Mary Ann Moon

Short-term low-dose corticosteroid prophylaxis reduces the incidence of graft-vs.-host disease in patients who undergo allogeneic haploidentical stem-cell transplantation to treat hematologic neoplasms, according to a report published online April 18 in the Journal of Clinical Oncology.

The key to selecting patients most likely to benefit from the corticosteroid therapy is to identify those at high risk for graft-vs.-host disease (GVHD) using two biomarkers: high levels of CD56bright natural killer cells in allogeneic grafts or high CD4:CD8 ratios in bone marrow grafts, according to Dr. Ying-Jun Chang of Peking University People’s Hospital, Beijing, and associates.

The investigators performed an open-label trial involving 228 patients aged 15-60 years treated at a single medical center during an 18-month period for acute myeloid leukemia, acute lymphoblastic leukemia, chronic myeloid leukemia, myelodysplastic syndrome, or other hematologic neoplasms. Using the two biomarkers, the patients were categorized as either high or low risk for developing GVHD. They were randomly assigned to three study groups: 72 high-risk patients who received short-term low-dose corticosteroids, 73 high-risk patients who received usual care, and 83 low-risk patients who received usual care.

The cumulative 100-day incidence of acute grade-II to grade-IV GVHD was significantly lower in the high-risk patients who received prophylaxis (21%) than in the high-risk patients who did not receive prophylaxis (48%). In fact, corticosteroids decreased the rate of GVHD so that it was comparable with that in the low-risk patients (26%), Dr. Chang and associates said (J Clin Oncol. 2016 Apr 18. doi: 10.1200/JCO.2015.63l.8817).

Moreover, in the high-risk patients the median interval until GVHD developed was 25 days for those who took corticosteroids, compared with only 15 days for those who did not. Median times to myeloid recovery and platelet recovery were significantly shorter for high-risk patients who received corticosteroids than for either of the other study groups. However, 3-year overall survival and leukemia-free survival were comparable among the three study groups.

The short-term low-dose regimen of corticosteroids did not raise the rate of adverse events, including infection, which suggests that it is preferable to standard corticosteroid regimens in this patient population. The incidences of cytomegalovirus or Epstein-Barr virus reactivation, post-transplantation lymphoproliferative disorder, hemorrhagic cystitis, bacteremia, and invasive fungal infections were comparable among the three study groups. Of note, the incidences of osteonecrosis of the femoral head and secondary hypertension were significantly lower among high-risk patients who received corticosteroid prophylaxis than among those who did not.

“These results provide the first test, to our knowledge, of a novel risk-stratification-directed prophylaxis strategy that effectively prevented acute GVHD among patients who were at high risk for GVHD, without unnecessarily exposing patients who were at low risk to excessive toxicity from additional immunosuppressive agents,” Dr. Chang and associates said.

Short-term low-dose corticosteroid prophylaxis reduces the incidence of graft-vs.-host disease in patients who undergo allogeneic haploidentical stem-cell transplantation to treat hematologic neoplasms, according to a report published online April 18 in the Journal of Clinical Oncology.

The key to selecting patients most likely to benefit from the corticosteroid therapy is to identify those at high risk for graft-vs.-host disease (GVHD) using two biomarkers: high levels of CD56bright natural killer cells in allogeneic grafts or high CD4:CD8 ratios in bone marrow grafts, according to Dr. Ying-Jun Chang of Peking University People’s Hospital, Beijing, and associates.

The investigators performed an open-label trial involving 228 patients aged 15-60 years treated at a single medical center during an 18-month period for acute myeloid leukemia, acute lymphoblastic leukemia, chronic myeloid leukemia, myelodysplastic syndrome, or other hematologic neoplasms. Using the two biomarkers, the patients were categorized as either high or low risk for developing GVHD. They were randomly assigned to three study groups: 72 high-risk patients who received short-term low-dose corticosteroids, 73 high-risk patients who received usual care, and 83 low-risk patients who received usual care.

The cumulative 100-day incidence of acute grade-II to grade-IV GVHD was significantly lower in the high-risk patients who received prophylaxis (21%) than in the high-risk patients who did not receive prophylaxis (48%). In fact, corticosteroids decreased the rate of GVHD so that it was comparable with that in the low-risk patients (26%), Dr. Chang and associates said (J Clin Oncol. 2016 Apr 18. doi: 10.1200/JCO.2015.63l.8817).

Moreover, in the high-risk patients the median interval until GVHD developed was 25 days for those who took corticosteroids, compared with only 15 days for those who did not. Median times to myeloid recovery and platelet recovery were significantly shorter for high-risk patients who received corticosteroids than for either of the other study groups. However, 3-year overall survival and leukemia-free survival were comparable among the three study groups.

The short-term low-dose regimen of corticosteroids did not raise the rate of adverse events, including infection, which suggests that it is preferable to standard corticosteroid regimens in this patient population. The incidences of cytomegalovirus or Epstein-Barr virus reactivation, post-transplantation lymphoproliferative disorder, hemorrhagic cystitis, bacteremia, and invasive fungal infections were comparable among the three study groups. Of note, the incidences of osteonecrosis of the femoral head and secondary hypertension were significantly lower among high-risk patients who received corticosteroid prophylaxis than among those who did not.

“These results provide the first test, to our knowledge, of a novel risk-stratification-directed prophylaxis strategy that effectively prevented acute GVHD among patients who were at high risk for GVHD, without unnecessarily exposing patients who were at low risk to excessive toxicity from additional immunosuppressive agents,” Dr. Chang and associates said.

Short-term low-dose corticosteroid prophylaxis reduces the incidence of graft-vs.-host disease in patients who undergo allogeneic haploidentical stem-cell transplantation to treat hematologic neoplasms, according to a report published online April 18 in the Journal of Clinical Oncology.

The key to selecting patients most likely to benefit from the corticosteroid therapy is to identify those at high risk for graft-vs.-host disease (GVHD) using two biomarkers: high levels of CD56bright natural killer cells in allogeneic grafts or high CD4:CD8 ratios in bone marrow grafts, according to Dr. Ying-Jun Chang of Peking University People’s Hospital, Beijing, and associates.

The investigators performed an open-label trial involving 228 patients aged 15-60 years treated at a single medical center during an 18-month period for acute myeloid leukemia, acute lymphoblastic leukemia, chronic myeloid leukemia, myelodysplastic syndrome, or other hematologic neoplasms. Using the two biomarkers, the patients were categorized as either high or low risk for developing GVHD. They were randomly assigned to three study groups: 72 high-risk patients who received short-term low-dose corticosteroids, 73 high-risk patients who received usual care, and 83 low-risk patients who received usual care.

