HealthDay (10/13, Preidt) reported, "A type of treatment for the sleep disorder known as obstructive sleep apnea significantly lowered blood pressure in men with hypertension," according to a study published in the Journal of Clinical Sleep Medicine. The research "included 221 men who were newly diagnosed with obstructive sleep apnea and also had either high blood pressure (hypertension) or type 2 diabetes." Investigators found that "significant decreases in both systolic and diastolic blood pressure readings (the top and bottom numbers in the reading) were seen in the men at three to six months after starting CPAP therapy, and also when tested again at nine to 12 months after starting the treatment."
Monday, October 15, 2012
Columnist: Obesity A Preventable Risk Factor For Chronic Renal Failure.
In his column in the Chicago Sun Times (10/13), Neil Steinberg wrote, "Obesity is particularly tied to high blood pressure and diabetes, so is 'an important and potentially preventive risk factor for chronic renal failure,' according to the American Society of Nephrology, which estimated that being obese quadruples the chances of kidney failure." Steinberg observed, "Given that, you would expect that a nation continually growing fatter and fatter would need more dialysis centers to handle skyrocketing kidney disease, and that is indeed the case." After a visit to a dialysis center, Steinberg concluded, "Dieting is not so hard when compared to dialysis."
No Advantage for Fresh Blood in ICU Transfusions
Direct MedPage Today Link
No Advantage for Fresh Blood in ICU Transfusions
By Kristina Fiore, Staff Writer, MedPage Today
Published: October 14, 2012
Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco and Dorothy Caputo, MA, BSN, RN, Nurse Planner
Action Points
Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.
For critically ill patients, transfusing fresher blood didn't translate to better outcomes.
Point out that the study found no differences in adverse effects whether the blood was fresh or old.
WASHINGTON -- For critically ill patients, transfusing fresher blood didn't translate to better outcomes, researchers said here.
In a single-center retrospective study, patients had the same overall rates of transfusion complications and other morbidities including length of ICU and hospital stays whether they were given red blood cells that were less than 8 days old, or more than two weeks old, according to Leanne Clifford, BM, of the Mayo Clinic in Rochester, Minn., and colleagues.
"We found a lack of evidence to say that older blood is associated with worse outcomes," Clifford reported during a late-breaking abstract session at the American Society of Anesthesiologists meeting.
Some work has shown that using older stores of blood may be tied to worse outcomes, although the literature is not definitive, Clifford said. Indeed, a study published last week in the Journal of the American Medical Association found that fresh blood didn't improve outcomes for premature infants.
To explore the question, Clifford and her colleagues conducted a retrospective study at their facility that compared 99 patients who received fresh cells with 99 controls. Participants were matched on the number of blood units transfused, the number of leukoreduced units, age, admission source, and primary body system affected.
They looked only at blood that was either less than 8 days old or more than 14 days old because a number of other studies had used those parameters.
Overall, they found no differences in adverse effects whether the blood was fresh or old.
Patients had the same rates of overall transfusion complications (1% in fresh, 2% in old, P=0.57), and overall morbidity was comparable between groups (P=0.11).
There were also had similar lengths of stay in the ICU (1.8 days versus 1.6, P=0.58) and in the hospital (8.6 days versus 8, P=0.39).
Clifford said her team did see more nosocomial infections with transfusions of fresh red blood cells (9.1% versus 2%, P=0.05), and mortality also appeared higher in the fresh blood group (20.2% versus 9.1%, P=0.02).
But she said these findings are likely due to chance given the small sample size of the study, and concluded that using older blood stores doesn't appear to have any impact on outcomes in critically ill patients.
Joel Zivot, MD, of Emory University in Atlanta, who moderated the session during which the findings were presented, said the study poses a "timely and important question," although he cautioned that future studies would need to look at the exact time the transfusion occurred.
A problem with ICU outcomes, he said, is that they depend on how many days the patient has been in the unit. For instance, a transfusion occurring on the first day may be more critical than one occurring after a few days, he said.
"This is the beginning," of research into this issue, he said. "It doesn't answer the question definitively. There is more work that needs to be done on this."
The researchers reported no conflicts of interest.
Primary source: American Society of Anesthesiologists Meeting
Source reference:
Clifford L, et al "Transfusion of aged red blood cells has no impact on the outcomes of critially ill patients" ASA Meeting 2012; Abstract LBC04.
View 4 comments or Add Your Knowledge ™
Kristina Fiore
Staff Writer
Kristina Fiore joined MedPage Today after earning a degree in science, health, and environmental reporting from NYU. She's had bylines in newspapers and trade and consumer magazines including Newsday, ABC News, New Jersey Monthly, and Earth Magazine. At MedPage Today, she reports with a focus on diabetes, nutrition, and addiction medicine.
No Advantage for Fresh Blood in ICU Transfusions
By Kristina Fiore, Staff Writer, MedPage Today
Published: October 14, 2012
Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco and Dorothy Caputo, MA, BSN, RN, Nurse Planner
Action Points
Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.
For critically ill patients, transfusing fresher blood didn't translate to better outcomes.
Point out that the study found no differences in adverse effects whether the blood was fresh or old.
WASHINGTON -- For critically ill patients, transfusing fresher blood didn't translate to better outcomes, researchers said here.
In a single-center retrospective study, patients had the same overall rates of transfusion complications and other morbidities including length of ICU and hospital stays whether they were given red blood cells that were less than 8 days old, or more than two weeks old, according to Leanne Clifford, BM, of the Mayo Clinic in Rochester, Minn., and colleagues.
"We found a lack of evidence to say that older blood is associated with worse outcomes," Clifford reported during a late-breaking abstract session at the American Society of Anesthesiologists meeting.
Some work has shown that using older stores of blood may be tied to worse outcomes, although the literature is not definitive, Clifford said. Indeed, a study published last week in the Journal of the American Medical Association found that fresh blood didn't improve outcomes for premature infants.
To explore the question, Clifford and her colleagues conducted a retrospective study at their facility that compared 99 patients who received fresh cells with 99 controls. Participants were matched on the number of blood units transfused, the number of leukoreduced units, age, admission source, and primary body system affected.
