Pages

Wednesday, November 18, 2015

Dallas-Based Dietary Supplement Maker Indicted For Fraud As Part Of “Widespread Crackdown.”


The Wall Street Journal (11/18, Burton, Subscription Publication) reports that dietary supplement maker USPlabs LLC and its executives were charged with fraud by a Federal grand jury in Texas on Tuesday. Officials from the Justice Department, the Food and Drug Administration, the Federal Trade Commission, the US Postal Inspection Service, and other agencies say the indictment was part of a nationwide effort targeting illegal marketing of dietary supplements.

The New York Times (11/17, B2, O'Connor) reports in its “Well” blog that the USPlabs indictment is “at the center” of a “yearlong federal investigation into the dietary supplement industry,” resulting in a “widespread crackdown on more than 100 companies accused of selling tainted or misleading products.” USPlabs sold a supplement, OxyElite Pro, linked to a 2013 outbreak of liver disease that killed one person and sickened 97 people.

Bloomberg News (11/17, Mittelman, Townsend) reports that SK Laboratories Inc., “which makes supplements for USPlabs, was also charged in the case.”

The AP (11/18, Tucker) reports that USPlabs was directed by the FDA to recall its OxyElite Pro product in 2013, and while it told the agency it would stop distributing it, it instead began a “surreptitious, all-hands-on-deck effort to sell as much OxyElite Pro as it could as quickly as possible,” according to the criminal complaint.

The Washington Post (11/17, Merle, Dennis) reports that USPlabs allegedly told retailers that some of its products had natural plant extracts that were actually a synthetic stimulant made in a chemical factory in China, the DOJ complaint alleges.

The Hill (11/18, Wheeler) reports that the DOJ also filed civil cases against Vibrant Life, Viruxo, Optimum Health, Bethel Nutritional Consulting and Regeneca Worldwide. The Federal Trade Commission “has also taken civil actions against Sunrise Nutraceuticals LLC, Health Nutrition Products and NPB Advertising Inc.” for allegedly “making false, misleading or unsubstantiated health and [effectiveness] claims.”

Also covering the story are Reuters (11/18, Bartz), a separate Bloomberg News (11/18, McLaughlin) article, the CBS News (11/18, Gibson) website, the NBC News (11/18, Fox) website, the NPR (11/17, Wagner) “The Two-Way,” the Dallas Morning News (11/18, Lindenberger), Stat (11/17, Swetlitz), Vox (11/17, Belluz), and the Food Safety News(11/18, Flynn).


Tuesday, November 17, 2015

FDA Approves Drug To Treat Multiple Myeloma.

Source: http://www.cancer.gov/images/cdr/live/CDR763079-750.jpg

The AP (11/17, Johnson) reports that the Food and Drug Administration approved Johnson & Johnson’s Darzalex (daratumumab), a drug “for treating the incurable blood cancer multiple myeloma in patients who’ve failed prior therapies and have few options left.” The drug is not only the first biologic, but also the first monoclonal antibody approved to treat multiple myeloma.

Also covering the story are Reuters (11/17, Pierson), HealthDay (11/17, Roberts), MedPage Today (11/17, Bankhead), and Medscape (11/17, Chustecka).



WHO Survey Indicates People Lack Understanding Of Antibiotics.

Image Source: http://ibraheem-altowaiher.deviantart.com/art/Antibiotics-MD-198124195

Reuters (11/17, Kelland) reports that according to the World Health Organization, peoples’ misunderstanding and ignorance of antibiotics is contributing to the increase in drug-resistant pathogens. A survey released by the WHO revealed that 64 percent of participants incorrectly believed that antibiotics could be used to treat colds and the flu. Additionally, a third of people surveyed believed that they should stop taking antibiotics when they feel better instead of completing the entire treatment course as prescribed.

CBS News (11/17) reports on its website that the WHO “surveyed nearly 10,000 people across 12 countries as part of the CDC’s ‘Get Smart About Antibiotics Week,’-- an effort to stop the threat posed by resistance to antibiotics.” Meanwhile, another “76 percent of respondents believed antibiotic resistance meant the body was becoming resistant, but it is actually the bacteria that is becoming resistant.” Medscape (11/17, Brooks) also reports on the story.




Sunday, November 15, 2015

Saturday, November 14, 2015

Is 120 mm Hg the new BP target? What headlines aren’t telling you

The results of the SPRINT trial are in, and you’ve probably heard that making 120 mm Hg the new blood pressure target helped lower mortality rates. Yet the study outcomes apply only to a specific subset of patients with hypertension. See whether or not your patients may fit into this category. Read more at AMA Wire®.

Tuesday, November 10, 2015

Lowering Blood Pressure Target May Lead To Lower Rates Of CV Events.

The CBS Evening News (11/9, story 9, 1:25, Pelley) reported that “a new study that says sharply lower blood pressure leads to significantly longer lives.” On ABC World News(11/9, story 8, 1:00, Muir), ABC’s Dr. Richard Besser reported, “The results were so startling, they stopped the study...early.”

