Patients with HIV infection should be screened routinely for chronic liver disease if their alanine aminotransferase (ALT) levels are elevated, according to a study published in AIDS Care.

“In HIV-positive individuals, liver disease (mostly due to hepatitis B and C virus [HBV and HCV]) is the third most common cause of mortality after AIDS-related illness and non-AIDS nonviral malignancy,” wrote Sumita Verma, MD, of Brighton and Sussex (U.K.) University Hospital, and her coauthors. “Our aim therefore was to assess prevalence, aetiology, and predictors of nonviral-related chronic liver disease (CLD) in a cohort with HIV monoinfection.”

Brighton and Sussex Medical School

Investigators recruited 3,872 HIV-positive subjects from a Southeast England teaching hospital between 2005 and 2012, of whom 1,654 (42.7%) were found to be at least two ALT levels above the upper limit of normal. Clinically significant CLD was classified as having at least F2 fibrosis (metavir scoring) on liver biopsy, having a liver stiffness measurement greater than F2 (metavir) on a transient elastography, moderate to severe hepatic steatosis on a liver biopsy, a portal hypertension that was either cirrhotic or noncirrhotic, hepatic decompensation, a liver-related mortality, or any combination of these factors. (AIDS Care. 2016 Ju 5. doi: 10.1080/09540121.2016.1191603)

Of the 1,654 subjects with HIV and elevated ALT levels, 1,047 (27.0%) had elevated ALT levels when tested again after 6 months, with 243 of those (23.2%) having a further radiologic or histologic examination done. The final cohort comprised 222 subjects, of which CLD was found in 147 (66.2%), while only 75 (33.8%) had no CLD despite having elevated ALT and HIV. CLD was determined to be “clinically significant” in one out of every four subjects who had it.

“Potential risk factors for CLD included alcohol use (44.2%), one or more feature of the [metabolic syndrome] (68%) and [antiretroviral] use (74.1%), with 68.7% having [more than one] risk factor [and] serum triglyceride (odds ratio, 1.482; 95% confidence interval. 1.053-2.086; P = .024) was the only independent predictor of CLD,” the investigators noted.

Furthermore, the study shows that “the most striking observation [is] that only 23% with persistently elevated ALT were investigated further, with only 58/1,047 (5.5%) undergoing objective assessment of hepatic fibrosis and 45/1,047 (4.3%) being referred to Hepatology.”

Dr. Verma and her coauthors did not report any relevant financial disclosures.

[email protected]

Patients with HIV infection should be screened routinely for chronic liver disease if their alanine aminotransferase (ALT) levels are elevated, according to a study published in AIDS Care.

“In HIV-positive individuals, liver disease (mostly due to hepatitis B and C virus [HBV and HCV]) is the third most common cause of mortality after AIDS-related illness and non-AIDS nonviral malignancy,” wrote Sumita Verma, MD, of Brighton and Sussex (U.K.) University Hospital, and her coauthors. “Our aim therefore was to assess prevalence, aetiology, and predictors of nonviral-related chronic liver disease (CLD) in a cohort with HIV monoinfection.”

Brighton and Sussex Medical School

Investigators recruited 3,872 HIV-positive subjects from a Southeast England teaching hospital between 2005 and 2012, of whom 1,654 (42.7%) were found to be at least two ALT levels above the upper limit of normal. Clinically significant CLD was classified as having at least F2 fibrosis (metavir scoring) on liver biopsy, having a liver stiffness measurement greater than F2 (metavir) on a transient elastography, moderate to severe hepatic steatosis on a liver biopsy, a portal hypertension that was either cirrhotic or noncirrhotic, hepatic decompensation, a liver-related mortality, or any combination of these factors. (AIDS Care. 2016 Ju 5. doi: 10.1080/09540121.2016.1191603)

Of the 1,654 subjects with HIV and elevated ALT levels, 1,047 (27.0%) had elevated ALT levels when tested again after 6 months, with 243 of those (23.2%) having a further radiologic or histologic examination done. The final cohort comprised 222 subjects, of which CLD was found in 147 (66.2%), while only 75 (33.8%) had no CLD despite having elevated ALT and HIV. CLD was determined to be “clinically significant” in one out of every four subjects who had it.

“Potential risk factors for CLD included alcohol use (44.2%), one or more feature of the [metabolic syndrome] (68%) and [antiretroviral] use (74.1%), with 68.7% having [more than one] risk factor [and] serum triglyceride (odds ratio, 1.482; 95% confidence interval. 1.053-2.086; P = .024) was the only independent predictor of CLD,” the investigators noted.

Furthermore, the study shows that “the most striking observation [is] that only 23% with persistently elevated ALT were investigated further, with only 58/1,047 (5.5%) undergoing objective assessment of hepatic fibrosis and 45/1,047 (4.3%) being referred to Hepatology.”

Dr. Verma and her coauthors did not report any relevant financial disclosures.

[email protected]

Patients with HIV infection should be screened routinely for chronic liver disease if their alanine aminotransferase (ALT) levels are elevated, according to a study published in AIDS Care.

“In HIV-positive individuals, liver disease (mostly due to hepatitis B and C virus [HBV and HCV]) is the third most common cause of mortality after AIDS-related illness and non-AIDS nonviral malignancy,” wrote Sumita Verma, MD, of Brighton and Sussex (U.K.) University Hospital, and her coauthors. “Our aim therefore was to assess prevalence, aetiology, and predictors of nonviral-related chronic liver disease (CLD) in a cohort with HIV monoinfection.”

Brighton and Sussex Medical School

Investigators recruited 3,872 HIV-positive subjects from a Southeast England teaching hospital between 2005 and 2012, of whom 1,654 (42.7%) were found to be at least two ALT levels above the upper limit of normal. Clinically significant CLD was classified as having at least F2 fibrosis (metavir scoring) on liver biopsy, having a liver stiffness measurement greater than F2 (metavir) on a transient elastography, moderate to severe hepatic steatosis on a liver biopsy, a portal hypertension that was either cirrhotic or noncirrhotic, hepatic decompensation, a liver-related mortality, or any combination of these factors. (AIDS Care. 2016 Ju 5. doi: 10.1080/09540121.2016.1191603)

Of the 1,654 subjects with HIV and elevated ALT levels, 1,047 (27.0%) had elevated ALT levels when tested again after 6 months, with 243 of those (23.2%) having a further radiologic or histologic examination done. The final cohort comprised 222 subjects, of which CLD was found in 147 (66.2%), while only 75 (33.8%) had no CLD despite having elevated ALT and HIV. CLD was determined to be “clinically significant” in one out of every four subjects who had it.

“Potential risk factors for CLD included alcohol use (44.2%), one or more feature of the [metabolic syndrome] (68%) and [antiretroviral] use (74.1%), with 68.7% having [more than one] risk factor [and] serum triglyceride (odds ratio, 1.482; 95% confidence interval. 1.053-2.086; P = .024) was the only independent predictor of CLD,” the investigators noted.

Furthermore, the study shows that “the most striking observation [is] that only 23% with persistently elevated ALT were investigated further, with only 58/1,047 (5.5%) undergoing objective assessment of hepatic fibrosis and 45/1,047 (4.3%) being referred to Hepatology.”

Dr. Verma and her coauthors did not report any relevant financial disclosures.

[email protected]

A device that uses transcranial focused ultrasound to destroy the MRI-identified pathologic area of the thalamus in essential tremor patients became the first of its kind to receive Food and Drug Administration approval for use in patients whose condition has been refractory to medications such as beta-blockers or anticonvulsant drugs.

In patients who have undergone evaluation by CT and MRI to determine their suitability for the procedure, the Exablate Neuro device delivers focused ultrasound at incrementally higher energies until patients achieve a reduction of tremor. Patients are awake and responsive during the entire treatment.

Courtesy Wikimedia Commons/FitzColinGerald/Creative Commons License

“As with other treatments for essential tremor, this new device is not a cure but could help patients enjoy a better quality of life,” said Carlos Peña, PhD, director of the division of neurological and physical medicine devices in the FDA’s Center for Devices and Radiological Health, in the agency’s announcement of the approval. The device “could help them to avoid more extensive surgical treatments,” such as thalamotomy or a deep brain stimulation device, Dr. Peña said.

The clinical data used to support the approval included a double-blind, controlled trial of 76 patients with essential tremor who had not responded to medication therapy.

The 56 patients who were randomly selected to receive the Exablate Neuro treatment showed nearly a 50% improvement in their tremors and motor function 3 months after treatment, compared with their baseline score. The 20 patients who received a sham control treatment had no improvement, and some experienced a slight worsening after the sham procedure before they crossed over into the treatment group at the 3-month time point.

At 12 months post procedure, the treatment group retained a 40% improvement in those scores, compared with baseline.

Adverse events reported by patients treated with the device were similar to those reported by patients who have undergone thalamotomy. Events included numbness/tingling of the fingers, headache, imbalance/unsteadiness, loss of control of body movements (ataxia), or gait disturbance.

Other side effects identified as possibly related to treatment with MR-guided focused ultrasound treatments include tissue damage in an area other than the treatment area, hemorrhage in the treated area requiring emergency treatment, skin burns with ulceration of the skin, skin retraction, and scar formation and blood clots.

InSightec manufacturers the Exablate Neuro device.

[email protected]

A device that uses transcranial focused ultrasound to destroy the MRI-identified pathologic area of the thalamus in essential tremor patients became the first of its kind to receive Food and Drug Administration approval for use in patients whose condition has been refractory to medications such as beta-blockers or anticonvulsant drugs.

In patients who have undergone evaluation by CT and MRI to determine their suitability for the procedure, the Exablate Neuro device delivers focused ultrasound at incrementally higher energies until patients achieve a reduction of tremor. Patients are awake and responsive during the entire treatment.

Courtesy Wikimedia Commons/FitzColinGerald/Creative Commons License

“As with other treatments for essential tremor, this new device is not a cure but could help patients enjoy a better quality of life,” said Carlos Peña, PhD, director of the division of neurological and physical medicine devices in the FDA’s Center for Devices and Radiological Health, in the agency’s announcement of the approval. The device “could help them to avoid more extensive surgical treatments,” such as thalamotomy or a deep brain stimulation device, Dr. Peña said.

The clinical data used to support the approval included a double-blind, controlled trial of 76 patients with essential tremor who had not responded to medication therapy.

The 56 patients who were randomly selected to receive the Exablate Neuro treatment showed nearly a 50% improvement in their tremors and motor function 3 months after treatment, compared with their baseline score. The 20 patients who received a sham control treatment had no improvement, and some experienced a slight worsening after the sham procedure before they crossed over into the treatment group at the 3-month time point.

At 12 months post procedure, the treatment group retained a 40% improvement in those scores, compared with baseline.

Adverse events reported by patients treated with the device were similar to those reported by patients who have undergone thalamotomy. Events included numbness/tingling of the fingers, headache, imbalance/unsteadiness, loss of control of body movements (ataxia), or gait disturbance.

