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Press Release Date: March 28, 2011

Low health literacy in older Americans is linked to poorer health status and a higher risk of death, according to a new evidence report by HHS’ Agency for Healthcare Research and Quality (AHRQ). More than 75 million English-speaking adults in the United States have limited health literacy

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For immediate release: Monday, May 17, 2011

Boston, MA – Men who regularly drink coffee appear to have a lower risk of developing a lethal form of prostate cancer, according to a new study led by Harvard School of Public Health (HSPH) researchers. What’s more, the lower risk was evident among men who drank either regular or decaffeinated coffee.

The study was published May 17, 2011, in an online edition of the Journal of the National Cancer Institute. Read the abstract.

“Few studies have specifically studied the association of coffee intake and the risk of lethal prostate cancer, the form of the disease that is the most critical to prevent. Our study is the largest to date to examine whether coffee could lower the risk of lethal prostate cancer,” said senior author Lorelei Mucci, associate professor of epidemiology at HSPH. Lethal prostate cancer is cancer that causes death or spreads to the bones.

Prostate cancer is the most frequently diagnosed form of cancer and the second leading cause of cancer death among U.S. men, affecting one in six men during their lifetime. More than 2 million men in the U.S. and 16 million men worldwide are prostate cancer survivors.

“At present we lack an understanding of risk factors that can be changed or controlled to lower the risk of lethal prostate cancer. If our findings are validated, coffee could represent one modifiable factor that may lower the risk of developing the most harmful form of prostate cancer,” said lead author Kathryn Wilson, a research fellow in epidemiology at HSPH.

The researchers chose to study coffee because it contains many beneficial compounds that act as antioxidants, reduce inflammation, and regulate insulin, all of which may influence prostate cancer. Coffee has been associated in prior studies with a lower risk of Parkinson’s disease, type 2 diabetes, gallstone disease, and liver cancer or cirrhosis.

The study examined the association between coffee consumption and the risk of prostate cancer, particularly the risk for aggressive prostate cancer among 47,911 U.S. men in the Health Professionals Follow-Up Study who reported their coffee consumption every four years from 1986 to 2008. During the study period, 5,035 cases of prostate cancer were reported, including 642 fatal or metastatic cases.

Among the findings:

· Men who consumed the most coffee (six or more cups daily) had nearly a 20% lower risk of developing any form of prostate cancer.

· The inverse association with coffee was even stronger for aggressive prostate cancer. Men who drank the most coffee had a 60% lower risk of developing lethal prostate cancer.

· The reduction in risk was seen whether the men drank decaffeinated or regular coffee, and does not appear to be due to caffeine.

· Even drinking one to three cups of coffee per day was associated with a 30% lower risk of lethal prostate cancer.

· Coffee drinkers were more likely to smoke and less likely to exercise, behaviors that may increase advanced prostate cancer risk. These and other lifestyle factors were controlled for in the study and coffee still was associated with a lower risk.

The results from this study need to be validated in additional populations that have a range of coffee exposure and a large number of lethal prostate cancer cases. If confirmed, the data would add to the list of other potential health benefits of coffee. The authors currently are planning additional studies to understand specific mechanisms by which coffee may specifically lower the risk of lethal prostate cancer.

Other HSPH researchers participating in the study include Edward Giovannucci and Meir Stampfer, professors of nutrition and epidemiology; Julie Kasperzyk, postdoctoral research fellow; Stacey Kenfield, research associate; Jennifer Stark, research fellow; and Rob van Dam, adjunct assistant professor in the Department of Nutrition.

The study was supported by the National Cancer Institute at the National Institutes of Health, the American Institute for Cancer Research, and the Prostate Cancer Foundation.

“Coffee Consumption and Prostate Cancer Risk and Progression in the Health Professionals Follow-up Study,” Kathryn M. Wilson, Julie L. Kasperzyk, Jennifer R. Stark, Stacey Kenfield, Rob M. van Dam, Meir J. Stampfer, Edward Giovannucci, Lorelei A. Mucci, Journal of the National Cancer Institute, online May 17, 2011.

For more information:

Marge Dwyer

Visit the HSPH website for the latest news, press releases and multimedia offerings.



