Screening blood donations for Zika proved costly, low yield

Revisit blood safety practices
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Testing donated blood for Zika virus in the United States confirmed just 8 authentic cases and cost nearly $42 million over a period of 15 months, investigators reported online May 10 in the New England Journal of Medicine.

That price did not reflect a commercial price hike, said Paula Saá, PhD, of the American Red Cross in Gaithersburg, MD, and her associates. Furthermore, more than half of the Zika cases had a low viral level that might not be infectious.

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Maternal-fetal Zika transmission can be devastating, and infections have been detected in asymptomatic blood donors. Therefore, in 2016, the Food and Drug Administration began recommending screening of blood donations. In response, the American Red Cross started screening pooled donations for Zika RNA by using a transcription-mediated amplification (TMA) test. Later in 2016, the FDA began recommending individually screening all blood donations; the Red Cross complied. For the study, Dr. Saá and her coinvestigators analyzed pooled and individual tests from a 15-month period during 2016-2017.

Among more than 4 million screened donations, 9% were tested in pools. All pooled tests were negative. The other 3.9 million donations were screened individually. Only 160 were positive, and just 6 were confirmed positive on repeat TMA. Two of these six confirmed positives also were RNA-positive on reverse transcription polymerase chain reaction, while two were equivocal and two were negative. The positive and equivocal donations were negative for Zika immunoglobulin M on enzyme-linked immunosorbent assay, which indicated acute infections. The RNA-negative infections were IgM-positive, indicating prior infections.

Three more donations were initially positive on TMA, were negative on repeat TMA, and were IgM-positive, bringing the total case count to nine. Among these, two donors had been infected in Florida, six had traveled to Zika-endemic areas, and one had received an experimental Zika vaccine, according to the researchers.

For each detection of authentic Zika virus RNA infection in U.S.-donated blood, testing had cost $5.3 million, they concluded. They called the current FDA recommendation to individually screen all U.S. blood donations for Zika virus “low-yield” and “high cost.” Of three acute infections with enough sample left for pooled testing, all were positive, they noted.

The American Red Cross and Grifols Diagnostic Solutions provided funding. Dr. Saá disclosed research support from Grifols, which makes the TMA test used in the study. She had no other conflicts of interest.

SOURCE: Saá P et al. New Engl J Med. 2018;378:1778-88.

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Despite these findings, it would be premature to stop testing U.S. blood donations for Zika virus, wrote Evan M. Bloch, MBChB; Paul M. Ness, MD; Aaron A.R. Tobian, MD, PhD; and Jeremy Sugarman, MD, MPH, in an editorial accompanying the study.

Nonetheless, “actual and perceived risks to the blood supply seem to be conflated,” the experts wrote. They noted that the United States currently has no active areas of Zika virus transmission and that confirmed mosquito-borne, locally acquired infections fell from 226 in 2016 to two the following year.

There is no historical precedent for ending a policy of testing blood donations for pathogens, they added. Consequently, ending widespread screening “may actually prove to be far more challenging than the decision to start.” For now, a precautionary, risk-based approach should entail “continuous review” of screening policies and “reassessment as new data emerge.”

The editorialists are with Johns Hopkins University and Johns Hopkins University’s Bergman Institute of Bioethics, both in Baltimore. They reported having no relevant conflicts of interest. These comments are from their editorial (New Engl J Med. 2018;378:19:1837-41).

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Despite these findings, it would be premature to stop testing U.S. blood donations for Zika virus, wrote Evan M. Bloch, MBChB; Paul M. Ness, MD; Aaron A.R. Tobian, MD, PhD; and Jeremy Sugarman, MD, MPH, in an editorial accompanying the study.

Nonetheless, “actual and perceived risks to the blood supply seem to be conflated,” the experts wrote. They noted that the United States currently has no active areas of Zika virus transmission and that confirmed mosquito-borne, locally acquired infections fell from 226 in 2016 to two the following year.

There is no historical precedent for ending a policy of testing blood donations for pathogens, they added. Consequently, ending widespread screening “may actually prove to be far more challenging than the decision to start.” For now, a precautionary, risk-based approach should entail “continuous review” of screening policies and “reassessment as new data emerge.”

The editorialists are with Johns Hopkins University and Johns Hopkins University’s Bergman Institute of Bioethics, both in Baltimore. They reported having no relevant conflicts of interest. These comments are from their editorial (New Engl J Med. 2018;378:19:1837-41).

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Despite these findings, it would be premature to stop testing U.S. blood donations for Zika virus, wrote Evan M. Bloch, MBChB; Paul M. Ness, MD; Aaron A.R. Tobian, MD, PhD; and Jeremy Sugarman, MD, MPH, in an editorial accompanying the study.

Nonetheless, “actual and perceived risks to the blood supply seem to be conflated,” the experts wrote. They noted that the United States currently has no active areas of Zika virus transmission and that confirmed mosquito-borne, locally acquired infections fell from 226 in 2016 to two the following year.

There is no historical precedent for ending a policy of testing blood donations for pathogens, they added. Consequently, ending widespread screening “may actually prove to be far more challenging than the decision to start.” For now, a precautionary, risk-based approach should entail “continuous review” of screening policies and “reassessment as new data emerge.”

The editorialists are with Johns Hopkins University and Johns Hopkins University’s Bergman Institute of Bioethics, both in Baltimore. They reported having no relevant conflicts of interest. These comments are from their editorial (New Engl J Med. 2018;378:19:1837-41).

Title
Revisit blood safety practices
Revisit blood safety practices

 

Testing donated blood for Zika virus in the United States confirmed just 8 authentic cases and cost nearly $42 million over a period of 15 months, investigators reported online May 10 in the New England Journal of Medicine.

That price did not reflect a commercial price hike, said Paula Saá, PhD, of the American Red Cross in Gaithersburg, MD, and her associates. Furthermore, more than half of the Zika cases had a low viral level that might not be infectious.

Vlad/Fotolia
Maternal-fetal Zika transmission can be devastating, and infections have been detected in asymptomatic blood donors. Therefore, in 2016, the Food and Drug Administration began recommending screening of blood donations. In response, the American Red Cross started screening pooled donations for Zika RNA by using a transcription-mediated amplification (TMA) test. Later in 2016, the FDA began recommending individually screening all blood donations; the Red Cross complied. For the study, Dr. Saá and her coinvestigators analyzed pooled and individual tests from a 15-month period during 2016-2017.

Among more than 4 million screened donations, 9% were tested in pools. All pooled tests were negative. The other 3.9 million donations were screened individually. Only 160 were positive, and just 6 were confirmed positive on repeat TMA. Two of these six confirmed positives also were RNA-positive on reverse transcription polymerase chain reaction, while two were equivocal and two were negative. The positive and equivocal donations were negative for Zika immunoglobulin M on enzyme-linked immunosorbent assay, which indicated acute infections. The RNA-negative infections were IgM-positive, indicating prior infections.

Three more donations were initially positive on TMA, were negative on repeat TMA, and were IgM-positive, bringing the total case count to nine. Among these, two donors had been infected in Florida, six had traveled to Zika-endemic areas, and one had received an experimental Zika vaccine, according to the researchers.

For each detection of authentic Zika virus RNA infection in U.S.-donated blood, testing had cost $5.3 million, they concluded. They called the current FDA recommendation to individually screen all U.S. blood donations for Zika virus “low-yield” and “high cost.” Of three acute infections with enough sample left for pooled testing, all were positive, they noted.

The American Red Cross and Grifols Diagnostic Solutions provided funding. Dr. Saá disclosed research support from Grifols, which makes the TMA test used in the study. She had no other conflicts of interest.

SOURCE: Saá P et al. New Engl J Med. 2018;378:1778-88.

 

Testing donated blood for Zika virus in the United States confirmed just 8 authentic cases and cost nearly $42 million over a period of 15 months, investigators reported online May 10 in the New England Journal of Medicine.

That price did not reflect a commercial price hike, said Paula Saá, PhD, of the American Red Cross in Gaithersburg, MD, and her associates. Furthermore, more than half of the Zika cases had a low viral level that might not be infectious.

Vlad/Fotolia
Maternal-fetal Zika transmission can be devastating, and infections have been detected in asymptomatic blood donors. Therefore, in 2016, the Food and Drug Administration began recommending screening of blood donations. In response, the American Red Cross started screening pooled donations for Zika RNA by using a transcription-mediated amplification (TMA) test. Later in 2016, the FDA began recommending individually screening all blood donations; the Red Cross complied. For the study, Dr. Saá and her coinvestigators analyzed pooled and individual tests from a 15-month period during 2016-2017.

Among more than 4 million screened donations, 9% were tested in pools. All pooled tests were negative. The other 3.9 million donations were screened individually. Only 160 were positive, and just 6 were confirmed positive on repeat TMA. Two of these six confirmed positives also were RNA-positive on reverse transcription polymerase chain reaction, while two were equivocal and two were negative. The positive and equivocal donations were negative for Zika immunoglobulin M on enzyme-linked immunosorbent assay, which indicated acute infections. The RNA-negative infections were IgM-positive, indicating prior infections.

Three more donations were initially positive on TMA, were negative on repeat TMA, and were IgM-positive, bringing the total case count to nine. Among these, two donors had been infected in Florida, six had traveled to Zika-endemic areas, and one had received an experimental Zika vaccine, according to the researchers.

For each detection of authentic Zika virus RNA infection in U.S.-donated blood, testing had cost $5.3 million, they concluded. They called the current FDA recommendation to individually screen all U.S. blood donations for Zika virus “low-yield” and “high cost.” Of three acute infections with enough sample left for pooled testing, all were positive, they noted.

The American Red Cross and Grifols Diagnostic Solutions provided funding. Dr. Saá disclosed research support from Grifols, which makes the TMA test used in the study. She had no other conflicts of interest.

SOURCE: Saá P et al. New Engl J Med. 2018;378:1778-88.

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Key clinical point: Individually screening all blood donations for Zika virus was low yield and costly.

Major finding: Testing confirmed only 8 authentic cases and cost nearly $42 million over 15 months.

Study details: Screening and confirmatory testing of 4,325,889 donations of blood in the United States during 2016-2017.

Disclosures: American Red Cross and Grifols Diagnostic Solutions provided funding. Grifols makes a test used in the study. Dr. Saá disclosed research support from Grifols but had no other conflicts of interest.

Source: Saá P et al. New Engl J Med. 2018;378:1778-88. doi: 10.1056/NEJMoa1714977
 

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Immediate postresection gemcitabine tops saline in low-grade non–muscle-invasive bladder cancer

Findings merit practice change
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Fri, 01/04/2019 - 14:17

 

For patients with suspected low-grade non–muscle-invasive bladder cancer, immediate postresection treatment with intravesicular gemcitabine significantly cut recurrence rates in a double-blind, multicenter, randomized, placebo-controlled trial.

In the intention-to-treat analysis, estimated rates of 4-year recurrence were 35% with gemcitabine and 47% with placebo saline (hazard ratio, 0.66; 95% confidence interval, 0.48-0.90; P less than .001), reported Edward D. Messing of the University of Rochester, New York, and his associates. Gemcitabine also significantly outperformed placebo in the preplanned analysis of patients with confirmed low-grade non–muscle-invasive urothelial cancer (estimated 4-year recurrence rates , 4% and 54% respectively; HR, 0.53; 95% CI, 0.35-0.81; P = .001).

Intravesicular gemcitabine did not significantly reduce all-cause mortality or tumor progression to muscle invasion. “In an underpowered post hoc subgroup analysis, there [also] was no evidence of a benefit of immediate post-TURBT [transurethral resection of bladder tumor] gemcitabine in patients with high-grade non–muscle-invasive urothelial cancer,” the researchers wrote. The report was published May 8 in JAMA.

Robust data already support single-dose intravesicular chemotherapy with mitomycin C or epirubicin immediately after patients undergo TURBT. But in reality, this practice is uncommon in the United States. Meanwhile, systemic gemcitabine already is used to treat bladder cancer, and its intravesicular use appears safe and at least as effective as other chemotherapies, the investigators noted. Therefore, the SWOG S0337 trial enrolled 416 symptomatic patients with suspected low-grade papillary urothelial cancer who received a single intravesicular instillation of either gemcitabine (2 g in 100 mL saline) or saline (100 mL) within 3 hours after transurethral resection of TURBT.

Ten percent of patients did not receive study drug instillation, usually for medical reasons. There were no grade 4-5 adverse events. Grade 3 or lower adverse events did not significantly differ between groups. The study did not capture reliable data on tumor size or treatment at or after recurrence, the researchers said. Taken together, the findings “support using this therapy, but further research is needed to compare gemcitabine with other intravesical agents.”

The National Cancer Institute provided funding. Eli Lilly provided the gemcitabine used in the study. Dr. Messing reported having no relevant conflicts of interest. Three coinvestigators disclosed ties to BioCancell, Incyte, and various other biopharmaceutical companies.

SOURCE: Messing EM et al. JAMA. 2018 May 8;319(18):1880-8.

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The well designed and executed study “provides important results for patients and physicians alike,” Samuel D. Kaffenberger, MD, David C. Miller, MD, MPH, and Matthew E. Nielsen, MD, MS, wrote in an editorial accompanying the study report in JAMA.

Recurrent bladder cancer exacts major emotional, medical, and monetary costs, the experts stressed. “The natural history of frequent recurrences drives a uniquely intensive and costly program of invasive surveillance and treatment.”

Thus, while the trial results are promising, their “ultimate benefit” will depend on “more consistent and proficient use of intravesical gemcitabine than has been observed for mitomycin,” they said. Disseminating this “simple, safe, effective, and affordable” treatment will require education and mobilization of patients and physicians, advocacy organizations, and health care system leaders.

