Heartfelt with Dr Melissa Walton-Shirley
View all posts »I'd take my chances with Chantix (varenicline)
Jul 28, 2011 10:47 EDT-
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The Pfizer rep stopped by the office this week. "What are your thoughts about the latest varenicline information?" she asked. "Well, I think the numbers of events were so small, it was not statistically significant," I said. She then went on to tell me she had heard that a couple of cardiologists were a little afraid to prescribe the drug. Later, I reviewed the information again, just to see if I'd missed something. This latest information upon which the FDA based its safety and warning update "was not powered to detect a statistical difference in the clinical end points," according to Mike O'Riordan's piece (FDA updates label for Chantix) in heartwire, but the cardiovascular events were numerically higher among the 353 patients. Since the lay public (and I'm sure the tobacco-industry folks who are equally as concerned about the safety of their product . . . er, kidding) as well as prescribers read this blog, let me explain the implication of this information in this way:
In the premarketing analyses of around 4500 patients exposed to Chantix, 450 patients utilized it for 24 weeks, 100 patients were on it for one year, and the vast majority were on it for 12 weeks or less. According to these studies, on the surface we'd all better rush to start swallowing some daily Chantix, even us NONsmokers! At the 0.5-mg dose bid here were the results:
|
Outcome |
Placebo (patients, n) |
Chantix (patients, n) |
|
Fatigue |
6 |
4 |
|
Rash |
2 |
1 |
|
Vomiting |
2 |
1 |
Now, surely we aren't going to think that varenicline is good for treating fatigue, rashes, or vomiting. The little-utilized and oft-frowned-upon commonsense approach to statistical analysis tells us these findings are highly likely due to chance. After reviewing all of the information of all of the thousands of patients who have been studied, there has never been a statistically significant increase in MI rates with varenicline. Even if in our wildest dreams by some statistical manipulation that we could somehow squeeze out the tobacco companies' holy grail of a marginally significant-adverse CV event rate with Chantix, the reduction in lung cancer and deaths from COPD alone would be worth the risk. Ask yourselves as prescribers, "Do I prescribe aspirin? Warfarin? Beta blockers? Amiodarone?" The 8% risk seen in some studies of causing gastric ulceration when we prescribe long-term aspirin reduces the CV event rates in some studies by 50%." The potential benefit outweighs the potential risk. Sound familiar?
As for all the hoopla about the psychiatric instability, insomnia, and bad dreams on varenicline, I have no doubt that these symptoms occur in some patients. They are a well-known side effect of nicotine withdrawal.
Memorable quotes and events from the pre-Chantix era
- "Sorry Dr Walton-Shirley. I went to the grocery, bought a pack of cigarettes, and threw it at him. I don't care. I can't live with that/" —From a spouse whose husband went cold turkey for a few days—before Chantix came on the market.
- "We are having some issues. His behavior is really odd. He's staying up all night watching TV and masturbating. . . . No, he's never had any psychiatric problems (was 57 years of age). He just started using those nicotine patches and quit smoking a few days ago." —Spouse said of her husband who spent several weeks on the psychiatric unit after a psychotic break triggered by nicotine withdrawal and patch utilization before Chantix came on the market.
- "I can't explain how it feels. I just feel terrible . . . very angry, and was afraid I was going to kill somebody, so I started back." —A female patient suffering from nicotine withdrawal around day 5, before Chantix came on the market.
- "I know you are going to kill me Dr Walton-Shirley, but I just had to have one." "You know you just had a heart attack two weeks ago from smoking," I replied. "I know, but you don't know how bad this gets. You've never been a smoker. You really get to the point that you don't care what happens. I'll keep trying". —A patient who died just a few years later, in his late 40s of multiple strokes after a series of MIs, before Chantix came on the market.
- "She got pretty mean. . . . I mean really mean. I can't live with her like that. I'd told her I'd rather she started back smoking, and I hate it, but in a way, I'm glad she did." —A husband whose wife had a severe episode of agitation from nicotine withdrawal before Chantix came on the market.
The above quotes were as common as pickup lines in a seedy bar (so my friends tell me, of course!) during the 15 years I practiced cardiology without Chantix. Nicotine withdrawal is a real phenomenon and it is as variable as the shape of our own nicotine receptors. That unique shape, almost like a fingerprint, explains why some patients simply "put them down" with very little thought while others struggle as if they are suffering from heroin addiction. If the patient is lucky enough that most of their nicotine receptors are filled by the varenicline molecule, they will easily coast off of tobacco products and wonder why we ever thought it was such a big deal. If it's mostly filled, it will reduce the symptoms, and if there is still a lot of space unoccupied in the receptor, they will suffer the same cold-turkey withdrawal symptoms as if they had never had it.
Then finally, I'd like to address the horrible end result of depression: suicide, a phenomenon nearly as old as life itself, and homicide, the evil entity that reaches back to the first generation of humanity when Cain killed his brother Abel (long before Chantix, I might add). I recall three conversations in the past 20 years in my office setting:
- "Dr Walton-Shirley, he's dead. He went home and put a gun in his mouth." —Of a smoker who had end-stage congestive heart failure and coronary artery disease and was turned down for hip replacement by his orthopedist; the patient had never even heard of Chantix.
- "Dr Walton-Shirley, did you hear about Mr X? He killed his girlfriend and he was waiting for her grandkids but it appeared he heard the sirens and committed suicide before the cops could get there." —Of a smoker and an alcohol abuser who committed these atrocities--long before Chantix came on the market.
- "He put a shotgun under his chin and somehow pulled the trigger." —Of a smoker with coronary artery disease, at least a decade before Chantix came on the market.
As a matter of fact, I've not had one single patient to commit suicide since Chantix came on the market. There were three in the 15 years before Chantix.
As for the nausea, gear up, because in about 40% of folks there will be a loss of appetite and some queasiness. I've found that instructing the patient to drink a full 8-oz glass of water with each dose really helps to knock or prevent nausea; 2% might require an antiemetic.
Every decision in life is a risk/benefit issue, and the decision to prescribe or take varenicline is no different. In my 20 years of taking care of heart-attack patients, I might be able to recall one patient who listed varenicline on his home med list at the time of a heart attack (and I'm not even certain about that one), as compared with the thousands of patients with ACS treated during my practice lifetime who have never tried it.
If I were a smoker, I can guarantee you that I'd take my "chances" with Chantix over a single cigarette any day.
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