Mortality Rates and Voting; Varenicline and Smoking in African Americans

Mortality Rates and Voting; Varenicline and Smoking in African Americans

June 18, 2022 0 By Jennifer Walker

TTHealthWatch is a weekly podcast from Texas Tech. In it, Elizabeth Tracey, director of electronic media for Johns Hopkins Medicine in Baltimore, and Rick Lange, MD, president of the Texas Tech University Health Sciences Center in El Paso, look at the top medical stories of the week.

This week’s topics include breast screening imaging comparison, varenicline (Chantix) for smoking cessation in African Americans, voting and health outcomes across the U.S., and testosterone supplements and cardiovascular disease.

Program notes:

0:40 Testosterone supplements and cardiovascular outcomes

1:43 Over 20 years of data

2:43 In short term appears safe

3:00 Tomosynthesis in breast screening

4:03 No difference in interval breast cancers

5:03 Better than either technique

6:02 Surrogate for effectiveness of screening

6:31 Political environment and mortality rates

7:33 Contributions to mortality gap

8:31 Evidence base with regard to policy

9:10 Varenicline and smoking in African Americans

10:10 Varenicline 1 mg twice daily

11:10 Less likely to stop smoking

12:10 Multimodality important

13:20 End


Elizabeth Tracey: Are there advantages to tomosynthesis for breast cancer screening?

Rick Lange, MD: The political environment and mortality rates in the United States.

Elizabeth: How can we improve smoking cessation efforts among African Americans?

Rick: And does testosterone treatment result in increased cardiac events and mortality in men?

Elizabeth: That’s what we’re talking about this week on TTHealthWatch, your weekly look at the medical headlines from Texas Tech University Health Sciences Center in El Paso. I’m Elizabeth Tracey, a Baltimore-based medical journalist.

Rick: And I’m Rick Lange, president of Texas Tech University Health Sciences Center in El Paso, where I’m also dean of the Paul L. Foster School of Medicine.

Elizabeth: Rick, we have talked an awful lot in our many years of podcasting about testosterone supplementation, so I think I would like to turn to that one first. That’s in The Lancet. It’s taking a look at these adverse cardiovascular events and mortality in men who are taking testosterone.

Rick: I’m going to narrow it down just a little bit more because testosterone use has just about tripled or quadrupled over the last couple of decades. It’s probably overused, but there is a group of men in whom its use is actually indicated. These are men that have hypogonadism. They clearly have low testosterone even for the age, because as men age their testosterone level goes down.

It’s known that hypogonadism results in sexual dysfunction, muscle wasting and weakness, osteoporosis, and reduced quality of life. In those individuals with a low serum testosterone, it is indicated by many medical societies to provide them testosterone, but there has been some concern that it increases the risk of cardiovascular events and also may increase mortality.

These authors aim to provide the most extensive individual participant dataset of testosterone trials available over 20 years of data. The men had to be randomized to placebo or testosterone, have individual data, and have continued treatment for at least a minimum of 3 months. Over 3,400 men followed for an average of 9½ months. What they discovered is that the individuals that received testosterone did not have an increased risk of cardiovascular events, and they did not have an increase in mortality. Testosterone treatment was safe in this particular group of men.

Elizabeth: I am not terribly persuaded with that really short time of follow-up.

Rick: It’s the best data we have right now in terms of randomized controlled trials. But you bring up a good point, what do long-term studies look like? I totally agree we need these and that’s what the authors also alluded to.

Then they asked, well, is there a group of men in whom testosterone treatment could actually increase cardiac events or death? They looked at patient age, baseline testosterone level, smoking status, and whether the men had diabetes. In none of those circumstances was testosterone associated with an increased risk. At least it’s reassuring to know in the short term, these men who would otherwise have an indication for testosterone can receive it safely.

Elizabeth: I’m guessing that we are going to see more about it at some point.

Rick: I hope so.