Dr. Kaffenberger and Dr. Miller are at the University of Michigan, Ann Arbor, and Dr. Nielsen is at the University of North Carolina at Chapel Hill. Dr. Nielsen disclosed stock options via the Grand Rounds Medical Advisory Board. Dr. Miller disclosed ties to Blue Cross Blue Shield of Michigan. Dr. Kaffenberger reported having no conflicts of interest. These comments summarize their editorial (JAMA. 2018 319;18:1864-65).

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The well designed and executed study “provides important results for patients and physicians alike,” Samuel D. Kaffenberger, MD, David C. Miller, MD, MPH, and Matthew E. Nielsen, MD, MS, wrote in an editorial accompanying the study report in JAMA.

Recurrent bladder cancer exacts major emotional, medical, and monetary costs, the experts stressed. “The natural history of frequent recurrences drives a uniquely intensive and costly program of invasive surveillance and treatment.”

Thus, while the trial results are promising, their “ultimate benefit” will depend on “more consistent and proficient use of intravesical gemcitabine than has been observed for mitomycin,” they said. Disseminating this “simple, safe, effective, and affordable” treatment will require education and mobilization of patients and physicians, advocacy organizations, and health care system leaders.

Dr. Kaffenberger and Dr. Miller are at the University of Michigan, Ann Arbor, and Dr. Nielsen is at the University of North Carolina at Chapel Hill. Dr. Nielsen disclosed stock options via the Grand Rounds Medical Advisory Board. Dr. Miller disclosed ties to Blue Cross Blue Shield of Michigan. Dr. Kaffenberger reported having no conflicts of interest. These comments summarize their editorial (JAMA. 2018 319;18:1864-65).

Body

 

The well designed and executed study “provides important results for patients and physicians alike,” Samuel D. Kaffenberger, MD, David C. Miller, MD, MPH, and Matthew E. Nielsen, MD, MS, wrote in an editorial accompanying the study report in JAMA.

Recurrent bladder cancer exacts major emotional, medical, and monetary costs, the experts stressed. “The natural history of frequent recurrences drives a uniquely intensive and costly program of invasive surveillance and treatment.”

Thus, while the trial results are promising, their “ultimate benefit” will depend on “more consistent and proficient use of intravesical gemcitabine than has been observed for mitomycin,” they said. Disseminating this “simple, safe, effective, and affordable” treatment will require education and mobilization of patients and physicians, advocacy organizations, and health care system leaders.

Dr. Kaffenberger and Dr. Miller are at the University of Michigan, Ann Arbor, and Dr. Nielsen is at the University of North Carolina at Chapel Hill. Dr. Nielsen disclosed stock options via the Grand Rounds Medical Advisory Board. Dr. Miller disclosed ties to Blue Cross Blue Shield of Michigan. Dr. Kaffenberger reported having no conflicts of interest. These comments summarize their editorial (JAMA. 2018 319;18:1864-65).

Title
Findings merit practice change
Findings merit practice change

 

For patients with suspected low-grade non–muscle-invasive bladder cancer, immediate postresection treatment with intravesicular gemcitabine significantly cut recurrence rates in a double-blind, multicenter, randomized, placebo-controlled trial.

In the intention-to-treat analysis, estimated rates of 4-year recurrence were 35% with gemcitabine and 47% with placebo saline (hazard ratio, 0.66; 95% confidence interval, 0.48-0.90; P less than .001), reported Edward D. Messing of the University of Rochester, New York, and his associates. Gemcitabine also significantly outperformed placebo in the preplanned analysis of patients with confirmed low-grade non–muscle-invasive urothelial cancer (estimated 4-year recurrence rates , 4% and 54% respectively; HR, 0.53; 95% CI, 0.35-0.81; P = .001).

Intravesicular gemcitabine did not significantly reduce all-cause mortality or tumor progression to muscle invasion. “In an underpowered post hoc subgroup analysis, there [also] was no evidence of a benefit of immediate post-TURBT [transurethral resection of bladder tumor] gemcitabine in patients with high-grade non–muscle-invasive urothelial cancer,” the researchers wrote. The report was published May 8 in JAMA.

Robust data already support single-dose intravesicular chemotherapy with mitomycin C or epirubicin immediately after patients undergo TURBT. But in reality, this practice is uncommon in the United States. Meanwhile, systemic gemcitabine already is used to treat bladder cancer, and its intravesicular use appears safe and at least as effective as other chemotherapies, the investigators noted. Therefore, the SWOG S0337 trial enrolled 416 symptomatic patients with suspected low-grade papillary urothelial cancer who received a single intravesicular instillation of either gemcitabine (2 g in 100 mL saline) or saline (100 mL) within 3 hours after transurethral resection of TURBT.

Ten percent of patients did not receive study drug instillation, usually for medical reasons. There were no grade 4-5 adverse events. Grade 3 or lower adverse events did not significantly differ between groups. The study did not capture reliable data on tumor size or treatment at or after recurrence, the researchers said. Taken together, the findings “support using this therapy, but further research is needed to compare gemcitabine with other intravesical agents.”

The National Cancer Institute provided funding. Eli Lilly provided the gemcitabine used in the study. Dr. Messing reported having no relevant conflicts of interest. Three coinvestigators disclosed ties to BioCancell, Incyte, and various other biopharmaceutical companies.

SOURCE: Messing EM et al. JAMA. 2018 May 8;319(18):1880-8.

 

For patients with suspected low-grade non–muscle-invasive bladder cancer, immediate postresection treatment with intravesicular gemcitabine significantly cut recurrence rates in a double-blind, multicenter, randomized, placebo-controlled trial.

In the intention-to-treat analysis, estimated rates of 4-year recurrence were 35% with gemcitabine and 47% with placebo saline (hazard ratio, 0.66; 95% confidence interval, 0.48-0.90; P less than .001), reported Edward D. Messing of the University of Rochester, New York, and his associates. Gemcitabine also significantly outperformed placebo in the preplanned analysis of patients with confirmed low-grade non–muscle-invasive urothelial cancer (estimated 4-year recurrence rates , 4% and 54% respectively; HR, 0.53; 95% CI, 0.35-0.81; P = .001).

Intravesicular gemcitabine did not significantly reduce all-cause mortality or tumor progression to muscle invasion. “In an underpowered post hoc subgroup analysis, there [also] was no evidence of a benefit of immediate post-TURBT [transurethral resection of bladder tumor] gemcitabine in patients with high-grade non–muscle-invasive urothelial cancer,” the researchers wrote. The report was published May 8 in JAMA.

Robust data already support single-dose intravesicular chemotherapy with mitomycin C or epirubicin immediately after patients undergo TURBT. But in reality, this practice is uncommon in the United States. Meanwhile, systemic gemcitabine already is used to treat bladder cancer, and its intravesicular use appears safe and at least as effective as other chemotherapies, the investigators noted. Therefore, the SWOG S0337 trial enrolled 416 symptomatic patients with suspected low-grade papillary urothelial cancer who received a single intravesicular instillation of either gemcitabine (2 g in 100 mL saline) or saline (100 mL) within 3 hours after transurethral resection of TURBT.

Ten percent of patients did not receive study drug instillation, usually for medical reasons. There were no grade 4-5 adverse events. Grade 3 or lower adverse events did not significantly differ between groups. The study did not capture reliable data on tumor size or treatment at or after recurrence, the researchers said. Taken together, the findings “support using this therapy, but further research is needed to compare gemcitabine with other intravesical agents.”

The National Cancer Institute provided funding. Eli Lilly provided the gemcitabine used in the study. Dr. Messing reported having no relevant conflicts of interest. Three coinvestigators disclosed ties to BioCancell, Incyte, and various other biopharmaceutical companies.

SOURCE: Messing EM et al. JAMA. 2018 May 8;319(18):1880-8.

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Key clinical point: Immediate postresection intravesicular gemcitabine significantly reduced the risk of recurrence in patients with suspected low-grade non–muscle-invasive bladder cancer.

Major finding: Estimated rates of 4-year recurrence were 35% with gemcitabine and 47% with placebo (hazard ratio, 0.66; P less than .001).

Study details: Phase 3 multicenter trial of 416 patients randomly assigned to receive gemcitabine (2 g in 100 mL saline) or placebo saline (100 mL) (SWOG S0337).

Disclosures: The National Cancer Institute provided funding. Eli Lilly provided the gemcitabine used in the study. Dr. Messing reported having no relevant conflicts of interest. Three coinvestigators disclosed ties to BioCancell, Incyte, and various other biopharmaceutical companies.

Source: Messing EM et al. JAMA. 2018 May 8;319(18):1880-8.
 

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Inadequate antibiotic use persists in gonorrhea

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Inappropriate treatment of gonorrhea persists despite growing antibiotic resistance, investigators reported in the Morbidity and Mortality Weekly Report.

In 2016, about 19% of gonorrhea cases diagnosed in the United States were not treated according to recommendations from the Centers for Disease Control and Prevention, wrote Emily J. Weston, MPH, and her associates. They recommended additional training and education on the need for providers to follow treatment recommendations.

Gonorrhea ranks second only to chlamydia among notifiable diseases in the United States, with 468,514 cases reported to local and state health departments in 2016. That number reflects an 18.5% increase from the year before, the investigators wrote. To combat emergent antibiotic resistance in gonorrhea, the CDC recommends dual therapy with 250 mg ceftriaxone (intramuscular) plus 1 g azithromycin (oral) for uncomplicated cases.

To assess adherence to this recommendation, Ms. Weston and her associates analyzed data for 3,213 gonorrhea cases with complete treatment data reported in the United States in 2016. The cases spanned seven CDC sentinel surveillance jurisdictions, including California (excluding San Francisco), Florida, Massachusetts, Minnesota, Philadelphia (Pa.), Baltimore (Md.), and Multnomah County (Oregon).

In all, 18.7% of patients did not receive CDC-recommended treatment, the investigators reported. Inappropriate treatment most often consisted of ceftriaxone (250 mg) alone (5.9%), ceftriaxone with doxycycline (4.4%), azithromycin only (3.1%), ceftriaxone with azithromycin of other or unknown dosages (2.1%), or doxycycline only (1.2%).

Rates of appropriate treatment varied from 79% to 83% among individual jurisdictions and were unrelated to patient race, ethnicity, sex, or age, the researchers found. Men who had sex with men were more likely to receive recommended treatment (85%) than were heterosexual men and women (79%). Patients also were more likely to receive appropriate treatment at family planning, reproductive health, or sexually transmitted disease clinics than in other health care settings.

The results highlight the need for state and local departments to identify and educate providers who are inadequately treating gonorrhea, the researchers concluded. “State and local health departments should continue to work with providers and patients to assure timely detection and treatment of gonorrhea according to current CDC treatment recommendations.”

The study received no external funding. The investigators reported having no conflicts of interest.

SOURCE: Weston EJ et al. MMWR. 2018 Apr 27. doi: 10.15585/mmwr.mm6716a4

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Inappropriate treatment of gonorrhea persists despite growing antibiotic resistance, investigators reported in the Morbidity and Mortality Weekly Report.

In 2016, about 19% of gonorrhea cases diagnosed in the United States were not treated according to recommendations from the Centers for Disease Control and Prevention, wrote Emily J. Weston, MPH, and her associates. They recommended additional training and education on the need for providers to follow treatment recommendations.

Gonorrhea ranks second only to chlamydia among notifiable diseases in the United States, with 468,514 cases reported to local and state health departments in 2016. That number reflects an 18.5% increase from the year before, the investigators wrote. To combat emergent antibiotic resistance in gonorrhea, the CDC recommends dual therapy with 250 mg ceftriaxone (intramuscular) plus 1 g azithromycin (oral) for uncomplicated cases.

To assess adherence to this recommendation, Ms. Weston and her associates analyzed data for 3,213 gonorrhea cases with complete treatment data reported in the United States in 2016. The cases spanned seven CDC sentinel surveillance jurisdictions, including California (excluding San Francisco), Florida, Massachusetts, Minnesota, Philadelphia (Pa.), Baltimore (Md.), and Multnomah County (Oregon).

In all, 18.7% of patients did not receive CDC-recommended treatment, the investigators reported. Inappropriate treatment most often consisted of ceftriaxone (250 mg) alone (5.9%), ceftriaxone with doxycycline (4.4%), azithromycin only (3.1%), ceftriaxone with azithromycin of other or unknown dosages (2.1%), or doxycycline only (1.2%).

Rates of appropriate treatment varied from 79% to 83% among individual jurisdictions and were unrelated to patient race, ethnicity, sex, or age, the researchers found. Men who had sex with men were more likely to receive recommended treatment (85%) than were heterosexual men and women (79%). Patients also were more likely to receive appropriate treatment at family planning, reproductive health, or sexually transmitted disease clinics than in other health care settings.

The results highlight the need for state and local departments to identify and educate providers who are inadequately treating gonorrhea, the researchers concluded. “State and local health departments should continue to work with providers and patients to assure timely detection and treatment of gonorrhea according to current CDC treatment recommendations.”

The study received no external funding. The investigators reported having no conflicts of interest.

SOURCE: Weston EJ et al. MMWR. 2018 Apr 27. doi: 10.15585/mmwr.mm6716a4

Inappropriate treatment of gonorrhea persists despite growing antibiotic resistance, investigators reported in the Morbidity and Mortality Weekly Report.

In 2016, about 19% of gonorrhea cases diagnosed in the United States were not treated according to recommendations from the Centers for Disease Control and Prevention, wrote Emily J. Weston, MPH, and her associates. They recommended additional training and education on the need for providers to follow treatment recommendations.

Gonorrhea ranks second only to chlamydia among notifiable diseases in the United States, with 468,514 cases reported to local and state health departments in 2016. That number reflects an 18.5% increase from the year before, the investigators wrote. To combat emergent antibiotic resistance in gonorrhea, the CDC recommends dual therapy with 250 mg ceftriaxone (intramuscular) plus 1 g azithromycin (oral) for uncomplicated cases.

