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Surgical discharge data highlight stewardship need at transition
NEW ORLEANS – Most antibiotic prescriptions written at the time of patient discharge at an academic hospital were inappropriate, according to a retrospective review of 2014 discharge data.
These drugs were prescribed despite the existence of a robust inpatient antibiotic stewardship program (ASP) at the hospital, Sarah Scarpato, MD, reported at IDWeek, an annual scientific meeting on infectious diseases.
Of 9,750 prescriptions written during the study year, 86% were for oral antibiotics and 14% were for outpatient parenteral antibiotic therapy. Among a random sample of 150 patients discharged on antibiotics, 22.7% had no clinical indication of infection, 13% received an antibiotic with inappropriate spectrum of activity, 17% received an incorrect dose, 55% received an antibiotic course that was too long, and 7.3% received a course that was too short, Dr. Scarpato said at the combined annual meetings of the Infectious Diseases Society of America, the Society of Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.
A total of 57.7% of surgical patients and 57.6% of medical patients received an antibiotic prescription that was inappropriate.
“A whopping 70% of prescriptions had at least one error in drug choice, dose, indication, or duration,” she said.
“The most common scenarios in which an antibiotic use was not indicated were prolonged surgical prophylaxis and prolonged prophylaxis in patients who had neutropenic fever during their hospitalization but were no longer neutropenic on discharge. The most common infectious indications were consistent with previous data, with genitourinary, respiratory, and skin and soft tissue being the most common, followed by gastrointestinal,” Dr. Scarpato of the Hospital of the University of Pennsylvania, Philadelphia, said.
In addition, she noted, “100% of patients discharged from cardiothoracic surgery, ear/nose/throat surgery, oral and maxillofacial surgery, neurosurgery, and neurology had at least one error. Oncology was the medical service with the highest rate of inappropriate prescriptions at 80%. The rest, including infectious diseases, had error rates between 40% and 60%.”
Also in line with previous data, fluoroquinolones were the most commonly prescribed antibiotics, accounting for 23.5%, followed by cephalosporins, penicillins, trimethoprim-sulfamethoxazole, and metronidazole.
“Antibiotic prescription in the absence of an acceptable indication and inappropriate duration accounted for the vast majority – 76% – of inappropriate prescriptions,” Dr. Scarpato said, noting that this may be because of a failure by physicians to account for antibiotics given as an inpatient, a lack of familiarity with a patient’s course because of hand-offs, the writing of a prescription with a given duration expecting discharge on a different day, or a lack of familiarity with recommended treatment durations.
“On average, we saw an excess of 3.8 days of unnecessary antibiotics per patient,” she said. The range, however, was 18 days too few to 36 days too many. Further, readmission rates at days 7 and 30 were 6.4% and 19.4%, respectively, for patients discharged on antibiotics, compared with 3.70% and 13.79% hospital wide. The respective rates among those discharged on outpatient parenteral antibiotic therapy were 5.6% and 16.4%, compared with 6.5% and 19.9% among those on oral antibiotic therapy.
The higher rates among those on oral vs. parenteral therapy may be because patients on outpatient parenteral antibiotic therapy are followed closely by a team of infectious disease physicians and pharmacists, while those discharged on oral therapy are not routinely monitored, or it may reflect an unintended consequence of switching from parenteral to oral therapy at discharge, Dr. Scarpato said.
Transitions of care are vulnerable times for patients, she said, noting that “nearly a quarter of patients suffer an adverse event from an error in transition of care during hospital discharge, and up to half of those who suffer an adverse drug reaction at discharge are prescribed an antibiotic.”
Though limited by the retrospective and descriptive nature of the study, and the single-center design, the findings demonstrate “a significant and unmet need for antimicrobial stewardship at transition in care, even at institutions such as ours that have a substantial inpatient ASP,” Dr. Scarpato concluded.
Dr. Scarpato reported having no conflicts of interest.
NEW ORLEANS – Most antibiotic prescriptions written at the time of patient discharge at an academic hospital were inappropriate, according to a retrospective review of 2014 discharge data.
These drugs were prescribed despite the existence of a robust inpatient antibiotic stewardship program (ASP) at the hospital, Sarah Scarpato, MD, reported at IDWeek, an annual scientific meeting on infectious diseases.
Of 9,750 prescriptions written during the study year, 86% were for oral antibiotics and 14% were for outpatient parenteral antibiotic therapy. Among a random sample of 150 patients discharged on antibiotics, 22.7% had no clinical indication of infection, 13% received an antibiotic with inappropriate spectrum of activity, 17% received an incorrect dose, 55% received an antibiotic course that was too long, and 7.3% received a course that was too short, Dr. Scarpato said at the combined annual meetings of the Infectious Diseases Society of America, the Society of Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.
A total of 57.7% of surgical patients and 57.6% of medical patients received an antibiotic prescription that was inappropriate.
“A whopping 70% of prescriptions had at least one error in drug choice, dose, indication, or duration,” she said.
“The most common scenarios in which an antibiotic use was not indicated were prolonged surgical prophylaxis and prolonged prophylaxis in patients who had neutropenic fever during their hospitalization but were no longer neutropenic on discharge. The most common infectious indications were consistent with previous data, with genitourinary, respiratory, and skin and soft tissue being the most common, followed by gastrointestinal,” Dr. Scarpato of the Hospital of the University of Pennsylvania, Philadelphia, said.
In addition, she noted, “100% of patients discharged from cardiothoracic surgery, ear/nose/throat surgery, oral and maxillofacial surgery, neurosurgery, and neurology had at least one error. Oncology was the medical service with the highest rate of inappropriate prescriptions at 80%. The rest, including infectious diseases, had error rates between 40% and 60%.”
Also in line with previous data, fluoroquinolones were the most commonly prescribed antibiotics, accounting for 23.5%, followed by cephalosporins, penicillins, trimethoprim-sulfamethoxazole, and metronidazole.
“Antibiotic prescription in the absence of an acceptable indication and inappropriate duration accounted for the vast majority – 76% – of inappropriate prescriptions,” Dr. Scarpato said, noting that this may be because of a failure by physicians to account for antibiotics given as an inpatient, a lack of familiarity with a patient’s course because of hand-offs, the writing of a prescription with a given duration expecting discharge on a different day, or a lack of familiarity with recommended treatment durations.
“On average, we saw an excess of 3.8 days of unnecessary antibiotics per patient,” she said. The range, however, was 18 days too few to 36 days too many. Further, readmission rates at days 7 and 30 were 6.4% and 19.4%, respectively, for patients discharged on antibiotics, compared with 3.70% and 13.79% hospital wide. The respective rates among those discharged on outpatient parenteral antibiotic therapy were 5.6% and 16.4%, compared with 6.5% and 19.9% among those on oral antibiotic therapy.
The higher rates among those on oral vs. parenteral therapy may be because patients on outpatient parenteral antibiotic therapy are followed closely by a team of infectious disease physicians and pharmacists, while those discharged on oral therapy are not routinely monitored, or it may reflect an unintended consequence of switching from parenteral to oral therapy at discharge, Dr. Scarpato said.
Transitions of care are vulnerable times for patients, she said, noting that “nearly a quarter of patients suffer an adverse event from an error in transition of care during hospital discharge, and up to half of those who suffer an adverse drug reaction at discharge are prescribed an antibiotic.”
Though limited by the retrospective and descriptive nature of the study, and the single-center design, the findings demonstrate “a significant and unmet need for antimicrobial stewardship at transition in care, even at institutions such as ours that have a substantial inpatient ASP,” Dr. Scarpato concluded.
Dr. Scarpato reported having no conflicts of interest.
NEW ORLEANS – Most antibiotic prescriptions written at the time of patient discharge at an academic hospital were inappropriate, according to a retrospective review of 2014 discharge data.
These drugs were prescribed despite the existence of a robust inpatient antibiotic stewardship program (ASP) at the hospital, Sarah Scarpato, MD, reported at IDWeek, an annual scientific meeting on infectious diseases.
Of 9,750 prescriptions written during the study year, 86% were for oral antibiotics and 14% were for outpatient parenteral antibiotic therapy. Among a random sample of 150 patients discharged on antibiotics, 22.7% had no clinical indication of infection, 13% received an antibiotic with inappropriate spectrum of activity, 17% received an incorrect dose, 55% received an antibiotic course that was too long, and 7.3% received a course that was too short, Dr. Scarpato said at the combined annual meetings of the Infectious Diseases Society of America, the Society of Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.
A total of 57.7% of surgical patients and 57.6% of medical patients received an antibiotic prescription that was inappropriate.
“A whopping 70% of prescriptions had at least one error in drug choice, dose, indication, or duration,” she said.
“The most common scenarios in which an antibiotic use was not indicated were prolonged surgical prophylaxis and prolonged prophylaxis in patients who had neutropenic fever during their hospitalization but were no longer neutropenic on discharge. The most common infectious indications were consistent with previous data, with genitourinary, respiratory, and skin and soft tissue being the most common, followed by gastrointestinal,” Dr. Scarpato of the Hospital of the University of Pennsylvania, Philadelphia, said.
In addition, she noted, “100% of patients discharged from cardiothoracic surgery, ear/nose/throat surgery, oral and maxillofacial surgery, neurosurgery, and neurology had at least one error. Oncology was the medical service with the highest rate of inappropriate prescriptions at 80%. The rest, including infectious diseases, had error rates between 40% and 60%.”
Also in line with previous data, fluoroquinolones were the most commonly prescribed antibiotics, accounting for 23.5%, followed by cephalosporins, penicillins, trimethoprim-sulfamethoxazole, and metronidazole.
