Warfarin tablets

TORONTO—Bridge anticoagulant therapy appears to be unnecessary in patients with atrial fibrillation (AFib) undergoing elective surgery, according to researchers.

In the BRIDGE study, AFib patients who stopped all anticoagulant therapy before elective surgery had no higher risk of thrombosis and a lower risk of major bleeding than patients who were given bridge therapy with low-molecular weight heparin after stopping warfarin.

This research was presented at the 2015 ISTH Congress (abstract LB002) and published in NEJM.

“Bridging has been controversial because there has been a lack of data demonstrating that it’s necessary, so people don’t know what to do,” said study author Thomas L. Ortel, MD, PhD, of Duke University Medical Center in Durham, North Carolina.

“You can go to 5 different doctors, and some will bridge, and others won’t. It just depends on what they feel they can safely do. This trial gives a firm answer to that question.”

The trial enrolled 1884 patients with AFib and atrial flutter. Roughly half received bridge therapy with dalteparin, and the other half received a placebo while halting their warfarin for up to 13 days around their elective surgeries. Patients were followed for up to 37 days after their procedures.

Among patients who stopped all anticoagulant therapy, the incidence of arterial thrombosis was 0.4%, compared to 0.3% for patients who received bridge therapy (P=0.01 for noninferiority).

Major bleeding events were significantly less common among the non-bridging group. They occurred in 1.3% of patients who were not on anticoagulant therapy and 3.2% of patients who received bridge therapy (P=0.005 for superiority).

“Bridging does not improve the outcome for stroke prevention but increases the risk of major bleeding complications,” Dr Ortel said. “That’s the counter balance. We’re not doing patients any good, and we are potentially hurting them.”

Dr Ortel noted that these findings are specific to AFib patients who take warfarin and should not be generalized to other types of patients or other anticoagulants. But the results will be taken into consideration by organizations that develop guidelines.

“This is the first study to provide high-quality clinical trial data demonstrating that, for patients with atrial fibrillation who need a procedure and who need to come off warfarin, they can simply stop and restart,” Dr Ortel said. “They do not need to be bridged.”

Warfarin tablets

TORONTO—Bridge anticoagulant therapy appears to be unnecessary in patients with atrial fibrillation (AFib) undergoing elective surgery, according to researchers.

In the BRIDGE study, AFib patients who stopped all anticoagulant therapy before elective surgery had no higher risk of thrombosis and a lower risk of major bleeding than patients who were given bridge therapy with low-molecular weight heparin after stopping warfarin.

This research was presented at the 2015 ISTH Congress (abstract LB002) and published in NEJM.

“Bridging has been controversial because there has been a lack of data demonstrating that it’s necessary, so people don’t know what to do,” said study author Thomas L. Ortel, MD, PhD, of Duke University Medical Center in Durham, North Carolina.

“You can go to 5 different doctors, and some will bridge, and others won’t. It just depends on what they feel they can safely do. This trial gives a firm answer to that question.”

The trial enrolled 1884 patients with AFib and atrial flutter. Roughly half received bridge therapy with dalteparin, and the other half received a placebo while halting their warfarin for up to 13 days around their elective surgeries. Patients were followed for up to 37 days after their procedures.

Among patients who stopped all anticoagulant therapy, the incidence of arterial thrombosis was 0.4%, compared to 0.3% for patients who received bridge therapy (P=0.01 for noninferiority).

Major bleeding events were significantly less common among the non-bridging group. They occurred in 1.3% of patients who were not on anticoagulant therapy and 3.2% of patients who received bridge therapy (P=0.005 for superiority).

“Bridging does not improve the outcome for stroke prevention but increases the risk of major bleeding complications,” Dr Ortel said. “That’s the counter balance. We’re not doing patients any good, and we are potentially hurting them.”

Dr Ortel noted that these findings are specific to AFib patients who take warfarin and should not be generalized to other types of patients or other anticoagulants. But the results will be taken into consideration by organizations that develop guidelines.

“This is the first study to provide high-quality clinical trial data demonstrating that, for patients with atrial fibrillation who need a procedure and who need to come off warfarin, they can simply stop and restart,” Dr Ortel said. “They do not need to be bridged.”

Warfarin tablets

TORONTO—Bridge anticoagulant therapy appears to be unnecessary in patients with atrial fibrillation (AFib) undergoing elective surgery, according to researchers.

In the BRIDGE study, AFib patients who stopped all anticoagulant therapy before elective surgery had no higher risk of thrombosis and a lower risk of major bleeding than patients who were given bridge therapy with low-molecular weight heparin after stopping warfarin.

This research was presented at the 2015 ISTH Congress (abstract LB002) and published in NEJM.

“Bridging has been controversial because there has been a lack of data demonstrating that it’s necessary, so people don’t know what to do,” said study author Thomas L. Ortel, MD, PhD, of Duke University Medical Center in Durham, North Carolina.

“You can go to 5 different doctors, and some will bridge, and others won’t. It just depends on what they feel they can safely do. This trial gives a firm answer to that question.”

The trial enrolled 1884 patients with AFib and atrial flutter. Roughly half received bridge therapy with dalteparin, and the other half received a placebo while halting their warfarin for up to 13 days around their elective surgeries. Patients were followed for up to 37 days after their procedures.

Among patients who stopped all anticoagulant therapy, the incidence of arterial thrombosis was 0.4%, compared to 0.3% for patients who received bridge therapy (P=0.01 for noninferiority).

Major bleeding events were significantly less common among the non-bridging group. They occurred in 1.3% of patients who were not on anticoagulant therapy and 3.2% of patients who received bridge therapy (P=0.005 for superiority).

“Bridging does not improve the outcome for stroke prevention but increases the risk of major bleeding complications,” Dr Ortel said. “That’s the counter balance. We’re not doing patients any good, and we are potentially hurting them.”

Dr Ortel noted that these findings are specific to AFib patients who take warfarin and should not be generalized to other types of patients or other anticoagulants. But the results will be taken into consideration by organizations that develop guidelines.

“This is the first study to provide high-quality clinical trial data demonstrating that, for patients with atrial fibrillation who need a procedure and who need to come off warfarin, they can simply stop and restart,” Dr Ortel said. “They do not need to be bridged.”

Micrograph showing MM

The US Food and Drug Administration (FDA) has granted a novel vaccine orphan designation as a treatment for multiple myeloma (MM).

The vaccine, known as ImMucin, targets the signal peptide domain of the MUC1 tumor antigen.

ImMucin works by “teaching” the immune system to identify and destroy cells that display a short, specific, 21-mer portion from MUC1, which appears on 90% of all cancer cells but not in patients’ blood.

Results of a phase 1/2 trial suggested that ImMucin was safe and active in MM patients. The trial included 15 MUC1-positive patients who had residual or biochemically progressive disease after autologous stem cell transplant.