To assess adherence to this recommendation, Ms. Weston and her associates analyzed data for 3,213 gonorrhea cases with complete treatment data reported in the United States in 2016. The cases spanned seven CDC sentinel surveillance jurisdictions, including California (excluding San Francisco), Florida, Massachusetts, Minnesota, Philadelphia (Pa.), Baltimore (Md.), and Multnomah County (Oregon).

In all, 18.7% of patients did not receive CDC-recommended treatment, the investigators reported. Inappropriate treatment most often consisted of ceftriaxone (250 mg) alone (5.9%), ceftriaxone with doxycycline (4.4%), azithromycin only (3.1%), ceftriaxone with azithromycin of other or unknown dosages (2.1%), or doxycycline only (1.2%).

Rates of appropriate treatment varied from 79% to 83% among individual jurisdictions and were unrelated to patient race, ethnicity, sex, or age, the researchers found. Men who had sex with men were more likely to receive recommended treatment (85%) than were heterosexual men and women (79%). Patients also were more likely to receive appropriate treatment at family planning, reproductive health, or sexually transmitted disease clinics than in other health care settings.

The results highlight the need for state and local departments to identify and educate providers who are inadequately treating gonorrhea, the researchers concluded. “State and local health departments should continue to work with providers and patients to assure timely detection and treatment of gonorrhea according to current CDC treatment recommendations.”

The study received no external funding. The investigators reported having no conflicts of interest.

SOURCE: Weston EJ et al. MMWR. 2018 Apr 27. doi: 10.15585/mmwr.mm6716a4

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Key clinical point: Inadequate treatment of gonorrhea persists despite its growing antibiotic resistance.

Major finding: In all, 18.7% patients did not receive CDC-recommended treatment.

Study details: Analyses of 3,213 cases from seven U.S. jurisdictions.

Disclosures: The investigators reported no external funding sources. They reported having no conflicts of interest.

Source: Weston EJ et al. MMWR. 2018 Apr 27. doi: 10.15585/mmwr.mm6716a4

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Pediatric epilepsy may be misdiagnosed as GI disease

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More than 2% of children with West syndrome, temporal lobe epilepsy, or Panayiotopoulos syndrome initially were misdiagnosed with gastrointestinal disorders, according to the results of a large single-center retrospective study.

Such misdiagnoses caused substantial diagnostic delays, increased the risk of cognitive deterioration, and exposed children to inappropriate radiation and invasive procedures, reported Giulia Carbonari and her associates at the University of Bologna, Italy.

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The results of this study suggest that epileptic spasms of West syndrome often are misdiagnosed as symptoms of gastroesophageal reflux disease (GERD). Thus, clinicians should consider epilepsy in the differential diagnosis of atypical gastroesophageal reflux in young children, the researchers wrote. The report was published online in Epilepsy & Behavior.

Several recent case reports have described pediatric epilepsies that were misdiagnosed and treated as gastrointestinal (GI) disorders. To better frame the problem, the investigators reviewed the medical records of 858 consecutive children with epilepsy treated at their center between 2010 and 2015.

A total of 21 patients (2.4%) were initially misdiagnosed with GI disease. Most were younger than 1 year old. Notably, 7 of 27 children (26%) with West syndrome were misdiagnosed – in six cases with GERD, and in one case with infant colic. In addition, 10 of 24 children (42%) with temporal lobe epilepsy were misdiagnosed with GERD (five cases), recurrent abdominal pain (two cases), or cyclic vomiting, gastric pain, or dysfunctional elimination syndrome (one case each). Finally, 4 of 38 children (11%) with Panayiotopoulos syndrome were misdiagnosed with cyclic vomiting (three cases) or GERD (one case).

Misdiagnoses typically caused at least a 3-month diagnostic delay (interquartile range, 2-18 months), and half of misdiagnosed children received inappropriate abdominal ultrasonography, upper alimentary canal radiography, or esophagogastroduodenoscopy. Eight patients also received inappropriate antireflux therapy, and one patient underwent inappropriate surgery, the researchers said.

They shared tips for avoiding these misdiagnoses. Epileptic spasms of West syndrome involve brief contractions (flexion or extension) of the neck, trunk, and extremities, usually in clusters. Psychomotor slowing also is common. Seizures in temporal lobe epilepsy often involve automatisms, mental status changes, and changes in skin color, blood pressure, and heart rate. Signs of Panayiotopoulos syndrome include emesis, cyanosis, pallor, changes in intestinal motility, gaze deviation, hypotonia, confusion, and unresponsiveness.

 

 


“A careful review of a patient’s medical history and a detailed description of paroxysmal episodes are the most important tools to reduce diagnostic errors,” they said.

No funding sources were reported. The researchers reported having no conflicts of interest.

SOURCE: Carbonari G et al. Epilepsy Behav. 2018 Apr 26. doi: 10.1016/j.yebeh.2018.03.034.

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More than 2% of children with West syndrome, temporal lobe epilepsy, or Panayiotopoulos syndrome initially were misdiagnosed with gastrointestinal disorders, according to the results of a large single-center retrospective study.

Such misdiagnoses caused substantial diagnostic delays, increased the risk of cognitive deterioration, and exposed children to inappropriate radiation and invasive procedures, reported Giulia Carbonari and her associates at the University of Bologna, Italy.

©Zerbor/Thinkstock
The results of this study suggest that epileptic spasms of West syndrome often are misdiagnosed as symptoms of gastroesophageal reflux disease (GERD). Thus, clinicians should consider epilepsy in the differential diagnosis of atypical gastroesophageal reflux in young children, the researchers wrote. The report was published online in Epilepsy & Behavior.

Several recent case reports have described pediatric epilepsies that were misdiagnosed and treated as gastrointestinal (GI) disorders. To better frame the problem, the investigators reviewed the medical records of 858 consecutive children with epilepsy treated at their center between 2010 and 2015.

A total of 21 patients (2.4%) were initially misdiagnosed with GI disease. Most were younger than 1 year old. Notably, 7 of 27 children (26%) with West syndrome were misdiagnosed – in six cases with GERD, and in one case with infant colic. In addition, 10 of 24 children (42%) with temporal lobe epilepsy were misdiagnosed with GERD (five cases), recurrent abdominal pain (two cases), or cyclic vomiting, gastric pain, or dysfunctional elimination syndrome (one case each). Finally, 4 of 38 children (11%) with Panayiotopoulos syndrome were misdiagnosed with cyclic vomiting (three cases) or GERD (one case).

Misdiagnoses typically caused at least a 3-month diagnostic delay (interquartile range, 2-18 months), and half of misdiagnosed children received inappropriate abdominal ultrasonography, upper alimentary canal radiography, or esophagogastroduodenoscopy. Eight patients also received inappropriate antireflux therapy, and one patient underwent inappropriate surgery, the researchers said.

They shared tips for avoiding these misdiagnoses. Epileptic spasms of West syndrome involve brief contractions (flexion or extension) of the neck, trunk, and extremities, usually in clusters. Psychomotor slowing also is common. Seizures in temporal lobe epilepsy often involve automatisms, mental status changes, and changes in skin color, blood pressure, and heart rate. Signs of Panayiotopoulos syndrome include emesis, cyanosis, pallor, changes in intestinal motility, gaze deviation, hypotonia, confusion, and unresponsiveness.

 

 


“A careful review of a patient’s medical history and a detailed description of paroxysmal episodes are the most important tools to reduce diagnostic errors,” they said.

No funding sources were reported. The researchers reported having no conflicts of interest.

SOURCE: Carbonari G et al. Epilepsy Behav. 2018 Apr 26. doi: 10.1016/j.yebeh.2018.03.034.

 

More than 2% of children with West syndrome, temporal lobe epilepsy, or Panayiotopoulos syndrome initially were misdiagnosed with gastrointestinal disorders, according to the results of a large single-center retrospective study.

Such misdiagnoses caused substantial diagnostic delays, increased the risk of cognitive deterioration, and exposed children to inappropriate radiation and invasive procedures, reported Giulia Carbonari and her associates at the University of Bologna, Italy.

©Zerbor/Thinkstock
The results of this study suggest that epileptic spasms of West syndrome often are misdiagnosed as symptoms of gastroesophageal reflux disease (GERD). Thus, clinicians should consider epilepsy in the differential diagnosis of atypical gastroesophageal reflux in young children, the researchers wrote. The report was published online in Epilepsy & Behavior.

Several recent case reports have described pediatric epilepsies that were misdiagnosed and treated as gastrointestinal (GI) disorders. To better frame the problem, the investigators reviewed the medical records of 858 consecutive children with epilepsy treated at their center between 2010 and 2015.

A total of 21 patients (2.4%) were initially misdiagnosed with GI disease. Most were younger than 1 year old. Notably, 7 of 27 children (26%) with West syndrome were misdiagnosed – in six cases with GERD, and in one case with infant colic. In addition, 10 of 24 children (42%) with temporal lobe epilepsy were misdiagnosed with GERD (five cases), recurrent abdominal pain (two cases), or cyclic vomiting, gastric pain, or dysfunctional elimination syndrome (one case each). Finally, 4 of 38 children (11%) with Panayiotopoulos syndrome were misdiagnosed with cyclic vomiting (three cases) or GERD (one case).

Misdiagnoses typically caused at least a 3-month diagnostic delay (interquartile range, 2-18 months), and half of misdiagnosed children received inappropriate abdominal ultrasonography, upper alimentary canal radiography, or esophagogastroduodenoscopy. Eight patients also received inappropriate antireflux therapy, and one patient underwent inappropriate surgery, the researchers said.

They shared tips for avoiding these misdiagnoses. Epileptic spasms of West syndrome involve brief contractions (flexion or extension) of the neck, trunk, and extremities, usually in clusters. Psychomotor slowing also is common. Seizures in temporal lobe epilepsy often involve automatisms, mental status changes, and changes in skin color, blood pressure, and heart rate. Signs of Panayiotopoulos syndrome include emesis, cyanosis, pallor, changes in intestinal motility, gaze deviation, hypotonia, confusion, and unresponsiveness.

 

 


“A careful review of a patient’s medical history and a detailed description of paroxysmal episodes are the most important tools to reduce diagnostic errors,” they said.

No funding sources were reported. The researchers reported having no conflicts of interest.

SOURCE: Carbonari G et al. Epilepsy Behav. 2018 Apr 26. doi: 10.1016/j.yebeh.2018.03.034.

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Key clinical point: Epilepsy is a differential diagnosis for atypical gastroesophageal reflux in younger children.

Major finding: In all, 2.4% children were misdiagnosed with gastrointestinal diseases over a 5-year period.

Study details: Single-center retrospective cohort study of 858 children with epilepsy.

Disclosures: No funding sources were reported. The researchers reported having no conflicts of interest.

Source: Carbonari G et al. Epilepsy Behav. 2018 Apr 26. doi: 10.1016/j.yebeh.2018.03.034.

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Glyburide failed to show noninferiority in gestational diabetes

Consider dosing, patient selection
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A randomized, multicenter trial failed to find glyburide noninferior to insulin for treatment of gestational diabetes, investigators reported.

The composite rate of macrosomia, neonatal hypoglycemia, and hyperbilirubinemia was 27.6% with oral glyburide and 23.4% with subcutaneous insulin (P = .19) therapy, said Marie-Victoire Sénat, MD, PhD, of Hôpital Bicêtre in Paris, and her associates. The upper limit of the 97.5% confidence interval for the difference between groups was 10.5%, exceeding the prespecified noninferiority margin of 7%. “These findings do not justify the use of glyburide as first-line treatment,” the researchers wrote. The report was published online May 1 in JAMA.

Glyburide is a common add-on therapy for gestational diabetes in the United States but is not used regularly in Europe. The treatments exert similar glycemic control, but meta-analyses and recent studies have linked glyburide to increased rates of neonatal macrosomia and hypoglycemia. However, trials comparing glyburide with insulin focused on maternal glycemic control and thus “were not optimally designed to investigate neonatal complications,” the researchers wrote.

For the study, they randomly assigned 914 women whose gestational diabetes persisted despite dietary intervention to receive either 2.5 mg glyburide once daily or 4 IU to 20 IU insulin one to four times daily. Patients up-titrated treatment as needed based on self-measured blood glucose levels. Glyburide first was increased by 2.5 mg on day 4 and thereafter by 5 mg every 4 days in morning and evening doses to a daily maximum of 20 mg. Prandial insulin was increased by 2 IU every 2 days, while basal or intermediate insulin was dosed at 4 IU to 8 IU at bedtime and increased by 2 IU every 2 days.

The difference in the composite endpoint still exceeded 4% between groups even after the researchers controlled for multiparity and gestational age at treatment. Rates of each individual complication were higher with glyburide than with insulin, although only hypoglycemia reached statistical significance (12.2% for glyburide versus 7.2% for insulin; P = .02).

Maternal hypoglycemia affected 3.8% of the glyburide arm and 1% of the insulin arm (P = .02), and 72% of glyburide patients maintained good fasting glycemic control versus 63% of insulin recipients (P = .003). Also, 58% of glyburide recipients had good postprandial glucose control versus 49% of insulin recipients (P = .051).

Questionnaires indicated that patients were more likely to find glyburide tolerable and to report that they would use it again, if needed, during a future pregnancy (P less than .001 for between-group comparisons). “Although the data do not allow a conclusion that glyburide is not inferior to insulin in the prevention of perinatal complications, the results suggest that the increase in complications may be no more than 10.5% compared with insulin,” the investigators wrote. “This result should be balanced with the ease of use and better satisfaction with glyburide.”

Dr. Sénat reported having no conflicts of interest. One coinvestigator disclosed ties to Ferring Laboratories.

SOURCE: Sénat M-V et al. JAMA. 319(17):1773-80.

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The researchers were “reasonable” to conclude that insulin should remain the first-line pharmacotherapy for gestational diabetes, according to Donald R. Coustan, MD, and Linda Barbour, MD, MSPH, whose editorial accompanied the study in JAMA.

