Dual SGLT1-2 inhibitor improved glycemic control in T1DM

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The addition of 400 mg daily sotagliflozin to optimized insulin therapy significantly improved the chances of lowering hemoglobin A1c levels to less than 7% without severe diabetic ketoacidosis or hypoglycemia, compared with placebo, in a pivotal phase III trial of adults with type 1 diabetes.

After 24 weeks, 58 (22%) of patients on placebo achieved this combined endpoint, compared with 44% of patients who received 400 mg oral daily sotagliflozin (P less than .001) and 34% of those who received 200 mg (P = .002), John B. Buse, MD, PhD, reported at the annual scientific sessions of the American Diabetes Association. “Sotagliflozin significantly reduced hemoglobin A1c in the setting of optimized insulin therapy, with a safety profile that supports further clinical development,” said Dr. Buse, lead investigator of the Tandem1 trial.

Amy Karon/Frontline Medical News
Dr. John B. Buse
Sotagliflozin (LX4211, Lexicon Pharmaceuticals) is an oral dual inhibitor of sodium-glucose transporter 1 (SGLT1), which is the main gastrointestinal transporter of glucose and galactose, and SGLT2, which handles 90% of renal glucose reabsorption, said Dr. Buse, professor of medicine at the University of North Carolina at Chapel Hill. “Inhibition of SGLT1 is done locally as the pill tumbles through the gastrointestinal tract, while SGLT2 inhibition is systemic,” he added. During a phase II placebo-controlled, dose-ranging trial – Tandem4 – patients with type 1 diabetes who received sotagliflozin plus optimized insulin for 12 weeks experienced significant reductions in HbA1c levels, significant rises in 24-hour urinary glucose excretion, and modest but statistically significant, dose-dependent decreases in body weight. However, as a group, sotagliflozin recipients also had three episodes of severe hypoglycemia and one episode of diabetic ketoacidosis (DKA), compared with one episode of DKA and none of severe hypoglycemia during the placebo run-in period.

To further evaluate the efficacy and safety of adjunctive sotagliflozin for type 1 diabetes, Dr. Buse and his associates randomly assigned 793 patients from 75 North American sites to receive either placebo or treatment at 200 mg or 400 mg for 24 weeks. Patients and investigators were blinded as to treatment arm. Patients received optimized insulin, and the trial arms were demographically and clinically similar at baseline. The average age was 46 years, mean body mass index was 30 kg per m2, average daily insulin dose was 0.73 U per kg, and mean baseline HbA1c was 7.58 % (standard deviation, 0.73%).

By week 24, HbA1c levels fell by an average of 8% on placebo, 43% on 200 mg sotagliflozin, and 49% on 400 mg sotagliflozin, Dr. Buse reported. “The decrease from baseline was highly significant at both doses of sotagliflozin, compared with placebo,” he noted. Adjunctive sotagliflozin therapy also led to significant reductions in bolus insulin doses, fasting blood glucose levels, and body weight as compared with placebo. Drops in body weight averaged 1.6 kg at 200 mg and 2.7 kg at 400 mg, while placebo patients gained an average of 0.8 kg.

There were no deaths during the trial. Rates of treatment-associated adverse events were similar across groups, and serious adverse events affected 3% of placebo patients, 4% of 200-mg patients, and 7% of 400-mg patients. In all, 7% of placebo recipients experienced severe hypoglycemia, compared with 4%-5% of patients on sotagliflozin. The incidence of DKA was 0% on placebo and 1%-3% on sotagliflozin, with a higher rate among patients on pumps, Dr. Buse noted. Most cases of DKA were considered mildly to moderately severe, with blood glucose levels under 250 mg per dL, he added. Sotagliflozin also was associated with dose-dependent increases in rates of diarrhea and genital mycotic infections, which reached about 10% in the 400-mg arm. However, less than 1% of patients stopped treatment because of either adverse event.

“This is the first report of a successful phase III trial of an oral antidiabetic as an adjunct to insulin therapy for type 1 diabetes,” Dr. Buse commented. Sotagliflozin met all prespecified endpoints in the trial, and the 400-mg dose significantly outperformed placebo on each endpoint, he added. A second phase III trial of sotagliflozin (inTandem2) is ongoing, and investigators plan to present pooled data from both trials later this year. Meanwhile, a third phase III trial (inTandem3) is comparing 400 mg sotagliflozin or placebo for patients receiving any type of insulin therapy.

Lexicon Pharmaceuticals developed sotagliflozin and funded the study. Dr. Buse disclosed research funding from Lexicon, AstraZeneca, Boehringer Ingelheim Pharmaceuticals, and several other pharmaceutical companies.

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The addition of 400 mg daily sotagliflozin to optimized insulin therapy significantly improved the chances of lowering hemoglobin A1c levels to less than 7% without severe diabetic ketoacidosis or hypoglycemia, compared with placebo, in a pivotal phase III trial of adults with type 1 diabetes.

After 24 weeks, 58 (22%) of patients on placebo achieved this combined endpoint, compared with 44% of patients who received 400 mg oral daily sotagliflozin (P less than .001) and 34% of those who received 200 mg (P = .002), John B. Buse, MD, PhD, reported at the annual scientific sessions of the American Diabetes Association. “Sotagliflozin significantly reduced hemoglobin A1c in the setting of optimized insulin therapy, with a safety profile that supports further clinical development,” said Dr. Buse, lead investigator of the Tandem1 trial.

Amy Karon/Frontline Medical News
Dr. John B. Buse
Sotagliflozin (LX4211, Lexicon Pharmaceuticals) is an oral dual inhibitor of sodium-glucose transporter 1 (SGLT1), which is the main gastrointestinal transporter of glucose and galactose, and SGLT2, which handles 90% of renal glucose reabsorption, said Dr. Buse, professor of medicine at the University of North Carolina at Chapel Hill. “Inhibition of SGLT1 is done locally as the pill tumbles through the gastrointestinal tract, while SGLT2 inhibition is systemic,” he added. During a phase II placebo-controlled, dose-ranging trial – Tandem4 – patients with type 1 diabetes who received sotagliflozin plus optimized insulin for 12 weeks experienced significant reductions in HbA1c levels, significant rises in 24-hour urinary glucose excretion, and modest but statistically significant, dose-dependent decreases in body weight. However, as a group, sotagliflozin recipients also had three episodes of severe hypoglycemia and one episode of diabetic ketoacidosis (DKA), compared with one episode of DKA and none of severe hypoglycemia during the placebo run-in period.

To further evaluate the efficacy and safety of adjunctive sotagliflozin for type 1 diabetes, Dr. Buse and his associates randomly assigned 793 patients from 75 North American sites to receive either placebo or treatment at 200 mg or 400 mg for 24 weeks. Patients and investigators were blinded as to treatment arm. Patients received optimized insulin, and the trial arms were demographically and clinically similar at baseline. The average age was 46 years, mean body mass index was 30 kg per m2, average daily insulin dose was 0.73 U per kg, and mean baseline HbA1c was 7.58 % (standard deviation, 0.73%).

By week 24, HbA1c levels fell by an average of 8% on placebo, 43% on 200 mg sotagliflozin, and 49% on 400 mg sotagliflozin, Dr. Buse reported. “The decrease from baseline was highly significant at both doses of sotagliflozin, compared with placebo,” he noted. Adjunctive sotagliflozin therapy also led to significant reductions in bolus insulin doses, fasting blood glucose levels, and body weight as compared with placebo. Drops in body weight averaged 1.6 kg at 200 mg and 2.7 kg at 400 mg, while placebo patients gained an average of 0.8 kg.

There were no deaths during the trial. Rates of treatment-associated adverse events were similar across groups, and serious adverse events affected 3% of placebo patients, 4% of 200-mg patients, and 7% of 400-mg patients. In all, 7% of placebo recipients experienced severe hypoglycemia, compared with 4%-5% of patients on sotagliflozin. The incidence of DKA was 0% on placebo and 1%-3% on sotagliflozin, with a higher rate among patients on pumps, Dr. Buse noted. Most cases of DKA were considered mildly to moderately severe, with blood glucose levels under 250 mg per dL, he added. Sotagliflozin also was associated with dose-dependent increases in rates of diarrhea and genital mycotic infections, which reached about 10% in the 400-mg arm. However, less than 1% of patients stopped treatment because of either adverse event.

“This is the first report of a successful phase III trial of an oral antidiabetic as an adjunct to insulin therapy for type 1 diabetes,” Dr. Buse commented. Sotagliflozin met all prespecified endpoints in the trial, and the 400-mg dose significantly outperformed placebo on each endpoint, he added. A second phase III trial of sotagliflozin (inTandem2) is ongoing, and investigators plan to present pooled data from both trials later this year. Meanwhile, a third phase III trial (inTandem3) is comparing 400 mg sotagliflozin or placebo for patients receiving any type of insulin therapy.

Lexicon Pharmaceuticals developed sotagliflozin and funded the study. Dr. Buse disclosed research funding from Lexicon, AstraZeneca, Boehringer Ingelheim Pharmaceuticals, and several other pharmaceutical companies.

 

The addition of 400 mg daily sotagliflozin to optimized insulin therapy significantly improved the chances of lowering hemoglobin A1c levels to less than 7% without severe diabetic ketoacidosis or hypoglycemia, compared with placebo, in a pivotal phase III trial of adults with type 1 diabetes.

After 24 weeks, 58 (22%) of patients on placebo achieved this combined endpoint, compared with 44% of patients who received 400 mg oral daily sotagliflozin (P less than .001) and 34% of those who received 200 mg (P = .002), John B. Buse, MD, PhD, reported at the annual scientific sessions of the American Diabetes Association. “Sotagliflozin significantly reduced hemoglobin A1c in the setting of optimized insulin therapy, with a safety profile that supports further clinical development,” said Dr. Buse, lead investigator of the Tandem1 trial.

Amy Karon/Frontline Medical News
Dr. John B. Buse
Sotagliflozin (LX4211, Lexicon Pharmaceuticals) is an oral dual inhibitor of sodium-glucose transporter 1 (SGLT1), which is the main gastrointestinal transporter of glucose and galactose, and SGLT2, which handles 90% of renal glucose reabsorption, said Dr. Buse, professor of medicine at the University of North Carolina at Chapel Hill. “Inhibition of SGLT1 is done locally as the pill tumbles through the gastrointestinal tract, while SGLT2 inhibition is systemic,” he added. During a phase II placebo-controlled, dose-ranging trial – Tandem4 – patients with type 1 diabetes who received sotagliflozin plus optimized insulin for 12 weeks experienced significant reductions in HbA1c levels, significant rises in 24-hour urinary glucose excretion, and modest but statistically significant, dose-dependent decreases in body weight. However, as a group, sotagliflozin recipients also had three episodes of severe hypoglycemia and one episode of diabetic ketoacidosis (DKA), compared with one episode of DKA and none of severe hypoglycemia during the placebo run-in period.

