Timothy O'Shea, PharmD
Timothy O'Shea, PharmD
Timothy O'Shea, PharmD, is a Clinical Pharmacist working at a large health insurance plan on the east coast. Additionally he works per diem at a retail pharmacy chain. He graduated from MCPHS University - Boston in 2015 and subsequently completed a PGY-1 Managed Care Pharmacy Residency. His professional interests include pharmacy legislation and managed care pharmacy. He can be followed on Twitter at @toshea125.

5 Smoking Cessation Studies Every Pharmacist Should Know

JUNE 13, 2017
According to the CDC, tobacco use is the single largest preventable cause of death and disease in the United States. Despite continuing declines in cigarette smoking, it kills an estimated 480,000 Americans every year. Additionally, smoking-related illness in the United States costs in excess of $300 billion a year, including nearly $170 billion in direct medical care and $156 billion in lost productivity.

Over the years, a number of landmark clinical studies on smoking cessation pharmacotherapy have been published, shaping how we treat people today. Here are 5 of those that every pharmacist should know:
 
1. Effectiveness of Nicotine Replacement Therapy (2012)1
Nicotine replacement therapy (NRT) is used to reduce an individual’s motivation to smoke and manage cravings to ultimately help quit. NRT has been used for more than 30 years and is currently available in 5 different formations including a patch, gum, lozenge, inhaler, and nasal spray.
 
In a 2012 article published in BMJ, researchers conducted a meta-analysis to further define the effectiveness of NRT. They sought to assess if differences exist in effect among different forms of NRT in achieving abstinence and whether a combination of NRT is more likely to lead to successful quitting than one type alone. In their analysis, researchers identified 117 clinical studies with more than 50,000 combined participants.
 
Study researchers noted that all forms of NRT can help people increase their chances of successfully stopping smoking although there are no clear differences in effectiveness between them. Evidence showed that combining a nicotine patch with a more rapid delivery form of NRT was more effective than a single type of NRT. Additionally, combination of NRT and bupropion was more effective than bupropion alone. There was no evidence from the analysis that NRT increases the risk of heart attacks.
 
Conclusion
There are no differences in effectiveness between different forms of NRT; however, using a combination approach may be beneficial to improve quit rates.
 
2. EAGLES Study (2016)2
Both Chantix (varenicline) and Zyban (bupropion) have been shown in clinical studies to significantly improve long-term smoking abstinence rates; however, safety concerns have been raised regarding their risk of neuropsychiatric events. Although studies have not supported any increased risk, the FDA mandated the manufacturers add boxed warnings in the prescribing information of each product. Due to the sensitivity of this adverse effect, and to give clinicians greater clarity regarding any potential risk, researchers conducted the largest study of its kind on this topic.
 
In a 2016 article, researchers described the methodology and results of a randomized, double-blind, placebo and active-controlled trial of varenicline and bupropion. 8144 participants from 16 countries were randomly assigned in a 1:1:1:1 ratio to receive varenicline, bupropion, nicotine patch, or placebo in 2 cohorts (psychiatric disorder vs no psychiatric disorder at baseline).The primary endpoint was the incidence of a composite measure of moderate and severe neuropsychiatric adverse events including anxiety, depression, hostility, mania, psychosis, and suicidal ideations.
 
At the conclusion of the study, the data showed that there was no significant increase in the rate of neuropsychiatric adverse events with either varenicline or bupropion relative to nicotine patch or placebo in either cohort. The overall incidence in each group was 4% varenicline, 4.5% bupropion, nicotine patch 3.9%, and placebo 3.7%. The study detected about a 4% significant difference in the rate of neuropsychiatric adverse events between the psychiatric and non-psychiatric cohorts, although there were no significant differences between individual groups. The results from this study led the FDA to remove the boxed warning from each product’s labeling.
 
Conclusion
Bupropion and varenicline do not increase the risk of neuropsychiatric effects relative to nicotine patch or placebo.
 
3. Impact of Counseling on Smoking Cessation Rates (2017)3
Patient counseling is an integral component to any smoking cessation program. Pharmacists, in particular, can play an important role in the retail and hospital setting, by assessing a smoker’s readiness to quit, suggesting possible medication options, and counseling on expectations of therapy. A number of studies have found that a combination of behavioral counseling and pharmacotherapy produces the best results for smoking cessation.
 
To further explore this topic, researchers conducted a meta-analysis to assess the effectiveness of more intensive counseling delivered on a one-to-one basis by a counselor. A total of 49 randomized controlled trials, including over 19,000 participants, were included for analysis in this study. All trials involved one or more face-to-face counseling sessions lasting at least 10 minutes. The outcome was smoking cessation at follow-up at least six months after the start of counseling.
 