Other side effects identified as possibly related to treatment with MR-guided focused ultrasound treatments include tissue damage in an area other than the treatment area, hemorrhage in the treated area requiring emergency treatment, skin burns with ulceration of the skin, skin retraction, and scar formation and blood clots.

InSightec manufacturers the Exablate Neuro device.

[email protected]

A device that uses transcranial focused ultrasound to destroy the MRI-identified pathologic area of the thalamus in essential tremor patients became the first of its kind to receive Food and Drug Administration approval for use in patients whose condition has been refractory to medications such as beta-blockers or anticonvulsant drugs.

In patients who have undergone evaluation by CT and MRI to determine their suitability for the procedure, the Exablate Neuro device delivers focused ultrasound at incrementally higher energies until patients achieve a reduction of tremor. Patients are awake and responsive during the entire treatment.

Courtesy Wikimedia Commons/FitzColinGerald/Creative Commons License

“As with other treatments for essential tremor, this new device is not a cure but could help patients enjoy a better quality of life,” said Carlos Peña, PhD, director of the division of neurological and physical medicine devices in the FDA’s Center for Devices and Radiological Health, in the agency’s announcement of the approval. The device “could help them to avoid more extensive surgical treatments,” such as thalamotomy or a deep brain stimulation device, Dr. Peña said.

The clinical data used to support the approval included a double-blind, controlled trial of 76 patients with essential tremor who had not responded to medication therapy.

The 56 patients who were randomly selected to receive the Exablate Neuro treatment showed nearly a 50% improvement in their tremors and motor function 3 months after treatment, compared with their baseline score. The 20 patients who received a sham control treatment had no improvement, and some experienced a slight worsening after the sham procedure before they crossed over into the treatment group at the 3-month time point.

At 12 months post procedure, the treatment group retained a 40% improvement in those scores, compared with baseline.

Adverse events reported by patients treated with the device were similar to those reported by patients who have undergone thalamotomy. Events included numbness/tingling of the fingers, headache, imbalance/unsteadiness, loss of control of body movements (ataxia), or gait disturbance.

Other side effects identified as possibly related to treatment with MR-guided focused ultrasound treatments include tissue damage in an area other than the treatment area, hemorrhage in the treated area requiring emergency treatment, skin burns with ulceration of the skin, skin retraction, and scar formation and blood clots.

InSightec manufacturers the Exablate Neuro device.

[email protected]

The Food and Drug Administration has approved adapalene gel 0.1% for over-the-counter use, making it the first retinoid for treating acne that will be available in the United States without a prescription.

The approval also makes the product, marketed as Differin Gel 0.1%, “the first new active ingredient for acne treatment for OTC use since the 1980s,” according to an FDA statement announcing the approval July 8. Differin Gel is approved for use in people aged 12 years and older.

The switch to OTC status was supported by postmarketing safety data; by consumer studies data, which included a label comprehension study, a self-selection study, and an “actual use” study; and data from a “maximal use” study submitted by the manufacturer.

“Overall, results from the consumer studies showed that consumers can understand the information on the OTC label, appropriately select whether the product is right for them, and use the product appropriately,” according to the FDA statement. “The maximal use trial, a study of absorption of the drug through acne-affected skin when applied daily over a large surface area (face, shoulders, upper back, and chest), demonstrated that absorption is limited, thus supporting safe use of Differin Gel 0.1% by people using it OTC.”

The FDA noted that “some other retinoid drugs have been shown to cause birth defects,” and it advises that women “who are pregnant, planning to become pregnant, or [are] breast-feeding” should ask a doctor before using the product.

“While there have been no adequate and well-controlled studies of Differin Gel 0.1% in pregnant women, there is no specific evidence that Differin Gel 0.1%, when used topically as directed, causes birth defects in humans,” according to the FDA.

Consumers should follow the OTC Drug Facts label “and consult with their health care providers if their symptoms do not improve,” the FDA added.

At an April 2016 meeting, the FDA’s nonprescription drugs advisory committee unanimously voted that the safety of adapalene gel 0.1% for OTC use for treating acne had been “adequately demonstrated.”

Galderma Laboratories markets Differin Gel 0.1%.

The Food and Drug Administration has approved adapalene gel 0.1% for over-the-counter use, making it the first retinoid for treating acne that will be available in the United States without a prescription.

The approval also makes the product, marketed as Differin Gel 0.1%, “the first new active ingredient for acne treatment for OTC use since the 1980s,” according to an FDA statement announcing the approval July 8. Differin Gel is approved for use in people aged 12 years and older.

The switch to OTC status was supported by postmarketing safety data; by consumer studies data, which included a label comprehension study, a self-selection study, and an “actual use” study; and data from a “maximal use” study submitted by the manufacturer.

“Overall, results from the consumer studies showed that consumers can understand the information on the OTC label, appropriately select whether the product is right for them, and use the product appropriately,” according to the FDA statement. “The maximal use trial, a study of absorption of the drug through acne-affected skin when applied daily over a large surface area (face, shoulders, upper back, and chest), demonstrated that absorption is limited, thus supporting safe use of Differin Gel 0.1% by people using it OTC.”

The FDA noted that “some other retinoid drugs have been shown to cause birth defects,” and it advises that women “who are pregnant, planning to become pregnant, or [are] breast-feeding” should ask a doctor before using the product.

“While there have been no adequate and well-controlled studies of Differin Gel 0.1% in pregnant women, there is no specific evidence that Differin Gel 0.1%, when used topically as directed, causes birth defects in humans,” according to the FDA.

Consumers should follow the OTC Drug Facts label “and consult with their health care providers if their symptoms do not improve,” the FDA added.

At an April 2016 meeting, the FDA’s nonprescription drugs advisory committee unanimously voted that the safety of adapalene gel 0.1% for OTC use for treating acne had been “adequately demonstrated.”

Galderma Laboratories markets Differin Gel 0.1%.

The Food and Drug Administration has approved adapalene gel 0.1% for over-the-counter use, making it the first retinoid for treating acne that will be available in the United States without a prescription.

The approval also makes the product, marketed as Differin Gel 0.1%, “the first new active ingredient for acne treatment for OTC use since the 1980s,” according to an FDA statement announcing the approval July 8. Differin Gel is approved for use in people aged 12 years and older.

The switch to OTC status was supported by postmarketing safety data; by consumer studies data, which included a label comprehension study, a self-selection study, and an “actual use” study; and data from a “maximal use” study submitted by the manufacturer.

“Overall, results from the consumer studies showed that consumers can understand the information on the OTC label, appropriately select whether the product is right for them, and use the product appropriately,” according to the FDA statement. “The maximal use trial, a study of absorption of the drug through acne-affected skin when applied daily over a large surface area (face, shoulders, upper back, and chest), demonstrated that absorption is limited, thus supporting safe use of Differin Gel 0.1% by people using it OTC.”

The FDA noted that “some other retinoid drugs have been shown to cause birth defects,” and it advises that women “who are pregnant, planning to become pregnant, or [are] breast-feeding” should ask a doctor before using the product.

“While there have been no adequate and well-controlled studies of Differin Gel 0.1% in pregnant women, there is no specific evidence that Differin Gel 0.1%, when used topically as directed, causes birth defects in humans,” according to the FDA.

Consumers should follow the OTC Drug Facts label “and consult with their health care providers if their symptoms do not improve,” the FDA added.

At an April 2016 meeting, the FDA’s nonprescription drugs advisory committee unanimously voted that the safety of adapalene gel 0.1% for OTC use for treating acne had been “adequately demonstrated.”

Galderma Laboratories markets Differin Gel 0.1%.

The Food and Drug Administration has approved adapalene gel 0.1% for over-the-counter use, making it the first retinoid for treating acne that will be available in the United States without a prescription.

The approval also makes the product, marketed as Differin Gel 0.1%, “the first new active ingredient for acne treatment for OTC use since the 1980s,” according to an FDA statement announcing the approval July 8. Differin Gel is approved for use in people aged 12 years and older.

The switch to OTC status was supported by postmarketing safety data; by consumer studies data, which included a label comprehension study, a self-selection study, and an “actual use” study; and data from a “maximal use” study submitted by the manufacturer.

“Overall, results from the consumer studies showed that consumers can understand the information on the OTC label, appropriately select whether the product is right for them, and use the product appropriately,” according to the FDA statement. “The maximal use trial, a study of absorption of the drug through acne-affected skin when applied daily over a large surface area (face, shoulders, upper back, and chest), demonstrated that absorption is limited, thus supporting safe use of Differin Gel 0.1% by people using it OTC.”

The FDA noted that “some other retinoid drugs have been shown to cause birth defects,” and it advises that women “who are pregnant, planning to become pregnant, or [are] breast-feeding” should ask a doctor before using the product.

“While there have been no adequate and well-controlled studies of Differin Gel 0.1% in pregnant women, there is no specific evidence that Differin Gel 0.1%, when used topically as directed, causes birth defects in humans,” according to the FDA.

Consumers should follow the OTC Drug Facts label “and consult with their health care providers if their symptoms do not improve,” the FDA added.

At an April 2016 meeting, the FDA’s nonprescription drugs advisory committee unanimously voted that the safety of adapalene gel 0.1% for OTC use for treating acne had been “adequately demonstrated.”

Galderma Laboratories markets Differin Gel 0.1%.

[email protected]

The Food and Drug Administration has approved adapalene gel 0.1% for over-the-counter use, making it the first retinoid for treating acne that will be available in the United States without a prescription.

The approval also makes the product, marketed as Differin Gel 0.1%, “the first new active ingredient for acne treatment for OTC use since the 1980s,” according to an FDA statement announcing the approval July 8. Differin Gel is approved for use in people aged 12 years and older.

The switch to OTC status was supported by postmarketing safety data; by consumer studies data, which included a label comprehension study, a self-selection study, and an “actual use” study; and data from a “maximal use” study submitted by the manufacturer.

“Overall, results from the consumer studies showed that consumers can understand the information on the OTC label, appropriately select whether the product is right for them, and use the product appropriately,” according to the FDA statement. “The maximal use trial, a study of absorption of the drug through acne-affected skin when applied daily over a large surface area (face, shoulders, upper back, and chest), demonstrated that absorption is limited, thus supporting safe use of Differin Gel 0.1% by people using it OTC.”

The FDA noted that “some other retinoid drugs have been shown to cause birth defects,” and it advises that women “who are pregnant, planning to become pregnant, or [are] breast-feeding” should ask a doctor before using the product.

“While there have been no adequate and well-controlled studies of Differin Gel 0.1% in pregnant women, there is no specific evidence that Differin Gel 0.1%, when used topically as directed, causes birth defects in humans,” according to the FDA.

Consumers should follow the OTC Drug Facts label “and consult with their health care providers if their symptoms do not improve,” the FDA added.