In a 1,300-word article, the New York Times (11/10, Kolata, Subscription Publication) reports that investigators found that “among the 9,361 hypertension patients followed for an average of 3.2 years, there were 27 percent fewer deaths (155 compared with 210) and 38 percent fewer cases of heart failure (62 compared with 100) among patients who achieved the systolic pressure target of 120 than among those who achieved the current 140 target.” Altogether, “there was a 25 percent reduction — 243 compared with 319 — in people who had a heart attack, heart failure or stroke or died from heart disease, Dr. Paul K. Whelton, a principal investigator for the study, said.” The findings were presented at the American Heart Association meeting and published in the New England Journal of Medicine.

The AP (11/10, Marchione) reports that “too-low blood pressure, fainting episodes and more worrisome, kidney problems were 1 percent to 2 percent higher in the lower pressure group.” However, “falls that cause injury due to lightheadedness were not more common, as had been feared especially for older people.”

The Seattle Times (11/10, Aleccia) reports that “the study, dubbed the Systolic Blood Pressure Intervention Trial — or SPRINT — was stopped in September, nearly two years early, when it became clear that radically lowering blood pressure for many people older than 50 helped prevent heart attacks and other heart problems and deaths.”




Friday, October 30, 2015

Reduced-Fat Diets No More Effective Than Other Weight-Loss Diets, Meta-Analysis Suggests.


Bloomberg News (10/29, Tozzi) reports that a meta-analysis published Oct. 29 in The Lancet Diabetes & Endocrinology “finds reducing fat isn’t any more effective for losing weight than other diets.”

The CBS News (10/29, Marcus) website reports that after analyzing data from “53 studies” including “more than 68,000 adults,” researchers found that “reduced-fat diets only led to more weight loss when compared with no diet at all.” Individuals “on low-carbohydrate diets lost substantially more weight than those who went the low-fat route.”

TIME (10/29, Sifferlin) reports that the study authors concluded that “public health guidelines should stop recommending low-fat diets for weight loss, stressing that more research is needed to find what strategy is most effective and able to be maintained.”

Also covering the story are CNBC (10/29, Ferris), VoxHealthDay (10/29, Doheny), AFP (10/29), the Telegraph (UK) (10/29, Donnelly), and The Guardian (UK) (10/29, Boseley).

Friday, October 23, 2015

FDA Warns Hepatitis C Drugs Could Cause Severe Liver Damage To Patients With Underlying Liver Disease.

The Wall Street Journal (10/23, Loftus, Subscription Publication) reports that the Food and Drug Administration issued a warning on Thursday that AbbVie Inc.’s Viekira Pak (ombitasvir/paritaprevir/ritonavir with dasabuvir) and Technivie (ombitasvir/paritaprevir/ritonavir) may cause severe liver damage to patients who have an underlying liver disease.

The Washington Post (10/23, Dennis) reports that the FDA said it had received reports of at least 26 cases since late 2014 of patients “who either died or had to undergo liver transplantation” after taking the hepatitis C drugs, with the liver damage occurring in the first month of treatment. According to the Post, the agency “will require AbbVie to add new warnings to the safety labels of the drugs for patients who already have advanced liver disease linked to hepatitis C” and “urged doctors to closely monitor patients taking the drugs for symptoms of worsening liver disease.” Bloomberg News (10/23, Bloomfield) and the AP (10/23, Perrone) also cover the story.

Wednesday, October 7, 2015

Late Bedtimes May Be Linked To Weight Gain Over Time.


On its website, CBS News (10/3, Welch) reported that research published in Sleep suggests that “going to bed later during the workweek is associated with weight gain over time.” Investigators looked at “data on more than 3,300 teens and young adults recorded at different intervals over the course of about 15 years.”

HealthDay (10/3, Preidt) reported that the investigators “found that each extra hour of late bedtime was associated with a more than two-point increase in body mass index (BMI).” The data indicated that the association “between late bedtimes and BMI increase was not significantly affected by total sleep time, amount of exercise, or time spent in front of computers or televisions.”

Wednesday, September 30, 2015

Calcium Supplements May Not Strengthen Bones In Women Under 80, Study Finds.



David Muir reported on ABC World News (9/29, story 10, 0:30, Muir) that new research finds “taking daily calcium supplements does little to strengthen bones in women under 80.” Muir reported, “Only women over 80 and in nursing homes saw hip fractures decrease by 23 percent.”

Correspondent Rehema Ellis reported on NBC Nightly News (9/29, story 7, 2:15, Holt) that investigators “concluded that most people over 50 won’t get stronger bones if they increase their calcium intake.” The findings were published in the British Medical Journal.

Meanwhile, NBC News (9/30) reports on its website that the “extra calcium doesn’t go to strengthen bones but instead can build up in the arteries, causing heart disease, or in the kidneys, causing kidney stones.”

TIME (9/30, Sifferlin) reports the results from the meta-analysis “suggest that clinicians, advocacy organizations and health policymakers should not recommend increasing calcium intake for fracture prevention either with calcium supplements or through dietary sources,” the New Zealand researchers wrote. TIME adds that the “new results also fall in line with the guidance provided by the United States Preventative Services Task Force in 2013,” which, based on the evidence available, ultimately concluded that “post-menopausal women should not take daily supplements.”