The patients received 6 or 12 bi-weekly intradermal doses of ImMucin co-administered with human granulocyte-macrophage colony-stimulating factor.

The researchers said the vaccine was well-tolerated, as all adverse events were temporary, grade 1-2 in nature, and resolved spontaneously.

There was a significant decrease in soluble MUC1 levels in 9 patients, and 11 patients had stable disease or clinical improvement that persisted for 17.5 months to more than 41.3 months.

A follow-on study (which is ongoing) in patients who responded to ImMucin has shown that some patients can go more than 4 years without requiring any further treatment for their disease.

ImMucin is under development by Vaxil Biotherapeutics Ltd. The vaccine also has orphan designation as a treatment for MM in the European Union.

About orphan designation

The FDA grants orphan designation to encourage companies to develop therapies for diseases that affect fewer than 200,000 individuals in the US.

Orphan designation provides a company with research and development tax credits, an opportunity to obtain grant funding, exemption from FDA application fees, and other benefits.

If the FDA approves ImMucin to treat patients with MM, orphan designation will provide Vaxil Biotherapeutics with 7 years of marketing exclusivity in the US.

Micrograph showing MM

The US Food and Drug Administration (FDA) has granted a novel vaccine orphan designation as a treatment for multiple myeloma (MM).

The vaccine, known as ImMucin, targets the signal peptide domain of the MUC1 tumor antigen.

ImMucin works by “teaching” the immune system to identify and destroy cells that display a short, specific, 21-mer portion from MUC1, which appears on 90% of all cancer cells but not in patients’ blood.

Results of a phase 1/2 trial suggested that ImMucin was safe and active in MM patients. The trial included 15 MUC1-positive patients who had residual or biochemically progressive disease after autologous stem cell transplant.

The patients received 6 or 12 bi-weekly intradermal doses of ImMucin co-administered with human granulocyte-macrophage colony-stimulating factor.

The researchers said the vaccine was well-tolerated, as all adverse events were temporary, grade 1-2 in nature, and resolved spontaneously.

There was a significant decrease in soluble MUC1 levels in 9 patients, and 11 patients had stable disease or clinical improvement that persisted for 17.5 months to more than 41.3 months.

A follow-on study (which is ongoing) in patients who responded to ImMucin has shown that some patients can go more than 4 years without requiring any further treatment for their disease.

ImMucin is under development by Vaxil Biotherapeutics Ltd. The vaccine also has orphan designation as a treatment for MM in the European Union.

About orphan designation

The FDA grants orphan designation to encourage companies to develop therapies for diseases that affect fewer than 200,000 individuals in the US.

Orphan designation provides a company with research and development tax credits, an opportunity to obtain grant funding, exemption from FDA application fees, and other benefits.

If the FDA approves ImMucin to treat patients with MM, orphan designation will provide Vaxil Biotherapeutics with 7 years of marketing exclusivity in the US.

Micrograph showing MM

The US Food and Drug Administration (FDA) has granted a novel vaccine orphan designation as a treatment for multiple myeloma (MM).

The vaccine, known as ImMucin, targets the signal peptide domain of the MUC1 tumor antigen.

ImMucin works by “teaching” the immune system to identify and destroy cells that display a short, specific, 21-mer portion from MUC1, which appears on 90% of all cancer cells but not in patients’ blood.

Results of a phase 1/2 trial suggested that ImMucin was safe and active in MM patients. The trial included 15 MUC1-positive patients who had residual or biochemically progressive disease after autologous stem cell transplant.

The patients received 6 or 12 bi-weekly intradermal doses of ImMucin co-administered with human granulocyte-macrophage colony-stimulating factor.

The researchers said the vaccine was well-tolerated, as all adverse events were temporary, grade 1-2 in nature, and resolved spontaneously.

There was a significant decrease in soluble MUC1 levels in 9 patients, and 11 patients had stable disease or clinical improvement that persisted for 17.5 months to more than 41.3 months.

A follow-on study (which is ongoing) in patients who responded to ImMucin has shown that some patients can go more than 4 years without requiring any further treatment for their disease.

ImMucin is under development by Vaxil Biotherapeutics Ltd. The vaccine also has orphan designation as a treatment for MM in the European Union.

About orphan designation

The FDA grants orphan designation to encourage companies to develop therapies for diseases that affect fewer than 200,000 individuals in the US.

Orphan designation provides a company with research and development tax credits, an opportunity to obtain grant funding, exemption from FDA application fees, and other benefits.

If the FDA approves ImMucin to treat patients with MM, orphan designation will provide Vaxil Biotherapeutics with 7 years of marketing exclusivity in the US.

Despite all its glamour and opportunities to write columns like this one, primary care does not attract as many clinicians as it needs to provide for the aging population. Some have proposed that this is because when learners rotate with us, they witness frustration with preauthorizations and physician-patient relationships poisoned by opioid addiction – not the intangible spiritual fulfillment of long-term relationships with people who share their lives with us.

In addition, many primary care providers have other competing interests that take them away from practice. This trend will likely increase as practitioners work beyond the age of 65 years but at reduced hours. These demands naturally decrease patient access and can theoretically lead to dissatisfaction, which is potentially devastating if we are reimbursed based upon satisfaction scores.

So, do reduced hours frustrate patients?

Laura Panattoni, Ph.D., and her colleagues at the Palo Alto Medical Foundation Research Institute, Mountain View, Calif., evaluated the relationship between physicians’ clinical time, continuity of care, access to care, and patient satisfaction with the physician (J. Gen. Intern. Med. 2015;30:327-33). The study was a cross-section survey of physicians in family and internal medicine and their patients.

The investigators found that greater office time was directly associated with increased continuity and access but with lower patient satisfaction scores. Restated, reduced clinical hours were associated with improved patient satisfaction.

These findings are interesting and important at many levels. First, they suggest that clinicians who choose less than a full-time clinical obligation can keep their patients happy. Second, we can hypothesize that what is lost in continuity and access is made up for in effective communication delivered by clinicians who are happy themselves. Third, practice redesign should not require full-time commitment to deliver on the satisfaction side of the equation. The world is clamoring for alternative care models where electronic “touches” alleviate the pressure for “patients in rooms.” Studies have shown that up to 93% of patients would select a physician who allows them to communicate with them electronically. About 450,000 patients will see a doctor through the Internet this year. UnitedHealth Group started covering telemedicine and plans to expand this to 20 million customers next year.

I personally spend one-third of my time seeing patients in rooms, but I am electronically and telephonically accessible to them every day at all times. Maybe this helps keep my patients happy, despite me not being in the office every day.

Dr. Ebbert is professor of medicine, a general internist at the Mayo Clinic in Rochester, Minn., and a diplomate of the American Board of Addiction Medicine. The opinions expressed are those of the author and do not necessarily represent the views and opinions of the Mayo Clinic. The opinions expressed in this article should not be used to diagnose or treat any medical condition, nor should they be used as a substitute for medical advice from a qualified, board-certified, practicing clinician. Dr. Ebbert has no relevant financial disclosures about this article. Follow Dr. Ebbert on Twitter @jonebbert.