To further evaluate the efficacy and safety of adjunctive sotagliflozin for type 1 diabetes, Dr. Buse and his associates randomly assigned 793 patients from 75 North American sites to receive either placebo or treatment at 200 mg or 400 mg for 24 weeks. Patients and investigators were blinded as to treatment arm. Patients received optimized insulin, and the trial arms were demographically and clinically similar at baseline. The average age was 46 years, mean body mass index was 30 kg per m2, average daily insulin dose was 0.73 U per kg, and mean baseline HbA1c was 7.58 % (standard deviation, 0.73%).

By week 24, HbA1c levels fell by an average of 8% on placebo, 43% on 200 mg sotagliflozin, and 49% on 400 mg sotagliflozin, Dr. Buse reported. “The decrease from baseline was highly significant at both doses of sotagliflozin, compared with placebo,” he noted. Adjunctive sotagliflozin therapy also led to significant reductions in bolus insulin doses, fasting blood glucose levels, and body weight as compared with placebo. Drops in body weight averaged 1.6 kg at 200 mg and 2.7 kg at 400 mg, while placebo patients gained an average of 0.8 kg.

There were no deaths during the trial. Rates of treatment-associated adverse events were similar across groups, and serious adverse events affected 3% of placebo patients, 4% of 200-mg patients, and 7% of 400-mg patients. In all, 7% of placebo recipients experienced severe hypoglycemia, compared with 4%-5% of patients on sotagliflozin. The incidence of DKA was 0% on placebo and 1%-3% on sotagliflozin, with a higher rate among patients on pumps, Dr. Buse noted. Most cases of DKA were considered mildly to moderately severe, with blood glucose levels under 250 mg per dL, he added. Sotagliflozin also was associated with dose-dependent increases in rates of diarrhea and genital mycotic infections, which reached about 10% in the 400-mg arm. However, less than 1% of patients stopped treatment because of either adverse event.

“This is the first report of a successful phase III trial of an oral antidiabetic as an adjunct to insulin therapy for type 1 diabetes,” Dr. Buse commented. Sotagliflozin met all prespecified endpoints in the trial, and the 400-mg dose significantly outperformed placebo on each endpoint, he added. A second phase III trial of sotagliflozin (inTandem2) is ongoing, and investigators plan to present pooled data from both trials later this year. Meanwhile, a third phase III trial (inTandem3) is comparing 400 mg sotagliflozin or placebo for patients receiving any type of insulin therapy.

Lexicon Pharmaceuticals developed sotagliflozin and funded the study. Dr. Buse disclosed research funding from Lexicon, AstraZeneca, Boehringer Ingelheim Pharmaceuticals, and several other pharmaceutical companies.

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Key clinical point: Augmenting optimized insulin with a dual SGLT1-2 inhibitor significantly increased the chances of improved glycemic control without severe hypoglycemia or diabetic ketoacidosis in adults with type 1 diabetes.

Major finding: After 24 weeks, 22% of the placebo group achieved this combined endpoint, compared with 44% of patients receiving 400 mg oral daily sotagliflozin (P less than .001) and 34% of patients receiving 200 mg (P = .002).

Data source: A multicenter, randomized, double-blind phase III trial of 793 adults with type 1 diabetes.

Disclosures: Lexicon Pharmaceuticals developed sotagliflozin and funded the study. Dr. Buse disclosed research funding from Lexicon, AstraZeneca, Boehringer Ingelheim Pharmaceuticals, and several other pharmaceutical companies.

Majority of AML patients do not receive recommended molecular genetic testing

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Majority of AML patients do not receive recommended molecular genetic testing

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CHICAGO—While 67% of newly diagnosed patients with acute myeloid leukemia (AML) receive some genetic testing, only 9% receive all 7 of the genetic tests recommended by the National Comprehensive Cancer Network (NCCN), according to new research.

The data comes from the CONNECT MDS/AML Disease Registry, which collects treatment and outcome statistics from 86 sites across the United States, both academic medical centers and community settings. The findings reflect data gathered from 2013 to 2016.

Previously, data on genetic testing in AML patients came primarily from clinical trials, where adherence to guidelines is very high. The current analysis evaluated adherence to genetic testing guidelines in AML treated outside the clinic trial setting.

Daniel A. Pollyea, MD, of the University of Colorado Comprehensive Cancer Center in Aurora, presented the findings on behalf of the CONNECT MDS/AML Disease Registry Scientific Steering Committee (abstract 7022).

The CONNECT registry is a US prospective, observational cohort study of patients with newly diagnosed AML or myelodysplastic syndromes (MDS) aged 55 years or older. Enrollment is ongoing and study clinicians make all clinical decisions.

NCCN guidelines recommend testing AML patients for NPM1, FLT3-ITD, CEBPA, IDH1, IDH2, DNMT3A, and KIT mutations.

“We now know a tremendous amount about the genetic underpinnings of the disease,” Dr Pollyea said.

“We can test for these genetic changes in the clinic to see what’s making a patient’s disease tick. And often there are targeted therapies that can be matched with these genetic changes," he added. "But there’s a disconnect between what can be done, what should be done, and what is being done.”

The current analysis evaluated genetic testing in 259 AML patients, 173 (67%) of whom had some genetic testing.

The likelihood of patients getting tested varied by type of treatment center, age, karyotype, and insurance.

Patients treated at academic medical centers had higher rates of testing than those treated at community clinics (76% and 62%, respectively), P= 0.018

Patients younger than 65 years more often were tested than older patients (83% and 60%, respectively), P= 0.0003.

Patients with non-Medicare insurance were more often tested than those with Medicare (74% and 61%, respectively), P= .025.

And patients with normal karyotype were more often tested than those with abnormal karyotype (77% and 59%, respectively), P= 0.006.

Of the 173 patients who had some genetic testing, only 15 (9%) had all the molecular tests recommended by NCCN.

Of the 7 recommended tests, NPM1 (77%) and FLT3-ITD (76%) were most often reported and DNMT3A least often (16%).

Dr Pollyea attributed the lack of adherence to the guidelines in part to willingness of insurance companies to pay for testing.

He also suggested the guidelines themselves might need adjustment, given the low adherence rate.

Nevertheless, he affirmed the guidelines are well founded. “I think the guidelines are pretty solid and, in my opinion, I would say they don’t go far enough in recommending genetic testing.”

“We’re in our infancy with this testing, and even earlier than infancy in seeing how we’re doing on testing. But now with this registry we at least have the infrastructure available to ask these kinds of questions,” Dr Pollyea added. 

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CHICAGO—While 67% of newly diagnosed patients with acute myeloid leukemia (AML) receive some genetic testing, only 9% receive all 7 of the genetic tests recommended by the National Comprehensive Cancer Network (NCCN), according to new research.

The data comes from the CONNECT MDS/AML Disease Registry, which collects treatment and outcome statistics from 86 sites across the United States, both academic medical centers and community settings. The findings reflect data gathered from 2013 to 2016.

Previously, data on genetic testing in AML patients came primarily from clinical trials, where adherence to guidelines is very high. The current analysis evaluated adherence to genetic testing guidelines in AML treated outside the clinic trial setting.

Daniel A. Pollyea, MD, of the University of Colorado Comprehensive Cancer Center in Aurora, presented the findings on behalf of the CONNECT MDS/AML Disease Registry Scientific Steering Committee (abstract 7022).

The CONNECT registry is a US prospective, observational cohort study of patients with newly diagnosed AML or myelodysplastic syndromes (MDS) aged 55 years or older. Enrollment is ongoing and study clinicians make all clinical decisions.

NCCN guidelines recommend testing AML patients for NPM1, FLT3-ITD, CEBPA, IDH1, IDH2, DNMT3A, and KIT mutations.

“We now know a tremendous amount about the genetic underpinnings of the disease,” Dr Pollyea said.

“We can test for these genetic changes in the clinic to see what’s making a patient’s disease tick. And often there are targeted therapies that can be matched with these genetic changes," he added. "But there’s a disconnect between what can be done, what should be done, and what is being done.”

The current analysis evaluated genetic testing in 259 AML patients, 173 (67%) of whom had some genetic testing.

The likelihood of patients getting tested varied by type of treatment center, age, karyotype, and insurance.

Patients treated at academic medical centers had higher rates of testing than those treated at community clinics (76% and 62%, respectively), P= 0.018

Patients younger than 65 years more often were tested than older patients (83% and 60%, respectively), P= 0.0003.

Patients with non-Medicare insurance were more often tested than those with Medicare (74% and 61%, respectively), P= .025.

And patients with normal karyotype were more often tested than those with abnormal karyotype (77% and 59%, respectively), P= 0.006.

Of the 173 patients who had some genetic testing, only 15 (9%) had all the molecular tests recommended by NCCN.

Of the 7 recommended tests, NPM1 (77%) and FLT3-ITD (76%) were most often reported and DNMT3A least often (16%).

Dr Pollyea attributed the lack of adherence to the guidelines in part to willingness of insurance companies to pay for testing.

He also suggested the guidelines themselves might need adjustment, given the low adherence rate.

Nevertheless, he affirmed the guidelines are well founded. “I think the guidelines are pretty solid and, in my opinion, I would say they don’t go far enough in recommending genetic testing.”

“We’re in our infancy with this testing, and even earlier than infancy in seeing how we’re doing on testing. But now with this registry we at least have the infrastructure available to ask these kinds of questions,” Dr Pollyea added. 

General Medical Sciences
DNA helices Image courtesy of the National Institute of

CHICAGO—While 67% of newly diagnosed patients with acute myeloid leukemia (AML) receive some genetic testing, only 9% receive all 7 of the genetic tests recommended by the National Comprehensive Cancer Network (NCCN), according to new research.

The data comes from the CONNECT MDS/AML Disease Registry, which collects treatment and outcome statistics from 86 sites across the United States, both academic medical centers and community settings. The findings reflect data gathered from 2013 to 2016.

Previously, data on genetic testing in AML patients came primarily from clinical trials, where adherence to guidelines is very high. The current analysis evaluated adherence to genetic testing guidelines in AML treated outside the clinic trial setting.

Daniel A. Pollyea, MD, of the University of Colorado Comprehensive Cancer Center in Aurora, presented the findings on behalf of the CONNECT MDS/AML Disease Registry Scientific Steering Committee (abstract 7022).