They looked only at blood that was either less than 8 days old or more than 14 days old because a number of other studies had used those parameters.
Overall, they found no differences in adverse effects whether the blood was fresh or old.
Patients had the same rates of overall transfusion complications (1% in fresh, 2% in old, P=0.57), and overall morbidity was comparable between groups (P=0.11).
There were also had similar lengths of stay in the ICU (1.8 days versus 1.6, P=0.58) and in the hospital (8.6 days versus 8, P=0.39).
Clifford said her team did see more nosocomial infections with transfusions of fresh red blood cells (9.1% versus 2%, P=0.05), and mortality also appeared higher in the fresh blood group (20.2% versus 9.1%, P=0.02).
But she said these findings are likely due to chance given the small sample size of the study, and concluded that using older blood stores doesn't appear to have any impact on outcomes in critically ill patients.
Joel Zivot, MD, of Emory University in Atlanta, who moderated the session during which the findings were presented, said the study poses a "timely and important question," although he cautioned that future studies would need to look at the exact time the transfusion occurred.
A problem with ICU outcomes, he said, is that they depend on how many days the patient has been in the unit. For instance, a transfusion occurring on the first day may be more critical than one occurring after a few days, he said.
"This is the beginning," of research into this issue, he said. "It doesn't answer the question definitively. There is more work that needs to be done on this."
The researchers reported no conflicts of interest.
Primary source: American Society of Anesthesiologists Meeting
Source reference:
Clifford L, et al "Transfusion of aged red blood cells has no impact on the outcomes of critially ill patients" ASA Meeting 2012; Abstract LBC04.
View 4 comments or Add Your Knowledge ™
Kristina Fiore
Staff Writer
Kristina Fiore joined MedPage Today after earning a degree in science, health, and environmental reporting from NYU. She's had bylines in newspapers and trade and consumer magazines including Newsday, ABC News, New Jersey Monthly, and Earth Magazine. At MedPage Today, she reports with a focus on diabetes, nutrition, and addiction medicine.
Tuesday, October 9, 2012
Terlipressin for hepatorenal syndrome
Direct ACP online link
Gluud LL, Christensen K, Christensen E, et al. Terlipressin for hepatorenal syndrome. Cochrane Database Syst Rev. 2012 Sep 12;9:CD005162. (Review)
Review: Terlipressin may reduce mortality and improve renal function in type 1 hepatorenal syndrome.
PMID: 22972083
BACKGROUND: Clinical trials suggest that terlipressin improves renal function in hepatorenal syndrome, but the evidence concerning mortality is equivocal.
OBJECTIVES: To assess the beneficial and harmful effects of terlipressin alone or with albumin versus placebo, no intervention or albumin for hepatorenal syndrome. SEARCH
METHODS: Eligible trials were identified through electronic (The Cochrane Library, MEDLINE, EMBASE and Science Citation Index databases) and manual searches until January 2012.
SELECTION CRITERIA: Randomised clinical trials involving patients with type 1 or type 2 hepatorenal syndrome were included irrespective of publication status or language.
DATA COLLECTION AND ANALYSIS: The review authors independently extracted data from trial reports and undertook correspondence with the authors. Primary outcome measures included mortality, reversal of hepatorenal syndrome and adverse events. Intention-to-treat, random-effects model meta-analyses were performed and results were expressed as risk ratios (RR) with 95% confidence intervals (CI), and the I(2) statistic provided a measure of intertrial heterogeneity. Subgroup, sensitivity, regression and sequential analyses were performed.
MAIN RESULTS: We identified six randomised clinical trials. All had high risk of bias. Five trials assessed terlipressin (with albumin in three trials) versus no intervention (with albumin in three trials) and one trial assessed terlipressin versus albumin. Data from five randomised trials on terlipressin alone (one trial) or terlipressin and albumin (four trials) were included in the review. In total, 74 of 155 (47.7%) patients randomised to terlipressin alone or terlipressin with albumin versus 98 of 154 (63.6%) patients randomised to no intervention, placebo or albumin died. Random-effects model meta-analysis found that terlipressin reduced mortality (RR 0.76, 95% CI 0.61 to 0.95). The results were stable when repeated with trials on terlipressin plus albumin, trials on patients with type 2 hepatorenal syndrome, and trials with a low risk of selection bias. No evidence of bias or small study effects were identified in regression analyses. In a trial sequential analysis on mortality, the cumulative Z curve approached but did not cross the monitoring boundary suggesting that the results were not stable to adjustment for sparse data and multiple comparisons. Analyses of the remaining outcome measures found that terlipressin and albumin increased the number of patients with reversal of hepatorenal syndrome as well as adverse events, including cardiovascular and gastrointestinal symptoms.
AUTHORS' CONCLUSIONS: Terlipressin may reduce mortality and improve renal function in patients with type 1 hepatorenal syndrome. Whether the evidence is strong enough to support the intervention for clinical practice could be debated due to the results of the trial sequential analyses. However, the outcome measures assessed are objective, which reduces the risk of bias.
Gluud LL, Christensen K, Christensen E, et al. Terlipressin for hepatorenal syndrome. Cochrane Database Syst Rev. 2012 Sep 12;9:CD005162. (Review)
Review: Terlipressin may reduce mortality and improve renal function in type 1 hepatorenal syndrome.
PMID: 22972083
BACKGROUND: Clinical trials suggest that terlipressin improves renal function in hepatorenal syndrome, but the evidence concerning mortality is equivocal.
OBJECTIVES: To assess the beneficial and harmful effects of terlipressin alone or with albumin versus placebo, no intervention or albumin for hepatorenal syndrome. SEARCH
METHODS: Eligible trials were identified through electronic (The Cochrane Library, MEDLINE, EMBASE and Science Citation Index databases) and manual searches until January 2012.
SELECTION CRITERIA: Randomised clinical trials involving patients with type 1 or type 2 hepatorenal syndrome were included irrespective of publication status or language.