The cumulative 100-day incidence of acute grade-II to grade-IV GVHD was significantly lower in the high-risk patients who received prophylaxis (21%) than in the high-risk patients who did not receive prophylaxis (48%). In fact, corticosteroids decreased the rate of GVHD so that it was comparable with that in the low-risk patients (26%), Dr. Chang and associates said (J Clin Oncol. 2016 Apr 18. doi: 10.1200/JCO.2015.63l.8817).

Moreover, in the high-risk patients the median interval until GVHD developed was 25 days for those who took corticosteroids, compared with only 15 days for those who did not. Median times to myeloid recovery and platelet recovery were significantly shorter for high-risk patients who received corticosteroids than for either of the other study groups. However, 3-year overall survival and leukemia-free survival were comparable among the three study groups.

The short-term low-dose regimen of corticosteroids did not raise the rate of adverse events, including infection, which suggests that it is preferable to standard corticosteroid regimens in this patient population. The incidences of cytomegalovirus or Epstein-Barr virus reactivation, post-transplantation lymphoproliferative disorder, hemorrhagic cystitis, bacteremia, and invasive fungal infections were comparable among the three study groups. Of note, the incidences of osteonecrosis of the femoral head and secondary hypertension were significantly lower among high-risk patients who received corticosteroid prophylaxis than among those who did not.

“These results provide the first test, to our knowledge, of a novel risk-stratification-directed prophylaxis strategy that effectively prevented acute GVHD among patients who were at high risk for GVHD, without unnecessarily exposing patients who were at low risk to excessive toxicity from additional immunosuppressive agents,” Dr. Chang and associates said.

In allogeneic hematopoietic stem-cell transplantation, the donor’s status regarding Epstein-Barr virus affects the recipient’s risk of developing graft-vs-host disease – a “completely new and striking” finding, according to a report published online April 18 in the Journal of Clinical Oncology.

Approximately 80% of the general population has been infected with EBV and carries persistent virus in memory B cells. When viral material is transmitted to stem-cell recipients, it is known to cause posttransplantation lymphoproliferative disorder. Until now, however, no data were available to examine EBV serology’s effect on other posttransplantation outcomes, said Dr. Jan Styczynski of the department of pediatric hematology and oncology at Nicolaus Copernicus University, Bydgoszcz, Poland, and his associates.

They analyzed information in the European Society of Blood and Marrow Transplantation database for 11,364 patients with acute lymphoblastic leukemia or acute myeloblastic leukemia who underwent stem-cell transplantation between 1997 and 2012 and who were followed for approximately 5 years. Most of the donors (82%) were seropositive for EBV. Acute graft-vs-host disease (GVHD) developed in 32% and chronic GVHD developed in 40% of these stem cell–transplant recipients.

The incidence of chronic GVHD was significantly higher when the donor was EBV-seropositive (41%) than when the donor was EBV-seronegative (31%). Similarly, the incidence of acute GVHD was significantly higher when the donor was EBV-seropositive (32% vs 30%), but the magnitude of the difference between the two groups was smaller. The risk for GVHD increased even though patients receiving transplants from EBV-seropositive donors underwent more intensive GVHD prophylaxis than did those who had seronegative donors, the investigators said (J Clin Oncol. 2016 Apr 18. doi: 10.1200/JCO.2015.64.2405).

In contrast, the transplant recipients’ EBV status did not affect their risk of developing GVHD.

“Despite the effect of donor EBV serostatus on GVHD, we did not observe a corresponding GVHD-related death rate, and as a result, there was no effect on overall survival, relapse-free survival, relapse incidence, and nonrelapse mortality. However, it should be kept in mind that many other pre- and posttransplantation factors play a role in contributing to final transplantation outcomes,” Dr. Styczynski and his associates noted.

The current recommendation to monitor transplantation recipients for EBV and to give them “preemptive” rituximab to stave off the development of posttransplantation lymphoproliferative disorder might prove useful in also preventing GVHD, they added.

In allogeneic hematopoietic stem-cell transplantation, the donor’s status regarding Epstein-Barr virus affects the recipient’s risk of developing graft-vs-host disease – a “completely new and striking” finding, according to a report published online April 18 in the Journal of Clinical Oncology.

Approximately 80% of the general population has been infected with EBV and carries persistent virus in memory B cells. When viral material is transmitted to stem-cell recipients, it is known to cause posttransplantation lymphoproliferative disorder. Until now, however, no data were available to examine EBV serology’s effect on other posttransplantation outcomes, said Dr. Jan Styczynski of the department of pediatric hematology and oncology at Nicolaus Copernicus University, Bydgoszcz, Poland, and his associates.

They analyzed information in the European Society of Blood and Marrow Transplantation database for 11,364 patients with acute lymphoblastic leukemia or acute myeloblastic leukemia who underwent stem-cell transplantation between 1997 and 2012 and who were followed for approximately 5 years. Most of the donors (82%) were seropositive for EBV. Acute graft-vs-host disease (GVHD) developed in 32% and chronic GVHD developed in 40% of these stem cell–transplant recipients.

The incidence of chronic GVHD was significantly higher when the donor was EBV-seropositive (41%) than when the donor was EBV-seronegative (31%). Similarly, the incidence of acute GVHD was significantly higher when the donor was EBV-seropositive (32% vs 30%), but the magnitude of the difference between the two groups was smaller. The risk for GVHD increased even though patients receiving transplants from EBV-seropositive donors underwent more intensive GVHD prophylaxis than did those who had seronegative donors, the investigators said (J Clin Oncol. 2016 Apr 18. doi: 10.1200/JCO.2015.64.2405).

In contrast, the transplant recipients’ EBV status did not affect their risk of developing GVHD.

“Despite the effect of donor EBV serostatus on GVHD, we did not observe a corresponding GVHD-related death rate, and as a result, there was no effect on overall survival, relapse-free survival, relapse incidence, and nonrelapse mortality. However, it should be kept in mind that many other pre- and posttransplantation factors play a role in contributing to final transplantation outcomes,” Dr. Styczynski and his associates noted.

The current recommendation to monitor transplantation recipients for EBV and to give them “preemptive” rituximab to stave off the development of posttransplantation lymphoproliferative disorder might prove useful in also preventing GVHD, they added.

In allogeneic hematopoietic stem-cell transplantation, the donor’s status regarding Epstein-Barr virus affects the recipient’s risk of developing graft-vs-host disease – a “completely new and striking” finding, according to a report published online April 18 in the Journal of Clinical Oncology.

Approximately 80% of the general population has been infected with EBV and carries persistent virus in memory B cells. When viral material is transmitted to stem-cell recipients, it is known to cause posttransplantation lymphoproliferative disorder. Until now, however, no data were available to examine EBV serology’s effect on other posttransplantation outcomes, said Dr. Jan Styczynski of the department of pediatric hematology and oncology at Nicolaus Copernicus University, Bydgoszcz, Poland, and his associates.