“Antibiotic prescription in the absence of an acceptable indication and inappropriate duration accounted for the vast majority – 76% – of inappropriate prescriptions,” Dr. Scarpato said, noting that this may be because of a failure by physicians to account for antibiotics given as an inpatient, a lack of familiarity with a patient’s course because of hand-offs, the writing of a prescription with a given duration expecting discharge on a different day, or a lack of familiarity with recommended treatment durations.
“On average, we saw an excess of 3.8 days of unnecessary antibiotics per patient,” she said. The range, however, was 18 days too few to 36 days too many. Further, readmission rates at days 7 and 30 were 6.4% and 19.4%, respectively, for patients discharged on antibiotics, compared with 3.70% and 13.79% hospital wide. The respective rates among those discharged on outpatient parenteral antibiotic therapy were 5.6% and 16.4%, compared with 6.5% and 19.9% among those on oral antibiotic therapy.
The higher rates among those on oral vs. parenteral therapy may be because patients on outpatient parenteral antibiotic therapy are followed closely by a team of infectious disease physicians and pharmacists, while those discharged on oral therapy are not routinely monitored, or it may reflect an unintended consequence of switching from parenteral to oral therapy at discharge, Dr. Scarpato said.
Transitions of care are vulnerable times for patients, she said, noting that “nearly a quarter of patients suffer an adverse event from an error in transition of care during hospital discharge, and up to half of those who suffer an adverse drug reaction at discharge are prescribed an antibiotic.”
Though limited by the retrospective and descriptive nature of the study, and the single-center design, the findings demonstrate “a significant and unmet need for antimicrobial stewardship at transition in care, even at institutions such as ours that have a substantial inpatient ASP,” Dr. Scarpato concluded.
Dr. Scarpato reported having no conflicts of interest.
AT IDWEEK 2016
Key clinical point:
Major finding: 70% of prescriptions had at least one error in drug choice, dose, indication, or duration.
Data source: A review of discharge data for 150 patients at an academic hospital.
Disclosures: Dr. Scarpato reported having no conflicts of interest.
Predicting response to cytarabine in AML patients
New research suggests the protein SAMHD1 could be used to predict which
patients with acute myeloid leukemia (AML) will respond to treatment
with cytarabine.
Researchers found that response to cytarabine
was inversely correlated with SAMHD1 expression in AML cell lines, mouse
models of the disease, and adult patients with AML.
Jindrich Cinatl, PhD, of the University of Frankfurt in Germany, and his colleagues reported these findings in Nature Medicine.
The researchers first analyzed 13 AML cell lines and found that SAMHD1 reduces the cytotoxic effect of cytarabine. When the team depleted SAMHD1 in these cell lines, they were “markedly sensitized” to cytarabine.
The researchers also cultivated cytarabine-resistant AML cell lines and found that SAMHD1 levels increased along with cytarabine resistance. However, depleting SAMHD1 resensitized the cells to cytarabine.
Investigation revealed that SAMHD1 removes the phosphate residues from the active form of cytarabine, Ara-CTP, and converts the drug to its inactive form, Ara-C.
The researchers then evaluated the role of SAMHD1 in AML in vivo. They transplanted SAMHD1-knockout AML cells and wild-type SAMHD1 AML cells into mice and treated the mice with cytarabine or phosphate-buffered saline.
Mice that received SAMHD1-knockout AML cells and cytarabine had significantly longer survival than mice that received wild-type SAMHD1 AML cells and cytarabine or either AML cell type plus phosphate-buffered saline.
Next, the researchers tested blasts isolated from the bone marrow of patients with therapy-naive AML.
The team found that basal SAMHD1 expression was significantly correlated with cytarabine IC50 values. And depleting SAMHD1 diminished cytarabine IC50 values by 3- to 15-fold.
Lastly, the researchers assessed whether SAMHD1 expression might be used to predict response to cytarabine-based therapy in patients with AML.
The team analyzed a cohort of 150 adult AML patients who had received 1 to 2 courses of induction therapy including cytarabine—either 2 cycles of 7+3 or 7+3 plus high-dose cytarabine in combination with mitoxantrone.
Analysis revealed that SAMHD1 expression was “markedly increased” among patients who did not achieve a complete remission (CR) at the end of induction.
Of the 112 patients who achieved a CR, 90 were scored as “SAMHD1 low,” and 22 were scored as “SAMHD1 high.” The CR rate was 44% in the SAMHD1-high cohort and 90% in the SAMHD1-low cohort.
In addition, the researchers found the level of SAMHD1 expression in blasts at patients’ initial diagnosis was predictive of event-free survival, relapse-free survival, and overall survival.
The team said these results suggest SAMHD1 could be used to guide treatment with cytarabine-based therapies in patients with AML. 
New research suggests the protein SAMHD1 could be used to predict which
patients with acute myeloid leukemia (AML) will respond to treatment
with cytarabine.
Researchers found that response to cytarabine
was inversely correlated with SAMHD1 expression in AML cell lines, mouse
models of the disease, and adult patients with AML.
Jindrich Cinatl, PhD, of the University of Frankfurt in Germany, and his colleagues reported these findings in Nature Medicine.
The researchers first analyzed 13 AML cell lines and found that SAMHD1 reduces the cytotoxic effect of cytarabine. When the team depleted SAMHD1 in these cell lines, they were “markedly sensitized” to cytarabine.
The researchers also cultivated cytarabine-resistant AML cell lines and found that SAMHD1 levels increased along with cytarabine resistance. However, depleting SAMHD1 resensitized the cells to cytarabine.
Investigation revealed that SAMHD1 removes the phosphate residues from the active form of cytarabine, Ara-CTP, and converts the drug to its inactive form, Ara-C.
The researchers then evaluated the role of SAMHD1 in AML in vivo. They transplanted SAMHD1-knockout AML cells and wild-type SAMHD1 AML cells into mice and treated the mice with cytarabine or phosphate-buffered saline.
Mice that received SAMHD1-knockout AML cells and cytarabine had significantly longer survival than mice that received wild-type SAMHD1 AML cells and cytarabine or either AML cell type plus phosphate-buffered saline.
Next, the researchers tested blasts isolated from the bone marrow of patients with therapy-naive AML.
The team found that basal SAMHD1 expression was significantly correlated with cytarabine IC50 values. And depleting SAMHD1 diminished cytarabine IC50 values by 3- to 15-fold.
Lastly, the researchers assessed whether SAMHD1 expression might be used to predict response to cytarabine-based therapy in patients with AML.
The team analyzed a cohort of 150 adult AML patients who had received 1 to 2 courses of induction therapy including cytarabine—either 2 cycles of 7+3 or 7+3 plus high-dose cytarabine in combination with mitoxantrone.
Analysis revealed that SAMHD1 expression was “markedly increased” among patients who did not achieve a complete remission (CR) at the end of induction.
Of the 112 patients who achieved a CR, 90 were scored as “SAMHD1 low,” and 22 were scored as “SAMHD1 high.” The CR rate was 44% in the SAMHD1-high cohort and 90% in the SAMHD1-low cohort.
In addition, the researchers found the level of SAMHD1 expression in blasts at patients’ initial diagnosis was predictive of event-free survival, relapse-free survival, and overall survival.
The team said these results suggest SAMHD1 could be used to guide treatment with cytarabine-based therapies in patients with AML.
New research suggests the protein SAMHD1 could be used to predict which
patients with acute myeloid leukemia (AML) will respond to treatment
with cytarabine.
Researchers found that response to cytarabine
was inversely correlated with SAMHD1 expression in AML cell lines, mouse
models of the disease, and adult patients with AML.
Jindrich Cinatl, PhD, of the University of Frankfurt in Germany, and his colleagues reported these findings in Nature Medicine.
The researchers first analyzed 13 AML cell lines and found that SAMHD1 reduces the cytotoxic effect of cytarabine. When the team depleted SAMHD1 in these cell lines, they were “markedly sensitized” to cytarabine.
The researchers also cultivated cytarabine-resistant AML cell lines and found that SAMHD1 levels increased along with cytarabine resistance. However, depleting SAMHD1 resensitized the cells to cytarabine.
Investigation revealed that SAMHD1 removes the phosphate residues from the active form of cytarabine, Ara-CTP, and converts the drug to its inactive form, Ara-C.
The researchers then evaluated the role of SAMHD1 in AML in vivo. They transplanted SAMHD1-knockout AML cells and wild-type SAMHD1 AML cells into mice and treated the mice with cytarabine or phosphate-buffered saline.
Mice that received SAMHD1-knockout AML cells and cytarabine had significantly longer survival than mice that received wild-type SAMHD1 AML cells and cytarabine or either AML cell type plus phosphate-buffered saline.
Next, the researchers tested blasts isolated from the bone marrow of patients with therapy-naive AML.
The team found that basal SAMHD1 expression was significantly correlated with cytarabine IC50 values. And depleting SAMHD1 diminished cytarabine IC50 values by 3- to 15-fold.
Lastly, the researchers assessed whether SAMHD1 expression might be used to predict response to cytarabine-based therapy in patients with AML.
The team analyzed a cohort of 150 adult AML patients who had received 1 to 2 courses of induction therapy including cytarabine—either 2 cycles of 7+3 or 7+3 plus high-dose cytarabine in combination with mitoxantrone.
Analysis revealed that SAMHD1 expression was “markedly increased” among patients who did not achieve a complete remission (CR) at the end of induction.