Despite all its glamour and opportunities to write columns like this one, primary care does not attract as many clinicians as it needs to provide for the aging population. Some have proposed that this is because when learners rotate with us, they witness frustration with preauthorizations and physician-patient relationships poisoned by opioid addiction – not the intangible spiritual fulfillment of long-term relationships with people who share their lives with us.

In addition, many primary care providers have other competing interests that take them away from practice. This trend will likely increase as practitioners work beyond the age of 65 years but at reduced hours. These demands naturally decrease patient access and can theoretically lead to dissatisfaction, which is potentially devastating if we are reimbursed based upon satisfaction scores.

So, do reduced hours frustrate patients?

Laura Panattoni, Ph.D., and her colleagues at the Palo Alto Medical Foundation Research Institute, Mountain View, Calif., evaluated the relationship between physicians’ clinical time, continuity of care, access to care, and patient satisfaction with the physician (J. Gen. Intern. Med. 2015;30:327-33). The study was a cross-section survey of physicians in family and internal medicine and their patients.

The investigators found that greater office time was directly associated with increased continuity and access but with lower patient satisfaction scores. Restated, reduced clinical hours were associated with improved patient satisfaction.

These findings are interesting and important at many levels. First, they suggest that clinicians who choose less than a full-time clinical obligation can keep their patients happy. Second, we can hypothesize that what is lost in continuity and access is made up for in effective communication delivered by clinicians who are happy themselves. Third, practice redesign should not require full-time commitment to deliver on the satisfaction side of the equation. The world is clamoring for alternative care models where electronic “touches” alleviate the pressure for “patients in rooms.” Studies have shown that up to 93% of patients would select a physician who allows them to communicate with them electronically. About 450,000 patients will see a doctor through the Internet this year. UnitedHealth Group started covering telemedicine and plans to expand this to 20 million customers next year.

I personally spend one-third of my time seeing patients in rooms, but I am electronically and telephonically accessible to them every day at all times. Maybe this helps keep my patients happy, despite me not being in the office every day.

Dr. Ebbert is professor of medicine, a general internist at the Mayo Clinic in Rochester, Minn., and a diplomate of the American Board of Addiction Medicine. The opinions expressed are those of the author and do not necessarily represent the views and opinions of the Mayo Clinic. The opinions expressed in this article should not be used to diagnose or treat any medical condition, nor should they be used as a substitute for medical advice from a qualified, board-certified, practicing clinician. Dr. Ebbert has no relevant financial disclosures about this article. Follow Dr. Ebbert on Twitter @jonebbert.

Despite all its glamour and opportunities to write columns like this one, primary care does not attract as many clinicians as it needs to provide for the aging population. Some have proposed that this is because when learners rotate with us, they witness frustration with preauthorizations and physician-patient relationships poisoned by opioid addiction – not the intangible spiritual fulfillment of long-term relationships with people who share their lives with us.

In addition, many primary care providers have other competing interests that take them away from practice. This trend will likely increase as practitioners work beyond the age of 65 years but at reduced hours. These demands naturally decrease patient access and can theoretically lead to dissatisfaction, which is potentially devastating if we are reimbursed based upon satisfaction scores.

So, do reduced hours frustrate patients?

Laura Panattoni, Ph.D., and her colleagues at the Palo Alto Medical Foundation Research Institute, Mountain View, Calif., evaluated the relationship between physicians’ clinical time, continuity of care, access to care, and patient satisfaction with the physician (J. Gen. Intern. Med. 2015;30:327-33). The study was a cross-section survey of physicians in family and internal medicine and their patients.

The investigators found that greater office time was directly associated with increased continuity and access but with lower patient satisfaction scores. Restated, reduced clinical hours were associated with improved patient satisfaction.

These findings are interesting and important at many levels. First, they suggest that clinicians who choose less than a full-time clinical obligation can keep their patients happy. Second, we can hypothesize that what is lost in continuity and access is made up for in effective communication delivered by clinicians who are happy themselves. Third, practice redesign should not require full-time commitment to deliver on the satisfaction side of the equation. The world is clamoring for alternative care models where electronic “touches” alleviate the pressure for “patients in rooms.” Studies have shown that up to 93% of patients would select a physician who allows them to communicate with them electronically. About 450,000 patients will see a doctor through the Internet this year. UnitedHealth Group started covering telemedicine and plans to expand this to 20 million customers next year.

I personally spend one-third of my time seeing patients in rooms, but I am electronically and telephonically accessible to them every day at all times. Maybe this helps keep my patients happy, despite me not being in the office every day.

Dr. Ebbert is professor of medicine, a general internist at the Mayo Clinic in Rochester, Minn., and a diplomate of the American Board of Addiction Medicine. The opinions expressed are those of the author and do not necessarily represent the views and opinions of the Mayo Clinic. The opinions expressed in this article should not be used to diagnose or treat any medical condition, nor should they be used as a substitute for medical advice from a qualified, board-certified, practicing clinician. Dr. Ebbert has no relevant financial disclosures about this article. Follow Dr. Ebbert on Twitter @jonebbert.

NEW YORK (Reuters Health) - When patients with atrialfibrillation need surgery or other invasive therapy, doctors can safely interrupt their warfarin therapy without offering a bridging anticoagulation regimen, according to a new U.S.-Canadian study.

The test of 1,884 patients treated at 108 centers found virtually identical rates of arterial thromboembolism in people who were switched to low-molecular-weight heparin and volunteers who got matching placebo twice daily immediately before and after the procedure.

In contrast, the incidence of major bleeding nearly tripled with bridging; it was 1.3% without heparin and 3.2% with the anticoagulant (p=0.005).

The study is "the first to give us really high-quality data. It allows us to make a recommendation that, at least with atrial fibrillation, you don't need to use bridging therapy," coauthor Dr. Thomas Ortel, chief of hematology at Duke University in Durham, North Carolina, told Reuters Health by phone.

"There may be certain high-risk patients where you may still wish to use it, but the vast majority of these patients really don't need anything done in the perioperative setting," he said.

The findings were presented Monday at the International Society on Thrombosis and Haemostasis 2015 Congress in Toronto and released online by the New England Journal of Medicine.

This is an issue doctors have wrestled with for years.

"Each year, this common clinical scenario affects approximately one in six warfarin-treated patients with atrial fibrillation," the researchers wrote in the Journal.

"Recommendations and guidelines have been conflicting," said Dr. Ortel. "We feel this is something more definitive."

In all patients, warfarin was halted five days before the procedure and restarted within 24 hours after the procedure.

In the bridging group, patients subcutaneously received 100 IU of dalteparin per kilogram of body weight or matching placebo twice daily, beginning three days before the procedure. Treatment was suspended 24 hours before the procedure.