The CONNECT registry is a US prospective, observational cohort study of patients with newly diagnosed AML or myelodysplastic syndromes (MDS) aged 55 years or older. Enrollment is ongoing and study clinicians make all clinical decisions.

NCCN guidelines recommend testing AML patients for NPM1, FLT3-ITD, CEBPA, IDH1, IDH2, DNMT3A, and KIT mutations.

“We now know a tremendous amount about the genetic underpinnings of the disease,” Dr Pollyea said.

“We can test for these genetic changes in the clinic to see what’s making a patient’s disease tick. And often there are targeted therapies that can be matched with these genetic changes," he added. "But there’s a disconnect between what can be done, what should be done, and what is being done.”

The current analysis evaluated genetic testing in 259 AML patients, 173 (67%) of whom had some genetic testing.

The likelihood of patients getting tested varied by type of treatment center, age, karyotype, and insurance.

Patients treated at academic medical centers had higher rates of testing than those treated at community clinics (76% and 62%, respectively), P= 0.018

Patients younger than 65 years more often were tested than older patients (83% and 60%, respectively), P= 0.0003.

Patients with non-Medicare insurance were more often tested than those with Medicare (74% and 61%, respectively), P= .025.

And patients with normal karyotype were more often tested than those with abnormal karyotype (77% and 59%, respectively), P= 0.006.

Of the 173 patients who had some genetic testing, only 15 (9%) had all the molecular tests recommended by NCCN.

Of the 7 recommended tests, NPM1 (77%) and FLT3-ITD (76%) were most often reported and DNMT3A least often (16%).

Dr Pollyea attributed the lack of adherence to the guidelines in part to willingness of insurance companies to pay for testing.

He also suggested the guidelines themselves might need adjustment, given the low adherence rate.

Nevertheless, he affirmed the guidelines are well founded. “I think the guidelines are pretty solid and, in my opinion, I would say they don’t go far enough in recommending genetic testing.”

“We’re in our infancy with this testing, and even earlier than infancy in seeing how we’re doing on testing. But now with this registry we at least have the infrastructure available to ask these kinds of questions,” Dr Pollyea added. 

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Bedside CGM boosts glucose control in hospital

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BY RANDY DOTINGA

– Bedside continuous glucose monitoring (CGM) with a wireless hookup to a response team allowed doctors and nurses to gain better blood sugar control in hospitalized high-risk patients with diabetes, according to research reported at the annual scientific sessions of the American Diabetes Association.

“Continuous glucose monitoring and wireless connections can be useful in the hospital setting, not just in the outpatient setting,” said Maria Isabel Garcia, RN, of Scripps Whittier Diabetes Institute. “They help us to prevent problems rather than fixing them after they happen.”

Randy Dotinga/Frontline Medical News
Maria Isabel Garcia
Normally, nurses at Scripps Mercy Hospital in Chula Vista, Calif., measure the glucose of hospitalized patients four times a day through finger sticks. But this makes it difficult to closely monitor significant swings in glucose levels, especially after patients are treated with insulin, she said in an interview.

Research suggests that complications due to dangerous blood sugar levels can lead to longer hospital stays, she noted.

For the study, researchers assigned 45 high-risk hospitalized patients with type 2 diabetes to be monitored by DexCom G4 CGM devices. The patients were being treated for a variety of conditions, and all were expected to be hospitalized for more than 2 days.

Researchers housed the normal-sized CGM devices in toolbox-sized containers at bedside. “We don’t want the equipment to get misplaced if the patient has to go from room to room or if the patient is discharged and takes the equipment by mistake,” Ms. Garcia said.

The patients were 43-82 years old (median, 61.4 years; standard deviation, 9.8), 56% male, 73% Hispanic (with 60% preferring to speak Spanish). The mean hemoglobin A1c was 10.2% (SD, 2.3), and the mean body mass index was 32.9 (SD, 8).

The patients were randomized to two groups. In both, the CGM devices were operative and tracked blood sugar levels. In one group, the information was transmitted via wireless hookup to a team of researchers (during the day) or a telemetry team (at night), who were alerted via alarms if blood sugar levels seemed too high or low. The teams would then alert nurses who’d confirm the levels via bedside testing and take appropriate action.

CGM data were gathered from the patients for an average of 4.2 days each (SD, 2.49; range 2-10), and the number of readings per patient ranged from 102 to 2,334 each (median 859.4; SD, 627.8).

The findings suggest that wireless transmission of CGM allowed hospital staff to improve blood sugar control. Readings under 70 mg/dL occurred 0.7% of the time in patients monitored via wireless hookup and 1.4% in the others. Readings over 250 mg/dL appeared 9.8% and 13.2% of the time, respectively and readings over 300 mg/dL appeared 2.6% and 5.1% of the time, respectively.

The investigators plan to recruit 460 patients for the study, Ms. Garcia said. Results may be available within a couple of years, she said.

DexCom provided the CGM devices for the study, which was funded by Diabetes Research Connection and the Confidence Foundation. Ms. Garcia reports no disclosures.
 

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BY RANDY DOTINGA

– Bedside continuous glucose monitoring (CGM) with a wireless hookup to a response team allowed doctors and nurses to gain better blood sugar control in hospitalized high-risk patients with diabetes, according to research reported at the annual scientific sessions of the American Diabetes Association.

“Continuous glucose monitoring and wireless connections can be useful in the hospital setting, not just in the outpatient setting,” said Maria Isabel Garcia, RN, of Scripps Whittier Diabetes Institute. “They help us to prevent problems rather than fixing them after they happen.”

Randy Dotinga/Frontline Medical News
Maria Isabel Garcia
Normally, nurses at Scripps Mercy Hospital in Chula Vista, Calif., measure the glucose of hospitalized patients four times a day through finger sticks. But this makes it difficult to closely monitor significant swings in glucose levels, especially after patients are treated with insulin, she said in an interview.

Research suggests that complications due to dangerous blood sugar levels can lead to longer hospital stays, she noted.

For the study, researchers assigned 45 high-risk hospitalized patients with type 2 diabetes to be monitored by DexCom G4 CGM devices. The patients were being treated for a variety of conditions, and all were expected to be hospitalized for more than 2 days.

Researchers housed the normal-sized CGM devices in toolbox-sized containers at bedside. “We don’t want the equipment to get misplaced if the patient has to go from room to room or if the patient is discharged and takes the equipment by mistake,” Ms. Garcia said.

The patients were 43-82 years old (median, 61.4 years; standard deviation, 9.8), 56% male, 73% Hispanic (with 60% preferring to speak Spanish). The mean hemoglobin A1c was 10.2% (SD, 2.3), and the mean body mass index was 32.9 (SD, 8).

The patients were randomized to two groups. In both, the CGM devices were operative and tracked blood sugar levels. In one group, the information was transmitted via wireless hookup to a team of researchers (during the day) or a telemetry team (at night), who were alerted via alarms if blood sugar levels seemed too high or low. The teams would then alert nurses who’d confirm the levels via bedside testing and take appropriate action.

CGM data were gathered from the patients for an average of 4.2 days each (SD, 2.49; range 2-10), and the number of readings per patient ranged from 102 to 2,334 each (median 859.4; SD, 627.8).

The findings suggest that wireless transmission of CGM allowed hospital staff to improve blood sugar control. Readings under 70 mg/dL occurred 0.7% of the time in patients monitored via wireless hookup and 1.4% in the others. Readings over 250 mg/dL appeared 9.8% and 13.2% of the time, respectively and readings over 300 mg/dL appeared 2.6% and 5.1% of the time, respectively.

The investigators plan to recruit 460 patients for the study, Ms. Garcia said. Results may be available within a couple of years, she said.

DexCom provided the CGM devices for the study, which was funded by Diabetes Research Connection and the Confidence Foundation. Ms. Garcia reports no disclosures.
 

 

BY RANDY DOTINGA

– Bedside continuous glucose monitoring (CGM) with a wireless hookup to a response team allowed doctors and nurses to gain better blood sugar control in hospitalized high-risk patients with diabetes, according to research reported at the annual scientific sessions of the American Diabetes Association.

“Continuous glucose monitoring and wireless connections can be useful in the hospital setting, not just in the outpatient setting,” said Maria Isabel Garcia, RN, of Scripps Whittier Diabetes Institute. “They help us to prevent problems rather than fixing them after they happen.”

Randy Dotinga/Frontline Medical News
Maria Isabel Garcia
Normally, nurses at Scripps Mercy Hospital in Chula Vista, Calif., measure the glucose of hospitalized patients four times a day through finger sticks. But this makes it difficult to closely monitor significant swings in glucose levels, especially after patients are treated with insulin, she said in an interview.

Research suggests that complications due to dangerous blood sugar levels can lead to longer hospital stays, she noted.

For the study, researchers assigned 45 high-risk hospitalized patients with type 2 diabetes to be monitored by DexCom G4 CGM devices. The patients were being treated for a variety of conditions, and all were expected to be hospitalized for more than 2 days.

Researchers housed the normal-sized CGM devices in toolbox-sized containers at bedside. “We don’t want the equipment to get misplaced if the patient has to go from room to room or if the patient is discharged and takes the equipment by mistake,” Ms. Garcia said.

The patients were 43-82 years old (median, 61.4 years; standard deviation, 9.8), 56% male, 73% Hispanic (with 60% preferring to speak Spanish). The mean hemoglobin A1c was 10.2% (SD, 2.3), and the mean body mass index was 32.9 (SD, 8).

The patients were randomized to two groups. In both, the CGM devices were operative and tracked blood sugar levels. In one group, the information was transmitted via wireless hookup to a team of researchers (during the day) or a telemetry team (at night), who were alerted via alarms if blood sugar levels seemed too high or low. The teams would then alert nurses who’d confirm the levels via bedside testing and take appropriate action.

CGM data were gathered from the patients for an average of 4.2 days each (SD, 2.49; range 2-10), and the number of readings per patient ranged from 102 to 2,334 each (median 859.4; SD, 627.8).

The findings suggest that wireless transmission of CGM allowed hospital staff to improve blood sugar control. Readings under 70 mg/dL occurred 0.7% of the time in patients monitored via wireless hookup and 1.4% in the others. Readings over 250 mg/dL appeared 9.8% and 13.2% of the time, respectively and readings over 300 mg/dL appeared 2.6% and 5.1% of the time, respectively.

The investigators plan to recruit 460 patients for the study, Ms. Garcia said. Results may be available within a couple of years, she said.