Of the 112 patients who achieved a CR, 90 were scored as “SAMHD1 low,” and 22 were scored as “SAMHD1 high.” The CR rate was 44% in the SAMHD1-high cohort and 90% in the SAMHD1-low cohort.
In addition, the researchers found the level of SAMHD1 expression in blasts at patients’ initial diagnosis was predictive of event-free survival, relapse-free survival, and overall survival.
The team said these results suggest SAMHD1 could be used to guide treatment with cytarabine-based therapies in patients with AML.
Venetoclax approved to treat CLL in Australia
venetoclax (US version)
Photo courtesy of Abbvie
The Australian Therapeutic Goods Administration (TGA) has approved the BCL-2 inhibitor venetoclax (Venclexta™, formerly ABT-199) for use in certain patients with chronic lymphocytic leukemia (CLL).
The drug is now approved to treat Australian patients with relapsed or refractory CLL who have 17p deletion or no other treatment options.
Venetoclax is being developed by AbbVie and Genentech, a member of the Roche Group. The drug is jointly commercialized by the companies in the US and by AbbVie outside of the US.
Now that venetoclax has been approved by the TGA, it can be registered on the Australian Register of Therapeutic Goods and legally marketed and sold in Australia.
To make the drug affordable to the Australian public, the manufacturer can apply to the Pharmaceutical Benefits Advisory Committee to have the cost of the drug subsidized by the Australian government on the Pharmaceutical Benefits Scheme (PBS).
Venetoclax is not listed on the PBS. Historically, the delay between TGA approval and PBS listing ranges from 14 months to 31 months for cancer drugs.
Phase 2 trials
Venetoclax has produced high objective response rates (ORR) in two phase 2 trials of CLL patients.
In one of these trials, researchers tested venetoclax in 107 patients with previously treated CLL and 17p deletion. The results were published in The Lancet Oncology in June 2016.
The ORR in this trial was 79%. At the time of analysis, the median duration of response had not been reached. The same was true for progression-free survival and overall survival.
The progression-free survival estimate for 12 months was 72%, and the overall survival estimate was 87%.
The incidence of treatment-emergent adverse events was 96%, and the incidence of serious adverse events was 55%.
Grade 3 laboratory tumor lysis syndrome (TLS) was reported in 5 patients. Three of these patients continued on venetoclax, but 2 patients required a dose interruption of 1 day each.
In the second trial, researchers tested venetoclax in 64 patients with CLL who had failed treatment with ibrutinib and/or idelalisib. Results from this trial were presented at the 2016 ASH Annual Meeting.
The ORR was 67%. At 11.8 months of follow-up, the median duration of response, progression-free survival, and overall survival had not been reached. The estimated 12-month progression-free survival was 80%.
The incidence of adverse events was 100%, and the incidence of serious adverse events was 53%. No clinical TLS was observed, but 1 patient met Howard criteria for laboratory TLS.
In the past, TLS has caused deaths in patients receiving venetoclax. In response, AbbVie stopped dose-escalation in patients receiving the drug and suspended enrollment in phase 1 trials.
However, researchers subsequently found that a modified dosing schedule, prophylaxis, and patient monitoring can reduce the risk of TLS.
venetoclax (US version)
Photo courtesy of Abbvie
The Australian Therapeutic Goods Administration (TGA) has approved the BCL-2 inhibitor venetoclax (Venclexta™, formerly ABT-199) for use in certain patients with chronic lymphocytic leukemia (CLL).
The drug is now approved to treat Australian patients with relapsed or refractory CLL who have 17p deletion or no other treatment options.
Venetoclax is being developed by AbbVie and Genentech, a member of the Roche Group. The drug is jointly commercialized by the companies in the US and by AbbVie outside of the US.
Now that venetoclax has been approved by the TGA, it can be registered on the Australian Register of Therapeutic Goods and legally marketed and sold in Australia.
To make the drug affordable to the Australian public, the manufacturer can apply to the Pharmaceutical Benefits Advisory Committee to have the cost of the drug subsidized by the Australian government on the Pharmaceutical Benefits Scheme (PBS).
Venetoclax is not listed on the PBS. Historically, the delay between TGA approval and PBS listing ranges from 14 months to 31 months for cancer drugs.
Phase 2 trials
Venetoclax has produced high objective response rates (ORR) in two phase 2 trials of CLL patients.
In one of these trials, researchers tested venetoclax in 107 patients with previously treated CLL and 17p deletion. The results were published in The Lancet Oncology in June 2016.
The ORR in this trial was 79%. At the time of analysis, the median duration of response had not been reached. The same was true for progression-free survival and overall survival.
The progression-free survival estimate for 12 months was 72%, and the overall survival estimate was 87%.
The incidence of treatment-emergent adverse events was 96%, and the incidence of serious adverse events was 55%.
Grade 3 laboratory tumor lysis syndrome (TLS) was reported in 5 patients. Three of these patients continued on venetoclax, but 2 patients required a dose interruption of 1 day each.
In the second trial, researchers tested venetoclax in 64 patients with CLL who had failed treatment with ibrutinib and/or idelalisib. Results from this trial were presented at the 2016 ASH Annual Meeting.
The ORR was 67%. At 11.8 months of follow-up, the median duration of response, progression-free survival, and overall survival had not been reached. The estimated 12-month progression-free survival was 80%.
The incidence of adverse events was 100%, and the incidence of serious adverse events was 53%. No clinical TLS was observed, but 1 patient met Howard criteria for laboratory TLS.
In the past, TLS has caused deaths in patients receiving venetoclax. In response, AbbVie stopped dose-escalation in patients receiving the drug and suspended enrollment in phase 1 trials.
However, researchers subsequently found that a modified dosing schedule, prophylaxis, and patient monitoring can reduce the risk of TLS.
venetoclax (US version)
Photo courtesy of Abbvie
The Australian Therapeutic Goods Administration (TGA) has approved the BCL-2 inhibitor venetoclax (Venclexta™, formerly ABT-199) for use in certain patients with chronic lymphocytic leukemia (CLL).
The drug is now approved to treat Australian patients with relapsed or refractory CLL who have 17p deletion or no other treatment options.
Venetoclax is being developed by AbbVie and Genentech, a member of the Roche Group. The drug is jointly commercialized by the companies in the US and by AbbVie outside of the US.
Now that venetoclax has been approved by the TGA, it can be registered on the Australian Register of Therapeutic Goods and legally marketed and sold in Australia.
To make the drug affordable to the Australian public, the manufacturer can apply to the Pharmaceutical Benefits Advisory Committee to have the cost of the drug subsidized by the Australian government on the Pharmaceutical Benefits Scheme (PBS).
Venetoclax is not listed on the PBS. Historically, the delay between TGA approval and PBS listing ranges from 14 months to 31 months for cancer drugs.
Phase 2 trials
Venetoclax has produced high objective response rates (ORR) in two phase 2 trials of CLL patients.
In one of these trials, researchers tested venetoclax in 107 patients with previously treated CLL and 17p deletion. The results were published in The Lancet Oncology in June 2016.
The ORR in this trial was 79%. At the time of analysis, the median duration of response had not been reached. The same was true for progression-free survival and overall survival.
The progression-free survival estimate for 12 months was 72%, and the overall survival estimate was 87%.
The incidence of treatment-emergent adverse events was 96%, and the incidence of serious adverse events was 55%.
Grade 3 laboratory tumor lysis syndrome (TLS) was reported in 5 patients. Three of these patients continued on venetoclax, but 2 patients required a dose interruption of 1 day each.
In the second trial, researchers tested venetoclax in 64 patients with CLL who had failed treatment with ibrutinib and/or idelalisib. Results from this trial were presented at the 2016 ASH Annual Meeting.
The ORR was 67%. At 11.8 months of follow-up, the median duration of response, progression-free survival, and overall survival had not been reached. The estimated 12-month progression-free survival was 80%.
The incidence of adverse events was 100%, and the incidence of serious adverse events was 53%. No clinical TLS was observed, but 1 patient met Howard criteria for laboratory TLS.
In the past, TLS has caused deaths in patients receiving venetoclax. In response, AbbVie stopped dose-escalation in patients receiving the drug and suspended enrollment in phase 1 trials.
However, researchers subsequently found that a modified dosing schedule, prophylaxis, and patient monitoring can reduce the risk of TLS.
NCI launches program to expedite drug research
Photo by Bill Branson
The National Cancer Institute (NCI) has launched a new drug formulary designed to provide investigators at NCI-designated cancer centers with quicker access to approved and investigational agents for use in preclinical studies and clinical trials.
The formulary will enable NCI to act as an intermediary between investigators and participating pharmaceutical companies, facilitating the arrangements for access to and use of pharmaceutical agents.
Following company approval, investigators will be able to obtain agents from the formulary and test them in preclinical or clinical studies, including studies combining formulary agents from different companies.
The NCI says having agents available through the formulary will expedite the start of clinical trials by alleviating the lengthy negotiation process—sometimes up to 18 months—that has been required for investigators to access such agents on their own.
“The NCI Formulary will help researchers begin testing promising drug combinations more quickly, potentially helping patients much sooner,” said NCI Acting Director Douglas Lowy, MD.
“Rather than spending time negotiating agreements, investigators will be able to focus on the important research that can ultimately lead to improved cancer care.”
