Skip to main content

Moderate Drinking After Heart Attack Tied to Lower Mortality

March 27, 2012 — Men who drink 2 glasses of alcohol a day after surviving a heart attack are less likely to die from heart disease or other causes than either nondrinkers or those who drink more, according to a study of nearly 2000 health professionals published online March 28 in the European Heart Journal.
Jennifer K. Pai, ScD, assistant professor of medicine and associate epidemiologist, Channing Laboratory, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, and colleagues used data from the Health Professionals Follow-up Study to track the survival of 1818 men who suffered a heart attack between 1986 and 2006, following-up some participants for as long as 20 years. During the follow-up, some 468 men died.
Although moderate alcohol consumption (between 10.0 and 29.9 g/day) is associated with a lower risk for heart disease and reduced mortality from all causes in healthy populations, the data on post–myocardial infarction (MI) drinking is limited and somewhat contradictory, the authors write.
In the current study, moderate drinking showed clear benefits post-MI in both multivariable-adjusted and unadjusted hazard ratios (HRs). The multivariable-adjusted HR for death from any cause for moderate drinkers compared with nondrinkers was 0.66 (95% confidence interval [CI], 0.51 - 0.86). For light drinkers, who reported consuming between 0.1 and 9.9 g of alcohol per day, the HR was 0.78 (95% CI, 0.62 - 0.97). For heavy drinkers, who consumed 30 g or more of alcohol daily, the HR for all-cause mortality was 0.87 (95% CI, 0.61 - 1.25; Pquadratic = .006). The data were adjusted for age at diagnosis, questionnaire follow-up cycle, smoking, body mass index (BMI), physical activity, diabetes, hypertension, lipid-lowering medications, aspirin use, and heart failure.
When just cardiovascular mortality is considered, the benefit for moderate drinkers is more pronounced, with a multivariable-adjusted HR of 0.58 (95% CI, 0.39 - 0.84) compared with 0.74 for light drinkers (95% CI, 0.54 - 1.02) and 0.98 for heavy drinkers (95% CI, 0.60 - 1.60; Pquadratic = .003).
"Our findings clearly demonstrate that long-term moderate alcohol consumption among men who survived a heart attack was associated with reduced risk of total and cardiovascular mortality," Dr. Pai said in a news release. "We also found that among men who consumed moderate amounts of alcohol prior to a heart attack, those who continued to consume alcohol 'in moderation' afterwards also had better long-term prognosis."
In this study, participants responded to a questionnaire about alcohol consumption and diet every 4 years and were asked about lifestyle and medical factors (including smoking and BMI) every 2 years. Previous prospective studies examining post-MI alcohol consumption did not include validated measures of pre- and post-MI drinking with long-term follow-up.
Most participants in this study did not change alcohol consumption levels after MI diagnosis. Multivariable-adjusted HRs for total mortality, considering pre-MI alcohol only, compared with nondrinkers, were 0.91 (95% CI, 0.72 - 1.16) for light drinkers, 0.70 (95% CI, 0.52 - 0.93) for moderate drinkers, and 1.00 (95% CI, 0.70 - 1.42) for heavy drinkers. When considering only post-MI consumption, multivariable HRs for total mortality were 0.90 (95% CI, 0.71 - 1.13) for light drinkers, 0.70 (95% CI, 0.52 - 0.92) for moderate drinkers, and 0.79 (95% CI, 0.53 - 1.17) for heavy drinkers.
For cardiovascular morality, the multivariable-adjusted HR for pre-MI alcohol consumption was 0.74 (95% CI, 0.52 - 1.04) for light drinkers, 0.78 (95% CI, 0.53 - 1.15) for moderate drinkers, and 0.85 (95% CI, 0.50 - 1.44) for heavy drinkers. When considering post-MI consumption only, the multivariable HRs for cardiovascular mortality were 0.73 (95% CI, 0.53 - 1.01) for light drinkers, 0.62 (95% CI, 0.42 - 0.93) for moderate drinkers, and 0.77 (95% CI, 0.44 - 1.35) for heavy drinkers.
The study results hinted at an inverse association between alcohol consumption and mortality among patients who increased alcohol consumption, from less than 10 g/day before a heart attack to 10 to 29.9 g/day post-MI. The small number of cases in the analysis led to a CI that crossed 1.0 in multivariable adjustment, and so was not statistically significant.
The data showed that heavy drinking carried a hazard ratio essentially as high as nondrinking.
"Our results, showing the greatest benefit among moderate drinkers and a suggestion of excess mortality among men who consumed more than two drinks a day after a heart attack, emphasise the importance of alcohol in moderation," Dr. Pai said in the release.
"In addition, other studies have shown that any benefits from light drinking are entirely eliminated after episodes of binge drinking," she noted.
The data does not necessarily extrapolate to women, Dr. Pai said in the release. "However, in all other cases of alcohol and chronic disease, associations are similar except at lower quantities for women. Thus, an association is likely to be observed at 5-14.9g per day, or up to a drink a day for women."
The authors have disclosed no relevant financial relationships.