Dalteparin/placebo therapy resumed within 24 hours after the procedure if that procedure carried a low risk of bleeding, and within 48 to 72 hours if the bleeding risk was high. Treatment continued until the international normalized ratio hit 2.0, usually for five to 10 days. Patients were followed for 30 to 37 days after the procedure.

In the placebo group, 0.4% developed an arterial thromboembolism versus 0.3% of the patients who received the heparin (p=0.01 for noninferiority). The rates were based on 1,813 patients who remained in the study until the end.

"For many of the patients it actually is not surprising because the risk of thromboembolism is pretty low," said Dr. Ortel. "But the issue has been that nobody has shown that you really can skip low-molecular-weight heparin as a bridge. There's quite a bit of conflicting thought out there among providers, as well as among patients, about whether something like this needs to be done."

"Major bleeding occurred in 1.3% of the patients (12 of 918) in the no-bridging group and 3.2% (29 of 895) in the bridging group, which indicated that no bridging was superior to bridging with regard to major bleeding," the researchers reported. None of the major bleeding episodes was fatal.

The two treatments produced no difference in the likelihood of death, acute myocardial infarction, pulmonary embolism ordeep vein thrombosis.

Dr. Ortel said the findings, if widely adopted, could save money by reducing the use of low-molecular-weight heparin and decreasing the expense of treating bleeding complications. "There are several different ways this could affect costs.

He cautioned that the study, known as BRIDGE, "does not apply to patients with prosthetic heart valves or patients with venous thromboembolism, like a deep vein thrombosis or pulmonary embolism. But for patients with atrial fibrillation, it's high-quality data that should indicate that people do not need to use anything to bridge these folks."

The National Heart, Lung, and Blood Institute funded this research. Ten coauthors reported relationships with pharmaceutical companies.

—Reuters Health

NEW YORK (Reuters Health) - When patients with atrialfibrillation need surgery or other invasive therapy, doctors can safely interrupt their warfarin therapy without offering a bridging anticoagulation regimen, according to a new U.S.-Canadian study.

The test of 1,884 patients treated at 108 centers found virtually identical rates of arterial thromboembolism in people who were switched to low-molecular-weight heparin and volunteers who got matching placebo twice daily immediately before and after the procedure.

In contrast, the incidence of major bleeding nearly tripled with bridging; it was 1.3% without heparin and 3.2% with the anticoagulant (p=0.005).

The study is "the first to give us really high-quality data. It allows us to make a recommendation that, at least with atrial fibrillation, you don't need to use bridging therapy," coauthor Dr. Thomas Ortel, chief of hematology at Duke University in Durham, North Carolina, told Reuters Health by phone.

"There may be certain high-risk patients where you may still wish to use it, but the vast majority of these patients really don't need anything done in the perioperative setting," he said.

The findings were presented Monday at the International Society on Thrombosis and Haemostasis 2015 Congress in Toronto and released online by the New England Journal of Medicine.

This is an issue doctors have wrestled with for years.

"Each year, this common clinical scenario affects approximately one in six warfarin-treated patients with atrial fibrillation," the researchers wrote in the Journal.

"Recommendations and guidelines have been conflicting," said Dr. Ortel. "We feel this is something more definitive."

In all patients, warfarin was halted five days before the procedure and restarted within 24 hours after the procedure.

In the bridging group, patients subcutaneously received 100 IU of dalteparin per kilogram of body weight or matching placebo twice daily, beginning three days before the procedure. Treatment was suspended 24 hours before the procedure.

Dalteparin/placebo therapy resumed within 24 hours after the procedure if that procedure carried a low risk of bleeding, and within 48 to 72 hours if the bleeding risk was high. Treatment continued until the international normalized ratio hit 2.0, usually for five to 10 days. Patients were followed for 30 to 37 days after the procedure.

In the placebo group, 0.4% developed an arterial thromboembolism versus 0.3% of the patients who received the heparin (p=0.01 for noninferiority). The rates were based on 1,813 patients who remained in the study until the end.

"For many of the patients it actually is not surprising because the risk of thromboembolism is pretty low," said Dr. Ortel. "But the issue has been that nobody has shown that you really can skip low-molecular-weight heparin as a bridge. There's quite a bit of conflicting thought out there among providers, as well as among patients, about whether something like this needs to be done."

"Major bleeding occurred in 1.3% of the patients (12 of 918) in the no-bridging group and 3.2% (29 of 895) in the bridging group, which indicated that no bridging was superior to bridging with regard to major bleeding," the researchers reported. None of the major bleeding episodes was fatal.

The two treatments produced no difference in the likelihood of death, acute myocardial infarction, pulmonary embolism ordeep vein thrombosis.

Dr. Ortel said the findings, if widely adopted, could save money by reducing the use of low-molecular-weight heparin and decreasing the expense of treating bleeding complications. "There are several different ways this could affect costs.

He cautioned that the study, known as BRIDGE, "does not apply to patients with prosthetic heart valves or patients with venous thromboembolism, like a deep vein thrombosis or pulmonary embolism. But for patients with atrial fibrillation, it's high-quality data that should indicate that people do not need to use anything to bridge these folks."

The National Heart, Lung, and Blood Institute funded this research. Ten coauthors reported relationships with pharmaceutical companies.

—Reuters Health

NEW YORK (Reuters Health) - When patients with atrialfibrillation need surgery or other invasive therapy, doctors can safely interrupt their warfarin therapy without offering a bridging anticoagulation regimen, according to a new U.S.-Canadian study.

The test of 1,884 patients treated at 108 centers found virtually identical rates of arterial thromboembolism in people who were switched to low-molecular-weight heparin and volunteers who got matching placebo twice daily immediately before and after the procedure.

In contrast, the incidence of major bleeding nearly tripled with bridging; it was 1.3% without heparin and 3.2% with the anticoagulant (p=0.005).

The study is "the first to give us really high-quality data. It allows us to make a recommendation that, at least with atrial fibrillation, you don't need to use bridging therapy," coauthor Dr. Thomas Ortel, chief of hematology at Duke University in Durham, North Carolina, told Reuters Health by phone.

"There may be certain high-risk patients where you may still wish to use it, but the vast majority of these patients really don't need anything done in the perioperative setting," he said.

The findings were presented Monday at the International Society on Thrombosis and Haemostasis 2015 Congress in Toronto and released online by the New England Journal of Medicine.

This is an issue doctors have wrestled with for years.

"Each year, this common clinical scenario affects approximately one in six warfarin-treated patients with atrial fibrillation," the researchers wrote in the Journal.

"Recommendations and guidelines have been conflicting," said Dr. Ortel. "We feel this is something more definitive."

In all patients, warfarin was halted five days before the procedure and restarted within 24 hours after the procedure.

In the bridging group, patients subcutaneously received 100 IU of dalteparin per kilogram of body weight or matching placebo twice daily, beginning three days before the procedure. Treatment was suspended 24 hours before the procedure.

