VIENNA – Vaginal rejuvenation is a major practice growth opportunity for dermatologists who have expertise with lasers, Peter Bjerring, MD, said at the annual congress of the European Academy of Dermatology and Venereology.

The rejuvenation procedures involve heating the connective tissue of the vaginal wall to 40-42 C in order to stimulate tissue remodeling with formation of new collagen and elastic fibers. The evidence base for vaginal rejuvenation using a variety of noninvasive energy-based devices developed for vaginal use isn’t nearly as extensive as it is for skin rejuvenation using lasers. Research is beginning to increase for this indication, but current results are primarily limited to small single-arm studies based on self-reported improvements. Further, studies don’t compare outcomes vs another treatment, such as estrogen cream.

Despite the minimal evidence base for laser procedures, “feminine rejuvenation is becoming very popular. These are (women) who might present to a dermatologist or to a gynecologist,” observed Dr. Bjerring, medical director and head of the Skin and Laser Center at Malholm (Denmark) Hospital.

Minimally ablative or nonablative fractional laser therapy for vaginal rejuvenation requires no anesthesia and no downtime. The lasers being used for this purpose are similar to those already used most often for skin resurfacing and rejuvenation of the face and neck: fractional CO₂ lasers at the 10,600-nm wavelength, such as the MonaLisa Touch or FemTouch, and 2,940-nm nonablative erbium:yttrium-aluminum-garnet (Er:YAG) lasers such as the IntimaLase. A course of treatment with these devices typically consists of three, 15-minute sessions at 4- to 6-week intervals.

Dr. Bjerring noted that this mechanism of benefit has been demonstrated by Italian investigators who conducted a histologic study of the effects of microablative fractional CO₂ laser therapy on ex vivo specimens of atrophic vaginal tissue obtained from women with vulvovaginal atrophy who underwent major surgery for pelvic organ prolapse.

The investigators treated one side of the atrophic vaginal wall specimen with the microablative fractional CO₂ laser and left the contralateral area untreated as a control. They documented that laser therapy restored the vaginal squamous stratified epithelium, with enhanced storage of glycogen in the epithelial cells and shedding of glycogen-rich cells at the epithelial surface. In the connective tissue, activated fibroblasts synthesized new collagen-laden extracellular matrix. All this was accomplished without damage to adjacent untreated tissue (Menopause 2015 Aug;22(8):845-9).

In a single-arm study performed by many of the same Italian investigators, 77 postmenopausal women underwent a course of fractional microablative CO₂ laser therapy because they experienced painful sexual intercourse due to vulvovaginal atrophy. At 12 weeks of followup, the group reported significant improvement in sexual function and satisfaction with their sexual life as measured by the Short Form-12 and the Female Sexual Function Index. Self-rated scores of vaginal burning, dryness, and itching improved significantly, as did complaints of pain during intercourse or urination. At baseline, 20 of the 77 women were not sexually active due to the severity of their vulvovaginal atrophy; at followup, 17 of the 20 had reestablished sexual activity (Climacteric. 2015 Apr;18(2):219-25).

Dr. Bjerring also highlighted an American study, again single-arm, in which 27 women with genitourinary syndrome of menopause were examined at baseline and again 3 months after their third and final treatment with a fractional CO₂ laser. At follow up, 26 of the 27 pronounced themselves satisfied or extremely satisfied with the results, with significant improvement in the same outcome measures used in the Italian study. At follow up, 25 of the women had an increase in comfortable dilator size (Menopause 2016 Oct;23(10):1102-7).

Dr. Bjerring reported having no financial conflicts of interest regarding his presentation.
 

[email protected]
 

VIENNA – Vaginal rejuvenation is a major practice growth opportunity for dermatologists who have expertise with lasers, Peter Bjerring, MD, said at the annual congress of the European Academy of Dermatology and Venereology.

The rejuvenation procedures involve heating the connective tissue of the vaginal wall to 40-42 C in order to stimulate tissue remodeling with formation of new collagen and elastic fibers. The evidence base for vaginal rejuvenation using a variety of noninvasive energy-based devices developed for vaginal use isn’t nearly as extensive as it is for skin rejuvenation using lasers. Research is beginning to increase for this indication, but current results are primarily limited to small single-arm studies based on self-reported improvements. Further, studies don’t compare outcomes vs another treatment, such as estrogen cream.

Despite the minimal evidence base for laser procedures, “feminine rejuvenation is becoming very popular. These are (women) who might present to a dermatologist or to a gynecologist,” observed Dr. Bjerring, medical director and head of the Skin and Laser Center at Malholm (Denmark) Hospital.

Minimally ablative or nonablative fractional laser therapy for vaginal rejuvenation requires no anesthesia and no downtime. The lasers being used for this purpose are similar to those already used most often for skin resurfacing and rejuvenation of the face and neck: fractional CO₂ lasers at the 10,600-nm wavelength, such as the MonaLisa Touch or FemTouch, and 2,940-nm nonablative erbium:yttrium-aluminum-garnet (Er:YAG) lasers such as the IntimaLase. A course of treatment with these devices typically consists of three, 15-minute sessions at 4- to 6-week intervals.

Dr. Bjerring noted that this mechanism of benefit has been demonstrated by Italian investigators who conducted a histologic study of the effects of microablative fractional CO₂ laser therapy on ex vivo specimens of atrophic vaginal tissue obtained from women with vulvovaginal atrophy who underwent major surgery for pelvic organ prolapse.

The investigators treated one side of the atrophic vaginal wall specimen with the microablative fractional CO₂ laser and left the contralateral area untreated as a control. They documented that laser therapy restored the vaginal squamous stratified epithelium, with enhanced storage of glycogen in the epithelial cells and shedding of glycogen-rich cells at the epithelial surface. In the connective tissue, activated fibroblasts synthesized new collagen-laden extracellular matrix. All this was accomplished without damage to adjacent untreated tissue (Menopause 2015 Aug;22(8):845-9).

In a single-arm study performed by many of the same Italian investigators, 77 postmenopausal women underwent a course of fractional microablative CO₂ laser therapy because they experienced painful sexual intercourse due to vulvovaginal atrophy. At 12 weeks of followup, the group reported significant improvement in sexual function and satisfaction with their sexual life as measured by the Short Form-12 and the Female Sexual Function Index. Self-rated scores of vaginal burning, dryness, and itching improved significantly, as did complaints of pain during intercourse or urination. At baseline, 20 of the 77 women were not sexually active due to the severity of their vulvovaginal atrophy; at followup, 17 of the 20 had reestablished sexual activity (Climacteric. 2015 Apr;18(2):219-25).

Dr. Bjerring also highlighted an American study, again single-arm, in which 27 women with genitourinary syndrome of menopause were examined at baseline and again 3 months after their third and final treatment with a fractional CO₂ laser. At follow up, 26 of the 27 pronounced themselves satisfied or extremely satisfied with the results, with significant improvement in the same outcome measures used in the Italian study. At follow up, 25 of the women had an increase in comfortable dilator size (Menopause 2016 Oct;23(10):1102-7).

Dr. Bjerring reported having no financial conflicts of interest regarding his presentation.
 

[email protected]
 

VIENNA – Vaginal rejuvenation is a major practice growth opportunity for dermatologists who have expertise with lasers, Peter Bjerring, MD, said at the annual congress of the European Academy of Dermatology and Venereology.

The rejuvenation procedures involve heating the connective tissue of the vaginal wall to 40-42 C in order to stimulate tissue remodeling with formation of new collagen and elastic fibers. The evidence base for vaginal rejuvenation using a variety of noninvasive energy-based devices developed for vaginal use isn’t nearly as extensive as it is for skin rejuvenation using lasers. Research is beginning to increase for this indication, but current results are primarily limited to small single-arm studies based on self-reported improvements. Further, studies don’t compare outcomes vs another treatment, such as estrogen cream.

Despite the minimal evidence base for laser procedures, “feminine rejuvenation is becoming very popular. These are (women) who might present to a dermatologist or to a gynecologist,” observed Dr. Bjerring, medical director and head of the Skin and Laser Center at Malholm (Denmark) Hospital.

Minimally ablative or nonablative fractional laser therapy for vaginal rejuvenation requires no anesthesia and no downtime. The lasers being used for this purpose are similar to those already used most often for skin resurfacing and rejuvenation of the face and neck: fractional CO₂ lasers at the 10,600-nm wavelength, such as the MonaLisa Touch or FemTouch, and 2,940-nm nonablative erbium:yttrium-aluminum-garnet (Er:YAG) lasers such as the IntimaLase. A course of treatment with these devices typically consists of three, 15-minute sessions at 4- to 6-week intervals.