Comments

Popular posts from this blog

Antidepressants Linked to Higher Diabetes Risk in Kids

Pediatric patients who use antidepressants may have an elevated risk for type 2 diabetes, the authors of a new study report. In a retrospective cohort study of more than 119,000 youths 5 to 20 years of age, the risk for incident type 2 diabetes was nearly twice as high among current users of certain types of antidepressants as among former users, Mehmet Burcu, PhD, and colleagues report in an article  published online October 16 in  JAMA Pediatrics . The risk intensified with increasing duration of use, greater cumulative doses, and higher daily doses of these antidepressants. The findings point to a growing need for closer monitoring of these products, including greater balancing of risks and benefits, in the pediatric population, the authors caution. They undertook the study because, despite growing evidence of an association between antidepressant use and an increased risk for type 2 diabetes in adults, similar research in pediatric patients was scarce. "To our know...

Contact Precautions May Have Unintended Consequences

Contact precautions, including gloves, gowns, and isolated rooms, have helped stem the transmission of hospital pathogens but have also had some negative consequences, according to findings from a new study. Healthcare worker (HCWs) visited patients on contact precautions less frequently than other patients and spent less time with those patients when they did visit, report Daniel J. Morgan, MD, from the University of Maryland School of Medicine and the Veterans Affairs (VA) Maryland Health Care System, Baltimore, and colleagues. Moreover, patients on contact precautions also received fewer outside visitors. "Less contact with HCWs suggests that other unintended consequences of contact precautions still exist," Dr. Morgan and coauthors write. "The resulting decrease in HCW contact may lead to increased adverse events and a lower quality of patient care due to less consistent patient monitoring and poorer adherence to standard adverse event prevention methods (such...