The NCI Formulary includes 15 targeted agents:
- Alectinib (ALK inhibitor, tyrosine kinase inhibitor)
- Atezolizumab (PD-L1 blocking monoclonal antibody)
- Bevacizumab (anti-angiogenesis inhibitor, monoclonal antibody)
- Cobimetinib (MEK1/2 inhibitor)
- Ensartinib (ALK inhibitor)
- Ipilimumab (anti-CTLA-4 monoclonal antibody)
- Larotrectinib (tyrosine kinase inhibitor)
- LY3039478 (Notch inhibitor)
- Nivolumab (PD-1 blocking monoclonal antibody)
- Obinutuzumab (anti-CD20 monoclonal antibody)
- Pertuzumab (anti-HER2 monoclonal antibody)
- Prexasertib (checkpoint kinase 1 inhibitor)
- Trastuzumab (anti-HER2 monoclonal antibody)
- Vemurafenib (BRAF mutant v600 inhibitor)
- Vismodegib (Hedgehog inhibitor)
The agents are products of 6 different pharmaceutical companies: Bristol-Myers Squibb, Eli Lilly and Company, Genentech, Kyowa Hakko Kirin, Loxo Oncology, and Xcovery Holding Company LLC.
“The agreements with these companies demonstrate our shared commitment to expedite cancer clinical trials and improve outcomes for patients,” said James Doroshow, MD, NCI deputy director for clinical and translational research.
“We are very pleased that several additional pharmaceutical companies have already pledged a willingness to participate and are in various stages of negotiation with NCI. By the end of 2017, we expect to have doubled the number of partnerships and drugs available in the NCI Formulary.”
Photo by Bill Branson
The National Cancer Institute (NCI) has launched a new drug formulary designed to provide investigators at NCI-designated cancer centers with quicker access to approved and investigational agents for use in preclinical studies and clinical trials.
The formulary will enable NCI to act as an intermediary between investigators and participating pharmaceutical companies, facilitating the arrangements for access to and use of pharmaceutical agents.
Following company approval, investigators will be able to obtain agents from the formulary and test them in preclinical or clinical studies, including studies combining formulary agents from different companies.
The NCI says having agents available through the formulary will expedite the start of clinical trials by alleviating the lengthy negotiation process—sometimes up to 18 months—that has been required for investigators to access such agents on their own.
“The NCI Formulary will help researchers begin testing promising drug combinations more quickly, potentially helping patients much sooner,” said NCI Acting Director Douglas Lowy, MD.
“Rather than spending time negotiating agreements, investigators will be able to focus on the important research that can ultimately lead to improved cancer care.”
The NCI Formulary includes 15 targeted agents:
- Alectinib (ALK inhibitor, tyrosine kinase inhibitor)
- Atezolizumab (PD-L1 blocking monoclonal antibody)
- Bevacizumab (anti-angiogenesis inhibitor, monoclonal antibody)
- Cobimetinib (MEK1/2 inhibitor)
- Ensartinib (ALK inhibitor)
- Ipilimumab (anti-CTLA-4 monoclonal antibody)
- Larotrectinib (tyrosine kinase inhibitor)
- LY3039478 (Notch inhibitor)
- Nivolumab (PD-1 blocking monoclonal antibody)
- Obinutuzumab (anti-CD20 monoclonal antibody)
- Pertuzumab (anti-HER2 monoclonal antibody)
- Prexasertib (checkpoint kinase 1 inhibitor)
- Trastuzumab (anti-HER2 monoclonal antibody)
- Vemurafenib (BRAF mutant v600 inhibitor)
- Vismodegib (Hedgehog inhibitor)
The agents are products of 6 different pharmaceutical companies: Bristol-Myers Squibb, Eli Lilly and Company, Genentech, Kyowa Hakko Kirin, Loxo Oncology, and Xcovery Holding Company LLC.
“The agreements with these companies demonstrate our shared commitment to expedite cancer clinical trials and improve outcomes for patients,” said James Doroshow, MD, NCI deputy director for clinical and translational research.
“We are very pleased that several additional pharmaceutical companies have already pledged a willingness to participate and are in various stages of negotiation with NCI. By the end of 2017, we expect to have doubled the number of partnerships and drugs available in the NCI Formulary.”
Photo by Bill Branson
The National Cancer Institute (NCI) has launched a new drug formulary designed to provide investigators at NCI-designated cancer centers with quicker access to approved and investigational agents for use in preclinical studies and clinical trials.
The formulary will enable NCI to act as an intermediary between investigators and participating pharmaceutical companies, facilitating the arrangements for access to and use of pharmaceutical agents.
Following company approval, investigators will be able to obtain agents from the formulary and test them in preclinical or clinical studies, including studies combining formulary agents from different companies.
The NCI says having agents available through the formulary will expedite the start of clinical trials by alleviating the lengthy negotiation process—sometimes up to 18 months—that has been required for investigators to access such agents on their own.
“The NCI Formulary will help researchers begin testing promising drug combinations more quickly, potentially helping patients much sooner,” said NCI Acting Director Douglas Lowy, MD.
“Rather than spending time negotiating agreements, investigators will be able to focus on the important research that can ultimately lead to improved cancer care.”
The NCI Formulary includes 15 targeted agents:
- Alectinib (ALK inhibitor, tyrosine kinase inhibitor)
- Atezolizumab (PD-L1 blocking monoclonal antibody)
- Bevacizumab (anti-angiogenesis inhibitor, monoclonal antibody)
- Cobimetinib (MEK1/2 inhibitor)
- Ensartinib (ALK inhibitor)
- Ipilimumab (anti-CTLA-4 monoclonal antibody)
- Larotrectinib (tyrosine kinase inhibitor)
- LY3039478 (Notch inhibitor)
- Nivolumab (PD-1 blocking monoclonal antibody)
- Obinutuzumab (anti-CD20 monoclonal antibody)
- Pertuzumab (anti-HER2 monoclonal antibody)
- Prexasertib (checkpoint kinase 1 inhibitor)
- Trastuzumab (anti-HER2 monoclonal antibody)
- Vemurafenib (BRAF mutant v600 inhibitor)
- Vismodegib (Hedgehog inhibitor)
The agents are products of 6 different pharmaceutical companies: Bristol-Myers Squibb, Eli Lilly and Company, Genentech, Kyowa Hakko Kirin, Loxo Oncology, and Xcovery Holding Company LLC.
“The agreements with these companies demonstrate our shared commitment to expedite cancer clinical trials and improve outcomes for patients,” said James Doroshow, MD, NCI deputy director for clinical and translational research.
“We are very pleased that several additional pharmaceutical companies have already pledged a willingness to participate and are in various stages of negotiation with NCI. By the end of 2017, we expect to have doubled the number of partnerships and drugs available in the NCI Formulary.”
Intervention may improve warfarin management
Photo courtesy of NIGMS
Researchers have developed an intervention intended to help hospitals and clinicians improve the management of patients on warfarin.
The team implemented the intervention at 8 medical centers in the New England region of the Veterans Health Administration (VA).
These
centers saw an improvement in time in the therapeutic range
(TTR) that was significantly better than the improvement seen in medical
centers without the intervention.
“Insufficient attention has been given in the past to how we can improve the management of warfarin,” said Adam Rose, MD, of Boston University School of Medicine in Massachusetts.
“This study demonstrates that a relatively simple approach can have a large impact.”
Dr Rose and his colleagues described this study in the Annals of Pharmacotherapy.
Intervention
The researchers implemented the intervention at 8 VA sites in New England known as Veterans Integrated Service Network 1 (VISN 1).
The team described the intervention as performance measurement augmented by targeted audit and feedback. Performance was measured via an online reporting system—known as a dashboard—that provided real-time data to clinicians.
The dashboard reported TTR at the patient and site level. The dashboard also reported processes of care that have been linked to TTR, including timely follow-up when the international normalized ratio (INR) is very low or very high, gaps in monitoring, and the proportion of patients with a mean INR value between 2.3 and 2.7.
The dashboard allowed clinicians to call patients who had been lost to follow-up, had low TTR, or were in need of urgent follow-up as a result of extreme INR values.
Results
The researchers examined changes in anticoagulation control, measured as TTR, after the intervention was implemented. They compared changes at VISN 1 sites with 116 other VA sites.
A total of 11,794 patients within VISN 1 and 1,248,782 patients outside of VISN 1 received warfarin for at least part of the study period.
At VISN 1 sites, TTR improved from 66.4% to 69.2%. At the other sites, TTR improved from 65.9% to 66.4% (P<0.001 for the between-group difference).
The researchers said improvement in TTR correlated strongly with the extent of improvement on process-of-care measures, which varied widely across VISN 1 sites.
“Patients who used these measures did better clinically than those in the control group,” Dr Rose said. “This study serves as a model for how other sites and health networks could feasibly approach improving the management of warfarin in their systems.”
“If all anticoagulation clinics in the VA were to achieve this level of improvement, it would prevent 48 strokes and 68 major bleeding events each year, with a savings to the VA system of more than $4 million annually.”
Photo courtesy of NIGMS
Researchers have developed an intervention intended to help hospitals and clinicians improve the management of patients on warfarin.
The team implemented the intervention at 8 medical centers in the New England region of the Veterans Health Administration (VA).
These
centers saw an improvement in time in the therapeutic range
(TTR) that was significantly better than the improvement seen in medical
centers without the intervention.
“Insufficient attention has been given in the past to how we can improve the management of warfarin,” said Adam Rose, MD, of Boston University School of Medicine in Massachusetts.
“This study demonstrates that a relatively simple approach can have a large impact.”
Dr Rose and his colleagues described this study in the Annals of Pharmacotherapy.