Dr. Bjerring noted that this mechanism of benefit has been demonstrated by Italian investigators who conducted a histologic study of the effects of microablative fractional CO₂ laser therapy on ex vivo specimens of atrophic vaginal tissue obtained from women with vulvovaginal atrophy who underwent major surgery for pelvic organ prolapse.

The investigators treated one side of the atrophic vaginal wall specimen with the microablative fractional CO₂ laser and left the contralateral area untreated as a control. They documented that laser therapy restored the vaginal squamous stratified epithelium, with enhanced storage of glycogen in the epithelial cells and shedding of glycogen-rich cells at the epithelial surface. In the connective tissue, activated fibroblasts synthesized new collagen-laden extracellular matrix. All this was accomplished without damage to adjacent untreated tissue (Menopause 2015 Aug;22(8):845-9).

In a single-arm study performed by many of the same Italian investigators, 77 postmenopausal women underwent a course of fractional microablative CO₂ laser therapy because they experienced painful sexual intercourse due to vulvovaginal atrophy. At 12 weeks of followup, the group reported significant improvement in sexual function and satisfaction with their sexual life as measured by the Short Form-12 and the Female Sexual Function Index. Self-rated scores of vaginal burning, dryness, and itching improved significantly, as did complaints of pain during intercourse or urination. At baseline, 20 of the 77 women were not sexually active due to the severity of their vulvovaginal atrophy; at followup, 17 of the 20 had reestablished sexual activity (Climacteric. 2015 Apr;18(2):219-25).

Dr. Bjerring also highlighted an American study, again single-arm, in which 27 women with genitourinary syndrome of menopause were examined at baseline and again 3 months after their third and final treatment with a fractional CO₂ laser. At follow up, 26 of the 27 pronounced themselves satisfied or extremely satisfied with the results, with significant improvement in the same outcome measures used in the Italian study. At follow up, 25 of the women had an increase in comfortable dilator size (Menopause 2016 Oct;23(10):1102-7).

Dr. Bjerring reported having no financial conflicts of interest regarding his presentation.
 

[email protected]
 

SNOWMASS, COLO. – Overlooking the common modifiable risk factors in patients with atrial fibrillation is missing out on an excellent opportunity to help curb the growing global pandemic of the arrhythmia, Patrick T. O’Gara, MD, said at the Annual Cardiovascular Conference at Snowmass.

“My purpose here is a wake up call to improve screening for and treatment of modifiable risk factors in patients with atrial fibrillation,” declared Dr. O’Gara, professor of medicine at Harvard Medical School, Boston.

[email protected]
 

SNOWMASS, COLO. – Overlooking the common modifiable risk factors in patients with atrial fibrillation is missing out on an excellent opportunity to help curb the growing global pandemic of the arrhythmia, Patrick T. O’Gara, MD, said at the Annual Cardiovascular Conference at Snowmass.

“My purpose here is a wake up call to improve screening for and treatment of modifiable risk factors in patients with atrial fibrillation,” declared Dr. O’Gara, professor of medicine at Harvard Medical School, Boston.

[email protected]
 

SNOWMASS, COLO. – Overlooking the common modifiable risk factors in patients with atrial fibrillation is missing out on an excellent opportunity to help curb the growing global pandemic of the arrhythmia, Patrick T. O’Gara, MD, said at the Annual Cardiovascular Conference at Snowmass.

“My purpose here is a wake up call to improve screening for and treatment of modifiable risk factors in patients with atrial fibrillation,” declared Dr. O’Gara, professor of medicine at Harvard Medical School, Boston.

[email protected]
 

NEW ORLEANS – The greater the lifetime number of cardiac procedures entailing exposure to low-dose ionizing radiation, the higher the associated cancer risk in adults with congenital heart disease, Sarah Cohen, MD, reported at the American Heart Association scientific sessions.

This finding takes on added clinical import because the use of such procedures has increased markedly in patients with adult congenital heart disease, added Dr. Cohen of McGill University in Montreal.

She presented analyses of nearly 25,000 patients in the Quebec congenital heart disease database who were ages 18-64 with no history of cancer in January 1995; 602 of them were diagnosed with cancer during follow-up through 2009. Each was matched to four cancer-free controls in the database on the basis of age, sex, congenital heart disease severity, and calendar year.

Patients with a lifetime total of four or five cardiac procedures involving exposure to low-dose ionizing radiation were 1.7-fold more likely to be diagnosed with cancer during follow-up than were those with a history of no such procedures or just one. With a lifetime history of six or more of the procedures, the relative risk climbed to 2.2-fold.

Nearly 90% of the malignancies were genitourinary, respiratory, digestive, breast, or hematologic cancers.

Dr. Cohen and her coinvestigators also conducted a cohort study comparing the relative risk of developing cancer in 1,781 high-exposure Quebec adults in the database who had a lifetime history of four or more cardiac procedures involving radiation exposure to more than 20,000 others with a history of not more than one such procedure. The high-exposure group had a 3.3-fold greater rate of malignancy during follow-up.

In a separate study, Dr. Cohen’s McGill colleagues analyzed the Quebec database and documented the sharp rise over time in low-dose ionizing radiation cardiac procedures, including catheter-based diagnostic procedures, structural heart interventions, nuclear procedures, coronary interventions, computed tomography scans of the chest, coronary interventions, and insertion or repair of pacemakers and implantable cardioverter-defibrillators. In 1990, the rate was 18.5 such procedures per 1,000 patients per year. By 2005, it had nearly tripled to 51.9 per 1,000 per year. The age at first procedure dropped from 5 years to 9 months (Circulation 2016 Jan 5;133[1]:12-20).

Dr. Cohen reported having no financial disclosures.
 

[email protected]
 

NEW ORLEANS – The greater the lifetime number of cardiac procedures entailing exposure to low-dose ionizing radiation, the higher the associated cancer risk in adults with congenital heart disease, Sarah Cohen, MD, reported at the American Heart Association scientific sessions.

This finding takes on added clinical import because the use of such procedures has increased markedly in patients with adult congenital heart disease, added Dr. Cohen of McGill University in Montreal.

She presented analyses of nearly 25,000 patients in the Quebec congenital heart disease database who were ages 18-64 with no history of cancer in January 1995; 602 of them were diagnosed with cancer during follow-up through 2009. Each was matched to four cancer-free controls in the database on the basis of age, sex, congenital heart disease severity, and calendar year.

Patients with a lifetime total of four or five cardiac procedures involving exposure to low-dose ionizing radiation were 1.7-fold more likely to be diagnosed with cancer during follow-up than were those with a history of no such procedures or just one. With a lifetime history of six or more of the procedures, the relative risk climbed to 2.2-fold.

Nearly 90% of the malignancies were genitourinary, respiratory, digestive, breast, or hematologic cancers.

Dr. Cohen and her coinvestigators also conducted a cohort study comparing the relative risk of developing cancer in 1,781 high-exposure Quebec adults in the database who had a lifetime history of four or more cardiac procedures involving radiation exposure to more than 20,000 others with a history of not more than one such procedure. The high-exposure group had a 3.3-fold greater rate of malignancy during follow-up.

In a separate study, Dr. Cohen’s McGill colleagues analyzed the Quebec database and documented the sharp rise over time in low-dose ionizing radiation cardiac procedures, including catheter-based diagnostic procedures, structural heart interventions, nuclear procedures, coronary interventions, computed tomography scans of the chest, coronary interventions, and insertion or repair of pacemakers and implantable cardioverter-defibrillators. In 1990, the rate was 18.5 such procedures per 1,000 patients per year. By 2005, it had nearly tripled to 51.9 per 1,000 per year. The age at first procedure dropped from 5 years to 9 months (Circulation 2016 Jan 5;133[1]:12-20).

Dr. Cohen reported having no financial disclosures.
 

[email protected]
 

NEW ORLEANS – The greater the lifetime number of cardiac procedures entailing exposure to low-dose ionizing radiation, the higher the associated cancer risk in adults with congenital heart disease, Sarah Cohen, MD, reported at the American Heart Association scientific sessions.

This finding takes on added clinical import because the use of such procedures has increased markedly in patients with adult congenital heart disease, added Dr. Cohen of McGill University in Montreal.

She presented analyses of nearly 25,000 patients in the Quebec congenital heart disease database who were ages 18-64 with no history of cancer in January 1995; 602 of them were diagnosed with cancer during follow-up through 2009. Each was matched to four cancer-free controls in the database on the basis of age, sex, congenital heart disease severity, and calendar year.