Also covering the story are HealthDay (9/30), LiveScience(9/30), and the Telegraph (UK) (9/30).


Friday, September 18, 2015

Diabetes Medication May Reduce Deaths From Cardiovascular Disease, Study Suggests.

The New York Times (9/18, B2, Pollack, Subscription Publication) reports that “for the first time, a widely used modern diabetes” medication “has been shown to reduce deaths from cardiovascular disease, a long-sought goal of treatment, researchers announced” yesterday. The research(9/18) was presented at the annual meeting of the European Association for the Study of Diabetes and published in The New England Journal of Medicine.

On its website, NBC News (9/17) reports that the medication, “called Jardiance [empagliflozin], lowered heart disease deaths by 38 percent and deaths from any cause by 32 percent over three years.”

The AP (9/18, Johnson) reports that the findings “were particularly striking because nearly four-fifths of the participants were already taking standard medicines to control blood sugar, blood pressure and cholesterol, plus taking either Jardiance or a” placebo.

CDC Says Flu Vaccine May Be More Effective This Year.

The CBS Evening News (9/17, story 12, 1:45, Pelley) reported that this year’s influenza vaccine may be more effective than last year’s. According to Dr. Jon Lapook, “Last year, the vaccine was only 23 percent effective because the predominant strain mutated after the vaccine had already been manufactured.” CDC “officials say this year’s flu vaccine is well-matched right now to circulating viruses.”

The Los Angeles Times (9/18, Kaplan) reports that this year, “flu watchdogs at the CDC have scrutinized 199 flu specimens collected in the United States and elsewhere between May 24 and Sept. 5.” They found that “the majority of those specimens – 118 of them – were H3N2 viruses, and all of them were built in a way that should make them vulnerable to this year’s vaccines.”

McClatchy (9/18, Mueller) reports that “by including components of H3N2 in this season’s flu vaccine, health care professionals hope to raise vaccine effectiveness against predominant strains back up to the 50 to 60 percent range.”

The AP (9/18, Neergaard) reports that, “all told, at least 171 million doses of flu vaccine are expected this year.” Meanwhile, Dr. Tom Frieden, director of the Centers for Disease Control and Prevention, said “it doesn’t matter which flu vaccine you get, just get one.”

Tuesday, September 15, 2015

Guidelines For Chronic Kidney Disease Diagnosis Cause Debate Among Physicians.



The New York Times (9/15, Span, Subscription Publication) reports that the guidelines for the diagnosis of chronic kidney disease are causing debate among physicians, with some arguing “that the guidelines should be recalibrated by age.” Authors of a recent viewpoint article in JAMA “propose that in people older than 65, the diagnosis should require a G.F.R. [glomerular filtration rate] reading less than 45,” as opposed to the current reading of 60, which they estimate will reduce “a third to half of the chronic kidney disease diagnosed.” Authors of an opposing viewpoint article, however, “warned against changing the guidelines,” saying that people need to know that they have low GFR levels in order to “take some steps to reduce the risk of eventual kidney failure, even if that’s already extremely low.”

Monday, September 14, 2015

Aggressive Blood-Pressure Reduction May Reduce Cardiovascular Problems, Deaths.

During its Friday broadcast, NBC Nightly News (9/11, story 7, 2:05, Snow) reported, “The National Institutes of Health said today that more aggressively lowering target blood pressure would cut the death rate by a staggering 25 percent.”

In a 1,200-word story on its front page, the New York Times(9/12, A1, Kolata, Subscription Publication) reported that in the study, researchers “randomly assigned more than 9,300 men and women ages 50 and over who were at high risk of heart disease or had kidney disease to one of two systolic blood pressure targets: less than 120 millimeters of mercury, which is lower than any guideline ever suggested, or less than 140.” The researchers “found that patients who were assigned to reach a systolic blood pressure goal below 120 — far lower than current guidelines of 140, and 150 for people over 60 — had their risk of heart attacks, heart failure and strokes reduced by a third and their risk of death reduced by nearly a quarter.”

The AP (9/12, Neergaard) reported that “the benefit was strong enough that NIH stopped the study about a year early.”

The Wall Street Journal (9/12, A1, Armao, Whalen, Subscription Publication) reported on its front page that during a conference call during which the findings were announced, Dr. Gary H. Gibbons, director of the National Heart, Lung and Blood Institute, said, “More intensive management of high blood pressure in people 50 years and older can save lives and reduce cardiovascular complications, such as heart attacks.” Gibbons added, “This new important information has the potential to benefit a portion of the estimated one in three adults in the United States who suffer from high blood pressure, as well as millions of others worldwide.”

On its front page, the Washington Post (9/12, A1, Bernstein) points out that “the NHBLI was the primary sponsor of the” research. In a statement, Dr. Gibbons said, “This study provides potentially lifesaving information that will be useful to health care providers as they consider the best treatment options for some of their patients, particularly those over the age of 50.”