Intervention
The researchers implemented the intervention at 8 VA sites in New England known as Veterans Integrated Service Network 1 (VISN 1).
The team described the intervention as performance measurement augmented by targeted audit and feedback. Performance was measured via an online reporting system—known as a dashboard—that provided real-time data to clinicians.
The dashboard reported TTR at the patient and site level. The dashboard also reported processes of care that have been linked to TTR, including timely follow-up when the international normalized ratio (INR) is very low or very high, gaps in monitoring, and the proportion of patients with a mean INR value between 2.3 and 2.7.
The dashboard allowed clinicians to call patients who had been lost to follow-up, had low TTR, or were in need of urgent follow-up as a result of extreme INR values.
Results
The researchers examined changes in anticoagulation control, measured as TTR, after the intervention was implemented. They compared changes at VISN 1 sites with 116 other VA sites.
A total of 11,794 patients within VISN 1 and 1,248,782 patients outside of VISN 1 received warfarin for at least part of the study period.
At VISN 1 sites, TTR improved from 66.4% to 69.2%. At the other sites, TTR improved from 65.9% to 66.4% (P<0.001 for the between-group difference).
The researchers said improvement in TTR correlated strongly with the extent of improvement on process-of-care measures, which varied widely across VISN 1 sites.
“Patients who used these measures did better clinically than those in the control group,” Dr Rose said. “This study serves as a model for how other sites and health networks could feasibly approach improving the management of warfarin in their systems.”
“If all anticoagulation clinics in the VA were to achieve this level of improvement, it would prevent 48 strokes and 68 major bleeding events each year, with a savings to the VA system of more than $4 million annually.”
Photo courtesy of NIGMS
Researchers have developed an intervention intended to help hospitals and clinicians improve the management of patients on warfarin.
The team implemented the intervention at 8 medical centers in the New England region of the Veterans Health Administration (VA).
These
centers saw an improvement in time in the therapeutic range
(TTR) that was significantly better than the improvement seen in medical
centers without the intervention.
“Insufficient attention has been given in the past to how we can improve the management of warfarin,” said Adam Rose, MD, of Boston University School of Medicine in Massachusetts.
“This study demonstrates that a relatively simple approach can have a large impact.”
Dr Rose and his colleagues described this study in the Annals of Pharmacotherapy.
Intervention
The researchers implemented the intervention at 8 VA sites in New England known as Veterans Integrated Service Network 1 (VISN 1).
The team described the intervention as performance measurement augmented by targeted audit and feedback. Performance was measured via an online reporting system—known as a dashboard—that provided real-time data to clinicians.
The dashboard reported TTR at the patient and site level. The dashboard also reported processes of care that have been linked to TTR, including timely follow-up when the international normalized ratio (INR) is very low or very high, gaps in monitoring, and the proportion of patients with a mean INR value between 2.3 and 2.7.
The dashboard allowed clinicians to call patients who had been lost to follow-up, had low TTR, or were in need of urgent follow-up as a result of extreme INR values.
Results
The researchers examined changes in anticoagulation control, measured as TTR, after the intervention was implemented. They compared changes at VISN 1 sites with 116 other VA sites.
A total of 11,794 patients within VISN 1 and 1,248,782 patients outside of VISN 1 received warfarin for at least part of the study period.
At VISN 1 sites, TTR improved from 66.4% to 69.2%. At the other sites, TTR improved from 65.9% to 66.4% (P<0.001 for the between-group difference).
The researchers said improvement in TTR correlated strongly with the extent of improvement on process-of-care measures, which varied widely across VISN 1 sites.
“Patients who used these measures did better clinically than those in the control group,” Dr Rose said. “This study serves as a model for how other sites and health networks could feasibly approach improving the management of warfarin in their systems.”
“If all anticoagulation clinics in the VA were to achieve this level of improvement, it would prevent 48 strokes and 68 major bleeding events each year, with a savings to the VA system of more than $4 million annually.”
Shorter Length of Stay May Not Mean Higher Readmission Rates
Length of stay (LOS) in hospitals may drop, but it doesn’t necessarily lead to higher readmission rates, according to a study by Kyoto University researchers.
In Japan, the researchers say, acute care hospital stays are longer than in other developed countries but have shortened over the past decade—mainly due to the Diagnosis Procedure Combination Per-Diem Payment System (DPC/PDPS). Under that system, introduced in 2003, hospital reimbursements from insurers reduce as LOS increases for individual patients.
Related: Risk of Readmission After Pneumonia
Concerns that excessive reductions might worsen the quality of health care led the researchers to investigate what the last 10 years of DPC/PDPS have meant for early-stage cancer surgical patients.
They analyzed 4 years of data from 804 hospitals on 42,585 surgical patients with gastric cancer, 40,156 with lung cancer, and 15,467 with colon cancer, comparing LOS with unplanned readmissions within 30 days.
They found LOS was reduced—although slightly—by about 0.5 d/y. Mean overall LOS for gastric cancer patients dropped from 21.85 days to 19.89; for lung cancer patients, from 15.61 to 14.25; for colon cancer patients, from 18.70 to 17.18.
Related: Survival After Long-Term Residence in an Intensive Care Unit
However, unplanned emergency readmission rates remained relatively stable at about 2% or declined slightly. Readmission rates were significantly lower only for lung cancer patients; declines were not significant for the other groups.
Both preoperative and postoperative LOS also decreased during the study period. In particular, the researchers note, improvements in postoperative care may have shortened LOS. They also suggest that downward trends reflect improvements due to better medical techniques, procedure choices, and advances in clinical pathways.
Source:
Kunisawa S, Fushimi K, Imanaka Y. PLoS One. 2016;11(11): e0166269.
doi: 10.1371/journal.pone.0166269.
Length of stay (LOS) in hospitals may drop, but it doesn’t necessarily lead to higher readmission rates, according to a study by Kyoto University researchers.
In Japan, the researchers say, acute care hospital stays are longer than in other developed countries but have shortened over the past decade—mainly due to the Diagnosis Procedure Combination Per-Diem Payment System (DPC/PDPS). Under that system, introduced in 2003, hospital reimbursements from insurers reduce as LOS increases for individual patients.
Related: Risk of Readmission After Pneumonia
Concerns that excessive reductions might worsen the quality of health care led the researchers to investigate what the last 10 years of DPC/PDPS have meant for early-stage cancer surgical patients.
They analyzed 4 years of data from 804 hospitals on 42,585 surgical patients with gastric cancer, 40,156 with lung cancer, and 15,467 with colon cancer, comparing LOS with unplanned readmissions within 30 days.
They found LOS was reduced—although slightly—by about 0.5 d/y. Mean overall LOS for gastric cancer patients dropped from 21.85 days to 19.89; for lung cancer patients, from 15.61 to 14.25; for colon cancer patients, from 18.70 to 17.18.
Related: Survival After Long-Term Residence in an Intensive Care Unit
However, unplanned emergency readmission rates remained relatively stable at about 2% or declined slightly. Readmission rates were significantly lower only for lung cancer patients; declines were not significant for the other groups.
Both preoperative and postoperative LOS also decreased during the study period. In particular, the researchers note, improvements in postoperative care may have shortened LOS. They also suggest that downward trends reflect improvements due to better medical techniques, procedure choices, and advances in clinical pathways.
Source:
Kunisawa S, Fushimi K, Imanaka Y. PLoS One. 2016;11(11): e0166269.
doi: 10.1371/journal.pone.0166269.
Length of stay (LOS) in hospitals may drop, but it doesn’t necessarily lead to higher readmission rates, according to a study by Kyoto University researchers.
In Japan, the researchers say, acute care hospital stays are longer than in other developed countries but have shortened over the past decade—mainly due to the Diagnosis Procedure Combination Per-Diem Payment System (DPC/PDPS). Under that system, introduced in 2003, hospital reimbursements from insurers reduce as LOS increases for individual patients.
Related: Risk of Readmission After Pneumonia
Concerns that excessive reductions might worsen the quality of health care led the researchers to investigate what the last 10 years of DPC/PDPS have meant for early-stage cancer surgical patients.
They analyzed 4 years of data from 804 hospitals on 42,585 surgical patients with gastric cancer, 40,156 with lung cancer, and 15,467 with colon cancer, comparing LOS with unplanned readmissions within 30 days.
They found LOS was reduced—although slightly—by about 0.5 d/y. Mean overall LOS for gastric cancer patients dropped from 21.85 days to 19.89; for lung cancer patients, from 15.61 to 14.25; for colon cancer patients, from 18.70 to 17.18.
Related: Survival After Long-Term Residence in an Intensive Care Unit
However, unplanned emergency readmission rates remained relatively stable at about 2% or declined slightly. Readmission rates were significantly lower only for lung cancer patients; declines were not significant for the other groups.
Both preoperative and postoperative LOS also decreased during the study period. In particular, the researchers note, improvements in postoperative care may have shortened LOS. They also suggest that downward trends reflect improvements due to better medical techniques, procedure choices, and advances in clinical pathways.
Source:
Kunisawa S, Fushimi K, Imanaka Y. PLoS One. 2016;11(11): e0166269.
doi: 10.1371/journal.pone.0166269.
How Many Shades of Gray?
The hyperpigmentation on both of this 56-year-old man’s legs is asymptomatic. But it has steadily worsened, causing him a great deal of distress.
A few months before the dyschromia manifested, he underwent orthopedic surgery and developed a postop infection. He was prescribed minocycline. As of today, he has been taking a 100-mg bid dose for three months.
He is otherwise healthy and not taking any other medications.