Patients with a lifetime total of four or five cardiac procedures involving exposure to low-dose ionizing radiation were 1.7-fold more likely to be diagnosed with cancer during follow-up than were those with a history of no such procedures or just one. With a lifetime history of six or more of the procedures, the relative risk climbed to 2.2-fold.

Nearly 90% of the malignancies were genitourinary, respiratory, digestive, breast, or hematologic cancers.

Dr. Cohen and her coinvestigators also conducted a cohort study comparing the relative risk of developing cancer in 1,781 high-exposure Quebec adults in the database who had a lifetime history of four or more cardiac procedures involving radiation exposure to more than 20,000 others with a history of not more than one such procedure. The high-exposure group had a 3.3-fold greater rate of malignancy during follow-up.

In a separate study, Dr. Cohen’s McGill colleagues analyzed the Quebec database and documented the sharp rise over time in low-dose ionizing radiation cardiac procedures, including catheter-based diagnostic procedures, structural heart interventions, nuclear procedures, coronary interventions, computed tomography scans of the chest, coronary interventions, and insertion or repair of pacemakers and implantable cardioverter-defibrillators. In 1990, the rate was 18.5 such procedures per 1,000 patients per year. By 2005, it had nearly tripled to 51.9 per 1,000 per year. The age at first procedure dropped from 5 years to 9 months (Circulation 2016 Jan 5;133[1]:12-20).

Dr. Cohen reported having no financial disclosures.
 

[email protected]
 

SAN FRANCISCO – The human monoclonal IgG4 antibody nivolumab was safe and effective as a salvage treatment for patients in a randomized phase III trial who failed standard chemotherapy for advanced gastric or gastroesophageal junction cancer.

Nivolumab, which blocks the human programmed cell death-1 receptor, was superior to placebo with respect to overall survival, progression-free survival, and overall response rate, Yoon-Koo Kang, MD, reported at the symposium sponsored by ASCO, ASTRO, the American Gastroenterological Association, and the Society of Surgical Oncology.

For the study (ONO-4538), 493 patients with ECOG performance status of 0-1 and unresectable advanced or recurrent advanced gastric or gastroesophageal cancer who failed 2 or more prior chemotherapy regimens were randomized to receive placebo or nivolumab in a 2:1 ratio. Nivolumab treatment was associated with significantly improved median overall survival at the time of data cut-off 5.6 months after the last patient was randomized (5.32 months vs. 4.14 months with placebo; hazard ratio, 0.63), said Dr. Kang of Asan Medical Center, University of Ulsan, Seoul, Korea.

The overall survival rate at 12 months was 26.6% vs. 10.9%, respectively, he said.

The overall response rate was 11.2% vs. 0%, and median progression-free survival was 1.61 months vs. 1.45 months (hazard ratio, 0.60) with nivolumab vs. placebo, respectively.

“Median duration of response was 9.53 months,” he said.

Study subjects were adults aged 20 years or older who were enrolled from 49 centers in Japan, Korea, and Taiwan. The 330 patients in the nivolumab group received 3 mg/kg every 2 weeks until toxicity became unacceptable or disease progressed. Treatment-related adverse events occurred in 42.7% vs. 26.7% of nivolumab and placebo group patients, respectively, and grade 3 or greater events occurred in 11.5% vs. 5.5%, respectively.

Grade 3 or 4 events reported in more than 2% of patients were diarrhea, fatigue, decreased appetite, pyrexia, and increased AST and ALT in the treatment group, and fatigue and decreased appetite in the placebo group. The rates of discontinuation of active treatment due to drug-related adverse events were similar at 2.7% and 2.5% in the groups, respectively, he said, noting that the safety profile was consistent with findings in prior studies involving patients with solid tumors.

The findings demonstrate a clinical benefit with nivolumab in pretreated advanced or recurrent gastric cancer, and establish a strong basis for conducting additional studies of the drug in such patients, he concluded.

ONO-4538 was funded by Ono Pharmaceutical Co., Ltd. and Bristol-Myers Squibb. Dr. Kang reported a consulting or advisory role with Lilly/ImClone, Novartis, Ono Pharmaceutical, Roche/Genentech, and Taiho Pharmaceutical, and research funding from Bayer, Novartis, and Roche/Genentech.

[email protected]

SAN FRANCISCO – The human monoclonal IgG4 antibody nivolumab was safe and effective as a salvage treatment for patients in a randomized phase III trial who failed standard chemotherapy for advanced gastric or gastroesophageal junction cancer.

Nivolumab, which blocks the human programmed cell death-1 receptor, was superior to placebo with respect to overall survival, progression-free survival, and overall response rate, Yoon-Koo Kang, MD, reported at the symposium sponsored by ASCO, ASTRO, the American Gastroenterological Association, and the Society of Surgical Oncology.

For the study (ONO-4538), 493 patients with ECOG performance status of 0-1 and unresectable advanced or recurrent advanced gastric or gastroesophageal cancer who failed 2 or more prior chemotherapy regimens were randomized to receive placebo or nivolumab in a 2:1 ratio. Nivolumab treatment was associated with significantly improved median overall survival at the time of data cut-off 5.6 months after the last patient was randomized (5.32 months vs. 4.14 months with placebo; hazard ratio, 0.63), said Dr. Kang of Asan Medical Center, University of Ulsan, Seoul, Korea.

The overall survival rate at 12 months was 26.6% vs. 10.9%, respectively, he said.

The overall response rate was 11.2% vs. 0%, and median progression-free survival was 1.61 months vs. 1.45 months (hazard ratio, 0.60) with nivolumab vs. placebo, respectively.

“Median duration of response was 9.53 months,” he said.

Study subjects were adults aged 20 years or older who were enrolled from 49 centers in Japan, Korea, and Taiwan. The 330 patients in the nivolumab group received 3 mg/kg every 2 weeks until toxicity became unacceptable or disease progressed. Treatment-related adverse events occurred in 42.7% vs. 26.7% of nivolumab and placebo group patients, respectively, and grade 3 or greater events occurred in 11.5% vs. 5.5%, respectively.

Grade 3 or 4 events reported in more than 2% of patients were diarrhea, fatigue, decreased appetite, pyrexia, and increased AST and ALT in the treatment group, and fatigue and decreased appetite in the placebo group. The rates of discontinuation of active treatment due to drug-related adverse events were similar at 2.7% and 2.5% in the groups, respectively, he said, noting that the safety profile was consistent with findings in prior studies involving patients with solid tumors.

The findings demonstrate a clinical benefit with nivolumab in pretreated advanced or recurrent gastric cancer, and establish a strong basis for conducting additional studies of the drug in such patients, he concluded.

ONO-4538 was funded by Ono Pharmaceutical Co., Ltd. and Bristol-Myers Squibb. Dr. Kang reported a consulting or advisory role with Lilly/ImClone, Novartis, Ono Pharmaceutical, Roche/Genentech, and Taiho Pharmaceutical, and research funding from Bayer, Novartis, and Roche/Genentech.

[email protected]

SAN FRANCISCO – The human monoclonal IgG4 antibody nivolumab was safe and effective as a salvage treatment for patients in a randomized phase III trial who failed standard chemotherapy for advanced gastric or gastroesophageal junction cancer.

Nivolumab, which blocks the human programmed cell death-1 receptor, was superior to placebo with respect to overall survival, progression-free survival, and overall response rate, Yoon-Koo Kang, MD, reported at the symposium sponsored by ASCO, ASTRO, the American Gastroenterological Association, and the Society of Surgical Oncology.

For the study (ONO-4538), 493 patients with ECOG performance status of 0-1 and unresectable advanced or recurrent advanced gastric or gastroesophageal cancer who failed 2 or more prior chemotherapy regimens were randomized to receive placebo or nivolumab in a 2:1 ratio. Nivolumab treatment was associated with significantly improved median overall survival at the time of data cut-off 5.6 months after the last patient was randomized (5.32 months vs. 4.14 months with placebo; hazard ratio, 0.63), said Dr. Kang of Asan Medical Center, University of Ulsan, Seoul, Korea.

The overall survival rate at 12 months was 26.6% vs. 10.9%, respectively, he said.

The overall response rate was 11.2% vs. 0%, and median progression-free survival was 1.61 months vs. 1.45 months (hazard ratio, 0.60) with nivolumab vs. placebo, respectively.

“Median duration of response was 9.53 months,” he said.