DexCom provided the CGM devices for the study, which was funded by Diabetes Research Connection and the Confidence Foundation. Ms. Garcia reports no disclosures.
 

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Key clinical point: Blood sugar control in hospitalized patients seems to improve when continuous glucose monitoring devices with a wireless hookup provide alerts to a response team about high or low readings.

Major finding: Readings under 70 mg/dL occurred 0.7% of the time in patients monitored via wireless hookup and 1.4% in other patients. Readings over 250 mg/dL appeared 9.8% and 13.2% of the time, respectively, and readings over 300 mg/dL appeared 2.6% and 5.1% of the time, respectively.

Data source: Early results from a pilot randomized, controlled study of 45 hospitalized, high-risk patients with type 2 diabetes. CGM devices measured glucose levels in all patients, but they were only transmitted via wireless hookup to teams in one group.

Disclosures: DexCom provided the CGM machines for the study, which was funded by Diabetes Research Connection and the Confidence Foundation. Garcia reports no disclosures.
 

Rapid culture, stewardship improve S. aureus bacteremia outcomes

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– Community hospitals could see positive outcomes using a Staphylococcus aureus bacteremia strategy that combines rapid blood cultures to speed diagnosis with antibiotic stewardship to guide treatment.

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– Community hospitals could see positive outcomes using a Staphylococcus aureus bacteremia strategy that combines rapid blood cultures to speed diagnosis with antibiotic stewardship to guide treatment.

 

– Community hospitals could see positive outcomes using a Staphylococcus aureus bacteremia strategy that combines rapid blood cultures to speed diagnosis with antibiotic stewardship to guide treatment.

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Key clinical point: Community hospitals could see positive outcomes using a Staphylococcus aureus bacteremia strategy combining rapid blood cultures with antibiotic stewardship.

Major finding: 30-day mortality dropped from 15.6% prior to the protocol to 13.3% after implementation.

Data source: A retrospective comparison of 33 patients receiving traditional diagnosis and management versus 33 others with a new rapid blood culture and stewardship program approach.

Disclosures: Dr. Roiko had no relevant financial disclosures.

Routine blood glucose monitoring does not improve control or QOL

No benefits from routine blood glucose monitoring
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Self-monitoring of blood glucose in patients with non–insulin-treated type 2 diabetes mellitus (T2DM) does not appear to make any difference to blood glucose control or quality of life, a new study has found.

The researchers report the results of the Monitor Trial in which 418 patients with non–insulin-treated T2DM were randomized either to once-daily self-monitoring of blood glucose with automatic tailored messages, once-daily monitoring with no messages, and no monitoring. Their report appears in the June 10 online edition of JAMA Internal Medicine, timed to appear simultaneously with the data’s presentation at the annual meeting of the American Diabetes Association

After 1 year, there were no significant differences in hemoglobin A1c levels or health-related quality of life measures – either physical or mental – between the three groups (JAMA Intern Med. 2017 Jun 10. doi: 10.1001/jamainternmed.
2017.1233
).

Researchers also saw no significant differences in rates of insulin initiation, the incidence of hypoglycemia, or health care utilization.

“This null result occurred despite training participants and primary care clinicians on the use and interpretation of the meter results,” wrote Laura A. Young, MD, of the University of North Carolina at Chapel Hill.

While the findings reflect data from earlier studies suggesting limited usefulness of self-monitoring of blood glucose in these patients, the authors commented that self-monitoring has persisted as a cornerstone of clinical management of non–insulin-treated T2DM.

“As the first large pragmatic U.S. trial of SMBG [self-monitoring of blood glucose], our findings provide evidence to guide patients and clinicians making important clinical decisions about routine blood glucose monitoring,” they wrote. “Based on these findings, patients and clinicians should engage in dialogue regarding SMBG with the current evidence suggesting that SMBG should not be routine for most patients with non– insulin-treated T2DM.”

The main difference seen between the three groups was in the Summary of Diabetes Self-Care Activities, which the authors said reflected the intervention itself.

Patients taking a GLP-1 agonist at baseline were significantly more likely to increase their dose of the drug if they were in one of the self-monitoring groups, compared with the no-monitoring group, but the authors noted that the numbers were small.

Researchers also saw that African Americans in the self-monitoring with messaging group had significantly lower health-related quality of life scores, compared with the no-monitoring group, although this difference was not seen with the self-monitoring without messaging.

The participants in the trial, which was conducted at 15 primary care practices in central North Carolina, were all older than 30 years and had HbA1c levels between 6.5% and 9.5% in the 6 months before screening.

Compliance rates were similar between the two self-monitoring groups and declined at a similar rate.

The authors cautioned that their study was not powered to examine the effectiveness of self-monitoring versus no monitoring in certain clinical situations, such as the initiation of a new medication or a change in medication dose.

“Proponents of routine SMBG have cited evidence that this testing approach is useful for patients with newly diagnosed diabetes or patients with poorer glycemic control,” they said.” Although disease duration, experience using SMBG, baseline glycemic control, antihyperglycemic treatment, age, race, health literacy, and number of comorbidities made no discernible difference in glycemic control at 52 weeks, absence of evidence is not evidence of absence.”

They also commented on the potential influence of more tailored interventions such as the messaging, saying that while earlier smaller studies had suggested this could be of benefit, this was not shown in their study.

The study was supported by a Patient-Centered Outcomes Research Institute Award and the National Center for Advancing Translational Sciences, National Institutes of Health. Two authors declared grants and nonfinancial support from a range of pharmaceutical companies, and the University of North Carolina licensed its interest in copyright works to Telcare for a glucose messaging and treatment algorithm for the purposes of commercialization.

Body

 

In most care settings, the statement “you have diabetes” still triggers prescription of a glucometer and instruction on how to perform self-monitoring of blood glucose. Every 3 months thereafter, patients’ glucose logs are reviewed and routine self-monitoring of blood glucose is encouraged, regardless of patients’ risk of hypoglycemia or severe hyperglycemia, because common sense tells us that patients who proactively manage and monitor their diabetes should achieve better outcomes.

The surprising finding of this study make us question the current seemingly common sense–based strategy to encourage routine self-monitoring of blood glucose, and support the Choosing Wisely recommendations of the Society of General Internal Medicine and Endocrine Society that discourage frequent blood glucose monitoring among patients with type 2 diabetes. Routine self-monitoring of blood glucose merits a “less is more” designation because there were no clear benefits accrued, which leaves only possible harms.

Elaine C. Khoong, MD, is from the department of medicine, University of California, San Francisco, and Joseph S. Ross, MD, is from the section of general internal medicine, Yale University School of Medicine and associate editor of JAMA Internal Medicine. These comments are adapted from an accompanying editorial (JAMA Intern Med. 2017. Jun 10. doi: 10.1001/jamainternmed.2017.1233 ). Dr. Ross receives research funding through Yale University from Medtronic and the Food and Drug Administration, from Johnson & Johnson, the Centers for Medicare and Medicaid Services, the Blue Cross Blue Shield Association, and from the Laura and John Arnold Foundation. No other disclosures were declared.

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In most care settings, the statement “you have diabetes” still triggers prescription of a glucometer and instruction on how to perform self-monitoring of blood glucose. Every 3 months thereafter, patients’ glucose logs are reviewed and routine self-monitoring of blood glucose is encouraged, regardless of patients’ risk of hypoglycemia or severe hyperglycemia, because common sense tells us that patients who proactively manage and monitor their diabetes should achieve better outcomes.

The surprising finding of this study make us question the current seemingly common sense–based strategy to encourage routine self-monitoring of blood glucose, and support the Choosing Wisely recommendations of the Society of General Internal Medicine and Endocrine Society that discourage frequent blood glucose monitoring among patients with type 2 diabetes. Routine self-monitoring of blood glucose merits a “less is more” designation because there were no clear benefits accrued, which leaves only possible harms.

Elaine C. Khoong, MD, is from the department of medicine, University of California, San Francisco, and Joseph S. Ross, MD, is from the section of general internal medicine, Yale University School of Medicine and associate editor of JAMA Internal Medicine. These comments are adapted from an accompanying editorial (JAMA Intern Med. 2017. Jun 10. doi: 10.1001/jamainternmed.2017.1233 ). Dr. Ross receives research funding through Yale University from Medtronic and the Food and Drug Administration, from Johnson & Johnson, the Centers for Medicare and Medicaid Services, the Blue Cross Blue Shield Association, and from the Laura and John Arnold Foundation. No other disclosures were declared.

Body

 

In most care settings, the statement “you have diabetes” still triggers prescription of a glucometer and instruction on how to perform self-monitoring of blood glucose. Every 3 months thereafter, patients’ glucose logs are reviewed and routine self-monitoring of blood glucose is encouraged, regardless of patients’ risk of hypoglycemia or severe hyperglycemia, because common sense tells us that patients who proactively manage and monitor their diabetes should achieve better outcomes.

The surprising finding of this study make us question the current seemingly common sense–based strategy to encourage routine self-monitoring of blood glucose, and support the Choosing Wisely recommendations of the Society of General Internal Medicine and Endocrine Society that discourage frequent blood glucose monitoring among patients with type 2 diabetes. Routine self-monitoring of blood glucose merits a “less is more” designation because there were no clear benefits accrued, which leaves only possible harms.

Elaine C. Khoong, MD, is from the department of medicine, University of California, San Francisco, and Joseph S. Ross, MD, is from the section of general internal medicine, Yale University School of Medicine and associate editor of JAMA Internal Medicine. These comments are adapted from an accompanying editorial (JAMA Intern Med. 2017. Jun 10. doi: 10.1001/jamainternmed.2017.1233 ). Dr. Ross receives research funding through Yale University from Medtronic and the Food and Drug Administration, from Johnson & Johnson, the Centers for Medicare and Medicaid Services, the Blue Cross Blue Shield Association, and from the Laura and John Arnold Foundation. No other disclosures were declared.

Title
No benefits from routine blood glucose monitoring
No benefits from routine blood glucose monitoring

 

Self-monitoring of blood glucose in patients with non–insulin-treated type 2 diabetes mellitus (T2DM) does not appear to make any difference to blood glucose control or quality of life, a new study has found.

The researchers report the results of the Monitor Trial in which 418 patients with non–insulin-treated T2DM were randomized either to once-daily self-monitoring of blood glucose with automatic tailored messages, once-daily monitoring with no messages, and no monitoring. Their report appears in the June 10 online edition of JAMA Internal Medicine, timed to appear simultaneously with the data’s presentation at the annual meeting of the American Diabetes Association

After 1 year, there were no significant differences in hemoglobin A1c levels or health-related quality of life measures – either physical or mental – between the three groups (JAMA Intern Med. 2017 Jun 10. doi: 10.1001/jamainternmed.
2017.1233
).