Harvard School of Public Health is dedicated to advancing the public’s health through learning, discovery and communication. More than 400 faculty members are engaged in teaching and training the 1,000-plus student body in a broad spectrum of disciplines crucial to the health and well being of individuals and populations around the world. Programs and projects range from the molecular biology of AIDS vaccines to the epidemiology of cancer; from risk analysis to violence prevention; from maternal and children’s health to quality of care measurement; from health care management to international health and human rights. For more information on the school visit

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Embargoed for Release
Thursday, May 26, 2011
11 a.m. EDT
NHLBI Communications Office
NIH stops clinical trial on combination cholesterol treatment
Lack of efficacy in reducing cardiovascular events prompts decision

The National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health has stopped a clinical trial studying a blood lipid treatment 18 months earlier than planned. The trial found that adding high dose, extended-release niacin to statin treatment in people with heart and vascular disease, did not reduce the risk of cardiovascular events, including heart attacks and stroke.

Participants were selected for AIM-HIGH because they were at risk for cardiovascular events despite well-controlled low-density lipoprotein (LDL or bad cholesterol). Their increased risk was due to a history of cardiovascular disease and a combination of low high-density lipoprotein (HDL or good cholesterol) and high triglycerides, another form of fat in the blood. Low HDL and elevated triglycerides are associated with an increased risk of cardiovascular events. While lowering LDL decreases the risk of cardiovascular events, it has not been shown that raising HDL similarly reduces the risk of cardiovascular events.

During the study’s 32 months of follow-up, participants who took high dose, extended-release niacin and statin treatment had increased HDL cholesterol and lowered triglyceride levels compared to participants who took a statin alone. However, the combination treatment did not reduce fatal or non-fatal heart attacks, strokes, hospitalizations for acute coronary syndrome, or revascularization procedures to improve blood flow in the arteries of the heart and brain.

“Seeking new and improved ways to manage cholesterol levels is vital in the battle against cardiovascular disease,” said Susan B. Shurin, M.D., acting director of the NHLBI. “”This study sought to confirm earlier and smaller studies. Although we did not see the expected clinical benefit, we have answered an important scientific question about treatment for cardiovascular disease. We thank the research volunteers whose participation is key in advancing our knowledge in this critical public health area, and the dedicated investigators who conducted the study.”

The AIM-HIGH trial, which stands for Atherothrombosis Intervention in Metabolic Syndrome with Low HDL/High Triglycerides: Impact on Global Health, enrolled 3,414 participants in the United States and Canada with a history of cardiovascular disease who were taking a statin drug to keep their LDL cholesterol low. Study participants also had low HDL cholesterol and high triglycerides, which meant that they were at significant risk of experiencing future cardiovascular events. Niacin, also known as Vitamin B3, has long been known to raise HDL and lower triglycerides. Eligible participants were randomly assigned to either high dose, extended-release niacin (Niaspan) in gradually increasing doses up to 2,000 mg per day (1,718 people) or a placebo treatment (1,696 people). All participants were prescribed simvastatin (Zocor), and 515 participants were given a second LDL cholesterol-lowering drug, ezetimibe (Zetia), in order to maintain LDL cholesterol levels at the target range between 40-80 mg/dL.

The NHLBI funded the AIM-HIGH study with additional support from Abbott Laboratories, a pharmaceutical company based in Abbott Park, Ill. Abbott also provided Niaspan and Merck Pharmaceuticals, based in Whitehouse Station, N.J., provided Zocor. All drugs used in the study were approved for marketing in the United States and Canada and have been on the market for many years.

Researchers began recruiting participants in early 2006. The study was scheduled to finish in 2012. The average age of the participants was 64 years. Pre-existing medical conditions included coronary artery disease (92 percent); metabolic syndrome, which is a cluster of risk factors for heart disease (81 percent); high blood pressure (71 percent); and diabetes (34 percent). More than half of participants reported having a heart attack prior to entering the study.

The rationale for the AIM-HIGH study was based in part on a large number of observational studies that consistently showed that low HDL cholesterol increases the risk of cardiovascular events in men and women, independent of high LDL cholesterol. In addition, previous small clinical studies showed that relatively high residual cardiovascular risk exists among patients with cardiovascular disease, low HDL cholesterol, and high triglycerides despite intensive management of LDL cholesterol.