DATA COLLECTION AND ANALYSIS: The review authors independently extracted data from trial reports and undertook correspondence with the authors. Primary outcome measures included mortality, reversal of hepatorenal syndrome and adverse events. Intention-to-treat, random-effects model meta-analyses were performed and results were expressed as risk ratios (RR) with 95% confidence intervals (CI), and the I(2) statistic provided a measure of intertrial heterogeneity. Subgroup, sensitivity, regression and sequential analyses were performed.
MAIN RESULTS: We identified six randomised clinical trials. All had high risk of bias. Five trials assessed terlipressin (with albumin in three trials) versus no intervention (with albumin in three trials) and one trial assessed terlipressin versus albumin. Data from five randomised trials on terlipressin alone (one trial) or terlipressin and albumin (four trials) were included in the review. In total, 74 of 155 (47.7%) patients randomised to terlipressin alone or terlipressin with albumin versus 98 of 154 (63.6%) patients randomised to no intervention, placebo or albumin died. Random-effects model meta-analysis found that terlipressin reduced mortality (RR 0.76, 95% CI 0.61 to 0.95). The results were stable when repeated with trials on terlipressin plus albumin, trials on patients with type 2 hepatorenal syndrome, and trials with a low risk of selection bias. No evidence of bias or small study effects were identified in regression analyses. In a trial sequential analysis on mortality, the cumulative Z curve approached but did not cross the monitoring boundary suggesting that the results were not stable to adjustment for sparse data and multiple comparisons. Analyses of the remaining outcome measures found that terlipressin and albumin increased the number of patients with reversal of hepatorenal syndrome as well as adverse events, including cardiovascular and gastrointestinal symptoms.
AUTHORS' CONCLUSIONS: Terlipressin may reduce mortality and improve renal function in patients with type 1 hepatorenal syndrome. Whether the evidence is strong enough to support the intervention for clinical practice could be debated due to the results of the trial sequential analyses. However, the outcome measures assessed are objective, which reduces the risk of bias.
Friday, October 5, 2012
Fungal-Meningitis Outbreak Widens.
An update from the US Centers for Disease Control and Prevention, indicating the meningitis outbreak has now been reported in six states, spurred extensive media coverage, most of which noted that Federal health authorities are expecting more cases to emerge.
ABC World News (10/4, story 7, 1:30, Sawyer) reported, "A CDC warning about a growing outbreak of meningitis: At least five people have now died; and there 35 cases across six states." NBC News 
(10/5, Fox) in its "Vitals" blog reports that the 35 cases "include 25 people in Tennessee, one in North Carolina, two in Florida, three in Virginia, two in Maryland, and in Indiana," according to the CDC; and "three of the deaths were in Tennessee, one in Virginia and one in Maryland."
(10/5, Fox) in its "Vitals" blog reports that the 35 cases "include 25 people in Tennessee, one in North Carolina, two in Florida, three in Virginia, two in Maryland, and in Indiana," according to the CDC; and "three of the deaths were in Tennessee, one in Virginia and one in Maryland."
The CBS Evening News (10/4, story 4, 2:20, Pelley) reported, "The suspected source is tainted vials of steroids that were shipped to 23 states." In a subsequent story, the CBS Evening News (10/4, story 5, 0:40, Pelley) added, "The CDC is investigating how the vials were contaminated."
The Los Angeles Times (10/5, Muskal) reports that officials from the CDC and the Food and Drug Administration provided the update during a "telephone news conference" Thursday. The FDA's Center for Drug Evaluation and Research, Office of Compliance Director Dr. Ilisa Bernstein said that all of the reported cases "have been blamed on three product lots from the New England Compounding Center, a specialty pharmacy" in Framingham, Massachusetts. She noted that the lots date is from July, but added that "out of an abundance of caution," the agency is "advising medical practitioners to discontinue using all of the company's products." Dr. Benjamin Park, a CDC medical officer, told the news conference that the "scope of the outbreak is difficult to determine because the medication has been distributed in 23 states to an estimated 75 facilities." Therefore, Dr. Park added, "We expect to see additional cases soon."
(10/5, Muskal) reports that officials from the CDC and the Food and Drug Administration provided the update during a "telephone news conference" Thursday. The FDA's Center for Drug Evaluation and Research, Office of Compliance Director Dr. Ilisa Bernstein said that all of the reported cases "have been blamed on three product lots from the New England Compounding Center, a specialty pharmacy" in Framingham, Massachusetts. She noted that the lots date is from July, but added that "out of an abundance of caution," the agency is "advising medical practitioners to discontinue using all of the company's products." Dr. Benjamin Park, a CDC medical officer, told the news conference that the "scope of the outbreak is difficult to determine because the medication has been distributed in 23 states to an estimated 75 facilities." Therefore, Dr. Park added, "We expect to see additional cases soon."
The Wall Street Journal (10/5, A3, Rockoff, Martin, Subscription Publication) reports that officials at the Massachusetts Department of Public Health said the New England Compounding Center relinquished its state operating license on Oct. 3, after the FDA found the fungi, aspergillus, on the inside of a sealed, steroid-injection vial.
(10/5, A3, Rockoff, Martin, Subscription Publication) reports that officials at the Massachusetts Department of Public Health said the New England Compounding Center relinquished its state operating license on Oct. 3, after the FDA found the fungi, aspergillus, on the inside of a sealed, steroid-injection vial.
Meningitis Outbreak Spurs Oversight Concerns. In a front-page "news analysis," the New York Times (10/5, A1, Tavernise, Pollack, Subscription Publication), noting that compounding pharmacies "make their own drug products" and the FDA does not have the authority to approve the drugs, says the big question is why "would pain clinics around the country rely on a pharmacy that mixes its own brand of unapproved drugs, especially for a delicate procedure like an epidural injection?" Some physicians "say compounding pharmacies offer specialty products or dosages not easily found elsewhere, or sometimes simply better prices than big drug companies." Notably, the Times points out that Pharmacy Compounding Accreditation Board Director Joe Cabaleiro "said that the New England center had never applied for accreditation as meeting the industry's quality standards." Moreover, according to James H. Ruble at the University of Utah College of Pharmacy, the FDA does prohibit mass-producing and shipping compounded drugs "across state lines."