Elizabeth: Yeah. Talking about another long-term issue that we have talked about many times — and that’s the use of tomosynthesis in breast cancer detection for women — I still remember when this came over the transom, when this technique was developed. I remember the first time that I had this particular exam using this method of imaging and having to pay a copay at the time. We’ll talk a little bit more about that aspect of it.

What they were doing in this case was examining whether tomosynthesis screening, which they call DBT (digital breast tomosynthesis), is associated with a lower likelihood of interval invasive breast cancer and advanced breast cancer compared with digital mammography. They also included in that their extent of breast density and a woman’s breast cancer risk.

A huge cohort here, 504,000+ women 40 to 79 years of age. Over a million screening digital mammography and tomosynthesis exams from 2011 through 2018 at 44 Breast Cancer Surveillance Consortium facilities.

What they basically found was that this issue of interval invasive breast cancer rates, which is what do we find — do we find breast cancer when we’re between the recommended intervals? Of course, there is some controversy about that, should you be screened every year or every 2 years. But they found that these were not significantly different for the two techniques. The advanced cancer rates also were not significantly different.

Well, what was the advantage of tomosynthesis? There was a lower rate of false positives and then of subsequent biopsies that women had to have. The authors make the point that some 83% now of facilities across the U.S. do have tomosynthesis available. This may turn out to be a point that ends up being moot and most insurance companies are not charging women copays when it comes to paying for these exams, so it may be moot from that issue also. As far as I’m concerned, I think it points to a clear need for something that’s better than either of these techniques for discerning breast cancers.

Rick: DBT was established really to help detect breast cancer in women to whom a traditional mammography gave equivocal results, in women with dense breast tissue. We failed to identify the group in whom DBT was helpful, those with both dense breasts and a higher risk of cancer at baseline based upon historical factors, only comprised about 3.6% of these women. This suggests that 96% of women can have either technique. Now, should women have both? No, because that increases their risk of radiation.

Elizabeth: I thought that the editorialists brought up a couple of things that were really interesting — to me, anyway. The distribution of facilities, they note that for minority women, it can be rather challenging to access tomosynthesis. Those women also have the highest incidence of breast cancer, so that disproportion is something that clearly needs to be dealt with. They also offer that this interval cancer diagnosis can be used as a plausible surrogate marker for the effectiveness of screening mammography in reducing overall breast cancer mortality. I at least am persuaded by that particular notion.

Rick: Right. As you said, it says that the outcome was interval cancer, it wasn’t mortality. That’s the hard endpoint and they didn’t have that data. I agree with you. I think that that’s a pretty persuasive argument.

Elizabeth: This is another one I think we are going to be hearing more about. Let’s turn then to the BMJ and one that really tickled me.

Rick: I’ll be interested in knowing why you picked this particular one. It looks at the political environment and mortality rates in the United States from 2001 to 2019.

What these investigators did was they tried to assess the recent trends in mortality rates in the United States based upon how each county in the U.S. voted for the President. It’s a cross-sectional study. It included 99.8% of the U.S. population. That’s pretty darn good. They used the CDC database and they linked it to the county-level data on U.S. presidential elections. They said, did you vote Republican or Democrat? That’s it.

The mortality rates decreased pretty much in almost every county, but it decreased by 22% in Democratic counties and only 11% in Republican counties. It was true for male and females.

The black population experienced similar improvements in age-adjusted mortality rates, regardless of whether it was Democrat or Republican. The Republican counties that experienced the highest mortality were those in rural [areas] and particularly men. Contributions to that mortality gap between Republican and Democratic counties included heart disease, cancer, chronic lower respiratory tract disease, injuries, and suicide as well. Elizabeth, why did you pick this particular study?

Elizabeth: I found it really interesting because, of course, it’s echoed in the COVID data and in the vaccination rates and in who was hospitalized. All the observations that you’ve just identified were abundantly true when it came to that also. It suggests to me that, is this a leadership issue? Are we not getting adequate leadership for the population to do things that are health protective?