At an April 2016 meeting, the FDA’s nonprescription drugs advisory committee unanimously voted that the safety of adapalene gel 0.1% for OTC use for treating acne had been “adequately demonstrated.”

Galderma Laboratories markets Differin Gel 0.1%.

[email protected]

The Food and Drug Administration has approved adapalene gel 0.1% for over-the-counter use, making it the first retinoid for treating acne that will be available in the United States without a prescription.

The approval also makes the product, marketed as Differin Gel 0.1%, “the first new active ingredient for acne treatment for OTC use since the 1980s,” according to an FDA statement announcing the approval July 8. Differin Gel is approved for use in people aged 12 years and older.

The switch to OTC status was supported by postmarketing safety data; by consumer studies data, which included a label comprehension study, a self-selection study, and an “actual use” study; and data from a “maximal use” study submitted by the manufacturer.

“Overall, results from the consumer studies showed that consumers can understand the information on the OTC label, appropriately select whether the product is right for them, and use the product appropriately,” according to the FDA statement. “The maximal use trial, a study of absorption of the drug through acne-affected skin when applied daily over a large surface area (face, shoulders, upper back, and chest), demonstrated that absorption is limited, thus supporting safe use of Differin Gel 0.1% by people using it OTC.”

The FDA noted that “some other retinoid drugs have been shown to cause birth defects,” and it advises that women “who are pregnant, planning to become pregnant, or [are] breast-feeding” should ask a doctor before using the product.

“While there have been no adequate and well-controlled studies of Differin Gel 0.1% in pregnant women, there is no specific evidence that Differin Gel 0.1%, when used topically as directed, causes birth defects in humans,” according to the FDA.

Consumers should follow the OTC Drug Facts label “and consult with their health care providers if their symptoms do not improve,” the FDA added.

At an April 2016 meeting, the FDA’s nonprescription drugs advisory committee unanimously voted that the safety of adapalene gel 0.1% for OTC use for treating acne had been “adequately demonstrated.”

Galderma Laboratories markets Differin Gel 0.1%.

[email protected]

Many commonly used prescription drugs, many OTC agents, and also several complimentary or alternative medications, can either trigger heart failure or exacerbate the disease in patients with existing heart failure according to a Scientific Statement written by a committee of the American Heart Association and released on July 11.

This first-ever authoritative U.S. overview of what is known about drugs that can affect heart failure was compiled to address an important practice issue for the large and growing number of U.S. patients with heart failure, estimated to be nearly 6 million Americans, and “provide some guidance to health care providers in how to minimize polypharmacy, improve medication safety, as well as identify the medications that could exacerbate or cause heart failure,” said Robert L. Page II, PharmD, chair of the committee and a professor of clinical pharmacy at the University of Colorado at Denver, Aurora.

Although the comprehensive statement lists 88 distinct prescription drugs or drug classes as agents that pose major or moderate threats for causing or worsening heart failure, “from the American public’s perspective, importance should be placed on educating patients regarding the impact that OTC medications can have on their heart failure,” Dr. Page said in an interview. “For example, nonsteroidal anti-inflammatory drugs like ibuprofen or naproxen can cause sodium and water retention and antagonize the effects of evidence-based heart failure pharmacotherapies. Additionally, OTC medications like pseudoephedrine, which many cough and cold products contain, can increase blood pressure and afterload,” he noted. The risks these drugs pose becomes even greater when they are taken at higher doses.

NSAIDs

The statement cites already existing guidance from the American College of Cardiology and American Heart Association that for patients with existing heart failure, use of NSAIDs should either be avoided or withdrawn when possible. The statement advises educating patients to communicate with their health care provider before taking any OTC medication or complimentary or alternative medication, avoid these agents when their efficacy and safety is uncertain, and evaluate the labels of these products for their sodium content (although the sodium content from inactive ingredients may be difficult to find in labeling).

“Currently, we teach patients to read food labels for sodium content, but we also need to educate patients on how to read OTC medication labels for both ingredients and sodium content. Many OTC antacids may have a large sodium load,” Dr. Page said. The statement includes a list of 14 prescription drugs and also highlights several OTC formulations that have an especially high sodium content.

Metformin

Among the many prescription drugs listed, one notable entry is for the oral hypoglycemic agent metformin that today is among the most widely used drugs for treating type 2 diabetes and is especially relevant for heart failure patients because, as the statement notes, 38% also have diabetes. The statement details the long history of metformin and heart failure, noting that until a decade ago, the drug had a contraindication for patients with heart failure, that metformin’s label still carries a black box warning for cautious use in heart failure patients, and that earlier in 2016, the Food and Drug Administration cautioned that metformin should not be used in patients with an estimated glomerular filtration rate of less than 30 mL/minute per 1.73 m². The statement also endorsed a recommendation from the American Diabetes Association that metformin not be used in patients with unstable heart failure or those hospitalized for heart failure.

Antihypertensives, biologics, and more

Other notable prescription drugs listed as potentially having a major impact on causing or worsening heart failure include the antihypertensive drugs diltiazem, verapamil, and moxonidine, the tumor necrosis factor–inhibitors that are widely used to treat rheumatologic and gastroenterologic diseases, the antipsychotic clozapine, and a long list of anticancer medications, including several anthracyclines and many types of newer biologic agents.

The statement also lists several specific recommendations to health care providers for improving oversight of the drugs taken by patients with heart failure or those at risk for heart failure. These include a comprehensive medication review during each clinical encounter. The statement also suggests a “medication flow sheet” for each patient that contains the basic information regarding the regimen for each medication taken by a patient: the brand and generic name, the purpose of the medication, and its dosage. “These medication flow sheets should be used by patients as a tool to enhance safety and adherence, and they should show their flow sheets at each provider visit,” Dr. Page said.

Managing myriad meds

The statement also calls for stopping medications without a well defined indication for a patient, avoid prescribing new drugs to address side effects of other drugs, and suggests establishing a “captain” among the health care providers seen by each patient who would be particularly responsible for overseeing and keeping track of the medications the patient takes.

“Ideally, this ‘captain’ would be the patient’s primary care provider, who should be in contact with the other specialists that the patient may be seeing. However, this does not always happen,” said Dr. Page. “Therefore, I encourage each patient with heart failure to contact both their primary care provider and their health care provider who is managing their heart failure before taking or stopping any new medication including prescription, OTC, herbal, complimentary or alternative medication or supplement. Health care providers need to encourage patients to be actively engaged in their medication management.”

Dr. Page had no disclosures.

Many commonly used prescription drugs, many OTC agents, and also several complimentary or alternative medications, can either trigger heart failure or exacerbate the disease in patients with existing heart failure according to a Scientific Statement written by a committee of the American Heart Association and released on July 11.

This first-ever authoritative U.S. overview of what is known about drugs that can affect heart failure was compiled to address an important practice issue for the large and growing number of U.S. patients with heart failure, estimated to be nearly 6 million Americans, and “provide some guidance to health care providers in how to minimize polypharmacy, improve medication safety, as well as identify the medications that could exacerbate or cause heart failure,” said Robert L. Page II, PharmD, chair of the committee and a professor of clinical pharmacy at the University of Colorado at Denver, Aurora.

Although the comprehensive statement lists 88 distinct prescription drugs or drug classes as agents that pose major or moderate threats for causing or worsening heart failure, “from the American public’s perspective, importance should be placed on educating patients regarding the impact that OTC medications can have on their heart failure,” Dr. Page said in an interview. “For example, nonsteroidal anti-inflammatory drugs like ibuprofen or naproxen can cause sodium and water retention and antagonize the effects of evidence-based heart failure pharmacotherapies. Additionally, OTC medications like pseudoephedrine, which many cough and cold products contain, can increase blood pressure and afterload,” he noted. The risks these drugs pose becomes even greater when they are taken at higher doses.

NSAIDs

The statement cites already existing guidance from the American College of Cardiology and American Heart Association that for patients with existing heart failure, use of NSAIDs should either be avoided or withdrawn when possible. The statement advises educating patients to communicate with their health care provider before taking any OTC medication or complimentary or alternative medication, avoid these agents when their efficacy and safety is uncertain, and evaluate the labels of these products for their sodium content (although the sodium content from inactive ingredients may be difficult to find in labeling).

“Currently, we teach patients to read food labels for sodium content, but we also need to educate patients on how to read OTC medication labels for both ingredients and sodium content. Many OTC antacids may have a large sodium load,” Dr. Page said. The statement includes a list of 14 prescription drugs and also highlights several OTC formulations that have an especially high sodium content.

Metformin

Among the many prescription drugs listed, one notable entry is for the oral hypoglycemic agent metformin that today is among the most widely used drugs for treating type 2 diabetes and is especially relevant for heart failure patients because, as the statement notes, 38% also have diabetes. The statement details the long history of metformin and heart failure, noting that until a decade ago, the drug had a contraindication for patients with heart failure, that metformin’s label still carries a black box warning for cautious use in heart failure patients, and that earlier in 2016, the Food and Drug Administration cautioned that metformin should not be used in patients with an estimated glomerular filtration rate of less than 30 mL/minute per 1.73 m². The statement also endorsed a recommendation from the American Diabetes Association that metformin not be used in patients with unstable heart failure or those hospitalized for heart failure.

Antihypertensives, biologics, and more

Other notable prescription drugs listed as potentially having a major impact on causing or worsening heart failure include the antihypertensive drugs diltiazem, verapamil, and moxonidine, the tumor necrosis factor–inhibitors that are widely used to treat rheumatologic and gastroenterologic diseases, the antipsychotic clozapine, and a long list of anticancer medications, including several anthracyclines and many types of newer biologic agents.

The statement also lists several specific recommendations to health care providers for improving oversight of the drugs taken by patients with heart failure or those at risk for heart failure. These include a comprehensive medication review during each clinical encounter. The statement also suggests a “medication flow sheet” for each patient that contains the basic information regarding the regimen for each medication taken by a patient: the brand and generic name, the purpose of the medication, and its dosage. “These medication flow sheets should be used by patients as a tool to enhance safety and adherence, and they should show their flow sheets at each provider visit,” Dr. Page said.

Managing myriad meds

The statement also calls for stopping medications without a well defined indication for a patient, avoid prescribing new drugs to address side effects of other drugs, and suggests establishing a “captain” among the health care providers seen by each patient who would be particularly responsible for overseeing and keeping track of the medications the patient takes.

“Ideally, this ‘captain’ would be the patient’s primary care provider, who should be in contact with the other specialists that the patient may be seeing. However, this does not always happen,” said Dr. Page. “Therefore, I encourage each patient with heart failure to contact both their primary care provider and their health care provider who is managing their heart failure before taking or stopping any new medication including prescription, OTC, herbal, complimentary or alternative medication or supplement. Health care providers need to encourage patients to be actively engaged in their medication management.”

Dr. Page had no disclosures.