“Use of glyburide may be most appropriate when insulin injections are not acceptable or practical,” they wrote. They suggested “frankly” counseling pregnant women about glyburide crossing the placenta and about “unanswered questions regarding long-term effects on offspring.”

Ideally, pregnant women should receive glyburide 1 hour before meals so that its effect peaks 3-4 hours later, according to the experts. But the study authors did not describe treatment timing with respect to meals, did not adjust initial dosing based on fasting or postprandial hyperglycemia, and only increased the dose every 4 days, they noted.

Although insulin was dosed much more flexibly, the glyburide group had better fasting glucose than did controls (72% vs. 63%; P = .003), the editorialists noted. Glyburide is most likely to succeed in younger women without fasting hyperglycemia and whose gestational diabetes begins later in pregnancy. Better dosing and patient selection might make glyburide more effective while also helping prevent maternal hypoglycemia and adverse perinatal outcomes, they contended.

Dr. Coustan is with Brown University, Providence, R.I. Dr. Barbour is with University of Colorado at Denver, Aurora. They reported having no conflicts of interest. These comments paraphrase their editorial ( JAMA. 2018;319[17]:1769-70 ).

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The researchers were “reasonable” to conclude that insulin should remain the first-line pharmacotherapy for gestational diabetes, according to Donald R. Coustan, MD, and Linda Barbour, MD, MSPH, whose editorial accompanied the study in JAMA.

“Use of glyburide may be most appropriate when insulin injections are not acceptable or practical,” they wrote. They suggested “frankly” counseling pregnant women about glyburide crossing the placenta and about “unanswered questions regarding long-term effects on offspring.”

Ideally, pregnant women should receive glyburide 1 hour before meals so that its effect peaks 3-4 hours later, according to the experts. But the study authors did not describe treatment timing with respect to meals, did not adjust initial dosing based on fasting or postprandial hyperglycemia, and only increased the dose every 4 days, they noted.

Although insulin was dosed much more flexibly, the glyburide group had better fasting glucose than did controls (72% vs. 63%; P = .003), the editorialists noted. Glyburide is most likely to succeed in younger women without fasting hyperglycemia and whose gestational diabetes begins later in pregnancy. Better dosing and patient selection might make glyburide more effective while also helping prevent maternal hypoglycemia and adverse perinatal outcomes, they contended.

Dr. Coustan is with Brown University, Providence, R.I. Dr. Barbour is with University of Colorado at Denver, Aurora. They reported having no conflicts of interest. These comments paraphrase their editorial ( JAMA. 2018;319[17]:1769-70 ).

Body

 

The researchers were “reasonable” to conclude that insulin should remain the first-line pharmacotherapy for gestational diabetes, according to Donald R. Coustan, MD, and Linda Barbour, MD, MSPH, whose editorial accompanied the study in JAMA.

“Use of glyburide may be most appropriate when insulin injections are not acceptable or practical,” they wrote. They suggested “frankly” counseling pregnant women about glyburide crossing the placenta and about “unanswered questions regarding long-term effects on offspring.”

Ideally, pregnant women should receive glyburide 1 hour before meals so that its effect peaks 3-4 hours later, according to the experts. But the study authors did not describe treatment timing with respect to meals, did not adjust initial dosing based on fasting or postprandial hyperglycemia, and only increased the dose every 4 days, they noted.

Although insulin was dosed much more flexibly, the glyburide group had better fasting glucose than did controls (72% vs. 63%; P = .003), the editorialists noted. Glyburide is most likely to succeed in younger women without fasting hyperglycemia and whose gestational diabetes begins later in pregnancy. Better dosing and patient selection might make glyburide more effective while also helping prevent maternal hypoglycemia and adverse perinatal outcomes, they contended.

Dr. Coustan is with Brown University, Providence, R.I. Dr. Barbour is with University of Colorado at Denver, Aurora. They reported having no conflicts of interest. These comments paraphrase their editorial ( JAMA. 2018;319[17]:1769-70 ).

Title
Consider dosing, patient selection
Consider dosing, patient selection

 

A randomized, multicenter trial failed to find glyburide noninferior to insulin for treatment of gestational diabetes, investigators reported.

The composite rate of macrosomia, neonatal hypoglycemia, and hyperbilirubinemia was 27.6% with oral glyburide and 23.4% with subcutaneous insulin (P = .19) therapy, said Marie-Victoire Sénat, MD, PhD, of Hôpital Bicêtre in Paris, and her associates. The upper limit of the 97.5% confidence interval for the difference between groups was 10.5%, exceeding the prespecified noninferiority margin of 7%. “These findings do not justify the use of glyburide as first-line treatment,” the researchers wrote. The report was published online May 1 in JAMA.

Glyburide is a common add-on therapy for gestational diabetes in the United States but is not used regularly in Europe. The treatments exert similar glycemic control, but meta-analyses and recent studies have linked glyburide to increased rates of neonatal macrosomia and hypoglycemia. However, trials comparing glyburide with insulin focused on maternal glycemic control and thus “were not optimally designed to investigate neonatal complications,” the researchers wrote.

For the study, they randomly assigned 914 women whose gestational diabetes persisted despite dietary intervention to receive either 2.5 mg glyburide once daily or 4 IU to 20 IU insulin one to four times daily. Patients up-titrated treatment as needed based on self-measured blood glucose levels. Glyburide first was increased by 2.5 mg on day 4 and thereafter by 5 mg every 4 days in morning and evening doses to a daily maximum of 20 mg. Prandial insulin was increased by 2 IU every 2 days, while basal or intermediate insulin was dosed at 4 IU to 8 IU at bedtime and increased by 2 IU every 2 days.

The difference in the composite endpoint still exceeded 4% between groups even after the researchers controlled for multiparity and gestational age at treatment. Rates of each individual complication were higher with glyburide than with insulin, although only hypoglycemia reached statistical significance (12.2% for glyburide versus 7.2% for insulin; P = .02).

Maternal hypoglycemia affected 3.8% of the glyburide arm and 1% of the insulin arm (P = .02), and 72% of glyburide patients maintained good fasting glycemic control versus 63% of insulin recipients (P = .003). Also, 58% of glyburide recipients had good postprandial glucose control versus 49% of insulin recipients (P = .051).

Questionnaires indicated that patients were more likely to find glyburide tolerable and to report that they would use it again, if needed, during a future pregnancy (P less than .001 for between-group comparisons). “Although the data do not allow a conclusion that glyburide is not inferior to insulin in the prevention of perinatal complications, the results suggest that the increase in complications may be no more than 10.5% compared with insulin,” the investigators wrote. “This result should be balanced with the ease of use and better satisfaction with glyburide.”

Dr. Sénat reported having no conflicts of interest. One coinvestigator disclosed ties to Ferring Laboratories.

SOURCE: Sénat M-V et al. JAMA. 319(17):1773-80.

 

A randomized, multicenter trial failed to find glyburide noninferior to insulin for treatment of gestational diabetes, investigators reported.

The composite rate of macrosomia, neonatal hypoglycemia, and hyperbilirubinemia was 27.6% with oral glyburide and 23.4% with subcutaneous insulin (P = .19) therapy, said Marie-Victoire Sénat, MD, PhD, of Hôpital Bicêtre in Paris, and her associates. The upper limit of the 97.5% confidence interval for the difference between groups was 10.5%, exceeding the prespecified noninferiority margin of 7%. “These findings do not justify the use of glyburide as first-line treatment,” the researchers wrote. The report was published online May 1 in JAMA.

Glyburide is a common add-on therapy for gestational diabetes in the United States but is not used regularly in Europe. The treatments exert similar glycemic control, but meta-analyses and recent studies have linked glyburide to increased rates of neonatal macrosomia and hypoglycemia. However, trials comparing glyburide with insulin focused on maternal glycemic control and thus “were not optimally designed to investigate neonatal complications,” the researchers wrote.

For the study, they randomly assigned 914 women whose gestational diabetes persisted despite dietary intervention to receive either 2.5 mg glyburide once daily or 4 IU to 20 IU insulin one to four times daily. Patients up-titrated treatment as needed based on self-measured blood glucose levels. Glyburide first was increased by 2.5 mg on day 4 and thereafter by 5 mg every 4 days in morning and evening doses to a daily maximum of 20 mg. Prandial insulin was increased by 2 IU every 2 days, while basal or intermediate insulin was dosed at 4 IU to 8 IU at bedtime and increased by 2 IU every 2 days.

The difference in the composite endpoint still exceeded 4% between groups even after the researchers controlled for multiparity and gestational age at treatment. Rates of each individual complication were higher with glyburide than with insulin, although only hypoglycemia reached statistical significance (12.2% for glyburide versus 7.2% for insulin; P = .02).

Maternal hypoglycemia affected 3.8% of the glyburide arm and 1% of the insulin arm (P = .02), and 72% of glyburide patients maintained good fasting glycemic control versus 63% of insulin recipients (P = .003). Also, 58% of glyburide recipients had good postprandial glucose control versus 49% of insulin recipients (P = .051).

Questionnaires indicated that patients were more likely to find glyburide tolerable and to report that they would use it again, if needed, during a future pregnancy (P less than .001 for between-group comparisons). “Although the data do not allow a conclusion that glyburide is not inferior to insulin in the prevention of perinatal complications, the results suggest that the increase in complications may be no more than 10.5% compared with insulin,” the investigators wrote. “This result should be balanced with the ease of use and better satisfaction with glyburide.”

Dr. Sénat reported having no conflicts of interest. One coinvestigator disclosed ties to Ferring Laboratories.

SOURCE: Sénat M-V et al. JAMA. 319(17):1773-80.

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Key clinical point: A large trial failed to justify the use of glyburide as first-line therapy for gestational diabetes.

Major finding: Combined rates of macrosomia, neonatal hypoglycemia, and hyperbilirubinemia were 27.6% in the glyburide group and 23.4% in the insulin group (P = .19). The upper limit of the confidence interval for the difference between groups was 10.5%, exceeding the prespecified noninferiority margin of 7%.

Study details: Multicenter randomized trial of 914 women with gestational diabetes.

Disclosures: Dr. Sénat reported having no conflicts of interest. One coinvestigator disclosed ties to Ferring Laboratories.

Source: Sénat M-V et al. JAMA. 319(17):1773-80.

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Allergy, eczema common after pediatric solid organ transplantation

Track atopy, allergy in pediatric transplantation
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Tue, 02/14/2023 - 13:05

 

A total of 34% of children who underwent solid organ transplantation subsequently developed eczema, food allergy, rhinitis, eosinophilic gastrointestinal disease, or asthma, according to the results of a single-center retrospective cohort study.

Another 6.6% of patients developed autoimmunity, usually autoimmune cytopenia, inflammatory bowel disease, or vasculitis, wrote Nufar Marcus, MD, of the University of Toronto, and her associates.

Posttransplant allergy, autoimmunity, and immune-mediated disorders (PTAA) likely share a common pathogenesis “and may represent a unique state of post-transplant immune-dysregulation,” they wrote. The report was published in the Journal of Pediatrics.

The study included 273 children who underwent solid organ transplantation and were followed for a median 3.6 years (range, 1.7-6.3 years). None had immune-mediated conditions or allergies diagnosed at baseline. Posttransplantation allergies most commonly included eczema (51%), asthma (32%), food allergy (25%, including 5% with associated anaphylaxis), rhinitis (17%), and eosinophilic esophagitis, gastritis, or enteritis (13%).

aniaostudio/Thinkstock.com
Median age at transplantation was 2.9 years (range, 0.7-10.3 years) and 59% of patients were male. Procedures usually involved liver (111) or heart (103) transplantation, while 52 patients underwent kidney transplantation and 7 underwent multivisceral transplantation. Heart transplantation patients were significantly more likely to develop asthma and autoimmunity, while liver transplantation patients had a significantly greater incidence of food allergies and eosinophilic gastrointestinal disease. “Recipients of multivisceral transplantation [also] had a high prevalence of autoimmunity [43%],” the researchers wrote.

Although only 31% of patients had information available on family history of allergy, those with a positive family history of allergy had a fivefold greater odds of posttransplantation PTAA, compared with other patients. Other risk factors for PTAA included female sex, young age at transplantation, eosinophilia, and a positive test for Epstein-Barr virus after transplantation, Dr. Marcus and associates said.

“The association of blood eosinophilia and PTAA reached statistical significance only when the transplant recipient was at least 6 months of age, demonstrating the nonspecific nature of abnormally high eosinophil counts during the first months of life,” they noted. The longer patients had eosinophilia after transplantation, the more likely they were to develop PTAA, “suggest[ing] a potential detrimental effect of prolonged activation of the eosinophilic-associated immune arms.”

 

 


Factors that appeared unlinked with PTAA included acute organ rejection, duration of posttransplantation steroidal treatment, organ type (living versus cadaveric), donor/recipient blood type and compatibility, infections besides Epstein-Barr virus, and posttransplant lymphoproliferative disease. “The specific type of post-transplantation immunosuppression regimen was neither associated nor protective of PTAA,” the investigators wrote. “However, a significant limitation was our inability to assess the effect of tacrolimus, as nearly all the cohort (97.8%) was treated with this medication.”

Ashley’s Angels fund provided support. The researchers reported having no conflicts of interest.

SOURCE: Marcus N et al. J Pediatr. 2018;196:154-60.

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The study is one of several to highlight the occurrence of atopy and allergy following solid organ transplantation in children, Helen M. Evans, MBChB, wrote in an editorial accompanying the report by Marcus et al.

This report differed because it studied the differences in rates of atopy and allergy between transplanted solid organ groups. These occurred in 41% and 40% of liver and heart recipients, respectively, but in only 4% of kidney recipients. Atopy or allergy developed in 57% of multivisceral transplant patients, but the number of patients was very small (n = 7). The majority of the conditions developed within 1 year of transplantation.