They analyzed information in the European Society of Blood and Marrow Transplantation database for 11,364 patients with acute lymphoblastic leukemia or acute myeloblastic leukemia who underwent stem-cell transplantation between 1997 and 2012 and who were followed for approximately 5 years. Most of the donors (82%) were seropositive for EBV. Acute graft-vs-host disease (GVHD) developed in 32% and chronic GVHD developed in 40% of these stem cell–transplant recipients.

The incidence of chronic GVHD was significantly higher when the donor was EBV-seropositive (41%) than when the donor was EBV-seronegative (31%). Similarly, the incidence of acute GVHD was significantly higher when the donor was EBV-seropositive (32% vs 30%), but the magnitude of the difference between the two groups was smaller. The risk for GVHD increased even though patients receiving transplants from EBV-seropositive donors underwent more intensive GVHD prophylaxis than did those who had seronegative donors, the investigators said (J Clin Oncol. 2016 Apr 18. doi: 10.1200/JCO.2015.64.2405).

In contrast, the transplant recipients’ EBV status did not affect their risk of developing GVHD.

“Despite the effect of donor EBV serostatus on GVHD, we did not observe a corresponding GVHD-related death rate, and as a result, there was no effect on overall survival, relapse-free survival, relapse incidence, and nonrelapse mortality. However, it should be kept in mind that many other pre- and posttransplantation factors play a role in contributing to final transplantation outcomes,” Dr. Styczynski and his associates noted.

The current recommendation to monitor transplantation recipients for EBV and to give them “preemptive” rituximab to stave off the development of posttransplantation lymphoproliferative disorder might prove useful in also preventing GVHD, they added.

The benefit of adding lumbar fusion surgery to decompression surgery for spinal stenosis was nonexistent in one large clinical trial and very modest in another, according to separate reports published online April 13 in the New England Journal of Medicine.

Both studies indicated that, given the considerable cost and the potential complications associated with lumbar fusion, it may not be worthwhile to add it to decompression surgery for spinal stenosis. “The goal of surgery in lumbar spinal stenosis is to improve walking distance and to relieve pain by decompression of the nerve roots. The addition of instrumented fusion – ‘just to be sure’ – for the treatment of the most frequent forms of lumbar spinal stenosis does not create any added value for patients and might be regarded as an overcautious and unnecessary treatment,” Dr. Wilco C. Peul and Dr. Wouter A. Moojen said in an editorial accompanying the two reports.

Surgical decompression of spinal stenosis using laminectomy is increasingly being supplemented with lumbar fusion, which is thought to firm up spinal instability and minimize the risk of future deformity. In the United States, approximately half of patients who have surgery for spinal stenosis undergo fusion procedures. Of those who also show degenerative spondylolisthesis on preoperative imaging studies, 96% undergo fusion procedures because many spine surgeons see this as a sign of instability and a mandatory indication for fusion. However, the evidence supporting the use of fusion plus decompression, as opposed to decompression alone, is weak, according to the investigators who conducted the Swedish Spinal Stenosis Study. The other study in the New England Journal of Medicine, the Spinal Laminectomy Versus Instrumented Pedicle Screw (SLIP) trial, was conducted in the United States.

Both of those clinical trials were performed to shed further light on the issue.

In the Swedish Spinal Stenosis Study, the investigators assessed outcomes in 247 patients aged 50-80 years who were treated at seven Swedish hospitals over the course of 6 years. This open-label, superiority trial randomly assigned 124 patients to decompression surgery alone and 123 to decompression plus fusion. The primary outcome measure was score on the Oswestry Disability Index (ODI), which measures disability and quality of life in patients with low-back pain, 2 years after surgery. The ODI scale runs from 0 to 100, with higher scores indicating more severe disability, said Dr. Peter Försth of the department of surgical sciences at Uppsala (Sweden) University and the Stockholm Spine Center and his associates.

At 2 years, there was no significant difference between the two study groups; the decompression-only group had a mean ODI score of 24, and the fusion group had a mean score of 27. The ODI scores in both groups had improved from baseline to a similar degree: by 17 points with decompression alone and by 15 points with fusion. In addition, fusion surgery was not superior to decompression alone regardless of whether patients had any degree of spondylolisthesis and regardless of whether they had severe spondylolisthesis involving a vertebral slip of 7.4 mm or more, the investigators reported (N Engl J Med. 2016 April 13. doi: 10.1056/NEJMoa1513721).The two study groups also showed no significant differences in secondary outcome measures, including performance on the 6-minute walk test and subjective patient assessment of improvement in walking ability. Moreover, these results persisted in the 144 patients who were assessed at 5-year follow-up.

In contrast, decompression alone was associated with fewer complications than decompression plus fusion. Postoperative wound infection developed in only 4% of the decompression-only group, compared with 10% of the fusion group. Although this study wasn’t adequately powered to draw firm conclusions regarding complications, a previous analysis of registry data reported that adding fusion surgery to decompression surgery doubles the risk of severe adverse events in older patients, Dr. Försth and his associates said.

Decompression alone also was markedly less expensive than fusion surgery. Mean direct costs were $6,800 higher for fusion than for decompression alone, because of the additional operating time needed, the extended hospital stay, and the cost of the implant.

In the SLIP trial, the researchers compared outcomes in 66 patients aged 50-80 years who all had spinal stenosis with grade 1 degenerative spondylolisthesis. The participants were randomly assigned to undergo decompression alone (35 patients) or decompression plus fusion (31 patients) at five U.S. medical centers, said Dr. Zoher Ghogawala of the Alan and Jacqueline B. Stuart Spine Research Center in the department of neurosurgery at Lahey Hospital and Medical Center, Burlington, Mass., and his associates.

The primary outcome measure was the physical-component summary score on the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) 2 years after surgery. This scale also runs from 0 to 100, but higher scores indicate better physical health. Five points was prespecified as the minimal clinically important difference on the SF-36.

At 2 years, patients in the fusion group showed a small but significant advantage of 5.7 points on the SF-36, with a mean score of 15.2, compared with patients in the decompression-only group (mean score, 9.5). However, the ODI scores, a secondary outcome measure in this study, were not significantly different between the two study groups, Dr. Ghogawala and his associates reported (N Engl J Med. 2016 April 13. doi: 10.1056/NEJMoa1508788).Surgical complications, blood loss, and length of stay all were significantly greater with fusion than with decompression alone.

Dr. Försth’s study was supported by Uppsala University, Uppsala County Council, the Stockholm Spine Center, and Johnson & Johnson. Two of his associates reported ties to Medtronic and Quantify Research. Dr. Ghogawala’s study was supported by the Jean and David Wallace Foundation, the Greenwich Lumbar Stenosis SLIP Study Fund. His associates reported ties to numerous industry sources.