USA Today (9/12, Szabo) reported, however, that “NIH researchers did not provide any details about how many lives were saved or the side effects of lowering blood pressure so dramatically.”

Also covering the story were Reuters (9/12, Berkrot), Forbes (9/12, Hedgecock), the NPR (9/12, Stein) “Shots” blog, Newsweek (9/12, Firger), CNN (9/12, Capelouto, Goldschmidt), the Huffington Post (9/12), TIME (9/12, Luckerson), Medscape (9/12, O'Riordan), and HealthDay(9/12, Thompson, Reinberg).


Sunday, September 13, 2015

Metformin potentially underused among patients with mild kidney disease, study finds


More patients would be eligible for metformin use if estimated glomerular filtration rate (eGFR) were used to define kidney disease rather than serum creatinine (sCr), a recent study concluded.

Researchers used data from the 1999 to 2010 National Health and Nutrition Examination Survey (NHANES) to analyze 3,902 adult participants with diabetes (defined by self-report or an HbA1c ≥6.5%) who reported a routine site for health care. Results were published online on Aug. 25 by Diabetes Care

Across all 12 years, 66.4% of adults with diabetes were treated with a diabetes medication, and this percentage increased over time, from 61.3% in 1999 to 2000 to 69.7% in 2009 to 2010. Metformin use among those with diabetes and a routine site for health care increased from 26.1% to 44.5%.

Among NHANES adults with diabetes and routine care access, 8.8% were ineligible for metformin because of the FDA's contraindication among individuals with sCr ≥1.4 mg/dL for women and ≥1.5 mg/dL for men. Compared with those who were eligible for the drug, those ineligible were older and more likely to be non-Hispanic black or to have a yearly family income less than $45,000.

Researchers also looked at the patients using (eGFR) categories: likely safe to take metformin, ≥45 mL/min/1.73 m2; contraindicated, <30 mL/min/1.73 m2; and indeterminate, 30 to 44 mL/min/1.73 m2. Evidence has shown eGFR to be a more accurate estimate of kidney function than sCr, the authors noted.

Among individuals ineligible for metformin using conventional sCr thresholds, 14.6% had an eGFR ≥45 mL/min/1.73 m2 and 50% had an eGFR between 30 and 44 mL/min/1.73 m2. Only 35.7% of study participants would be ineligible for metformin based on an eGFR <30 mL/min/1.73 m2.

Based on these results, just by adding those for whom metformin is safe according to eGFR criteria, the researchers estimated the number of individuals eligible for metformin in the U.S. can be expanded by between 86,900 and 834,800 people, depending on which method is used to estimate GFR. Most of the potentially eligible patients are male and non-Hispanic blacks. This figure does not take into account the population with eGFR of indeterminate safety (30 to 44 mL/min/1.73 m2), which could range from 784,700 to 1,636,000 people. A randomized controlled trial is needed to clarify whether metformin use in this subgroup would be safe and efficacious, the authors noted.

Limitations of the study are that NHANES is not a clinical database, although the researchers restricted the study population to those who self-reported a routine site for health care. They also noted that they could not determine the reasoning behind low levels of metformin use, which could include non-renal clinical conditions that contraindicate the use of metformin, such as liver disease.

Friday, August 14, 2015

Pioglitazone use not associated with increased risk of bladder cancer, study finds

Pioglitazone was not found to be associated with a statistically significant increased risk of bladder cancer or 8 of 10 additional cancers in a recent study.

In a large, long-term study, researchers analyzed pioglitazone use and associated risks of the following cancers: bladder, prostate, female breast, lung/bronchus, endometrial, colon, non-Hodgkin lymphoma, pancreas, kidney/renal pelvis, rectum, and melanoma. Results were published on July 21 by the Journal of the American Medical Association.

Of 193,099 people studied, 34,181 (18%) received pioglitazone and 1,261 had incident bladder cancer. Crude incidences of bladder cancer in users and nonusers were 89.8 and 75.9 per 100,000 person-years, respectively, and ever having taken pioglitazone was not associated with bladder cancer risk (adjusted hazard ratio [HR], 1.06; 95% CI, 0.89 to 1.26). However, the study cannot exclude up to a 54% increased risk of bladder cancer, the authors noted.

Use of other diabetes medications, such as metformin, sulfonylureas, insulin, and other thiazolidinediones, was also not significantly associated with bladder cancer risk, with adjusted HRs ranging from 0.91 to 1.09, according to the study.

Although use of pioglitazone was not associated with 8 of 10 additional cancers in adjusted analyses of 236,507 people (HRs ranged from 0.81 to 1.15), use of the medication was associated with increased risk of prostate cancer (HR, 1.13; 95% CI, 1.02 to 1.26) and pancreatic cancer (HR, 1.41; 95% CI, 1.16 to 1.71). Crude incidences of the cancers in pioglitazone users and nonusers were 453.3 versus 449.3 for prostate and 81.1 versus 48.4 for pancreatic per 100,000 person-years. "The increased prostate and pancreatic cancer risks associated with ever use of pioglitazone merit further investigation to assess whether they are causal or are due to chance, residual confounding, or reverse causality," the study authors wrote.

