Nicotine Replacement Approaches Reviewed

May 17, 2019

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Nicotine Replacement Approaches Reviewed

A Cochrane Database review published April 18, 2019 set out to compare the safety and longer term efficacy (6 months or more) of different approaches to nicotine replacement therapy (NRT), including dosage forms, doses, durations and schedules.

Selection criteria included randomized trials comparing various forms of NRT to one another measuring smoking abstinence at a minimum of 6 months in patients motivated to quit. Studies comparing NRT to placebo or other pharmacotherapies were excluded, as were studies less than 6 months in duration.

A total of 63 trials including over 41,000 subjects were selected for inclusion. Most subjects were adults, and most smoked at least 15 cigarettes per day.

The reviewers concluded the following with high certainty of evidence:

Combination therapy (patches plus short-acting dosage form) resulted in higher long-term abstinence rates than monotherapy.
- RR 1.25, 95% CI 1.15-1.36; 14 studies, 11,356 subjects
- Subjects using combination therapy were 15-36% more likely to quit smoking successfully than those using a single agent.
Higher dose (4mg) nicotine gum is more effective than lower dose (2mg) gum.
- RR 1.43, 95% CI 1.12-1.83, 5 studies, 856 subjects
- Subgroup analysis suggests that only highly dependent smokers may benefit.
Fast-acting NRT (gum or lozenge, for example) resulted in quit rates similar to those observed with patches.
- RR 0.90, 95% CI 0.77-1.05; 8 studies, 3319 subjects

The following are supported by moderate certainty of evidence:

21mg patches are more effective than 14mg patches.
- RR 1.48, 95% CI 1.06-2.08; 1 study, 537 subjects
Starting NRT use prior to quitting (preloading) may improve quit rates compared to waiting to start NRT on the quit date.
- RR 1.25, 95% CI 1.08-1.44; 9 studies, 4395 subjects

The following have low or very low certainty evidence of effect, and require further study:

Scheduled fast-acting NRT vs. ad lib dosing
Fast-acting dosage form comparisons
Duration of patch use
Duration of gum use
Duration of combination therapy use
Tapering of patch vs. abrupt discontinuation of therapy
No-cost vs. purchased NRT
Length of provision of no-cost NRT

Most comparisons found low rates of adverse effects, and no evidence of an effect on cardiac adverse events or significant adverse effects was noted. Generally, safety observations had low or very low certainty of evidence due to inconsistencies in measuring and reporting, and included:

Differences in adverse effects and serious adverse effects by dosage form
Study withdrawal rates due to treatment, with the exception of the following:
- Withdrawal rates were greater amongst nicotine nasal spray users compared to patches.
  - RR 3.47, 95% CI 1.15-10.46; 1 trial, 922 subjects

Reference: Lindson N, Chepkin SC, Ye W, Fanshawe TR, Bullen C, Hartmann-Boyce J. Different doses, durations and modes of delivery of nicotine replacement therapy for smoking cessation. Cochrane Database of Syst Rev 2019;(4 ): DOI 10.1002/14651858.CD013308.

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