The benefit of adding lumbar fusion surgery to decompression surgery for spinal stenosis was nonexistent in one large clinical trial and very modest in another, according to separate reports published online April 13 in the New England Journal of Medicine.

Both studies indicated that, given the considerable cost and the potential complications associated with lumbar fusion, it may not be worthwhile to add it to decompression surgery for spinal stenosis. “The goal of surgery in lumbar spinal stenosis is to improve walking distance and to relieve pain by decompression of the nerve roots. The addition of instrumented fusion – ‘just to be sure’ – for the treatment of the most frequent forms of lumbar spinal stenosis does not create any added value for patients and might be regarded as an overcautious and unnecessary treatment,” Dr. Wilco C. Peul and Dr. Wouter A. Moojen said in an editorial accompanying the two reports.

Surgical decompression of spinal stenosis using laminectomy is increasingly being supplemented with lumbar fusion, which is thought to firm up spinal instability and minimize the risk of future deformity. In the United States, approximately half of patients who have surgery for spinal stenosis undergo fusion procedures. Of those who also show degenerative spondylolisthesis on preoperative imaging studies, 96% undergo fusion procedures because many spine surgeons see this as a sign of instability and a mandatory indication for fusion. However, the evidence supporting the use of fusion plus decompression, as opposed to decompression alone, is weak, according to the investigators who conducted the Swedish Spinal Stenosis Study. The other study in the New England Journal of Medicine, the Spinal Laminectomy Versus Instrumented Pedicle Screw (SLIP) trial, was conducted in the United States.

Both of those clinical trials were performed to shed further light on the issue.

In the Swedish Spinal Stenosis Study, the investigators assessed outcomes in 247 patients aged 50-80 years who were treated at seven Swedish hospitals over the course of 6 years. This open-label, superiority trial randomly assigned 124 patients to decompression surgery alone and 123 to decompression plus fusion. The primary outcome measure was score on the Oswestry Disability Index (ODI), which measures disability and quality of life in patients with low-back pain, 2 years after surgery. The ODI scale runs from 0 to 100, with higher scores indicating more severe disability, said Dr. Peter Försth of the department of surgical sciences at Uppsala (Sweden) University and the Stockholm Spine Center and his associates.

At 2 years, there was no significant difference between the two study groups; the decompression-only group had a mean ODI score of 24, and the fusion group had a mean score of 27. The ODI scores in both groups had improved from baseline to a similar degree: by 17 points with decompression alone and by 15 points with fusion. In addition, fusion surgery was not superior to decompression alone regardless of whether patients had any degree of spondylolisthesis and regardless of whether they had severe spondylolisthesis involving a vertebral slip of 7.4 mm or more, the investigators reported (N Engl J Med. 2016 April 13. doi: 10.1056/NEJMoa1513721).The two study groups also showed no significant differences in secondary outcome measures, including performance on the 6-minute walk test and subjective patient assessment of improvement in walking ability. Moreover, these results persisted in the 144 patients who were assessed at 5-year follow-up.

In contrast, decompression alone was associated with fewer complications than decompression plus fusion. Postoperative wound infection developed in only 4% of the decompression-only group, compared with 10% of the fusion group. Although this study wasn’t adequately powered to draw firm conclusions regarding complications, a previous analysis of registry data reported that adding fusion surgery to decompression surgery doubles the risk of severe adverse events in older patients, Dr. Försth and his associates said.

Decompression alone also was markedly less expensive than fusion surgery. Mean direct costs were $6,800 higher for fusion than for decompression alone, because of the additional operating time needed, the extended hospital stay, and the cost of the implant.

In the SLIP trial, the researchers compared outcomes in 66 patients aged 50-80 years who all had spinal stenosis with grade 1 degenerative spondylolisthesis. The participants were randomly assigned to undergo decompression alone (35 patients) or decompression plus fusion (31 patients) at five U.S. medical centers, said Dr. Zoher Ghogawala of the Alan and Jacqueline B. Stuart Spine Research Center in the department of neurosurgery at Lahey Hospital and Medical Center, Burlington, Mass., and his associates.

The primary outcome measure was the physical-component summary score on the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) 2 years after surgery. This scale also runs from 0 to 100, but higher scores indicate better physical health. Five points was prespecified as the minimal clinically important difference on the SF-36.

At 2 years, patients in the fusion group showed a small but significant advantage of 5.7 points on the SF-36, with a mean score of 15.2, compared with patients in the decompression-only group (mean score, 9.5). However, the ODI scores, a secondary outcome measure in this study, were not significantly different between the two study groups, Dr. Ghogawala and his associates reported (N Engl J Med. 2016 April 13. doi: 10.1056/NEJMoa1508788).Surgical complications, blood loss, and length of stay all were significantly greater with fusion than with decompression alone.

Dr. Försth’s study was supported by Uppsala University, Uppsala County Council, the Stockholm Spine Center, and Johnson & Johnson. Two of his associates reported ties to Medtronic and Quantify Research. Dr. Ghogawala’s study was supported by the Jean and David Wallace Foundation, the Greenwich Lumbar Stenosis SLIP Study Fund. His associates reported ties to numerous industry sources.

The benefit of adding lumbar fusion surgery to decompression surgery for spinal stenosis was nonexistent in one large clinical trial and very modest in another, according to separate reports published online April 13 in the New England Journal of Medicine.

Both studies indicated that, given the considerable cost and the potential complications associated with lumbar fusion, it may not be worthwhile to add it to decompression surgery for spinal stenosis. “The goal of surgery in lumbar spinal stenosis is to improve walking distance and to relieve pain by decompression of the nerve roots. The addition of instrumented fusion – ‘just to be sure’ – for the treatment of the most frequent forms of lumbar spinal stenosis does not create any added value for patients and might be regarded as an overcautious and unnecessary treatment,” Dr. Wilco C. Peul and Dr. Wouter A. Moojen said in an editorial accompanying the two reports.

Surgical decompression of spinal stenosis using laminectomy is increasingly being supplemented with lumbar fusion, which is thought to firm up spinal instability and minimize the risk of future deformity. In the United States, approximately half of patients who have surgery for spinal stenosis undergo fusion procedures. Of those who also show degenerative spondylolisthesis on preoperative imaging studies, 96% undergo fusion procedures because many spine surgeons see this as a sign of instability and a mandatory indication for fusion. However, the evidence supporting the use of fusion plus decompression, as opposed to decompression alone, is weak, according to the investigators who conducted the Swedish Spinal Stenosis Study. The other study in the New England Journal of Medicine, the Spinal Laminectomy Versus Instrumented Pedicle Screw (SLIP) trial, was conducted in the United States.