Dalteparin/placebo therapy resumed within 24 hours after the procedure if that procedure carried a low risk of bleeding, and within 48 to 72 hours if the bleeding risk was high. Treatment continued until the international normalized ratio hit 2.0, usually for five to 10 days. Patients were followed for 30 to 37 days after the procedure.

In the placebo group, 0.4% developed an arterial thromboembolism versus 0.3% of the patients who received the heparin (p=0.01 for noninferiority). The rates were based on 1,813 patients who remained in the study until the end.

"For many of the patients it actually is not surprising because the risk of thromboembolism is pretty low," said Dr. Ortel. "But the issue has been that nobody has shown that you really can skip low-molecular-weight heparin as a bridge. There's quite a bit of conflicting thought out there among providers, as well as among patients, about whether something like this needs to be done."

"Major bleeding occurred in 1.3% of the patients (12 of 918) in the no-bridging group and 3.2% (29 of 895) in the bridging group, which indicated that no bridging was superior to bridging with regard to major bleeding," the researchers reported. None of the major bleeding episodes was fatal.

The two treatments produced no difference in the likelihood of death, acute myocardial infarction, pulmonary embolism ordeep vein thrombosis.

Dr. Ortel said the findings, if widely adopted, could save money by reducing the use of low-molecular-weight heparin and decreasing the expense of treating bleeding complications. "There are several different ways this could affect costs.

He cautioned that the study, known as BRIDGE, "does not apply to patients with prosthetic heart valves or patients with venous thromboembolism, like a deep vein thrombosis or pulmonary embolism. But for patients with atrial fibrillation, it's high-quality data that should indicate that people do not need to use anything to bridge these folks."

The National Heart, Lung, and Blood Institute funded this research. Ten coauthors reported relationships with pharmaceutical companies.

—Reuters Health

Without the option of recommending physician certification as a condition for flibanserin approval, the Food and Drug Administration advisory panel vote might have shifted against approval of the drug for treating hypoactive sexual desire disorder in premenopausal women.

At a joint meeting of two FDA advisory panels in June, members of the Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee voted 18-6 that the overall benefit-risk profile of flibanserin supported approval for treating hypoactive sexual desire disorder (HSDD) in premenopausal women, provided that certain risk management options beyond labeling were implemented. If approved by the FDA, flibanserin would be the first drug approved for treating HSDD.

Assurance that prescribers would be fully apprised of the serious risks of hypotension and syncope associated with the drug, exacerbation of those side effects when combined with alcohol or a CYP3A4 inhibitor – and the modest effects over placebo – was cited by several of the panelists who voted in favor of approval.

All of those voting in favor of approval chose the option of supporting approval “only if certain risk management options beyond labeling are implemented.” None of the panelists voted for the option of supporting approval with “labeling alone to manage the risks.”

The conditions include a risk management plan to address serious adverse effects associated with the drug, a requirement for physician certification, and postmarketing studies to further evaluate and monitor the drug’s safety and efficacy.

The risks of hypotension and syncope, and central nervous system depression are also exacerbated by moderate or strong CYP3A4 inhibitors, but the interaction with alcohol was raised as a particularly serious issue because of the high rate of alcohol use and binge drinking among women who would likely be treated with flibanserin, according to FDA reviewers.

Courtesy of Sprout Pharmaceuticals

The risk of drug interactions can be mitigated with drug interaction screening programs used in health care systems, such as in electronic medical records and pharmacies, while alcohol use is a patient-dependent behavior, is common among women, and therefore more difficult to control, Kimberly Lehrfeld, Pharm.D., a team leader in the division of risk management in the FDA’s office of medication error prevention and analysis, said at the meeting. Several panelists recommended that alcohol use be a contraindication.

Physician certification is among the Elements to Assure Safe Use or ETASU, which along with a medication guide and a communication plan for health care providers, are components of a Risk Evaluation and Mitigation Strategy (REMS), a way to help manage the risks of a drug or biologic while still making it available to patients who need it.

Physician certification is part of the REMS for drugs such as mifepristone (Mifeprex), thalidomide (Thalomid), and natalizumab (Tysabri).

“A risk strategy that gets physicians the information they need to use it properly is going to be key,” said Dr. Robert Silbergleit, who voted for approval.”A REMS strategy is going to be very important because I think that the most likely risks … are going to come from physicians who don’t use the drug properly because they’re not properly educated.”

Dr. Silbergleit, a professor in the department of emergency medicine at the University of Michigan, Ann Arbor, said he was also concerned about the marketing of the drug. “Clinicians may be in the situation where they have to counter direct-to-consumer marketing that could lead to misuse of the drug,” he said at the meeting.

Also voting for approval, Marjorie Shaw Phillips, R.Ph., pharmacy coordinator at Georgia Regents Medical Center in Augusta, said that everyone needs to be aware of the potential safety concerns. But while she does not think pharmacy registration would be beneficial, there is a role for the pharmacist to confirm that it’s an educated provider prescribing the drug and that they’ve discussed the risks with the patient.

She added that it will be important for physicians to set realistic expectations for patients.

“It’s not a magical little pink pill, and there are going to be a whole lot of women with sexual dysfunction for whom there’s no evidence that it’s going to benefit them,” she said at the meeting.

The panel did not specifically recommend pharmacy certification, but pharmacists would have to verify that the prescribing physicians are certified, if the drug is approved, an FDA official said at the meeting.

A decision from the FDA is expected in August. The FDA panelists reported having no relevant financial disclosures.

Sprout Pharmaceuticals, flibanserin’s manufacturer, said in a statement that the company looks forward “to continuing our work with the FDA as it completes its review of our new drug application, including the discussion of a Risks Evaluation and Mitigation Strategy.” If approved, the company plans to market flibanserin as “Addyi.”

[email protected]

Without the option of recommending physician certification as a condition for flibanserin approval, the Food and Drug Administration advisory panel vote might have shifted against approval of the drug for treating hypoactive sexual desire disorder in premenopausal women.

At a joint meeting of two FDA advisory panels in June, members of the Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee voted 18-6 that the overall benefit-risk profile of flibanserin supported approval for treating hypoactive sexual desire disorder (HSDD) in premenopausal women, provided that certain risk management options beyond labeling were implemented. If approved by the FDA, flibanserin would be the first drug approved for treating HSDD.

Assurance that prescribers would be fully apprised of the serious risks of hypotension and syncope associated with the drug, exacerbation of those side effects when combined with alcohol or a CYP3A4 inhibitor – and the modest effects over placebo – was cited by several of the panelists who voted in favor of approval.

All of those voting in favor of approval chose the option of supporting approval “only if certain risk management options beyond labeling are implemented.” None of the panelists voted for the option of supporting approval with “labeling alone to manage the risks.”

The conditions include a risk management plan to address serious adverse effects associated with the drug, a requirement for physician certification, and postmarketing studies to further evaluate and monitor the drug’s safety and efficacy.

