Journal Club Alcohol and Health: Current Evidence July–August 2004

Featured Article Alcohol Consumption and Cardiovascular Disease Mortality in Hypertensive Men Malinski MK, et al. Arch Intern Med. 2004;164(6):623–628.

Study Objective To assess the relationship between moderate alcohol consumption and cardiovascular disease (CVD) mortality total mortality among men with hypertension

Study Design A prospective cohort study of physicians with current or past hypertension

Assessing Validity of an Article about Prognosis –Are the results valid? –What are the results? –How can I apply the results to patient care?

Are the Results Valid? Was the sample of patients representative? Were the patients sufficiently homogeneous with respect to prognostic risk? Was follow-up sufficiently complete? Were objective and unbiased outcome criteria used?

Was the sample of patients representative? Subjects: –all males –physicians –history of current or past treatment for hypertension –without myocardial infarction, stroke, cancer, or liver disease at baseline

Were the patients sufficiently homogeneous with respect to prognostic risk? Subjects weren’t necessarily at the same point in the course of their hypertension. –However, none had experienced hypertension complications. Potential confounders adjusted for include: –age, smoking, exercise, body mass index, history of angina, and diabetes.

Was follow-up sufficiently complete? The percent loss to follow-up is unknown. –Researchers followed subjects for an average of 5.4 years. –They appropriately used survival statistical methods to analyze data.

Were objective and unbiased outcome criteria used? Deaths were determined by review of a national death database. Trained nosologists determined mortality and cardiovascular mortality by reviewing death certificates for any deaths.

What are the Results? How likely are the outcomes over time? How precise are the estimates of likelihood?

How likely are the outcomes and how precise are the estimates? 7% of subjects died in 5 years. Monthly Consumption (n=1505) Weekly Consumption (n=5710) Daily Consumption (n=4472) P Value for Trend Total Mortality 0.86* (CI 0.67–1.10) 0.72 (CI 0.60–0.86) 0.73 (CI 0.61–0.87) <0.001 CVD Mortality 0.83 (CI 0.62–1.13) 0.61 (CI 0.49–0.77) 0.56 (CI 0.44–0.71) <0.001 *Adjusted relative risk; compared to those who rarely/never drank (n=2438)

How Can I Apply the Results to Patient Care? Were the study patients and their management similar to those in my practice? Was the follow-up sufficiently long? Can I use the results in the management of patients in my practice?

Were the study patients and their management similar to those in my practice? They are probably similar given that both moderate drinking and hypertension are common. How hypertension was managed in this large study is unknown and probably very variable. The results are not relevant to heavy drinkers.

Was the follow-up sufficiently long? Follow-up was long enough to accrue sufficient numbers of outcomes to show differences by alcohol consumption levels.

Can I use the results in the management of patients in my practice? Authors note several limitations: Self-reported, non-validated measure of alcohol intake, at one point in time –Unable to assess drinking patterns or changes –No comparison of different types of alcohol –Addressed how often but not how much

Can I use the results in the management of patients in my practice? (cont.) Self-reported blood pressure and hypertension values potentially subject to misclassification Possibly tainted reference group that may include former drinkers who stopped drinking due to comorbid conditions that raised their risk of death Lack of generalizability to populations with higher levels of consumption

Can I use the results in the management of patients in my practice? (cont.) The 2 most important issues that limit the utility of this study: It was not a randomized trial. –The results could be due to other factors (e.g., unmeasured confounders like healthy behaviors). It reported only how often, but not how much, study subjects were drinking.

Can I use the results in the management of patients in my practice? (cont.) These results—moderate drinking does not increase, and may decrease, mortality in men with hypertension—suggest that there is no imperative for these men to cut down or abstain. –In fact, abstinence may increase risk of death in men with hypertension who drink moderate amounts.

Can I use the results in the management of patients in my practice? (cont.) The results, if replicated, suggest that moderate drinking may be beneficial for men with hypertension, with respect to reducing total and cardiovascular mortality. Although unknown, results may not apply to men with comorbidity, women, or to patients with worse blood pressure control (or end organ damage).