Both of those clinical trials were performed to shed further light on the issue.

In the Swedish Spinal Stenosis Study, the investigators assessed outcomes in 247 patients aged 50-80 years who were treated at seven Swedish hospitals over the course of 6 years. This open-label, superiority trial randomly assigned 124 patients to decompression surgery alone and 123 to decompression plus fusion. The primary outcome measure was score on the Oswestry Disability Index (ODI), which measures disability and quality of life in patients with low-back pain, 2 years after surgery. The ODI scale runs from 0 to 100, with higher scores indicating more severe disability, said Dr. Peter Försth of the department of surgical sciences at Uppsala (Sweden) University and the Stockholm Spine Center and his associates.

At 2 years, there was no significant difference between the two study groups; the decompression-only group had a mean ODI score of 24, and the fusion group had a mean score of 27. The ODI scores in both groups had improved from baseline to a similar degree: by 17 points with decompression alone and by 15 points with fusion. In addition, fusion surgery was not superior to decompression alone regardless of whether patients had any degree of spondylolisthesis and regardless of whether they had severe spondylolisthesis involving a vertebral slip of 7.4 mm or more, the investigators reported (N Engl J Med. 2016 April 13. doi: 10.1056/NEJMoa1513721).The two study groups also showed no significant differences in secondary outcome measures, including performance on the 6-minute walk test and subjective patient assessment of improvement in walking ability. Moreover, these results persisted in the 144 patients who were assessed at 5-year follow-up.

In contrast, decompression alone was associated with fewer complications than decompression plus fusion. Postoperative wound infection developed in only 4% of the decompression-only group, compared with 10% of the fusion group. Although this study wasn’t adequately powered to draw firm conclusions regarding complications, a previous analysis of registry data reported that adding fusion surgery to decompression surgery doubles the risk of severe adverse events in older patients, Dr. Försth and his associates said.

Decompression alone also was markedly less expensive than fusion surgery. Mean direct costs were $6,800 higher for fusion than for decompression alone, because of the additional operating time needed, the extended hospital stay, and the cost of the implant.

In the SLIP trial, the researchers compared outcomes in 66 patients aged 50-80 years who all had spinal stenosis with grade 1 degenerative spondylolisthesis. The participants were randomly assigned to undergo decompression alone (35 patients) or decompression plus fusion (31 patients) at five U.S. medical centers, said Dr. Zoher Ghogawala of the Alan and Jacqueline B. Stuart Spine Research Center in the department of neurosurgery at Lahey Hospital and Medical Center, Burlington, Mass., and his associates.

The primary outcome measure was the physical-component summary score on the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) 2 years after surgery. This scale also runs from 0 to 100, but higher scores indicate better physical health. Five points was prespecified as the minimal clinically important difference on the SF-36.

At 2 years, patients in the fusion group showed a small but significant advantage of 5.7 points on the SF-36, with a mean score of 15.2, compared with patients in the decompression-only group (mean score, 9.5). However, the ODI scores, a secondary outcome measure in this study, were not significantly different between the two study groups, Dr. Ghogawala and his associates reported (N Engl J Med. 2016 April 13. doi: 10.1056/NEJMoa1508788).Surgical complications, blood loss, and length of stay all were significantly greater with fusion than with decompression alone.

Dr. Försth’s study was supported by Uppsala University, Uppsala County Council, the Stockholm Spine Center, and Johnson & Johnson. Two of his associates reported ties to Medtronic and Quantify Research. Dr. Ghogawala’s study was supported by the Jean and David Wallace Foundation, the Greenwich Lumbar Stenosis SLIP Study Fund. His associates reported ties to numerous industry sources.

A rapid bedside diagnostic test for influenza showed consistent sensitivity and specificity across four consecutive flu seasons in a single pediatric ED in France, according to a report in Diagnostic Microbiology and Infectious Disease.

During flu seasons, it is difficult to distinguish young children who have the flu from those who have serious bacterial infections because clinical symptoms alone cannot differentiate the two conditions and fever may be the only symptom during the onset of a bacterial infection. Rapid influenza diagnostic tests purport to help ED clinicians estimate the probability of influenza at the bedside, which in turn can reduce the need for further diagnostic testing, length of ED stay, inappropriate use of antibiotics, and the costs of care, said Dr. E. Avril of the pediatric ED, University Hospital in Nantes, France, and associates.

©mik38/Fotolia.com

To assess the diagnostic value of one rapid influenza diagnostic test used in this setting every winter, the investigators studied 764 patients younger than age 5 years who were admitted to the ED during four consecutive flu seasons with fever of no known origin. The prevalence of influenza varied widely during the study period, from a low of 30% to a high of 62%.

The rapid diagnostic test performed comparably well across the four flu seasons, with only a modest decrease in sensitivity and specificity during the 2010 H₁N₁ flu pandemic. The bedside test had an overall sensitivity of 0.82, a specificity of 0.98, a positive likelihood ratio of 37.8, and a negative likelihood ratio of 0.19. These results are similar to those of two previous small-scale studies that found sensitivities of 69%-85% and specificities of 83%-98%, Dr. Avril and associates said (Diag Microbiol Infect Dis. 2016 doi:10.1016/j.diagmicrobio.2016.03.015).

These findings “support the rational use of rapid influenza diagnostic tests in clinical practice for young children presenting with fever without a source during flu season,” the investigators said.

Dr. Avril and associates added that they assessed only one rapid diagnostic test for influenza (QuickVue) – the only one available in their ED because of cost – but that there are 22 such tests commercially available. Nantes University Hospital supported the study. Dr. Avril and associates reported having no relevant disclosures.

A rapid bedside diagnostic test for influenza showed consistent sensitivity and specificity across four consecutive flu seasons in a single pediatric ED in France, according to a report in Diagnostic Microbiology and Infectious Disease.

During flu seasons, it is difficult to distinguish young children who have the flu from those who have serious bacterial infections because clinical symptoms alone cannot differentiate the two conditions and fever may be the only symptom during the onset of a bacterial infection. Rapid influenza diagnostic tests purport to help ED clinicians estimate the probability of influenza at the bedside, which in turn can reduce the need for further diagnostic testing, length of ED stay, inappropriate use of antibiotics, and the costs of care, said Dr. E. Avril of the pediatric ED, University Hospital in Nantes, France, and associates.

©mik38/Fotolia.com

To assess the diagnostic value of one rapid influenza diagnostic test used in this setting every winter, the investigators studied 764 patients younger than age 5 years who were admitted to the ED during four consecutive flu seasons with fever of no known origin. The prevalence of influenza varied widely during the study period, from a low of 30% to a high of 62%.

