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Drug effective in smoking cessation studies

Rating

3 Star

Drug effective in smoking cessation studies

Our Review Summary

This news story was based on a report of two double-blind randomized studies comparing the newer drug, varenicline, with bupropion and placebo as aids to smoking cessation. This newer drug may help quell nicotine cravings by binding to receptors in the brain that control the release of dopamine, which is often stimulated by nicotine. More sustained levels of dopamine may help with cravings and withdrawal from nicotine. The studies discussed were both funded by Pfizer and reports of side effects were limited, as only nausea was listed and qualified as “mild” by the primary researcher. Despite the headline (“Drug effective in smoking cessation studies”), which we know is usually not written by the reporter, the journalists are appropriately cautious about the findings and provide information about the funding source and potential conflicts of interest. Abstinence rates at one year for each smoking cessation drug and placebo are presented; however, the news story lacks a comparison with abstinence rates for alternative (non-drug) methods of smoking cessation and does not provide enough information about the long-term risks of the newer drug or side effects. Longer-term data, larger controlled studies and more information on the safety of varenicline (vs. the more studied bupropion) are necessary before this drug is presented as a viable option for smoking cessation. Given that the drug has not yet been approved for smoking cessation in the U.S., the story’s generally positive tone fails to remind readers of hurdles still to be passed on the road to approval. For example, the drug’s performance is not much better than published rates for bupropion (Zyban) in other randomized clinical trials designed to test the latter versus placebo.

Criteria

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

No mention of the cost of varenicline.

Does the story adequately explain/quantify the harms of the intervention?

Not Satisfactory

Only mention of harm was nausea. The issue is that 1) rate of nausea

was not mentioned, rather rate of quitting due to nausea was; 2) this might be significantly more common in the active drug

group than the placebo group, but we can’t know.

Does the story seem to grasp the quality of the evidence?

Not Satisfactory

Brief mention of clinical evidence, but this is incomplete. The numbers were from 2 fairly well-designed

randomized, double-blind trials (N=2000 total). Abstinence was evaluated between varenicline, bupropion and placebo groups

at 12 weeks, then continuous abstinence for another 40 weeks. During weeks 9-52 carbon monoxide (CM) levels were taken to

confirm quit rates. The numbers presented are the continuous abstinence rates from weeks 9-52, based on these CM

measurements.

Does the story use independent sources and identify conflicts of interest?

Not Satisfactory

The only person interviewed was the lead

investigator of the Pfizer-sponsored trial. She downplayed side effects.

Does the story compare the new approach with existing alternatives?

Not Satisfactory

Mentions other drug treatment, which was

used as a comparison in this double-blind study; however, no quantitative comparison of non-drug methods of smoking cessation

(e.g. behavioral interventions, support groups, nicotine replacement) with regards to abstinence rates. No discussion of

side effects of bupropion. No comparison of tolerability of side effects between valenicline and bupropion. Importantly, the

study may not have provided, or the story omitted, the important counseling component that is recommended as a complement to

drug therapy.

Does the story establish the availability of the treatment/test/product/procedure?

Satisfactory

Mentions that the drug is not yet approved.

Does the story establish the true novelty of the approach?

Satisfactory

Nicotine receptor agonist:

new drug with old mechanism (nicotine replacement).

Total Score: 4 of 9 Satisfactory

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