Study subjects were adults aged 20 years or older who were enrolled from 49 centers in Japan, Korea, and Taiwan. The 330 patients in the nivolumab group received 3 mg/kg every 2 weeks until toxicity became unacceptable or disease progressed. Treatment-related adverse events occurred in 42.7% vs. 26.7% of nivolumab and placebo group patients, respectively, and grade 3 or greater events occurred in 11.5% vs. 5.5%, respectively.

Grade 3 or 4 events reported in more than 2% of patients were diarrhea, fatigue, decreased appetite, pyrexia, and increased AST and ALT in the treatment group, and fatigue and decreased appetite in the placebo group. The rates of discontinuation of active treatment due to drug-related adverse events were similar at 2.7% and 2.5% in the groups, respectively, he said, noting that the safety profile was consistent with findings in prior studies involving patients with solid tumors.

The findings demonstrate a clinical benefit with nivolumab in pretreated advanced or recurrent gastric cancer, and establish a strong basis for conducting additional studies of the drug in such patients, he concluded.

ONO-4538 was funded by Ono Pharmaceutical Co., Ltd. and Bristol-Myers Squibb. Dr. Kang reported a consulting or advisory role with Lilly/ImClone, Novartis, Ono Pharmaceutical, Roche/Genentech, and Taiho Pharmaceutical, and research funding from Bayer, Novartis, and Roche/Genentech.

[email protected]

A new report by the National Academies of Sciences, Engineering and Medicine shines a light on what the existing literature says about the perceived health benefits and dangers of using cannabis and cannabinoids.

“What little we know for certain about the effects of marijuana on human health — and all that we have reason to suspect — justifies serious national concern,” wrote the authors of the report, the evidence and research review of which was chaired by Marie McCormick, MD, of Harvard University in Boston. “The committee’s major recommendation called for an intensification and more comprehensive research effort into the effects of marijuana on the health of the American people.”

The authors concluded current literature shows substantial evidence stating that cannabis is effective at managing chronic pain in adults, while oral cannabinoid use is effective in mitigating nausea or vomiting induced by chemotherapy and improving patient-reported spasticity in patients with multiple sclerosis. Additionally, cannabinoids – specifically, nabiximols – are moderately effective in the short term for improving sleep disturbances brought on by obstructive sleep apnea syndrome, fibromyalgia, chronic pain, and multiple sclerosis.

However, there is limited evidence to support cannabis or cannabinoid use for reducing weight loss or inducing appetite in HIV/AIDS patients, improving clinician-measured spasicity or Tourette syndrome symptoms, reducing anxiety, improving symptoms brought on by post-traumatic stress, and improving outcomes in patients who have suffered traumatic brain injury or intracranial hemorrhage.

Additionally, there is no evidence to support the use of cannabis or cannabinoids in treating cancers or cancer-related anorexia, irritable bowel syndrome symptoms, epilepsy, spinal cord-related spasticity, symptoms of amyotrophic lateral sclerosis, Huntington’s disease, Parkinson’s disease, schizophrenia, and dystonia.

“Present data on drug use progression neither support nor refute the suggestion that medical availability would increase drug abuse,” the authors noted. “However, this question is beyond the issues normally considered for medical uses of drugs and should not be a factor in evaluating the therapeutic potential of marijuana or cannabinoids.”

From a mental health standpoint, suicidal thoughts were found to be more likely in individuals who frequently used cannabis or cannabinoids. Symptoms like depression and anxiety are also more likely in those who smoke marijuana and have bipolar disorder. There is also “limited evidence of a statistical association between sustained abstinence from cannabis use [and] impairments in the cognitive domains of learning, memory, and attention.”

Among the other significant findings of the report, children who live in states where marijuana has been legalized are significantly more likely to ingest cannabis or cannabinoids; so far, marijuana use in some form – either recreational or medical – has been approved in 28 states and Washington, DC. Furthermore, adolescents who use marijuana are more likely to experience difficulties in social and educational development. And individuals of any age who smoke marijuana and drive are more likely to be involved in a car accident.

Also noteworthy is the lack of evidence pointing to marijuana use causing cancer. While chronic marijuana smoking was found to be linked to bronchitis, it was not found to cause cancers that are most commonly associated with chronic smoking of tobacco.

“This report highlights that there are critical gaps in our understanding of the health effects of cannabis,” explained John H. Krystal, MD, of Yale University in New Haven, Connecticut.

A reviewer of the report, Dr. Krystal elaborated on the gaps that exist in the current literature, saying “One reason for these gaps has been regulatory and practical challenges facing those who attempted to conduct this research. For example, what supply of cannabis should they use? Where, in the typical hospital settings where research is conducted, should patients participating in research be permitted to smoke cannabis? What standards should the institutional review committees employ when evaluating studies that involve the administration of cannabis or other cannabinoids?”

Ultimately, Dr. Krystal stated, “what should be evident from this summary is that only a few of the many publicized clinical applications for cannabis are adequately supported by acceptable research standards for determining safety or efficacy.” Specifically, states that have approved cannabis use for managing PTSD symptoms are doing so based off “meager” evidence, and in some cases, are circumventing FDA regulatory processes in a way. This could not only compromise patient care, but muddy the waters for physicians who want to treat their patients safely while also following legal avenues.

“Physicians may face a tension between their roles as physicians [and] their wish to provide a legal path for access to cannabinoids for their patients,” Dr. Krystal said, adding that “the endorsement of particular cannabis prescription practices by the states, even for clinical indications where cannabis has not been shown to be safe and effective, may create pressure for physicians to engage in ineffective or unsafe cannabis prescription practices.”

Ultimately, the report underlines areas of need in terms of understanding and effectively using cannabis and cannabinoid in treating patients. Calling the report a “call to arms” for those in the health care – and, specifically, the public health – arena, Dr. Krystal added that he hopes the findings of the report will be used for educating “legislators, physicians, and consumers [about the] potential benefits and risks of cannabis and thereby help to guide both legislation, clinical practice, and perhaps recreational use.”
 

[email protected]

A new report by the National Academies of Sciences, Engineering and Medicine shines a light on what the existing literature says about the perceived health benefits and dangers of using cannabis and cannabinoids.

“What little we know for certain about the effects of marijuana on human health — and all that we have reason to suspect — justifies serious national concern,” wrote the authors of the report, the evidence and research review of which was chaired by Marie McCormick, MD, of Harvard University in Boston. “The committee’s major recommendation called for an intensification and more comprehensive research effort into the effects of marijuana on the health of the American people.”

The authors concluded current literature shows substantial evidence stating that cannabis is effective at managing chronic pain in adults, while oral cannabinoid use is effective in mitigating nausea or vomiting induced by chemotherapy and improving patient-reported spasticity in patients with multiple sclerosis. Additionally, cannabinoids – specifically, nabiximols – are moderately effective in the short term for improving sleep disturbances brought on by obstructive sleep apnea syndrome, fibromyalgia, chronic pain, and multiple sclerosis.

However, there is limited evidence to support cannabis or cannabinoid use for reducing weight loss or inducing appetite in HIV/AIDS patients, improving clinician-measured spasicity or Tourette syndrome symptoms, reducing anxiety, improving symptoms brought on by post-traumatic stress, and improving outcomes in patients who have suffered traumatic brain injury or intracranial hemorrhage.

Additionally, there is no evidence to support the use of cannabis or cannabinoids in treating cancers or cancer-related anorexia, irritable bowel syndrome symptoms, epilepsy, spinal cord-related spasticity, symptoms of amyotrophic lateral sclerosis, Huntington’s disease, Parkinson’s disease, schizophrenia, and dystonia.

“Present data on drug use progression neither support nor refute the suggestion that medical availability would increase drug abuse,” the authors noted. “However, this question is beyond the issues normally considered for medical uses of drugs and should not be a factor in evaluating the therapeutic potential of marijuana or cannabinoids.”

From a mental health standpoint, suicidal thoughts were found to be more likely in individuals who frequently used cannabis or cannabinoids. Symptoms like depression and anxiety are also more likely in those who smoke marijuana and have bipolar disorder. There is also “limited evidence of a statistical association between sustained abstinence from cannabis use [and] impairments in the cognitive domains of learning, memory, and attention.”

Among the other significant findings of the report, children who live in states where marijuana has been legalized are significantly more likely to ingest cannabis or cannabinoids; so far, marijuana use in some form – either recreational or medical – has been approved in 28 states and Washington, DC. Furthermore, adolescents who use marijuana are more likely to experience difficulties in social and educational development. And individuals of any age who smoke marijuana and drive are more likely to be involved in a car accident.

Also noteworthy is the lack of evidence pointing to marijuana use causing cancer. While chronic marijuana smoking was found to be linked to bronchitis, it was not found to cause cancers that are most commonly associated with chronic smoking of tobacco.