Researchers also saw no significant differences in rates of insulin initiation, the incidence of hypoglycemia, or health care utilization.

“This null result occurred despite training participants and primary care clinicians on the use and interpretation of the meter results,” wrote Laura A. Young, MD, of the University of North Carolina at Chapel Hill.

While the findings reflect data from earlier studies suggesting limited usefulness of self-monitoring of blood glucose in these patients, the authors commented that self-monitoring has persisted as a cornerstone of clinical management of non–insulin-treated T2DM.

“As the first large pragmatic U.S. trial of SMBG [self-monitoring of blood glucose], our findings provide evidence to guide patients and clinicians making important clinical decisions about routine blood glucose monitoring,” they wrote. “Based on these findings, patients and clinicians should engage in dialogue regarding SMBG with the current evidence suggesting that SMBG should not be routine for most patients with non– insulin-treated T2DM.”

The main difference seen between the three groups was in the Summary of Diabetes Self-Care Activities, which the authors said reflected the intervention itself.

Patients taking a GLP-1 agonist at baseline were significantly more likely to increase their dose of the drug if they were in one of the self-monitoring groups, compared with the no-monitoring group, but the authors noted that the numbers were small.

Researchers also saw that African Americans in the self-monitoring with messaging group had significantly lower health-related quality of life scores, compared with the no-monitoring group, although this difference was not seen with the self-monitoring without messaging.

The participants in the trial, which was conducted at 15 primary care practices in central North Carolina, were all older than 30 years and had HbA1c levels between 6.5% and 9.5% in the 6 months before screening.

Compliance rates were similar between the two self-monitoring groups and declined at a similar rate.

The authors cautioned that their study was not powered to examine the effectiveness of self-monitoring versus no monitoring in certain clinical situations, such as the initiation of a new medication or a change in medication dose.

“Proponents of routine SMBG have cited evidence that this testing approach is useful for patients with newly diagnosed diabetes or patients with poorer glycemic control,” they said.” Although disease duration, experience using SMBG, baseline glycemic control, antihyperglycemic treatment, age, race, health literacy, and number of comorbidities made no discernible difference in glycemic control at 52 weeks, absence of evidence is not evidence of absence.”

They also commented on the potential influence of more tailored interventions such as the messaging, saying that while earlier smaller studies had suggested this could be of benefit, this was not shown in their study.

The study was supported by a Patient-Centered Outcomes Research Institute Award and the National Center for Advancing Translational Sciences, National Institutes of Health. Two authors declared grants and nonfinancial support from a range of pharmaceutical companies, and the University of North Carolina licensed its interest in copyright works to Telcare for a glucose messaging and treatment algorithm for the purposes of commercialization.

 

Self-monitoring of blood glucose in patients with non–insulin-treated type 2 diabetes mellitus (T2DM) does not appear to make any difference to blood glucose control or quality of life, a new study has found.

The researchers report the results of the Monitor Trial in which 418 patients with non–insulin-treated T2DM were randomized either to once-daily self-monitoring of blood glucose with automatic tailored messages, once-daily monitoring with no messages, and no monitoring. Their report appears in the June 10 online edition of JAMA Internal Medicine, timed to appear simultaneously with the data’s presentation at the annual meeting of the American Diabetes Association

After 1 year, there were no significant differences in hemoglobin A1c levels or health-related quality of life measures – either physical or mental – between the three groups (JAMA Intern Med. 2017 Jun 10. doi: 10.1001/jamainternmed.
2017.1233
).

Researchers also saw no significant differences in rates of insulin initiation, the incidence of hypoglycemia, or health care utilization.

“This null result occurred despite training participants and primary care clinicians on the use and interpretation of the meter results,” wrote Laura A. Young, MD, of the University of North Carolina at Chapel Hill.

While the findings reflect data from earlier studies suggesting limited usefulness of self-monitoring of blood glucose in these patients, the authors commented that self-monitoring has persisted as a cornerstone of clinical management of non–insulin-treated T2DM.

“As the first large pragmatic U.S. trial of SMBG [self-monitoring of blood glucose], our findings provide evidence to guide patients and clinicians making important clinical decisions about routine blood glucose monitoring,” they wrote. “Based on these findings, patients and clinicians should engage in dialogue regarding SMBG with the current evidence suggesting that SMBG should not be routine for most patients with non– insulin-treated T2DM.”

The main difference seen between the three groups was in the Summary of Diabetes Self-Care Activities, which the authors said reflected the intervention itself.

Patients taking a GLP-1 agonist at baseline were significantly more likely to increase their dose of the drug if they were in one of the self-monitoring groups, compared with the no-monitoring group, but the authors noted that the numbers were small.

Researchers also saw that African Americans in the self-monitoring with messaging group had significantly lower health-related quality of life scores, compared with the no-monitoring group, although this difference was not seen with the self-monitoring without messaging.

The participants in the trial, which was conducted at 15 primary care practices in central North Carolina, were all older than 30 years and had HbA1c levels between 6.5% and 9.5% in the 6 months before screening.

Compliance rates were similar between the two self-monitoring groups and declined at a similar rate.

The authors cautioned that their study was not powered to examine the effectiveness of self-monitoring versus no monitoring in certain clinical situations, such as the initiation of a new medication or a change in medication dose.

“Proponents of routine SMBG have cited evidence that this testing approach is useful for patients with newly diagnosed diabetes or patients with poorer glycemic control,” they said.” Although disease duration, experience using SMBG, baseline glycemic control, antihyperglycemic treatment, age, race, health literacy, and number of comorbidities made no discernible difference in glycemic control at 52 weeks, absence of evidence is not evidence of absence.”

They also commented on the potential influence of more tailored interventions such as the messaging, saying that while earlier smaller studies had suggested this could be of benefit, this was not shown in their study.

The study was supported by a Patient-Centered Outcomes Research Institute Award and the National Center for Advancing Translational Sciences, National Institutes of Health. Two authors declared grants and nonfinancial support from a range of pharmaceutical companies, and the University of North Carolina licensed its interest in copyright works to Telcare for a glucose messaging and treatment algorithm for the purposes of commercialization.

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Key clinical point: Routine blood glucose monitoring is not associated with improvements in blood glucose control in patients with non–insulin-treated type 2 diabetes mellitus.

Major finding: Patients with non–insulin-treated T2DM who do not use routine self-monitoring of blood glucose show the same blood glucose control and health-related quality of life as those who do self-monitor.

Data source: A 1-year open-label randomized trial in 418 patients with T2DM.

Disclosures: The study was supported by a Patient-Centered Outcomes Research Institute Award and the National Center for Advancing Translational Sciences, National Institutes of Health. Two authors declared grants and nonfinancial support from a range of pharmaceutical companies, and the University of North Carolina licensed its interest in copyright works to Telcare for a glucose messaging and treatment algorithm for the purposes of commercialization.

When fecal transplants for C. diff. fail, try, try again

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When fecal transplants for C. diff. fail, try, try again

 

– The best remedy for a failed fecal microbiota transplant for recurrent Clostridium difficile infection is most likely a second – or even a third or fourth attempt, according to Monika Fischer, MD.

Fecal microbiota transplants (FMTs) cure the large majority of those with recurrent C. difficile. But for those who don’t respond or who have an early recurrence, repeating the procedure will almost always effect cure, she said at the annual Digestive Disease Week.
 

 

“My recommendation would be to repeat FMT once you make sure the diagnosis actually is recurrent C. difficile,” said Dr. Fischer of Indiana University, Indianapolis. “There are sufficient data showing that the success rate after two FMTs significantly increases independent of the delivery route. But the effectiveness rate is highest when FMT is delivered via colonoscopy, so I recommend the second FMT be delivered that way.”

Recurrent failures can also be a sign that something else is amiss clinically, she said. So before proceeding with multiple procedures, some detective work may be in order. It’s best to start with confirmatory testing for the organism, she said.

“We have seen that about 25% of patients referred for FMT don’t actually have C. difficile at all,” Dr. Fischer said. “Be thinking about an alternative diagnosis when the stool tests negative, but the patient is still symptomatic, or if, before the FMT, there was less than a 50% improvement with vancomycin or fidaxomicin therapy.”

“When evaluating a patient for FMT failure, it should be confirmed by stool testing, preferably by toxin testing. Recent studies suggest that PCR [polymerase chain reaction]–positive but toxin-negative patients may be colonized with C. difficile but that an alternative pathology is driving the symptoms. Toxin-negative patients’ outcome is similar with or without treatment, and it is very rare that toxin-negative patients develop CDI [C. difficile infection]–related complications.”

For these patients, the problem could be any of the conditions that cause chronic diarrhea: inflammatory bowel disease, irritable bowel syndrome, celiac disease, microscopic colitis, bile salt malabsorption, chronic pancreatitis, or some other kind of infection. If C. difficile is the confirmed etiology, repeated FMTs are the way to go, Dr. Fischer said.

However, it may be worth mixing up the delivery method. The ever-expanding data on FMT continue to show that colonoscopy delivery has the lowest failure rate – about 10%. Enema is the least successful, with a 40% failure rate. In between those are nasoduodenal tube delivery, which is associated with a 20% failure rate, and oral capsules, with a failure rate varying from 12% to 30%. Fresh stool is also more effective than frozen, which, in turn, is more effective than the lyophilized preparation, Dr. Fischer said.

“Options are to repeat FMT via colonoscopy, but for patients who have had several failures, consider using the upper and lower route at the same time, and give fresh stool, especially if the first transplants used frozen.”

Although the efficacy of FMT doesn’t appear to depend on donor characteristics, patient characteristics do seem to play a role. Dr. Fischer and her colleagues have created an assessment tool to predict who may be at risk for failure. The model was developed in a 300-patient FMT cohort at two centers and validated in a third academic center FMT population. Of 24 clinical variables, three were incorporated into the failure risk model: severe disease (odds ratio, 6), inpatient status (OR, 3.8), and the number of prior C. difficile–related hospitalizations (OR, 1.4 for each one). For severe disease, patients got 5 points on the scale; for inpatient status, 4 points; and for each prior hospitalization, 1 point.

“Patients in the low-risk category [0] had up to 5% chance of failing. Patients with intermediate risk [1-2] had a 15% chance of failing, and patients in the high-risk category [3 or more points] had higher than 35% chance of not responding to single FMT,” Dr. Fischer said.