Study results identified that individual counseling significantly increased the chance of quitting. Compared to minimal behavioral support (brief advice, self-help materials) individual counseling was 57% more effective when pharmacotherapy was not offered to anyone. When all participants received pharmacotherapy, the benefit decreased to 24%.
 
Conclusion               
Individually-delivered smoking cessation counseling can greatly assists smokers to quit.
 
4. Gender Differences in Medication Effectiveness (2017)4,5
By the early 2000s, evidence started to emerge that linked biological factors with the effectiveness of smoking cessation therapy. A meta-analysis of 14 studies was conducted to assess gender differences in long-term smoking cessation rates with the nicotine patch and found the effect was half as great in women.

In 2016, researchers published one of the most robust analyses of gender differences with smoking cessation pharmacotherapy. The study was designed to estimate differences in the efficacy of the nicotine patch, varenicline, and sustained-release bupropion through a network meta-analysis study design. The analysis included 28 clinical studies resenting more than 14,000 smokers.
 
The study found that relative to placebo, all medications improved quit rates for both women and men. Similar outcomes were seen in both men and women treated with varenicline. More importantly, however, in women varenicline was 41% more efficacious than nicotine patch and 28% more effective than bupropion (both measures met statistical significance). No differences were found when comparing bupropion versus nicotine patch.
 
Conclusion
Varenicline appears to be more effective than nicotine patch and bupropion in women. Therefore, clinicians should strongly consider varenicline as the first option treatment for women.
 
5. Gradual vs Abrupt Smoking Cessation (2016)6
For years, smokers have been advised to quit abruptly by setting a day to stop smoking. This belief has been supported by smoking cessation guidelines and a number of clinical studies. Despite this, many smokers report stopping gradually.  Additionally, one systematic review of 10 randomized trials found a non-significant difference in quit rates from an abrupt versus gradual approach.
 
To further answer this question, researchers conducted a non-inferiority trial to examine differences between quitting abruptly versus gradually. A total of 697 adult smokers were randomly assigned to gradually reduce tobacco use over 2 weeks before a planned quit day or to stop smoking abruptly on a planned quit date. Both groups received behavioral support from nurses and used nicotine replacement before and after quit day. At baseline, 16.9% of participants had no preference with regard to intervention assignment; 32.1% would have chosen abrupt cessation, and 50.9% would have chosen gradual cessation.
 
The primary outcome measure was prolonged validated abstinence from smoking 4 weeks after quit day. The secondary outcome was prolonged, validated, 6-month abstinence. The study showed that at 4 weeks, there was a statistically significant 20% improvement in abstinence with the abrupt-cessation group (49% vs 39.2%; 95% CI 0.66 to 0.93). The abstinence rate at 6 months was also found to be statistically significant at a 29% improvement with the abrupt group. The difference was seen regardless of abrupt vs gradual preference at baseline.
 
Conclusion
Abrupt cessation of smoking is more likely to lead to short-term and sustained abstinence as compared to gradual cessation.
 
References
  1. Stead LF, Perera R, Bullen C, et al. Nicotine replacement therapy for smoking cessation. Cochrane Database of Syst Rev. 2012, Issue 11. Art. No.: CD000146. doi: 10.1002/14651858.CD000146.pub4. 
  2. Anthenelli R,, Benowitz N, West R, et al. Neuropsychiatric safety and efficacy of varenicline, bupropion, and nicotine patch in smokers with and without psychiatric disorders (EAGLES): a double-blind, randomised, placebo-controlled clinical trial. Lancet. 2016 Jun 18;387(10037):2507-20. doi: 10.1016/S0140-6736(16)30272-0.
  3. Lancaster T, Stead LF. Individual behavioural counselling for smoking cessation. Cochrane Database Syst Rev. 2017;3:CD001292.
  4. Perkins KA, Scott J. Sex differences in long-term smoking cessation rates due to nicotine patch. Nicotine Tob Res. 2008 Jul;10(7):1245-50. doi: 10.1080/14622200802097506.
  5. Smith PH, Weinberger AH, Zhang J. Sex Differences in Smoking Cessation Pharmacotherapy Comparative Efficacy: A Network Meta-analysis. Nicotine Tob Res. 2017 Mar 1;19(3):273-281. doi: 10.1093/ntr/ntw144.
  6. Lindson-Hawley N, Banting M, West R, Michie S, Shinkins B, Aveyard P. Gradual Versus Abrupt Smoking Cessation: A Randomized, Controlled Noninferiority Trial. Ann Intern Med. 2016;164(9):585-592.


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