The recent spike in these reports could signify better recognition of the problem or “the widespread switch of primary immunosuppression from cyclosporine to tacrolimus over the last few decades,” wrote Dr. Evans.

Most of these reports have been single-center retrospective studies, which are subject to inconsistent case definitions and recall bias, she noted. “The time is right for well-conducted multicenter prospective studies to better inform the true extent of these conditions after solid organ transplantation.”

In the meantime, transplantation centers should routinely track de novo eczema, allergy, and eosinophilic gastrointestinal disease in children being assessed for solid organ transplantation, and should take “rigorous” personal and family histories, said Dr. Evans. Ultimately, this work will help “minimize the risk of children developing these conditions” and “effectively treat them in the setting of immunosuppression after transplantation.”
 

Dr. Evans is a pediatric gastroenterologist at Starship Child Health in Aukland, New Zealand. She reported having no conflicts of interest. These comments summarize her editorial ( J Pediatr. 2018;196:10-11 ).

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The study is one of several to highlight the occurrence of atopy and allergy following solid organ transplantation in children, Helen M. Evans, MBChB, wrote in an editorial accompanying the report by Marcus et al.

This report differed because it studied the differences in rates of atopy and allergy between transplanted solid organ groups. These occurred in 41% and 40% of liver and heart recipients, respectively, but in only 4% of kidney recipients. Atopy or allergy developed in 57% of multivisceral transplant patients, but the number of patients was very small (n = 7). The majority of the conditions developed within 1 year of transplantation.

The recent spike in these reports could signify better recognition of the problem or “the widespread switch of primary immunosuppression from cyclosporine to tacrolimus over the last few decades,” wrote Dr. Evans.

Most of these reports have been single-center retrospective studies, which are subject to inconsistent case definitions and recall bias, she noted. “The time is right for well-conducted multicenter prospective studies to better inform the true extent of these conditions after solid organ transplantation.”

In the meantime, transplantation centers should routinely track de novo eczema, allergy, and eosinophilic gastrointestinal disease in children being assessed for solid organ transplantation, and should take “rigorous” personal and family histories, said Dr. Evans. Ultimately, this work will help “minimize the risk of children developing these conditions” and “effectively treat them in the setting of immunosuppression after transplantation.”
 

Dr. Evans is a pediatric gastroenterologist at Starship Child Health in Aukland, New Zealand. She reported having no conflicts of interest. These comments summarize her editorial ( J Pediatr. 2018;196:10-11 ).

Body

 

The study is one of several to highlight the occurrence of atopy and allergy following solid organ transplantation in children, Helen M. Evans, MBChB, wrote in an editorial accompanying the report by Marcus et al.

This report differed because it studied the differences in rates of atopy and allergy between transplanted solid organ groups. These occurred in 41% and 40% of liver and heart recipients, respectively, but in only 4% of kidney recipients. Atopy or allergy developed in 57% of multivisceral transplant patients, but the number of patients was very small (n = 7). The majority of the conditions developed within 1 year of transplantation.

The recent spike in these reports could signify better recognition of the problem or “the widespread switch of primary immunosuppression from cyclosporine to tacrolimus over the last few decades,” wrote Dr. Evans.

Most of these reports have been single-center retrospective studies, which are subject to inconsistent case definitions and recall bias, she noted. “The time is right for well-conducted multicenter prospective studies to better inform the true extent of these conditions after solid organ transplantation.”

In the meantime, transplantation centers should routinely track de novo eczema, allergy, and eosinophilic gastrointestinal disease in children being assessed for solid organ transplantation, and should take “rigorous” personal and family histories, said Dr. Evans. Ultimately, this work will help “minimize the risk of children developing these conditions” and “effectively treat them in the setting of immunosuppression after transplantation.”
 

Dr. Evans is a pediatric gastroenterologist at Starship Child Health in Aukland, New Zealand. She reported having no conflicts of interest. These comments summarize her editorial ( J Pediatr. 2018;196:10-11 ).

Title
Track atopy, allergy in pediatric transplantation
Track atopy, allergy in pediatric transplantation

 

A total of 34% of children who underwent solid organ transplantation subsequently developed eczema, food allergy, rhinitis, eosinophilic gastrointestinal disease, or asthma, according to the results of a single-center retrospective cohort study.

Another 6.6% of patients developed autoimmunity, usually autoimmune cytopenia, inflammatory bowel disease, or vasculitis, wrote Nufar Marcus, MD, of the University of Toronto, and her associates.

Posttransplant allergy, autoimmunity, and immune-mediated disorders (PTAA) likely share a common pathogenesis “and may represent a unique state of post-transplant immune-dysregulation,” they wrote. The report was published in the Journal of Pediatrics.

The study included 273 children who underwent solid organ transplantation and were followed for a median 3.6 years (range, 1.7-6.3 years). None had immune-mediated conditions or allergies diagnosed at baseline. Posttransplantation allergies most commonly included eczema (51%), asthma (32%), food allergy (25%, including 5% with associated anaphylaxis), rhinitis (17%), and eosinophilic esophagitis, gastritis, or enteritis (13%).

aniaostudio/Thinkstock.com
Median age at transplantation was 2.9 years (range, 0.7-10.3 years) and 59% of patients were male. Procedures usually involved liver (111) or heart (103) transplantation, while 52 patients underwent kidney transplantation and 7 underwent multivisceral transplantation. Heart transplantation patients were significantly more likely to develop asthma and autoimmunity, while liver transplantation patients had a significantly greater incidence of food allergies and eosinophilic gastrointestinal disease. “Recipients of multivisceral transplantation [also] had a high prevalence of autoimmunity [43%],” the researchers wrote.

Although only 31% of patients had information available on family history of allergy, those with a positive family history of allergy had a fivefold greater odds of posttransplantation PTAA, compared with other patients. Other risk factors for PTAA included female sex, young age at transplantation, eosinophilia, and a positive test for Epstein-Barr virus after transplantation, Dr. Marcus and associates said.

“The association of blood eosinophilia and PTAA reached statistical significance only when the transplant recipient was at least 6 months of age, demonstrating the nonspecific nature of abnormally high eosinophil counts during the first months of life,” they noted. The longer patients had eosinophilia after transplantation, the more likely they were to develop PTAA, “suggest[ing] a potential detrimental effect of prolonged activation of the eosinophilic-associated immune arms.”

 

 


Factors that appeared unlinked with PTAA included acute organ rejection, duration of posttransplantation steroidal treatment, organ type (living versus cadaveric), donor/recipient blood type and compatibility, infections besides Epstein-Barr virus, and posttransplant lymphoproliferative disease. “The specific type of post-transplantation immunosuppression regimen was neither associated nor protective of PTAA,” the investigators wrote. “However, a significant limitation was our inability to assess the effect of tacrolimus, as nearly all the cohort (97.8%) was treated with this medication.”

Ashley’s Angels fund provided support. The researchers reported having no conflicts of interest.

SOURCE: Marcus N et al. J Pediatr. 2018;196:154-60.

 

A total of 34% of children who underwent solid organ transplantation subsequently developed eczema, food allergy, rhinitis, eosinophilic gastrointestinal disease, or asthma, according to the results of a single-center retrospective cohort study.

Another 6.6% of patients developed autoimmunity, usually autoimmune cytopenia, inflammatory bowel disease, or vasculitis, wrote Nufar Marcus, MD, of the University of Toronto, and her associates.

Posttransplant allergy, autoimmunity, and immune-mediated disorders (PTAA) likely share a common pathogenesis “and may represent a unique state of post-transplant immune-dysregulation,” they wrote. The report was published in the Journal of Pediatrics.

The study included 273 children who underwent solid organ transplantation and were followed for a median 3.6 years (range, 1.7-6.3 years). None had immune-mediated conditions or allergies diagnosed at baseline. Posttransplantation allergies most commonly included eczema (51%), asthma (32%), food allergy (25%, including 5% with associated anaphylaxis), rhinitis (17%), and eosinophilic esophagitis, gastritis, or enteritis (13%).

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Median age at transplantation was 2.9 years (range, 0.7-10.3 years) and 59% of patients were male. Procedures usually involved liver (111) or heart (103) transplantation, while 52 patients underwent kidney transplantation and 7 underwent multivisceral transplantation. Heart transplantation patients were significantly more likely to develop asthma and autoimmunity, while liver transplantation patients had a significantly greater incidence of food allergies and eosinophilic gastrointestinal disease. “Recipients of multivisceral transplantation [also] had a high prevalence of autoimmunity [43%],” the researchers wrote.

Although only 31% of patients had information available on family history of allergy, those with a positive family history of allergy had a fivefold greater odds of posttransplantation PTAA, compared with other patients. Other risk factors for PTAA included female sex, young age at transplantation, eosinophilia, and a positive test for Epstein-Barr virus after transplantation, Dr. Marcus and associates said.

“The association of blood eosinophilia and PTAA reached statistical significance only when the transplant recipient was at least 6 months of age, demonstrating the nonspecific nature of abnormally high eosinophil counts during the first months of life,” they noted. The longer patients had eosinophilia after transplantation, the more likely they were to develop PTAA, “suggest[ing] a potential detrimental effect of prolonged activation of the eosinophilic-associated immune arms.”

 

 


Factors that appeared unlinked with PTAA included acute organ rejection, duration of posttransplantation steroidal treatment, organ type (living versus cadaveric), donor/recipient blood type and compatibility, infections besides Epstein-Barr virus, and posttransplant lymphoproliferative disease. “The specific type of post-transplantation immunosuppression regimen was neither associated nor protective of PTAA,” the investigators wrote. “However, a significant limitation was our inability to assess the effect of tacrolimus, as nearly all the cohort (97.8%) was treated with this medication.”

Ashley’s Angels fund provided support. The researchers reported having no conflicts of interest.

SOURCE: Marcus N et al. J Pediatr. 2018;196:154-60.

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Key clinical point: Children undergoing solid organ transplantation often developed allergy or autoimmunity.

Major finding: A total 34% of children developed posttransplantation allergy or autoimmunity such as eczema, asthma, food allergy, and eosinophilic gastrointestinal disease. Study details: Single-center retrospective cross-sectional study of 273 patients aged 18 and under who underwent solid organ transplantation followed for a median 3.6 years.

Disclosures: Ashley’s Angels fund provided support. The researchers reported having no conflicts of interest.

Source: Marcus N et al. J Pediatr. 2018;196:154-60.

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Alpha fetoprotein boosted detection of early-stage liver cancer

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For patients with cirrhosis, adding serum alpha fetoprotein testing to ultrasound significantly boosted its ability to detect early-stage hepatocellular carcinoma, according to the results of a systematic review and meta-analysis reported in the May issue of Gastroenterology.

Used alone, ultrasound detected only 45% of early-stage hepatocellular carcinomas (95% confidence interval, 30%-62%), reported Kristina Tzartzeva, MD, of the University of Texas, Dallas, with her associates. Adding alpha fetoprotein (AFP) increased this sensitivity to 63% (95% CI, 48%-75%; P = .002). Few studies evaluated alternative surveillance tools, such as CT or MRI.

Diagnosing liver cancer early is key to survival and thus is a central issue in cirrhosis management. However, the best surveillance strategy remains uncertain, hinging as it does on sensitivity, specificity, and cost. The American Association for the Study of Liver Diseases and the European Association for the Study of the Liver recommend that cirrhotic patients undergo twice-yearly ultrasound to screen for hepatocellular carcinoma (HCC), but they disagree about the value of adding serum biomarker AFP testing. Meanwhile, more and more clinics are using CT and MRI because of concerns about the unreliability of ultrasound. “Given few direct comparative studies, we are forced to primarily rely on indirect comparisons across studies,” the reviewers wrote.

To do so, they searched MEDLINE and Scopus and identified 32 studies of HCC surveillance that comprised 13,367 patients, nearly all with baseline cirrhosis. The studies were published from 1990 to August 2016.

Ultrasound detected HCC of any stage with a sensitivity of 84% (95% CI, 76%-92%), but its sensitivity for detecting early-stage disease was less than 50%. In studies that performed direct comparisons, ultrasound alone was significantly less sensitive than ultrasound plus AFP for detecting all stages of HCC (relative risk, 0.80; 95% CI, 0.72-0.88) and early-stage disease (0.78; 0.66-0.92). However, ultrasound alone was more specific than ultrasound plus AFP (RR, 1.08; 95% CI, 1.05-1.09).

Four studies of about 900 patients evaluated cross-sectional imaging with CT or MRI. In one single-center, randomized trial, CT had a sensitivity of 63% for detecting early-stage disease, but the 95% CI for this estimate was very wide (30%-87%) and CT did not significantly outperform ultrasound (Aliment Pharmacol Ther. 2013;38:303-12). In another study, MRI and ultrasound had significantly different sensitivities of 84% and 26% for detecting (usually) early-stage disease (JAMA Oncol. 2017;3[4]:456-63).

 

 

“Ultrasound currently forms the backbone of professional society recommendations for HCC surveillance; however, our meta-analysis highlights its suboptimal sensitivity for detection of hepatocellular carcinoma at an early stage. Using ultrasound in combination with AFP appears to significantly improve sensitivity for detecting early HCC with a small, albeit statistically significant, trade-off in specificity. There are currently insufficient data to support routine use of CT- or MRI-based surveillance in all patients with cirrhosis,” the reviewers concluded.

The National Cancer Institute and Cancer Prevention Research Institute of Texas provided funding. None of the reviewers had conflicts of interest.

SOURCE: Tzartzeva K et al. Gastroenterology. 2018 Feb 6. doi: 10.1053/j.gastro.2018.01.064.

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For patients with cirrhosis, adding serum alpha fetoprotein testing to ultrasound significantly boosted its ability to detect early-stage hepatocellular carcinoma, according to the results of a systematic review and meta-analysis reported in the May issue of Gastroenterology.