She also examined this tool in an extended cohort of nearly 500 patients at four additional sites; about 5% had failed more than two FMTs. “We identified two additional risk factors for failing multiple transplants,” Dr. Fischer said. “These were immunocompromised state, which increased the risk by 4 times, and male gender, which increased the risk by 2.5 times.”

She offered some options for the rare patient who has failed repeat FMTs and doesn’t want to try again. “There are some alternative or adjunctive therapies to repeat FMTs that may be considered, in lieu of repeating FMT for the third or fourth time or even following the first FMT failure, if dictated by patient preference. We sometimes offer these for elderly or frail patients or those with a limited life expectancy. These therapy options are from small, nonrandomized trials in multiply recurrent C. difficile infections but have not been vetted in the FMT nonresponder population.”

These include a vancomycin taper, or a vancomycin taper followed by fidaxomicin. Another option, albeit with limited applicability, is suppressive low-dose vancomycin 125 mg given every day, every other day, or every third day, indefinitely. “This can be especially good for elderly, frail patients with limited life expectancy, needing ongoing antibiotic therapy for urinary tract infections,” she said.

Finally, an 8-week vancomycin taper with daily kefir ingestion has been helpful for some patients. Although probiotics have never been proven helpful in C. difficile infections or FMT success, kefir is a different sort of supplement, she said.

“Kefir is different from yogurt. It contains bacteriocins like nisin, a protein with antibacterial properties produced by Lactococcus lactis.”

 

 

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– The best remedy for a failed fecal microbiota transplant for recurrent Clostridium difficile infection is most likely a second – or even a third or fourth attempt, according to Monika Fischer, MD.

Fecal microbiota transplants (FMTs) cure the large majority of those with recurrent C. difficile. But for those who don’t respond or who have an early recurrence, repeating the procedure will almost always effect cure, she said at the annual Digestive Disease Week.
 

 

“My recommendation would be to repeat FMT once you make sure the diagnosis actually is recurrent C. difficile,” said Dr. Fischer of Indiana University, Indianapolis. “There are sufficient data showing that the success rate after two FMTs significantly increases independent of the delivery route. But the effectiveness rate is highest when FMT is delivered via colonoscopy, so I recommend the second FMT be delivered that way.”

Recurrent failures can also be a sign that something else is amiss clinically, she said. So before proceeding with multiple procedures, some detective work may be in order. It’s best to start with confirmatory testing for the organism, she said.

“We have seen that about 25% of patients referred for FMT don’t actually have C. difficile at all,” Dr. Fischer said. “Be thinking about an alternative diagnosis when the stool tests negative, but the patient is still symptomatic, or if, before the FMT, there was less than a 50% improvement with vancomycin or fidaxomicin therapy.”

“When evaluating a patient for FMT failure, it should be confirmed by stool testing, preferably by toxin testing. Recent studies suggest that PCR [polymerase chain reaction]–positive but toxin-negative patients may be colonized with C. difficile but that an alternative pathology is driving the symptoms. Toxin-negative patients’ outcome is similar with or without treatment, and it is very rare that toxin-negative patients develop CDI [C. difficile infection]–related complications.”

For these patients, the problem could be any of the conditions that cause chronic diarrhea: inflammatory bowel disease, irritable bowel syndrome, celiac disease, microscopic colitis, bile salt malabsorption, chronic pancreatitis, or some other kind of infection. If C. difficile is the confirmed etiology, repeated FMTs are the way to go, Dr. Fischer said.

However, it may be worth mixing up the delivery method. The ever-expanding data on FMT continue to show that colonoscopy delivery has the lowest failure rate – about 10%. Enema is the least successful, with a 40% failure rate. In between those are nasoduodenal tube delivery, which is associated with a 20% failure rate, and oral capsules, with a failure rate varying from 12% to 30%. Fresh stool is also more effective than frozen, which, in turn, is more effective than the lyophilized preparation, Dr. Fischer said.

“Options are to repeat FMT via colonoscopy, but for patients who have had several failures, consider using the upper and lower route at the same time, and give fresh stool, especially if the first transplants used frozen.”

Although the efficacy of FMT doesn’t appear to depend on donor characteristics, patient characteristics do seem to play a role. Dr. Fischer and her colleagues have created an assessment tool to predict who may be at risk for failure. The model was developed in a 300-patient FMT cohort at two centers and validated in a third academic center FMT population. Of 24 clinical variables, three were incorporated into the failure risk model: severe disease (odds ratio, 6), inpatient status (OR, 3.8), and the number of prior C. difficile–related hospitalizations (OR, 1.4 for each one). For severe disease, patients got 5 points on the scale; for inpatient status, 4 points; and for each prior hospitalization, 1 point.

“Patients in the low-risk category [0] had up to 5% chance of failing. Patients with intermediate risk [1-2] had a 15% chance of failing, and patients in the high-risk category [3 or more points] had higher than 35% chance of not responding to single FMT,” Dr. Fischer said.

She also examined this tool in an extended cohort of nearly 500 patients at four additional sites; about 5% had failed more than two FMTs. “We identified two additional risk factors for failing multiple transplants,” Dr. Fischer said. “These were immunocompromised state, which increased the risk by 4 times, and male gender, which increased the risk by 2.5 times.”

She offered some options for the rare patient who has failed repeat FMTs and doesn’t want to try again. “There are some alternative or adjunctive therapies to repeat FMTs that may be considered, in lieu of repeating FMT for the third or fourth time or even following the first FMT failure, if dictated by patient preference. We sometimes offer these for elderly or frail patients or those with a limited life expectancy. These therapy options are from small, nonrandomized trials in multiply recurrent C. difficile infections but have not been vetted in the FMT nonresponder population.”

These include a vancomycin taper, or a vancomycin taper followed by fidaxomicin. Another option, albeit with limited applicability, is suppressive low-dose vancomycin 125 mg given every day, every other day, or every third day, indefinitely. “This can be especially good for elderly, frail patients with limited life expectancy, needing ongoing antibiotic therapy for urinary tract infections,” she said.

Finally, an 8-week vancomycin taper with daily kefir ingestion has been helpful for some patients. Although probiotics have never been proven helpful in C. difficile infections or FMT success, kefir is a different sort of supplement, she said.

“Kefir is different from yogurt. It contains bacteriocins like nisin, a protein with antibacterial properties produced by Lactococcus lactis.”

 

 

 

– The best remedy for a failed fecal microbiota transplant for recurrent Clostridium difficile infection is most likely a second – or even a third or fourth attempt, according to Monika Fischer, MD.

Fecal microbiota transplants (FMTs) cure the large majority of those with recurrent C. difficile. But for those who don’t respond or who have an early recurrence, repeating the procedure will almost always effect cure, she said at the annual Digestive Disease Week.
 

 

“My recommendation would be to repeat FMT once you make sure the diagnosis actually is recurrent C. difficile,” said Dr. Fischer of Indiana University, Indianapolis. “There are sufficient data showing that the success rate after two FMTs significantly increases independent of the delivery route. But the effectiveness rate is highest when FMT is delivered via colonoscopy, so I recommend the second FMT be delivered that way.”

Recurrent failures can also be a sign that something else is amiss clinically, she said. So before proceeding with multiple procedures, some detective work may be in order. It’s best to start with confirmatory testing for the organism, she said.

“We have seen that about 25% of patients referred for FMT don’t actually have C. difficile at all,” Dr. Fischer said. “Be thinking about an alternative diagnosis when the stool tests negative, but the patient is still symptomatic, or if, before the FMT, there was less than a 50% improvement with vancomycin or fidaxomicin therapy.”

“When evaluating a patient for FMT failure, it should be confirmed by stool testing, preferably by toxin testing. Recent studies suggest that PCR [polymerase chain reaction]–positive but toxin-negative patients may be colonized with C. difficile but that an alternative pathology is driving the symptoms. Toxin-negative patients’ outcome is similar with or without treatment, and it is very rare that toxin-negative patients develop CDI [C. difficile infection]–related complications.”

For these patients, the problem could be any of the conditions that cause chronic diarrhea: inflammatory bowel disease, irritable bowel syndrome, celiac disease, microscopic colitis, bile salt malabsorption, chronic pancreatitis, or some other kind of infection. If C. difficile is the confirmed etiology, repeated FMTs are the way to go, Dr. Fischer said.

However, it may be worth mixing up the delivery method. The ever-expanding data on FMT continue to show that colonoscopy delivery has the lowest failure rate – about 10%. Enema is the least successful, with a 40% failure rate. In between those are nasoduodenal tube delivery, which is associated with a 20% failure rate, and oral capsules, with a failure rate varying from 12% to 30%. Fresh stool is also more effective than frozen, which, in turn, is more effective than the lyophilized preparation, Dr. Fischer said.

“Options are to repeat FMT via colonoscopy, but for patients who have had several failures, consider using the upper and lower route at the same time, and give fresh stool, especially if the first transplants used frozen.”

Although the efficacy of FMT doesn’t appear to depend on donor characteristics, patient characteristics do seem to play a role. Dr. Fischer and her colleagues have created an assessment tool to predict who may be at risk for failure. The model was developed in a 300-patient FMT cohort at two centers and validated in a third academic center FMT population. Of 24 clinical variables, three were incorporated into the failure risk model: severe disease (odds ratio, 6), inpatient status (OR, 3.8), and the number of prior C. difficile–related hospitalizations (OR, 1.4 for each one). For severe disease, patients got 5 points on the scale; for inpatient status, 4 points; and for each prior hospitalization, 1 point.

“Patients in the low-risk category [0] had up to 5% chance of failing. Patients with intermediate risk [1-2] had a 15% chance of failing, and patients in the high-risk category [3 or more points] had higher than 35% chance of not responding to single FMT,” Dr. Fischer said.

She also examined this tool in an extended cohort of nearly 500 patients at four additional sites; about 5% had failed more than two FMTs. “We identified two additional risk factors for failing multiple transplants,” Dr. Fischer said. “These were immunocompromised state, which increased the risk by 4 times, and male gender, which increased the risk by 2.5 times.”

She offered some options for the rare patient who has failed repeat FMTs and doesn’t want to try again. “There are some alternative or adjunctive therapies to repeat FMTs that may be considered, in lieu of repeating FMT for the third or fourth time or even following the first FMT failure, if dictated by patient preference. We sometimes offer these for elderly or frail patients or those with a limited life expectancy. These therapy options are from small, nonrandomized trials in multiply recurrent C. difficile infections but have not been vetted in the FMT nonresponder population.”

These include a vancomycin taper, or a vancomycin taper followed by fidaxomicin. Another option, albeit with limited applicability, is suppressive low-dose vancomycin 125 mg given every day, every other day, or every third day, indefinitely. “This can be especially good for elderly, frail patients with limited life expectancy, needing ongoing antibiotic therapy for urinary tract infections,” she said.