Use of insulin was associated with a decreased risk of prostate cancer (HR, 0.90; 95% CI, 0.81 to 0.99). Use of metformin (HR, 1.21; 95% CI, 1.02 to 1.43), insulin (HR, 2.34; 95% CI, 1.97 to 2.78), and sulfonylureas (HR, 1.49; 95% CI, 1.22 to 1.81) and never having 2 prescriptions of a diabetes medication from the same class within 6 months (HR, 1.55; 95% CI, 1.02 to 2.36) were each associated with increased risk of pancreatic cancer. The fact that other diabetes medications were also associated with an increased risk of pancreatic cancer suggests reverse causality because hyperglycemia is an early manifestation of the cancer, the authors wrote.

The researchers noted that their observational study has potential for unmeasured confounding; has limited statistical power for subgroup analyses related to time since initiation, dose, and duration; and could not exclude all patients with type 1 diabetes (although they minimized this by excluding those under 40).

Wednesday, July 15, 2015

New warnings required for nonaspirin NSAIDs

The FDA issued a safety alert last week regarding cardiovascular warnings for nonaspirin NSAIDs.

Prescription NSAIDs have carried warnings about heart attack and stroke risk since 2005. After reviewing new safety information, the FDA decided to strengthen the existing warning and require that all labels for prescription NSAIDs include the following information:

  • The risk of heart attack or stroke can occur as early as the first weeks of NSAID use; it may increase with longer use and appears to be greater at higher doses.
  • All NSAIDs were previously thought to have a similar risk for heart attack or stroke. Newer information makes this less clear but is not sufficient for the FDA to determine that any particular NSAID definitely has a higher or lower risk than any other.
  • NSAIDs can increase the risk of heart attack or stroke in patients with or without heart disease or heart disease risk factors.
  • In general, patients with heart disease or risk factors for heart disease have a greater likelihood of heart attack or stroke after NSAID use than patients without these risk factors because their baseline risk is higher.
  • Patients treated with NSAIDs after a first heart attack were more likely to die in the first year afterward than those who were not treated with NSAIDs after their first heart attack.
  • Heart failure risk is increased with NSAID use.

The agency is also requesting that these changes be made to the labels of over-the-counter nonaspirin NSAIDs.

The FDA recommended that patients and health care professionals remain alert for heart-related side effects the entire time NSAIDs are taken. Patients who are taking NSAIDs should seek medical attention immediately if they experience such symptoms as chest pain, shortness of breath or trouble breathing, weakness in one part or side of their body, or slurred speech, the FDA said.

The safety alert, which was issued July 9, is available online

Tuesday, June 2, 2015

ACE inhibitors, ARBs most effective against ESRD in patients with diabetes, kidney disease

Angiotensin-converting enzyme (ACE) inhibitors and angiotensin-receptor blockers (ARBs) appear most effective in preventing end-stage renal disease (ESRD) in patients with diabetes and kidney disease, although no regimen to lower blood pressure seems to prolong survival, a recent analysis has found.

Researchers performed a network meta-analysis of randomized trials comparing the effects of oral blood pressure-lowering agents in adults who had diabetic kidney disease. The primary outcomes were all-cause mortality and ESRD; secondary safety and cardiovascular outcomes were also assessed. All drug regimens were ranked comparatively against placebo. The study results were published online on May 23 by The Lancet

Overall, 157 studies involving 43,256 patients were included in the meta-analysis. The mean patient age was 52.5 years. The drug classes compared with placebo or standard treatment were ACE inhibitors, ARBs, aldosterone antagonists, beta-blockers, calcium-channel blockers, endothelin inhibitors, and renin inhibitors. None of the drug regimens examined appeared to be more effective in reducing all-cause mortality. ESRD was significantly less likely in patients treated with an ARB and an ACE inhibitor (odds ratio, 0.62; 95% CI, 0.43 to 0.90) and in those treated with only an ARB (odds ratio, 0.77; 95% CI, 0.65 to 0.92) versus those treated with placebo.

Hyperkalemia and acute kidney injury did not appear to increase significantly with any regimen (calcium-channel blocker, beta-blocker, ACE inhibitor plus diuretic, endothelin inhibitor, diuretic, renin inhibitor, ARB, ACE inhibitor, aldosterone antagonist, and ACE inhibitor plus ARB for hyperkalemia; ACE inhibitor plus calcium-channel blocker, calcium-channel blocker, ACE inhibitor, renin inhibitor, endothelin inhibitor, ARB, aldosterone antagonist, and ACE inhibitor plus ARB for acute kidney injury). However, the authors noted that ACE inhibitor plus ARB was the regimen with the highest odds ratios for these 2 outcomes (odds ratios, 2.69 [95% CI, 0.97 to 7.47] and 2.69 [95% CI, 0.98 to 7.38]).