Used alone, ultrasound detected only 45% of early-stage hepatocellular carcinomas (95% confidence interval, 30%-62%), reported Kristina Tzartzeva, MD, of the University of Texas, Dallas, with her associates. Adding alpha fetoprotein (AFP) increased this sensitivity to 63% (95% CI, 48%-75%; P = .002). Few studies evaluated alternative surveillance tools, such as CT or MRI.

Diagnosing liver cancer early is key to survival and thus is a central issue in cirrhosis management. However, the best surveillance strategy remains uncertain, hinging as it does on sensitivity, specificity, and cost. The American Association for the Study of Liver Diseases and the European Association for the Study of the Liver recommend that cirrhotic patients undergo twice-yearly ultrasound to screen for hepatocellular carcinoma (HCC), but they disagree about the value of adding serum biomarker AFP testing. Meanwhile, more and more clinics are using CT and MRI because of concerns about the unreliability of ultrasound. “Given few direct comparative studies, we are forced to primarily rely on indirect comparisons across studies,” the reviewers wrote.

To do so, they searched MEDLINE and Scopus and identified 32 studies of HCC surveillance that comprised 13,367 patients, nearly all with baseline cirrhosis. The studies were published from 1990 to August 2016.

Ultrasound detected HCC of any stage with a sensitivity of 84% (95% CI, 76%-92%), but its sensitivity for detecting early-stage disease was less than 50%. In studies that performed direct comparisons, ultrasound alone was significantly less sensitive than ultrasound plus AFP for detecting all stages of HCC (relative risk, 0.80; 95% CI, 0.72-0.88) and early-stage disease (0.78; 0.66-0.92). However, ultrasound alone was more specific than ultrasound plus AFP (RR, 1.08; 95% CI, 1.05-1.09).

Four studies of about 900 patients evaluated cross-sectional imaging with CT or MRI. In one single-center, randomized trial, CT had a sensitivity of 63% for detecting early-stage disease, but the 95% CI for this estimate was very wide (30%-87%) and CT did not significantly outperform ultrasound (Aliment Pharmacol Ther. 2013;38:303-12). In another study, MRI and ultrasound had significantly different sensitivities of 84% and 26% for detecting (usually) early-stage disease (JAMA Oncol. 2017;3[4]:456-63).

 

 

“Ultrasound currently forms the backbone of professional society recommendations for HCC surveillance; however, our meta-analysis highlights its suboptimal sensitivity for detection of hepatocellular carcinoma at an early stage. Using ultrasound in combination with AFP appears to significantly improve sensitivity for detecting early HCC with a small, albeit statistically significant, trade-off in specificity. There are currently insufficient data to support routine use of CT- or MRI-based surveillance in all patients with cirrhosis,” the reviewers concluded.

The National Cancer Institute and Cancer Prevention Research Institute of Texas provided funding. None of the reviewers had conflicts of interest.

SOURCE: Tzartzeva K et al. Gastroenterology. 2018 Feb 6. doi: 10.1053/j.gastro.2018.01.064.

 

For patients with cirrhosis, adding serum alpha fetoprotein testing to ultrasound significantly boosted its ability to detect early-stage hepatocellular carcinoma, according to the results of a systematic review and meta-analysis reported in the May issue of Gastroenterology.

Used alone, ultrasound detected only 45% of early-stage hepatocellular carcinomas (95% confidence interval, 30%-62%), reported Kristina Tzartzeva, MD, of the University of Texas, Dallas, with her associates. Adding alpha fetoprotein (AFP) increased this sensitivity to 63% (95% CI, 48%-75%; P = .002). Few studies evaluated alternative surveillance tools, such as CT or MRI.

Diagnosing liver cancer early is key to survival and thus is a central issue in cirrhosis management. However, the best surveillance strategy remains uncertain, hinging as it does on sensitivity, specificity, and cost. The American Association for the Study of Liver Diseases and the European Association for the Study of the Liver recommend that cirrhotic patients undergo twice-yearly ultrasound to screen for hepatocellular carcinoma (HCC), but they disagree about the value of adding serum biomarker AFP testing. Meanwhile, more and more clinics are using CT and MRI because of concerns about the unreliability of ultrasound. “Given few direct comparative studies, we are forced to primarily rely on indirect comparisons across studies,” the reviewers wrote.

To do so, they searched MEDLINE and Scopus and identified 32 studies of HCC surveillance that comprised 13,367 patients, nearly all with baseline cirrhosis. The studies were published from 1990 to August 2016.

Ultrasound detected HCC of any stage with a sensitivity of 84% (95% CI, 76%-92%), but its sensitivity for detecting early-stage disease was less than 50%. In studies that performed direct comparisons, ultrasound alone was significantly less sensitive than ultrasound plus AFP for detecting all stages of HCC (relative risk, 0.80; 95% CI, 0.72-0.88) and early-stage disease (0.78; 0.66-0.92). However, ultrasound alone was more specific than ultrasound plus AFP (RR, 1.08; 95% CI, 1.05-1.09).

Four studies of about 900 patients evaluated cross-sectional imaging with CT or MRI. In one single-center, randomized trial, CT had a sensitivity of 63% for detecting early-stage disease, but the 95% CI for this estimate was very wide (30%-87%) and CT did not significantly outperform ultrasound (Aliment Pharmacol Ther. 2013;38:303-12). In another study, MRI and ultrasound had significantly different sensitivities of 84% and 26% for detecting (usually) early-stage disease (JAMA Oncol. 2017;3[4]:456-63).

 

 

“Ultrasound currently forms the backbone of professional society recommendations for HCC surveillance; however, our meta-analysis highlights its suboptimal sensitivity for detection of hepatocellular carcinoma at an early stage. Using ultrasound in combination with AFP appears to significantly improve sensitivity for detecting early HCC with a small, albeit statistically significant, trade-off in specificity. There are currently insufficient data to support routine use of CT- or MRI-based surveillance in all patients with cirrhosis,” the reviewers concluded.

The National Cancer Institute and Cancer Prevention Research Institute of Texas provided funding. None of the reviewers had conflicts of interest.

SOURCE: Tzartzeva K et al. Gastroenterology. 2018 Feb 6. doi: 10.1053/j.gastro.2018.01.064.

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Key clinical point: Ultrasound unreliably detects hepatocellular carcinoma, but adding alpha fetoprotein increases its sensitivity.

Major finding: Used alone, ultrasound detected only 47% of early-stage cases. Adding alpha fetoprotein increased this sensitivity to 63% (P = .002).

Study details: Systematic review and meta-analysis of 32 studies comprising 13,367 patients and spanning from 1990 to August 2016.

Disclosures: The National Cancer Institute and Cancer Prevention Research Institute of Texas provided funding. None of the researchers had conflicts of interest.

Source: Tzartzeva K et al. Gastroenterology. 2018 Feb 6. doi: 10.1053/j.gastro.2018.01.064.

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One in seven Americans had fecal incontinence

An important step forward
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Fri, 01/18/2019 - 17:32

 

One in seven respondents to a national survey reported a history of fecal incontinence, including one-third within the preceding week, investigators reported.

“Fecal incontinence [FI] is age-related and more prevalent among individuals with inflammatory bowel disease, celiac disease, irritable bowel syndrome, or diabetes than people without these disorders. Proactive screening for FI among these groups is warranted,” Stacy B. Menees, MD, and her associates wrote in the May issue of Gastroenterology (doi: 10.1053/j.gastro.2018.01.062).

Accurately determining the prevalence of FI is difficult because patients are reluctant to disclose symptoms and physicians often do not ask. In one study of HMO enrollees, about a third of patients had a history of FI but fewer than 3% had a medical diagnosis. In other studies, the prevalence of FI has ranged from 2% to 21%. Population aging fuels the need to narrow these estimates because FI becomes more common with age, the investigators noted.

Accordingly, in October 2015, they used a mobile app called MyGIHealth to survey nearly 72,000 individuals about fecal incontinence and other GI symptoms. The survey took about 15 minutes to complete, in return for which respondents could receive cash, shop online, or donate to charity. The investigators assessed FI severity by analyzing responses to the National Institutes of Health FI Patient Reported Outcomes Measurement Information System questionnaire.

Of the 10,033 respondents reporting a history of fecal incontinence (14.4%), 33.3% had experienced at least one episode in the past week. About a third of individuals with FI said it interfered with their daily activities. “Increasing age and concomitant diarrhea and constipation were associated with increased odds [of] FI,” the researchers wrote. Compared with individuals aged 18-24 years, the odds of having ever experienced FI rose by 29% among those aged 25-45 years, by 72% among those aged 45-64 years, and by 118% among persons aged 65 years and older.

Self-reported FI also was significantly more common among individuals with Crohn’s disease (41%), ulcerative colitis (37%), celiac disease (34%), irritable bowel syndrome (13%), or diabetes (13%) than it was among persons without these conditions. Corresponding odds ratios ranged from about 1.5 (diabetes) to 2.8 (celiac disease).

For individuals reporting FI within the past week, greater severity (based on their responses to the NIH FI Patient Reported Outcomes Measurement Information System questionnaire) significantly correlated with being non-Hispanic black (P = .03) or Latino (P = .02) and with having Crohn’s disease (P less than .001), celiac disease (P less than .001), diabetes (P = .04), human immunodeficiency syndrome (P = .001), or chronic idiopathic constipation (P less than .001). “Our study is the first to find differences among racial/ethnic groups regarding FI severity,” the researchers noted. They did not speculate on reasons for the finding, but stressed the importance of screening for FI and screening patients with FI for serious GI diseases.

Ironwood Pharmaceuticals funded the National GI Survey, but the investigators received no funding for this study. Three coinvestigators reported ties to Ironwood Pharmaceuticals and My Total Health.

SOURCE: Menees SB et al. Gastroenterology. 2018 Feb 3. doi: 10.1053/j.gastro.2018.01.062.

Body

 

Fecal incontinence (FI) is a common problem associated with significant social anxiety and decreased quality of life for patients who experience it. Unfortunately, patients are not always forthcoming regarding their symptoms, and physicians often fail to inquire directly about incontinence symptoms.

Previous studies have shown the prevalence of FI to vary widely across different populations. Using novel technology through a mobile app, researchers at the University of Michigan, Ann Arbor, and Cedars-Sinai Medical Center, Los Angeles, have been able to perform the largest population-based study of community-dwelling Americans. They confirmed that FI is indeed a common problem experienced across the spectrum of age, sex, race, and socioeconomic status and interferes with the daily activities of more than one-third of those who experience it.

This study supports previous findings of an age-related increase in FI, with the highest prevalence in patients over age 65 years. Interestingly, males were more likely than female to have experienced FI within the past week, but not more likely to have ever experienced FI. While FI is often thought of as a primarily female problem (related to past obstetrical injury), it is important to remember that it likely affects both sexes equally.

Other significant risk factors include diabetes and gastrointestinal disorders. This study also confirms prior population-based findings that patients with chronic constipation are more likely to suffer FI. Finally, this study also identified risk factors associated with FI symptom severity including diabetes, HIV/AIDS, Crohn’s disease, celiac disease, and chronic constipation. This is also the first study to show differences between racial/ethnic groups, suggesting higher FI symptom scores in Latinos and African-Americans.

The strengths of this study include its size and the anonymity provided by an internet-based survey regarding a potentially embarrassing topic; however, it also may have led to the potential exclusion of older individuals or those without regular internet access.

In summary, I believe this is an important study which confirms that FI is a common among Americans while helping to identify potential risk factors for the presence and severity of FI. I am hopeful that with increased awareness, health care providers will become more prudent in screening their patients for FI, particularly in these higher-risk populations.
 

Stephanie A. McAbee, MD, is an assistant professor of medicine in the division of gastroenterology, hepatology, and nutrition at Vanderbilt University Medical Center, Nashville, Tenn. She has no conflicts of interest.

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Fecal incontinence (FI) is a common problem associated with significant social anxiety and decreased quality of life for patients who experience it. Unfortunately, patients are not always forthcoming regarding their symptoms, and physicians often fail to inquire directly about incontinence symptoms.

Previous studies have shown the prevalence of FI to vary widely across different populations. Using novel technology through a mobile app, researchers at the University of Michigan, Ann Arbor, and Cedars-Sinai Medical Center, Los Angeles, have been able to perform the largest population-based study of community-dwelling Americans. They confirmed that FI is indeed a common problem experienced across the spectrum of age, sex, race, and socioeconomic status and interferes with the daily activities of more than one-third of those who experience it.

This study supports previous findings of an age-related increase in FI, with the highest prevalence in patients over age 65 years. Interestingly, males were more likely than female to have experienced FI within the past week, but not more likely to have ever experienced FI. While FI is often thought of as a primarily female problem (related to past obstetrical injury), it is important to remember that it likely affects both sexes equally.

Other significant risk factors include diabetes and gastrointestinal disorders. This study also confirms prior population-based findings that patients with chronic constipation are more likely to suffer FI. Finally, this study also identified risk factors associated with FI symptom severity including diabetes, HIV/AIDS, Crohn’s disease, celiac disease, and chronic constipation. This is also the first study to show differences between racial/ethnic groups, suggesting higher FI symptom scores in Latinos and African-Americans.

The strengths of this study include its size and the anonymity provided by an internet-based survey regarding a potentially embarrassing topic; however, it also may have led to the potential exclusion of older individuals or those without regular internet access.

In summary, I believe this is an important study which confirms that FI is a common among Americans while helping to identify potential risk factors for the presence and severity of FI. I am hopeful that with increased awareness, health care providers will become more prudent in screening their patients for FI, particularly in these higher-risk populations.
 

Stephanie A. McAbee, MD, is an assistant professor of medicine in the division of gastroenterology, hepatology, and nutrition at Vanderbilt University Medical Center, Nashville, Tenn. She has no conflicts of interest.

Body

 

Fecal incontinence (FI) is a common problem associated with significant social anxiety and decreased quality of life for patients who experience it. Unfortunately, patients are not always forthcoming regarding their symptoms, and physicians often fail to inquire directly about incontinence symptoms.