Many commonly used prescription drugs, many OTC agents, and also several complimentary or alternative medications, can either trigger heart failure or exacerbate the disease in patients with existing heart failure according to a Scientific Statement written by a committee of the American Heart Association and released on July 11.

This first-ever authoritative U.S. overview of what is known about drugs that can affect heart failure was compiled to address an important practice issue for the large and growing number of U.S. patients with heart failure, estimated to be nearly 6 million Americans, and “provide some guidance to health care providers in how to minimize polypharmacy, improve medication safety, as well as identify the medications that could exacerbate or cause heart failure,” said Robert L. Page II, PharmD, chair of the committee and a professor of clinical pharmacy at the University of Colorado at Denver, Aurora.

Although the comprehensive statement lists 88 distinct prescription drugs or drug classes as agents that pose major or moderate threats for causing or worsening heart failure, “from the American public’s perspective, importance should be placed on educating patients regarding the impact that OTC medications can have on their heart failure,” Dr. Page said in an interview. “For example, nonsteroidal anti-inflammatory drugs like ibuprofen or naproxen can cause sodium and water retention and antagonize the effects of evidence-based heart failure pharmacotherapies. Additionally, OTC medications like pseudoephedrine, which many cough and cold products contain, can increase blood pressure and afterload,” he noted. The risks these drugs pose becomes even greater when they are taken at higher doses.

NSAIDs

The statement cites already existing guidance from the American College of Cardiology and American Heart Association that for patients with existing heart failure, use of NSAIDs should either be avoided or withdrawn when possible. The statement advises educating patients to communicate with their health care provider before taking any OTC medication or complimentary or alternative medication, avoid these agents when their efficacy and safety is uncertain, and evaluate the labels of these products for their sodium content (although the sodium content from inactive ingredients may be difficult to find in labeling).

“Currently, we teach patients to read food labels for sodium content, but we also need to educate patients on how to read OTC medication labels for both ingredients and sodium content. Many OTC antacids may have a large sodium load,” Dr. Page said. The statement includes a list of 14 prescription drugs and also highlights several OTC formulations that have an especially high sodium content.

Metformin

Among the many prescription drugs listed, one notable entry is for the oral hypoglycemic agent metformin that today is among the most widely used drugs for treating type 2 diabetes and is especially relevant for heart failure patients because, as the statement notes, 38% also have diabetes. The statement details the long history of metformin and heart failure, noting that until a decade ago, the drug had a contraindication for patients with heart failure, that metformin’s label still carries a black box warning for cautious use in heart failure patients, and that earlier in 2016, the Food and Drug Administration cautioned that metformin should not be used in patients with an estimated glomerular filtration rate of less than 30 mL/minute per 1.73 m². The statement also endorsed a recommendation from the American Diabetes Association that metformin not be used in patients with unstable heart failure or those hospitalized for heart failure.

Antihypertensives, biologics, and more

Other notable prescription drugs listed as potentially having a major impact on causing or worsening heart failure include the antihypertensive drugs diltiazem, verapamil, and moxonidine, the tumor necrosis factor–inhibitors that are widely used to treat rheumatologic and gastroenterologic diseases, the antipsychotic clozapine, and a long list of anticancer medications, including several anthracyclines and many types of newer biologic agents.

The statement also lists several specific recommendations to health care providers for improving oversight of the drugs taken by patients with heart failure or those at risk for heart failure. These include a comprehensive medication review during each clinical encounter. The statement also suggests a “medication flow sheet” for each patient that contains the basic information regarding the regimen for each medication taken by a patient: the brand and generic name, the purpose of the medication, and its dosage. “These medication flow sheets should be used by patients as a tool to enhance safety and adherence, and they should show their flow sheets at each provider visit,” Dr. Page said.

Managing myriad meds

The statement also calls for stopping medications without a well defined indication for a patient, avoid prescribing new drugs to address side effects of other drugs, and suggests establishing a “captain” among the health care providers seen by each patient who would be particularly responsible for overseeing and keeping track of the medications the patient takes.

“Ideally, this ‘captain’ would be the patient’s primary care provider, who should be in contact with the other specialists that the patient may be seeing. However, this does not always happen,” said Dr. Page. “Therefore, I encourage each patient with heart failure to contact both their primary care provider and their health care provider who is managing their heart failure before taking or stopping any new medication including prescription, OTC, herbal, complimentary or alternative medication or supplement. Health care providers need to encourage patients to be actively engaged in their medication management.”

Dr. Page had no disclosures.

Repeat infusions of mesenchymal stromal stem cells appear to inhibit the development of chronic graft-versus-host disease (cGVHD) in patients who have undergone an allogeneic stem cell transplant.

The 2-year cumulative incidence of cGVHD among those randomized to receive repeated infusions of umbilical cord–derived mesenchymal stromal cells (MSCs) was half that of controls treated with a saline placebo, based on results from a randomized phase II, double blind trial in 124 patients with hematologic malignancies who underwent an HLA-haploidentical allogeneic hematopoietic stem cell transplantation (HSCT).

“Our goal was to minimize the incidence of cGVHD, reduce the severity of cGVHD, and demonstrate the safety of MSC infusions. We performed repeated infusions of MSCs once a month for a total of four rounds for each patient. Over the median 47-month posttransplantation period, the incidence of cGVHD was lower in the MSCs group than in the non-MSCs control group,” Lei Gao, MD, of the Third Military Medical University in Chongqing, China, and colleagues wrote in the Journal of Clinical Oncology (2016 Jul 11. doi: 10.1200/JCO.2015.65.3642).

Although cGVHD is associated with a reduced risk of leukemia relapse, it is still the leading cause of nonrelapse deaths after HSCT. The incidence of cGVHD is higher among recipients of HLA-haploidentical HSCT, in which the donor and recipient have identical HLA alleles on only one copy of chromosome, than among HLA-matched recipients, who have identical alleles on both copies.

The researchers randomly assigned 124 patients who had undergo HLA-haploidentical HSCT to receive either placebo or MSCs at a dose of 3 x 10⁷ cells/100 mL per month for four cycles beginning 4 months after HSCT

Of the 124 randomized patients, 12 discontinued the study due to cGVHD or disease progression.

The 2-year cumulative incidence of cGVHD among patients treated with MSCs was 27%, compared with 49% for placebo-treated controls (P = .021). Seven patients in the control group but none in the MSC-treated group developed typical lung cGVHD (P = .047).

The investigators also observed increases in memory B lymphocytes and regulatory T cells, and in the ratio of type 1 to type 2 T-helper cells, as well as a decrease in natural killer cells.

The finding that the MSC infusions increased the number of regulatory T cells while decreasing the incidence of cGVHD suggests that regulatory T cells play an inhibitory role, the investigators said.

The study was supported by the Chinese Academy of Sciences. Chinese National Natural Science Foundation, and other Chinese government grants. The authors reported having no relationships to disclose.

Repeat infusions of mesenchymal stromal stem cells appear to inhibit the development of chronic graft-versus-host disease (cGVHD) in patients who have undergone an allogeneic stem cell transplant.

The 2-year cumulative incidence of cGVHD among those randomized to receive repeated infusions of umbilical cord–derived mesenchymal stromal cells (MSCs) was half that of controls treated with a saline placebo, based on results from a randomized phase II, double blind trial in 124 patients with hematologic malignancies who underwent an HLA-haploidentical allogeneic hematopoietic stem cell transplantation (HSCT).

“Our goal was to minimize the incidence of cGVHD, reduce the severity of cGVHD, and demonstrate the safety of MSC infusions. We performed repeated infusions of MSCs once a month for a total of four rounds for each patient. Over the median 47-month posttransplantation period, the incidence of cGVHD was lower in the MSCs group than in the non-MSCs control group,” Lei Gao, MD, of the Third Military Medical University in Chongqing, China, and colleagues wrote in the Journal of Clinical Oncology (2016 Jul 11. doi: 10.1200/JCO.2015.65.3642).

Although cGVHD is associated with a reduced risk of leukemia relapse, it is still the leading cause of nonrelapse deaths after HSCT. The incidence of cGVHD is higher among recipients of HLA-haploidentical HSCT, in which the donor and recipient have identical HLA alleles on only one copy of chromosome, than among HLA-matched recipients, who have identical alleles on both copies.

The researchers randomly assigned 124 patients who had undergo HLA-haploidentical HSCT to receive either placebo or MSCs at a dose of 3 x 10⁷ cells/100 mL per month for four cycles beginning 4 months after HSCT

Of the 124 randomized patients, 12 discontinued the study due to cGVHD or disease progression.

The 2-year cumulative incidence of cGVHD among patients treated with MSCs was 27%, compared with 49% for placebo-treated controls (P = .021). Seven patients in the control group but none in the MSC-treated group developed typical lung cGVHD (P = .047).

The investigators also observed increases in memory B lymphocytes and regulatory T cells, and in the ratio of type 1 to type 2 T-helper cells, as well as a decrease in natural killer cells.

The finding that the MSC infusions increased the number of regulatory T cells while decreasing the incidence of cGVHD suggests that regulatory T cells play an inhibitory role, the investigators said.

The study was supported by the Chinese Academy of Sciences. Chinese National Natural Science Foundation, and other Chinese government grants. The authors reported having no relationships to disclose.

Repeat infusions of mesenchymal stromal stem cells appear to inhibit the development of chronic graft-versus-host disease (cGVHD) in patients who have undergone an allogeneic stem cell transplant.

The 2-year cumulative incidence of cGVHD among those randomized to receive repeated infusions of umbilical cord–derived mesenchymal stromal cells (MSCs) was half that of controls treated with a saline placebo, based on results from a randomized phase II, double blind trial in 124 patients with hematologic malignancies who underwent an HLA-haploidentical allogeneic hematopoietic stem cell transplantation (HSCT).

“Our goal was to minimize the incidence of cGVHD, reduce the severity of cGVHD, and demonstrate the safety of MSC infusions. We performed repeated infusions of MSCs once a month for a total of four rounds for each patient. Over the median 47-month posttransplantation period, the incidence of cGVHD was lower in the MSCs group than in the non-MSCs control group,” Lei Gao, MD, of the Third Military Medical University in Chongqing, China, and colleagues wrote in the Journal of Clinical Oncology (2016 Jul 11. doi: 10.1200/JCO.2015.65.3642).

Although cGVHD is associated with a reduced risk of leukemia relapse, it is still the leading cause of nonrelapse deaths after HSCT. The incidence of cGVHD is higher among recipients of HLA-haploidentical HSCT, in which the donor and recipient have identical HLA alleles on only one copy of chromosome, than among HLA-matched recipients, who have identical alleles on both copies.

The researchers randomly assigned 124 patients who had undergo HLA-haploidentical HSCT to receive either placebo or MSCs at a dose of 3 x 10⁷ cells/100 mL per month for four cycles beginning 4 months after HSCT

Of the 124 randomized patients, 12 discontinued the study due to cGVHD or disease progression.