“This report highlights that there are critical gaps in our understanding of the health effects of cannabis,” explained John H. Krystal, MD, of Yale University in New Haven, Connecticut.

A reviewer of the report, Dr. Krystal elaborated on the gaps that exist in the current literature, saying “One reason for these gaps has been regulatory and practical challenges facing those who attempted to conduct this research. For example, what supply of cannabis should they use? Where, in the typical hospital settings where research is conducted, should patients participating in research be permitted to smoke cannabis? What standards should the institutional review committees employ when evaluating studies that involve the administration of cannabis or other cannabinoids?”

Ultimately, Dr. Krystal stated, “what should be evident from this summary is that only a few of the many publicized clinical applications for cannabis are adequately supported by acceptable research standards for determining safety or efficacy.” Specifically, states that have approved cannabis use for managing PTSD symptoms are doing so based off “meager” evidence, and in some cases, are circumventing FDA regulatory processes in a way. This could not only compromise patient care, but muddy the waters for physicians who want to treat their patients safely while also following legal avenues.

“Physicians may face a tension between their roles as physicians [and] their wish to provide a legal path for access to cannabinoids for their patients,” Dr. Krystal said, adding that “the endorsement of particular cannabis prescription practices by the states, even for clinical indications where cannabis has not been shown to be safe and effective, may create pressure for physicians to engage in ineffective or unsafe cannabis prescription practices.”

Ultimately, the report underlines areas of need in terms of understanding and effectively using cannabis and cannabinoid in treating patients. Calling the report a “call to arms” for those in the health care – and, specifically, the public health – arena, Dr. Krystal added that he hopes the findings of the report will be used for educating “legislators, physicians, and consumers [about the] potential benefits and risks of cannabis and thereby help to guide both legislation, clinical practice, and perhaps recreational use.”
 

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A new report by the National Academies of Sciences, Engineering and Medicine shines a light on what the existing literature says about the perceived health benefits and dangers of using cannabis and cannabinoids.

“What little we know for certain about the effects of marijuana on human health — and all that we have reason to suspect — justifies serious national concern,” wrote the authors of the report, the evidence and research review of which was chaired by Marie McCormick, MD, of Harvard University in Boston. “The committee’s major recommendation called for an intensification and more comprehensive research effort into the effects of marijuana on the health of the American people.”

The authors concluded current literature shows substantial evidence stating that cannabis is effective at managing chronic pain in adults, while oral cannabinoid use is effective in mitigating nausea or vomiting induced by chemotherapy and improving patient-reported spasticity in patients with multiple sclerosis. Additionally, cannabinoids – specifically, nabiximols – are moderately effective in the short term for improving sleep disturbances brought on by obstructive sleep apnea syndrome, fibromyalgia, chronic pain, and multiple sclerosis.

However, there is limited evidence to support cannabis or cannabinoid use for reducing weight loss or inducing appetite in HIV/AIDS patients, improving clinician-measured spasicity or Tourette syndrome symptoms, reducing anxiety, improving symptoms brought on by post-traumatic stress, and improving outcomes in patients who have suffered traumatic brain injury or intracranial hemorrhage.

Additionally, there is no evidence to support the use of cannabis or cannabinoids in treating cancers or cancer-related anorexia, irritable bowel syndrome symptoms, epilepsy, spinal cord-related spasticity, symptoms of amyotrophic lateral sclerosis, Huntington’s disease, Parkinson’s disease, schizophrenia, and dystonia.

“Present data on drug use progression neither support nor refute the suggestion that medical availability would increase drug abuse,” the authors noted. “However, this question is beyond the issues normally considered for medical uses of drugs and should not be a factor in evaluating the therapeutic potential of marijuana or cannabinoids.”

From a mental health standpoint, suicidal thoughts were found to be more likely in individuals who frequently used cannabis or cannabinoids. Symptoms like depression and anxiety are also more likely in those who smoke marijuana and have bipolar disorder. There is also “limited evidence of a statistical association between sustained abstinence from cannabis use [and] impairments in the cognitive domains of learning, memory, and attention.”

Among the other significant findings of the report, children who live in states where marijuana has been legalized are significantly more likely to ingest cannabis or cannabinoids; so far, marijuana use in some form – either recreational or medical – has been approved in 28 states and Washington, DC. Furthermore, adolescents who use marijuana are more likely to experience difficulties in social and educational development. And individuals of any age who smoke marijuana and drive are more likely to be involved in a car accident.

Also noteworthy is the lack of evidence pointing to marijuana use causing cancer. While chronic marijuana smoking was found to be linked to bronchitis, it was not found to cause cancers that are most commonly associated with chronic smoking of tobacco.

“This report highlights that there are critical gaps in our understanding of the health effects of cannabis,” explained John H. Krystal, MD, of Yale University in New Haven, Connecticut.

A reviewer of the report, Dr. Krystal elaborated on the gaps that exist in the current literature, saying “One reason for these gaps has been regulatory and practical challenges facing those who attempted to conduct this research. For example, what supply of cannabis should they use? Where, in the typical hospital settings where research is conducted, should patients participating in research be permitted to smoke cannabis? What standards should the institutional review committees employ when evaluating studies that involve the administration of cannabis or other cannabinoids?”

Ultimately, Dr. Krystal stated, “what should be evident from this summary is that only a few of the many publicized clinical applications for cannabis are adequately supported by acceptable research standards for determining safety or efficacy.” Specifically, states that have approved cannabis use for managing PTSD symptoms are doing so based off “meager” evidence, and in some cases, are circumventing FDA regulatory processes in a way. This could not only compromise patient care, but muddy the waters for physicians who want to treat their patients safely while also following legal avenues.

“Physicians may face a tension between their roles as physicians [and] their wish to provide a legal path for access to cannabinoids for their patients,” Dr. Krystal said, adding that “the endorsement of particular cannabis prescription practices by the states, even for clinical indications where cannabis has not been shown to be safe and effective, may create pressure for physicians to engage in ineffective or unsafe cannabis prescription practices.”

Ultimately, the report underlines areas of need in terms of understanding and effectively using cannabis and cannabinoid in treating patients. Calling the report a “call to arms” for those in the health care – and, specifically, the public health – arena, Dr. Krystal added that he hopes the findings of the report will be used for educating “legislators, physicians, and consumers [about the] potential benefits and risks of cannabis and thereby help to guide both legislation, clinical practice, and perhaps recreational use.”
 

[email protected]

Quality improvement (QI) interventions related to the use of central venous catheters (CVCs) were, on average, associated with 57% fewer infections and $1.85 million in net savings to hospitals within 1-3 years of implementation, based on the results of a meta-analysis of data from 113 hospitals.

“Hospitals that have already attained very low infection rates (through the use of quality improvement checklists) would likely see smaller clinical benefits and savings than in the studies we have reviewed,” said Dr. Teryl Nuckols of Cedars-Sinai Medical Center, Los Angeles. “Nonetheless, we found that QI interventions can be associated with declines in CLABSI (central line-associated bloodstream infection) and/or CRBSI (catheter-related bloodstream infection) and net savings when checklists are already in use, and when hospitals have CLABSI rates as low as 1.7-3.7 per 1,000 CVC-days.”

[email protected]

Quality improvement (QI) interventions related to the use of central venous catheters (CVCs) were, on average, associated with 57% fewer infections and $1.85 million in net savings to hospitals within 1-3 years of implementation, based on the results of a meta-analysis of data from 113 hospitals.

“Hospitals that have already attained very low infection rates (through the use of quality improvement checklists) would likely see smaller clinical benefits and savings than in the studies we have reviewed,” said Dr. Teryl Nuckols of Cedars-Sinai Medical Center, Los Angeles. “Nonetheless, we found that QI interventions can be associated with declines in CLABSI (central line-associated bloodstream infection) and/or CRBSI (catheter-related bloodstream infection) and net savings when checklists are already in use, and when hospitals have CLABSI rates as low as 1.7-3.7 per 1,000 CVC-days.”

[email protected]

Quality improvement (QI) interventions related to the use of central venous catheters (CVCs) were, on average, associated with 57% fewer infections and $1.85 million in net savings to hospitals within 1-3 years of implementation, based on the results of a meta-analysis of data from 113 hospitals.

“Hospitals that have already attained very low infection rates (through the use of quality improvement checklists) would likely see smaller clinical benefits and savings than in the studies we have reviewed,” said Dr. Teryl Nuckols of Cedars-Sinai Medical Center, Los Angeles. “Nonetheless, we found that QI interventions can be associated with declines in CLABSI (central line-associated bloodstream infection) and/or CRBSI (catheter-related bloodstream infection) and net savings when checklists are already in use, and when hospitals have CLABSI rates as low as 1.7-3.7 per 1,000 CVC-days.”