The authors noted that their study had limited primary data, that data for the ESRD outcome came mainly from patients with macroalbuminuria and patients with type 2 diabetes, and that acute kidney injury was not well defined, among other limitations. They concluded that based on available evidence, lowering blood pressure in adults with diabetes and kidney disease does not appear to improve survival but that ACE inhibitors and ARBs, together or alone, appear most effective in preventing ESRD in this population.

"However, we must consider the potential harms of these treatments in individual patients," the authors wrote. "Surveillance for treatment-related acute kidney injury and hyperkalaemia is important, as is better standardisation of the definitions of these adverse events and improved understanding of their outcomes, particularly in the context of future trials." They also noted that their results don't support the use of beta-blockers, calcium-channel blockers, renin inhibitors, or diuretic monotherapy in this patient population.

The authors of an accompanying comment said that the results "reignite the debate" about the utility of dual renin-angiotensin-aldosterone system (RAAS) blockade and said that the findings will help researchers design future trials examining this question. The comment authors pointed out that preventive treatments for end-stage kidney failure are urgently needed in diabetic patients.

"Screening for albuminuria and prompt initiation of lifestyle and pharmacological interventions is likely to prevent progression of chronic kidney disease and cardiovascular disease," they wrote. "Addition of dual ACE inhibitor and ARB treatment to this multifactorial management approach—if confirmed to be efficacious and cost effective—might further improve patients' outcomes in regions of the world where careful selection of patients and close monitoring are possible."

Saturday, May 16, 2015

Power Down in May for National High Blood Pressure Education Month

http://www.cdc.gov/Features/HighBloodPressure/

Photo: Doctor taking woman's blood pressureReducing high blood pressure can lower your risk for stroke and heart attack.

Less is better in some things, including in blood pressure. About 1 of 3 US adults—67 million people—have high blood pressure.1High blood pressure makes your heart work too hard and increases your risk of heart disease and stroke.

You can have high blood pressure and not know it. That is why it is called the silent killer. It is also why it is so important to have your blood pressure checked. If you know family or friends who haven't had their blood pressure checked recently, make it a point to ask them to do it in May, National High Blood Pressure Education Month.

It is easy to check blood pressure and it is painless. It can be checked by your doctor, and many pharmacies have free screenings.

Caution! Arteries Under Pressure

Photo: Senior man by swimming pool

Blood pressure is the force of blood on the walls of your blood vessels as blood flows through them. This pressure naturally rises and falls during the day, but when it is consistently too high, it is considered high blood pressure. The medical term is hypertension.

Like the pipes in your house, your arteries can fail if they are under too much pressure. The video, "High Blood Pressure Basics," illustrates the concept of high blood pressure.

More than 360,000 American deaths in 2010 included high blood pressure as a primary or contributing cause.2 That's 1,000 deaths each day.

Blood pressure has two numbers, systolic and diastolic, and is measured in millimeters of mercury (mmHg). Systolic pressure (the top number) is the force on the blood vessel walls when the heart beats and pumps blood out of the heart. Diastolic pressure (the bottom number) is the force that occurs when the heart relaxes in between beats.

If your blood pressure is less than 120 systolic and less than 80 diastolic, then your blood pressure is normal; between 120 and 139 systolic and 80–89 diastolic, you have prehypertension. Systolic of 140 or greater, or diastolic that is 90 or greater, is hypertension.

What Is Your Risk?

Men and women are about equally likely to develop high blood pressure over their lifetimes, but their risks vary at different ages. The condition affects more men than women before 64 years of age. For people aged 65 years or older, more women than men have high blood pressure.

Age

Men (%)

Women (%)

20–349.16.7
35–4424.417.6
45–5437.737.7
55–6452.052.0
65–7463.970.8
75+72.180.1

Data in this table are from the 2014 AHA Statistical Update, using 2007-2010 NHANES

African Americans develop high blood pressure more often, and at an earlier age, than whites and Hispanics do. More black women than men have high blood pressure.3

Racial or Ethnic Group

Men (%)

Women (%)

Blacks40.544.3
Mexican Americans28.627.8
Whites31.128.1
All31.329.6

Data in this table are from Health US 2012, using 2007-2010 NHANES

African American men are disproportionately affected by cardiovascular disease (CVD). One of the reasons for this has to do with the rates of uncontrolled high blood pressure among African American men. Uncontrolled high blood pressure among African American men aged 20 years and older is 59.7%; compared to 47.0% of white men. Uncontrolled hypertension among African American women is 47.3% compared to 43.2% for white women.2

Eliminating health disparities among various segments of the population is a CDC priority and a Healthy People 2010 goal.

Keep It Down in There!

If you have high blood pressure, there are steps you can take to get it under control, including—

  • Ask your doctor what your blood pressure should be.Set a goal to lower your pressure with your doctor and then discuss how you can reach your goal. Work with your health care team to make sure you meet that goal.
  • Take your blood pressure medication as directed. If you are having trouble, ask your doctor what you can do to make it easier. For example, you may want to discuss your medication schedule with your doctor if you are taking multiple drugs at different times of the day. Or you may want to discuss side effects you are feeling, or the cost of your medicine.
  • Quit smoking—and if you don't smoke, don't start.You can find tips and resources at CDC's Smoking and Tobacco Web site or Be Tobacco Free Web site.
  • Reduce sodium. Most Americans consume too much sodium, and it raises blood pressure in most people. Learn about tips to reduce your sodium.