However, efforts to find HDL-raising treatments that actually reduce this residual risk have thus far proved disappointing. Fenofibrate, an HDL-raising drug, failed to reduce the rate of cardiovascular events in patients with diabetes in the Action to Control Cardiovascular Risk in Diabetes (ACCORD trial) despite favorable effects on HDL and triglycerides. Another HDL-raising drug, torcetrapib, actually increased the rate of cardiovascular events in the Investigation of Lipid Level Management to Understand its Impact in Atherosclerotic Events (ILLUMINATE) trial despite lowering LDL and triglycerides and raising HDL levels, as intended.

Earlier studies of niacin had shown more favorable results. Unlike AIM-HIGH, the earlier studies were not designed specifically to evaluate the impact of raising HDL on the risk of cardiovascular events while maintaining excellent LDL control. Several other trials testing this hypothesis, including a large international trial of high dose, extended-release niacin, are still ongoing.
As is customary in clinical trials, the NHLBI established an independent data and safety monitoring board (DSMB) to monitor trial progress and participant safety. At a regularly scheduled meeting on April 25, 2011, the study’s DSMB concluded that high dose, extended-release niacin offered no benefits beyond statin therapy alone in reducing cardiovascular-related complications in this trial. The rate of clinical events was the same in both treatment groups, and there was no evidence that this would change by continuing the trial. For this reason, the DSMB recommended that the NHLBI end the study.

The DSMB also noted a small and unexplained increase in ischemic stroke rates in the high dose, extended-release niacin group. This contributed to the NHLBI acting director’s decision to stop the trial before its planned conclusion. During the 32-month follow-up period, there were 28 strokes (1.6 percent) reported during the trial among participants taking high dose, extended-release niacin versus 12 strokes (0.7 percent) reported in the control group. Nine of the 28 strokes in the niacin group occurred in participants who had discontinued the drug at least two months and up to four years before their stroke. Previous studies do not suggest that stroke is a potential complication of niacin, and it remains unclear whether this trend in AIM-HIGH arose by chance, was related to niacin administration or some other issue.

All AIM-HIGH study participants have been informed of the results and will be scheduled for clinic visits within the next 2.5 months. Participants will be followed for an additional 12 to 18 months.

“Patients who were not in the AIM-HIGH trial should not stop taking high dose, extended-release niacin without talking to their doctor first,” said Shurin.

“The lack of effect on cardiovascular events is unexpected and a striking contrast to the results of previous trials and observational studies,” said Jeffrey Probstfield, M.D., AIM-HIGH co-principal investigator and professor of medicine and epidemiology at the University of Washington, Seattle. “The AIM-HIGH findings do not support the trial’s hypothesis that, in the population studied, adding extended-release niacin to simvastatin in participants with well-controlled LDL cholesterol can provide additional clinical benefit.”

“The results from AIM-HIGH should not be extrapolated to apply to potentially higher-risk patients such as those with acute heart attack or acute coronary syndromes, or in patients whose LDL cholesterol is not as well-controlled as those in AIM-HIGH,” said William E. Boden, M.D., AIM-HIGH co-principal investigator and professor of medicine and preventive medicine at the University at Buffalo, N.Y.

The niacin tested in the study is a proprietary formulation used in doses of 500-2,000 milligrams (mg), manufactured by Abbott Laboratories and approved and regulated by the U.S. Food and Drug Administration. Low doses of niacin, typically 20 to 100 mg, can be found in multivitamin formulations available without a prescription. The FDA regulates the use of high doses of niacin (over 500 mg), which is approved by prescription for helping treat low HDL cholesterol and/or high triglycerides. At prescription-level doses, some people experience flushing. The extended-release formulation of niacin tested in AIM-HIGH was intended to help reduce the likelihood of flushing.

An estimated 1 in 7 Americans has high blood cholesterol. It is a major risk factor for cardiovascular disease, which kills 800,000 Americans a year. Cholesterol can build up in the walls of arteries and cause them to narrow, a condition known as atherosclerosis.

“As we continue to search for new approaches to treating cholesterol problems, it is important to remember the value of existing treatments. The key to treating high cholesterol so patients can reduce their risk of cardiovascular disease is to lower the level of LDL cholesterol, through well-established drug treatments such as statins and lifestyle changes,” said Patrice Desvigne-Nickens, M.D., NHLBI project officer for the AIM-HIGH trial.

The AIM-HIGH investigators will now focus on completing data collection and analysis. The preliminary outcomes of the study are expected to be reported at scientific meetings in the fall of 2011.