The 2-year cumulative incidence of cGVHD among patients treated with MSCs was 27%, compared with 49% for placebo-treated controls (P = .021). Seven patients in the control group but none in the MSC-treated group developed typical lung cGVHD (P = .047).

The investigators also observed increases in memory B lymphocytes and regulatory T cells, and in the ratio of type 1 to type 2 T-helper cells, as well as a decrease in natural killer cells.

The finding that the MSC infusions increased the number of regulatory T cells while decreasing the incidence of cGVHD suggests that regulatory T cells play an inhibitory role, the investigators said.

The study was supported by the Chinese Academy of Sciences. Chinese National Natural Science Foundation, and other Chinese government grants. The authors reported having no relationships to disclose.

Standard oncology measures are acceptable indicators of good-quality end of life care for hematologic malignancies, investigators report.

Six out of eight standard end of life (EOL) care measures were deemed acceptable (defined as greater than 55% agreement) based on 349 returned surveys from hematologic oncologists. Hospice enrollment more than 7 days before death, no chemotherapy less than 14 days before death, and no CPR and intubation within the last 30 days of life were acceptable measures to more than 75% of those surveyed.

No more than one hospitalization within 30 days of death and no more than one emergency room visit within 30 days of death did not meet the threshold for acceptance by the oncologists.

“These data suggest that the absence of hematology-specific measures is unlikely to be a major barrier to quality care and that more resources should be directed toward addressing barriers to compliance with established EOL quality measures than toward creating new ones,” Oreofe O. Odejide, MD, of the Dana-Farber Cancer Institute, Boston, and her associates reported (J Clin Oncol. 2016 July. doi: 10.1200/JCO.2016.67.8177).

The top barriers to end of life care were unrealistic patient expectations (97.3%), clinician concern about diminishing patient and family hope (71.3%), and unrealistic clinician expectations (59.0%), according to investigators.

Surveyed oncologists also reported that increasing access to palliative care services (93.7%), increasing access to inpatient hospice facilities (92.2%), and allowing hospice enrollment with disease-directed treatment (90.1%) would be the most helpful interventions to improve end of life care.

The Lymphoma Research Foundation, the Conquer Cancer Foundation, and investigators’ respective institutions funded this research. Dr. Odejide and four of her associates had no disclosures to report. Two investigators reported serving in advisory roles, holding patents, or having stock or ownership interest in UnitedHealthcare, UpToDate, or Recap Information Systems.

[email protected]

On Twitter @jessnicolecraig

Standard oncology measures are acceptable indicators of good-quality end of life care for hematologic malignancies, investigators report.

Six out of eight standard end of life (EOL) care measures were deemed acceptable (defined as greater than 55% agreement) based on 349 returned surveys from hematologic oncologists. Hospice enrollment more than 7 days before death, no chemotherapy less than 14 days before death, and no CPR and intubation within the last 30 days of life were acceptable measures to more than 75% of those surveyed.

No more than one hospitalization within 30 days of death and no more than one emergency room visit within 30 days of death did not meet the threshold for acceptance by the oncologists.

“These data suggest that the absence of hematology-specific measures is unlikely to be a major barrier to quality care and that more resources should be directed toward addressing barriers to compliance with established EOL quality measures than toward creating new ones,” Oreofe O. Odejide, MD, of the Dana-Farber Cancer Institute, Boston, and her associates reported (J Clin Oncol. 2016 July. doi: 10.1200/JCO.2016.67.8177).

The top barriers to end of life care were unrealistic patient expectations (97.3%), clinician concern about diminishing patient and family hope (71.3%), and unrealistic clinician expectations (59.0%), according to investigators.

Surveyed oncologists also reported that increasing access to palliative care services (93.7%), increasing access to inpatient hospice facilities (92.2%), and allowing hospice enrollment with disease-directed treatment (90.1%) would be the most helpful interventions to improve end of life care.

The Lymphoma Research Foundation, the Conquer Cancer Foundation, and investigators’ respective institutions funded this research. Dr. Odejide and four of her associates had no disclosures to report. Two investigators reported serving in advisory roles, holding patents, or having stock or ownership interest in UnitedHealthcare, UpToDate, or Recap Information Systems.

[email protected]

On Twitter @jessnicolecraig

Standard oncology measures are acceptable indicators of good-quality end of life care for hematologic malignancies, investigators report.

Six out of eight standard end of life (EOL) care measures were deemed acceptable (defined as greater than 55% agreement) based on 349 returned surveys from hematologic oncologists. Hospice enrollment more than 7 days before death, no chemotherapy less than 14 days before death, and no CPR and intubation within the last 30 days of life were acceptable measures to more than 75% of those surveyed.

No more than one hospitalization within 30 days of death and no more than one emergency room visit within 30 days of death did not meet the threshold for acceptance by the oncologists.

“These data suggest that the absence of hematology-specific measures is unlikely to be a major barrier to quality care and that more resources should be directed toward addressing barriers to compliance with established EOL quality measures than toward creating new ones,” Oreofe O. Odejide, MD, of the Dana-Farber Cancer Institute, Boston, and her associates reported (J Clin Oncol. 2016 July. doi: 10.1200/JCO.2016.67.8177).

The top barriers to end of life care were unrealistic patient expectations (97.3%), clinician concern about diminishing patient and family hope (71.3%), and unrealistic clinician expectations (59.0%), according to investigators.

Surveyed oncologists also reported that increasing access to palliative care services (93.7%), increasing access to inpatient hospice facilities (92.2%), and allowing hospice enrollment with disease-directed treatment (90.1%) would be the most helpful interventions to improve end of life care.

The Lymphoma Research Foundation, the Conquer Cancer Foundation, and investigators’ respective institutions funded this research. Dr. Odejide and four of her associates had no disclosures to report. Two investigators reported serving in advisory roles, holding patents, or having stock or ownership interest in UnitedHealthcare, UpToDate, or Recap Information Systems.

[email protected]

On Twitter @jessnicolecraig

Many commonly used prescription drugs, many OTC agents, and also several complimentary or alternative medications, can either trigger heart failure or exacerbate the disease in patients with existing heart failure according to a Scientific Statement written by a committee of the American Heart Association and released on July 11.

This first-ever authoritative U.S. overview of what is known about drugs that can affect heart failure was compiled to address an important practice issue for the large and growing number of U.S. patients with heart failure, estimated to be nearly 6 million Americans, and “provide some guidance to health care providers in how to minimize polypharmacy, improve medication safety, as well as identify the medications that could exacerbate or cause heart failure,” said Robert L. Page II, PharmD, chair of the committee and a professor of clinical pharmacy at the University of Colorado at Denver, Aurora.

Although the comprehensive statement lists 88 distinct prescription drugs or drug classes as agents that pose major or moderate threats for causing or worsening heart failure, “from the American public’s perspective, importance should be placed on educating patients regarding the impact that OTC medications can have on their heart failure,” Dr. Page said in an interview. “For example, nonsteroidal anti-inflammatory drugs like ibuprofen or naproxen can cause sodium and water retention and antagonize the effects of evidence-based heart failure pharmacotherapies. Additionally, OTC medications like pseudoephedrine, which many cough and cold products contain, can increase blood pressure and afterload,” he noted. The risks these drugs pose becomes even greater when they are taken at higher doses.

NSAIDs

The statement cites already existing guidance from the American College of Cardiology and American Heart Association that for patients with existing heart failure, use of NSAIDs should either be avoided or withdrawn when possible. The statement advises educating patients to communicate with their health care provider before taking any OTC medication or complimentary or alternative medication, avoid these agents when their efficacy and safety is uncertain, and evaluate the labels of these products for their sodium content (although the sodium content from inactive ingredients may be difficult to find in labeling).

“Currently, we teach patients to read food labels for sodium content, but we also need to educate patients on how to read OTC medication labels for both ingredients and sodium content. Many OTC antacids may have a large sodium load,” Dr. Page said. The statement includes a list of 14 prescription drugs and also highlights several OTC formulations that have an especially high sodium content.

Metformin

Among the many prescription drugs listed, one notable entry is for the oral hypoglycemic agent metformin that today is among the most widely used drugs for treating type 2 diabetes and is especially relevant for heart failure patients because, as the statement notes, 38% also have diabetes. The statement details the long history of metformin and heart failure, noting that until a decade ago, the drug had a contraindication for patients with heart failure, that metformin’s label still carries a black box warning for cautious use in heart failure patients, and that earlier in 2016, the Food and Drug Administration cautioned that metformin should not be used in patients with an estimated glomerular filtration rate of less than 30 mL/minute per 1.73 m². The statement also endorsed a recommendation from the American Diabetes Association that metformin not be used in patients with unstable heart failure or those hospitalized for heart failure.

Antihypertensives, biologics, and more

Other notable prescription drugs listed as potentially having a major impact on causing or worsening heart failure include the antihypertensive drugs diltiazem, verapamil, and moxonidine, the tumor necrosis factor–inhibitors that are widely used to treat rheumatologic and gastroenterologic diseases, the antipsychotic clozapine, and a long list of anticancer medications, including several anthracyclines and many types of newer biologic agents.

The statement also lists several specific recommendations to health care providers for improving oversight of the drugs taken by patients with heart failure or those at risk for heart failure. These include a comprehensive medication review during each clinical encounter. The statement also suggests a “medication flow sheet” for each patient that contains the basic information regarding the regimen for each medication taken by a patient: the brand and generic name, the purpose of the medication, and its dosage. “These medication flow sheets should be used by patients as a tool to enhance safety and adherence, and they should show their flow sheets at each provider visit,” Dr. Page said.

Managing myriad meds

The statement also calls for stopping medications without a well defined indication for a patient, avoid prescribing new drugs to address side effects of other drugs, and suggests establishing a “captain” among the health care providers seen by each patient who would be particularly responsible for overseeing and keeping track of the medications the patient takes.

“Ideally, this ‘captain’ would be the patient’s primary care provider, who should be in contact with the other specialists that the patient may be seeing. However, this does not always happen,” said Dr. Page. “Therefore, I encourage each patient with heart failure to contact both their primary care provider and their health care provider who is managing their heart failure before taking or stopping any new medication including prescription, OTC, herbal, complimentary or alternative medication or supplement. Health care providers need to encourage patients to be actively engaged in their medication management.”

Dr. Page had no disclosures.

[email protected]

On Twitter @mitchelzoler

Many commonly used prescription drugs, many OTC agents, and also several complimentary or alternative medications, can either trigger heart failure or exacerbate the disease in patients with existing heart failure according to a Scientific Statement written by a committee of the American Heart Association and released on July 11.