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SAN FRANCISCO – The use of positron emission tomography to assess esophageal tumor response to induction chemotherapy and to guide a regimen change in those who failed to respond was associated with an improved pathologic complete response (pCR) rate in patients in a phase II randomized trial.

Of 257 patients with esophageal and gastroesophageal junction (GEJ) adenocarcinomas who were randomized after a baseline PET scan to receive induction chemotherapy with either modified FOLFOX-6 (oxaliplatin, leucovorin, and 5-fluorouracil) on days 1, 15, and 29, or carboplatin/paclitaxel (CP) on days 1, 8, 22, and 29, 39 patients and 49 patients, respectively, were found on a repeat PET scan performed between days 36 and 42 after initiation of therapy to be nonresponders. Those patients were switched to the alternative regimen during preoperative chemoradiation therapy (CRT). Eligible subjects underwent surgical resection 6 weeks after CRT. The pCR rate after surgery among those who were switched because of initial nonresponse was 18%, compared with an expected rate of 5% based on data from prior studies in which chemotherapy was not changed in nonresponders. The rate was 26% in PET responders, Karyn A. Goodman, MD, reported at the symposium, sponsored by ASCO, ASTRO, the American Gastroenterological Association, and the Society of Surgical Oncology..

Eraxion/Thinkstock.com

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SAN FRANCISCO – The use of positron emission tomography to assess esophageal tumor response to induction chemotherapy and to guide a regimen change in those who failed to respond was associated with an improved pathologic complete response (pCR) rate in patients in a phase II randomized trial.

Of 257 patients with esophageal and gastroesophageal junction (GEJ) adenocarcinomas who were randomized after a baseline PET scan to receive induction chemotherapy with either modified FOLFOX-6 (oxaliplatin, leucovorin, and 5-fluorouracil) on days 1, 15, and 29, or carboplatin/paclitaxel (CP) on days 1, 8, 22, and 29, 39 patients and 49 patients, respectively, were found on a repeat PET scan performed between days 36 and 42 after initiation of therapy to be nonresponders. Those patients were switched to the alternative regimen during preoperative chemoradiation therapy (CRT). Eligible subjects underwent surgical resection 6 weeks after CRT. The pCR rate after surgery among those who were switched because of initial nonresponse was 18%, compared with an expected rate of 5% based on data from prior studies in which chemotherapy was not changed in nonresponders. The rate was 26% in PET responders, Karyn A. Goodman, MD, reported at the symposium, sponsored by ASCO, ASTRO, the American Gastroenterological Association, and the Society of Surgical Oncology..

Eraxion/Thinkstock.com

[email protected]

SAN FRANCISCO – The use of positron emission tomography to assess esophageal tumor response to induction chemotherapy and to guide a regimen change in those who failed to respond was associated with an improved pathologic complete response (pCR) rate in patients in a phase II randomized trial.

Of 257 patients with esophageal and gastroesophageal junction (GEJ) adenocarcinomas who were randomized after a baseline PET scan to receive induction chemotherapy with either modified FOLFOX-6 (oxaliplatin, leucovorin, and 5-fluorouracil) on days 1, 15, and 29, or carboplatin/paclitaxel (CP) on days 1, 8, 22, and 29, 39 patients and 49 patients, respectively, were found on a repeat PET scan performed between days 36 and 42 after initiation of therapy to be nonresponders. Those patients were switched to the alternative regimen during preoperative chemoradiation therapy (CRT). Eligible subjects underwent surgical resection 6 weeks after CRT. The pCR rate after surgery among those who were switched because of initial nonresponse was 18%, compared with an expected rate of 5% based on data from prior studies in which chemotherapy was not changed in nonresponders. The rate was 26% in PET responders, Karyn A. Goodman, MD, reported at the symposium, sponsored by ASCO, ASTRO, the American Gastroenterological Association, and the Society of Surgical Oncology..

Eraxion/Thinkstock.com

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Prescription medications
Photo courtesy of the CDC

Results of a meta-analysis support the idea that statins can reduce the risk of venous thromboembolism (VTE).

Researchers analyzed data from 36 studies involving more than 3.2 million people and found an “extensive body of evidence on the clinical benefit of statin[s] in the occurrence of VTE.”

The team believes these findings could potentially lead to new guidelines and an expansion of the use of statins.

“These findings underscore a potential beneficial role of statin therapy on VTE in addition to its established role in cardiovascular disease prevention,” said Kamlesh Khunti, MD, PhD, of the University of Leicester in the UK.

Dr Khunti and his colleagues reported these findings in The Lancet Haematology.

The researchers analyzed data from 36 studies. This included 13 cohort studies with a total of 3,148,259 subjects and 23 randomized, controlled trials (RCTs) of 118,464 subjects in which statins were compared to placebo or no treatment.

In the observational studies, statin use was associated with a significant reduction in the risk of VTE, when compared to no statin use. The pooled relative risk (RR) was 0.75 (P<0.0001).

Statin use was associated with a significant reduction in the risk of deep vein thrombosis (DVT), with an RR of 0.77 (P<0.0001). (There were only 2 observational studies looking specifically at DVT outcomes.)

However, there was no significant reduction in the risk of pulmonary embolism (PE) with statin use. The RR was 1.02 (P=0.90). (There was only 1 observational study reporting specifically on PE outcomes.)

In the RCTs, statin use was associated with a significant reduction in the risk of VTE, with an RR of 0.85 (P=0.038).

Statin use was also associated with a significant reduction in DVT risk, with an RR of 0.45, but not PE risk, with an RR of 0.77 (no P values available). (There was only 1 RCT that reported specifically on DVT and PE outcomes.)

The RCTs also showed significant differences in VTE risk according to type of statin used. Patients receiving rosuvastatin had the lowest risk of VTE when compared to those receiving other statins, with an RR of 0.57 (P=0.015).

“Currently, statins are only approved for lipid lowering in the primary and secondary prevention of cardiovascular disease,” said study author Setor Kunutsor, MBChB, PhD, of the University of Bristol in the UK.

“But they have shown great promise beyond their established lipid-lowering effects, and these include potential beneficial impact on multiple disease conditions. These results provide an extensive body of evidence on the clinical benefit of statin[s] in the occurrence of VTE and may support a true protective effect.”

Prescription medications
Photo courtesy of the CDC

Results of a meta-analysis support the idea that statins can reduce the risk of venous thromboembolism (VTE).

Researchers analyzed data from 36 studies involving more than 3.2 million people and found an “extensive body of evidence on the clinical benefit of statin[s] in the occurrence of VTE.”

The team believes these findings could potentially lead to new guidelines and an expansion of the use of statins.

“These findings underscore a potential beneficial role of statin therapy on VTE in addition to its established role in cardiovascular disease prevention,” said Kamlesh Khunti, MD, PhD, of the University of Leicester in the UK.

Dr Khunti and his colleagues reported these findings in The Lancet Haematology.

The researchers analyzed data from 36 studies. This included 13 cohort studies with a total of 3,148,259 subjects and 23 randomized, controlled trials (RCTs) of 118,464 subjects in which statins were compared to placebo or no treatment.

In the observational studies, statin use was associated with a significant reduction in the risk of VTE, when compared to no statin use. The pooled relative risk (RR) was 0.75 (P<0.0001).

Statin use was associated with a significant reduction in the risk of deep vein thrombosis (DVT), with an RR of 0.77 (P<0.0001). (There were only 2 observational studies looking specifically at DVT outcomes.)

However, there was no significant reduction in the risk of pulmonary embolism (PE) with statin use. The RR was 1.02 (P=0.90). (There was only 1 observational study reporting specifically on PE outcomes.)

In the RCTs, statin use was associated with a significant reduction in the risk of VTE, with an RR of 0.85 (P=0.038).

Statin use was also associated with a significant reduction in DVT risk, with an RR of 0.45, but not PE risk, with an RR of 0.77 (no P values available). (There was only 1 RCT that reported specifically on DVT and PE outcomes.)

The RCTs also showed significant differences in VTE risk according to type of statin used. Patients receiving rosuvastatin had the lowest risk of VTE when compared to those receiving other statins, with an RR of 0.57 (P=0.015).

“Currently, statins are only approved for lipid lowering in the primary and secondary prevention of cardiovascular disease,” said study author Setor Kunutsor, MBChB, PhD, of the University of Bristol in the UK.

