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The role of anti-inflammatory medications such as aspirin to prevent frailty is unknown. We studied 12,101 men ≥60 years who participated in the Physicians' Health Study I, a completed aspirin trial. Annual questionnaires collected data on aspirin use, lifestyle, and clinical variables. Average aspirin use was dichotomized: ≤60 vs >60 days/year. Frailty was assessed using a 33-item index. Propensity score methods addressed confounding by indication. Logistic regression models estimated odds of frailty as a function of categories of average aspirin use. Mean age was 71 years. Following an average of 11 years of follow-up, 15% reported aspirin use ≤60 days/year; 20% were frail. The OR (95%CI) for frailty was 0.85 (0.76-0.96) for average aspirin use >60 days/year vs ≤60 days/year. Results were similar using an alternate definition of frailty. Long-term regular aspirin use is inversely associated with frailty among older men, even after consideration of multi-morbidity and health behaviors.

Background: Coffee consumption is highly prevalent in the United States (US). While previous studies have reported a positive association of coffee consumption with hypertension (HTN) and coronary artery disease, only a few studies have examined the association of coffee consumption with risk of heart failure. Hence, we sought to examine the relation between coffee consumption and risk of heart failure among male physicians. Hypothesis: We hypothesized that coffee consumption is inversely associated with the risk of heart failure. Method: We prospectively studied 20,433 middle-aged and older men from The Physicians’ Health Study. Coffee consumption was assessed using a semi-quantitative food frequency questionnaire. The incidence of heart failure was assessed using annual questionnaires and validated in a subsample using review of medical records. We used Cox Proportional hazard model to compute the hazard ratios (HRs) and corresponding 95% confidence intervals (CIs) across categories of coffee and calorie adjusted caffeine intake, and cubic spline to estimate nonlinear trend. Results: The average age was 66.4 years. During a mean follow-up of 9.3 years, a total of 901 new cases of heart failure were reported. In a Cox model adjusting for age, diabetes, smoking, atrial fibrillation, exercise, and alcohol intake, the HRs (95% CIs) of heart failure were 1.0(reference), 0.89(0.67-1.20), 1.27(1.00-1.62), 0.99 (0.80 - 1.22), 1.19 (0.99- 1.43), and 1.37 (1.05 - 1.80) for coffee consumption of almost never, In a secondary analysis, higher caffeine intake was associated with a higher risk of heart failure, with Multivariable HRs (95% CIs) from the lowest to the highest quintile of dietary caffeine were 1.00(reference), 1.10 (0.90-1.35), 1.00 (0.81-1.25), 1.17 (0.95-1.45), and 1.25 (1.00-1.56), respectively; P for nonlinear trend = 0.06. Conclusion: Heavy (+4 cups/day), but not light to moderate, coffee consumption is associated with a higher risk of heart failure.

PR-1 Background Basic science and observational studies support a potential role of antioxidants, including vitamins E and C, in the prevention of cancer. Previous trials have suggested a possible benefit of vitamin E, in particular on prostate cancer. Few long-term trials have evaluated vitamin C alone in the prevention of cancer. Despite uncertainty regarding long-term effects, use of vitamin supplementation remains highly prevalent in the US. Methods The Physicians’ Health Study II (PHS II) evaluated the roles of supplementation with vitamin E (400 IU every other day) and vitamin C (500 mg daily) on risk of cancer in a randomized, double-blind, placebo-controlled trial of 14,641 U.S. male physicians initially aged ≥50 years. The trial included 1,274 (8.7%) men with prevalent cancer at randomization. The randomized vitamin E and C trial components terminated as scheduled on August 31, 2007, and identification of cancer endpoints that occurred prior to that date will continue through September 30, 2008. The primary endpoint of the vitamin E component was prostate cancer, with total cancer (defined as excluding non-melanoma skin cancer) as a secondary endpoint. For vitamin C, the primary endpoint was total cancer. All endpoints were reviewed and confirmed by an Endpoints Committee of physicians blinded to randomized treatment assignment. High rates of morbidity and mortality follow-up have been maintained in the PHS II. Results During a median (interquartile range) follow-up of 7.6 (7.1 to 9.6) years among men with a mean baseline age of 64.3 years, there have been 1,929 cases of cancer, including 1,013 cases of prostate cancer. Based upon preliminary results, those randomized to vitamin E had a relative risk of prostate cancer of 0.95 (490 events in the active group vs. 523 in the placebo group; 95% CI, 0.84-1.07; p=0.39), and a relative risk of total cancer of 1.04 (978 vs 951; 95% confidence interval, 0.95-1.14; p=0.38). For those randomized to vitamin C, the relative risk of total cancer was 1.00 (964 events in the active group, 965 in placebo; 95% CI, 0.92-1.10; p=0.95). In addition to updating the results above, we will also present the results for other site-specific cancers, as well as analyses that consider the effects of compliance, effect modification by baseline risk factors and baseline cancer, and potential adverse effects. Conclusion These preliminary data from a large-scale prevention trial of long duration indicate no beneficial effect of vitamin E supplementation on either prostate or total cancer, nor a beneficial effect of vitamin C supplementation on total cancer. These data will help inform clinical and public health recommendations regarding effects of vitamin E or vitamin C supplementation on risks of total and site-specific cancers. Citation Information: Cancer Prev Res 2008;1(7 Suppl):PR-1.

P32 We sought to investigate the association between periodontal disease (PD) and total and cardiovascular (CV) mortality in a large cohort of men. Methods: Of 104,388 men in the Physician s Health Study enrollment cohort, 88,882 who had no history of cancer, myocardial infarction, stroke or liver disease and provided information on PD were included in this analysis. A total of 10,264 patients reported history of PD. Results: During a mean follow-up of 5 years, 2,921 patients died, from which 1,461 had a CV death. The crude, age adjusted RR, showed an association between PD and total mortality (RR=1.31, C.I. 1.2-1.4, p table. Conclusion: This prospective cohort study suggests that PD is associated with increased mortality, particularly among smokers. However, whether this mild association is real or only due to residual confounding remains to be clarified. Table 1.