The risks of hypotension and syncope, and central nervous system depression are also exacerbated by moderate or strong CYP3A4 inhibitors, but the interaction with alcohol was raised as a particularly serious issue because of the high rate of alcohol use and binge drinking among women who would likely be treated with flibanserin, according to FDA reviewers.

Courtesy of Sprout Pharmaceuticals

The risk of drug interactions can be mitigated with drug interaction screening programs used in health care systems, such as in electronic medical records and pharmacies, while alcohol use is a patient-dependent behavior, is common among women, and therefore more difficult to control, Kimberly Lehrfeld, Pharm.D., a team leader in the division of risk management in the FDA’s office of medication error prevention and analysis, said at the meeting. Several panelists recommended that alcohol use be a contraindication.

Physician certification is among the Elements to Assure Safe Use or ETASU, which along with a medication guide and a communication plan for health care providers, are components of a Risk Evaluation and Mitigation Strategy (REMS), a way to help manage the risks of a drug or biologic while still making it available to patients who need it.

Physician certification is part of the REMS for drugs such as mifepristone (Mifeprex), thalidomide (Thalomid), and natalizumab (Tysabri).

“A risk strategy that gets physicians the information they need to use it properly is going to be key,” said Dr. Robert Silbergleit, who voted for approval.”A REMS strategy is going to be very important because I think that the most likely risks … are going to come from physicians who don’t use the drug properly because they’re not properly educated.”

Dr. Silbergleit, a professor in the department of emergency medicine at the University of Michigan, Ann Arbor, said he was also concerned about the marketing of the drug. “Clinicians may be in the situation where they have to counter direct-to-consumer marketing that could lead to misuse of the drug,” he said at the meeting.

Also voting for approval, Marjorie Shaw Phillips, R.Ph., pharmacy coordinator at Georgia Regents Medical Center in Augusta, said that everyone needs to be aware of the potential safety concerns. But while she does not think pharmacy registration would be beneficial, there is a role for the pharmacist to confirm that it’s an educated provider prescribing the drug and that they’ve discussed the risks with the patient.

She added that it will be important for physicians to set realistic expectations for patients.

“It’s not a magical little pink pill, and there are going to be a whole lot of women with sexual dysfunction for whom there’s no evidence that it’s going to benefit them,” she said at the meeting.

The panel did not specifically recommend pharmacy certification, but pharmacists would have to verify that the prescribing physicians are certified, if the drug is approved, an FDA official said at the meeting.

A decision from the FDA is expected in August. The FDA panelists reported having no relevant financial disclosures.

Sprout Pharmaceuticals, flibanserin’s manufacturer, said in a statement that the company looks forward “to continuing our work with the FDA as it completes its review of our new drug application, including the discussion of a Risks Evaluation and Mitigation Strategy.” If approved, the company plans to market flibanserin as “Addyi.”

[email protected]

Without the option of recommending physician certification as a condition for flibanserin approval, the Food and Drug Administration advisory panel vote might have shifted against approval of the drug for treating hypoactive sexual desire disorder in premenopausal women.

At a joint meeting of two FDA advisory panels in June, members of the Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee voted 18-6 that the overall benefit-risk profile of flibanserin supported approval for treating hypoactive sexual desire disorder (HSDD) in premenopausal women, provided that certain risk management options beyond labeling were implemented. If approved by the FDA, flibanserin would be the first drug approved for treating HSDD.

Assurance that prescribers would be fully apprised of the serious risks of hypotension and syncope associated with the drug, exacerbation of those side effects when combined with alcohol or a CYP3A4 inhibitor – and the modest effects over placebo – was cited by several of the panelists who voted in favor of approval.

All of those voting in favor of approval chose the option of supporting approval “only if certain risk management options beyond labeling are implemented.” None of the panelists voted for the option of supporting approval with “labeling alone to manage the risks.”

The conditions include a risk management plan to address serious adverse effects associated with the drug, a requirement for physician certification, and postmarketing studies to further evaluate and monitor the drug’s safety and efficacy.

The risks of hypotension and syncope, and central nervous system depression are also exacerbated by moderate or strong CYP3A4 inhibitors, but the interaction with alcohol was raised as a particularly serious issue because of the high rate of alcohol use and binge drinking among women who would likely be treated with flibanserin, according to FDA reviewers.

Courtesy of Sprout Pharmaceuticals

The risk of drug interactions can be mitigated with drug interaction screening programs used in health care systems, such as in electronic medical records and pharmacies, while alcohol use is a patient-dependent behavior, is common among women, and therefore more difficult to control, Kimberly Lehrfeld, Pharm.D., a team leader in the division of risk management in the FDA’s office of medication error prevention and analysis, said at the meeting. Several panelists recommended that alcohol use be a contraindication.

Physician certification is among the Elements to Assure Safe Use or ETASU, which along with a medication guide and a communication plan for health care providers, are components of a Risk Evaluation and Mitigation Strategy (REMS), a way to help manage the risks of a drug or biologic while still making it available to patients who need it.

Physician certification is part of the REMS for drugs such as mifepristone (Mifeprex), thalidomide (Thalomid), and natalizumab (Tysabri).

“A risk strategy that gets physicians the information they need to use it properly is going to be key,” said Dr. Robert Silbergleit, who voted for approval.”A REMS strategy is going to be very important because I think that the most likely risks … are going to come from physicians who don’t use the drug properly because they’re not properly educated.”

Dr. Silbergleit, a professor in the department of emergency medicine at the University of Michigan, Ann Arbor, said he was also concerned about the marketing of the drug. “Clinicians may be in the situation where they have to counter direct-to-consumer marketing that could lead to misuse of the drug,” he said at the meeting.

Also voting for approval, Marjorie Shaw Phillips, R.Ph., pharmacy coordinator at Georgia Regents Medical Center in Augusta, said that everyone needs to be aware of the potential safety concerns. But while she does not think pharmacy registration would be beneficial, there is a role for the pharmacist to confirm that it’s an educated provider prescribing the drug and that they’ve discussed the risks with the patient.

She added that it will be important for physicians to set realistic expectations for patients.

“It’s not a magical little pink pill, and there are going to be a whole lot of women with sexual dysfunction for whom there’s no evidence that it’s going to benefit them,” she said at the meeting.

The panel did not specifically recommend pharmacy certification, but pharmacists would have to verify that the prescribing physicians are certified, if the drug is approved, an FDA official said at the meeting.

A decision from the FDA is expected in August. The FDA panelists reported having no relevant financial disclosures.

Sprout Pharmaceuticals, flibanserin’s manufacturer, said in a statement that the company looks forward “to continuing our work with the FDA as it completes its review of our new drug application, including the discussion of a Risks Evaluation and Mitigation Strategy.” If approved, the company plans to market flibanserin as “Addyi.”