Finally, an 8-week vancomycin taper with daily kefir ingestion has been helpful for some patients. Although probiotics have never been proven helpful in C. difficile infections or FMT success, kefir is a different sort of supplement, she said.

“Kefir is different from yogurt. It contains bacteriocins like nisin, a protein with antibacterial properties produced by Lactococcus lactis.”

 

 

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Researchers design new, safer antiplatelet drug based on snake venom

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Researchers design new, safer antiplatelet drug based on snake venom

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Researchers say they have designed an antiplatelet drug based on snake venom protein that stimulates platelets to form blood clots by latching onto glycoprotein VI (GPVI), which is safer than some currently available antiplatelet drugs that target glycoproteins IIb/IIIa.

Earlier studies have shown that platelets missing GPVI do not form clots and do not lead to severe bleeding.

The researchers, therefore, designed a drug to interact with the protein glycoprotein VI.

They used trowaglerix, a protein in the venom of the Tropidolaemus wagleri snake, to block GPVI activity.

An earlier study by the team found that trowaglerix worked through GPVI antagonism.

Some currently available antiplatelet drugs are also based on protein found in snake venom but target GPIIa/IIIb instead, which leads to the side effect of bleeding.

“[W]hy that target leads to the bleeding side effect is not fully understood,” said lead co-author Tur-Fu Huang, PhD, of the National Taiwan University in Taipei.

Specifically, the team sequenced trowaglerix and found an alpha subunit that specifically targeted GPVI snaclec, which is snake venom C-type lectin protein.

They then used computational peptide design to create a series of Troα6/Troα10 peptides—a hexapeptide and decapeptide, respectively—which were derived from trowaglerix.

Mice administered this new drug, researchers report, had slower blood clot formation compared to untreated mice. In addition, the treated mice did not bleed longer than the untreated mice.

The team believes their research supports the concept that these hexa/decapeptides have therapeutic potential and can be a template for a new, safer class of antiplatelet drug with a limited bleeding side effect.

“In general, this type of molecule design does not last long in the body,” said co-author Jane Tseng, PhD, also of the National Taiwan University, “so techniques like formulation or delivery system are likely needed to extend the exposure time in the human body.”

She also indicated that the design needs to be optimized, “to ensure that the molecule only interacts with GPVI and not other proteins which can cause unintended reactions.”

The research team reported its findings in Arteriosclerosis, Thrombosis, and Vascular Biology, an American Heart Association journal.

The National Science Council of Taiwan supported the study. 

 

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Photo by gbohne from Berlin, DE
snake

Researchers say they have designed an antiplatelet drug based on snake venom protein that stimulates platelets to form blood clots by latching onto glycoprotein VI (GPVI), which is safer than some currently available antiplatelet drugs that target glycoproteins IIb/IIIa.

Earlier studies have shown that platelets missing GPVI do not form clots and do not lead to severe bleeding.

The researchers, therefore, designed a drug to interact with the protein glycoprotein VI.

They used trowaglerix, a protein in the venom of the Tropidolaemus wagleri snake, to block GPVI activity.

An earlier study by the team found that trowaglerix worked through GPVI antagonism.

Some currently available antiplatelet drugs are also based on protein found in snake venom but target GPIIa/IIIb instead, which leads to the side effect of bleeding.

“[W]hy that target leads to the bleeding side effect is not fully understood,” said lead co-author Tur-Fu Huang, PhD, of the National Taiwan University in Taipei.

Specifically, the team sequenced trowaglerix and found an alpha subunit that specifically targeted GPVI snaclec, which is snake venom C-type lectin protein.

They then used computational peptide design to create a series of Troα6/Troα10 peptides—a hexapeptide and decapeptide, respectively—which were derived from trowaglerix.

Mice administered this new drug, researchers report, had slower blood clot formation compared to untreated mice. In addition, the treated mice did not bleed longer than the untreated mice.

The team believes their research supports the concept that these hexa/decapeptides have therapeutic potential and can be a template for a new, safer class of antiplatelet drug with a limited bleeding side effect.

“In general, this type of molecule design does not last long in the body,” said co-author Jane Tseng, PhD, also of the National Taiwan University, “so techniques like formulation or delivery system are likely needed to extend the exposure time in the human body.”

She also indicated that the design needs to be optimized, “to ensure that the molecule only interacts with GPVI and not other proteins which can cause unintended reactions.”

The research team reported its findings in Arteriosclerosis, Thrombosis, and Vascular Biology, an American Heart Association journal.

The National Science Council of Taiwan supported the study. 

 

Photo by gbohne from Berlin, DE
snake

Researchers say they have designed an antiplatelet drug based on snake venom protein that stimulates platelets to form blood clots by latching onto glycoprotein VI (GPVI), which is safer than some currently available antiplatelet drugs that target glycoproteins IIb/IIIa.

Earlier studies have shown that platelets missing GPVI do not form clots and do not lead to severe bleeding.

The researchers, therefore, designed a drug to interact with the protein glycoprotein VI.

They used trowaglerix, a protein in the venom of the Tropidolaemus wagleri snake, to block GPVI activity.

An earlier study by the team found that trowaglerix worked through GPVI antagonism.

Some currently available antiplatelet drugs are also based on protein found in snake venom but target GPIIa/IIIb instead, which leads to the side effect of bleeding.

“[W]hy that target leads to the bleeding side effect is not fully understood,” said lead co-author Tur-Fu Huang, PhD, of the National Taiwan University in Taipei.

Specifically, the team sequenced trowaglerix and found an alpha subunit that specifically targeted GPVI snaclec, which is snake venom C-type lectin protein.

They then used computational peptide design to create a series of Troα6/Troα10 peptides—a hexapeptide and decapeptide, respectively—which were derived from trowaglerix.

Mice administered this new drug, researchers report, had slower blood clot formation compared to untreated mice. In addition, the treated mice did not bleed longer than the untreated mice.

The team believes their research supports the concept that these hexa/decapeptides have therapeutic potential and can be a template for a new, safer class of antiplatelet drug with a limited bleeding side effect.

“In general, this type of molecule design does not last long in the body,” said co-author Jane Tseng, PhD, also of the National Taiwan University, “so techniques like formulation or delivery system are likely needed to extend the exposure time in the human body.”

She also indicated that the design needs to be optimized, “to ensure that the molecule only interacts with GPVI and not other proteins which can cause unintended reactions.”

The research team reported its findings in Arteriosclerosis, Thrombosis, and Vascular Biology, an American Heart Association journal.

The National Science Council of Taiwan supported the study. 

 

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Recruiting survey notes strong demand for family physicians, psychiatrists

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Family medicine continues to be the most highly recruited specialty, based on nearly 3,300 permanent physician and advanced practitioner search assignments posted from April 1, 2016, to March 31, 2017, through Merritt Hawkins’ and AMN Healthcare’s physician staffing companies.

It is the 11th consecutive year that family physicians topped the search list, and the specialty’s continued dominance is “underscoring the continued urgent demand for primary care physicians in an evolving health system,” Merritt Hawkins said in its annual report on physician recruiting.

“Primary care is increasingly the province of international medical graduates,” according to the report, which notes that U.S.-based medical students continue to show low interest in primary care because of low compensation and the perceived high level of personal time commitment required.

Demand for primary care physicians continues to grow and is likely to be exacerbated by the value-based payment models that are emerging in the wake of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), the report added.

Psychiatry was the second most recruited specialty for just the second time in 24 years. The change “reflects a severe shortage of mental health professionals nationwide.”

The supply of psychiatrists is “already constrained and is soon going to diminish significantly. There currently are some 30,000 psychiatrists in active patient care in the United States, 60% of whom are 55 years or older, with many set to retire. ... With many psychiatrists aging out of the profession and with a preference among psychiatrists for outpatient practice settings, it is becoming increasingly difficult to recruit to inpatient settings.”

The report also notes that most searches were for “employment of the physician, rather than the private practice model,” the report states. “Physician employment is seen as necessary to implementation of value-based, capitated systems and to attracting today’s physician candidates.”

The top five most requested searches by medical specialty were:

  • Family medicine (607), ranked first in the previous year.
  • Psychiatry (256), ranked second in the previous year.
  • Internal medicine (193), ranked third in the previous year.
  • Nurse practitioner (137), ranked fifth in the previous year.
  • Ob.gyn (109), ranked sixth in the previous year.
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Family medicine continues to be the most highly recruited specialty, based on nearly 3,300 permanent physician and advanced practitioner search assignments posted from April 1, 2016, to March 31, 2017, through Merritt Hawkins’ and AMN Healthcare’s physician staffing companies.

It is the 11th consecutive year that family physicians topped the search list, and the specialty’s continued dominance is “underscoring the continued urgent demand for primary care physicians in an evolving health system,” Merritt Hawkins said in its annual report on physician recruiting.

“Primary care is increasingly the province of international medical graduates,” according to the report, which notes that U.S.-based medical students continue to show low interest in primary care because of low compensation and the perceived high level of personal time commitment required.

Demand for primary care physicians continues to grow and is likely to be exacerbated by the value-based payment models that are emerging in the wake of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), the report added.

Psychiatry was the second most recruited specialty for just the second time in 24 years. The change “reflects a severe shortage of mental health professionals nationwide.”

The supply of psychiatrists is “already constrained and is soon going to diminish significantly. There currently are some 30,000 psychiatrists in active patient care in the United States, 60% of whom are 55 years or older, with many set to retire. ... With many psychiatrists aging out of the profession and with a preference among psychiatrists for outpatient practice settings, it is becoming increasingly difficult to recruit to inpatient settings.”

The report also notes that most searches were for “employment of the physician, rather than the private practice model,” the report states. “Physician employment is seen as necessary to implementation of value-based, capitated systems and to attracting today’s physician candidates.”

The top five most requested searches by medical specialty were:

  • Family medicine (607), ranked first in the previous year.
  • Psychiatry (256), ranked second in the previous year.
  • Internal medicine (193), ranked third in the previous year.
  • Nurse practitioner (137), ranked fifth in the previous year.
  • Ob.gyn (109), ranked sixth in the previous year.

 

Family medicine continues to be the most highly recruited specialty, based on nearly 3,300 permanent physician and advanced practitioner search assignments posted from April 1, 2016, to March 31, 2017, through Merritt Hawkins’ and AMN Healthcare’s physician staffing companies.

It is the 11th consecutive year that family physicians topped the search list, and the specialty’s continued dominance is “underscoring the continued urgent demand for primary care physicians in an evolving health system,” Merritt Hawkins said in its annual report on physician recruiting.