Missing Data Lead FDA Panel to Vote Against Rivaroxaban for ACS May 23, 2012 (Updated May 24, 2012) (Silver Spring, Maryland) — The missing data issues plaguing the ATLAS ACS 2 TIMI 51 trial of the factor Xa inhibitor rivaroxaban (Xarelto, Bayer Healthcare/Janssen Pharmaceuticals) have prevented the drug from earning the endorsement of the FDA Cardiovascular and Renal Drugs Advisory Committee. At its May 23 meeting, the panel voted six to four (with one abstention) against recommending that the FDA approve rivaroxaban for reducing the risk of thrombotic cardiovascular events in patients with acute coronary syndrome or unstable angina in combination with aspirin, aspirin plus clopidogrel, or ticlopidine. Janssen's application is based on the results of the ATLAS ACS 2 phase 3 and the ATLAS ACS TIMI 46 phase 2 trial. The placebo-controlled ATLAS ACS 2 showed rivaroxaban reduced the risk of both all-cause and cardiovascular mortality while increasing the risk of bleeding and intracranial hemorrhage, but the studies were hindered by early patient withdrawals and missing data. We Don't Know What We're Missing Based on the ATLAS ACS 2 results, FDA reviewer Dr Karen Hicks recommended approval of rivaroxaban for the requested indications except all-cause mortality. However, another FDA reviewer, Dr Thomas Marciniak, was adamant that the trial results are not interpretable because about 12% of the patients had incomplete follow-up, far higher than the 1% to 1.5% differences in the end-point rates between rivaroxaban and placebo. A total of 1294 subjects discontinued the trial prematurely, and the company was only able to contact 183, of which 177 were confirmed to be alive. Because of the patient dropouts, the company adopted a "modified intention-to-treat analysis," whereby patients were observed for 30 days after randomization or the global end date for the trial, instead of observing all the patients until the end of the trial as the FDA originally suggested. Marciniak criticized the sponsor's efforts to follow the patients and said that three patient deaths not counted in the modified intention-to-treat analysis may just be the "tip of the iceberg." Because the percentage of patients whose ultimate vital status remains unknown is much greater than the reported differences in mortality rates, the claimed mortality benefits are not reliable. The majority of the panel sided with Marciniak. For example, Dr Sanjay Kaul (University of California, Los Angeles) voted "no" because "there was enough uncertainty in the quality and robustness of the data that dissuaded me from voting yes. . . . The 'missingness' of the data doesn't invalidate it, but it certainly makes it hard to infer [the conclusion]." Dr Steven Nissen (Cleveland Clinic, OH) said that the decision to use the modified intention-to-treat analysis had a "profound impact" on the interpretability of the data. "It's saying we don't care what happens after 30 days, [and] that colored the trial in ways we couldn't recover from." Given the risk of major bleeding, "I want to see better evidence that this strategy of adding an Xa inhibitor or a direct thrombin inhibitor or something else to a good antiplatelet agent is robustly better for the patient," Nissen said. He recommends that the companies run a new trial of the 2.5 twice-daily dose of rivaroxaban using a strict intention-to-treat approach, but, he said, "I don't expect the death benefit to be too robust." Several panelists said they were concerned that the patients who dropped out of the trial were disproportionately likely to have a bleeding event, which led them to quit the trial, or a "protopathic" event, as statistician Dr Scott Emerson (University of Washington, Seattle) put it. "We're worried that an impending event is what is changing their behavior. We see that all the time in clinical trials--that regularly measured end points do not pick up [all of] the events," he said. He said that since the company was only able to contact 183 of the over 1200 patients who dropped out, it is possible that the dropouts skew the outcomes comparison of the trial. "Differential event rates after dropout are the number-one thing we're afraid of, so you have to explore it" in a statistical sensitivity analysis of the potential impact of these unknown outcomes. "It would not surprise me if, at the end of the day, these data did not hold up under a proper sensitivity analysis," he said. "What I want to know is, among the people who had events, how differential was the follow-up, but I can tell you by just looking at it, there was a very slightly different amount of follow-up of the people in the treatment arm. But I don't know whether everyone in the treatment arm was cured and they were trekking in the Himalayas and everyone in the placebo arm went home to die. I don't know that that's not the case." Dr Maury Krantz (University of Colorado, Denver) voted in favor of approval but said he does not know how rivaroxaban would perform in general clinical practice, especially when used with aspirin and clopidogrel. "I felt very much torn by this. This isn't a simple paradigm shift. It means going to triple therapy, which is really a three-headed monster in many ways. I think that what you're going to see in practice, if this is not done carefully with the proper labeling and secondary studies, is really dramatic magnification of bleeding and perhaps minimization of the efficacy benefit."

May 23, 2012   (Updated May 24, 2012)  (Silver Spring, Maryland)  —  The missing data issues plaguing the  ATLAS ACS 2 TIMI 51   trial of the factor Xa inhibitor  rivaroxaban  (Xarelto, Bayer Healthcare/Janssen Pharmaceuticals) have prevented the drug from earning the endorsement of the  FDA  Cardiovascular and Renal Drugs Advisory Committee. At its May 23 meeting , the panel voted six to four (with one abstention) against recommending that the FDA approve rivaroxaban for reducing the risk of thrombotic cardiovascular events in patients with acute coronary syndrome or unstable angina in combination with aspirin, aspirin plus  clopidogrel , or  ticlopidine . Janssen's application is based on the results of the ATLAS ACS 2 phase 3 and the  ATLAS ACS TIMI 46   phase 2 trial. The placebo-controlled ATLAS ACS 2 showed rivaroxaban reduced the risk of both all-cause and cardiovascular mortality while increasing the ri...