The rapid diagnostic test performed comparably well across the four flu seasons, with only a modest decrease in sensitivity and specificity during the 2010 H₁N₁ flu pandemic. The bedside test had an overall sensitivity of 0.82, a specificity of 0.98, a positive likelihood ratio of 37.8, and a negative likelihood ratio of 0.19. These results are similar to those of two previous small-scale studies that found sensitivities of 69%-85% and specificities of 83%-98%, Dr. Avril and associates said (Diag Microbiol Infect Dis. 2016 doi:10.1016/j.diagmicrobio.2016.03.015).

These findings “support the rational use of rapid influenza diagnostic tests in clinical practice for young children presenting with fever without a source during flu season,” the investigators said.

Dr. Avril and associates added that they assessed only one rapid diagnostic test for influenza (QuickVue) – the only one available in their ED because of cost – but that there are 22 such tests commercially available. Nantes University Hospital supported the study. Dr. Avril and associates reported having no relevant disclosures.

A rapid bedside diagnostic test for influenza showed consistent sensitivity and specificity across four consecutive flu seasons in a single pediatric ED in France, according to a report in Diagnostic Microbiology and Infectious Disease.

During flu seasons, it is difficult to distinguish young children who have the flu from those who have serious bacterial infections because clinical symptoms alone cannot differentiate the two conditions and fever may be the only symptom during the onset of a bacterial infection. Rapid influenza diagnostic tests purport to help ED clinicians estimate the probability of influenza at the bedside, which in turn can reduce the need for further diagnostic testing, length of ED stay, inappropriate use of antibiotics, and the costs of care, said Dr. E. Avril of the pediatric ED, University Hospital in Nantes, France, and associates.

©mik38/Fotolia.com

To assess the diagnostic value of one rapid influenza diagnostic test used in this setting every winter, the investigators studied 764 patients younger than age 5 years who were admitted to the ED during four consecutive flu seasons with fever of no known origin. The prevalence of influenza varied widely during the study period, from a low of 30% to a high of 62%.

The rapid diagnostic test performed comparably well across the four flu seasons, with only a modest decrease in sensitivity and specificity during the 2010 H₁N₁ flu pandemic. The bedside test had an overall sensitivity of 0.82, a specificity of 0.98, a positive likelihood ratio of 37.8, and a negative likelihood ratio of 0.19. These results are similar to those of two previous small-scale studies that found sensitivities of 69%-85% and specificities of 83%-98%, Dr. Avril and associates said (Diag Microbiol Infect Dis. 2016 doi:10.1016/j.diagmicrobio.2016.03.015).

These findings “support the rational use of rapid influenza diagnostic tests in clinical practice for young children presenting with fever without a source during flu season,” the investigators said.

Dr. Avril and associates added that they assessed only one rapid diagnostic test for influenza (QuickVue) – the only one available in their ED because of cost – but that there are 22 such tests commercially available. Nantes University Hospital supported the study. Dr. Avril and associates reported having no relevant disclosures.

A rapid bedside diagnostic test for influenza showed consistent sensitivity and specificity across four consecutive flu seasons in a single pediatric ED in France, according to a report in Diagnostic Microbiology and Infectious Disease.

During flu seasons, it is difficult to distinguish young children who have the flu from those who have serious bacterial infections because clinical symptoms alone cannot differentiate the two conditions and fever may be the only symptom during the onset of a bacterial infection. Rapid influenza diagnostic tests purport to help ED clinicians estimate the probability of influenza at the bedside, which in turn can reduce the need for further diagnostic testing, length of ED stay, inappropriate use of antibiotics, and the costs of care, said Dr. E. Avril of the pediatric ED, University Hospital in Nantes, France, and associates.

©mik38/Fotolia.com

To assess the diagnostic value of one rapid influenza diagnostic test used in this setting every winter, the investigators studied 764 patients younger than age 5 years who were admitted to the ED during four consecutive flu seasons with fever of no known origin. The prevalence of influenza varied widely during the study period, from a low of 30% to a high of 62%.

The rapid diagnostic test performed comparably well across the four flu seasons, with only a modest decrease in sensitivity and specificity during the 2010 H₁N₁ flu pandemic. The bedside test had an overall sensitivity of 0.82, a specificity of 0.98, a positive likelihood ratio of 37.8, and a negative likelihood ratio of 0.19. These results are similar to those of two previous small-scale studies that found sensitivities of 69%-85% and specificities of 83%-98%, Dr. Avril and associates said (Diag Microbiol Infect Dis. 2016 doi:10.1016/j.diagmicrobio.2016.03.015).

These findings “support the rational use of rapid influenza diagnostic tests in clinical practice for young children presenting with fever without a source during flu season,” the investigators said.

Dr. Avril and associates added that they assessed only one rapid diagnostic test for influenza (QuickVue) – the only one available in their ED because of cost – but that there are 22 such tests commercially available. Nantes University Hospital supported the study. Dr. Avril and associates reported having no relevant disclosures.

A rapid bedside diagnostic test for influenza showed consistent sensitivity and specificity across four consecutive flu seasons in a single pediatric ED in France, according to a report in Diagnostic Microbiology and Infectious Disease.

During flu seasons, it is difficult to distinguish young children who have the flu from those who have serious bacterial infections because clinical symptoms alone cannot differentiate the two conditions and fever may be the only symptom during the onset of a bacterial infection. Rapid influenza diagnostic tests purport to help ED clinicians estimate the probability of influenza at the bedside, which in turn can reduce the need for further diagnostic testing, length of ED stay, inappropriate use of antibiotics, and the costs of care, said Dr. E. Avril of the pediatric ED, University Hospital in Nantes, France, and associates.

©mik38/Fotolia.com

To assess the diagnostic value of one rapid influenza diagnostic test used in this setting every winter, the investigators studied 764 patients younger than age 5 years who were admitted to the ED during four consecutive flu seasons with fever of no known origin. The prevalence of influenza varied widely during the study period, from a low of 30% to a high of 62%.

The rapid diagnostic test performed comparably well across the four flu seasons, with only a modest decrease in sensitivity and specificity during the 2010 H₁N₁ flu pandemic. The bedside test had an overall sensitivity of 0.82, a specificity of 0.98, a positive likelihood ratio of 37.8, and a negative likelihood ratio of 0.19. These results are similar to those of two previous small-scale studies that found sensitivities of 69%-85% and specificities of 83%-98%, Dr. Avril and associates said (Diag Microbiol Infect Dis. 2016 doi:10.1016/j.diagmicrobio.2016.03.015).

These findings “support the rational use of rapid influenza diagnostic tests in clinical practice for young children presenting with fever without a source during flu season,” the investigators said.