“But they have shown great promise beyond their established lipid-lowering effects, and these include potential beneficial impact on multiple disease conditions. These results provide an extensive body of evidence on the clinical benefit of statin[s] in the occurrence of VTE and may support a true protective effect.”

Prescription medications
Photo courtesy of the CDC

Results of a meta-analysis support the idea that statins can reduce the risk of venous thromboembolism (VTE).

Researchers analyzed data from 36 studies involving more than 3.2 million people and found an “extensive body of evidence on the clinical benefit of statin[s] in the occurrence of VTE.”

The team believes these findings could potentially lead to new guidelines and an expansion of the use of statins.

“These findings underscore a potential beneficial role of statin therapy on VTE in addition to its established role in cardiovascular disease prevention,” said Kamlesh Khunti, MD, PhD, of the University of Leicester in the UK.

Dr Khunti and his colleagues reported these findings in The Lancet Haematology.

The researchers analyzed data from 36 studies. This included 13 cohort studies with a total of 3,148,259 subjects and 23 randomized, controlled trials (RCTs) of 118,464 subjects in which statins were compared to placebo or no treatment.

In the observational studies, statin use was associated with a significant reduction in the risk of VTE, when compared to no statin use. The pooled relative risk (RR) was 0.75 (P<0.0001).

Statin use was associated with a significant reduction in the risk of deep vein thrombosis (DVT), with an RR of 0.77 (P<0.0001). (There were only 2 observational studies looking specifically at DVT outcomes.)

However, there was no significant reduction in the risk of pulmonary embolism (PE) with statin use. The RR was 1.02 (P=0.90). (There was only 1 observational study reporting specifically on PE outcomes.)

In the RCTs, statin use was associated with a significant reduction in the risk of VTE, with an RR of 0.85 (P=0.038).

Statin use was also associated with a significant reduction in DVT risk, with an RR of 0.45, but not PE risk, with an RR of 0.77 (no P values available). (There was only 1 RCT that reported specifically on DVT and PE outcomes.)

The RCTs also showed significant differences in VTE risk according to type of statin used. Patients receiving rosuvastatin had the lowest risk of VTE when compared to those receiving other statins, with an RR of 0.57 (P=0.015).

“Currently, statins are only approved for lipid lowering in the primary and secondary prevention of cardiovascular disease,” said study author Setor Kunutsor, MBChB, PhD, of the University of Bristol in the UK.

“But they have shown great promise beyond their established lipid-lowering effects, and these include potential beneficial impact on multiple disease conditions. These results provide an extensive body of evidence on the clinical benefit of statin[s] in the occurrence of VTE and may support a true protective effect.”

Clinical question: What is a safe target hemoglobin level for patients requiring red blood cell transfusion, and how long can red blood cells be stored prior to transfusion?

Background: The AABB, formerly the American Association of Blood Banks, notes several new, large, rigorous studies on transfusion thresholds were published since their last guideline in 2012. Additionally, there are concerns from initial studies of increased morbidity and mortality with transfusions of red blood cells stored for longer periods of time.

Study design: Systematic review and meta-analysis.

Setting: Summary findings from the AABB clinical transfusion medicine committee.

Synopsis: Thirty-one randomized clinical trials (RCTs) evaluating blood transfusion thresholds were reviewed and analyzed, including 12,587 patients across various clinical scenarios. The authors recommend a restrictive threshold of 7 g/dL for most hospitalized adult patients in the appropriate clinical context. For patients undergoing orthopedic or cardiac surgery, or with cardiovascular disease, a threshold of 8 g/dL is recommended, as it was the threshold used in studies of these patients (though such patients may actually tolerate a lower value).

No recommendations were made for patients with acute coronary syndrome, hematological or oncological disorders, severe thrombocytopenia, or chronic transfusion-dependent anemia given limited data.

To determine a safe period of time for blood storage prior to transfusion, 13 RCTs were reviewed and analyzed. The authors recommend that patients requiring transfusion receive red blood cell units at any period within the standard issue period (less than 42 days), rather than limit transfusion to fresh units (less than 10 days).

Bottom line: A restrictive red blood cell transfusion threshold of 7-8 g/dL is safe in most clinical settings, and there is no advantage to using fresh units as opposed to those stored for the standard period.

Citation: Carson JL, Guyatt G, Heddle NM, et al. Clinical practice guidelines from the AABB. JAMA. 2016;316(19):2025-35.

Dr. Murphy is a clinical instructor at the University of Utah School of Medicine and an academic hospitalist at the University of Utah Hospital.

Clinical question: What is a safe target hemoglobin level for patients requiring red blood cell transfusion, and how long can red blood cells be stored prior to transfusion?

Background: The AABB, formerly the American Association of Blood Banks, notes several new, large, rigorous studies on transfusion thresholds were published since their last guideline in 2012. Additionally, there are concerns from initial studies of increased morbidity and mortality with transfusions of red blood cells stored for longer periods of time.

Study design: Systematic review and meta-analysis.

Setting: Summary findings from the AABB clinical transfusion medicine committee.

Synopsis: Thirty-one randomized clinical trials (RCTs) evaluating blood transfusion thresholds were reviewed and analyzed, including 12,587 patients across various clinical scenarios. The authors recommend a restrictive threshold of 7 g/dL for most hospitalized adult patients in the appropriate clinical context. For patients undergoing orthopedic or cardiac surgery, or with cardiovascular disease, a threshold of 8 g/dL is recommended, as it was the threshold used in studies of these patients (though such patients may actually tolerate a lower value).

No recommendations were made for patients with acute coronary syndrome, hematological or oncological disorders, severe thrombocytopenia, or chronic transfusion-dependent anemia given limited data.

To determine a safe period of time for blood storage prior to transfusion, 13 RCTs were reviewed and analyzed. The authors recommend that patients requiring transfusion receive red blood cell units at any period within the standard issue period (less than 42 days), rather than limit transfusion to fresh units (less than 10 days).

Bottom line: A restrictive red blood cell transfusion threshold of 7-8 g/dL is safe in most clinical settings, and there is no advantage to using fresh units as opposed to those stored for the standard period.

Citation: Carson JL, Guyatt G, Heddle NM, et al. Clinical practice guidelines from the AABB. JAMA. 2016;316(19):2025-35.

Dr. Murphy is a clinical instructor at the University of Utah School of Medicine and an academic hospitalist at the University of Utah Hospital.

Clinical question: What is a safe target hemoglobin level for patients requiring red blood cell transfusion, and how long can red blood cells be stored prior to transfusion?

Background: The AABB, formerly the American Association of Blood Banks, notes several new, large, rigorous studies on transfusion thresholds were published since their last guideline in 2012. Additionally, there are concerns from initial studies of increased morbidity and mortality with transfusions of red blood cells stored for longer periods of time.

Study design: Systematic review and meta-analysis.

Setting: Summary findings from the AABB clinical transfusion medicine committee.

Synopsis: Thirty-one randomized clinical trials (RCTs) evaluating blood transfusion thresholds were reviewed and analyzed, including 12,587 patients across various clinical scenarios. The authors recommend a restrictive threshold of 7 g/dL for most hospitalized adult patients in the appropriate clinical context. For patients undergoing orthopedic or cardiac surgery, or with cardiovascular disease, a threshold of 8 g/dL is recommended, as it was the threshold used in studies of these patients (though such patients may actually tolerate a lower value).

No recommendations were made for patients with acute coronary syndrome, hematological or oncological disorders, severe thrombocytopenia, or chronic transfusion-dependent anemia given limited data.

To determine a safe period of time for blood storage prior to transfusion, 13 RCTs were reviewed and analyzed. The authors recommend that patients requiring transfusion receive red blood cell units at any period within the standard issue period (less than 42 days), rather than limit transfusion to fresh units (less than 10 days).

Bottom line: A restrictive red blood cell transfusion threshold of 7-8 g/dL is safe in most clinical settings, and there is no advantage to using fresh units as opposed to those stored for the standard period.

Citation: Carson JL, Guyatt G, Heddle NM, et al. Clinical practice guidelines from the AABB. JAMA. 2016;316(19):2025-35.

Dr. Murphy is a clinical instructor at the University of Utah School of Medicine and an academic hospitalist at the University of Utah Hospital.

Whether you’re a hospitalist who works only in a hospital, a hospitalist who works only in a post-acute care (PAC) setting, or a hospitalist who works in both types of facilities, knowing about current trends at PAC facilities and what the future may hold can help you excel in your current capacity and, ultimately, improve patient care.

The Hospitalist tapped experts in the post-acute space to tell us what they thought HM should know about working in PAC – which, in many ways, is quite different from the hospital setting. Here’s a compilation of their top eight must-knows.