(10/5, A1, Tavernise, Pollack, Subscription Publication), noting that compounding pharmacies "make their own drug products" and the FDA does not have the authority to approve the drugs, says the big question is why "would pain clinics around the country rely on a pharmacy that mixes its own brand of unapproved drugs, especially for a delicate procedure like an epidural injection?" Some physicians "say compounding pharmacies offer specialty products or dosages not easily found elsewhere, or sometimes simply better prices than big drug companies." Notably, the Times points out that Pharmacy Compounding Accreditation Board Director Joe Cabaleiro "said that the New England center had never applied for accreditation as meeting the industry's quality standards." Moreover, according to James H. Ruble at the University of Utah College of Pharmacy, the FDA does prohibit mass-producing and shipping compounded drugs "across state lines."
Similarly, the AP (10/5, Marchione) notes that the outbreak has reignited concerns about compound drug regulation. "Two people blinded in Washington, D.C. in 2005. Three dead in Virginia in 2006 and three more in Oregon the following year. Twenty-one dead polo horses in Florida in 2009. Earlier this year, 33 people in seven states with fungal eye infections. And now, at least five people dead and 35 sickened with fungal meningitis that has been linked to steroid shots for back pain." The AP says, "all these disasters" involved medicines that were "custom-mixed" by specialty compounding pharmacies.
(10/5, Marchione) notes that the outbreak has reignited concerns about compound drug regulation. "Two people blinded in Washington, D.C. in 2005. Three dead in Virginia in 2006 and three more in Oregon the following year. Twenty-one dead polo horses in Florida in 2009. Earlier this year, 33 people in seven states with fungal eye infections. And now, at least five people dead and 35 sickened with fungal meningitis that has been linked to steroid shots for back pain." The AP says, "all these disasters" involved medicines that were "custom-mixed" by specialty compounding pharmacies.Home Dialysis May Be An Option For Some Patients With CKD.
HealthDay (10/5, Reinberg) reports Dr. Bessie Young at the University of Washington's Epidemiologic Research and Information Center conducted a study, published online in the Clinical Journal of the American Society of Nephrology, that found home hemodialysis offers patients suffering from chronic kidney disease "considerable advantages over dialysis performed in a medical setting." Nevertheless, researchers found that "a hurdle exists in terms of acceptance. Although home-based hemodialysis equipment has become easier to learn and use in recent years, the technology is available to less than 2 percent of 500,000 dialysis patients in the United States, said Young."
(10/5, Reinberg) reports Dr. Bessie Young at the University of Washington's Epidemiologic Research and Information Center conducted a study, published online in the Clinical Journal of the American Society of Nephrology, that found home hemodialysis offers patients suffering from chronic kidney disease "considerable advantages over dialysis performed in a medical setting." Nevertheless, researchers found that "a hurdle exists in terms of acceptance. Although home-based hemodialysis equipment has become easier to learn and use in recent years, the technology is available to less than 2 percent of 500,000 dialysis patients in the United States, said Young."
The NBC News (10/5) website adds, "This could be a big change in kidney treatment in the United States, where doctors, patients and insurers are all used to the standard regime of visiting a stand-alone dialysis clinic. But the home option is cheaper and evidence is beginning to suggest that patients who can stick to the regime are healthier, the researchers said."
(10/5) website adds, "This could be a big change in kidney treatment in the United States, where doctors, patients and insurers are all used to the standard regime of visiting a stand-alone dialysis clinic. But the home option is cheaper and evidence is beginning to suggest that patients who can stick to the regime are healthier, the researchers said."More Data Refute Breast Cancer Tie to Insulin
MedPage Today Link
BERLIN – Use of the long-acting insulin glargine (Lantus) doesn't appear to carry an increased risk of breast cancer, according to a large but short-term study.
In a case-control study, there was no difference in breast cancer risk whether patients took glargine or a host of other short-acting insulins, including lispro (Humalog) or aspart (NovoLog), Lucien Abenhaim, MD, of the London School of Hygiene and Tropical Medicine, and colleagues reported at the European Association for the Study of Diabetes meeting.
"We see very little difference between those exposed to glargine versus other insulins," Abenhaim said during an oral presentation.
He cautioned, however, that the mean duration of insulin use was only 3.2 years and longer term trials are needed to better assess risk of breast cancer with insulin use.
Helen Colhoun, PhD, of the University of Dundee in Scotland, noted that this duration of exposure to insulin "is quite short."
"It isn't possible to really say that there is or there isn't any risk associated with much longer exposure to glargine," she said during the oral session at which the findings were presented.
Still, she concluded on the whole that the study was "painstaking" and "reassuring."
Several recent studies, including the randomized controlled ORIGIN trial, have failed to find an increased risk of cancer with insulin use. Concerns have traditionally stemmed from the fact that insulin is a growth factor, which could fuel tumor growth.
In addition, some have questioned whether newer, long-acting insulins given once daily, such as glargine – in contrast to more rapid acting formulations that are taken with meals – could confer additional risk.
So Abenhaim and colleagues conducted the International Study of Insulin and Cancer (ISICA), which was sponsored by Sanofi, maker of glargine. They conducted a systematic case-control study among 92 large centers the U.K., France, and Canada.
Among 39,958 breast cancer cases, 6.2% were diabetic, and 41.3% of these patients participated in the trial.
They were matched to diabetic controls from 582 general practices based on similarities in age, date, country, region, type of diabetes, and diabetes management – bringing the study total to 775 cases and 3,050 controls.
All were contacted via a telephone interview that involved a recall of medications, as well as verification with prescription records, Abenhaim said.
The majority of cases had primary invasive breast cancer, mostly in stage 1 or 2, and the mean age was about 66 in both groups.
Both cases and controls had been diagnosed with diabetes around age 53, the majority used oral antidiabetic drugs, and about a quarter used insulin.