Dr. Avril and associates added that they assessed only one rapid diagnostic test for influenza (QuickVue) – the only one available in their ED because of cost – but that there are 22 such tests commercially available. Nantes University Hospital supported the study. Dr. Avril and associates reported having no relevant disclosures.

A rapid bedside diagnostic test for influenza showed consistent sensitivity and specificity across four consecutive flu seasons in a single pediatric ED in France, according to a report in Diagnostic Microbiology and Infectious Disease.

During flu seasons, it is difficult to distinguish young children who have the flu from those who have serious bacterial infections because clinical symptoms alone cannot differentiate the two conditions and fever may be the only symptom during the onset of a bacterial infection. Rapid influenza diagnostic tests purport to help ED clinicians estimate the probability of influenza at the bedside, which in turn can reduce the need for further diagnostic testing, length of ED stay, inappropriate use of antibiotics, and the costs of care, said Dr. E. Avril of the pediatric ED, University Hospital in Nantes, France, and associates.

©mik38/Fotolia.com

To assess the diagnostic value of one rapid influenza diagnostic test used in this setting every winter, the investigators studied 764 patients younger than age 5 years who were admitted to the ED during four consecutive flu seasons with fever of no known origin. The prevalence of influenza varied widely during the study period, from a low of 30% to a high of 62%.

The rapid diagnostic test performed comparably well across the four flu seasons, with only a modest decrease in sensitivity and specificity during the 2010 H₁N₁ flu pandemic. The bedside test had an overall sensitivity of 0.82, a specificity of 0.98, a positive likelihood ratio of 37.8, and a negative likelihood ratio of 0.19. These results are similar to those of two previous small-scale studies that found sensitivities of 69%-85% and specificities of 83%-98%, Dr. Avril and associates said (Diag Microbiol Infect Dis. 2016 doi:10.1016/j.diagmicrobio.2016.03.015).

These findings “support the rational use of rapid influenza diagnostic tests in clinical practice for young children presenting with fever without a source during flu season,” the investigators said.

Dr. Avril and associates added that they assessed only one rapid diagnostic test for influenza (QuickVue) – the only one available in their ED because of cost – but that there are 22 such tests commercially available. Nantes University Hospital supported the study. Dr. Avril and associates reported having no relevant disclosures.

Many patients aged 50-59 years should start low-dose aspirin for the primary prevention of cardiovascular disease and colorectal cancer, according to the U.S. Preventive Services Task Force’s updated clinical practice guideline on aspirin therapy, published online April 11 in Annals of Internal Medicine.

The evidence is clear that the benefits outweigh the potential harms of low-dose aspirin in this age group if patients have a 10% or greater 10-year cardiovascular disease (CVD) risk, are not at increased risk of bleeding, have a life expectancy of at least 10 years, and are willing to take the treatment for at least 10 years, said Dr. Albert L. Siu and his associates in the USPSTF.

©American Heart Association

The organization based this guideline on 2 systematic reviews of the literature, updating its 2009 review on aspirin therapy to prevent cardiovascular disease and updating its 2007 review on aspirin therapy to prevent colorectal cancer. The findings from these reviews of the current evidence were used to develop a decision-analysis model to weigh the benefits and harms of treatment in various patient groups defined by age, gender, and risk factors.

Recent studies of primary prevention of CVD, which included 118,445 participants, “consistently demonstrated effectiveness of aspirin in preventing nonfatal MI and stroke.” Pooled analyses showed that low-dose aspirin reduced nonfatal MI and coronary events 17% (risk ratio, 0.83) and that any aspirin dose reduced them 22%. Low-dose aspirin also reduced all-cause mortality risk (RR, 0.95) in pooled analyses.

Aspirin therapy also reduced the risk of colorectal cancer, but this benefit didn’t appear until after 5-10 years of treatment. Three trials reported a 40% reduction (RR, 0.60) after 10-20 years of daily low-dose aspirin.

On the other side of the equation, major GI bleeding increased by 65% among aspirin users when the data from 15 CVD prevention trials were pooled. Similarly, pooled analyses showed a 33% increase in hemorrhagic stroke among aspirin users, compared with nonusers.

The benefits of low-dose aspirin were highest and the harms were lowest in patients aged 50-59 years, hence the first recommendation in the new guideline. In patients aged 60-69 years, the benefit-to-harm balance isn’t as clear-cut, so the decision to initiate or continue aspirin therapy in this age group must be made on an individual basis. “Some adults [at this age] may decide that avoiding an MI or stroke is very important and that having a GI bleeding event is not as significant. They may decide to take aspirin at a lower CVD risk level than those who are more concerned about GI bleeding. Adults who have a high likelihood of benefit with little potential for harm should be encouraged to consider aspirin use.

“Conversely, adults who have little potential of benefit or high risk for GI bleeding should be discouraged” from taking aspirin therapy, the investigators said (Ann Intern Med. 2016 Apr 11. doi: 10.7326/M16-0577).

The task force found that current evidence is insufficient to assess the balance of benefits and harms regarding aspirin therapy for adults younger than age 50 or older than age 70. In the latter group in particular, the picture is complicated by the effects of age, use of other medications, and concomitant illness. However, since cardiovascular risks are increased after age 70 and the incidences of MI and stroke are relatively high, the benefits of preventive aspirin could be substantial in this age group, said Dr. Siu of Icahn School of Medicine Mount Sinai, New York, and the Veterans Affairs Medical Center, the Bronx, and his associates.

The USPSTF guideline generally accords with existing recommendations from the American Heart Association, the American Stroke Association, the American Diabetes Association, the American Academy of Family Physicians, and the American College of Chest Physicians. At present, the American Cancer Society doesn’t have recommendations for or against aspirin therapy; the American Gastroenterological Association and the National Comprehensive Care Network “limit their recommendations to patients who are at increased risk for colorectal cancer,” Dr. Siu and his associates added.

Copies of the guideline and of the supporting literature reviews and the decision-analysis tool are available at www.uspreventiveservicestaskforce.org.

Many patients aged 50-59 years should start low-dose aspirin for the primary prevention of cardiovascular disease and colorectal cancer, according to the U.S. Preventive Services Task Force’s updated clinical practice guideline on aspirin therapy, published online April 11 in Annals of Internal Medicine.

The evidence is clear that the benefits outweigh the potential harms of low-dose aspirin in this age group if patients have a 10% or greater 10-year cardiovascular disease (CVD) risk, are not at increased risk of bleeding, have a life expectancy of at least 10 years, and are willing to take the treatment for at least 10 years, said Dr. Albert L. Siu and his associates in the USPSTF.

