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Research Briefs December 2018

Testing the Limits of Low-Dose Aspirin

Unless someone has already had a heart attack or other cardiovascular event, daily low-dose aspirin doesn’t prolong healthy independent living, according to the Aspirin in Reducing Events in the Elderly (ASPREE) trial.

The study began in 2010, enrolling 19,114 adults aged 65 years and older. The participants were treated with 100 mg/day of aspirin or placebo and followed for an average of 4.7 years.

Of the participants randomly assigned aspirin, 90.3% were still alive at the end of the treatment without persistent physical disability or dementia, as were 90.5% of participants on placebo. Rates of dementia were almost identical in both groups. Major cardiovascular events were similar, with 448 in the aspirin group and 474 in the placebo group.

The aspirin group had a slightly higher risk of death (5.9% vs. 5.2%), but the researchers advise interpreting this cautiously, as most of the deaths were attributed to cancer. A small increase in new cases of cancer was reported for the aspirin group, but that may have been due to chance. Heart disease accounted for 19% of deaths, and major bleeding for 5% of deaths. Participants taking aspirin were more likely than those on placebo to have significant bleeding (3.8% vs. 2.7%).

The researchers emphasize that, study findings notwithstanding, older adults should follow their physician’s advice about daily aspirin use. The new findings do not apply to people with an indication for aspirin, including stroke, heart attack, or other cardiovascular disease.

Source: NIH, September 16, 2018. Available at: https://bit.ly/2xnPo4S.. Accessed November 19, 2018.

Gastric Banding Versus Metformin

Gastric banding was just as successful as metformin alone in stabilizing prediabetes or new-onset type-2 diabetes (T2D) in the Beta Cell Restoration through Fat Mitigation study (BetaFat), an NIH-supported study. The study is part of the Restoring Insulin Secretion (RISE) study, a set of three clinical trials designed to find ways to reverse or slow the loss of insulin production and release in people at risk for T2D.

In this study, 44 patients were randomly assigned to have a gastric banding procedure, and 44 were taking metformin. After two years, people in the gastric banding group had lost an average of 23 pounds, versus 4 pounds for people in the metformin group. Insulin sensitivity improved similarly in both groups, as did functioning of insulin-producing cells. Both groups showed small improvements in blood glucose levels.

Source: NIH, October 3, 2018. Available at: https://bit.ly/2zgIQ9Q.. Accessed November 19, 2018.

Can Probiotics Beat MRSA?

Could a simple probiotic regimen wipe out methicillin-resistant Staphylococcus aureus (MRSA) infection in hospitals? An unexpected finding in a study by NIH researchers suggests that a “good” bacterium commonly found in probiotic digestive supplements works against S. aureus.

For the study, the researchers recruited 200 volunteers in Thailand, speculating that Thai citizens would not be affected by food sterilization or antibiotics as much as people in highly developed urban areas. The researchers analyzed fecal samples from each participant for bacteria correlated with the absence of S. aureus. They found 101 samples positive for Bacillus, primarily B. subtilis, which is often mixed with other bacteria in probiotic products. The researchers then sampled for S. aureus and found 25 positive gut samples and 26 positive nose samples. Strikingly, the researchers say, they found no S. aureus in any of the samples that contained Bacillus.

Using chromatography and mass spectrometry, the study team identified fengycins—a class of lipopeptides—as the specific Bacillus substance that inhibited the S. aureus sensing system. Other tests showed that fengycins had the same effect on several different strains of S. aureus, including the high-risk USA300 MRSA.

To further validate their findings, the researchers colonized the gut of mice with S. aureus and fed them B. subtilis spores. Probiotic Bacillus given every two days eliminated S. aureus. The same test using Bacillus where fengycin production had been removed had no effect: S. aureus grew as expected.

Source: NIH, October 10, 2018. Available at: https://bit.ly/2PrNBU8.. Accessed November 19, 2018.

Investigation Into New Antimalarial Drug Begins

In 2016, a staggering 216 million people developed malaria, and 445,000 died—primarily children in sub-Saharan Africa. But a new first-in-human study, sponsored by the National Institute of Allergy and Infectious Diseases, may help to reduce the numbers of future victims.

Enrollment has begun in a phase 1 trial to test the safety of DM1157, an investigational, modified form of chloroquine. Many strains of Plasmodium falciparum are now resistant to chloroquine. In fact, the parasites are able to expel the drug before it can affect them. Like chloroquine, DM1157 interferes with the parasites’ metabolism but it also inhibits the parasites’ ability to expel the drug.

The study will enroll up to 104 healthy volunteers between the ages of 18 and 45 years. One group will fast overnight and then receive either a single dose of the experimental drug at one of seven dosage levels, or a placebo. A second group will also fast and receive one dose at one of four dosage levels, and repeat the routine for two more consecutive days. A third group will be given either a single 300-mg dose or placebo after eating a high-fat meal.

The study is expected to be completed by June 2019.