“Primary care is increasingly the province of international medical graduates,” according to the report, which notes that U.S.-based medical students continue to show low interest in primary care because of low compensation and the perceived high level of personal time commitment required.

Demand for primary care physicians continues to grow and is likely to be exacerbated by the value-based payment models that are emerging in the wake of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), the report added.

Psychiatry was the second most recruited specialty for just the second time in 24 years. The change “reflects a severe shortage of mental health professionals nationwide.”

The supply of psychiatrists is “already constrained and is soon going to diminish significantly. There currently are some 30,000 psychiatrists in active patient care in the United States, 60% of whom are 55 years or older, with many set to retire. ... With many psychiatrists aging out of the profession and with a preference among psychiatrists for outpatient practice settings, it is becoming increasingly difficult to recruit to inpatient settings.”

The report also notes that most searches were for “employment of the physician, rather than the private practice model,” the report states. “Physician employment is seen as necessary to implementation of value-based, capitated systems and to attracting today’s physician candidates.”

The top five most requested searches by medical specialty were:

  • Family medicine (607), ranked first in the previous year.
  • Psychiatry (256), ranked second in the previous year.
  • Internal medicine (193), ranked third in the previous year.
  • Nurse practitioner (137), ranked fifth in the previous year.
  • Ob.gyn (109), ranked sixth in the previous year.
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Risks of keeping controlled substances in office tilt away from benefits

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Thu, 03/28/2019 - 14:51

 

I don’t stack narcotics in my office. Never have, never will.

Honestly, in this day and age, I don’t understand why anyone would.

I get the occasional patient with a bad migraine who wants to come in for “a shot.” Sorry, I don’t carry that. I suppose I could carry Ketorolac, but I try to run a simple, nonurgent practice. If you have an urgent situation, go to an emergency department or urgent care.

Dr. Allan M. Block, a neurologist in Scottsdale, Arizona.
Dr. Allan M. Block
The paperwork and regulations surrounding narcotics only seem to get bigger each year, and I just don’t want to deal with them. Besides, Arlan Cohn, MD, once wrote that narcotics in the office “tempt the burglar latent in the junkie; they tempt the junkie latent in the doctor.”

I couldn’t agree more. It’s better to avoid the problem altogether.

In 1998, on my very first day of work as an attending, the group I’d signed with put me in a satellite office normally used by their headache specialist. While familiarizing myself with what was where, I discovered a bottle of injectable meperidine. It wasn’t locked up, just sitting next to the zolmitriptan (Zomig) samples in an unsecured cabinet. I picked it up in shock to make sure I’d read the label correctly. I put it back down then (somewhat paranoid) picked it back up, wiped my fingerprints off, and put it down in the exact same spot it had been. Although it was obviously a serious infraction, I didn’t want to jeopardize my standing as a new hire. So, I just ignored it. But, I sure worried about what would happen if a DEA inspector showed up.

So, today, I just don’t deal with it. No controlled substances, less paperwork, fewer worries. Simplicity is bliss, and modern medicine has enough worries as it is.

This still gets me the occasional complaint of, “Well, my other neurologist did!” but, frankly, I don’t care. They can run their practice how they want, and I’ll run mine.

In a world of regulations, daily press stories on “pill mills” overusing narcotics, and my quarterly prescription tracking reports from the state board, I want to keep my involvement in them as minimal as possible. I may prescribe them, but I don’t want the potential nightmares of having them on site.
 

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

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I don’t stack narcotics in my office. Never have, never will.

Honestly, in this day and age, I don’t understand why anyone would.

I get the occasional patient with a bad migraine who wants to come in for “a shot.” Sorry, I don’t carry that. I suppose I could carry Ketorolac, but I try to run a simple, nonurgent practice. If you have an urgent situation, go to an emergency department or urgent care.

Dr. Allan M. Block, a neurologist in Scottsdale, Arizona.
Dr. Allan M. Block
The paperwork and regulations surrounding narcotics only seem to get bigger each year, and I just don’t want to deal with them. Besides, Arlan Cohn, MD, once wrote that narcotics in the office “tempt the burglar latent in the junkie; they tempt the junkie latent in the doctor.”

I couldn’t agree more. It’s better to avoid the problem altogether.

In 1998, on my very first day of work as an attending, the group I’d signed with put me in a satellite office normally used by their headache specialist. While familiarizing myself with what was where, I discovered a bottle of injectable meperidine. It wasn’t locked up, just sitting next to the zolmitriptan (Zomig) samples in an unsecured cabinet. I picked it up in shock to make sure I’d read the label correctly. I put it back down then (somewhat paranoid) picked it back up, wiped my fingerprints off, and put it down in the exact same spot it had been. Although it was obviously a serious infraction, I didn’t want to jeopardize my standing as a new hire. So, I just ignored it. But, I sure worried about what would happen if a DEA inspector showed up.

So, today, I just don’t deal with it. No controlled substances, less paperwork, fewer worries. Simplicity is bliss, and modern medicine has enough worries as it is.

This still gets me the occasional complaint of, “Well, my other neurologist did!” but, frankly, I don’t care. They can run their practice how they want, and I’ll run mine.

In a world of regulations, daily press stories on “pill mills” overusing narcotics, and my quarterly prescription tracking reports from the state board, I want to keep my involvement in them as minimal as possible. I may prescribe them, but I don’t want the potential nightmares of having them on site.
 

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

 

I don’t stack narcotics in my office. Never have, never will.

Honestly, in this day and age, I don’t understand why anyone would.

I get the occasional patient with a bad migraine who wants to come in for “a shot.” Sorry, I don’t carry that. I suppose I could carry Ketorolac, but I try to run a simple, nonurgent practice. If you have an urgent situation, go to an emergency department or urgent care.

Dr. Allan M. Block, a neurologist in Scottsdale, Arizona.
Dr. Allan M. Block
The paperwork and regulations surrounding narcotics only seem to get bigger each year, and I just don’t want to deal with them. Besides, Arlan Cohn, MD, once wrote that narcotics in the office “tempt the burglar latent in the junkie; they tempt the junkie latent in the doctor.”

I couldn’t agree more. It’s better to avoid the problem altogether.

In 1998, on my very first day of work as an attending, the group I’d signed with put me in a satellite office normally used by their headache specialist. While familiarizing myself with what was where, I discovered a bottle of injectable meperidine. It wasn’t locked up, just sitting next to the zolmitriptan (Zomig) samples in an unsecured cabinet. I picked it up in shock to make sure I’d read the label correctly. I put it back down then (somewhat paranoid) picked it back up, wiped my fingerprints off, and put it down in the exact same spot it had been. Although it was obviously a serious infraction, I didn’t want to jeopardize my standing as a new hire. So, I just ignored it. But, I sure worried about what would happen if a DEA inspector showed up.

So, today, I just don’t deal with it. No controlled substances, less paperwork, fewer worries. Simplicity is bliss, and modern medicine has enough worries as it is.

This still gets me the occasional complaint of, “Well, my other neurologist did!” but, frankly, I don’t care. They can run their practice how they want, and I’ll run mine.

In a world of regulations, daily press stories on “pill mills” overusing narcotics, and my quarterly prescription tracking reports from the state board, I want to keep my involvement in them as minimal as possible. I may prescribe them, but I don’t want the potential nightmares of having them on site.
 

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

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FDA approves generic version of HIV drug Truvada

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Fri, 01/18/2019 - 16:49

 

The U.S. Food and Drug Administration has approved the first generic version of emtricitabine and tenofovir disoproxil fumarate tablets, previously known by the brand name Truvada, for the treatment of HIV-1 infection.

Like Truvada, the generic version of the drug – produced by Teva Pharmaceuticals USA and approved in 200-mg/300-mg tablet form – is indicated for use in combination with other antiretrovirals for patients infected with HIV-1 and for pre-exposure prophylaxis (PrEP) to prevent sexually-acquired HIV infection in high-risk adults.

grandeduc/Thinkstock
According to the FDA press release, emtricitabine and tenofovir disoproxil fumarate – when used for PrEP – must “only be prescribed to individuals confirmed to be HIV-negative immediately prior to initial use and periodically during use,” as drug-resistant HIV-1 variants have been identified with the use of Truvada for PrEP following undetected acute HIV-1 infection.

Women infected with HIV-1 should not breastfeed while taking emtricitabine and tenofovir disoproxil fumarate, the FDA said, and the drug can be used only in pediatric patients weighing more than 17 kg.

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The U.S. Food and Drug Administration has approved the first generic version of emtricitabine and tenofovir disoproxil fumarate tablets, previously known by the brand name Truvada, for the treatment of HIV-1 infection.

Like Truvada, the generic version of the drug – produced by Teva Pharmaceuticals USA and approved in 200-mg/300-mg tablet form – is indicated for use in combination with other antiretrovirals for patients infected with HIV-1 and for pre-exposure prophylaxis (PrEP) to prevent sexually-acquired HIV infection in high-risk adults.

grandeduc/Thinkstock
According to the FDA press release, emtricitabine and tenofovir disoproxil fumarate – when used for PrEP – must “only be prescribed to individuals confirmed to be HIV-negative immediately prior to initial use and periodically during use,” as drug-resistant HIV-1 variants have been identified with the use of Truvada for PrEP following undetected acute HIV-1 infection.

Women infected with HIV-1 should not breastfeed while taking emtricitabine and tenofovir disoproxil fumarate, the FDA said, and the drug can be used only in pediatric patients weighing more than 17 kg.

 

The U.S. Food and Drug Administration has approved the first generic version of emtricitabine and tenofovir disoproxil fumarate tablets, previously known by the brand name Truvada, for the treatment of HIV-1 infection.

Like Truvada, the generic version of the drug – produced by Teva Pharmaceuticals USA and approved in 200-mg/300-mg tablet form – is indicated for use in combination with other antiretrovirals for patients infected with HIV-1 and for pre-exposure prophylaxis (PrEP) to prevent sexually-acquired HIV infection in high-risk adults.

grandeduc/Thinkstock
According to the FDA press release, emtricitabine and tenofovir disoproxil fumarate – when used for PrEP – must “only be prescribed to individuals confirmed to be HIV-negative immediately prior to initial use and periodically during use,” as drug-resistant HIV-1 variants have been identified with the use of Truvada for PrEP following undetected acute HIV-1 infection.

Women infected with HIV-1 should not breastfeed while taking emtricitabine and tenofovir disoproxil fumarate, the FDA said, and the drug can be used only in pediatric patients weighing more than 17 kg.

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