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Hello and welcome to pharmacy pearls i’m greg cummings pharmacist and certified diabetes educator most smokers seeking treatment for smoking cessation make repeated quit attempts as a result an increasing proportion of continuing smokers will have tried these medications before unfortunately abstinence rates are more than threefold lower for nicotine replacement
Therapy and twofold lower for bupropion when compared to initial treatment in this edition of pharmacy pearls will consider a study which examined the effectiveness of retreatment with varenicline to see how it compares in this regard please stay tuned to the end of the video for a link to the study first of all i have previously served as a consultant for pfizer
Conducting presentations on smoking cessation and participating in advisory meetings the study under consideration was published in the peer-reviewed journal clinical pharmacology and therapeutics in september 2014 it was industry sponsored and was a double-blind placebo-controlled randomized multicenter clinical study consisting of a 12-week drug treatment
Phase followed by a 40 week post drug treatment follow-up phase study participants were randomly assigned either varenicline or placebo the dosing of varenicline was titrated according to the usual protocol and compliance with the treatment regimen was confirmed by pill counts and patient self-report at each visit individual smoking cessation counseling was also
Provided to all participants smoking abstinence was assessed by patient self-report of no smoking not even a puff and no use of nicotine containing products confirmed by an exhale carbon monoxide value of 10 parts per million or less the primary study endpoint examined continuous abstinence rates for the last four weeks of the treatment phase but other time frames
Up to 52 weeks were also considered eligible participants were at least 18 years of age or older smoked at least 10 cigarettes per day during the four weeks before screening had an exhale carbon monoxide value greater than 10 parts per million at screening had no quit attempts in the past three months had previously taken varenicline for two or more weeks with the
Last dose taken at least three months before screening and were motivated to stop smoking exclusion criteria included any previous significant adverse reaction to varenicline previous participation in a varenicline study severe copd history of cancer within the past five years except cured basal cell or squamous cell carcinoma of the skin clinically significant
Vascular disease in the past two months history of a suicide attempt or any suicidal behavior in the past two years or current suicidal ideation at screening or baseline current depression or diagnosis or treatment of depression during the previous 12 months lifetime diagnosis of psychosis panic disorder other anxiety disorders or bipolar disorder active alcohol
Or substance abuse or dependence except for nicotine during the previous 12 months or the use of other smoking cessation or tobacco products electronic cigarettes marijuana or illegal or street drugs during the study participant baseline characteristics were similar for the two treatment groups 93% were caucasian the mean age was 47.5 years participants smoked
A mean of 20 cigarettes per day for an average of thirty years and had a mean fagerstrom test score of 5.6 corresponding to moderate dependence seventy-four percent of participants reported three or more previous lifetime quit attempts and all had tried using varenicline one or more times let’s now take a moment to examine the study results for the primary end
Point once again this consisted of continuous abstinence rates for weeks nine to twelve according to study results for every 100 people re treated with placebo for 12 weeks 12 people will stop smoking and 88 people will continue smoking the fact that roughly twelve percent of participants were able to quit with placebo could reflect the impact of smoking cessation
Counseling which sought to help patients develop coping strategies for achieving and maintaining abstinence by comparison according to study results for every 100 people retreated with varenicline for 12 weeks 46 people will stop smoking and 54 people will continue smoking of the 46 people who are able to stop smoking 12 people will stop regardless of treatment and
34 people will stop because of treatment with varenicline we can also express the effect of varenicline retreatment in terms of a number needed to treat to achieve smoking abstinence specifically for every three people retreated with varenicline versus placebo for 12 weeks one additional person will achieve continuous abstinence for weeks 9 to 12 of treatment but
That’s not all based on secondary endpoint data we also know that for every six people retreated with varenicline one additional person will achieve continuous abstinence for weeks nine to 52 of treatment and follow-up importantly these abstinence rates are consistent with those achieved by people taking varenicline for the first time indicating that it maintains
Its efficacy during retreatment the study also looked at the safety and tolerability of varenicline retreatment it found that seventy five point five percent of those taking varenicline experienced an adverse event versus 63.3 percent receiving placebo seven point two percent of varenicline users discontinued treatment due to tolerability versus two-point-nine
Percent with placebo and twelve point four percent of varenicline users decreased their dose or temporarily stopped treatment versus four point five percent with placebo the two most common adverse events for varenicline versus placebo were nausea wherein the number needed to herm was six and abnormal dreams which had a number needed to harm of nine ultimately this
Was consistent with previous studies and reflects the product monograph as an aside in order to minimize these adverse events patients should be counseled to take varenicline after eating and with a full glass of water in summary varenicline is effective and well-tolerated in smokers who have previously taken it with long-term abstinence rates comparable to those
Seen in people who have not taken it before therefore if a patient is willing to try varenicline again clinicians should be too thanks for watching to read the study upon which this video is based visit pharmacy pearls calm / retreatment please also show your support for pharmacy pearls by subscribing to my youtube channel
Transcribed from video
The Effectiveness of Varenicline Retreatment for Smoking Cessation By Pharmacy Pearls
