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Gradual smoking cessation may be possible with nicotine addiction pill

Reuters – A nicotine addiction pill can help smokers quit gradually when they can’t go cold turkey, a study finds, suggesting that it may be time to revisit practice guidelines that focus primarily on immediate cessation.

Smokers who took the pill, sold as Chantix in the U.S. and Champix elsewhere, were much more likely to quit after cutting back on cigarettes than smokers who didn’t use the drug, the study found.

“This allows us to reach a much broader population of smokers who aren’t willing to quit abruptly or set a quit date, and it shows that people can quit without going cold turkey,” said lead study author Dr. Jon Ebbert, a professor in primary care and internal medicine at the Mayo Clinic in Rochester, Minnesota. “This is very strong support for changing clinical practice to include gradual reduction aided by medication.”

Smoking is the leading cause of preventable death in the U.S., according to the Centers for Disease Control and Prevention. And tobacco kills one in 10 people worldwide, according to the World Health Organization.

Quitting can reduce the risk of heart attacks, strokes, and cancers of the mouth, throat, esophagus and bladder. Ten years after quitting, the risk of lung cancer drops by half, according to the CDC.

To see if Chantix, which is manufactured by Pfizer, could help smokers quit without going cold turkey, Ebbert and colleagues randomly assigned 1,510 people at 61 centers in 10 countries to receive either the drug or a placebo for 24 weeks.

They asked study participants to reduce cigarette use by 50 percent by the fourth week, and by 75 percent by the eight week, with the goal of quitting by week 12.

By the last ten weeks of treatment, weeks 15 to 24, the group taking the pill had significantly higher abstinence rates than the group on placebo.

This held true even after treatment stopped. For weeks 21 through 52 of the study, 27 percent of the people who had previously taken the drug successfully avoided smoking, compared with less than 10 percent of those who received the placebo.

“This is the first study of its kind to enroll a group of smokers who are not traditionally enrolled in clinical trials because they are not ready to quit,” said Dr. Caryn Lerman, professor of psychiatry and deputy director of the Abramson Cancer Center at the University of Pennsylvania in Philadelphia.

“It offers compelling evidence that gradual reduction should be considered to facilitate quitting,” she said.

But even though the approach helped some hard-to-reach smokers, the majority of them still failed to quit, noted Lerman, who wasn’t involved in the study. Other treatments, such as nicotine patches and gum, can also help some smokers cut back gradually, she said.

While the study shows that Chantix, which is known generically as varenicline, can be effective for some smokers, the group taking the pill also experienced more side effects such as nausea, abnormal dreams, insomnia, constipation, vomiting, and weight gain.

Previous research has linked Chantix to side effects including suicidal thoughts, erratic behavior and drowsiness. The U.S. Food and Drug Administration placed a black box warning – its most severe and restrictive warning – on the product in 2009, highlighting the drug’s adverse neuropsychological effects.

People with a history of major depressive or anxiety disorder, suicidal behavior, panic disorder, post-traumatic stress disorder, schizophrenia, or psychosis were excluded from the study, published in the American Medical Association’s journal JAMA.

SOURCE: JAMA, online February 17, 2015.


4 Star


Gradual smoking cessation may be possible with nicotine addiction pill

Our Review Summary

The story is an overview of a recent study that found the use of the smoking cessation drug Chantix (varenicline) increased the likelihood that smokers would be able to quit smoking, even if the drug treatment regimen was begun before the smoker had set a “quit date” for when they would stop smoking. The story is exceptionally strong at addressing both the quality of the evidence and the potential side effects of the drug. We wish it had addressed costs, delivered a truly independent perspective, and discussed similar medications that have been shown to offer some benefit.


Why This Matters

As we noted in our review of the New York Times story, smoking is a major health problem in the United States. The CDC reports that approximately one in five deaths in the United States is tied to smoking-related health effects. Smoking is linked to a significant increase in health risks related to heart disease, cancer, and stroke. These health problems come with a high economic cost. The CDC estimates that smoking is responsible for “at least $133 billion for direct medical care of adults and more than $156 billion in lost productivity” in the U.S. Anything that can help smokers kick the habit has the potential to significantly benefit both public health and the economy.


Does the story adequately discuss the costs of the intervention?

Not Satisfactory

The story does not tell us how much the smoking cessation drug costs or whether insurance companies will pay for it.

Does the story adequately quantify the benefits of the treatment/test/product/procedure?


There are two ways to think about benefits in a story like this one: the benefit of quitting smoking and the benefit of using the smoking cessation drug. The story thoroughly addresses both. First, the story tells readers exactly how much more likely people were to quit smoking when using the drug (compared to those using a placebo) — and that they were able to stay smoke-free for up to a year. Second, the story offers some specifics on how quitting smoking reduces health risks. For example, the story states: “Ten years after quitting [smoking], the risk of lung cancer drops by half, according to the CDC.”

Another area where the story excelled is in characterizing the motivation level of the study participants. It noted that they wanted to quit and were willing to start reducing their cigarette consumption — they just couldn’t “go cold turkey.” The competing Times piece wasn’t as clear on that point.

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


The story spends several paragraphs discussing potential side effects associated with Chantix — including the fact that the FDA has placed its black box warning on the drug in light of its possible neuropsychological effects. The story does not mention concerns related to possible cardiovascular health effects that were raised by the FDA in 2012.

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


The story does an exceptionally good job of clearly describing the study and its findings — including breaking down how study participants responded to treatment (or to the placebo) at various points in time over the length of the study.

Does the story commit disease-mongering?


No disease mongering here.

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

Not Satisfactory

The story notes that Chantix is made by Pfizer — but does not tell readers that Pfizer funded the study. Also, the story quotes two experts. One is an author of the study. The other is Dr. Caryn Lerman of Penn’s Abramson Cancer Center. According to declarations in her published work, Lerman has served as a consultant/advisor to Pfizer regarding medications for nicotine dependence. The story would have benefited from including an expert without (real or perceived) ties to Pfizer.

Does the story compare the new approach with existing alternatives?

Not Satisfactory

The story does discuss (albeit briefly) alternatives such as nicotine gum and patches. However, the story does not discuss the fact that bupropion is a competing drug that has been used as an aid to gradual smoking reduction and cessation. This is an important omission. Additionally, the story would have added valuable context if it had discussed the actual success rates of people who try to quit smoking “cold turkey” or by using other treatment methods.

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


The story makes clear that Chantix is already available in the U.S. and elsewhere.

Does the story establish the true novelty of the approach?


The story notes (quoting Dr. Lerman): “This is the first study of its kind to enroll a group of smokers who are not traditionally enrolled in clinical trials because they are not ready to quit.” While it’s true that this seems to be the first such study involving Chantix, nicotine replacement products and bupropion have both been studied in this context. Since we’ve already penalized the story for this omission above under “Alternatives,” we won’t do so again here.

Does the story appear to rely solely or largely on a news release?


The release include quotes and additional background material that go well beyond JAMA’s news release on the study.

Total Score: 7 of 10 Satisfactory


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