Source: NIH, September 10, 2018. Available at: https://bit.ly/2DxK9UZ.. Accessed November 19, 2018.

Congenital Syphilis Is On the Rise

Diagnoses of primary and secondary syphilis, the most infectious stages of the disease, jumped 76% from 2013 to 2017. And reported cases of congenital syphilis—passed from mother to infant during pregnancy—rose 44% between 2016 and 2017, from 16 cases to 23 cases per 100,000 live births, according to the Centers for Disease Control’s (CDC’s) annual Sexually Transmitted Disease Surveillance report. Those data highlight the need for better prenatal care that includes syphilis testing at the first visit and follow-up testing for women at high risk of the infection. Syphilis can cause miscarriage, newborn death, and severe, lifelong physical and mental health problems.

The 918 cases reported in 2017 represent the highest number of recorded cases in 20 years. Cases were reported in 37 states, primarily Western and Southern states. The report notes that the surge in cases parallels similar increases in syphilis among women of reproductive age, and outpaces national increases in sexually transmitted diseases (STDs) overall.

Syphilis during pregnancy is easily cured with the right antibiotics. Left untreated, a pregnant woman with syphilis has as much as an 80% chance of passing it on to her baby.

Early testing, prompt treatment, and follow-up are crucial. Recent CDC research found that one in three women who gave birth to a baby with syphilis in 2016 had been tested during pregnancy, but either acquired syphilis after that test or was not treated in time to cure the infection in the fetus.

“Too many women are falling through the cracks of the system,” said Gail Bolan, MD, director of the CDC’s Division of STD Prevention. The CDC recommends that all pregnant women be treated for syphilis at the first prenatal visit. But for many women, one test may not be enough. Women at high risk, or those who live in high-prevalence areas, should be tested again early in the third trimester and at delivery.

“To protect every baby,” Bolan says, “we have to start by protecting every mother.”

Source: NIH, September 25, 2018. Available at: https://bit.ly/2zgLRaa.. Accessed November 19, 2018.

Naloxone in the Workplace

According to 2017 data from the CDC’s National Center for Health Statistics, 115 Americans, on average, die every day from an opioid overdose—and it’s happening more and more often at work. Between 2013 and 2016, the Bureau of Labor Statistics finds, overdose deaths at work from the nonmedical use of drugs and alcohol increased by at least 38% annually.

Naloxone could be one of the first tools to help prevent overdose deaths in today’s workplace. To help employers decide whether to supply naloxone at work, the National Institute for Occupational Safety and Health (NIOSH) has released a new fact sheet that outlines questions to consider. Using Naloxone to Reverse Opioid Overdose in the Workplace: Information for Employers and Workers gives an overview of opioids and naloxone, a checklist to determine whether a naloxone program is appropriate, and information about how to implement and maintain a program.

Source: NIOSH, October 2018. Available at: www.cdc.gov/niosh/docs/2019-101/.. Accessed November 12, 2018.

Promising Results from Anti-HIV Combination Treatment

Reliable treatment with broadly neutralizing antibodies— bNAbs—could change the future for people living with human immunodeficiency virus (HIV). But studies have found that infusions of a single bNAb did not suppress HIV because some patients developed resistance.

Rockefeller University researchers, however, theorized that combining multiple antibodies that target distinct regions of HIV would both suppress the virus and prevent resistance. So, in an NIH-supported pilot study, they recruited 15 volunteers whose HIV was suppressed with antiretroviral treatment and who were sensitive to 3BNC117 and 10-1074, both potent bNAbs.

Participants received infusions of both bNAbs, stopped taking antiretroviral therapy (ART) two days later, and received additional infusions three and six weeks later.

Of the 11 people who completed the study, nine maintained viral suppression without ART for an average of 15 weeks, until the amount of bNAbs in their body fell below protective levels. In two of the nine participants, the virus was controlled through the end of the 30-week follow-up period. The remaining two participants were found to harbor HIV that was resistant to at least one bNAb, and they experienced viral rebound before 12 weeks after stopping ART.

The researchers are enrolling people with HIV in a larger study to determine an optimal regimen of bNAbs.

Source: NIH, September 26, 2018. Available at: https://bit.ly/2S08xlV.. Accessed November 16, 2018.

Gene Mutation May Lower Cardiometabolic Risk

A gene mutation that slows sugar metabolism in the gut may lower some people’s risk of diabetes, obesity, heart failure, and even death.

Researchers from Harvard University and Brigham and Women’s Hospital say their study is the first to fully evaluate the link between mutations in sodium glucose co-transporter-1 (SGLT-1)—the gene responsible for absorbing glucose in the gut—and cardiometabolic disease.

The researchers used genetic data from 8,478 participants in the 25-year Atherosclerosis Risk In Communities (ARIC) study. Participants who carried the mutation (6%) had a lower risk of type-2 diabetes, were less obese, had a lower incidence of heart failure, and a lower mortality rate than participants without the mutation, regardless of dietary intake.