This first-ever authoritative U.S. overview of what is known about drugs that can affect heart failure was compiled to address an important practice issue for the large and growing number of U.S. patients with heart failure, estimated to be nearly 6 million Americans, and “provide some guidance to health care providers in how to minimize polypharmacy, improve medication safety, as well as identify the medications that could exacerbate or cause heart failure,” said Robert L. Page II, PharmD, chair of the committee and a professor of clinical pharmacy at the University of Colorado at Denver, Aurora.

Although the comprehensive statement lists 88 distinct prescription drugs or drug classes as agents that pose major or moderate threats for causing or worsening heart failure, “from the American public’s perspective, importance should be placed on educating patients regarding the impact that OTC medications can have on their heart failure,” Dr. Page said in an interview. “For example, nonsteroidal anti-inflammatory drugs like ibuprofen or naproxen can cause sodium and water retention and antagonize the effects of evidence-based heart failure pharmacotherapies. Additionally, OTC medications like pseudoephedrine, which many cough and cold products contain, can increase blood pressure and afterload,” he noted. The risks these drugs pose becomes even greater when they are taken at higher doses.

NSAIDs

The statement cites already existing guidance from the American College of Cardiology and American Heart Association that for patients with existing heart failure, use of NSAIDs should either be avoided or withdrawn when possible. The statement advises educating patients to communicate with their health care provider before taking any OTC medication or complimentary or alternative medication, avoid these agents when their efficacy and safety is uncertain, and evaluate the labels of these products for their sodium content (although the sodium content from inactive ingredients may be difficult to find in labeling).

“Currently, we teach patients to read food labels for sodium content, but we also need to educate patients on how to read OTC medication labels for both ingredients and sodium content. Many OTC antacids may have a large sodium load,” Dr. Page said. The statement includes a list of 14 prescription drugs and also highlights several OTC formulations that have an especially high sodium content.

Metformin

Among the many prescription drugs listed, one notable entry is for the oral hypoglycemic agent metformin that today is among the most widely used drugs for treating type 2 diabetes and is especially relevant for heart failure patients because, as the statement notes, 38% also have diabetes. The statement details the long history of metformin and heart failure, noting that until a decade ago, the drug had a contraindication for patients with heart failure, that metformin’s label still carries a black box warning for cautious use in heart failure patients, and that earlier in 2016, the Food and Drug Administration cautioned that metformin should not be used in patients with an estimated glomerular filtration rate of less than 30 mL/minute per 1.73 m². The statement also endorsed a recommendation from the American Diabetes Association that metformin not be used in patients with unstable heart failure or those hospitalized for heart failure.

Antihypertensives, biologics, and more

Other notable prescription drugs listed as potentially having a major impact on causing or worsening heart failure include the antihypertensive drugs diltiazem, verapamil, and moxonidine, the tumor necrosis factor–inhibitors that are widely used to treat rheumatologic and gastroenterologic diseases, the antipsychotic clozapine, and a long list of anticancer medications, including several anthracyclines and many types of newer biologic agents.

The statement also lists several specific recommendations to health care providers for improving oversight of the drugs taken by patients with heart failure or those at risk for heart failure. These include a comprehensive medication review during each clinical encounter. The statement also suggests a “medication flow sheet” for each patient that contains the basic information regarding the regimen for each medication taken by a patient: the brand and generic name, the purpose of the medication, and its dosage. “These medication flow sheets should be used by patients as a tool to enhance safety and adherence, and they should show their flow sheets at each provider visit,” Dr. Page said.

Managing myriad meds

The statement also calls for stopping medications without a well defined indication for a patient, avoid prescribing new drugs to address side effects of other drugs, and suggests establishing a “captain” among the health care providers seen by each patient who would be particularly responsible for overseeing and keeping track of the medications the patient takes.

“Ideally, this ‘captain’ would be the patient’s primary care provider, who should be in contact with the other specialists that the patient may be seeing. However, this does not always happen,” said Dr. Page. “Therefore, I encourage each patient with heart failure to contact both their primary care provider and their health care provider who is managing their heart failure before taking or stopping any new medication including prescription, OTC, herbal, complimentary or alternative medication or supplement. Health care providers need to encourage patients to be actively engaged in their medication management.”

Dr. Page had no disclosures.

[email protected]

On Twitter @mitchelzoler

Many commonly used prescription drugs, many OTC agents, and also several complimentary or alternative medications, can either trigger heart failure or exacerbate the disease in patients with existing heart failure according to a Scientific Statement written by a committee of the American Heart Association and released on July 11.

This first-ever authoritative U.S. overview of what is known about drugs that can affect heart failure was compiled to address an important practice issue for the large and growing number of U.S. patients with heart failure, estimated to be nearly 6 million Americans, and “provide some guidance to health care providers in how to minimize polypharmacy, improve medication safety, as well as identify the medications that could exacerbate or cause heart failure,” said Robert L. Page II, PharmD, chair of the committee and a professor of clinical pharmacy at the University of Colorado at Denver, Aurora.

Although the comprehensive statement lists 88 distinct prescription drugs or drug classes as agents that pose major or moderate threats for causing or worsening heart failure, “from the American public’s perspective, importance should be placed on educating patients regarding the impact that OTC medications can have on their heart failure,” Dr. Page said in an interview. “For example, nonsteroidal anti-inflammatory drugs like ibuprofen or naproxen can cause sodium and water retention and antagonize the effects of evidence-based heart failure pharmacotherapies. Additionally, OTC medications like pseudoephedrine, which many cough and cold products contain, can increase blood pressure and afterload,” he noted. The risks these drugs pose becomes even greater when they are taken at higher doses.

NSAIDs

The statement cites already existing guidance from the American College of Cardiology and American Heart Association that for patients with existing heart failure, use of NSAIDs should either be avoided or withdrawn when possible. The statement advises educating patients to communicate with their health care provider before taking any OTC medication or complimentary or alternative medication, avoid these agents when their efficacy and safety is uncertain, and evaluate the labels of these products for their sodium content (although the sodium content from inactive ingredients may be difficult to find in labeling).

“Currently, we teach patients to read food labels for sodium content, but we also need to educate patients on how to read OTC medication labels for both ingredients and sodium content. Many OTC antacids may have a large sodium load,” Dr. Page said. The statement includes a list of 14 prescription drugs and also highlights several OTC formulations that have an especially high sodium content.

Metformin

Among the many prescription drugs listed, one notable entry is for the oral hypoglycemic agent metformin that today is among the most widely used drugs for treating type 2 diabetes and is especially relevant for heart failure patients because, as the statement notes, 38% also have diabetes. The statement details the long history of metformin and heart failure, noting that until a decade ago, the drug had a contraindication for patients with heart failure, that metformin’s label still carries a black box warning for cautious use in heart failure patients, and that earlier in 2016, the Food and Drug Administration cautioned that metformin should not be used in patients with an estimated glomerular filtration rate of less than 30 mL/minute per 1.73 m². The statement also endorsed a recommendation from the American Diabetes Association that metformin not be used in patients with unstable heart failure or those hospitalized for heart failure.

Antihypertensives, biologics, and more

Other notable prescription drugs listed as potentially having a major impact on causing or worsening heart failure include the antihypertensive drugs diltiazem, verapamil, and moxonidine, the tumor necrosis factor–inhibitors that are widely used to treat rheumatologic and gastroenterologic diseases, the antipsychotic clozapine, and a long list of anticancer medications, including several anthracyclines and many types of newer biologic agents.

The statement also lists several specific recommendations to health care providers for improving oversight of the drugs taken by patients with heart failure or those at risk for heart failure. These include a comprehensive medication review during each clinical encounter. The statement also suggests a “medication flow sheet” for each patient that contains the basic information regarding the regimen for each medication taken by a patient: the brand and generic name, the purpose of the medication, and its dosage. “These medication flow sheets should be used by patients as a tool to enhance safety and adherence, and they should show their flow sheets at each provider visit,” Dr. Page said.

Managing myriad meds

The statement also calls for stopping medications without a well defined indication for a patient, avoid prescribing new drugs to address side effects of other drugs, and suggests establishing a “captain” among the health care providers seen by each patient who would be particularly responsible for overseeing and keeping track of the medications the patient takes.

“Ideally, this ‘captain’ would be the patient’s primary care provider, who should be in contact with the other specialists that the patient may be seeing. However, this does not always happen,” said Dr. Page. “Therefore, I encourage each patient with heart failure to contact both their primary care provider and their health care provider who is managing their heart failure before taking or stopping any new medication including prescription, OTC, herbal, complimentary or alternative medication or supplement. Health care providers need to encourage patients to be actively engaged in their medication management.”

Dr. Page had no disclosures.

[email protected]

On Twitter @mitchelzoler

The multikinase inhibitor cabozantinib did not significantly improve overall survival, compared with prednisone in men with previously treated metastatic castration-resistant prostate cancer, reported investigators in the phase III COMET-1 trial.

Among 1,028 men with metastatic castration-resistant prostate cancer (mCRPC) median overall survival was 11.0 months for 682 patients randomly assigned to cabozantinib (Cabometyx), compared with 9.8 months for patients assigned to prednisone, a difference that was not statistically significant, reported Matthew Smith, MD, PhD, of Massachusetts General Hospital in Boston, and his colleagues.

©alexdans/Thinkstock

Cabozantinib was, however, associated with significant improvements over prednisone in bone scan response (BSR) at 12 weeks, radiographic progression-free survival (rPFS), and in effects on circulating tumor cells (CTCs), bone biomarkers, and symptomatic skeletal events (SSE), but not prostate-specific antigen (PSA)-related outcomes, the investigators reported (J Clin Oncol. 2016 Jul 11. doi: 10.1200/JCO.2015.65.5597).

“The biologic activities of cabozantinib are diverse, with bone effects, direct effects on cancer cells, and anti-angiogenic effects being demonstrated in preclinical models. It could be argued that the observed changes in BSR, bone biomarkers, and SSEs in our study are consistent with biologic effects in bone and bone metastases, and the improvements in CTCs suggest a direct antitumor effect, although the lack of improvement in PSA outcomes argues against such an effect,” they wrote.

Cabozantinib is an oral inhibitor of tyrosine kinases believed to be important factors in prostate cancer development and progression, including MET and vascular endothelial growth factor (VEGF) receptor 2.

In a phase II­ randomized discontinuation trial in men with mCRPC, cabozantinib was associated with reductions in soft tissue lesions, improvement in PFS, resolution of bone scans, and reductions in markers of bone turnover, pain, and use of narcotics.

To see whether the promising clinical activity observed in earlier studies could be sustained, the investigators conducted a phase III study comparing cabozantinib with prednisone in men with mCRPC who had experienced bone metastases and disease progression after therapy with docetaxel and abiraterone acetate and/or enzalutamide.

Patients were randomly assigned on a 2:1 basis to cabozantinib 60 mg once daily or prednisone 5 mg twice daily.