Find more information about this clinical trial (NCT00120289) at

To arrange an interview with an NHLBI spokesperson, please contact the NHLBI Communications Office at (301) 496-4236 or To arrange an interview with Jeffrey Probstfield, M.D., contact University of Washington School of Medicine, Office of Communications at 206-616-6730. To arrange an interview with William E. Boden, M.D., contact Ellen Goldbaum-Kolin in the Public Relations Department at 716-645-4605, or Dr. Boden at 716-859-1784.

Part of the National Institutes of Health, the National Heart, Lung, and Blood Institute (NHLBI) plans, conducts, and supports research related to the causes, prevention, diagnosis, and treatment of heart, blood vessel, lung, and blood diseases; and sleep disorders. The Institute also administers national health education campaigns on women and heart disease, healthy weight for children, and other topics. NHLBI press releases and other materials are available online at

About the National Institutes of Health (NIH): NIH, the nation’s medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit

Diseases and Conditions Index: High Blood Cholesterol:

AIM-HIGH Information Page

Your Guide to Living With Heart Disease:

Embargoed for Release
Wednesday, May 25, 2011
5 p.m. EDT
Robert Bock or Marianne Glass Miller
Study shows 19 percent of young adults have high blood pressure
NIH-funded analysis indicates higher risk for young adults than previously believed

Roughly 19 percent of young adults may have high blood pressure, according to an analysis of the National Longitudinal Study of Adolescent Health (Add Health), which is supported by the National Institutes of Health.

The researchers took blood pressure readings of more than 14,000 men and women between 24 and 32 years of age who were enrolled in the long-running study.

The analysis was conducted by Kathleen Mullan Harris, Ph.D., principal investigator of the study, and colleagues at the University of North Carolina at Chapel Hill. The study’s first author was Quynh C. Nguyen, of the University of North Carolina Gillings School of Public Health.

The findings were published online in Epidemiology.

The findings differ from those of the National Health and Nutrition Examination Survey (NHANES), which reported high blood pressure in 4 percent of adults 20 to 39 years of age.

The study authors were unable to pinpoint any reasons for the difference between the two studies.

“The Add Health analysis raises interesting questions,” said Steven Hirschfeld, Associate Director for Clinical Research for the NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development, which provides major funding for the study. “Investigations into the reasons underlying the reported differences between the Add Health and NHANES findings will no doubt yield additional insight into the measurement of high blood pressure in the young adult population.”

The Add Health study defined high blood pressure (hypertension) as 140/90 millimeters of mercury or greater. High blood pressure is a serious condition that can lead to coronary heart disease (also called coronary artery disease), heart failure, stroke, kidney failure, and other health problems.

Along with funding from the NICHD, the Add Health study also receives funding from 23 other federal agencies and private organizations.

“We explored several possible explanations for the difference between this study and NHANES, including participant characteristics, where they were examined, and the types of devices for measuring their blood pressure,” Dr. Harris said. “None of these factors could account for the differences in estimates between the two surveys.”

For the analysis, all 15,701 respondents to the most recent Add Health interview were asked whether they had been told by a health care professional that they had high blood pressure. After the interview, respondents remained seated for five minutes and study technicians took three readings of their blood pressure. The study technicians checked the accuracy of each reading and the average of the last two readings was entered into the study database. The Add Health researchers attempted to collect blood pressure readings on all of the study’s participants, including those in prisons and in the military.

High blood pressure was more prevalent among the Add Health respondents (19 percent) than in the NHANES respondents (4 percent). The study authors noted, however, that the proportion of respondents who reported they had been told by a health care provider that they had high blood pressure was similar: 11 percent for Add Health and 9 percent for NHANES.

The study authors wrote that many young people are unaware that they have high blood pressure. In such screenings of a large number of participants, it is expected that more participants would be found to have high blood pressure upon examination than would report that they had high blood pressure in the past.

The Add Health survey results fit this expected pattern, with 11 percent saying they had earlier been told they had high blood pressure, and 19 percent later having been found to have high blood pressure upon examination. This pattern was reversed for NHANES, with 9 percent reporting they had high blood pressure, and 4 percent measured with high blood pressure upon examination.

About the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): The NICHD sponsors research on development, before and after birth; maternal, child, and family health; reproductive biology and population issues; and medical rehabilitation. For more information, visit the Institute’s Web site at

About the National Institutes of Health (NIH): NIH, the nation’s medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit