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Newer hormonal contraception formulations linked to breast cancer risk*
The risk of developing breast cancer is about 20% higher among women who are current or recent users of hormonal contraceptives, compared with women who never used them, according to a prospective cohort study that included current contraception formulations.
Lina S. Mørch, PhD, of the University of Copenhagen, and colleagues conducted a nationwide, prospective cohort study of 1,797,932 women in Denmark who were aged 15-49 years between 1995 and 2012. The risk of developing breast cancer among all women currently using or who had recently used hormonal contraception correlated to a relative risk (RR) of 1.20 (95% confidence interval [CI], 1.14-1.26). The report was published in the New England Journal of Medicine.
The risk of breast cancer was heavily associated with the length of time during which the women had taken hormonal contraceptives. Women with less than a year of exposure had the lowest risk elevation (RR 1.09, 95% CI, 0.96-1.23), while women with more than 10 years of exposure faced the greatest increase in risk (RR 1.38, 95% CI, 1.26-1.51, P = .002).
The increased risk persisted even after women had stopped taking contraceptives. Researchers found that contraception use of less than a year (RR 1.01, 95% CI, 0.88-1.15), between 1 year and 5 years (RR 1.07, 95% CI, 0.94-1.20), and between 5 years and 10 years (RR 1.30, 95% CI, 1.06-1.58) correlated to increased risks of breast cancer 5-10 years after cessation of use. The number of events in women who had used hormonal contraceptive for more than 10 years was too small to accurately determine risks and was not reported in the study.
The combinations and formulations of oral contraceptives had little effect on breast cancer risk elevation, the researchers found. Triphasic and monophasic formulations containing levonorgestrel had similar relative risk levels of 1.21 (95% CI, 1.04-1.41) and 1.45 (95% CI, 1.26-1.67), respectively (P = .07). The relative risk was similar for intrauterine devices containing levonorgestrel (RR 1.21, 95% CI, 1.11-1.33).
The difference in risk between current and recent users of hormonal contraception and women who never took it was 13 (CI, 10-16) per 100,000 person-years, which translates into an one extra breast cancer diagnosis for every 7,690 women using hormonal contraception for 1 year.
“The estimated number of additional breast cancers that were associated with hormonal contraception did not include extra cases diagnosed after the discontinuation of long-term use. Even so, the estimated number of additional breast cancers among premenopausal women that were attributable to hormonal contraception is likely to be low,” the researchers wrote. “This risk should be weighed against important benefits of hormonal contraceptives such as good contraceptive efficacy and reduced risks of ovarian, endometrial, and perhaps colorectal cancer (at least for combined oral contraceptives that were commonly used in the 1970s and 1980s).
”Dr. Mørch and a coauthor received grant support from the Novo Nordisk Foundation and became employed by Novo Nordisk Foundation after the study was accepted for publication. No other relevant disclosures were reported.
Source: Mørch L. et al. N Engl J Med 2017;377(23):2228-39.
*12/7/2017: The headline for this story has been corrected to reflect an association between contraception and breast cancer risk.
The association between increased breast cancer risk and hormonal contraceptives is well documented but the research by Mørch et al. offers several factors for physicians to consider when prescribing hormonal contraceptives.
Mørch et al. found a 20% total increase in breast cancer in women but that finding is not consistent across age groups. As seen in the study, breast cancer risk was more than five times higher in women in their 40s than in women in their 30s, with an overall increase in breast cancer risk of 13 women per 100,000 women. The increased risk of breast cancer was much less pronounced in women under 35, at only 2 women per 100,000 women. For women in their 40s, hormonal contraceptives not only increase their cancer risk, but they can suffer uncommon adverse side effects such as myocardial infarction and stroke as well. Older women should consider using alternative methods of contraception, such as nonhormonal long-acting, reversible contraceptives.
But the breast cancer risk needs to be balanced against the benefits, including the association between oral contraceptives and substantial reductions in the risk of ovarian, endometrial, and colorectal cancers later in life.
Ultimately, the need for contraceptives that do not increase breast cancer risk is evident.
David J. Hunter , MBBS, ScD, is from the University of Oxford, England. He reported having no relevant financial disclosures. These comments are adapted from an editorial (N Engl J Med. 2017;377[23]:2276-7).
The association between increased breast cancer risk and hormonal contraceptives is well documented but the research by Mørch et al. offers several factors for physicians to consider when prescribing hormonal contraceptives.
Mørch et al. found a 20% total increase in breast cancer in women but that finding is not consistent across age groups. As seen in the study, breast cancer risk was more than five times higher in women in their 40s than in women in their 30s, with an overall increase in breast cancer risk of 13 women per 100,000 women. The increased risk of breast cancer was much less pronounced in women under 35, at only 2 women per 100,000 women. For women in their 40s, hormonal contraceptives not only increase their cancer risk, but they can suffer uncommon adverse side effects such as myocardial infarction and stroke as well. Older women should consider using alternative methods of contraception, such as nonhormonal long-acting, reversible contraceptives.
But the breast cancer risk needs to be balanced against the benefits, including the association between oral contraceptives and substantial reductions in the risk of ovarian, endometrial, and colorectal cancers later in life.
Ultimately, the need for contraceptives that do not increase breast cancer risk is evident.
David J. Hunter , MBBS, ScD, is from the University of Oxford, England. He reported having no relevant financial disclosures. These comments are adapted from an editorial (N Engl J Med. 2017;377[23]:2276-7).
The association between increased breast cancer risk and hormonal contraceptives is well documented but the research by Mørch et al. offers several factors for physicians to consider when prescribing hormonal contraceptives.
Mørch et al. found a 20% total increase in breast cancer in women but that finding is not consistent across age groups. As seen in the study, breast cancer risk was more than five times higher in women in their 40s than in women in their 30s, with an overall increase in breast cancer risk of 13 women per 100,000 women. The increased risk of breast cancer was much less pronounced in women under 35, at only 2 women per 100,000 women. For women in their 40s, hormonal contraceptives not only increase their cancer risk, but they can suffer uncommon adverse side effects such as myocardial infarction and stroke as well. Older women should consider using alternative methods of contraception, such as nonhormonal long-acting, reversible contraceptives.
But the breast cancer risk needs to be balanced against the benefits, including the association between oral contraceptives and substantial reductions in the risk of ovarian, endometrial, and colorectal cancers later in life.
Ultimately, the need for contraceptives that do not increase breast cancer risk is evident.
David J. Hunter , MBBS, ScD, is from the University of Oxford, England. He reported having no relevant financial disclosures. These comments are adapted from an editorial (N Engl J Med. 2017;377[23]:2276-7).
The risk of developing breast cancer is about 20% higher among women who are current or recent users of hormonal contraceptives, compared with women who never used them, according to a prospective cohort study that included current contraception formulations.
Lina S. Mørch, PhD, of the University of Copenhagen, and colleagues conducted a nationwide, prospective cohort study of 1,797,932 women in Denmark who were aged 15-49 years between 1995 and 2012. The risk of developing breast cancer among all women currently using or who had recently used hormonal contraception correlated to a relative risk (RR) of 1.20 (95% confidence interval [CI], 1.14-1.26). The report was published in the New England Journal of Medicine.
The risk of breast cancer was heavily associated with the length of time during which the women had taken hormonal contraceptives. Women with less than a year of exposure had the lowest risk elevation (RR 1.09, 95% CI, 0.96-1.23), while women with more than 10 years of exposure faced the greatest increase in risk (RR 1.38, 95% CI, 1.26-1.51, P = .002).
The increased risk persisted even after women had stopped taking contraceptives. Researchers found that contraception use of less than a year (RR 1.01, 95% CI, 0.88-1.15), between 1 year and 5 years (RR 1.07, 95% CI, 0.94-1.20), and between 5 years and 10 years (RR 1.30, 95% CI, 1.06-1.58) correlated to increased risks of breast cancer 5-10 years after cessation of use. The number of events in women who had used hormonal contraceptive for more than 10 years was too small to accurately determine risks and was not reported in the study.
The combinations and formulations of oral contraceptives had little effect on breast cancer risk elevation, the researchers found. Triphasic and monophasic formulations containing levonorgestrel had similar relative risk levels of 1.21 (95% CI, 1.04-1.41) and 1.45 (95% CI, 1.26-1.67), respectively (P = .07). The relative risk was similar for intrauterine devices containing levonorgestrel (RR 1.21, 95% CI, 1.11-1.33).
The difference in risk between current and recent users of hormonal contraception and women who never took it was 13 (CI, 10-16) per 100,000 person-years, which translates into an one extra breast cancer diagnosis for every 7,690 women using hormonal contraception for 1 year.
“The estimated number of additional breast cancers that were associated with hormonal contraception did not include extra cases diagnosed after the discontinuation of long-term use. Even so, the estimated number of additional breast cancers among premenopausal women that were attributable to hormonal contraception is likely to be low,” the researchers wrote. “This risk should be weighed against important benefits of hormonal contraceptives such as good contraceptive efficacy and reduced risks of ovarian, endometrial, and perhaps colorectal cancer (at least for combined oral contraceptives that were commonly used in the 1970s and 1980s).
”Dr. Mørch and a coauthor received grant support from the Novo Nordisk Foundation and became employed by Novo Nordisk Foundation after the study was accepted for publication. No other relevant disclosures were reported.
Source: Mørch L. et al. N Engl J Med 2017;377(23):2228-39.
*12/7/2017: The headline for this story has been corrected to reflect an association between contraception and breast cancer risk.
The risk of developing breast cancer is about 20% higher among women who are current or recent users of hormonal contraceptives, compared with women who never used them, according to a prospective cohort study that included current contraception formulations.
Lina S. Mørch, PhD, of the University of Copenhagen, and colleagues conducted a nationwide, prospective cohort study of 1,797,932 women in Denmark who were aged 15-49 years between 1995 and 2012. The risk of developing breast cancer among all women currently using or who had recently used hormonal contraception correlated to a relative risk (RR) of 1.20 (95% confidence interval [CI], 1.14-1.26). The report was published in the New England Journal of Medicine.
The risk of breast cancer was heavily associated with the length of time during which the women had taken hormonal contraceptives. Women with less than a year of exposure had the lowest risk elevation (RR 1.09, 95% CI, 0.96-1.23), while women with more than 10 years of exposure faced the greatest increase in risk (RR 1.38, 95% CI, 1.26-1.51, P = .002).
The increased risk persisted even after women had stopped taking contraceptives. Researchers found that contraception use of less than a year (RR 1.01, 95% CI, 0.88-1.15), between 1 year and 5 years (RR 1.07, 95% CI, 0.94-1.20), and between 5 years and 10 years (RR 1.30, 95% CI, 1.06-1.58) correlated to increased risks of breast cancer 5-10 years after cessation of use. The number of events in women who had used hormonal contraceptive for more than 10 years was too small to accurately determine risks and was not reported in the study.
The combinations and formulations of oral contraceptives had little effect on breast cancer risk elevation, the researchers found. Triphasic and monophasic formulations containing levonorgestrel had similar relative risk levels of 1.21 (95% CI, 1.04-1.41) and 1.45 (95% CI, 1.26-1.67), respectively (P = .07). The relative risk was similar for intrauterine devices containing levonorgestrel (RR 1.21, 95% CI, 1.11-1.33).
The difference in risk between current and recent users of hormonal contraception and women who never took it was 13 (CI, 10-16) per 100,000 person-years, which translates into an one extra breast cancer diagnosis for every 7,690 women using hormonal contraception for 1 year.
“The estimated number of additional breast cancers that were associated with hormonal contraception did not include extra cases diagnosed after the discontinuation of long-term use. Even so, the estimated number of additional breast cancers among premenopausal women that were attributable to hormonal contraception is likely to be low,” the researchers wrote. “This risk should be weighed against important benefits of hormonal contraceptives such as good contraceptive efficacy and reduced risks of ovarian, endometrial, and perhaps colorectal cancer (at least for combined oral contraceptives that were commonly used in the 1970s and 1980s).
”Dr. Mørch and a coauthor received grant support from the Novo Nordisk Foundation and became employed by Novo Nordisk Foundation after the study was accepted for publication. No other relevant disclosures were reported.
Source: Mørch L. et al. N Engl J Med 2017;377(23):2228-39.
*12/7/2017: The headline for this story has been corrected to reflect an association between contraception and breast cancer risk.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Key clinical point:
Major finding: The relative risk of breast cancer was 1.20 for current and recent users of hormonal contraception, compared with women who never used hormonal contraception (95% CI 1.14-1.26).
Data source: Nationwide, prospective cohort study of 1,797,932 women in Denmark aged 15-49 years between 1995 and 2012.
Disclosures: Dr. Mørch and a coauthor received grant support from the Novo Nordisk Foundation and became employed by Novo Nordisk Foundation after the study was accepted for publication. No other relevant disclosures were reported.
Source: Mørch L et al. N Engl J Med 2017;377(23):2228-39.
Preoperative IV acetaminophen has little to offer in gyn surgery, study finds
NATIONAL HARBOR, MD. – Intravenous (IV) acetaminophen does little to improve patient satisfaction and decrease pain after laparoscopic hysterectomy, according to results from a prospective, randomized trial.
Noah Rindos, MD, and his colleagues investigated the effectiveness of preoperative IV acetaminophen, encouraged by previous studies demonstrating its effectiveness in preoperative pain. Dr. Rindos of the University of Pittsburgh and his team researched acetaminophen as an alternative to opioid pain management.
“The theory is if you give something to block the pain, then you’ll have less of it after surgery. And then you won’t need as many narcotics,” Dr. Rindos said at the AAGL Global Congress.
Prior to surgery, 91 patients were administered 1,000 mg of IV acetaminophen and 92 received IV saline. Follow-up doses were administered 6 hours later. Induction of anesthesia and other postoperative pain management was uniform between the two cohorts. Patients also were asked to report their pain and nausea levels. Three patients withdrew from the study, two from postoperative pain and one for evaluation of stroke.
Using the visual analog scale, patients were asked to report their postoperative pain and nausea levels at 2, 4, 6, 12, and 24 hours. Patients also reported their satisfaction scores 24 hours post surgery.
Generalized abdominal pain visual analog scores between the IV saline and IV acetaminophen groups showed no significant differences at 2 hours (3.6 vs 4.4), 4 hours (3.5 vs. 3.9), 6 hours (3.6 vs. 3.8), 12 hours (3.3 vs. 3.7), and 24 hours (3.3 vs. 3.6). Similar results were observed for upper abdomen, lower abdomen and umbilical pain, and nausea. There was no statistically significant difference between saline and acetaminophen postoperative satisfaction scores (P = .319).
The results of this study are particularly relevant because of the relatively high cost of acetaminophen ($23.20 per dose in this study). The price, combined with the lack of effectiveness and the availability of alternatives, make the routine use of acetaminophen unnecessary during hysterectomy, Dr. Rindos said.“This has actually led to a practice change within our institution where we are no longer giving IV Tylenol preoperatively,” Dr. Rindos said. “If we have a large expense ... and we are not getting much benefit to the patient or to their overall satisfaction, maybe we should reevaluate the utility of it.”
The study was supported by the Magee-Womens Hospital Medical Staff Fund. Dr. Rindos reported having no relevant financial disclosures.
NATIONAL HARBOR, MD. – Intravenous (IV) acetaminophen does little to improve patient satisfaction and decrease pain after laparoscopic hysterectomy, according to results from a prospective, randomized trial.
Noah Rindos, MD, and his colleagues investigated the effectiveness of preoperative IV acetaminophen, encouraged by previous studies demonstrating its effectiveness in preoperative pain. Dr. Rindos of the University of Pittsburgh and his team researched acetaminophen as an alternative to opioid pain management.
“The theory is if you give something to block the pain, then you’ll have less of it after surgery. And then you won’t need as many narcotics,” Dr. Rindos said at the AAGL Global Congress.
Prior to surgery, 91 patients were administered 1,000 mg of IV acetaminophen and 92 received IV saline. Follow-up doses were administered 6 hours later. Induction of anesthesia and other postoperative pain management was uniform between the two cohorts. Patients also were asked to report their pain and nausea levels. Three patients withdrew from the study, two from postoperative pain and one for evaluation of stroke.
Using the visual analog scale, patients were asked to report their postoperative pain and nausea levels at 2, 4, 6, 12, and 24 hours. Patients also reported their satisfaction scores 24 hours post surgery.
Generalized abdominal pain visual analog scores between the IV saline and IV acetaminophen groups showed no significant differences at 2 hours (3.6 vs 4.4), 4 hours (3.5 vs. 3.9), 6 hours (3.6 vs. 3.8), 12 hours (3.3 vs. 3.7), and 24 hours (3.3 vs. 3.6). Similar results were observed for upper abdomen, lower abdomen and umbilical pain, and nausea. There was no statistically significant difference between saline and acetaminophen postoperative satisfaction scores (P = .319).
The results of this study are particularly relevant because of the relatively high cost of acetaminophen ($23.20 per dose in this study). The price, combined with the lack of effectiveness and the availability of alternatives, make the routine use of acetaminophen unnecessary during hysterectomy, Dr. Rindos said.“This has actually led to a practice change within our institution where we are no longer giving IV Tylenol preoperatively,” Dr. Rindos said. “If we have a large expense ... and we are not getting much benefit to the patient or to their overall satisfaction, maybe we should reevaluate the utility of it.”
The study was supported by the Magee-Womens Hospital Medical Staff Fund. Dr. Rindos reported having no relevant financial disclosures.
NATIONAL HARBOR, MD. – Intravenous (IV) acetaminophen does little to improve patient satisfaction and decrease pain after laparoscopic hysterectomy, according to results from a prospective, randomized trial.
Noah Rindos, MD, and his colleagues investigated the effectiveness of preoperative IV acetaminophen, encouraged by previous studies demonstrating its effectiveness in preoperative pain. Dr. Rindos of the University of Pittsburgh and his team researched acetaminophen as an alternative to opioid pain management.
“The theory is if you give something to block the pain, then you’ll have less of it after surgery. And then you won’t need as many narcotics,” Dr. Rindos said at the AAGL Global Congress.
Prior to surgery, 91 patients were administered 1,000 mg of IV acetaminophen and 92 received IV saline. Follow-up doses were administered 6 hours later. Induction of anesthesia and other postoperative pain management was uniform between the two cohorts. Patients also were asked to report their pain and nausea levels. Three patients withdrew from the study, two from postoperative pain and one for evaluation of stroke.
Using the visual analog scale, patients were asked to report their postoperative pain and nausea levels at 2, 4, 6, 12, and 24 hours. Patients also reported their satisfaction scores 24 hours post surgery.
Generalized abdominal pain visual analog scores between the IV saline and IV acetaminophen groups showed no significant differences at 2 hours (3.6 vs 4.4), 4 hours (3.5 vs. 3.9), 6 hours (3.6 vs. 3.8), 12 hours (3.3 vs. 3.7), and 24 hours (3.3 vs. 3.6). Similar results were observed for upper abdomen, lower abdomen and umbilical pain, and nausea. There was no statistically significant difference between saline and acetaminophen postoperative satisfaction scores (P = .319).
The results of this study are particularly relevant because of the relatively high cost of acetaminophen ($23.20 per dose in this study). The price, combined with the lack of effectiveness and the availability of alternatives, make the routine use of acetaminophen unnecessary during hysterectomy, Dr. Rindos said.“This has actually led to a practice change within our institution where we are no longer giving IV Tylenol preoperatively,” Dr. Rindos said. “If we have a large expense ... and we are not getting much benefit to the patient or to their overall satisfaction, maybe we should reevaluate the utility of it.”
The study was supported by the Magee-Womens Hospital Medical Staff Fund. Dr. Rindos reported having no relevant financial disclosures.
AT AAGL 2017
Key clinical point:
Major finding: Generalized abdominal pain and satisfaction scores at 24 hours post surgery were not significantly different between the placebo and IV acetaminophen groups (P = .275 and P = .319, respectively).
Data source: A prospective, double-blind, randomized study with 180 women assigned to receive IV acetaminophen or placebo at tertiary care and academic hospitals during February 2015-August 2016.
Disclosures: The study was supported by the Magee-Womens Hospital Medical Staff Fund. Dr. Rindos reported having no relevant financial disclosures.
Panel votes against universal blood donor screens for Zika virus
SILVER SPRING, MD – Universal testing of individual blood donations for the presence of Zika virus was unanimously rejected by voting members of the Food and Drug Administration’s Blood Products Advisory Committee at a December 1 meeting.
Universal individual donor testing, while comprehensive, is resource intensive and places a burden on the blood system that is not outweighed by the benefits, 10 of the 11 committee members concluded. The other committee member could not be reached by phone for this vote.
The committee instead recommended by a vote of 10 to 1 that mini-pool nucleic acid testing (MP-NAT) be performed in all states and territories with known cases of Zika virus infection and the presence of A. aegypti mosquitoes, as well as in states and territories with a high number of travelers from areas with Zika virus infections. Also, the committee members agreed that a trigger needs to be defined for when to undertake universal individual donor nucleic acid testing (ID-NAT) in those areas.
Additionally, the committee agreed that it was not necessary to maintain a Zika virus-negative blood inventory for at-risk patients, such as pregnant women and newborns. Zika virus, a vector-borne disease carried by the Aedes aegypti and Aedes albopictus mosquitoes, has also been transmitted via sexual contact and blood transfusion. Infection has been linked to fetal loss and microcephaly in the offspring of infected pregnant women. Other neurological disorders, including Guillain-Barré Syndrome, also have been linked to Zika virus infection.
Noting the complexity of managing an inventory of tested and non-tested blood, the committee rejected the separate inventory approach by a vote of 9 to 2.*
The panel was clearly divided on the possibility of eliminating all Zika virus testing in some states and territories; 5 members supported this measure, 4 opposed it, and 2 abstained from voting.
The panel unanimously rejected using screening questionnaires to determine whether to selectively test individual at-risk donors in areas with active vector-borne Zika virus infections. This option was considered particularly troublesome, they agreed, because it relies on the use of nonspecific, insensitive, and error-prone questionnaires.
Some level of Zika virus testing is needed to safeguard blood products, the committee said. Eliminating all Zika virus testing of blood products would open the door for infections via transfusion and would diminish preparedness against a potential epidemic, they unanimously determined.
Prior to voting, the committee listened to presentations on the epidemiology of Zika virus infections, the effectiveness of screening tests, and the risk for transmission via transfusion.
Carolyn Gould, MD, of the Centers for Disease Control and Prevention, Atlanta, reported that the number of laboratory-confirmed Zika virus infections in 2016 was 4,830 for travelers to endemic areas and 224 for locally-acquired cases. In 2017, those numbers dropped to 344 confirmed cases for travelers and 2 for locally-acquired cases.
More than 4 million blood donations in the United States and Puerto Rico have been screened for Zika virus RNA using the cobas assay, which is now FDA approved. The overall confirmed positive rate of Zika virus is 0.0007% in donations from the continental United States (29 positive results in 4,341,770 donations) and 0.326% in donations from Puerto Rico (356 out of 111,808 donations) based on data obtained from May 23, 2016 to October 7, 2017, according to Tony Hardiman, Blood Screening, Life Cycle Leader at Roche Molecular Systems.
Of the Zika virus-positive donors who were available for follow up, 23 of 27 had traveled to Zika-active areas, including 3 cases associated with domestic travel to Florida. “I was surprised that 4 of the 29 were from Cuba, but it does seem, as we just saw, (that) an increasing number are coming out from Cuba, from travel to Cuba,” Mr. Hardiman said during his presentation to the committee.
Findings concerning viral RNA duration in blood and other body fluids were presented by Michael Busch, MD of the University of California, San Francisco, who spoke during the public hearing portion of the meeting.**
According to Dr. Busch, blood is likely not infectious to others once donors develop Zika virus-neutralizing antibodies and their viral load levels become very low.
Based on his review of various studies, Dr. Busch concluded that mini-pool testing options with triggers for individual testing are appropriate and effective for detecting Zika virus in endemic areas.
“In Puerto Rico, within a day of picking up a mini-pool positive [result}, we would have ID-NAT in place,” Dr. Busch said. “The mini-pool testing is picking up 90% of those at highest risk.”
The committee recommendations serve as guidance to the FDA, which is not obligated to follow the committee’s recommendations.
*Correction 12/14/17: An earlier version of this story misstated the vote on maintaining a Zika virus-negative blood inventory for at-risk patients. The advisory committee voted against that approach.
**Correction 12/14/17: Dr. Michael Busch's name was misstated in an earlier version of this article.
SILVER SPRING, MD – Universal testing of individual blood donations for the presence of Zika virus was unanimously rejected by voting members of the Food and Drug Administration’s Blood Products Advisory Committee at a December 1 meeting.
Universal individual donor testing, while comprehensive, is resource intensive and places a burden on the blood system that is not outweighed by the benefits, 10 of the 11 committee members concluded. The other committee member could not be reached by phone for this vote.
The committee instead recommended by a vote of 10 to 1 that mini-pool nucleic acid testing (MP-NAT) be performed in all states and territories with known cases of Zika virus infection and the presence of A. aegypti mosquitoes, as well as in states and territories with a high number of travelers from areas with Zika virus infections. Also, the committee members agreed that a trigger needs to be defined for when to undertake universal individual donor nucleic acid testing (ID-NAT) in those areas.
Additionally, the committee agreed that it was not necessary to maintain a Zika virus-negative blood inventory for at-risk patients, such as pregnant women and newborns. Zika virus, a vector-borne disease carried by the Aedes aegypti and Aedes albopictus mosquitoes, has also been transmitted via sexual contact and blood transfusion. Infection has been linked to fetal loss and microcephaly in the offspring of infected pregnant women. Other neurological disorders, including Guillain-Barré Syndrome, also have been linked to Zika virus infection.
Noting the complexity of managing an inventory of tested and non-tested blood, the committee rejected the separate inventory approach by a vote of 9 to 2.*
The panel was clearly divided on the possibility of eliminating all Zika virus testing in some states and territories; 5 members supported this measure, 4 opposed it, and 2 abstained from voting.
The panel unanimously rejected using screening questionnaires to determine whether to selectively test individual at-risk donors in areas with active vector-borne Zika virus infections. This option was considered particularly troublesome, they agreed, because it relies on the use of nonspecific, insensitive, and error-prone questionnaires.
Some level of Zika virus testing is needed to safeguard blood products, the committee said. Eliminating all Zika virus testing of blood products would open the door for infections via transfusion and would diminish preparedness against a potential epidemic, they unanimously determined.
Prior to voting, the committee listened to presentations on the epidemiology of Zika virus infections, the effectiveness of screening tests, and the risk for transmission via transfusion.
Carolyn Gould, MD, of the Centers for Disease Control and Prevention, Atlanta, reported that the number of laboratory-confirmed Zika virus infections in 2016 was 4,830 for travelers to endemic areas and 224 for locally-acquired cases. In 2017, those numbers dropped to 344 confirmed cases for travelers and 2 for locally-acquired cases.
More than 4 million blood donations in the United States and Puerto Rico have been screened for Zika virus RNA using the cobas assay, which is now FDA approved. The overall confirmed positive rate of Zika virus is 0.0007% in donations from the continental United States (29 positive results in 4,341,770 donations) and 0.326% in donations from Puerto Rico (356 out of 111,808 donations) based on data obtained from May 23, 2016 to October 7, 2017, according to Tony Hardiman, Blood Screening, Life Cycle Leader at Roche Molecular Systems.
Of the Zika virus-positive donors who were available for follow up, 23 of 27 had traveled to Zika-active areas, including 3 cases associated with domestic travel to Florida. “I was surprised that 4 of the 29 were from Cuba, but it does seem, as we just saw, (that) an increasing number are coming out from Cuba, from travel to Cuba,” Mr. Hardiman said during his presentation to the committee.
Findings concerning viral RNA duration in blood and other body fluids were presented by Michael Busch, MD of the University of California, San Francisco, who spoke during the public hearing portion of the meeting.**
According to Dr. Busch, blood is likely not infectious to others once donors develop Zika virus-neutralizing antibodies and their viral load levels become very low.
Based on his review of various studies, Dr. Busch concluded that mini-pool testing options with triggers for individual testing are appropriate and effective for detecting Zika virus in endemic areas.
“In Puerto Rico, within a day of picking up a mini-pool positive [result}, we would have ID-NAT in place,” Dr. Busch said. “The mini-pool testing is picking up 90% of those at highest risk.”
The committee recommendations serve as guidance to the FDA, which is not obligated to follow the committee’s recommendations.
*Correction 12/14/17: An earlier version of this story misstated the vote on maintaining a Zika virus-negative blood inventory for at-risk patients. The advisory committee voted against that approach.
**Correction 12/14/17: Dr. Michael Busch's name was misstated in an earlier version of this article.
SILVER SPRING, MD – Universal testing of individual blood donations for the presence of Zika virus was unanimously rejected by voting members of the Food and Drug Administration’s Blood Products Advisory Committee at a December 1 meeting.
Universal individual donor testing, while comprehensive, is resource intensive and places a burden on the blood system that is not outweighed by the benefits, 10 of the 11 committee members concluded. The other committee member could not be reached by phone for this vote.
The committee instead recommended by a vote of 10 to 1 that mini-pool nucleic acid testing (MP-NAT) be performed in all states and territories with known cases of Zika virus infection and the presence of A. aegypti mosquitoes, as well as in states and territories with a high number of travelers from areas with Zika virus infections. Also, the committee members agreed that a trigger needs to be defined for when to undertake universal individual donor nucleic acid testing (ID-NAT) in those areas.
Additionally, the committee agreed that it was not necessary to maintain a Zika virus-negative blood inventory for at-risk patients, such as pregnant women and newborns. Zika virus, a vector-borne disease carried by the Aedes aegypti and Aedes albopictus mosquitoes, has also been transmitted via sexual contact and blood transfusion. Infection has been linked to fetal loss and microcephaly in the offspring of infected pregnant women. Other neurological disorders, including Guillain-Barré Syndrome, also have been linked to Zika virus infection.
Noting the complexity of managing an inventory of tested and non-tested blood, the committee rejected the separate inventory approach by a vote of 9 to 2.*
The panel was clearly divided on the possibility of eliminating all Zika virus testing in some states and territories; 5 members supported this measure, 4 opposed it, and 2 abstained from voting.
The panel unanimously rejected using screening questionnaires to determine whether to selectively test individual at-risk donors in areas with active vector-borne Zika virus infections. This option was considered particularly troublesome, they agreed, because it relies on the use of nonspecific, insensitive, and error-prone questionnaires.
Some level of Zika virus testing is needed to safeguard blood products, the committee said. Eliminating all Zika virus testing of blood products would open the door for infections via transfusion and would diminish preparedness against a potential epidemic, they unanimously determined.
Prior to voting, the committee listened to presentations on the epidemiology of Zika virus infections, the effectiveness of screening tests, and the risk for transmission via transfusion.
Carolyn Gould, MD, of the Centers for Disease Control and Prevention, Atlanta, reported that the number of laboratory-confirmed Zika virus infections in 2016 was 4,830 for travelers to endemic areas and 224 for locally-acquired cases. In 2017, those numbers dropped to 344 confirmed cases for travelers and 2 for locally-acquired cases.
More than 4 million blood donations in the United States and Puerto Rico have been screened for Zika virus RNA using the cobas assay, which is now FDA approved. The overall confirmed positive rate of Zika virus is 0.0007% in donations from the continental United States (29 positive results in 4,341,770 donations) and 0.326% in donations from Puerto Rico (356 out of 111,808 donations) based on data obtained from May 23, 2016 to October 7, 2017, according to Tony Hardiman, Blood Screening, Life Cycle Leader at Roche Molecular Systems.
Of the Zika virus-positive donors who were available for follow up, 23 of 27 had traveled to Zika-active areas, including 3 cases associated with domestic travel to Florida. “I was surprised that 4 of the 29 were from Cuba, but it does seem, as we just saw, (that) an increasing number are coming out from Cuba, from travel to Cuba,” Mr. Hardiman said during his presentation to the committee.
Findings concerning viral RNA duration in blood and other body fluids were presented by Michael Busch, MD of the University of California, San Francisco, who spoke during the public hearing portion of the meeting.**
According to Dr. Busch, blood is likely not infectious to others once donors develop Zika virus-neutralizing antibodies and their viral load levels become very low.
Based on his review of various studies, Dr. Busch concluded that mini-pool testing options with triggers for individual testing are appropriate and effective for detecting Zika virus in endemic areas.
“In Puerto Rico, within a day of picking up a mini-pool positive [result}, we would have ID-NAT in place,” Dr. Busch said. “The mini-pool testing is picking up 90% of those at highest risk.”
The committee recommendations serve as guidance to the FDA, which is not obligated to follow the committee’s recommendations.
*Correction 12/14/17: An earlier version of this story misstated the vote on maintaining a Zika virus-negative blood inventory for at-risk patients. The advisory committee voted against that approach.
**Correction 12/14/17: Dr. Michael Busch's name was misstated in an earlier version of this article.
AT AN FDA ADVISORY COMMITTEE MEETING
Intense urine output monitoring beneficial in ICU
Intense monitoring of urine output could be a useful tool in detecting acute kidney injury (AKI), according to a study conducted at the University of Pittsburgh.
Kui Jin, MD, of the University of Pittsburgh and his associates found that, after adjustment for baseline characteristics, intensive monitoring of urine output (UO) was associated with higher rates of AKI, with an odds ratio of 1.22. Intensive UO monitoring also was strongly associated with improved 30-day survival among patients developing AKI.
This retrospective cohort study included 15,724 adult patients admitted to the center’s ICUs during 2000-2008. All patients had either their UO or serum creatinine (SC) monitored. These patients were then divided into subcohorts that were monitored at one of two different intensities. UO intensive monitoring was defined by hourly recordings, with gaps no greater than 3 hours for the first 48 hours after ICU admission. The group receiving less intensive UO monitoring comprised patients who did not meet intensive monitoring criteria, regardless of their UO in the 7 days following ICU admission. The patients who had their SC intensively monitored had 3 calendar days of samples taken after their ICU admissions. Those who did not meet SC intensive monitoring criteria were placed into the less intensive SC monitoring group.
To understand the effect of the monitoring strategies on detecting the development of AKI, the researchers determined each patient’s baseline, admission, and reference serum creatinine levels. Baseline creatinine was defined as the lowest value in the year prior to hospital admission. Reference creatinine was the baseline creatinine, if available, or the lowest creatinine level recorded within 24 hours after ICU admission. A third method for determining reference creatinine levels was used for some patients, which involved making an estimation based on the Modification of Diet in Renal Disease equation for serum creatinine.
The crude rates of stage 2-3 AKI 7 days after admission to the ICU were similar between patients from both groups that had their UO monitored; 62.5% of intensive and 63.9% of less intensive patients displayed symptoms. After the researchers adjusted for baseline characteristics, however, intensive monitoring of UO was associated with greater rates of stage 2-3 AKI (OR, 1.22; P less than .001). Crude rates were higher in the patients who received intensive monitoring for SC, compared with patients who received less intensive monitoring for SC. Ultimately, Dr. Jin and his associates found that, when caring for patients with or without AKI, fluid management is one of the most important factors. Patients who underwent intensive UO monitoring received less fluid in their first 24 hours (3.6 L) in the ICU, compared with patients who received less intense UO monitoring (4.2 L). Patients who received intensive monitoring of their UO also were less likely to use vasopressors (29.9% vs. 43.3%; P less than .001), suggesting these patients were more hemodynamically stable. Further, the percentage of patients at or above 10% of fluid overload was lower in the group who received intensive monitoring of their UO (2.49% vs. 5.68%; P less than .001), during the first 72 hours in the ICU.
“Our results should help inform clinical decisions and ICU policy around frequency of monitoring of UO, especially for patients at high risk of AKI,” Dr. Jin and his colleagues wrote.
None of the authors had financial disclosures to report. Partial funding was provided by a research grant from C.R. Bard.
Intense monitoring of urine output could be a useful tool in detecting acute kidney injury (AKI), according to a study conducted at the University of Pittsburgh.
Kui Jin, MD, of the University of Pittsburgh and his associates found that, after adjustment for baseline characteristics, intensive monitoring of urine output (UO) was associated with higher rates of AKI, with an odds ratio of 1.22. Intensive UO monitoring also was strongly associated with improved 30-day survival among patients developing AKI.
This retrospective cohort study included 15,724 adult patients admitted to the center’s ICUs during 2000-2008. All patients had either their UO or serum creatinine (SC) monitored. These patients were then divided into subcohorts that were monitored at one of two different intensities. UO intensive monitoring was defined by hourly recordings, with gaps no greater than 3 hours for the first 48 hours after ICU admission. The group receiving less intensive UO monitoring comprised patients who did not meet intensive monitoring criteria, regardless of their UO in the 7 days following ICU admission. The patients who had their SC intensively monitored had 3 calendar days of samples taken after their ICU admissions. Those who did not meet SC intensive monitoring criteria were placed into the less intensive SC monitoring group.
To understand the effect of the monitoring strategies on detecting the development of AKI, the researchers determined each patient’s baseline, admission, and reference serum creatinine levels. Baseline creatinine was defined as the lowest value in the year prior to hospital admission. Reference creatinine was the baseline creatinine, if available, or the lowest creatinine level recorded within 24 hours after ICU admission. A third method for determining reference creatinine levels was used for some patients, which involved making an estimation based on the Modification of Diet in Renal Disease equation for serum creatinine.
The crude rates of stage 2-3 AKI 7 days after admission to the ICU were similar between patients from both groups that had their UO monitored; 62.5% of intensive and 63.9% of less intensive patients displayed symptoms. After the researchers adjusted for baseline characteristics, however, intensive monitoring of UO was associated with greater rates of stage 2-3 AKI (OR, 1.22; P less than .001). Crude rates were higher in the patients who received intensive monitoring for SC, compared with patients who received less intensive monitoring for SC. Ultimately, Dr. Jin and his associates found that, when caring for patients with or without AKI, fluid management is one of the most important factors. Patients who underwent intensive UO monitoring received less fluid in their first 24 hours (3.6 L) in the ICU, compared with patients who received less intense UO monitoring (4.2 L). Patients who received intensive monitoring of their UO also were less likely to use vasopressors (29.9% vs. 43.3%; P less than .001), suggesting these patients were more hemodynamically stable. Further, the percentage of patients at or above 10% of fluid overload was lower in the group who received intensive monitoring of their UO (2.49% vs. 5.68%; P less than .001), during the first 72 hours in the ICU.
“Our results should help inform clinical decisions and ICU policy around frequency of monitoring of UO, especially for patients at high risk of AKI,” Dr. Jin and his colleagues wrote.
None of the authors had financial disclosures to report. Partial funding was provided by a research grant from C.R. Bard.
Intense monitoring of urine output could be a useful tool in detecting acute kidney injury (AKI), according to a study conducted at the University of Pittsburgh.
Kui Jin, MD, of the University of Pittsburgh and his associates found that, after adjustment for baseline characteristics, intensive monitoring of urine output (UO) was associated with higher rates of AKI, with an odds ratio of 1.22. Intensive UO monitoring also was strongly associated with improved 30-day survival among patients developing AKI.
This retrospective cohort study included 15,724 adult patients admitted to the center’s ICUs during 2000-2008. All patients had either their UO or serum creatinine (SC) monitored. These patients were then divided into subcohorts that were monitored at one of two different intensities. UO intensive monitoring was defined by hourly recordings, with gaps no greater than 3 hours for the first 48 hours after ICU admission. The group receiving less intensive UO monitoring comprised patients who did not meet intensive monitoring criteria, regardless of their UO in the 7 days following ICU admission. The patients who had their SC intensively monitored had 3 calendar days of samples taken after their ICU admissions. Those who did not meet SC intensive monitoring criteria were placed into the less intensive SC monitoring group.
To understand the effect of the monitoring strategies on detecting the development of AKI, the researchers determined each patient’s baseline, admission, and reference serum creatinine levels. Baseline creatinine was defined as the lowest value in the year prior to hospital admission. Reference creatinine was the baseline creatinine, if available, or the lowest creatinine level recorded within 24 hours after ICU admission. A third method for determining reference creatinine levels was used for some patients, which involved making an estimation based on the Modification of Diet in Renal Disease equation for serum creatinine.
The crude rates of stage 2-3 AKI 7 days after admission to the ICU were similar between patients from both groups that had their UO monitored; 62.5% of intensive and 63.9% of less intensive patients displayed symptoms. After the researchers adjusted for baseline characteristics, however, intensive monitoring of UO was associated with greater rates of stage 2-3 AKI (OR, 1.22; P less than .001). Crude rates were higher in the patients who received intensive monitoring for SC, compared with patients who received less intensive monitoring for SC. Ultimately, Dr. Jin and his associates found that, when caring for patients with or without AKI, fluid management is one of the most important factors. Patients who underwent intensive UO monitoring received less fluid in their first 24 hours (3.6 L) in the ICU, compared with patients who received less intense UO monitoring (4.2 L). Patients who received intensive monitoring of their UO also were less likely to use vasopressors (29.9% vs. 43.3%; P less than .001), suggesting these patients were more hemodynamically stable. Further, the percentage of patients at or above 10% of fluid overload was lower in the group who received intensive monitoring of their UO (2.49% vs. 5.68%; P less than .001), during the first 72 hours in the ICU.
“Our results should help inform clinical decisions and ICU policy around frequency of monitoring of UO, especially for patients at high risk of AKI,” Dr. Jin and his colleagues wrote.
None of the authors had financial disclosures to report. Partial funding was provided by a research grant from C.R. Bard.
FROM CHEST
Key clinical point:
Major finding: AKI was more likely to be seen in patients who received intensive monitoring of their urine output (OR,1.22; P less than .001).
Data source: Retrospective cohort study at a single academic medical center of 15,724 adult patients admitted to the center’s ICUs during 2000-2008.
Disclosures: None of the authors had financial disclosures to report. Partial funding was provided by a research grant from C.R. Bard.
New buprenorphine formulation approved for medication-assisted treatment
The Food and Drug Administration has approved an extended-release, subcutaneous injection formulation of buprenorphine for use in treating moderate to severe opioid use disorder (OUD), the manufacturer of the drug announced Nov. 30.
The new product, called Sublocade, is a monthly injection intended for use in patients who have already begun treatment of OUD with transmucosal buprenorphine products, followed by a dose adjustment for a minimum of 7 days. Sublocade contains the partial mu-opioid agonist buprenorphine. By administering a consistent level of buprenorphine into the body, it ensures that levels of buprenorphine are delivered to the mu-opioid receptors, diminishing the effects of opioids, including the euphoric sensations associated with opioid use. During the clinical trial program, buprenorphine plasma concentrations of 2-3 ng/mL were found to bind to greater than 70% of mu-opioid receptors.
According to a statement from the FDA, Sublocade will be distributed only to health care providers as part of a Risk Evaluation and Mitigation Strategy to ensure that the product is not distributed directly to patients. Sublocade should be administered only by a health care professional. Self-injection of Sublocade into the blood stream instead of subcutaneously could lead to occlusion of blood vessels and embolism, according to one of the drug’s boxed warnings. It also should be used as part of a complete treatment program that includes counseling and psychosocial support.
The FDA is also requiring the manufacturer to conduct postmarketing studies to assess which patients would benefit from a higher dosing regimen, to determine whether Sublocade can be safely initiated without a dose stabilization period of sublingual buprenorphine, to assess the feasibility of administering Sublocade at a longer inter-dose interval than once monthly, and to determine a process for transitioning patients with long-term stability on a transmucosal buprenorphine dose to a monthly dose of Sublocade without the use of a higher dose for the first 2 months of treatment.
At recent joint meetings of the FDA’s Psychopharmacologic Drugs and Drug Safety and Risk Management advisory committees, panelists voted on Oct. 31 to recommend approval of Sublocade and on Nov. 1 for another subcutaneous buprenorphine injection formulation. These actions have not gone unnoticed by the American Medical Association.
“The AMA enthusiastically supports Food and Drug Administration Commissioner Scott Gottlieb’s efforts to advance policies and actions to treat those suffering from an opioid use disorder,” Patrice Harris, MD, immediate past chair of the American Medical Association Board of Trustees and a member of the AMA Opioid Task Force, said in a statement. “We also second his bold acknowledgment that criminal justice systems should offer [medication-assisted treatment] to those being detained. As he points out, ‘At the very moment when the criminal justice system could be dramatically lowering the risk of overdose, it is creating the conditions of reduced tolerance to opioids that substantially raises the risk of death upon release.’ With his clear explanation of the problem and solution, this situation can be remedied.”
The Food and Drug Administration has approved an extended-release, subcutaneous injection formulation of buprenorphine for use in treating moderate to severe opioid use disorder (OUD), the manufacturer of the drug announced Nov. 30.
The new product, called Sublocade, is a monthly injection intended for use in patients who have already begun treatment of OUD with transmucosal buprenorphine products, followed by a dose adjustment for a minimum of 7 days. Sublocade contains the partial mu-opioid agonist buprenorphine. By administering a consistent level of buprenorphine into the body, it ensures that levels of buprenorphine are delivered to the mu-opioid receptors, diminishing the effects of opioids, including the euphoric sensations associated with opioid use. During the clinical trial program, buprenorphine plasma concentrations of 2-3 ng/mL were found to bind to greater than 70% of mu-opioid receptors.
According to a statement from the FDA, Sublocade will be distributed only to health care providers as part of a Risk Evaluation and Mitigation Strategy to ensure that the product is not distributed directly to patients. Sublocade should be administered only by a health care professional. Self-injection of Sublocade into the blood stream instead of subcutaneously could lead to occlusion of blood vessels and embolism, according to one of the drug’s boxed warnings. It also should be used as part of a complete treatment program that includes counseling and psychosocial support.
The FDA is also requiring the manufacturer to conduct postmarketing studies to assess which patients would benefit from a higher dosing regimen, to determine whether Sublocade can be safely initiated without a dose stabilization period of sublingual buprenorphine, to assess the feasibility of administering Sublocade at a longer inter-dose interval than once monthly, and to determine a process for transitioning patients with long-term stability on a transmucosal buprenorphine dose to a monthly dose of Sublocade without the use of a higher dose for the first 2 months of treatment.
At recent joint meetings of the FDA’s Psychopharmacologic Drugs and Drug Safety and Risk Management advisory committees, panelists voted on Oct. 31 to recommend approval of Sublocade and on Nov. 1 for another subcutaneous buprenorphine injection formulation. These actions have not gone unnoticed by the American Medical Association.
“The AMA enthusiastically supports Food and Drug Administration Commissioner Scott Gottlieb’s efforts to advance policies and actions to treat those suffering from an opioid use disorder,” Patrice Harris, MD, immediate past chair of the American Medical Association Board of Trustees and a member of the AMA Opioid Task Force, said in a statement. “We also second his bold acknowledgment that criminal justice systems should offer [medication-assisted treatment] to those being detained. As he points out, ‘At the very moment when the criminal justice system could be dramatically lowering the risk of overdose, it is creating the conditions of reduced tolerance to opioids that substantially raises the risk of death upon release.’ With his clear explanation of the problem and solution, this situation can be remedied.”
The Food and Drug Administration has approved an extended-release, subcutaneous injection formulation of buprenorphine for use in treating moderate to severe opioid use disorder (OUD), the manufacturer of the drug announced Nov. 30.
The new product, called Sublocade, is a monthly injection intended for use in patients who have already begun treatment of OUD with transmucosal buprenorphine products, followed by a dose adjustment for a minimum of 7 days. Sublocade contains the partial mu-opioid agonist buprenorphine. By administering a consistent level of buprenorphine into the body, it ensures that levels of buprenorphine are delivered to the mu-opioid receptors, diminishing the effects of opioids, including the euphoric sensations associated with opioid use. During the clinical trial program, buprenorphine plasma concentrations of 2-3 ng/mL were found to bind to greater than 70% of mu-opioid receptors.
According to a statement from the FDA, Sublocade will be distributed only to health care providers as part of a Risk Evaluation and Mitigation Strategy to ensure that the product is not distributed directly to patients. Sublocade should be administered only by a health care professional. Self-injection of Sublocade into the blood stream instead of subcutaneously could lead to occlusion of blood vessels and embolism, according to one of the drug’s boxed warnings. It also should be used as part of a complete treatment program that includes counseling and psychosocial support.
The FDA is also requiring the manufacturer to conduct postmarketing studies to assess which patients would benefit from a higher dosing regimen, to determine whether Sublocade can be safely initiated without a dose stabilization period of sublingual buprenorphine, to assess the feasibility of administering Sublocade at a longer inter-dose interval than once monthly, and to determine a process for transitioning patients with long-term stability on a transmucosal buprenorphine dose to a monthly dose of Sublocade without the use of a higher dose for the first 2 months of treatment.
At recent joint meetings of the FDA’s Psychopharmacologic Drugs and Drug Safety and Risk Management advisory committees, panelists voted on Oct. 31 to recommend approval of Sublocade and on Nov. 1 for another subcutaneous buprenorphine injection formulation. These actions have not gone unnoticed by the American Medical Association.
“The AMA enthusiastically supports Food and Drug Administration Commissioner Scott Gottlieb’s efforts to advance policies and actions to treat those suffering from an opioid use disorder,” Patrice Harris, MD, immediate past chair of the American Medical Association Board of Trustees and a member of the AMA Opioid Task Force, said in a statement. “We also second his bold acknowledgment that criminal justice systems should offer [medication-assisted treatment] to those being detained. As he points out, ‘At the very moment when the criminal justice system could be dramatically lowering the risk of overdose, it is creating the conditions of reduced tolerance to opioids that substantially raises the risk of death upon release.’ With his clear explanation of the problem and solution, this situation can be remedied.”
Delayed HIV diagnoses still substantial for some at-risk groups
HIV diagnoses are coming sooner after infection, increasing physicians’ ability to treat and prevent the spread of HIV, according to a new Centers for Disease Control and Prevention (CDC) Vital Signs report.
As HIV testing has increased, the percentage of people aware of their HIV infection has also steadily grown. As of 2014, 85% of people living with HIV in the United States were aware of their infection. This knowledge allows individuals to seek antiretroviral treatment to suppress the virus, which decreases morbidity and mortality while reducing the risk of sexual transmission to others; knowing one’s HIV status, then, is incredibly important, clinicians say, because people who are unaware that they are HIV positive account for approximately 40% of ongoing transmissions.
While HIV testing has led to a reduction of HIV infection in the total population, several groups that are at a high risk of HIV infection are not getting tested as often as they should. According to the report, 29% of men who have sex with men, 42% of intravenous drugs users, and 59% of heterosexuals did not report having been tested within the past 12 months. Of the risk groups mentioned, at least two-thirds of people in each group had seen a health care provider in the last year. Heterosexual men are at particular risk of going undiagnosed because they are less likely to see a health care provider. This has led to half of heterosexual men who have HIV going undiagnosed for 5 years or more, the report notes.
Health care providers can improve testing by discussing HIV with patients and explaining that HIV testing is a routine part of any patient’s health care. Physicians should routinely test all patients aged 13-64 years, the CDC says. Testing should be emphasized in patients in high-risk groups; these patients should be tested at least once a year. Sexually active gay and bisexual men should ideally be tested every 3-6 months. Pregnant women, or those looking to become pregnant, should be tested to as soon as possible. If a pregnant woman is in a high-risk population, she should be tested again in the third trimester.
If a patient tests positive for HIV, the CDC report says it is important for clinicians connect them with treatment options and discuss prevention of transmission. The earlier a person begins HIV treatment, the greater the benefits will be. As part of the treatment, clinicians should encourage patients to stay on antiretroviral care to reduce the viral load in the body to either very low (less than 200 copies/mL) or undetectable levels.
“HIV is being diagnosed more quickly, the number of people who have the virus under control is up, and annual infections are down. So while we celebrate our progress, we pledge to work together to end this epidemic forever,” said CDC Director Brenda Fitzgerald, MD, in a statement.
HIV diagnoses are coming sooner after infection, increasing physicians’ ability to treat and prevent the spread of HIV, according to a new Centers for Disease Control and Prevention (CDC) Vital Signs report.
As HIV testing has increased, the percentage of people aware of their HIV infection has also steadily grown. As of 2014, 85% of people living with HIV in the United States were aware of their infection. This knowledge allows individuals to seek antiretroviral treatment to suppress the virus, which decreases morbidity and mortality while reducing the risk of sexual transmission to others; knowing one’s HIV status, then, is incredibly important, clinicians say, because people who are unaware that they are HIV positive account for approximately 40% of ongoing transmissions.
While HIV testing has led to a reduction of HIV infection in the total population, several groups that are at a high risk of HIV infection are not getting tested as often as they should. According to the report, 29% of men who have sex with men, 42% of intravenous drugs users, and 59% of heterosexuals did not report having been tested within the past 12 months. Of the risk groups mentioned, at least two-thirds of people in each group had seen a health care provider in the last year. Heterosexual men are at particular risk of going undiagnosed because they are less likely to see a health care provider. This has led to half of heterosexual men who have HIV going undiagnosed for 5 years or more, the report notes.
Health care providers can improve testing by discussing HIV with patients and explaining that HIV testing is a routine part of any patient’s health care. Physicians should routinely test all patients aged 13-64 years, the CDC says. Testing should be emphasized in patients in high-risk groups; these patients should be tested at least once a year. Sexually active gay and bisexual men should ideally be tested every 3-6 months. Pregnant women, or those looking to become pregnant, should be tested to as soon as possible. If a pregnant woman is in a high-risk population, she should be tested again in the third trimester.
If a patient tests positive for HIV, the CDC report says it is important for clinicians connect them with treatment options and discuss prevention of transmission. The earlier a person begins HIV treatment, the greater the benefits will be. As part of the treatment, clinicians should encourage patients to stay on antiretroviral care to reduce the viral load in the body to either very low (less than 200 copies/mL) or undetectable levels.
“HIV is being diagnosed more quickly, the number of people who have the virus under control is up, and annual infections are down. So while we celebrate our progress, we pledge to work together to end this epidemic forever,” said CDC Director Brenda Fitzgerald, MD, in a statement.
HIV diagnoses are coming sooner after infection, increasing physicians’ ability to treat and prevent the spread of HIV, according to a new Centers for Disease Control and Prevention (CDC) Vital Signs report.
As HIV testing has increased, the percentage of people aware of their HIV infection has also steadily grown. As of 2014, 85% of people living with HIV in the United States were aware of their infection. This knowledge allows individuals to seek antiretroviral treatment to suppress the virus, which decreases morbidity and mortality while reducing the risk of sexual transmission to others; knowing one’s HIV status, then, is incredibly important, clinicians say, because people who are unaware that they are HIV positive account for approximately 40% of ongoing transmissions.
While HIV testing has led to a reduction of HIV infection in the total population, several groups that are at a high risk of HIV infection are not getting tested as often as they should. According to the report, 29% of men who have sex with men, 42% of intravenous drugs users, and 59% of heterosexuals did not report having been tested within the past 12 months. Of the risk groups mentioned, at least two-thirds of people in each group had seen a health care provider in the last year. Heterosexual men are at particular risk of going undiagnosed because they are less likely to see a health care provider. This has led to half of heterosexual men who have HIV going undiagnosed for 5 years or more, the report notes.
Health care providers can improve testing by discussing HIV with patients and explaining that HIV testing is a routine part of any patient’s health care. Physicians should routinely test all patients aged 13-64 years, the CDC says. Testing should be emphasized in patients in high-risk groups; these patients should be tested at least once a year. Sexually active gay and bisexual men should ideally be tested every 3-6 months. Pregnant women, or those looking to become pregnant, should be tested to as soon as possible. If a pregnant woman is in a high-risk population, she should be tested again in the third trimester.
If a patient tests positive for HIV, the CDC report says it is important for clinicians connect them with treatment options and discuss prevention of transmission. The earlier a person begins HIV treatment, the greater the benefits will be. As part of the treatment, clinicians should encourage patients to stay on antiretroviral care to reduce the viral load in the body to either very low (less than 200 copies/mL) or undetectable levels.
“HIV is being diagnosed more quickly, the number of people who have the virus under control is up, and annual infections are down. So while we celebrate our progress, we pledge to work together to end this epidemic forever,” said CDC Director Brenda Fitzgerald, MD, in a statement.
FROM CDC VITAL SIGNS REPORT
Key clinical point:
Major finding: Approximately 15% of those living with HIV in 2015 were unaware of their infection and had a median diagnosis delay of 3 years.
Data source: Data of 39,720 individuals reported to the CDC’s National HIV Surveillance System from 50 states and the District of Columbia in 2015.
Disclosures: No conflicts of interest were reported.
Preop endocervical sampling pathology can guide trachelectomy planning
NATIONAL HARBOR, MD. – Pathologic findings from preoperative endocervical sampling were fairly consistent with the underlying pathologies identified at trachelectomy, based on a single-center, retrospective chart review presented at the AAGL Global Congress.
“Preoperative endocervical sampling can be performed safely and adequately with results consistent with final trachelectomy pathology,” said Sarah Krantz, MD, of Vanderbilt University, Nashville, Tenn. Importantly, performing preoperative sampling may identify a missed diagnosis of cancer and allows for subsequent appropriate preoperative planning, she added.
Dr. Krantz and her colleagues included 47 women who had a supracervical hysterectomy and subsequently underwent trachelectomy at Vanderbilt from April 1999 to April 2015. Indications for surgery included vaginal bleeding (24), abnormal pap smears (7), pain (16), prolapse (13), and cancer (2). If patients had a prior diagnosis of gynecologic malignancy, they were excluded from the study.
Endocervical sampling was performed in 18 of the 47 women by a gynecologist. Samples were collected by way of various methods, including Pap smear, endocervical brushings and curettage, and endometrial pipelle. The pathologic findings in endocervical samples coincided with the final surgical pathology in 9 of 10 patients with benign findings, 1 of 6 patients with dysplasia, and 2 of 2 patients with cancer.
Among the 29 women who did not undergo preoperative endocervical sampling, one was diagnosed with cervical cancer at final surgical pathology.
In the 24 women with vaginal bleeding, cervicitis was identified in 1 of 10 patients who underwent preoperative endocervical sampling and was found on final pathology in 12 of 24 patients.Given the high incidence of cervicitis in women who report vaginal bleeding, consideration should be given for medical management prior to surgical excision, Dr. Krantz said.
Dr. Krantz reported having no relevant financial disclosures.
NATIONAL HARBOR, MD. – Pathologic findings from preoperative endocervical sampling were fairly consistent with the underlying pathologies identified at trachelectomy, based on a single-center, retrospective chart review presented at the AAGL Global Congress.
“Preoperative endocervical sampling can be performed safely and adequately with results consistent with final trachelectomy pathology,” said Sarah Krantz, MD, of Vanderbilt University, Nashville, Tenn. Importantly, performing preoperative sampling may identify a missed diagnosis of cancer and allows for subsequent appropriate preoperative planning, she added.
Dr. Krantz and her colleagues included 47 women who had a supracervical hysterectomy and subsequently underwent trachelectomy at Vanderbilt from April 1999 to April 2015. Indications for surgery included vaginal bleeding (24), abnormal pap smears (7), pain (16), prolapse (13), and cancer (2). If patients had a prior diagnosis of gynecologic malignancy, they were excluded from the study.
Endocervical sampling was performed in 18 of the 47 women by a gynecologist. Samples were collected by way of various methods, including Pap smear, endocervical brushings and curettage, and endometrial pipelle. The pathologic findings in endocervical samples coincided with the final surgical pathology in 9 of 10 patients with benign findings, 1 of 6 patients with dysplasia, and 2 of 2 patients with cancer.
Among the 29 women who did not undergo preoperative endocervical sampling, one was diagnosed with cervical cancer at final surgical pathology.
In the 24 women with vaginal bleeding, cervicitis was identified in 1 of 10 patients who underwent preoperative endocervical sampling and was found on final pathology in 12 of 24 patients.Given the high incidence of cervicitis in women who report vaginal bleeding, consideration should be given for medical management prior to surgical excision, Dr. Krantz said.
Dr. Krantz reported having no relevant financial disclosures.
NATIONAL HARBOR, MD. – Pathologic findings from preoperative endocervical sampling were fairly consistent with the underlying pathologies identified at trachelectomy, based on a single-center, retrospective chart review presented at the AAGL Global Congress.
“Preoperative endocervical sampling can be performed safely and adequately with results consistent with final trachelectomy pathology,” said Sarah Krantz, MD, of Vanderbilt University, Nashville, Tenn. Importantly, performing preoperative sampling may identify a missed diagnosis of cancer and allows for subsequent appropriate preoperative planning, she added.
Dr. Krantz and her colleagues included 47 women who had a supracervical hysterectomy and subsequently underwent trachelectomy at Vanderbilt from April 1999 to April 2015. Indications for surgery included vaginal bleeding (24), abnormal pap smears (7), pain (16), prolapse (13), and cancer (2). If patients had a prior diagnosis of gynecologic malignancy, they were excluded from the study.
Endocervical sampling was performed in 18 of the 47 women by a gynecologist. Samples were collected by way of various methods, including Pap smear, endocervical brushings and curettage, and endometrial pipelle. The pathologic findings in endocervical samples coincided with the final surgical pathology in 9 of 10 patients with benign findings, 1 of 6 patients with dysplasia, and 2 of 2 patients with cancer.
Among the 29 women who did not undergo preoperative endocervical sampling, one was diagnosed with cervical cancer at final surgical pathology.
In the 24 women with vaginal bleeding, cervicitis was identified in 1 of 10 patients who underwent preoperative endocervical sampling and was found on final pathology in 12 of 24 patients.Given the high incidence of cervicitis in women who report vaginal bleeding, consideration should be given for medical management prior to surgical excision, Dr. Krantz said.
Dr. Krantz reported having no relevant financial disclosures.
AT AAGL 2017
Key clinical point:
Major finding: Among 18 women who had preoperative endocervical sampling, the pathology results matched those of the final surgical pathology in 9 of 10 patients with benign disorders, 1 of 6 patients with dysplasia, and 2 of 2 patients with cancer.
Data source: A retrospective chart review of 47 women who underwent trachelectomy at a single academic medical center from April 1999-April 2015.
Disclosures: Dr. Krantz reported having no relevant financial disclosures.
FDA addresses cell-based regenerative medicine in comprehensive new policy
The Food and Drug Administration has announced a new policy that addresses the rapid growth and development of regenerative medicine products, which include novel cellular therapies, with the aim of ensuring their safety and effectiveness.
“The framework – outlined in a suite of four guidance documents – builds upon the FDA’s existing risk-based regulatory approach to more clearly describe what products are regulated as drugs, devices, and/or biological products,” the FDA announced in a statement released on Nov. 16.
He added: “This is no longer the stuff of science fiction. This is the practical promise of modern applications of regenerative medicine.” But, while advances have benefited many patients, he referred to a small number of “unscrupulous actors” that have provided treatments that have harmed patients, which is why stricter FDA enforcement is needed.
Clarification of the existing regulations will “promote responsible and flexible regulation that leverages science to advance public health,” Dr. Gottlieb said during a media briefing held by the FDA to discuss the new framework.
During the briefing, in response to a question concerning adipose tissue injections and their associated risks, Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research, explained that the guidance documents will clearly delineate when adipose tissue will be classified as a structural tissue and a stem cell product. If a provider is purveying dangerous products, the FDA can “when necessary, undertake seizures, ask for injunctions, and in some cases when it has been determined that certain violations have occurred even criminal actions can be taken,” he said.
Earlier this year, a report of three patients who had severe visual loss after treatment with intravitreal injections of autologous adipose tissue for age-related macular degeneration was published (N Engl J Med. 2017;376:1047-53).
The new framework is composed of two final guidance documents and two draft guidance documents. The first final guidance document provides details about regulations concerning cell and tissue-based products and when those products are subject to regulation in surgical procedures. The second final guidance document elaborates on the definition of “minimal manipulation” and “homologous use” with the hopes of clarifying what products are subject to regulation. These documents will also explain how the FDA will provide a framework for premarket authorization for cell-based regenerative products.
One draft guidance outlines the FDA’s plan to simplify and expedite the application of the regulatory requirements for devices used in relation to regenerative medicine advanced therapies; the second draft guidance outlines the expedited programs that may be available to sponsors of regenerative therapies.
The Food and Drug Administration has announced a new policy that addresses the rapid growth and development of regenerative medicine products, which include novel cellular therapies, with the aim of ensuring their safety and effectiveness.
“The framework – outlined in a suite of four guidance documents – builds upon the FDA’s existing risk-based regulatory approach to more clearly describe what products are regulated as drugs, devices, and/or biological products,” the FDA announced in a statement released on Nov. 16.
He added: “This is no longer the stuff of science fiction. This is the practical promise of modern applications of regenerative medicine.” But, while advances have benefited many patients, he referred to a small number of “unscrupulous actors” that have provided treatments that have harmed patients, which is why stricter FDA enforcement is needed.
Clarification of the existing regulations will “promote responsible and flexible regulation that leverages science to advance public health,” Dr. Gottlieb said during a media briefing held by the FDA to discuss the new framework.
During the briefing, in response to a question concerning adipose tissue injections and their associated risks, Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research, explained that the guidance documents will clearly delineate when adipose tissue will be classified as a structural tissue and a stem cell product. If a provider is purveying dangerous products, the FDA can “when necessary, undertake seizures, ask for injunctions, and in some cases when it has been determined that certain violations have occurred even criminal actions can be taken,” he said.
Earlier this year, a report of three patients who had severe visual loss after treatment with intravitreal injections of autologous adipose tissue for age-related macular degeneration was published (N Engl J Med. 2017;376:1047-53).
The new framework is composed of two final guidance documents and two draft guidance documents. The first final guidance document provides details about regulations concerning cell and tissue-based products and when those products are subject to regulation in surgical procedures. The second final guidance document elaborates on the definition of “minimal manipulation” and “homologous use” with the hopes of clarifying what products are subject to regulation. These documents will also explain how the FDA will provide a framework for premarket authorization for cell-based regenerative products.
One draft guidance outlines the FDA’s plan to simplify and expedite the application of the regulatory requirements for devices used in relation to regenerative medicine advanced therapies; the second draft guidance outlines the expedited programs that may be available to sponsors of regenerative therapies.
The Food and Drug Administration has announced a new policy that addresses the rapid growth and development of regenerative medicine products, which include novel cellular therapies, with the aim of ensuring their safety and effectiveness.
“The framework – outlined in a suite of four guidance documents – builds upon the FDA’s existing risk-based regulatory approach to more clearly describe what products are regulated as drugs, devices, and/or biological products,” the FDA announced in a statement released on Nov. 16.
He added: “This is no longer the stuff of science fiction. This is the practical promise of modern applications of regenerative medicine.” But, while advances have benefited many patients, he referred to a small number of “unscrupulous actors” that have provided treatments that have harmed patients, which is why stricter FDA enforcement is needed.
Clarification of the existing regulations will “promote responsible and flexible regulation that leverages science to advance public health,” Dr. Gottlieb said during a media briefing held by the FDA to discuss the new framework.
During the briefing, in response to a question concerning adipose tissue injections and their associated risks, Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research, explained that the guidance documents will clearly delineate when adipose tissue will be classified as a structural tissue and a stem cell product. If a provider is purveying dangerous products, the FDA can “when necessary, undertake seizures, ask for injunctions, and in some cases when it has been determined that certain violations have occurred even criminal actions can be taken,” he said.
Earlier this year, a report of three patients who had severe visual loss after treatment with intravitreal injections of autologous adipose tissue for age-related macular degeneration was published (N Engl J Med. 2017;376:1047-53).
The new framework is composed of two final guidance documents and two draft guidance documents. The first final guidance document provides details about regulations concerning cell and tissue-based products and when those products are subject to regulation in surgical procedures. The second final guidance document elaborates on the definition of “minimal manipulation” and “homologous use” with the hopes of clarifying what products are subject to regulation. These documents will also explain how the FDA will provide a framework for premarket authorization for cell-based regenerative products.
One draft guidance outlines the FDA’s plan to simplify and expedite the application of the regulatory requirements for devices used in relation to regenerative medicine advanced therapies; the second draft guidance outlines the expedited programs that may be available to sponsors of regenerative therapies.
FROM an FDA MEDIA BRIEFING
Incidence of adenomyosis in hysterectomy patients higher than previously reported
NATIONAL HARBOR, MD – Patients who experience chronic pelvic pain have higher rates of adenomyosis than previously thought, suggest new findings presented at the AAGL Global Congress.
Samantha P. Nadella, MD, and her associates conducted a retrospective cohort study analyzing 101 women with chronic pelvic pain who underwent hysterectomy between April 2014 and December 2016. In total, 51 patients (50.5%) were found to have adenomyosis. Previous studies of adenomyosis had suggested an overall incidence rate of 20%-35%. Dr. Nadella, currently of Kaiser Permanente South Bay Medical Center in Harbor City, Calif., conducted the study during her fellowship in minimally invasive gynecology surgery at St. Joseph’s Hospital and Medical Center in Phoenix.
“Anytime women have pelvic pain, or abdominal pain, they are always sent to their gynecologist,” Dr. Nadella said in an interview. However, there are many disorders that may present with pelvic pain but are not related to uterine pathology, including pelvic floor muscle dysfunction, interstitial cystitis, and irritable bowel syndrome. As suggested in this study, pelvic pain is frequently present in patients with IBS, both with and without adenomyosis.
“When we’re talking about hysterectomy and surgical management for pelvic pain, we need to do our due diligence to make sure we are not missing more treatable disorders, especially those with conservative treatments,” Dr. Nadella said. “It is important to counsel patients who are undergoing surgery for pelvic pain by explaining what will happen and what they can expect, including postsurgical pain and need for ongoing treatments. Additionally, cross-disciplinary communication is key in delivering more effective and personalized treatment of pelvic pain.”
Dr. Nadella reported having no financial disclosures.
NATIONAL HARBOR, MD – Patients who experience chronic pelvic pain have higher rates of adenomyosis than previously thought, suggest new findings presented at the AAGL Global Congress.
Samantha P. Nadella, MD, and her associates conducted a retrospective cohort study analyzing 101 women with chronic pelvic pain who underwent hysterectomy between April 2014 and December 2016. In total, 51 patients (50.5%) were found to have adenomyosis. Previous studies of adenomyosis had suggested an overall incidence rate of 20%-35%. Dr. Nadella, currently of Kaiser Permanente South Bay Medical Center in Harbor City, Calif., conducted the study during her fellowship in minimally invasive gynecology surgery at St. Joseph’s Hospital and Medical Center in Phoenix.
“Anytime women have pelvic pain, or abdominal pain, they are always sent to their gynecologist,” Dr. Nadella said in an interview. However, there are many disorders that may present with pelvic pain but are not related to uterine pathology, including pelvic floor muscle dysfunction, interstitial cystitis, and irritable bowel syndrome. As suggested in this study, pelvic pain is frequently present in patients with IBS, both with and without adenomyosis.
“When we’re talking about hysterectomy and surgical management for pelvic pain, we need to do our due diligence to make sure we are not missing more treatable disorders, especially those with conservative treatments,” Dr. Nadella said. “It is important to counsel patients who are undergoing surgery for pelvic pain by explaining what will happen and what they can expect, including postsurgical pain and need for ongoing treatments. Additionally, cross-disciplinary communication is key in delivering more effective and personalized treatment of pelvic pain.”
Dr. Nadella reported having no financial disclosures.
NATIONAL HARBOR, MD – Patients who experience chronic pelvic pain have higher rates of adenomyosis than previously thought, suggest new findings presented at the AAGL Global Congress.
Samantha P. Nadella, MD, and her associates conducted a retrospective cohort study analyzing 101 women with chronic pelvic pain who underwent hysterectomy between April 2014 and December 2016. In total, 51 patients (50.5%) were found to have adenomyosis. Previous studies of adenomyosis had suggested an overall incidence rate of 20%-35%. Dr. Nadella, currently of Kaiser Permanente South Bay Medical Center in Harbor City, Calif., conducted the study during her fellowship in minimally invasive gynecology surgery at St. Joseph’s Hospital and Medical Center in Phoenix.
“Anytime women have pelvic pain, or abdominal pain, they are always sent to their gynecologist,” Dr. Nadella said in an interview. However, there are many disorders that may present with pelvic pain but are not related to uterine pathology, including pelvic floor muscle dysfunction, interstitial cystitis, and irritable bowel syndrome. As suggested in this study, pelvic pain is frequently present in patients with IBS, both with and without adenomyosis.
“When we’re talking about hysterectomy and surgical management for pelvic pain, we need to do our due diligence to make sure we are not missing more treatable disorders, especially those with conservative treatments,” Dr. Nadella said. “It is important to counsel patients who are undergoing surgery for pelvic pain by explaining what will happen and what they can expect, including postsurgical pain and need for ongoing treatments. Additionally, cross-disciplinary communication is key in delivering more effective and personalized treatment of pelvic pain.”
Dr. Nadella reported having no financial disclosures.
AT AAGL 2017
Key clinical point:
Major finding: In total, 51 of 101 (50.5%) patients undergoing hysterectomy had adenomyosis.
Data source: Retrospective cohort study of 101 patients with chronic pain undergoing hysterectomy between April 2014 and December 2016 at a community hospital.
Disclosures: Dr. Nadella reported having no financial disclosures.
Genetic testing may improve diagnosis of endometriosis
NATIONAL HARBOR, MD. –Genetic testing could provide a useful noninvasive diagnostic tool in identifying patients with endometriosis, according to a study conducted by Nick Fogelson, MD, of Pearl Women’s Center in Portland, Ore., and his colleagues.
Dr. Fogelson presented the findings from a blinded, randomized pilot study at the AAGL Global Congress. The study included two groups of 200 women each. The first group of women had previously been diagnosed with endometriosis. The second group comprised women with no evidence of endometriosis. In the group with endometriosis, the test correctly identified endometriosis in 189 of the 200 women (95%). The women with no evidence of endometriosis were accurately identified as having a low risk of developing endometriosis in 176 of 200 women (88%).
The samples were collected from around the United States as part of ongoing research by the Utah-based genetics company Juneau Biosciences.
Both groups were genotyped for 1,067 low-frequency DNA variants associated with endometriosis using a proprietary algorithm. The researchers then compared genotype results with a large dataset of 1,000 genotyped endometriosis patients and 33,000 published controls and assessed patient risk of developing endometriosis by weighting each genotype by the logarithm of the odds ratio.
“We’re getting toward a time when you will be able to tell if someone has endometriosis by looking at their genetics,” Dr. Fogelson said.
The genetic analysis hold potential in a disease state where misdiagnosis by nonexpert physicians can be high. Dr. Fogelson estimated that the misdiagnosis rate in endometriosis based on physical exam and patient history alone is about 50%. Compounding this issue, many insurers have reduced payment for diagnostic laparoscopy leading to surgeons’ placing patients on long-term medication treatments when they would benefit from surgery, Dr. Fogelson said.
“Noninvasive DNA testing may help to direct symptomatic patients to specialists who can effectively treat the disease state.” Dr. Fogelson and his colleagues wrote in the study abstract. “DNA markers might have better correlation to the subtypes and extent of disease than histology alone.”
Additional trials are currently underway using the genetic marker test; one is a prospective study and is expected to be completed in early 2018.
Dr. Fogelson reported having no conflicts of interest. Other researchers on the study work for Juneau Biosciences and receive stock options as part of their compensation.
NATIONAL HARBOR, MD. –Genetic testing could provide a useful noninvasive diagnostic tool in identifying patients with endometriosis, according to a study conducted by Nick Fogelson, MD, of Pearl Women’s Center in Portland, Ore., and his colleagues.
Dr. Fogelson presented the findings from a blinded, randomized pilot study at the AAGL Global Congress. The study included two groups of 200 women each. The first group of women had previously been diagnosed with endometriosis. The second group comprised women with no evidence of endometriosis. In the group with endometriosis, the test correctly identified endometriosis in 189 of the 200 women (95%). The women with no evidence of endometriosis were accurately identified as having a low risk of developing endometriosis in 176 of 200 women (88%).
The samples were collected from around the United States as part of ongoing research by the Utah-based genetics company Juneau Biosciences.
Both groups were genotyped for 1,067 low-frequency DNA variants associated with endometriosis using a proprietary algorithm. The researchers then compared genotype results with a large dataset of 1,000 genotyped endometriosis patients and 33,000 published controls and assessed patient risk of developing endometriosis by weighting each genotype by the logarithm of the odds ratio.
“We’re getting toward a time when you will be able to tell if someone has endometriosis by looking at their genetics,” Dr. Fogelson said.
The genetic analysis hold potential in a disease state where misdiagnosis by nonexpert physicians can be high. Dr. Fogelson estimated that the misdiagnosis rate in endometriosis based on physical exam and patient history alone is about 50%. Compounding this issue, many insurers have reduced payment for diagnostic laparoscopy leading to surgeons’ placing patients on long-term medication treatments when they would benefit from surgery, Dr. Fogelson said.
“Noninvasive DNA testing may help to direct symptomatic patients to specialists who can effectively treat the disease state.” Dr. Fogelson and his colleagues wrote in the study abstract. “DNA markers might have better correlation to the subtypes and extent of disease than histology alone.”
Additional trials are currently underway using the genetic marker test; one is a prospective study and is expected to be completed in early 2018.
Dr. Fogelson reported having no conflicts of interest. Other researchers on the study work for Juneau Biosciences and receive stock options as part of their compensation.
NATIONAL HARBOR, MD. –Genetic testing could provide a useful noninvasive diagnostic tool in identifying patients with endometriosis, according to a study conducted by Nick Fogelson, MD, of Pearl Women’s Center in Portland, Ore., and his colleagues.
Dr. Fogelson presented the findings from a blinded, randomized pilot study at the AAGL Global Congress. The study included two groups of 200 women each. The first group of women had previously been diagnosed with endometriosis. The second group comprised women with no evidence of endometriosis. In the group with endometriosis, the test correctly identified endometriosis in 189 of the 200 women (95%). The women with no evidence of endometriosis were accurately identified as having a low risk of developing endometriosis in 176 of 200 women (88%).
The samples were collected from around the United States as part of ongoing research by the Utah-based genetics company Juneau Biosciences.
Both groups were genotyped for 1,067 low-frequency DNA variants associated with endometriosis using a proprietary algorithm. The researchers then compared genotype results with a large dataset of 1,000 genotyped endometriosis patients and 33,000 published controls and assessed patient risk of developing endometriosis by weighting each genotype by the logarithm of the odds ratio.
“We’re getting toward a time when you will be able to tell if someone has endometriosis by looking at their genetics,” Dr. Fogelson said.
The genetic analysis hold potential in a disease state where misdiagnosis by nonexpert physicians can be high. Dr. Fogelson estimated that the misdiagnosis rate in endometriosis based on physical exam and patient history alone is about 50%. Compounding this issue, many insurers have reduced payment for diagnostic laparoscopy leading to surgeons’ placing patients on long-term medication treatments when they would benefit from surgery, Dr. Fogelson said.
“Noninvasive DNA testing may help to direct symptomatic patients to specialists who can effectively treat the disease state.” Dr. Fogelson and his colleagues wrote in the study abstract. “DNA markers might have better correlation to the subtypes and extent of disease than histology alone.”
Additional trials are currently underway using the genetic marker test; one is a prospective study and is expected to be completed in early 2018.
Dr. Fogelson reported having no conflicts of interest. Other researchers on the study work for Juneau Biosciences and receive stock options as part of their compensation.
AT AAGL 2017
Key clinical point:
Major finding: A total of 189 of 200 women (95%) with endometriosis were correctly classified with the disorder. Also, 176 of 200 women (88%) with no evidence of endometriosis were correctly classified as having a low risk of endometriosis.
Data source: Blinded, randomized pilot study of two groups composed of 200 women each. One group consisted of women with confirmed endometriosis and the other group consisted of women with no evidence of endometriosis.
Disclosures: Dr. Fogelson reported having no conflicts of interest. Other researchers on the study work for Juneau Biosciences and receive stock options as part of their compensation.