As noted before, there was no difference in overall survival, the primary endpoint, between the treatment groups, but BSR at 12 weeks was superior with cabozantinib, occurring in 42% vs. 3% of patients on prednisone (P less than .001). Radiographic PFS was also better with cabozantinib, at 5.6 vs. 2.8 months (hazard ratio, 0.48; P less than .001).

More patients on cabozantinib experienced grade 3 or greater adverse events (71% vs. 56%) and nearly three times as many patients discontinued the assigned drug because of adverse events (33% vs, 12%, respectively).

The study was supported by Exelixis. Dr. Smith disclosed a consulting/advisory role for Exelixis, and several coauthors reported research funding from the company. Dr. Alumkal and Dr. Beer disclosed research funding and/or consulting with various companies, not including Exelixis.

[email protected]

The multikinase inhibitor cabozantinib did not significantly improve overall survival, compared with prednisone in men with previously treated metastatic castration-resistant prostate cancer, reported investigators in the phase III COMET-1 trial.

Among 1,028 men with metastatic castration-resistant prostate cancer (mCRPC) median overall survival was 11.0 months for 682 patients randomly assigned to cabozantinib (Cabometyx), compared with 9.8 months for patients assigned to prednisone, a difference that was not statistically significant, reported Matthew Smith, MD, PhD, of Massachusetts General Hospital in Boston, and his colleagues.

©alexdans/Thinkstock

Cabozantinib was, however, associated with significant improvements over prednisone in bone scan response (BSR) at 12 weeks, radiographic progression-free survival (rPFS), and in effects on circulating tumor cells (CTCs), bone biomarkers, and symptomatic skeletal events (SSE), but not prostate-specific antigen (PSA)-related outcomes, the investigators reported (J Clin Oncol. 2016 Jul 11. doi: 10.1200/JCO.2015.65.5597).

“The biologic activities of cabozantinib are diverse, with bone effects, direct effects on cancer cells, and anti-angiogenic effects being demonstrated in preclinical models. It could be argued that the observed changes in BSR, bone biomarkers, and SSEs in our study are consistent with biologic effects in bone and bone metastases, and the improvements in CTCs suggest a direct antitumor effect, although the lack of improvement in PSA outcomes argues against such an effect,” they wrote.

Cabozantinib is an oral inhibitor of tyrosine kinases believed to be important factors in prostate cancer development and progression, including MET and vascular endothelial growth factor (VEGF) receptor 2.

In a phase II­ randomized discontinuation trial in men with mCRPC, cabozantinib was associated with reductions in soft tissue lesions, improvement in PFS, resolution of bone scans, and reductions in markers of bone turnover, pain, and use of narcotics.

To see whether the promising clinical activity observed in earlier studies could be sustained, the investigators conducted a phase III study comparing cabozantinib with prednisone in men with mCRPC who had experienced bone metastases and disease progression after therapy with docetaxel and abiraterone acetate and/or enzalutamide.

Patients were randomly assigned on a 2:1 basis to cabozantinib 60 mg once daily or prednisone 5 mg twice daily.

As noted before, there was no difference in overall survival, the primary endpoint, between the treatment groups, but BSR at 12 weeks was superior with cabozantinib, occurring in 42% vs. 3% of patients on prednisone (P less than .001). Radiographic PFS was also better with cabozantinib, at 5.6 vs. 2.8 months (hazard ratio, 0.48; P less than .001).

More patients on cabozantinib experienced grade 3 or greater adverse events (71% vs. 56%) and nearly three times as many patients discontinued the assigned drug because of adverse events (33% vs, 12%, respectively).

The study was supported by Exelixis. Dr. Smith disclosed a consulting/advisory role for Exelixis, and several coauthors reported research funding from the company. Dr. Alumkal and Dr. Beer disclosed research funding and/or consulting with various companies, not including Exelixis.

[email protected]

The multikinase inhibitor cabozantinib did not significantly improve overall survival, compared with prednisone in men with previously treated metastatic castration-resistant prostate cancer, reported investigators in the phase III COMET-1 trial.

Among 1,028 men with metastatic castration-resistant prostate cancer (mCRPC) median overall survival was 11.0 months for 682 patients randomly assigned to cabozantinib (Cabometyx), compared with 9.8 months for patients assigned to prednisone, a difference that was not statistically significant, reported Matthew Smith, MD, PhD, of Massachusetts General Hospital in Boston, and his colleagues.

©alexdans/Thinkstock

Cabozantinib was, however, associated with significant improvements over prednisone in bone scan response (BSR) at 12 weeks, radiographic progression-free survival (rPFS), and in effects on circulating tumor cells (CTCs), bone biomarkers, and symptomatic skeletal events (SSE), but not prostate-specific antigen (PSA)-related outcomes, the investigators reported (J Clin Oncol. 2016 Jul 11. doi: 10.1200/JCO.2015.65.5597).

“The biologic activities of cabozantinib are diverse, with bone effects, direct effects on cancer cells, and anti-angiogenic effects being demonstrated in preclinical models. It could be argued that the observed changes in BSR, bone biomarkers, and SSEs in our study are consistent with biologic effects in bone and bone metastases, and the improvements in CTCs suggest a direct antitumor effect, although the lack of improvement in PSA outcomes argues against such an effect,” they wrote.

Cabozantinib is an oral inhibitor of tyrosine kinases believed to be important factors in prostate cancer development and progression, including MET and vascular endothelial growth factor (VEGF) receptor 2.

In a phase II­ randomized discontinuation trial in men with mCRPC, cabozantinib was associated with reductions in soft tissue lesions, improvement in PFS, resolution of bone scans, and reductions in markers of bone turnover, pain, and use of narcotics.

To see whether the promising clinical activity observed in earlier studies could be sustained, the investigators conducted a phase III study comparing cabozantinib with prednisone in men with mCRPC who had experienced bone metastases and disease progression after therapy with docetaxel and abiraterone acetate and/or enzalutamide.

Patients were randomly assigned on a 2:1 basis to cabozantinib 60 mg once daily or prednisone 5 mg twice daily.

As noted before, there was no difference in overall survival, the primary endpoint, between the treatment groups, but BSR at 12 weeks was superior with cabozantinib, occurring in 42% vs. 3% of patients on prednisone (P less than .001). Radiographic PFS was also better with cabozantinib, at 5.6 vs. 2.8 months (hazard ratio, 0.48; P less than .001).

More patients on cabozantinib experienced grade 3 or greater adverse events (71% vs. 56%) and nearly three times as many patients discontinued the assigned drug because of adverse events (33% vs, 12%, respectively).

The study was supported by Exelixis. Dr. Smith disclosed a consulting/advisory role for Exelixis, and several coauthors reported research funding from the company. Dr. Alumkal and Dr. Beer disclosed research funding and/or consulting with various companies, not including Exelixis.

[email protected]

SAN DIEGO – Device companies are working hard to bring obesity management to the endoscopy suite.

The field is called endobariatrics, and its goal is to fill the gap between surgery and pharmacotherapy. Drugs and lifestyle counseling don’t work too well, but a lot of people don’t want to go under the knife, so something is needed in the middle. Endobariatrics has the potential to be a boon for both obese patients and gastroenterology practices.

Several new investigational devices and approaches were showcased at the annual Digestive Disease Week; some “are beginning to approach the kind of results we see with surgical techniques,” said Steven Edmundowicz, MD, medical director of the University of Colorado Digestive Health Center, Aurora.

“We are seeing a tremendous amount of development in this space, but it’s early, and we have to be cautious,” he said. There have already been a few disappointments, including the EndoBarrier, a fluoropolymer liner anchored in the duodenal bulb and unfurled down the duodenum to block food absorption. A key U.S. trial was recently halted due to liver abscesses.

Dr. Edmundowicz reviewed the latest developments presented at DDW.

Self-assembling magnets for dual-path enteral anastomoses

The goal of the GI Windows system is to create a partial jejunoileal, side to side bypass without surgery. A 28-mm magnet ring is introduced to the ileum by colonoscopy, and a second ring to the jejunum by endoscopy. The rings snap together and tissue caught between them dies from pressure necrosis, leaving patients with a jejunoileal communication. Once food reaches that point, it either diverts through the anastomosis or continues past it down the digestive track. The magnets pass after the anastomosis forms in a week or so.

In a 6-month feasibility study from the Czech Republic, 10 obese patients lost 28.3% of their excess weight without diet restrictions. Those with diabetes had a mean hemoglobin A_1c drop of 1.8%, and normalization of fasting blood glucose levels. The procedure took just over an hour and a half after the first five cases.

“I am very excited about [this]; I really want to see where the data are going,” Dr. Edmundowicz said.

Duodenal mucosal resurfacing

The idea of the Revita System (Fractyl) is to ablate “diabetic mucosa” in the duodenum so that normal mucosa can replace it. Saline is injected endoscopically under a portion of the duodenal mucosa to lift it off the muscularis; once isolated, the mucosa is destroyed – some in the audience thought “cooked” was a better word – by exposure to a hot water balloon catheter threaded into the lumen.

Thirty-nine overweight or obese type 2 diabetics had a 1.2% improvement at 6 months from a baseline hemoglobin A_1c of 9.6% in a series from Santiago, Chile. Weight loss was modest in the trial; the system is being developed for type 2 diabetics.

There is some histologic support for the notion of a diabetic mucosa with both structural and hormonal aberrations, but it’s unclear if it’s a sign or cause of sickness. Even so, “the mucosa regenerates” and won’t be diabetic “for a while” after the procedure, said investigator Manoel Galvao Neto, MD, of the Gastro Obeso Center, São Paulo.

Gastric balloons

Inflating a balloon in the stomach to make people feel full isn’t new, but the notion of putting the balloon into a capsule that patients can swallow and inflating it through a tether is a more recent notion.

The Obalon (Obalon Therapeutics) is one such device. In an unblinded, sham-controlled trial with 336 obese patients, subjects who got the 250-mL, nitrogen-filled Obalons – most received three – lost about 3% more of their total body weight at 24 weeks than those who did not. Although swallowed, Obalon is removed endoscopically. Meanwhile, 34 obese patients who swallowed the 550-mL, fluid-filled Elipse balloon (Allurion) had a total body weight loss of 9.5% and mean excess weight loss of 37.2% at 4 months, by which time Elipse deflates on its own and passes without endoscopic retrieval.

“This is a very promising approach. I am very excited about digested balloons,” said Dr. Edmundowicz, an investigator in the Obalon study.

Endoscopic sleeve gastroplasty

Endoscopic sleeve gastroplasty duplicates sleeve gastrectomy with stitches placed endoscopically to seal off the greater curvature of the stomach; functionally, patients are left with a narrow sleeve of a stomach. In a multicenter series presented at DDW, 242 patients had a mean total body weight loss of 19.8% at 18 months, with a low incidence of complications. “Weight loss appears to be continuing,” Dr. Edmundowicz said. Investigators used the Apollo OverStitch (Apollo Endosurgery) to place the sutures.