Photo: Two women riding bicyclesThere are other healthy habits, that can help keep your blood pressure under control—

  • Achieve and maintain a healthy body weight.
  • Participate in 30 minutes of moderate physical activity on most days of the week.
  • Eat a healthy diet that is high in fruits and vegetables and low in sodium, saturated fats, trans fat, and cholesterol.
  • Manage stress.
  • Limit the amount of alcohol you drink (no more than one drink each day for women and two for men).
  • If you have high blood pressure and are prescribed medication, take it as directed.
  • If you have a family member who has high blood pressure, you can help by taking many of the steps listed above with them. Go for walks together or cook meals with lower sodium. Make it a family affair!
  • Check your blood pressure regularly.

Resources

The Dietary Approaches to Stop Hypertension (DASH) can help control high blood pressure through a healthy diet.

"I can do it!" is the message of the My Blood Pressure Wallet Card that helps patients monitor their blood pressure readings, remember to take their medications, and keep up the lifestyle changes that will help lower their blood pressure.

Million Hearts® is a national initiative to prevent 1 million heart attacks and strokes in the United States by 2017. Launched by the US Department of Health and Human Services (HHS), it aligns existing efforts and creates new programs to help Americans live longer, more productive lives. The CDC and Centers for Medicare and Medicaid Services, co-leaders of Million Hearts™ within HHS, are working alongside other federal agencies and private-sector organizations to make a long-lasting impact against cardiovascular disease.

References

  1. CDC. Vital signs: awareness and treatment of uncontrolled hypertension among adults—United States, 2003–2010. MMWR. 2012;61:703-9.
  2. Go AS, Mozaffarian D, Roger VL, et al. Heart disease and stroke statistics-2014 update: a report from the American Heart Association. Circulation.2014;129:e28-e292.
  3. CDC. Health, United States, 2012: With Special Feature on Emergency Care. Atlanta, GA: US Department of Health and Human Services; 2013.
  4. CDC. A Closer Look at African American Men and High Blood Pressure Control: A Review of Psychosocial Factors and Systems-Level Interventions. Atlanta, GA: US Department of Health and Human Services; 2010.

Tuesday, May 12, 2015

PE recurrence same with vena cava filter plus anticoagulation as anticoagulation alone

Adding an inferior vena cava filter did not reduce the risk of recurrent pulmonary embolism (PE) compared to anticoagulation alone, according to a recent study of French patients hospitalized with PE.

The open-label trial included patients who were hospitalized with acute, symptomatic PE associated with lower-limb venous thrombosis and who met at least 1 criterion for severity between 2006 and 2012. The patients were randomized to retrievable inferior vena cava filter implantation plus anticoagulation (n=200) or anticoagulation alone (n=199) and were followed for 6 months. Patients with a contraindication to anticoagulation therapy and those with recurrence despite adequate anticoagulation were excluded. Results were published in the April 28 Journal of the American Medical Association

Filters were successfully inserted in 193 patients, and they were retrieved, at 3 months after placement, in 153 of the 164 patients in whom retrieval was attempted. By 3 months, 6 patients in the filter group had a recurrent PE (3.0% of the group, all were fatal), compared to 3 patients in the anticoagulation-only group (1.5% of the group; 2 fatal; P=0.50 for PE recurrence). The groups also had similar rates of recurrence within 6 months, symptomatic deep venous thrombosis, major bleeding, and mortality within 3 or 6 months. Filter thrombosis occurred in 3 patients. One patient died of cardiac arrest during filter insertion.

Implantation of the filters did not reduce risk of symptomatic PE recurrence, and thus the study's results do not support use of inferior vena cava filters in PE patients who can be treated with anticoagulation, the study authors concluded. The rate of PE recurrence in the study was less than expected, but this shows that "modern management with full-dose anticoagulation is likely very effective even in patients usually considered to be at high risk for recurrence," the authors wrote.

The study was limited by its open-label design and its small size, and the results do not exclude the possibility of benefit from filters in certain subgroups of patients with venous thromboembolism, such as those with PE and hemodynamic instability. The study used the ALN brand of filter (provided by the manufacturer for the study), but given existing evidence of similarities among retrievable filter models, the results are probably applicable to other retrievable filters, the authors said.