EXAMINATION
From the knees down, both legs display marked circumferential, bluish gray hyperpigmentation. It is not seen on any other areas (eg, arms, face, sclerae, or trunk).
What is the diagnosis?
This type of bluish gray hyperpigmentation is an uncommon idiosyncratic effect of minocycline ingestion. Although long-term, high-dose use of the drug is usually responsible, hyperpigmentation has been reported with short-term use at relatively low doses. The most common presentation is in acne patients taking minocycline who notice color changes in their gums, sclerae, and nail beds.
Four distinct variations of hyperpigmentation have been described: a slate gray color on the face, a circumscribed distribution on arms and legs, a diffuse muddy brown discoloration on sun-exposed skin, and development on the thorax in old scars. In addition to affecting the skin, it can stain internal organs, heart valves, joints, and bones. Biopsy will reveal pigment granules in dendritic cells and extracellularly in the dermis.
In some cases, the discoloration can be permanent, but it typically clears upon cessation of the offending drug. In this particular case, the benefits of minocycline outweighed any concern about the dyschromia. Alternately, a 755-nm Q-switched alexandrite laser has been used successfully.
There are numerous causes of dyschromia, including other drugs (eg, antimalarials, amiodarones, gold and silver salts) and medical conditions (eg, Addison disease, onchronosis).
TAKE-HOME LEARNING POINTS
- Though uncommon, there is an association between minocycline use and various forms of hyperpigmentation.
- The discoloration ranges from slate gray to muddy brown and can be seen on the sclerae, face, gums, trunk, and legs, as well as in scars.
- Though more common with long-term, high-dose use of the drug, dyschromia has been reported after as little as three months of therapy.
- Other drugs that can cause hyperpigmentation include antimalarials, amiodarone, and silver and gold salts.
- Most cases resolve upon cessation of the drug; for those that don’t, a 755-nm Q-switched alexandrite laser is effective.
The hyperpigmentation on both of this 56-year-old man’s legs is asymptomatic. But it has steadily worsened, causing him a great deal of distress.
A few months before the dyschromia manifested, he underwent orthopedic surgery and developed a postop infection. He was prescribed minocycline. As of today, he has been taking a 100-mg bid dose for three months.
He is otherwise healthy and not taking any other medications.
EXAMINATION
From the knees down, both legs display marked circumferential, bluish gray hyperpigmentation. It is not seen on any other areas (eg, arms, face, sclerae, or trunk).
What is the diagnosis?
This type of bluish gray hyperpigmentation is an uncommon idiosyncratic effect of minocycline ingestion. Although long-term, high-dose use of the drug is usually responsible, hyperpigmentation has been reported with short-term use at relatively low doses. The most common presentation is in acne patients taking minocycline who notice color changes in their gums, sclerae, and nail beds.
Four distinct variations of hyperpigmentation have been described: a slate gray color on the face, a circumscribed distribution on arms and legs, a diffuse muddy brown discoloration on sun-exposed skin, and development on the thorax in old scars. In addition to affecting the skin, it can stain internal organs, heart valves, joints, and bones. Biopsy will reveal pigment granules in dendritic cells and extracellularly in the dermis.
In some cases, the discoloration can be permanent, but it typically clears upon cessation of the offending drug. In this particular case, the benefits of minocycline outweighed any concern about the dyschromia. Alternately, a 755-nm Q-switched alexandrite laser has been used successfully.
There are numerous causes of dyschromia, including other drugs (eg, antimalarials, amiodarones, gold and silver salts) and medical conditions (eg, Addison disease, onchronosis).
TAKE-HOME LEARNING POINTS
- Though uncommon, there is an association between minocycline use and various forms of hyperpigmentation.
- The discoloration ranges from slate gray to muddy brown and can be seen on the sclerae, face, gums, trunk, and legs, as well as in scars.
- Though more common with long-term, high-dose use of the drug, dyschromia has been reported after as little as three months of therapy.
- Other drugs that can cause hyperpigmentation include antimalarials, amiodarone, and silver and gold salts.
- Most cases resolve upon cessation of the drug; for those that don’t, a 755-nm Q-switched alexandrite laser is effective.
The hyperpigmentation on both of this 56-year-old man’s legs is asymptomatic. But it has steadily worsened, causing him a great deal of distress.
A few months before the dyschromia manifested, he underwent orthopedic surgery and developed a postop infection. He was prescribed minocycline. As of today, he has been taking a 100-mg bid dose for three months.
He is otherwise healthy and not taking any other medications.
EXAMINATION
From the knees down, both legs display marked circumferential, bluish gray hyperpigmentation. It is not seen on any other areas (eg, arms, face, sclerae, or trunk).
What is the diagnosis?
This type of bluish gray hyperpigmentation is an uncommon idiosyncratic effect of minocycline ingestion. Although long-term, high-dose use of the drug is usually responsible, hyperpigmentation has been reported with short-term use at relatively low doses. The most common presentation is in acne patients taking minocycline who notice color changes in their gums, sclerae, and nail beds.
Four distinct variations of hyperpigmentation have been described: a slate gray color on the face, a circumscribed distribution on arms and legs, a diffuse muddy brown discoloration on sun-exposed skin, and development on the thorax in old scars. In addition to affecting the skin, it can stain internal organs, heart valves, joints, and bones. Biopsy will reveal pigment granules in dendritic cells and extracellularly in the dermis.
In some cases, the discoloration can be permanent, but it typically clears upon cessation of the offending drug. In this particular case, the benefits of minocycline outweighed any concern about the dyschromia. Alternately, a 755-nm Q-switched alexandrite laser has been used successfully.
There are numerous causes of dyschromia, including other drugs (eg, antimalarials, amiodarones, gold and silver salts) and medical conditions (eg, Addison disease, onchronosis).
TAKE-HOME LEARNING POINTS
- Though uncommon, there is an association between minocycline use and various forms of hyperpigmentation.
- The discoloration ranges from slate gray to muddy brown and can be seen on the sclerae, face, gums, trunk, and legs, as well as in scars.
- Though more common with long-term, high-dose use of the drug, dyschromia has been reported after as little as three months of therapy.
- Other drugs that can cause hyperpigmentation include antimalarials, amiodarone, and silver and gold salts.
- Most cases resolve upon cessation of the drug; for those that don’t, a 755-nm Q-switched alexandrite laser is effective.
Itchy scalp
Based on the patient’s history, the FP suspected that this was a case of either head lice or seborrhea. He put on gloves to examine the hair and found nits (eggs) glued to the hair. There was an especially high density of them behind her ears (which is always a good place to begin the exam for head lice). The nits were pearly as expected, but no live adult head lice were found.
The FP was aware that nits are far more numerous than adult head lice. The scalp itself was unremarkable and there was no seborrhea. While it is possible to look at nits under a microscope to see if there are live larvae inside, the history of 2 weeks of symptoms without treatment was sufficient to assume that this was an active case of head lice, rather than dead or hatched nits from a previous case.
The mother confirmed that the child hadn’t been treated for head lice in the past and claimed that she washed her daughter's hair every night. The FP explained that any child in school or around other children can easily get head lice—regardless of their personal hygiene habits. The FP asked if it was okay to check the mother’s hair, and found a few nits behind her ears, as well.
There are many treatment options for head lice, including 2 nonprescription products that cost less than $15 each: 1% permethrin cream rinse (Nix) and pyrethrins with piperonyl butoxide (RID) shampoo. There are also more expensive prescription products, including malathion 0.5%, benzyl alcohol 5% lotion, spinosad, and ivermectin 0.5% lotion. A 2001 Cochrane review found no evidence that any one pediculicide was better than another.1 However, the review only included studies of permethrin, synergized pyrethrin, and malathion.
In this case, the mother chose to buy the over-the-counter 1% permethrin cream rinse for herself and her daughter. While the FP was not able to examine the patient’s father or older brother, he did suggest that they all do the treatment simultaneously to avoid one family member remaining infested (and then reinfesting the rest of the family).
1. Dodd CS. Interventions for treating headlice. Cochrane Database Syst Rev. 2001;CD001165.
Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Mayeaux EJ, Usatine R. Lice. In: Usatine R, Smith M, Mayeaux EJ, et al, eds. Color Atlas of Family Medicine. 2nd ed. New York, NY: McGraw-Hill; 2013: 570-574.
To learn more about the Color Atlas of Family Medicine, see: www.amazon.com/Color-Family-Medicine-Richard-Usatine/dp/0071769641/
You can now get the second edition of the Color Atlas of Family Medicine as an app by clicking on this link: usatinemedia.com
Based on the patient’s history, the FP suspected that this was a case of either head lice or seborrhea. He put on gloves to examine the hair and found nits (eggs) glued to the hair. There was an especially high density of them behind her ears (which is always a good place to begin the exam for head lice). The nits were pearly as expected, but no live adult head lice were found.
The FP was aware that nits are far more numerous than adult head lice. The scalp itself was unremarkable and there was no seborrhea. While it is possible to look at nits under a microscope to see if there are live larvae inside, the history of 2 weeks of symptoms without treatment was sufficient to assume that this was an active case of head lice, rather than dead or hatched nits from a previous case.
The mother confirmed that the child hadn’t been treated for head lice in the past and claimed that she washed her daughter's hair every night. The FP explained that any child in school or around other children can easily get head lice—regardless of their personal hygiene habits. The FP asked if it was okay to check the mother’s hair, and found a few nits behind her ears, as well.