Previous studies have shown the prevalence of FI to vary widely across different populations. Using novel technology through a mobile app, researchers at the University of Michigan, Ann Arbor, and Cedars-Sinai Medical Center, Los Angeles, have been able to perform the largest population-based study of community-dwelling Americans. They confirmed that FI is indeed a common problem experienced across the spectrum of age, sex, race, and socioeconomic status and interferes with the daily activities of more than one-third of those who experience it.

This study supports previous findings of an age-related increase in FI, with the highest prevalence in patients over age 65 years. Interestingly, males were more likely than female to have experienced FI within the past week, but not more likely to have ever experienced FI. While FI is often thought of as a primarily female problem (related to past obstetrical injury), it is important to remember that it likely affects both sexes equally.

Other significant risk factors include diabetes and gastrointestinal disorders. This study also confirms prior population-based findings that patients with chronic constipation are more likely to suffer FI. Finally, this study also identified risk factors associated with FI symptom severity including diabetes, HIV/AIDS, Crohn’s disease, celiac disease, and chronic constipation. This is also the first study to show differences between racial/ethnic groups, suggesting higher FI symptom scores in Latinos and African-Americans.

The strengths of this study include its size and the anonymity provided by an internet-based survey regarding a potentially embarrassing topic; however, it also may have led to the potential exclusion of older individuals or those without regular internet access.

In summary, I believe this is an important study which confirms that FI is a common among Americans while helping to identify potential risk factors for the presence and severity of FI. I am hopeful that with increased awareness, health care providers will become more prudent in screening their patients for FI, particularly in these higher-risk populations.
 

Stephanie A. McAbee, MD, is an assistant professor of medicine in the division of gastroenterology, hepatology, and nutrition at Vanderbilt University Medical Center, Nashville, Tenn. She has no conflicts of interest.

Title
An important step forward
An important step forward

 

One in seven respondents to a national survey reported a history of fecal incontinence, including one-third within the preceding week, investigators reported.

“Fecal incontinence [FI] is age-related and more prevalent among individuals with inflammatory bowel disease, celiac disease, irritable bowel syndrome, or diabetes than people without these disorders. Proactive screening for FI among these groups is warranted,” Stacy B. Menees, MD, and her associates wrote in the May issue of Gastroenterology (doi: 10.1053/j.gastro.2018.01.062).

Accurately determining the prevalence of FI is difficult because patients are reluctant to disclose symptoms and physicians often do not ask. In one study of HMO enrollees, about a third of patients had a history of FI but fewer than 3% had a medical diagnosis. In other studies, the prevalence of FI has ranged from 2% to 21%. Population aging fuels the need to narrow these estimates because FI becomes more common with age, the investigators noted.

Accordingly, in October 2015, they used a mobile app called MyGIHealth to survey nearly 72,000 individuals about fecal incontinence and other GI symptoms. The survey took about 15 minutes to complete, in return for which respondents could receive cash, shop online, or donate to charity. The investigators assessed FI severity by analyzing responses to the National Institutes of Health FI Patient Reported Outcomes Measurement Information System questionnaire.

Of the 10,033 respondents reporting a history of fecal incontinence (14.4%), 33.3% had experienced at least one episode in the past week. About a third of individuals with FI said it interfered with their daily activities. “Increasing age and concomitant diarrhea and constipation were associated with increased odds [of] FI,” the researchers wrote. Compared with individuals aged 18-24 years, the odds of having ever experienced FI rose by 29% among those aged 25-45 years, by 72% among those aged 45-64 years, and by 118% among persons aged 65 years and older.

Self-reported FI also was significantly more common among individuals with Crohn’s disease (41%), ulcerative colitis (37%), celiac disease (34%), irritable bowel syndrome (13%), or diabetes (13%) than it was among persons without these conditions. Corresponding odds ratios ranged from about 1.5 (diabetes) to 2.8 (celiac disease).

For individuals reporting FI within the past week, greater severity (based on their responses to the NIH FI Patient Reported Outcomes Measurement Information System questionnaire) significantly correlated with being non-Hispanic black (P = .03) or Latino (P = .02) and with having Crohn’s disease (P less than .001), celiac disease (P less than .001), diabetes (P = .04), human immunodeficiency syndrome (P = .001), or chronic idiopathic constipation (P less than .001). “Our study is the first to find differences among racial/ethnic groups regarding FI severity,” the researchers noted. They did not speculate on reasons for the finding, but stressed the importance of screening for FI and screening patients with FI for serious GI diseases.

Ironwood Pharmaceuticals funded the National GI Survey, but the investigators received no funding for this study. Three coinvestigators reported ties to Ironwood Pharmaceuticals and My Total Health.

SOURCE: Menees SB et al. Gastroenterology. 2018 Feb 3. doi: 10.1053/j.gastro.2018.01.062.

 

One in seven respondents to a national survey reported a history of fecal incontinence, including one-third within the preceding week, investigators reported.

“Fecal incontinence [FI] is age-related and more prevalent among individuals with inflammatory bowel disease, celiac disease, irritable bowel syndrome, or diabetes than people without these disorders. Proactive screening for FI among these groups is warranted,” Stacy B. Menees, MD, and her associates wrote in the May issue of Gastroenterology (doi: 10.1053/j.gastro.2018.01.062).

Accurately determining the prevalence of FI is difficult because patients are reluctant to disclose symptoms and physicians often do not ask. In one study of HMO enrollees, about a third of patients had a history of FI but fewer than 3% had a medical diagnosis. In other studies, the prevalence of FI has ranged from 2% to 21%. Population aging fuels the need to narrow these estimates because FI becomes more common with age, the investigators noted.

Accordingly, in October 2015, they used a mobile app called MyGIHealth to survey nearly 72,000 individuals about fecal incontinence and other GI symptoms. The survey took about 15 minutes to complete, in return for which respondents could receive cash, shop online, or donate to charity. The investigators assessed FI severity by analyzing responses to the National Institutes of Health FI Patient Reported Outcomes Measurement Information System questionnaire.

Of the 10,033 respondents reporting a history of fecal incontinence (14.4%), 33.3% had experienced at least one episode in the past week. About a third of individuals with FI said it interfered with their daily activities. “Increasing age and concomitant diarrhea and constipation were associated with increased odds [of] FI,” the researchers wrote. Compared with individuals aged 18-24 years, the odds of having ever experienced FI rose by 29% among those aged 25-45 years, by 72% among those aged 45-64 years, and by 118% among persons aged 65 years and older.

Self-reported FI also was significantly more common among individuals with Crohn’s disease (41%), ulcerative colitis (37%), celiac disease (34%), irritable bowel syndrome (13%), or diabetes (13%) than it was among persons without these conditions. Corresponding odds ratios ranged from about 1.5 (diabetes) to 2.8 (celiac disease).

For individuals reporting FI within the past week, greater severity (based on their responses to the NIH FI Patient Reported Outcomes Measurement Information System questionnaire) significantly correlated with being non-Hispanic black (P = .03) or Latino (P = .02) and with having Crohn’s disease (P less than .001), celiac disease (P less than .001), diabetes (P = .04), human immunodeficiency syndrome (P = .001), or chronic idiopathic constipation (P less than .001). “Our study is the first to find differences among racial/ethnic groups regarding FI severity,” the researchers noted. They did not speculate on reasons for the finding, but stressed the importance of screening for FI and screening patients with FI for serious GI diseases.

Ironwood Pharmaceuticals funded the National GI Survey, but the investigators received no funding for this study. Three coinvestigators reported ties to Ironwood Pharmaceuticals and My Total Health.

SOURCE: Menees SB et al. Gastroenterology. 2018 Feb 3. doi: 10.1053/j.gastro.2018.01.062.

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Key clinical point: One in seven (14%) individuals had experienced fecal incontinence (FI), one-third within the past week.

Major finding: Self-reported FI was significantly more common among individuals with Crohn’s disease (41%), ulcerative colitis (37%), celiac disease (34%), irritable bowel syndrome (13%), or diabetes (13%) than among individuals without these diagnoses.

Study details: Analysis of 71,812 responses to the National GI Survey, conducted in October 2015.

Disclosures: Although Ironwood Pharmaceuticals funded the National GI Survey, the investigators received no funding for this study. Three coinvestigators reported ties to Ironwood Pharmaceuticals and My Total Health.

Source: Menees SB et al. Gastroenterology. 2018 Feb 3. doi: 10.1053/j.gastro.2018.01.062.

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Heavy drinking did not worsen clinical outcomes from drug-induced liver injury

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Heavy drinking was not associated with higher proportions of liver-related deaths or liver transplantation among patients with drug-induced liver injury (DILI), according to the results of a prospective multicenter cohort study reported in the May issue of Clinical Gastroenterology and Hepatology.

Anabolic steroids were the most common cause of DILI among heavy drinkers, defined as men who averaged more than three drinks a day or women who averaged more than two drinks daily, said Lara Dakhoul, MD, of Indiana University, Indianapolis, and her associates. There also was no evidence that heavy alcohol consumption increased the risk of liver injury attributable to isoniazid exposure, the researchers wrote in.

Although consuming alcohol significantly increases the risk of acetaminophen-induced liver injury, there is much less clarity about the relationship between drinking and hepatotoxicity from drugs such as duloxetine or antituberculosis medications, the researchers noted. In fact, one recent study found that drinking led to less severe liver injury among individuals with DILI. To better elucidate these links, the investigators studied 1,198 individuals with confirmed or probable DILI who enrolled in the DILI Network study (DILIN) between 2004 and 2016. At enrollment, all participants were asked if they consumed alcohol, and those who reported drinking within the past 12 months were offered a shortened version of the Skinner Alcohol Dependence Scale to collect details on alcohol consumption, including type, amount, and frequency.

In all, 601 persons reported consuming at least one alcoholic drink in the preceding year, of whom 348 completed the Skinner questionnaire. A total of 80 individuals reported heavy alcohol consumption. Heavy drinkers were typically in their early 40s, while nondrinkers tended to be nearly 50 years old (P less than .01). Heavy drinkers were also more often men (63%) while nondrinkers were usually women (65%; P less than .01). Heavy drinkers were significantly more likely to have DILI secondary to anabolic steroid exposure (13%) than were nondrinkers (2%; P less than .001). However, latency, pattern of liver injury, peak enzyme levels, and patterns of recovery from steroid hepatotoxicity were similar regardless of alcohol history.

A total of eight patients with DILI died of liver-related causes or underwent liver transplantation, and proportions of patients with these outcomes were similar regardless of alcohol history. These eight patients had no evidence of hepatitis C virus infection, but three appeared to have underlying alcoholic liver disease with superimposed acute-on-chronic liver failure. Heavy drinkers did not have significantly higher DILI severity scores than nondrinkers, but they did have significantly higher peak serum levels of alanine aminotransferase (1,323 U/L vs. 754, respectively; P = .02) and significantly higher levels of bilirubin (16.1 vs. 12.7 mg/dL; P = .03).

The two fatal cases of DILI among heavy drinkers involved a 44-year-old man with underlying alcoholic cirrhosis and steatohepatitis who developed acute-on-chronic liver failure 11 days after starting niacin, and a 76-year-old man with chronic obstructive pulmonary disease and bronchitis flare who developed severe liver injury and skin rash 6 days after starting azithromycin.

The study was not able to assess whether heavy alcohol consumption contributed to liver injury from specific agents, the researchers said. Additionally, a substantial number of drinkers did not complete the Skinner questionnaire, and those who did might have underestimated or underreported their own alcohol consumption. “Counterbalancing these issues are the [study’s] unique strengths, such as prospective design, larger sample size, well-characterized DILI phenotype, and careful, structured adjudication of causality and severity,” the researchers wrote.

 

 


Funders included the National Institute of Diabetes and Digestive and Kidney Diseases and the National Cancer Institute. Dr. Dakhoul had no conflicts of interest. On coinvestigator disclosed ties to numerous pharmaceutical companies.

SOURCE: Dakhoul L et al. Clin Gastro Hepatol. 2018 Jan 3. doi: 10.1016/j.cgh.2017.12.036.

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Heavy drinking was not associated with higher proportions of liver-related deaths or liver transplantation among patients with drug-induced liver injury (DILI), according to the results of a prospective multicenter cohort study reported in the May issue of Clinical Gastroenterology and Hepatology.

Anabolic steroids were the most common cause of DILI among heavy drinkers, defined as men who averaged more than three drinks a day or women who averaged more than two drinks daily, said Lara Dakhoul, MD, of Indiana University, Indianapolis, and her associates. There also was no evidence that heavy alcohol consumption increased the risk of liver injury attributable to isoniazid exposure, the researchers wrote in.

Although consuming alcohol significantly increases the risk of acetaminophen-induced liver injury, there is much less clarity about the relationship between drinking and hepatotoxicity from drugs such as duloxetine or antituberculosis medications, the researchers noted. In fact, one recent study found that drinking led to less severe liver injury among individuals with DILI. To better elucidate these links, the investigators studied 1,198 individuals with confirmed or probable DILI who enrolled in the DILI Network study (DILIN) between 2004 and 2016. At enrollment, all participants were asked if they consumed alcohol, and those who reported drinking within the past 12 months were offered a shortened version of the Skinner Alcohol Dependence Scale to collect details on alcohol consumption, including type, amount, and frequency.

In all, 601 persons reported consuming at least one alcoholic drink in the preceding year, of whom 348 completed the Skinner questionnaire. A total of 80 individuals reported heavy alcohol consumption. Heavy drinkers were typically in their early 40s, while nondrinkers tended to be nearly 50 years old (P less than .01). Heavy drinkers were also more often men (63%) while nondrinkers were usually women (65%; P less than .01). Heavy drinkers were significantly more likely to have DILI secondary to anabolic steroid exposure (13%) than were nondrinkers (2%; P less than .001). However, latency, pattern of liver injury, peak enzyme levels, and patterns of recovery from steroid hepatotoxicity were similar regardless of alcohol history.