Rick: That’s one possible explanation. There are a couple other possible explanations. It could be the harmful effect of Republican policies, but it could actually represent a preference for Republican candidates among the disadvantaged voters. I would say it’s kind of the 30,000-foot view, whether it’s causal or not, or whether there are other factors that we need to examine. I think that remains to be seen.

Elizabeth: I agree with that and I also think we really need evidence base. We talk about this all the time in medicine and we need the evidence base with regard to policy and leadership also. So many things that became politicized that we saw in spades during the pandemic is just something that cannot inform what we are telling people to do from a public health standpoint.

Rick: Right. I would agree with you. The counties that tended to be more lax, led by governors who did not promote vaccination, did not promote social isolation, had the worst outcomes. There is no question about that. There is no doubt about that politics, whether local or at the national level, do affect mortality and outcomes.

Elizabeth: Let’s turn now to JAMA:the effect of varenicline, which is a smoking cessation medication, added to counseling on smoking cessation among African American daily smokers. This is part of what is called the “Kick It at Swope” trial.

We knew already, of course, that African American smokers have among the highest rates of tobacco-attributable morbidity and mortality in the U.S. This trial enrolled 500 African American adults who were daily smokers of all smoking levels. This is also really important because it turns out that the tendency among a lot of African American or black smokers is to smoke not that many cigarettes a day — and this was something that clearly educated me — 10 cigarettes or fewer and frequently that precludes their ability to do be part of a clinical trial.

Participants were provided with 6 sessions of culturally relevant, individualized counseling and they were randomized to receive varenicline 1 mg twice daily, or placebo for 12 weeks. They randomized them further by sex and smoking level, so 1 to 10 cigarettes or more than 10.

The primary outcome was looking at salivary cotinine-verified 7-day smoking abstinence at week 26; 88% completed their trial. Participants who received varenicline were significantly more likely than those who received the placebo to be abstinent at week 26, almost 16% versus 6.5%, and the light smokers, 22% versus 8.5%. Clearly, it seems like varenicline is helpful in these folks along with this other intervention. It seems like it ought to be employed.

Rick: I applaud you, Elizabeth. This particular one targets a specific population at a higher mortality despite the fact they smoke less, and they are also less likely than white populations to stop smoking. A part of that may be decreased access to healthcare. We know that abstinence is related to do other people around you smoke. There is a higher incidence of people surrounding them continuing to smoke. They also are more likely to smoke menthol cigarettes. The cigarette advertising industry has targeted African Americans, so this is really good news for our African American population.

Elizabeth: One of the things that I thought was really inexplicable to me — and that neither the editorialists nor the authors explain very well — is why some of the other interventions that are somewhat efficacious in white smokers are not efficacious in Black smokers, bupropion and nicotine patches, which were associated with greater abstinence than placebo among whites, but not among Blacks.

Rick: That wasn’t studied in this particular trial, but there is some other evidence to suggest that varenicline is more effective than these other methods.

Elizabeth: Yeah. I would just really be interested in that. It’s like, why those other modalities? Because what we have talked about so many times is that the multitude of modalities seemed to be important in achieving success. If, in addition to varenicline, we added these other things or figured out why they are not efficacious in Black smokers, it seems like that would help.

Rick: And I agree with you; having a variety of different treatment options would help. The other thing that’s going to help is the FDA banned menthol cigarettes and that’s 72% to 79% of African Americans smoke menthol cigarettes, as opposed to less than 20% of whites.

Elizabeth: I finally just note that the editorialist talks about clinicians and that they are less likely to intervene in patients who smoke lightly and may not recommend a full range of pharmacotherapy for these individuals because they think it’s not as necessary.

Rick: This study points out the fact that that’s the vast majority of African American males — [they] smoke fewer cigarettes than Caucasians. It has increased mortality and, as you said, they are less likely to be offered treatment. This study shows that in fact treatment is very effective in those individuals.

Elizabeth: On that good news note, then, that’s a look at this week’s medical headlines from Texas Tech. I’m Elizabeth Tracey.

Rick: And I’m Rick Lange. Y’all listen up and make healthy choices.