There are many treatment options for head lice, including 2 nonprescription products that cost less than $15 each: 1% permethrin cream rinse (Nix) and pyrethrins with piperonyl butoxide (RID) shampoo. There are also more expensive prescription products, including malathion 0.5%, benzyl alcohol 5% lotion, spinosad, and ivermectin 0.5% lotion. A 2001 Cochrane review found no evidence that any one pediculicide was better than another.1 However, the review only included studies of permethrin, synergized pyrethrin, and malathion.
In this case, the mother chose to buy the over-the-counter 1% permethrin cream rinse for herself and her daughter. While the FP was not able to examine the patient’s father or older brother, he did suggest that they all do the treatment simultaneously to avoid one family member remaining infested (and then reinfesting the rest of the family).
1. Dodd CS. Interventions for treating headlice. Cochrane Database Syst Rev. 2001;CD001165.
Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Mayeaux EJ, Usatine R. Lice. In: Usatine R, Smith M, Mayeaux EJ, et al, eds. Color Atlas of Family Medicine. 2nd ed. New York, NY: McGraw-Hill; 2013: 570-574.
To learn more about the Color Atlas of Family Medicine, see: www.amazon.com/Color-Family-Medicine-Richard-Usatine/dp/0071769641/
You can now get the second edition of the Color Atlas of Family Medicine as an app by clicking on this link: usatinemedia.com
Based on the patient’s history, the FP suspected that this was a case of either head lice or seborrhea. He put on gloves to examine the hair and found nits (eggs) glued to the hair. There was an especially high density of them behind her ears (which is always a good place to begin the exam for head lice). The nits were pearly as expected, but no live adult head lice were found.
The FP was aware that nits are far more numerous than adult head lice. The scalp itself was unremarkable and there was no seborrhea. While it is possible to look at nits under a microscope to see if there are live larvae inside, the history of 2 weeks of symptoms without treatment was sufficient to assume that this was an active case of head lice, rather than dead or hatched nits from a previous case.
The mother confirmed that the child hadn’t been treated for head lice in the past and claimed that she washed her daughter's hair every night. The FP explained that any child in school or around other children can easily get head lice—regardless of their personal hygiene habits. The FP asked if it was okay to check the mother’s hair, and found a few nits behind her ears, as well.
There are many treatment options for head lice, including 2 nonprescription products that cost less than $15 each: 1% permethrin cream rinse (Nix) and pyrethrins with piperonyl butoxide (RID) shampoo. There are also more expensive prescription products, including malathion 0.5%, benzyl alcohol 5% lotion, spinosad, and ivermectin 0.5% lotion. A 2001 Cochrane review found no evidence that any one pediculicide was better than another.1 However, the review only included studies of permethrin, synergized pyrethrin, and malathion.
In this case, the mother chose to buy the over-the-counter 1% permethrin cream rinse for herself and her daughter. While the FP was not able to examine the patient’s father or older brother, he did suggest that they all do the treatment simultaneously to avoid one family member remaining infested (and then reinfesting the rest of the family).
1. Dodd CS. Interventions for treating headlice. Cochrane Database Syst Rev. 2001;CD001165.
Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Mayeaux EJ, Usatine R. Lice. In: Usatine R, Smith M, Mayeaux EJ, et al, eds. Color Atlas of Family Medicine. 2nd ed. New York, NY: McGraw-Hill; 2013: 570-574.
To learn more about the Color Atlas of Family Medicine, see: www.amazon.com/Color-Family-Medicine-Richard-Usatine/dp/0071769641/
You can now get the second edition of the Color Atlas of Family Medicine as an app by clicking on this link: usatinemedia.com
Non–vitamin K antagonist oral anticoagulants for planned atrial fibrillation cardioversions
Clinical question: How does edoxaban compare with enoxaparin-warfarin in patients with nonvalvular atrial fibrillation undergoing cardioversion?
Background: Studies on non–vitamin K antagonist oral anticoagulants (NOACs) for patients with nonvalvular atrial fibrillation undergoing cardioversion are limited.
Study design: Multicenter, prospective, randomized trial.
Setting: Nineteen countries at 239 study sites.
Synopsis: This trial compared edoxaban with enoxaparin-warfarin. The study was stratified by cardioversion approach, anticoagulant experience, selected edoxaban dose, and region. There were 2,199 patients, mean age was 64, mean CHA2DS2-VASc score was 2.6, and mean therapeutic time on warfarin was 70.8%.
The primary efficacy endpoint was a composite of stroke, systemic emboli, myocardial infarction, and cardiovascular mortality, which occurred in 5 (1%) patients in the edoxaban group versus 11 (1%) in the enoxaparin-warfarin group (odds ratio, 0.46; 95% CI, 0.12-1.43).
The primary safety endpoint was major and clinically relevant nonmajor bleeding for patients receiving at least one dose of the study drug, occurring in 16 (1%) of 1,067 patients given edoxaban versus 11 (1%) of 1,082 patients given enoxaparin-warfarin (OR, 1.48; 95% CI, 0.64-3.55).
Bottom line: In patients with nonvalvular atrial fibrillation undergoing cardioversion, edoxaban had low rates of major bleeding and thromboembolism similar to enoxaparin-warfarin therapy.
Citation: Goette A, Merino JL, Ezekowitz MD, et al. Edoxaban versus enoxaparin-warfarin in patients undergoing cardioversion of atrial fibrillation (ENSURE-AF): a randomised, open-label, phase 3b trial. Lancet. 2016;388(10055):1995-2003.
Dr. Fernandez de la Vara is an instructor at the University of Miami Miller School of Medicine and chief medical resident at the University of Miami Hospital.
Clinical question: How does edoxaban compare with enoxaparin-warfarin in patients with nonvalvular atrial fibrillation undergoing cardioversion?
Background: Studies on non–vitamin K antagonist oral anticoagulants (NOACs) for patients with nonvalvular atrial fibrillation undergoing cardioversion are limited.
Study design: Multicenter, prospective, randomized trial.
Setting: Nineteen countries at 239 study sites.
Synopsis: This trial compared edoxaban with enoxaparin-warfarin. The study was stratified by cardioversion approach, anticoagulant experience, selected edoxaban dose, and region. There were 2,199 patients, mean age was 64, mean CHA2DS2-VASc score was 2.6, and mean therapeutic time on warfarin was 70.8%.
The primary efficacy endpoint was a composite of stroke, systemic emboli, myocardial infarction, and cardiovascular mortality, which occurred in 5 (1%) patients in the edoxaban group versus 11 (1%) in the enoxaparin-warfarin group (odds ratio, 0.46; 95% CI, 0.12-1.43).
The primary safety endpoint was major and clinically relevant nonmajor bleeding for patients receiving at least one dose of the study drug, occurring in 16 (1%) of 1,067 patients given edoxaban versus 11 (1%) of 1,082 patients given enoxaparin-warfarin (OR, 1.48; 95% CI, 0.64-3.55).
Bottom line: In patients with nonvalvular atrial fibrillation undergoing cardioversion, edoxaban had low rates of major bleeding and thromboembolism similar to enoxaparin-warfarin therapy.
Citation: Goette A, Merino JL, Ezekowitz MD, et al. Edoxaban versus enoxaparin-warfarin in patients undergoing cardioversion of atrial fibrillation (ENSURE-AF): a randomised, open-label, phase 3b trial. Lancet. 2016;388(10055):1995-2003.
Dr. Fernandez de la Vara is an instructor at the University of Miami Miller School of Medicine and chief medical resident at the University of Miami Hospital.
Clinical question: How does edoxaban compare with enoxaparin-warfarin in patients with nonvalvular atrial fibrillation undergoing cardioversion?
Background: Studies on non–vitamin K antagonist oral anticoagulants (NOACs) for patients with nonvalvular atrial fibrillation undergoing cardioversion are limited.
Study design: Multicenter, prospective, randomized trial.
Setting: Nineteen countries at 239 study sites.
Synopsis: This trial compared edoxaban with enoxaparin-warfarin. The study was stratified by cardioversion approach, anticoagulant experience, selected edoxaban dose, and region. There were 2,199 patients, mean age was 64, mean CHA2DS2-VASc score was 2.6, and mean therapeutic time on warfarin was 70.8%.
The primary efficacy endpoint was a composite of stroke, systemic emboli, myocardial infarction, and cardiovascular mortality, which occurred in 5 (1%) patients in the edoxaban group versus 11 (1%) in the enoxaparin-warfarin group (odds ratio, 0.46; 95% CI, 0.12-1.43).
The primary safety endpoint was major and clinically relevant nonmajor bleeding for patients receiving at least one dose of the study drug, occurring in 16 (1%) of 1,067 patients given edoxaban versus 11 (1%) of 1,082 patients given enoxaparin-warfarin (OR, 1.48; 95% CI, 0.64-3.55).
Bottom line: In patients with nonvalvular atrial fibrillation undergoing cardioversion, edoxaban had low rates of major bleeding and thromboembolism similar to enoxaparin-warfarin therapy.
Citation: Goette A, Merino JL, Ezekowitz MD, et al. Edoxaban versus enoxaparin-warfarin in patients undergoing cardioversion of atrial fibrillation (ENSURE-AF): a randomised, open-label, phase 3b trial. Lancet. 2016;388(10055):1995-2003.
Dr. Fernandez de la Vara is an instructor at the University of Miami Miller School of Medicine and chief medical resident at the University of Miami Hospital.
Older adults can sustain asymptomatic cervical fractures
HOLLYWOOD, FLA. –
The 4-year review found that 21% of older patients with a confirmed C-spine fracture reported no pain on history or physical exam, and that 76% of these fractures needed treatment – twin findings suggesting that asymptomatic neck fractures may be undiagnosed and untreated in this population.