©American Heart Association

The organization based this guideline on 2 systematic reviews of the literature, updating its 2009 review on aspirin therapy to prevent cardiovascular disease and updating its 2007 review on aspirin therapy to prevent colorectal cancer. The findings from these reviews of the current evidence were used to develop a decision-analysis model to weigh the benefits and harms of treatment in various patient groups defined by age, gender, and risk factors.

Recent studies of primary prevention of CVD, which included 118,445 participants, “consistently demonstrated effectiveness of aspirin in preventing nonfatal MI and stroke.” Pooled analyses showed that low-dose aspirin reduced nonfatal MI and coronary events 17% (risk ratio, 0.83) and that any aspirin dose reduced them 22%. Low-dose aspirin also reduced all-cause mortality risk (RR, 0.95) in pooled analyses.

Aspirin therapy also reduced the risk of colorectal cancer, but this benefit didn’t appear until after 5-10 years of treatment. Three trials reported a 40% reduction (RR, 0.60) after 10-20 years of daily low-dose aspirin.

On the other side of the equation, major GI bleeding increased by 65% among aspirin users when the data from 15 CVD prevention trials were pooled. Similarly, pooled analyses showed a 33% increase in hemorrhagic stroke among aspirin users, compared with nonusers.

The benefits of low-dose aspirin were highest and the harms were lowest in patients aged 50-59 years, hence the first recommendation in the new guideline. In patients aged 60-69 years, the benefit-to-harm balance isn’t as clear-cut, so the decision to initiate or continue aspirin therapy in this age group must be made on an individual basis. “Some adults [at this age] may decide that avoiding an MI or stroke is very important and that having a GI bleeding event is not as significant. They may decide to take aspirin at a lower CVD risk level than those who are more concerned about GI bleeding. Adults who have a high likelihood of benefit with little potential for harm should be encouraged to consider aspirin use.

“Conversely, adults who have little potential of benefit or high risk for GI bleeding should be discouraged” from taking aspirin therapy, the investigators said (Ann Intern Med. 2016 Apr 11. doi: 10.7326/M16-0577).

The task force found that current evidence is insufficient to assess the balance of benefits and harms regarding aspirin therapy for adults younger than age 50 or older than age 70. In the latter group in particular, the picture is complicated by the effects of age, use of other medications, and concomitant illness. However, since cardiovascular risks are increased after age 70 and the incidences of MI and stroke are relatively high, the benefits of preventive aspirin could be substantial in this age group, said Dr. Siu of Icahn School of Medicine Mount Sinai, New York, and the Veterans Affairs Medical Center, the Bronx, and his associates.

The USPSTF guideline generally accords with existing recommendations from the American Heart Association, the American Stroke Association, the American Diabetes Association, the American Academy of Family Physicians, and the American College of Chest Physicians. At present, the American Cancer Society doesn’t have recommendations for or against aspirin therapy; the American Gastroenterological Association and the National Comprehensive Care Network “limit their recommendations to patients who are at increased risk for colorectal cancer,” Dr. Siu and his associates added.

Copies of the guideline and of the supporting literature reviews and the decision-analysis tool are available at www.uspreventiveservicestaskforce.org.

Many patients aged 50-59 years should start low-dose aspirin for the primary prevention of cardiovascular disease and colorectal cancer, according to the U.S. Preventive Services Task Force’s updated clinical practice guideline on aspirin therapy, published online April 11 in Annals of Internal Medicine.

The evidence is clear that the benefits outweigh the potential harms of low-dose aspirin in this age group if patients have a 10% or greater 10-year cardiovascular disease (CVD) risk, are not at increased risk of bleeding, have a life expectancy of at least 10 years, and are willing to take the treatment for at least 10 years, said Dr. Albert L. Siu and his associates in the USPSTF.

©American Heart Association

The organization based this guideline on 2 systematic reviews of the literature, updating its 2009 review on aspirin therapy to prevent cardiovascular disease and updating its 2007 review on aspirin therapy to prevent colorectal cancer. The findings from these reviews of the current evidence were used to develop a decision-analysis model to weigh the benefits and harms of treatment in various patient groups defined by age, gender, and risk factors.

Recent studies of primary prevention of CVD, which included 118,445 participants, “consistently demonstrated effectiveness of aspirin in preventing nonfatal MI and stroke.” Pooled analyses showed that low-dose aspirin reduced nonfatal MI and coronary events 17% (risk ratio, 0.83) and that any aspirin dose reduced them 22%. Low-dose aspirin also reduced all-cause mortality risk (RR, 0.95) in pooled analyses.

Aspirin therapy also reduced the risk of colorectal cancer, but this benefit didn’t appear until after 5-10 years of treatment. Three trials reported a 40% reduction (RR, 0.60) after 10-20 years of daily low-dose aspirin.

On the other side of the equation, major GI bleeding increased by 65% among aspirin users when the data from 15 CVD prevention trials were pooled. Similarly, pooled analyses showed a 33% increase in hemorrhagic stroke among aspirin users, compared with nonusers.

The benefits of low-dose aspirin were highest and the harms were lowest in patients aged 50-59 years, hence the first recommendation in the new guideline. In patients aged 60-69 years, the benefit-to-harm balance isn’t as clear-cut, so the decision to initiate or continue aspirin therapy in this age group must be made on an individual basis. “Some adults [at this age] may decide that avoiding an MI or stroke is very important and that having a GI bleeding event is not as significant. They may decide to take aspirin at a lower CVD risk level than those who are more concerned about GI bleeding. Adults who have a high likelihood of benefit with little potential for harm should be encouraged to consider aspirin use.

“Conversely, adults who have little potential of benefit or high risk for GI bleeding should be discouraged” from taking aspirin therapy, the investigators said (Ann Intern Med. 2016 Apr 11. doi: 10.7326/M16-0577).

The task force found that current evidence is insufficient to assess the balance of benefits and harms regarding aspirin therapy for adults younger than age 50 or older than age 70. In the latter group in particular, the picture is complicated by the effects of age, use of other medications, and concomitant illness. However, since cardiovascular risks are increased after age 70 and the incidences of MI and stroke are relatively high, the benefits of preventive aspirin could be substantial in this age group, said Dr. Siu of Icahn School of Medicine Mount Sinai, New York, and the Veterans Affairs Medical Center, the Bronx, and his associates.

The USPSTF guideline generally accords with existing recommendations from the American Heart Association, the American Stroke Association, the American Diabetes Association, the American Academy of Family Physicians, and the American College of Chest Physicians. At present, the American Cancer Society doesn’t have recommendations for or against aspirin therapy; the American Gastroenterological Association and the National Comprehensive Care Network “limit their recommendations to patients who are at increased risk for colorectal cancer,” Dr. Siu and his associates added.

Copies of the guideline and of the supporting literature reviews and the decision-analysis tool are available at www.uspreventiveservicestaskforce.org.