[email protected]

Background There is increased interest among oncology and palliative professionals in providing appropriately timed hospice services for cancer patients. End of life (EoL) metrics have been included in oncology quality programs, but accurate EoL data and benchmarks are hard to obtain.

Objective To improve EoL care by measuring patterns of care among recently deceased patients.

Methods Care utilization among deceased patients was analyzed by using software integrated with patient electronic health records. The data was verified by chart review.

Results Of 179 cancer deaths, tumor registry data differed from chart review in 7% of cases with regard to dates and/or location of death. Institutional EoL metrics were significantly affected by a large number of patients (37%) with advanced illnesses who had clinical diagnoses of cancer made at the end of life, but who had not been managed by oncologists. This population of patients who had not been managed by oncologists was older, less likely to use hospice, and more likely to use the intensive care unit than were oncologist-managed cancer patients. Among the patients of individual oncologists, the median stay in hospice ranged from 6-28 days. Data collection and chart review took an average of 27 minutes per case with combined efforts by a data analyst and oncology practitioner.

Limitations Single institution with comprehensive electronic medical record; some patients were treated outside of the system.

Conclusion Acquiring accurate data on EoL metrics is time consuming. Compared with chart review, other data sources have inaccuracies and include some patients who have not been managed by oncologists. Accurate attribution to individual physicians requires chart review by an experienced clinician.

Click on the PDF icon at the top of this introduction to read the full article.

Background There is increased interest among oncology and palliative professionals in providing appropriately timed hospice services for cancer patients. End of life (EoL) metrics have been included in oncology quality programs, but accurate EoL data and benchmarks are hard to obtain.

Objective To improve EoL care by measuring patterns of care among recently deceased patients.

Methods Care utilization among deceased patients was analyzed by using software integrated with patient electronic health records. The data was verified by chart review.

Results Of 179 cancer deaths, tumor registry data differed from chart review in 7% of cases with regard to dates and/or location of death. Institutional EoL metrics were significantly affected by a large number of patients (37%) with advanced illnesses who had clinical diagnoses of cancer made at the end of life, but who had not been managed by oncologists. This population of patients who had not been managed by oncologists was older, less likely to use hospice, and more likely to use the intensive care unit than were oncologist-managed cancer patients. Among the patients of individual oncologists, the median stay in hospice ranged from 6-28 days. Data collection and chart review took an average of 27 minutes per case with combined efforts by a data analyst and oncology practitioner.

Limitations Single institution with comprehensive electronic medical record; some patients were treated outside of the system.

Conclusion Acquiring accurate data on EoL metrics is time consuming. Compared with chart review, other data sources have inaccuracies and include some patients who have not been managed by oncologists. Accurate attribution to individual physicians requires chart review by an experienced clinician.

Click on the PDF icon at the top of this introduction to read the full article.

Background There is increased interest among oncology and palliative professionals in providing appropriately timed hospice services for cancer patients. End of life (EoL) metrics have been included in oncology quality programs, but accurate EoL data and benchmarks are hard to obtain.

Objective To improve EoL care by measuring patterns of care among recently deceased patients.

Methods Care utilization among deceased patients was analyzed by using software integrated with patient electronic health records. The data was verified by chart review.

Results Of 179 cancer deaths, tumor registry data differed from chart review in 7% of cases with regard to dates and/or location of death. Institutional EoL metrics were significantly affected by a large number of patients (37%) with advanced illnesses who had clinical diagnoses of cancer made at the end of life, but who had not been managed by oncologists. This population of patients who had not been managed by oncologists was older, less likely to use hospice, and more likely to use the intensive care unit than were oncologist-managed cancer patients. Among the patients of individual oncologists, the median stay in hospice ranged from 6-28 days. Data collection and chart review took an average of 27 minutes per case with combined efforts by a data analyst and oncology practitioner.

Limitations Single institution with comprehensive electronic medical record; some patients were treated outside of the system.

Conclusion Acquiring accurate data on EoL metrics is time consuming. Compared with chart review, other data sources have inaccuracies and include some patients who have not been managed by oncologists. Accurate attribution to individual physicians requires chart review by an experienced clinician.

Click on the PDF icon at the top of this introduction to read the full article.

Background The Summa Cancer Institute in Akron, Ohio, sought to improve access to and the timeliness of lung cancer care by hiring an oncology-certified nurse navigator. The nurse navigator was charged with coordinating diagnostic procedures and specialty oncology consultations, and with facilitating a multidisciplinary thoracic oncology tumor board.

Objective To test the hypothesis that nurse navigation would improve the timeliness of and access to diagnostic medical services among men and women with newly diagnosed lung cancer.

Methods A conducted a retrospective review of 460 patients with lung cancer to evaluate access to care and the timeliness of the care received in the non-navigated and nurse-navigated cohorts.

Results During December 2009-September 2013, the time between the suspicion of cancer on chest X-ray to treatment was 64 days. During October 2013-March 2014, the nurse navigator helped reduce that timespan to 45 days (P < .001).

Limitations Long-term follow-up on clinical outcomes remains premature.

Conclusion This finding attests to the successful implementation of nurse navigation to improve access and timeliness of lung cancer care in a community oncology practice.

Click on the PDF icon at the top of this introduction to read the full article.

Background The Summa Cancer Institute in Akron, Ohio, sought to improve access to and the timeliness of lung cancer care by hiring an oncology-certified nurse navigator. The nurse navigator was charged with coordinating diagnostic procedures and specialty oncology consultations, and with facilitating a multidisciplinary thoracic oncology tumor board.

Objective To test the hypothesis that nurse navigation would improve the timeliness of and access to diagnostic medical services among men and women with newly diagnosed lung cancer.

Methods A conducted a retrospective review of 460 patients with lung cancer to evaluate access to care and the timeliness of the care received in the non-navigated and nurse-navigated cohorts.

Results During December 2009-September 2013, the time between the suspicion of cancer on chest X-ray to treatment was 64 days. During October 2013-March 2014, the nurse navigator helped reduce that timespan to 45 days (P < .001).

Limitations Long-term follow-up on clinical outcomes remains premature.

Conclusion This finding attests to the successful implementation of nurse navigation to improve access and timeliness of lung cancer care in a community oncology practice.

Click on the PDF icon at the top of this introduction to read the full article.

Background The Summa Cancer Institute in Akron, Ohio, sought to improve access to and the timeliness of lung cancer care by hiring an oncology-certified nurse navigator. The nurse navigator was charged with coordinating diagnostic procedures and specialty oncology consultations, and with facilitating a multidisciplinary thoracic oncology tumor board.

Objective To test the hypothesis that nurse navigation would improve the timeliness of and access to diagnostic medical services among men and women with newly diagnosed lung cancer.

Methods A conducted a retrospective review of 460 patients with lung cancer to evaluate access to care and the timeliness of the care received in the non-navigated and nurse-navigated cohorts.