A total of eight patients with DILI died of liver-related causes or underwent liver transplantation, and proportions of patients with these outcomes were similar regardless of alcohol history. These eight patients had no evidence of hepatitis C virus infection, but three appeared to have underlying alcoholic liver disease with superimposed acute-on-chronic liver failure. Heavy drinkers did not have significantly higher DILI severity scores than nondrinkers, but they did have significantly higher peak serum levels of alanine aminotransferase (1,323 U/L vs. 754, respectively; P = .02) and significantly higher levels of bilirubin (16.1 vs. 12.7 mg/dL; P = .03).

The two fatal cases of DILI among heavy drinkers involved a 44-year-old man with underlying alcoholic cirrhosis and steatohepatitis who developed acute-on-chronic liver failure 11 days after starting niacin, and a 76-year-old man with chronic obstructive pulmonary disease and bronchitis flare who developed severe liver injury and skin rash 6 days after starting azithromycin.

The study was not able to assess whether heavy alcohol consumption contributed to liver injury from specific agents, the researchers said. Additionally, a substantial number of drinkers did not complete the Skinner questionnaire, and those who did might have underestimated or underreported their own alcohol consumption. “Counterbalancing these issues are the [study’s] unique strengths, such as prospective design, larger sample size, well-characterized DILI phenotype, and careful, structured adjudication of causality and severity,” the researchers wrote.

 

 


Funders included the National Institute of Diabetes and Digestive and Kidney Diseases and the National Cancer Institute. Dr. Dakhoul had no conflicts of interest. On coinvestigator disclosed ties to numerous pharmaceutical companies.

SOURCE: Dakhoul L et al. Clin Gastro Hepatol. 2018 Jan 3. doi: 10.1016/j.cgh.2017.12.036.

 

Heavy drinking was not associated with higher proportions of liver-related deaths or liver transplantation among patients with drug-induced liver injury (DILI), according to the results of a prospective multicenter cohort study reported in the May issue of Clinical Gastroenterology and Hepatology.

Anabolic steroids were the most common cause of DILI among heavy drinkers, defined as men who averaged more than three drinks a day or women who averaged more than two drinks daily, said Lara Dakhoul, MD, of Indiana University, Indianapolis, and her associates. There also was no evidence that heavy alcohol consumption increased the risk of liver injury attributable to isoniazid exposure, the researchers wrote in.

Although consuming alcohol significantly increases the risk of acetaminophen-induced liver injury, there is much less clarity about the relationship between drinking and hepatotoxicity from drugs such as duloxetine or antituberculosis medications, the researchers noted. In fact, one recent study found that drinking led to less severe liver injury among individuals with DILI. To better elucidate these links, the investigators studied 1,198 individuals with confirmed or probable DILI who enrolled in the DILI Network study (DILIN) between 2004 and 2016. At enrollment, all participants were asked if they consumed alcohol, and those who reported drinking within the past 12 months were offered a shortened version of the Skinner Alcohol Dependence Scale to collect details on alcohol consumption, including type, amount, and frequency.

In all, 601 persons reported consuming at least one alcoholic drink in the preceding year, of whom 348 completed the Skinner questionnaire. A total of 80 individuals reported heavy alcohol consumption. Heavy drinkers were typically in their early 40s, while nondrinkers tended to be nearly 50 years old (P less than .01). Heavy drinkers were also more often men (63%) while nondrinkers were usually women (65%; P less than .01). Heavy drinkers were significantly more likely to have DILI secondary to anabolic steroid exposure (13%) than were nondrinkers (2%; P less than .001). However, latency, pattern of liver injury, peak enzyme levels, and patterns of recovery from steroid hepatotoxicity were similar regardless of alcohol history.

A total of eight patients with DILI died of liver-related causes or underwent liver transplantation, and proportions of patients with these outcomes were similar regardless of alcohol history. These eight patients had no evidence of hepatitis C virus infection, but three appeared to have underlying alcoholic liver disease with superimposed acute-on-chronic liver failure. Heavy drinkers did not have significantly higher DILI severity scores than nondrinkers, but they did have significantly higher peak serum levels of alanine aminotransferase (1,323 U/L vs. 754, respectively; P = .02) and significantly higher levels of bilirubin (16.1 vs. 12.7 mg/dL; P = .03).

The two fatal cases of DILI among heavy drinkers involved a 44-year-old man with underlying alcoholic cirrhosis and steatohepatitis who developed acute-on-chronic liver failure 11 days after starting niacin, and a 76-year-old man with chronic obstructive pulmonary disease and bronchitis flare who developed severe liver injury and skin rash 6 days after starting azithromycin.

The study was not able to assess whether heavy alcohol consumption contributed to liver injury from specific agents, the researchers said. Additionally, a substantial number of drinkers did not complete the Skinner questionnaire, and those who did might have underestimated or underreported their own alcohol consumption. “Counterbalancing these issues are the [study’s] unique strengths, such as prospective design, larger sample size, well-characterized DILI phenotype, and careful, structured adjudication of causality and severity,” the researchers wrote.

 

 


Funders included the National Institute of Diabetes and Digestive and Kidney Diseases and the National Cancer Institute. Dr. Dakhoul had no conflicts of interest. On coinvestigator disclosed ties to numerous pharmaceutical companies.

SOURCE: Dakhoul L et al. Clin Gastro Hepatol. 2018 Jan 3. doi: 10.1016/j.cgh.2017.12.036.

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Key clinical point: Heavy alcohol consumption was not associated with worse outcomes of drug-induced liver toxicity.

Major finding: Proportions of patients with liver-related deaths and liver transplantation were statistically similar regardless of alcohol consumption history (P = .18).

Study details: Prospective study of 1,198 individuals with probable drug-induced liver injury.

Disclosures: Funders included the National Institute of Diabetes and Digestive and Kidney Diseases and the National Cancer Institute. Dr. Dakhoul had no conflicts. One coinvestigator disclosed ties to numerous pharmaceutical companies.

Source: Dakhoul L et al. Clin Gastro Hepatol. 2018 Jan 3. doi: 10.1016/j.cgh.2017.12.036.

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Prompt palliative care cut hospital costs in pooled study

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For adults with serious illness, consulting with a palliative care team within 3 days of hospital admission significantly reduced hospital costs, according to findings from a systematic review and meta-analysis.

In a pooled analysis of six cohort studies, average cost savings per admission were $3,237 (95% confidence interval, –$3,581 to −$2,893) overall, $4,251 for patients with cancer, and $2,105 for patients with other serious illnesses (all P values less than .001), reported Peter May, PhD, of Trinity College Dublin, and his associates.

In this latter group, prompt palliative care consultations saved more when patients had at least four comorbidities rather than two or fewer comorbidities, the reviewers wrote. The report was published in JAMA Internal Medicine.

About one in four Medicare beneficiaries dies in acute care hospitals, often after weeks of intensive, costly care that may not reflect personal wishes, according to an earlier study (JAMA. 2013;309:470-7). Economic studies have tried to pinpoint the cost savings of palliative care. These studies have found it important to consider both the clinical characteristics of patients and the amount of time between admission and palliative consultations, the reviewers noted. However, heterogeneity among older studies had precluded pooled analyses.

The six studies in this meta-analysis were identified by a search of Embase, PsycINFO, CENTRAL, PubMed, CINAHL, and EconLit databases for economic studies of hospital-based palliative care consultations. The studies were published between 2008 and 2017 and included 133,118 adults with cancer, chronic obstructive pulmonary disease, major organ failure, AIDS/HIV, or serious neurodegenerative disease. Patients tended to be in their 60s and were usually Medicare beneficiaries, although one study focused only on Medicaid enrollees. Forty-one percent of patients had a primary diagnosis of cancer, and 93% were discharged alive. Most also had at least two comorbidities. Only 3.6% received a palliative care consultation (range, 2.2% to 22.3%).

The link that they found between more comorbidities and greater cost savings “is the reverse of prior research that assumed that long-stay, high-cost hospitalized patients could not have their care trajectories affected by palliative care,” the researchers wrote. “Current palliative care provision in the United States is characterized by widespread understaffing. Our results suggest that acute care hospitals may be able to reduce costs for this population by increasing palliative care capacity to meet national guidelines.”

Dr. May received grant support from The Atlantic Philanthropies. The reviewers reported having no conflicts of interest.

SOURCE: May P et al. JAMA Intern Med. 2018 Apr 30. doi: 10.1001/jamainternmed.2018.0750.

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For adults with serious illness, consulting with a palliative care team within 3 days of hospital admission significantly reduced hospital costs, according to findings from a systematic review and meta-analysis.

In a pooled analysis of six cohort studies, average cost savings per admission were $3,237 (95% confidence interval, –$3,581 to −$2,893) overall, $4,251 for patients with cancer, and $2,105 for patients with other serious illnesses (all P values less than .001), reported Peter May, PhD, of Trinity College Dublin, and his associates.

In this latter group, prompt palliative care consultations saved more when patients had at least four comorbidities rather than two or fewer comorbidities, the reviewers wrote. The report was published in JAMA Internal Medicine.

About one in four Medicare beneficiaries dies in acute care hospitals, often after weeks of intensive, costly care that may not reflect personal wishes, according to an earlier study (JAMA. 2013;309:470-7). Economic studies have tried to pinpoint the cost savings of palliative care. These studies have found it important to consider both the clinical characteristics of patients and the amount of time between admission and palliative consultations, the reviewers noted. However, heterogeneity among older studies had precluded pooled analyses.

The six studies in this meta-analysis were identified by a search of Embase, PsycINFO, CENTRAL, PubMed, CINAHL, and EconLit databases for economic studies of hospital-based palliative care consultations. The studies were published between 2008 and 2017 and included 133,118 adults with cancer, chronic obstructive pulmonary disease, major organ failure, AIDS/HIV, or serious neurodegenerative disease. Patients tended to be in their 60s and were usually Medicare beneficiaries, although one study focused only on Medicaid enrollees. Forty-one percent of patients had a primary diagnosis of cancer, and 93% were discharged alive. Most also had at least two comorbidities. Only 3.6% received a palliative care consultation (range, 2.2% to 22.3%).

The link that they found between more comorbidities and greater cost savings “is the reverse of prior research that assumed that long-stay, high-cost hospitalized patients could not have their care trajectories affected by palliative care,” the researchers wrote. “Current palliative care provision in the United States is characterized by widespread understaffing. Our results suggest that acute care hospitals may be able to reduce costs for this population by increasing palliative care capacity to meet national guidelines.”

Dr. May received grant support from The Atlantic Philanthropies. The reviewers reported having no conflicts of interest.

SOURCE: May P et al. JAMA Intern Med. 2018 Apr 30. doi: 10.1001/jamainternmed.2018.0750.

For adults with serious illness, consulting with a palliative care team within 3 days of hospital admission significantly reduced hospital costs, according to findings from a systematic review and meta-analysis.

In a pooled analysis of six cohort studies, average cost savings per admission were $3,237 (95% confidence interval, –$3,581 to −$2,893) overall, $4,251 for patients with cancer, and $2,105 for patients with other serious illnesses (all P values less than .001), reported Peter May, PhD, of Trinity College Dublin, and his associates.

In this latter group, prompt palliative care consultations saved more when patients had at least four comorbidities rather than two or fewer comorbidities, the reviewers wrote. The report was published in JAMA Internal Medicine.

About one in four Medicare beneficiaries dies in acute care hospitals, often after weeks of intensive, costly care that may not reflect personal wishes, according to an earlier study (JAMA. 2013;309:470-7). Economic studies have tried to pinpoint the cost savings of palliative care. These studies have found it important to consider both the clinical characteristics of patients and the amount of time between admission and palliative consultations, the reviewers noted. However, heterogeneity among older studies had precluded pooled analyses.

The six studies in this meta-analysis were identified by a search of Embase, PsycINFO, CENTRAL, PubMed, CINAHL, and EconLit databases for economic studies of hospital-based palliative care consultations. The studies were published between 2008 and 2017 and included 133,118 adults with cancer, chronic obstructive pulmonary disease, major organ failure, AIDS/HIV, or serious neurodegenerative disease. Patients tended to be in their 60s and were usually Medicare beneficiaries, although one study focused only on Medicaid enrollees. Forty-one percent of patients had a primary diagnosis of cancer, and 93% were discharged alive. Most also had at least two comorbidities. Only 3.6% received a palliative care consultation (range, 2.2% to 22.3%).

The link that they found between more comorbidities and greater cost savings “is the reverse of prior research that assumed that long-stay, high-cost hospitalized patients could not have their care trajectories affected by palliative care,” the researchers wrote. “Current palliative care provision in the United States is characterized by widespread understaffing. Our results suggest that acute care hospitals may be able to reduce costs for this population by increasing palliative care capacity to meet national guidelines.”

Dr. May received grant support from The Atlantic Philanthropies. The reviewers reported having no conflicts of interest.

SOURCE: May P et al. JAMA Intern Med. 2018 Apr 30. doi: 10.1001/jamainternmed.2018.0750.

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Key clinical point: Consider palliative care consultations within 3 days to cut hospital costs for adults with serious illnesses.

Major finding: Average cost savings per admission were $3,237 overall, $4,251 for patients with cancer, and $2,105 for patients with other serious illnesses (all P-values less than .001).

Study details: Systematic review and meta-analysis of six cohort studies of 133,118 adults with cancer, chronic obstructive pulmonary disease, major organ failure, AIDS/HIV, or serious neurodegenerative disease.

Disclosures: Dr. May received grant support from The Atlantic Philanthropies. The reviewers reported having no conflicts of interest.

Source: May P et al. JAMA Intern Med. 2018 Apr 30. doi: 10.1001/jamainternmed.2018.0750.

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