Abenhaim and colleagues found no increased risk of breast cancer with glargine use compared with other insulins:
- Glargine: OR 1.04, 95% CI 0.76 to 1.44
- Lispro: OR 1.23, 95% CI 0.79 to 1.92
- Aspart: OR 0.95, 95% CI 0.64 to 1.40
- Human: OR 0.81, 95% CI 0.55 to 1.20
Results did not change in a series of sensitivity analyses, he added.
The only factor that appeared to be related to breast cancer was having a duration of diabetes of longer than 10 years, Abenhaim reported (OR 1.31, 95% CI 1.10 to 1.56).
Colhoun said a "major weakness" of the study was its reliance on patient recall of diabetes therapy.
"Recall from patients and practitioners seems to me to be a difficult way to do a study in an era when we have so many really good drug databases that give you almost perfect capture of drug exposures," she said.
The study was supported by Sanofi.
The researchers reported relationships with Sanofi.
Primary source: European Association for the Study of Diabetes meeting
Source reference:
Abenhaim L, et al "The International Study of Insulin and Cancer" EASD 201; DOI: 10.1016/S0140-6736(10)61374-8.
Source reference:
Abenhaim L, et al "The International Study of Insulin and Cancer" EASD 201; DOI: 10.1016/S0140-6736(10)61374-8.
Researchers See More Ischemic Events With Glyburide Than Gliclazide.
HeartWire (10/4, Wood) reports, "An observational study focused on the cardiotoxic effects of sulfonylurea drugs has found that the risk of ischemic events may be higher with a specific subclass of these agents than with others." Investigators "reviewed administrative health records for the province of Alberta, Canada, identifying more than 11 000 diabetic patients using either gliclazide or glyburide who also had a history of ischemic heart disease." The researchers found that "rates of ACS-related hospitalization or death were higher among patients taking glyburide than those taking gliclazide." The findings were presented at the European Association for the Study of Diabetes 2012 Meeting.
(10/4, Wood) reports, "An observational study focused on the cardiotoxic effects of sulfonylurea drugs has found that the risk of ischemic events may be higher with a specific subclass of these agents than with others." Investigators "reviewed administrative health records for the province of Alberta, Canada, identifying more than 11 000 diabetic patients using either gliclazide or glyburide who also had a history of ischemic heart disease." The researchers found that "rates of ACS-related hospitalization or death were higher among patients taking glyburide than those taking gliclazide." The findings were presented at the European Association for the Study of Diabetes 2012 Meeting.
Testing Inflammation Markers May Help Predict Risk Of Cardiac Events.
MedPage Today (10/4, Walsh) reports, "Adding a marker of inflammation such as C-reactive protein or fibrinogen to a cardiovascular risk profile could improve the model's predictive ability for a future cardiac event," according to a meta-analysis published in the New England Journal of Medicine. MedPage Today points out that "recently, guidelines from the American Heart Association and American College of Cardiology deemed it 'reasonable' for CRP levels to be measured in patients considered to be at intermediate risk for cardiovascular disease, but further guidance is expected from the National Heart, Lung and Blood Institute."
(10/4, Walsh) reports, "Adding a marker of inflammation such as C-reactive protein or fibrinogen to a cardiovascular risk profile could improve the model's predictive ability for a future cardiac event," according to a meta-analysis published in the New England Journal of Medicine. MedPage Today points out that "recently, guidelines from the American Heart Association and American College of Cardiology deemed it 'reasonable' for CRP levels to be measured in patients considered to be at intermediate risk for cardiovascular disease, but further guidance is expected from the National Heart, Lung and Blood Institute."
HealthDay (10/4, Reinberg) reports that investigators "analyzed 52 studies that included more than 246,000 people who had no history of cardiovascular disease." The researchers "found that measuring C-reactive protein or fibrinogen, along with other standard tests such as blood pressure and cholesterol, in about 13,000 people identified as being at risk for cardiovascular disease could prevent a few strokes and heart attacks over time."
(10/4, Reinberg) reports that investigators "analyzed 52 studies that included more than 246,000 people who had no history of cardiovascular disease." The researchers "found that measuring C-reactive protein or fibrinogen, along with other standard tests such as blood pressure and cholesterol, in about 13,000 people identified as being at risk for cardiovascular disease could prevent a few strokes and heart attacks over time."
WebMD (10/4, Boyles) reports, however, that "while the tests were predictive in men with no history of heart attack or stroke, they did not appear to be useful to women."
(10/4, Boyles) reports, however, that "while the tests were predictive in men with no history of heart attack or stroke, they did not appear to be useful to women."
HeartWire (10/4, Hughes) reports that one of the study's lead authors "told heartwire that the current results suggested that if all patients at intermediate risk (10-year risk of 10% to 20%) were screened for either CRP or fibrinogen, 5% would be reclassified as high risk (>20% risk) and so eligible for statins, and this would prevent one cardiovascular event for every 400 to 500 patients screened," but he "did not want to be drawn into discussions as to whether this was worthwhile or cost-effective, saying this was the job of guidelines committees and health economists."
(10/4, Hughes) reports that one of the study's lead authors "told heartwire that the current results suggested that if all patients at intermediate risk (10-year risk of 10% to 20%) were screened for either CRP or fibrinogen, 5% would be reclassified as high risk (>20% risk) and so eligible for statins, and this would prevent one cardiovascular event for every 400 to 500 patients screened," but he "did not want to be drawn into discussions as to whether this was worthwhile or cost-effective, saying this was the job of guidelines committees and health economists."Stem Cell Transplants Come Back to Haunt
MedPage Today Link
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Long-term survivors of blood-related cancers who had stem cell transplants are at risk of developing risk factors that can lead to heart disease, researchers found.
Overall, the presence of hypertension, diabetes, and dyslipidemia was significantly higher among hematopoietic cell transplant (HCT) recipients compared with the general population, according to Saro H. Armenian, DO, MPH, of City of Hope in Duarte, Calif., and colleagues.
Importantly, those who received hematopoietic cells from a donor had a greater risk of developing these cardiovascular risk factors compared with autologous cells transplant recipients, researchers reported online in Blood: Journal of the American Society of Hematology.