Results During December 2009-September 2013, the time between the suspicion of cancer on chest X-ray to treatment was 64 days. During October 2013-March 2014, the nurse navigator helped reduce that timespan to 45 days (P < .001).

Limitations Long-term follow-up on clinical outcomes remains premature.

Conclusion This finding attests to the successful implementation of nurse navigation to improve access and timeliness of lung cancer care in a community oncology practice.

Click on the PDF icon at the top of this introduction to read the full article.

At best, only moderate-quality evidence supports the use of medical cannabinoids, and for only two conditions. And low-quality evidence only “suggests” that these agents may improve other medical conditions, but that limited effectiveness applies only to the four conditions that have been studied, according to a report published online June 23 in JAMA.

This doesn’t necessarily mean that cannabinoids have poor efficacy but instead likely reflects the dearth of high-quality research into their medical usefulness.

In what they described as the first comprehensive review to evaluate the efficacy of numerous cannabinoids across a broad range of indications, researchers analyzed data from 79 studies involving 6,462 participants performed from 1975 to early 2015. The studies assessed nabilone, dronabinol, nabiximols, levonantradol, THC, THC/CBD, and ajuvenic acid, delivered via oral capsules, cigarettes, vaporizers, oromucosal sprays, or intramuscular injection, said Penny F. Whiting, Ph.D., of University Hospitals Bristol (England) and her associates.

Most of the studies suggested that cannabinoids improved symptoms for nearly all the 10 medical conditions included in this meta-analysis, but most of the studies were of poor quality so their conclusions were questionable. These agents’ efficacy did not vary according to the type of cannabinoid assessed or the mode of delivery.

Moderate-quality evidence indicated that cannabinoids may be beneficial for chronic neuropathic or cancer pain, and moderate-quality evidence indicated that they may also be beneficial for spasticity due to multiple sclerosis or traumatic paraplegia. Low-quality evidence suggested that cannabinoids may improve nausea and vomiting due to chemotherapy, may improve appetite and induce weight gain in HIV infection, and may improve sleep in primary sleep disorders as well as in conditions that disrupt sleep such as fibromyalgia, multiple sclerosis, and chronic pain. Very low-quality evidence (due to extremely small sample sizes) suggested that cannabinoids may greatly improve tic severity in Tourette’s syndrome, Dr. Whiting and her associates said (JAMA 2015 June 23 [doi:10.1001/jama.2015.6358]).

Otherwise, the evidence did not support cannabinoids’ efficacy in anxiety, depression, psychosis, or glaucoma. Adverse events included asthenia, problems with balance, confusion, dizziness, disorientation, dry mouth, fatigue, and somnolence.

At best, only moderate-quality evidence supports the use of medical cannabinoids, and for only two conditions. And low-quality evidence only “suggests” that these agents may improve other medical conditions, but that limited effectiveness applies only to the four conditions that have been studied, according to a report published online June 23 in JAMA.

This doesn’t necessarily mean that cannabinoids have poor efficacy but instead likely reflects the dearth of high-quality research into their medical usefulness.

In what they described as the first comprehensive review to evaluate the efficacy of numerous cannabinoids across a broad range of indications, researchers analyzed data from 79 studies involving 6,462 participants performed from 1975 to early 2015. The studies assessed nabilone, dronabinol, nabiximols, levonantradol, THC, THC/CBD, and ajuvenic acid, delivered via oral capsules, cigarettes, vaporizers, oromucosal sprays, or intramuscular injection, said Penny F. Whiting, Ph.D., of University Hospitals Bristol (England) and her associates.

Most of the studies suggested that cannabinoids improved symptoms for nearly all the 10 medical conditions included in this meta-analysis, but most of the studies were of poor quality so their conclusions were questionable. These agents’ efficacy did not vary according to the type of cannabinoid assessed or the mode of delivery.

Moderate-quality evidence indicated that cannabinoids may be beneficial for chronic neuropathic or cancer pain, and moderate-quality evidence indicated that they may also be beneficial for spasticity due to multiple sclerosis or traumatic paraplegia. Low-quality evidence suggested that cannabinoids may improve nausea and vomiting due to chemotherapy, may improve appetite and induce weight gain in HIV infection, and may improve sleep in primary sleep disorders as well as in conditions that disrupt sleep such as fibromyalgia, multiple sclerosis, and chronic pain. Very low-quality evidence (due to extremely small sample sizes) suggested that cannabinoids may greatly improve tic severity in Tourette’s syndrome, Dr. Whiting and her associates said (JAMA 2015 June 23 [doi:10.1001/jama.2015.6358]).

Otherwise, the evidence did not support cannabinoids’ efficacy in anxiety, depression, psychosis, or glaucoma. Adverse events included asthenia, problems with balance, confusion, dizziness, disorientation, dry mouth, fatigue, and somnolence.

At best, only moderate-quality evidence supports the use of medical cannabinoids, and for only two conditions. And low-quality evidence only “suggests” that these agents may improve other medical conditions, but that limited effectiveness applies only to the four conditions that have been studied, according to a report published online June 23 in JAMA.

This doesn’t necessarily mean that cannabinoids have poor efficacy but instead likely reflects the dearth of high-quality research into their medical usefulness.

In what they described as the first comprehensive review to evaluate the efficacy of numerous cannabinoids across a broad range of indications, researchers analyzed data from 79 studies involving 6,462 participants performed from 1975 to early 2015. The studies assessed nabilone, dronabinol, nabiximols, levonantradol, THC, THC/CBD, and ajuvenic acid, delivered via oral capsules, cigarettes, vaporizers, oromucosal sprays, or intramuscular injection, said Penny F. Whiting, Ph.D., of University Hospitals Bristol (England) and her associates.

Most of the studies suggested that cannabinoids improved symptoms for nearly all the 10 medical conditions included in this meta-analysis, but most of the studies were of poor quality so their conclusions were questionable. These agents’ efficacy did not vary according to the type of cannabinoid assessed or the mode of delivery.

Moderate-quality evidence indicated that cannabinoids may be beneficial for chronic neuropathic or cancer pain, and moderate-quality evidence indicated that they may also be beneficial for spasticity due to multiple sclerosis or traumatic paraplegia. Low-quality evidence suggested that cannabinoids may improve nausea and vomiting due to chemotherapy, may improve appetite and induce weight gain in HIV infection, and may improve sleep in primary sleep disorders as well as in conditions that disrupt sleep such as fibromyalgia, multiple sclerosis, and chronic pain. Very low-quality evidence (due to extremely small sample sizes) suggested that cannabinoids may greatly improve tic severity in Tourette’s syndrome, Dr. Whiting and her associates said (JAMA 2015 June 23 [doi:10.1001/jama.2015.6358]).

Otherwise, the evidence did not support cannabinoids’ efficacy in anxiety, depression, psychosis, or glaucoma. Adverse events included asthenia, problems with balance, confusion, dizziness, disorientation, dry mouth, fatigue, and somnolence.