Aspiration therapy

With Food and Drug Administration approval on June 14, AspireAssist (Aspire Bariatrics) is probably the best known of the newer approaches. Patients drain a portion of their meals through an endoscopically placed percutaneous gastrostomy tube a half hour or so after eating. It takes 5-10 minutes. The agency is eager to keep it out of the hands of bulimics.

One-year data were reported at DDW; 111 obese AspireAssist subjects lost a mean of 37.2% of their excess weight versus 13% in 60 patients randomized to lifestyle counseling alone.

“It may not be aesthetically pleasing, but it certainly works. It’s a viable technology,” said Dr. Edmundowicz, who was an investigator.

The studies were funded by companies developing the devices and techniques. Dr. Edmundowicz has stock options, or is a consultant or researcher, Aspire, Obalon, GI Dynamics, Elira, and other firms.

[email protected]

SAN DIEGO – Device companies are working hard to bring obesity management to the endoscopy suite.

The field is called endobariatrics, and its goal is to fill the gap between surgery and pharmacotherapy. Drugs and lifestyle counseling don’t work too well, but a lot of people don’t want to go under the knife, so something is needed in the middle. Endobariatrics has the potential to be a boon for both obese patients and gastroenterology practices.

Several new investigational devices and approaches were showcased at the annual Digestive Disease Week; some “are beginning to approach the kind of results we see with surgical techniques,” said Steven Edmundowicz, MD, medical director of the University of Colorado Digestive Health Center, Aurora.

“We are seeing a tremendous amount of development in this space, but it’s early, and we have to be cautious,” he said. There have already been a few disappointments, including the EndoBarrier, a fluoropolymer liner anchored in the duodenal bulb and unfurled down the duodenum to block food absorption. A key U.S. trial was recently halted due to liver abscesses.

Dr. Edmundowicz reviewed the latest developments presented at DDW.

Self-assembling magnets for dual-path enteral anastomoses

The goal of the GI Windows system is to create a partial jejunoileal, side to side bypass without surgery. A 28-mm magnet ring is introduced to the ileum by colonoscopy, and a second ring to the jejunum by endoscopy. The rings snap together and tissue caught between them dies from pressure necrosis, leaving patients with a jejunoileal communication. Once food reaches that point, it either diverts through the anastomosis or continues past it down the digestive track. The magnets pass after the anastomosis forms in a week or so.

In a 6-month feasibility study from the Czech Republic, 10 obese patients lost 28.3% of their excess weight without diet restrictions. Those with diabetes had a mean hemoglobin A_1c drop of 1.8%, and normalization of fasting blood glucose levels. The procedure took just over an hour and a half after the first five cases.

“I am very excited about [this]; I really want to see where the data are going,” Dr. Edmundowicz said.

Duodenal mucosal resurfacing

The idea of the Revita System (Fractyl) is to ablate “diabetic mucosa” in the duodenum so that normal mucosa can replace it. Saline is injected endoscopically under a portion of the duodenal mucosa to lift it off the muscularis; once isolated, the mucosa is destroyed – some in the audience thought “cooked” was a better word – by exposure to a hot water balloon catheter threaded into the lumen.

Thirty-nine overweight or obese type 2 diabetics had a 1.2% improvement at 6 months from a baseline hemoglobin A_1c of 9.6% in a series from Santiago, Chile. Weight loss was modest in the trial; the system is being developed for type 2 diabetics.

There is some histologic support for the notion of a diabetic mucosa with both structural and hormonal aberrations, but it’s unclear if it’s a sign or cause of sickness. Even so, “the mucosa regenerates” and won’t be diabetic “for a while” after the procedure, said investigator Manoel Galvao Neto, MD, of the Gastro Obeso Center, São Paulo.

Gastric balloons

Inflating a balloon in the stomach to make people feel full isn’t new, but the notion of putting the balloon into a capsule that patients can swallow and inflating it through a tether is a more recent notion.

The Obalon (Obalon Therapeutics) is one such device. In an unblinded, sham-controlled trial with 336 obese patients, subjects who got the 250-mL, nitrogen-filled Obalons – most received three – lost about 3% more of their total body weight at 24 weeks than those who did not. Although swallowed, Obalon is removed endoscopically. Meanwhile, 34 obese patients who swallowed the 550-mL, fluid-filled Elipse balloon (Allurion) had a total body weight loss of 9.5% and mean excess weight loss of 37.2% at 4 months, by which time Elipse deflates on its own and passes without endoscopic retrieval.

“This is a very promising approach. I am very excited about digested balloons,” said Dr. Edmundowicz, an investigator in the Obalon study.

Endoscopic sleeve gastroplasty

Endoscopic sleeve gastroplasty duplicates sleeve gastrectomy with stitches placed endoscopically to seal off the greater curvature of the stomach; functionally, patients are left with a narrow sleeve of a stomach. In a multicenter series presented at DDW, 242 patients had a mean total body weight loss of 19.8% at 18 months, with a low incidence of complications. “Weight loss appears to be continuing,” Dr. Edmundowicz said. Investigators used the Apollo OverStitch (Apollo Endosurgery) to place the sutures.

Aspiration therapy

With Food and Drug Administration approval on June 14, AspireAssist (Aspire Bariatrics) is probably the best known of the newer approaches. Patients drain a portion of their meals through an endoscopically placed percutaneous gastrostomy tube a half hour or so after eating. It takes 5-10 minutes. The agency is eager to keep it out of the hands of bulimics.

One-year data were reported at DDW; 111 obese AspireAssist subjects lost a mean of 37.2% of their excess weight versus 13% in 60 patients randomized to lifestyle counseling alone.

“It may not be aesthetically pleasing, but it certainly works. It’s a viable technology,” said Dr. Edmundowicz, who was an investigator.

The studies were funded by companies developing the devices and techniques. Dr. Edmundowicz has stock options, or is a consultant or researcher, Aspire, Obalon, GI Dynamics, Elira, and other firms.

[email protected]

SAN DIEGO – Device companies are working hard to bring obesity management to the endoscopy suite.

The field is called endobariatrics, and its goal is to fill the gap between surgery and pharmacotherapy. Drugs and lifestyle counseling don’t work too well, but a lot of people don’t want to go under the knife, so something is needed in the middle. Endobariatrics has the potential to be a boon for both obese patients and gastroenterology practices.

Several new investigational devices and approaches were showcased at the annual Digestive Disease Week; some “are beginning to approach the kind of results we see with surgical techniques,” said Steven Edmundowicz, MD, medical director of the University of Colorado Digestive Health Center, Aurora.

“We are seeing a tremendous amount of development in this space, but it’s early, and we have to be cautious,” he said. There have already been a few disappointments, including the EndoBarrier, a fluoropolymer liner anchored in the duodenal bulb and unfurled down the duodenum to block food absorption. A key U.S. trial was recently halted due to liver abscesses.

Dr. Edmundowicz reviewed the latest developments presented at DDW.

Self-assembling magnets for dual-path enteral anastomoses

The goal of the GI Windows system is to create a partial jejunoileal, side to side bypass without surgery. A 28-mm magnet ring is introduced to the ileum by colonoscopy, and a second ring to the jejunum by endoscopy. The rings snap together and tissue caught between them dies from pressure necrosis, leaving patients with a jejunoileal communication. Once food reaches that point, it either diverts through the anastomosis or continues past it down the digestive track. The magnets pass after the anastomosis forms in a week or so.

In a 6-month feasibility study from the Czech Republic, 10 obese patients lost 28.3% of their excess weight without diet restrictions. Those with diabetes had a mean hemoglobin A_1c drop of 1.8%, and normalization of fasting blood glucose levels. The procedure took just over an hour and a half after the first five cases.

“I am very excited about [this]; I really want to see where the data are going,” Dr. Edmundowicz said.

Duodenal mucosal resurfacing

The idea of the Revita System (Fractyl) is to ablate “diabetic mucosa” in the duodenum so that normal mucosa can replace it. Saline is injected endoscopically under a portion of the duodenal mucosa to lift it off the muscularis; once isolated, the mucosa is destroyed – some in the audience thought “cooked” was a better word – by exposure to a hot water balloon catheter threaded into the lumen.

Thirty-nine overweight or obese type 2 diabetics had a 1.2% improvement at 6 months from a baseline hemoglobin A_1c of 9.6% in a series from Santiago, Chile. Weight loss was modest in the trial; the system is being developed for type 2 diabetics.

There is some histologic support for the notion of a diabetic mucosa with both structural and hormonal aberrations, but it’s unclear if it’s a sign or cause of sickness. Even so, “the mucosa regenerates” and won’t be diabetic “for a while” after the procedure, said investigator Manoel Galvao Neto, MD, of the Gastro Obeso Center, São Paulo.

Gastric balloons

Inflating a balloon in the stomach to make people feel full isn’t new, but the notion of putting the balloon into a capsule that patients can swallow and inflating it through a tether is a more recent notion.

The Obalon (Obalon Therapeutics) is one such device. In an unblinded, sham-controlled trial with 336 obese patients, subjects who got the 250-mL, nitrogen-filled Obalons – most received three – lost about 3% more of their total body weight at 24 weeks than those who did not. Although swallowed, Obalon is removed endoscopically. Meanwhile, 34 obese patients who swallowed the 550-mL, fluid-filled Elipse balloon (Allurion) had a total body weight loss of 9.5% and mean excess weight loss of 37.2% at 4 months, by which time Elipse deflates on its own and passes without endoscopic retrieval.

“This is a very promising approach. I am very excited about digested balloons,” said Dr. Edmundowicz, an investigator in the Obalon study.

Endoscopic sleeve gastroplasty

Endoscopic sleeve gastroplasty duplicates sleeve gastrectomy with stitches placed endoscopically to seal off the greater curvature of the stomach; functionally, patients are left with a narrow sleeve of a stomach. In a multicenter series presented at DDW, 242 patients had a mean total body weight loss of 19.8% at 18 months, with a low incidence of complications. “Weight loss appears to be continuing,” Dr. Edmundowicz said. Investigators used the Apollo OverStitch (Apollo Endosurgery) to place the sutures.

Aspiration therapy

With Food and Drug Administration approval on June 14, AspireAssist (Aspire Bariatrics) is probably the best known of the newer approaches. Patients drain a portion of their meals through an endoscopically placed percutaneous gastrostomy tube a half hour or so after eating. It takes 5-10 minutes. The agency is eager to keep it out of the hands of bulimics.

One-year data were reported at DDW; 111 obese AspireAssist subjects lost a mean of 37.2% of their excess weight versus 13% in 60 patients randomized to lifestyle counseling alone.

“It may not be aesthetically pleasing, but it certainly works. It’s a viable technology,” said Dr. Edmundowicz, who was an investigator.

The studies were funded by companies developing the devices and techniques. Dr. Edmundowicz has stock options, or is a consultant or researcher, Aspire, Obalon, GI Dynamics, Elira, and other firms.

[email protected]