The authors pointed to two factors that could increase the cardiovascular risk in these patients:
- Pre-transplant chemotherapy and radiation
- Treatment for the transplant complication of graft-versus-host disease (GVHD)
Donor cell recipients generally undergo higher doses of chemotherapy plus total body radiation to condition the body for the foreign cells.
Patients who received allogeneic HCT developed hypertension, diabetes, and dyslipidemia in significantly shorter periods compared to autologous HCT:
- Hypertension -- 0.2 versus 3.7 years (P<0.01)
- Diabetes -- 1.2 versus 3.3 years (P<0.01)
- Dyslipidemia -- 0.2 versus 1.6 years (P<0.01)
Researchers also found a linear relationship with the number of risk factors and the development of cardiovascular disease, which included heart failure, coronary artery disease, myocardial infarction, and stroke.
A total of 115 patients out of the cohort of 1,885 developed cardiovascular disease: 4.7% had no risk factors, 7% had one, and 11.2% had two or more at 10 years. The trend was significant atP<0.01.
Armenian and colleagues noted that advances in blood-forming stem cell strategies allow recipients to live longer, but they often have one or more chronic, post-transplant health conditions.
They pointed to a study that found the cumulative incidence of severe or life-threatening conditions to be 40% at 15 years after HCT.
But studies examining factors related to cardiovascular risk in these patients have been limited by small size, short follow-up, lack of comparisons between autologous and allogeneic donors, and lack of age and gender comparisons, the investigators said.
"Our study sought to better determine the specific factors before and after transplant that can lead to heart disease in a large group of transplant recipients," Armenian said in a statement.
Researchers retrospectively analyzed medical records of patients who underwent a first-time HCT for a blood cancer at City of Hope between 1995 and 2004 and had survived at least one year. The median age was 44, women comprised 57% of the cohort, and 63% were white. The median follow-up after HCT was 6 years.
Patients were being treated for Hodgkin or non-Hodgkin lymphoma (38.6%), acute lymphoblastic or myeloid leukemia (25.6%), multiple myeloma (15.3%), chronic leukemia (12.8%), or other type of blood cancer (7.7%).
Treatment-related exposures included pre-HCT anthracycline chemotherapy and chest radiation, as well as high-dose chemotherapy and radiation related to the conditioning regimen. Patients being treated for GVHD generally received corticosteroids and cyclosporine and sometimes mycophenolate mofetil, tacrolimus, or sirolimus.
To be included, patients had to have clinically validated hypertension, diabetes, or dyslipidemia for a minimum of 6 months and the condition had to persist for more than a year after HCT.
The cumulative incidence of the cardiovascular risk factors at 10 years after HCT was:
- Hypertension -- 37%
- Diabetes -- 18%
- Dyslipidemia -- 47%
When Armenian and colleagues performed a multivariate analysis, significant predictors of developing all three cardiovascular risk factors were older age (both 35-55 and a higher risk for age >55) and obesity (≥30 kg/m2).
Patients who had chemotherapy plus total body radiation had a 1.5-fold increased risk of diabetes and a 1.4-fold increased risk of high cholesterol, regardless of HCT type.
And allogeneic HCT without acute GVHD carried a 5.2-fold higher risk for hypertension, 2.6-fold higher risk for diabetes, and a 2.2-fold higher risk for dyslipidemia.
The risk increased when the allogeneic recipients had grade II, III, or IV acute GVHD (HRs 9.1, 5.8, and 3.2, respectively).
The study was limited by its retrospective nature and lack of access to information about gonadal dysfunction, smoking history, family history, and physical activity history, the authors noted.
They also did not have access to lifetime doses of immunosuppressive therapy, and the study did not include those who underwent T-cell-depleted HCT.
The study was funding by the National Institutes of Health and the Lymphoma/Leukemia Society Scholar Award for Clinical Research.
The authors reported they have no relevant financial conflicts of interest to disclose.
From the American Heart Association:
Primary source: Blood: Journal of the American Society of Hematology
Source reference:
Armenian SH, et al "Cardiovascular risk factors in hematopoietic cell transplantation (HCT) survivors: role in development of subsequent cardiovascular disease" Blood 2012; DOI: 10.1182/blood-2012-06-437178.
Source reference:
Armenian SH, et al "Cardiovascular risk factors in hematopoietic cell transplantation (HCT) survivors: role in development of subsequent cardiovascular disease" Blood 2012; DOI: 10.1182/blood-2012-06-437178.
Add Your Knowledge ™
Chris Kaiser
Cardiology Editor
Chris has written and edited for medical publications for more than 15 years. As the news editor for aUnited Business Media journal, he was awarded Best News Section. He has a B.A. from La Salle University and an M.A. from Villanova University. Chris is based outside of Philadelphia and is also involved with the theater as a writer, director, and occasional actor.
Beta Blockers May Not Prevent Heart Attacks, Strokes In Some Patients.
On its website, ABC News (10/3) reports that a study published in the Journal of the American Medical Association suggests that "beta-blocker pills don't prevent heart attacks, strokes or cardiac deaths in patients with heart disease, but doctors are torn over whether there's enough in the study to make them want to stop prescribing the drugs."
(10/3) reports that a study published in the Journal of the American Medical Association suggests that "beta-blocker pills don't prevent heart attacks, strokes or cardiac deaths in patients with heart disease, but doctors are torn over whether there's enough in the study to make them want to stop prescribing the drugs."
Forbes (10/3, Husten) reports that "Sriapl Bangalore and colleagues analyzed data from 44,708 patients enrolled in the Reduction of Atherothrombosis for Continued Health (REACH registry), 31% of whom had a prior MI, 27% of whom had documented CAD without MI, and 42% of whom only had CAD risk factors." Participants "who received beta blockers were compared with matched controls and were followed for a median of 44 months."
(10/3, Husten) reports that "Sriapl Bangalore and colleagues analyzed data from 44,708 patients enrolled in the Reduction of Atherothrombosis for Continued Health (REACH registry), 31% of whom had a prior MI, 27% of whom had documented CAD without MI, and 42% of whom only had CAD risk factors." Participants "who received beta blockers were compared with matched controls and were followed for a median of 44 months."