The researchers suggest that their findings “open the door to improved therapies” for cardiometabolic diseases.

Source: NIH, October 9, 2018. Available at: https://bit.ly/2A1sOBi.. Accessed November 19, 2018.

MVP Data Reveal Gene Mutations Ruling Cholesterol

Veterans Administration (VA) researchers have identified three genetic mutations that govern cholesterol levels, which could lead to new drugs for treating cardiovascular disease and diabetes.

Using data from the Million Veteran Program (MVP), the researchers found that people with mutations for PDE3B, PCSK9, and ANGPTL4 had better cholesterol and triglyceride levels than people without the mutations.

The PDE3B mutation appears to protect against heart disease, and a PCSK9 mutation may reduce the risk not only of heart disease, but of abdominal aortic aneurysm. The ANGPTL4 mutation was linked to a lower risk of type-2 diabetes.

MVP, one of the world’s largest databases of health and genomic information, partners with veterans receiving care in the veterans health administration (VHA) to study how genes affect health. It has enrolled more than 700,000 veterans to date.

Source: U.S. Department of Veterans Affairs, October 25, 2018. Available at: https://bit.ly/2OUoNmN.. Accessed November 19, 2018.

Are Doctors Willing to PrEP Young Patients?

In 2015, young people aged 13 to 24 years—disproportionately young men and boys—accounted for 23% of new HIV infections. Pre-exposure prophylaxis (PrEP) can prevent HIV, and has been found safe and effective for young people, but are health care providers who treat adolescents willing to prescribe it?

Researchers from the University of California, San Francisco say internal medicine and infectious diseases providers have expressed concerns about adherence, development of resistant HIV strains, higher-risk sexual behavior, cost, toxicity, and lack of evidence. However, data are lacking among youth health care providers. To find out how aware those clinicians are about PrEP, and how willing they are to prescribe it, the researchers conducted an online survey of members of the Society of Adolescent Health and Medicine.

Almost all of the 162 respondents had heard of PrEP, and agreed that it prevents HIV. Of the respondents, 57 (35%) had prescribed PrEP. While 73% said they had treated few to no young patients with HIV, 65% were willing to prescribe it to adolescents (aged 13 to 17) and young adults. Only 30 respondents said they would refer adolescents and 25 respondents would refer young adults.

Among the providers who would refer or were not willing to prescribe to adolescents, 35 (67%) would prescribe PrEP if it were FDA-approved for adolescents.

Willingness to prescribe was associated with the provider having enough knowledge to safely provide PrEP to adolescents and a belief that adolescents would adhere to a daily medication regimen. Some providers also said they would prefer to know that they could ensure confidentiality.

The researchers say their findings highlight potential opportunities to reduce HIV incidence among young people by shaping educational and implementation tools to improve provider self-efficacy and youth adherence.

Source: Journal of Adolescent Health, August 2018, 63(2), pp. 242–244. doi: 10.1016/j.jadohealth.2018.03.016. Accessed November 16, 2018.

Does Coffee Help or Harm HBV Patients?

Coffee drinking has been linked to the reduced risk of fibrosis progression, liver cirrhosis, and hepatocellular carcinoma in some patients, including those with hepatitis C virus infection, but the results of studies in patients with hepatitis B virus (HBV) infection have been inconsistent. Given the “global impact of HBV infection and the wide consumption of coffee,” researchers from Tzu Chi University, Taiwan, wanted to find out more.

They analyzed data from 328 patients with chronic HBV infection who were enrolled in a population-based gastroesophageal reflux disease study. 155 of those patients also entered into a five-year follow-up study.

Among the patients with chronic HBV, 137 did not drink coffee. Of the 191 patients who did drink coffee, 61 drank it on fewer than four days a week, and 130 drank it on four or more days.

Initially, the researchers observed an inverse association between coffee drinking and serum aspartate aminotransferase levels, as well as predicting indices of liver fibrosis in patients with HBV infection. Patients who drank four or more cups of coffee per day had a 70% decrease of serum AST, a 70% decrease of the aspartate aminotransferase to platelet ratio (APRI) index, and a 70% decrease of fibrosis-4 (FIB-4) index values.

Those findings indicated that coffee might have a “generally beneficial” effect on liver inflammation and fibrosis progression in patients with chronic liver disease, the researchers say. However, at the end of the five-year follow-up, the incidences of liver cirrhosis complications and changes of serum-predicting indices of liver fibrosis were comparable between coffee drinkers with HBV and nondrinkers with HBV. That indicated, the researchers believe, that the beneficial effect “seems to be outweighed” in patients with chronic HBV infection.

They suggest that the protective effects of coffee consumption on liver inflammation and insulin resistance may not be able to surpass the direct carcinogenic effect of HBV, and even the HBV virus replication.

Source: Journal of the Formosan Medical Association, August 17, 2018. Available at: https://bit.ly/2PDr9LS.. Accessed November 19, 2018.