The 183-patient study also found no significant pain differences between age groups: The silent injuries were just as common among 55-year-olds as among 65-year-olds, Christopher Healey, MD, said at the annual scientific assembly of the Eastern Association for the Surgery of Trauma.
“I guess we can say, ‘55 is the new 65,’ when it comes to this injury,” said Dr. Healey of the Iowa Methodist Medical Center, Des Moines. “In our study the rate of a pain-free neck fracture in 55-year-olds was equivalent to that in their older counterpoints, so they also represent a group at increased risk.”
Dr. Healey and his colleagues conducted a 4-year review of trauma patients aged 55 years and older who were treated for a C-spine fracture. All of the patients had a Glasgow Coma 
There were no differences in the mechanism of injury between the pain-free and pain-positive groups. The most common source of injury was a fall from the person’s own height (39% vs. 49%), followed by a high fall (21% vs. 19%). Motor vehicle crashes came in third (37% vs. 30%), with other methods of injury accounting for about 3% of each group.
The level of fracture was widely dispersed among both groups and not associated with pain. Asymptomatic fractures occurred at C1 and C2 vertabrae (about 13%); C3 (26%); C4 (10%); C5 (12%); and C6 and C7 (30%).
Perhaps surprisingly, patients who didn’t report pain had significantly higher Injury Severity Scores (15 vs. 10). They were also significantly more likely to have injuries to other body regions (71% vs. 47%), including the head (22% vs. 16%), thorax/abdomen (39% vs. 20%), and extremities (33% vs. 20%).
A third of those with a pain-free fracture had breaks at multiple levels. Their hospital stays were significantly longer than were those of patients with painful fractures (7 vs. 5 days).
These findings of more severe injuries in the asymptomatic group led Dr. Healey to suggest that distracting pain might be playing a part in the phenomenon.
When the group was split into 10-year age increments, asymptomatic fractures occurred in about 20% of each group from 55-64 years up to 85 years and older.
The majority of both groups required treatment (91% with pain; 76% asymptomatic), Dr. Healey said. The most common treatment in each group was a cervical collar (61% with pain vs. 46% asymptomatic ). A cervical-thoracic-lumbar-sacral orthosis brace was used in 8% of those with pain and 11% of the asymptomatic patients.
Invasive procedures were performed in just as many of the asymptomatic patients as in those who had pain. These included vertebral fusion (11% asymptomatic vs. 9% with pain) and cervical halo (8% vs. 13%).
The lesson here, Dr. Healey concluded, is that pain is not always a reliable indicator of neck injury in older patients. “Older adults can break their neck and have no pain at all. This is concerning, because the presence or absence of neck pain is a major component in many clearance protocols for C-spine trauma. This begs the question whether we should be treating our older patients by general adult guidelines. I would advocate the development of trauma guidelines that are specific for the older or geriatric patient.”
Dr. Healey had no financial disclosures.
HOLLYWOOD, FLA. –
The 4-year review found that 21% of older patients with a confirmed C-spine fracture reported no pain on history or physical exam, and that 76% of these fractures needed treatment – twin findings suggesting that asymptomatic neck fractures may be undiagnosed and untreated in this population.
The 183-patient study also found no significant pain differences between age groups: The silent injuries were just as common among 55-year-olds as among 65-year-olds, Christopher Healey, MD, said at the annual scientific assembly of the Eastern Association for the Surgery of Trauma.
“I guess we can say, ‘55 is the new 65,’ when it comes to this injury,” said Dr. Healey of the Iowa Methodist Medical Center, Des Moines. “In our study the rate of a pain-free neck fracture in 55-year-olds was equivalent to that in their older counterpoints, so they also represent a group at increased risk.”
Dr. Healey and his colleagues conducted a 4-year review of trauma patients aged 55 years and older who were treated for a C-spine fracture. All of the patients had a Glasgow Coma
There were no differences in the mechanism of injury between the pain-free and pain-positive groups. The most common source of injury was a fall from the person’s own height (39% vs. 49%), followed by a high fall (21% vs. 19%). Motor vehicle crashes came in third (37% vs. 30%), with other methods of injury accounting for about 3% of each group.
The level of fracture was widely dispersed among both groups and not associated with pain. Asymptomatic fractures occurred at C1 and C2 vertabrae (about 13%); C3 (26%); C4 (10%); C5 (12%); and C6 and C7 (30%).
Perhaps surprisingly, patients who didn’t report pain had significantly higher Injury Severity Scores (15 vs. 10). They were also significantly more likely to have injuries to other body regions (71% vs. 47%), including the head (22% vs. 16%), thorax/abdomen (39% vs. 20%), and extremities (33% vs. 20%).
A third of those with a pain-free fracture had breaks at multiple levels. Their hospital stays were significantly longer than were those of patients with painful fractures (7 vs. 5 days).
These findings of more severe injuries in the asymptomatic group led Dr. Healey to suggest that distracting pain might be playing a part in the phenomenon.
When the group was split into 10-year age increments, asymptomatic fractures occurred in about 20% of each group from 55-64 years up to 85 years and older.
The majority of both groups required treatment (91% with pain; 76% asymptomatic), Dr. Healey said. The most common treatment in each group was a cervical collar (61% with pain vs. 46% asymptomatic ). A cervical-thoracic-lumbar-sacral orthosis brace was used in 8% of those with pain and 11% of the asymptomatic patients.
Invasive procedures were performed in just as many of the asymptomatic patients as in those who had pain. These included vertebral fusion (11% asymptomatic vs. 9% with pain) and cervical halo (8% vs. 13%).
The lesson here, Dr. Healey concluded, is that pain is not always a reliable indicator of neck injury in older patients. “Older adults can break their neck and have no pain at all. This is concerning, because the presence or absence of neck pain is a major component in many clearance protocols for C-spine trauma. This begs the question whether we should be treating our older patients by general adult guidelines. I would advocate the development of trauma guidelines that are specific for the older or geriatric patient.”
Dr. Healey had no financial disclosures.
HOLLYWOOD, FLA. –
The 4-year review found that 21% of older patients with a confirmed C-spine fracture reported no pain on history or physical exam, and that 76% of these fractures needed treatment – twin findings suggesting that asymptomatic neck fractures may be undiagnosed and untreated in this population.
The 183-patient study also found no significant pain differences between age groups: The silent injuries were just as common among 55-year-olds as among 65-year-olds, Christopher Healey, MD, said at the annual scientific assembly of the Eastern Association for the Surgery of Trauma.
“I guess we can say, ‘55 is the new 65,’ when it comes to this injury,” said Dr. Healey of the Iowa Methodist Medical Center, Des Moines. “In our study the rate of a pain-free neck fracture in 55-year-olds was equivalent to that in their older counterpoints, so they also represent a group at increased risk.”
Dr. Healey and his colleagues conducted a 4-year review of trauma patients aged 55 years and older who were treated for a C-spine fracture. All of the patients had a Glasgow Coma
There were no differences in the mechanism of injury between the pain-free and pain-positive groups. The most common source of injury was a fall from the person’s own height (39% vs. 49%), followed by a high fall (21% vs. 19%). Motor vehicle crashes came in third (37% vs. 30%), with other methods of injury accounting for about 3% of each group.
The level of fracture was widely dispersed among both groups and not associated with pain. Asymptomatic fractures occurred at C1 and C2 vertabrae (about 13%); C3 (26%); C4 (10%); C5 (12%); and C6 and C7 (30%).
Perhaps surprisingly, patients who didn’t report pain had significantly higher Injury Severity Scores (15 vs. 10). They were also significantly more likely to have injuries to other body regions (71% vs. 47%), including the head (22% vs. 16%), thorax/abdomen (39% vs. 20%), and extremities (33% vs. 20%).
A third of those with a pain-free fracture had breaks at multiple levels. Their hospital stays were significantly longer than were those of patients with painful fractures (7 vs. 5 days).
These findings of more severe injuries in the asymptomatic group led Dr. Healey to suggest that distracting pain might be playing a part in the phenomenon.
When the group was split into 10-year age increments, asymptomatic fractures occurred in about 20% of each group from 55-64 years up to 85 years and older.
The majority of both groups required treatment (91% with pain; 76% asymptomatic), Dr. Healey said. The most common treatment in each group was a cervical collar (61% with pain vs. 46% asymptomatic ). A cervical-thoracic-lumbar-sacral orthosis brace was used in 8% of those with pain and 11% of the asymptomatic patients.
Invasive procedures were performed in just as many of the asymptomatic patients as in those who had pain. These included vertebral fusion (11% asymptomatic vs. 9% with pain) and cervical halo (8% vs. 13%).
The lesson here, Dr. Healey concluded, is that pain is not always a reliable indicator of neck injury in older patients. “Older adults can break their neck and have no pain at all. This is concerning, because the presence or absence of neck pain is a major component in many clearance protocols for C-spine trauma. This begs the question whether we should be treating our older patients by general adult guidelines. I would advocate the development of trauma guidelines that are specific for the older or geriatric patient.”
Dr. Healey had no financial disclosures.
Key clinical point: Older trauma patients can present with pain-free cervical fractures. Major finding: Cervical fractures were asymptomatic in 21% of the study group; of these, 76% required treatment.
Data source: The 4-year retrospective study comprised 183 older patients with confirmed cervical fractures.
Disclosures: Dr. Healey had no financial disclosures.