HealthDay (10/3, Reinberg) reports, "For those with heart disease or who had a heart attack, the researchers found no difference between those taking beta blockers and those not taking them when it came to death, heart attack or stroke. The rates for being hospitalized for a cardiac procedure, however, were higher among those taking beta blockers." Meanwhile, "among patients who had risk factors for heart disease, those taking beta blockers were at higher risk for dying or being hospitalized for a cardiac procedure, compared to those not taking them, the researchers noted."
(10/3, Reinberg) reports, "For those with heart disease or who had a heart attack, the researchers found no difference between those taking beta blockers and those not taking them when it came to death, heart attack or stroke. The rates for being hospitalized for a cardiac procedure, however, were higher among those taking beta blockers." Meanwhile, "among patients who had risk factors for heart disease, those taking beta blockers were at higher risk for dying or being hospitalized for a cardiac procedure, compared to those not taking them, the researchers noted."
HeartWire (10/3, Nainggolan) reports, "Bangalore says there is somewhat of a disconnect between what current guidelines recommend-which is broadly in line with what he and his colleagues found-and what doctors on the ground are actually doing."
(10/3, Nainggolan) reports, "Bangalore says there is somewhat of a disconnect between what current guidelines recommend-which is broadly in line with what he and his colleagues found-and what doctors on the ground are actually doing."
MedPage Today (10/3, Kaiser) reports that the researchers "pointed out that their findings reflect secondary prevention guidelines from the American Heart Association/American College of Cardiology, which give short-term beta-blocker therapy (up to three years after MI) a class I recommendation, but longer-term therapy gets a class IIa recommendation." Also covering the story areWebMD (10/3, DeNoon) and Reuters (10/3, Joelving).
(10/3, Kaiser) reports that the researchers "pointed out that their findings reflect secondary prevention guidelines from the American Heart Association/American College of Cardiology, which give short-term beta-blocker therapy (up to three years after MI) a class I recommendation, but longer-term therapy gets a class IIa recommendation." Also covering the story areWebMD (10/3, DeNoon) and Reuters (10/3, Joelving).Replacing IV catheters as needed is as safe as routine replacement, study finds
Replacing peripheral intravenous (IV) catheters when clinically indicated is just as safe as routine, time-based replacement, a new study found.
Researchers randomized 3,283 patients from three hospitals in Queensland, Australia to clinically indicated replacement, or routine replacement every third day, of IV catheters. "Clinically indicated" circumstances for replacement included completion of therapy, phlebitis, infiltration, occlusion, accidental removal, or suspected infection. At randomization, all patients were at least 18 years old and were expected to need an intravenous catheter for more than four days. The main outcome was phlebitis during catheterization or within 48 hours after catheter removal, and the secondary endpoints were catheter-related bloodstream and local infections, all bloodstream infections, catheter tip colonization, infusion failure, number of catheters used, duration of therapy, mortality and costs.
IV catheter dwell times were 48-561 hours in the clinically indicated group and 48-96 hours in the routine replacement group. The mean dwell time for catheters that were in situ on day three was 99 hours for the clinically indicated group and 70 hours for the routine replacement group. In both groups, 7% of patients had phlebitis. Secondary outcomes were also similar between groups, and there were no serious adverse events in either group. Results were published online Sept. 22 by The Lancet.
The data predict that, with a "clinical indication" approach, IV catheter use will be extended by a little more than a day on average, the authors noted, and that one in every five patients will avoid an unnecessary procedure. In the U.S., switching to this approach could save up to $60 million and two million hours of staff time, as well as prevent up to six million unnecessary IV catheter insertions. Since routine replacement doesn't help lower the rate of catheter-related complications, policies should be revised and "research attention should now focus on other interventions," such as improved insertion, securement and flushing strategies, they wrote.
In a comment, colleagues said the study was of high quality and makes a "major contribution" to the debate about catheter replacement. It also made an important finding that almost 30% of catheters had some sort of failure, thus future studies that target ways to prevent such failures "might have even greater implications for cost, reduction of unnecessary invasive procedures, and staff workloads," they wrote.
Meningitis outbreak under investigation.
The AP (10/2, Loller) reports that "a cluster of meningitis cases that left two people dead in Nashville is under investigation by the Tennessee Department of Health and the Centers for Disease Control and Prevention." The article says that "according to the Department of Health, 11 patients who had lumbar epidural steroid injections at Nashville's Saint Thomas Outpatient Neurosurgery Center have come down with the disease." Curtis Allen, a spokesman for the CDC, "said there also has been a case in North Carolina in someone who received the same type of injection," the AP adds.
The New York Times (10/2, A19, Grady, Subscription Publication) reports that "doctors think the infections were caused by contamination of the steroid with the fungus, known as aspergillus." It adds that "one lot of the medication has been recalled, and more than 700 patients who received the shots at the Nashville clinic, which has closed, have been notified."
Meanwhile, the Nashville (TN) Business Journal (10/2, Snyder, Subscription Publication) reports that "the patients' form of meningitis is not transmitted from person to person." Citing a news release, the article said that "the Saint Thomas Outpatient Neurosurgery Center has been closed since Sept. 20, and 'will not reopen until (the Tennessee Department of Health, Centers for Disease Control) and the center are confident the current concerns have been resolved.'"
The Tennessean (10/2, Tamburin, Wilemon) reports TDH Commissioner Dr. John Dreyzehner said that "about 737 patients who received the same injection at the center during that window have been alerted and examined." According to the article, "Dreyzehner said epidural steroid injections are a common, safe way to alleviate lower-back pain." Dreyzehner said that "this is a very, very unusual event," adding, "this is not a complication that would be expected in the normal course of things."
Health Officials Urging People To Get Flu Shot.
Several news sites and media outlets reported that health officials are urging people to get vaccinated against influenza.
ABC World News (9/27, story 5, 0:30, Stephanopoulos) reported that the nation's top doctors at the Centers for Disease Control "sounded the alarm" on Thursday about this year's flu season, which starts next month. Officials noted that even though last year's season was mild, this year's could be "unpredictable."