Fecal transplants for recurrent C. diff may resolve symptoms with few adverse events

Low-strength evidence shows fecal microbiota transplantation (FMT) effectively treats recurrent Clostridium difficile infections (CDIs), with few short-term adverse events, a review found.

annals.jpg

Researchers conducted a literature search to find 2 randomized, controlled trials (RCTs); 28 case-series studies; and 5 case reports (included only for reporting harms) assessing FMT. Results of their analysis, which was funded by the Department of Veterans Affairs, appeared in the May 5 Annals of Internal Medicine

Across all studies of FMT for recurrent CDI, symptom resolution was seen in 85% of cases. In the 2 RCTs, totaling 36 patients with recurrent CDI, 27 (75%) had resolution of CDI symptoms without recurrence. One RCT comparing FMT with 2 control groups reported resolution of symptoms in 81% of patients who received FMT, 31% of patients who received vancomycin, and 23% of patients who received vancomycin plus bowel lavage (P<0.001 for both control groups vs. FMT). An RCT comparing different FMT routes of administration for CDI recurrence reported no difference between groups (60% had their symptoms resolved in the nasogastric tube group, as did 80% in the colonoscopy group; P=0.63). Among the 480 patients in 21 case-series studies who received FMT for recurrent CDI, 85% had resolution of symptoms without recurrence.

There were 7 studies reporting on patients with refractory CDI treated with FMT, and they used various methods and did not compared FMT with standard therapy. Reported resolution of symptoms ranged widely (0% to 100%; overall resolution rate, 55%).

Case-series studies included 7 patients treated with FMT for initial CDI, with mixed results. Six cases were part of a series of 14 patients with refractory CDI, and 1 case was part of a series of 4 patients. Among the 6 cases, 1 was cured after FMT. The other, single case received FMT as initial treatment of an episode of postantibiotic-associated colitis and had symptom resolution within 48 hours.

"[L]ow-strength evidence supports FMT as having a substantial effect and few short-term adverse events for adults with recurrent CDI," the authors wrote. "There is insufficient evidence about FMT for patients with refractory CDI or for initial treatment of CDI. Evidence is insufficient about whether treatment effects vary by FMT donor, preparation, or delivery method."

The author of an accompanying editorial stated that FMT is effective, provides durable cures, and can result in a cost savings of $17,000 per patient in recurrent cases. Remaining issues include the need for regulations to standardize the treatment, which is currently considered a biologic by the FDA, and the potential effects of transplanting a microbiome from one patient to another.

"The excitement about FMT is justified given its high efficacy in treating recurrent CDI, relative availability and simplicity, and favorable cost profile compared with other therapies," the editorial stated.

Wednesday, March 18, 2015

Restrictive vs. liberal transfusion strategies may not matter after cardiac surgery

Restrictive transfusion thresholds after cardiac surgery didn't improve outcomes compared to liberal ones, a study found.

The Transfusion Indication Threshold Reduction (TITRe2), a multicenter, parallel-group trial, recruited patients age 16 and older undergoing nonemergency cardiac surgery at 17 British centers. Patients with a postoperative hemoglobin level of less than 9 g/dL were randomly assigned to a restrictive transfusion threshold of hemoglobin level <7.5 g/dL (n=1,000) or a liberal transfusion threshold of <9 g/dL (n=1,003). In the liberal-threshold group, patients received 1 unit of red cells immediately after randomization and received another unit if the hemoglobin level remained or dropped below 9 g/dL again. In the restrictive-threshold group, patients received 1 unit if the hemoglobin level dropped below 7.5 g/dL and another unit if the level remained or dropped below 7.5 g/dL again.

The primary outcome was a composite of a serious infection (sepsis or a wound infection) or an ischemic event such as a permanent stroke, myocardial infarction, infarction of the gut, or acute kidney injury within 3 months. Health care costs, excluding the index surgery, were estimated from the day of surgery to 3 months afterward. Results appeared in the March 12 New England Journal of Medicine

Transfusion rates after randomization were 53.4% in the restrictive strategy group and 92.2% in the liberal strategy group. Primary outcomes occurred in 35.1% of the patients in the restrictive-threshold group and 33.0% of the patients in the liberal-threshold group (odds ratio, 1.11; 95% CI, 0.91 to 1.34; P=0.30). There were more deaths in the restrictive-threshold group than in the liberal-threshold group (4.2% vs. 2.6%; hazard ratio=1.64; 95% CI, 1.00 to 2.67; P=0.045). The researchers noted that serious postoperative complications, excluding primary-outcome events, occurred in 35.7% of participants in the restrictive-threshold group and 34.2% of participants in the liberal-threshold group. Total costs did not differ significantly between the groups.

The study creates new uncertainty about using a restrictive threshold for transfusion after cardiac surgery, the researchers wrote. The TITRe2 trial differs from previous observational studies of transfusion thresholds in that all the participants had cardiovascular disease and a substantial proportion of participants were likely to have been dependent on oxygen supplementation immediately after surgery. This group may have been at the limits of their cardiovascular reserve and may benefit from higher hemoglobin levels, the authors speculated. "Patients with cardiovascular disease may represent a specific high-risk group for which more liberal transfusion thresholds are to be recommended," they wrote.

The results are surprising, said an accompanying editorial. "Cardiac surgery departments should review the findings of the TITRe2 trial and decide which threshold they deem to be most appropriate for transfusion. Protocols should be developed to minimize deviation from the agreed-upon approach, and feedback should be provided to hold operators accountable to the institution's standard of care," the editorialist wrote.