 participants, of which 9 comparing the efficacy of patch doses with each other [Lindson et al., 2019] were selected. Three publications containing recommendations [Shields et al., 2016; HAS, 2014; NICE, 2013] concerning high patch doses were found as well and were used when preparing this state-of-knowledge report. The analysis by the authors of the SR shows that 42/44-mg patches have an estimated effect comparable to that of 21/22-mg patches (RR = 1.09; 95% CI: 0.93 to 1.29; 5 studies, N = 1655, I2 = 38%), this with a level of scientific evidence considered high by the authors, who, additionally, are confident that these conclusions are applicable to individuals who smoke up to 38 cigarettes a day. As well, according to their analysis, 21/25-mg patches are more efficacious than 14/15-mg patches (RR = 1.24; 95% CI: 1.07 to 1.44; 4 studies, N = 3983, I2 = 0%). The update by the authors of the SR on the efficacy of nicotine patches in combination with a fast-acting NRT strengthened the conclusions that this strategy is beneficial (RR = 1.25; 95% CI: 1.15 to 1.36; 14 studies, N =11,356, I2 = 4%). The duration of patch use in the selected studies varied from 6 to 24 weeks and included, in most cases, a period of gradual withdrawal from NRT. According to the analyses, the different NRTs seem to have a similar safety profile, although this conclusion is based on a low level of scientific evidence. As regards the recommendations concerning high doses, they appear in local initiatives and in certain combinations but are seldom encountered in CPGs or guidance documents. In Quebec and certain other jurisdictions, coverage of this type of treatment is authorized for duration of 12 consecutive weeks per 12-month period. In concrete terms, coverage is thus authorized for a total of 84 patches and 840 fast-acting NRT units. This coverage varies positively or negatively between different jurisdictions, from an increase in the quantity covered under the exception drug program to a restriction by way of a fixed lifetime amount. CONCLUSIONS: This state-of-knowledge report shows that 42-mg and 21-mg patches have similar efficacy with regard to the long-term abstinence rate. However, the population that smokes more than 38 cigarettes a day was underrepresented in the studies, and it is difficult to extrapolate the efficacy results to this subpopulation. Furthermore, although the safety profile is similar, according to the available data, the level of scientific evidence is low, and the studies were not designed with sufficient statistical power to properly compare this clinical parameter. The significantly higher dropout rate among the participants in the groups using high nicotine patch doses may have been due to adverse events that were underreported in these studies. Other studies are needed to better document this hypothesis. Currently, the coverage of NRTs does not preclude the use of higher patch doses, even though the total quantity of patches remains the same, and the use of combination therapy, which is the more efficacious one, is authorized for a duration of 12 consecutive weeks per 12-month period. To increase access to this service, the option of covering more than one trial per 12-month period might be examined, mainly to help and encourage individuals who relapse to try quitting again.

Authors' methods: A systematic review (SR) of SRs and clinical practice guidelines (CPGs) was carried out in accordance with INESSS's standards. The search was conducted in three databases for items published in French or English between January 2013 and December 2018 for CPGs and between January 2016 and December 2018 for SRs. To find items containing clinical recommendations, a grey literature search was performed by consulting, among other things, the websites of agencies, bodies, associations, institutions and learned societies recognized in this area. The bibliographies of the selected publications were examined for other relevant items. As well, items drafted by associations, professional bodies and Quebec and Canadian regulatory bodies were consulted and the Google search engine queried in order to specifically contextualize the use of high nicotine patch doses and the measures supporting coverage of smoking cessation aids.

Project Status: Completed

URL for project: https://www.inesss.qc.ca/publications/repertoire-des-publications/publication/strategies-de-cessation-tabagique.html

Year Published: 2019

URL for published report: https://www.inesss.qc.ca/publications/repertoire-des-publications/publication/strategies-de-cessation-tabagique.html

Requestor: Minister of Health

English language abstract: An English language summary is available

Publication Type: Other

Country: Canada

Province: Quebec

Organisation Name: Institut national d'excellence en sante et en services sociaux

Contact Address: L'Institut national d'excellence en sante et en services sociaux (INESSS) , 2021, avenue Union, bureau 10.083, Montreal, Quebec, Canada, H3A 2S9;Tel: 1+514-873-2563, Fax: 1+514-873-1369

Contact Name: demande@inesss.qc.ca

Contact Email: demande@inesss.qc.ca

Copyright: Gouvernement du Québec