NBC Nightly News (9/27, story 7, 1:50, Guthrie) reported, "More than 85 million doses of vaccine have already been distributed, and more is on the way. But like every year, many are skipping the shot."
USA Today (9/28, Szabo) quoted Howard Koh, assistant secretary for health at the Department of Health and Human Services, who was speaking at a news conference in Washington organized by the National Foundation for Infectious Disease. "People cannot become complacent this season. When it comes to the flu, we cannot look to the past to predict what will happen this season," he said.
(9/28, Szabo) quoted Howard Koh, assistant secretary for health at the Department of Health and Human Services, who was speaking at a news conference in Washington organized by the National Foundation for Infectious Disease. "People cannot become complacent this season. When it comes to the flu, we cannot look to the past to predict what will happen this season," he said.
Reuters (9/28, Simpson) noted that Koh and officials from several other health organizations, including the American Medical Association and the American Academy of Pediatrics, promoted vaccination as a first-line defense against the virus. Koh was also vaccinated by a nurse at the news conference.
(9/28, Simpson) noted that Koh and officials from several other health organizations, including the American Medical Association and the American Academy of Pediatrics, promoted vaccination as a first-line defense against the virus. Koh was also vaccinated by a nurse at the news conference.
The AP (9/28, Neergaard) reports that "federal health authorities said Thursday that this year's vaccine contains protection against two different strains that have begun circling the globe. And just because flu was mild last winter doesn't mean it won't bounce back with its usual ferocity this winter." According to the news wire, "flu vaccination is recommended for virtually everyone older than six months of age, but the government says just 42 percent of Americans were immunized last year." The AP also covers the story in a separate report .
(9/28, Neergaard) reports that "federal health authorities said Thursday that this year's vaccine contains protection against two different strains that have begun circling the globe. And just because flu was mild last winter doesn't mean it won't bounce back with its usual ferocity this winter." According to the news wire, "flu vaccination is recommended for virtually everyone older than six months of age, but the government says just 42 percent of Americans were immunized last year." The AP also covers the story in a separate report .
NBC News (9/28) reports in its "Vitals" blog that "just about everyone is supposed to get a flu shot every year, and two groups are particular no-brainers -- pregnant women and health care workers," but "new numbers released on Thursday show that fewer than half of pregnant women got vaccinated last year and just two-thirds of health care workers did." The article describes that "although they've been pushing flu vaccination hard for more than a decade, public health officials admit they are still finding it a hard sell."
(9/28) reports in its "Vitals" blog that "just about everyone is supposed to get a flu shot every year, and two groups are particular no-brainers -- pregnant women and health care workers," but "new numbers released on Thursday show that fewer than half of pregnant women got vaccinated last year and just two-thirds of health care workers did." The article describes that "although they've been pushing flu vaccination hard for more than a decade, public health officials admit they are still finding it a hard sell."
CBS News (9/28, Jaslow) reports on its website that "flu season begins as early as October and may last until May, according to the Centers for Disease Control and Prevention (CDC)." The article said that the CDC unveiled new statistics this week "on how many people actually got last year's vaccine in the Sept 27 issue of its journal, Morbidity and Mortality Weekly Report." CBS News details that "the report showed vaccination rates remained steady with that of previous years, with about 128 million people getting the shot during last year's flu season -- about 42 percent of the U.S. Population."
(9/28, Jaslow) reports on its website that "flu season begins as early as October and may last until May, according to the Centers for Disease Control and Prevention (CDC)." The article said that the CDC unveiled new statistics this week "on how many people actually got last year's vaccine in the Sept 27 issue of its journal, Morbidity and Mortality Weekly Report." CBS News details that "the report showed vaccination rates remained steady with that of previous years, with about 128 million people getting the shot during last year's flu season -- about 42 percent of the U.S. Population."
HealthDay (9/28, Reinberg) reports that "this year's vaccine contains the same strains as last year's, plus two new strains -- one for a new influenza A virus and another for a new influenza B, Dr. Daniel Jernigan, deputy director of the U.S. Centers for Disease Control and Prevention's Influenza Division, said at the news conference." Also covering the story are MedPage Today (9/28, Neale) and the New Hampshire Sentinel Source (9/28).
(9/28, Reinberg) reports that "this year's vaccine contains the same strains as last year's, plus two new strains -- one for a new influenza A virus and another for a new influenza B, Dr. Daniel Jernigan, deputy director of the U.S. Centers for Disease Control and Prevention's Influenza Division, said at the news conference." Also covering the story are MedPage Today (9/28, Neale) and the New Hampshire Sentinel Source (9/28).
NYTimes Urges Healthcare Workers To Get Vaccinated. In an editorial, the New York Times (9/28, A34, Subscription Publication) reports that "health care workers should know better than anyone that it is important to get vaccinated against the flu virus to protect their own health and prevent the possibility of infecting patients." While the article notes that "there were some encouraging signs in an analysis issued Thursday by the Centers for Disease Control and Prevention that doctors and nurses are beginning to get the message," it points out that "other health care workers -- a broad group that includes clinical personnel like nurse practitioners and physician assistants and various nonprofessional aides and assistants -- show remarkable indifference to performing what ought to be considered their civic duty." The editorial goes on to suggest that "even without making it mandatory, employers can make a difference by promoting vaccination through educational campaigns, by providing incentives and making vaccine easily available at no cost."
(9/28, A34, Subscription Publication) reports that "health care workers should know better than anyone that it is important to get vaccinated against the flu virus to protect their own health and prevent the possibility of infecting patients." While the article notes that "there were some encouraging signs in an analysis issued Thursday by the Centers for Disease Control and Prevention that doctors and nurses are beginning to get the message," it points out that "other health care workers -- a broad group that includes clinical personnel like nurse practitioners and physician assistants and various nonprofessional aides and assistants -- show remarkable indifference to performing what ought to be considered their civic duty." The editorial goes on to suggest that "even without making it mandatory, employers can make a difference by promoting vaccination through educational campaigns, by providing incentives and making vaccine easily available at no cost."
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