1. PAC settings rely more on mid-level medical staff than hospitals do.

PAC facilities employ more mid-level providers, such as nurse practitioners and physician assistants, because they can support the level of medical complexity and decision making 95% of the time, says James D. Tollman, MD, FHM, president of Essex Inpatient Physicians in Boxford, Mass. Further, they are more heavily staffed by licensed practical nurses than are acute-care settings.

2. Testing takes longer, and options are limited.

Access to some acute urgent resources such as laboratory testing, imaging tests, and pharmacy products is more challenging at PAC facilities because most of these resources are not on-site. Consequently, there is a time lag between ordering tests and new medications and implementing these orders.

“If a patient needs something performed diagnostically immediately, they usually have to be transported to the emergency room or a facility with the necessary testing equipment,” Dr. Tollman says.

3. Patient populations mainly include rehab and terminally ill patients.

Patients are typically sent to a PAC facility either to recover from an illness or injury or because they are chronically ill and have exhausted treatment options. Regarding the latter, “They are mostly there for palliation; we don’t perform daily tests or prescribe aggressive medications on these patients,” Dr. Nazir says.

Dr. Cummings explains that PAC clinicians go through “the dying process with the patient.”

“They may or may not have assistance from hospice organizations,” she says, “and when they don’t, [hospitalists] take on the role of palliative-care providers.”

Dr. Cummings has seen an increase in psychiatric patients entering PAC facilities.

“Many patients with chronic psychological problems are aging, and there are fewer inpatient psychiatric beds available to those with concurrent medical and psychiatric problems,” she says. Much of this work is now being done in PAC settings.

4. You can build a relationship with your patient.

Because the pace of a PAC facility is slower and a patient typically stays in a PAC facility longer than at a hospital, there’s time for a hospitalist to have more in-depth conversations with patients and their families.

“Building a deeper relationship with a patient may give the hospitalist an opportunity to discover the cause of an acute problem,” Dr. Nazir says. “They can go in-depth into the psychosocial aspect of medicine and may be able to find out what led to the initial problem and the real root cause, which can help prevent future recurrences, such as repeat falls or forgetting to take a medication.”
 

5. Using EHRs can improve transitions.

Care transitions between a hospital and PAC facility can be compromised by a lack of information sharing, and they can affect the quality and safety of patient care, says Dori Cross, a doctoral candidate in health services organization and policy at the University of Michigan School of Public Health in Ann Arbor. Handoffs between providers require information continuity – information that is complete, timely, and in a usable format – to ensure appropriate medical decisions and to provide high-quality care during and after transition.

Electronic health records (EHRs) as well as health information exchanges (HIEs) allow providers to communicate and share patient information. For example, hospitals can send information electronically to PAC facilities (“push” exchange) or make information available online securely for PAC providers to log in and access (“pull” exchange). According to a 2014 survey data by the American Hospital Association, more than 50% of hospitals report sending structured summary-of-care records electronically to long-term care settings; a little less than half of those hospitals (23% of the total sample of hospitals) were also receiving information electronically from long-term care sites.¹

“This bidirectional exchange, in particular, can make it easier to share information across provider organizations electronically and, in turn, improve care delivery,” says Ms. Cross, who authored an accepted paper on the subject in the Journal of Post-Acute and Long-Term Medicine.

6. Hospitalists can work with providers in PAC settings to improve transitions.

Despite improvements in the electronic transfer of medical information, gaps still exist and can cause problems. One chasm when discharging patients to a PAC facility, is when a hospital IT system is incapable of communicating with the PAC facility system. In this instance, Dr. Nazir says, the hospitalist “can help bridge the gap.”

“[We] can verbally relay relevant information to physicians at PAC facilities so they understand the patient’s status, needs, and expectations,” he says. “Furthermore, hospitalists and a PAC facility’s administration can brainstorm methods to improve the systems of care so the patient receives more effective and timely care.”
 

7. Hospitalists switching to the PAC setting should have formal training.

The two main obstacles for hospitalists who change from working in a hospital to a PAC facility are the lack of exposure to PAC work in training and the assumption that it requires the same skills sets of a typical hospitalist, according to Manoj K. Mathew, MD, SFHM, national medical director of Los Angeles–based Agilon Health. The PAC setting has quite a number of differences compared with a hospital setting. For example, some regulations apply specifically to PAC facilities. In addition to formal training, hospitalists can benefit from using SHM’s Post-Acute Care Transitions Toolkit, having a mentor, or using resources from other organizations that function in this space such as The Society for Post-Acute and Long-Term Care Medicine, Dr. Nazir says.

Dr. Manoj K. Mathew

8. A variety of payors and payment models are in play.

Commercial insurers continue to be major payors for PAC, especially for individuals younger than 65 years. Medicare and Medicaid, administered by the Centers for Medicare & Medicaid Services, are the primary payors for patients aged 65 years and older.

Reference

Cross DA, Adler-Milstein J. Investing in post-acute care transitions: electronic information exchange between hospitals and long-term care facilities [published online ahead of print Sept. 14, 2016]. JAMDA. doi: http://dx.doi.org/10.1016/j.jamda.2016.07.024.

Whether you’re a hospitalist who works only in a hospital, a hospitalist who works only in a post-acute care (PAC) setting, or a hospitalist who works in both types of facilities, knowing about current trends at PAC facilities and what the future may hold can help you excel in your current capacity and, ultimately, improve patient care.

The Hospitalist tapped experts in the post-acute space to tell us what they thought HM should know about working in PAC – which, in many ways, is quite different from the hospital setting. Here’s a compilation of their top eight must-knows.

1. PAC settings rely more on mid-level medical staff than hospitals do.

PAC facilities employ more mid-level providers, such as nurse practitioners and physician assistants, because they can support the level of medical complexity and decision making 95% of the time, says James D. Tollman, MD, FHM, president of Essex Inpatient Physicians in Boxford, Mass. Further, they are more heavily staffed by licensed practical nurses than are acute-care settings.

2. Testing takes longer, and options are limited.

Access to some acute urgent resources such as laboratory testing, imaging tests, and pharmacy products is more challenging at PAC facilities because most of these resources are not on-site. Consequently, there is a time lag between ordering tests and new medications and implementing these orders.

“If a patient needs something performed diagnostically immediately, they usually have to be transported to the emergency room or a facility with the necessary testing equipment,” Dr. Tollman says.

3. Patient populations mainly include rehab and terminally ill patients.

Patients are typically sent to a PAC facility either to recover from an illness or injury or because they are chronically ill and have exhausted treatment options. Regarding the latter, “They are mostly there for palliation; we don’t perform daily tests or prescribe aggressive medications on these patients,” Dr. Nazir says.

Dr. Cummings explains that PAC clinicians go through “the dying process with the patient.”

“They may or may not have assistance from hospice organizations,” she says, “and when they don’t, [hospitalists] take on the role of palliative-care providers.”

Dr. Cummings has seen an increase in psychiatric patients entering PAC facilities.

“Many patients with chronic psychological problems are aging, and there are fewer inpatient psychiatric beds available to those with concurrent medical and psychiatric problems,” she says. Much of this work is now being done in PAC settings.

4. You can build a relationship with your patient.

Because the pace of a PAC facility is slower and a patient typically stays in a PAC facility longer than at a hospital, there’s time for a hospitalist to have more in-depth conversations with patients and their families.

“Building a deeper relationship with a patient may give the hospitalist an opportunity to discover the cause of an acute problem,” Dr. Nazir says. “They can go in-depth into the psychosocial aspect of medicine and may be able to find out what led to the initial problem and the real root cause, which can help prevent future recurrences, such as repeat falls or forgetting to take a medication.”
 

5. Using EHRs can improve transitions.

Care transitions between a hospital and PAC facility can be compromised by a lack of information sharing, and they can affect the quality and safety of patient care, says Dori Cross, a doctoral candidate in health services organization and policy at the University of Michigan School of Public Health in Ann Arbor. Handoffs between providers require information continuity – information that is complete, timely, and in a usable format – to ensure appropriate medical decisions and to provide high-quality care during and after transition.

Electronic health records (EHRs) as well as health information exchanges (HIEs) allow providers to communicate and share patient information. For example, hospitals can send information electronically to PAC facilities (“push” exchange) or make information available online securely for PAC providers to log in and access (“pull” exchange). According to a 2014 survey data by the American Hospital Association, more than 50% of hospitals report sending structured summary-of-care records electronically to long-term care settings; a little less than half of those hospitals (23% of the total sample of hospitals) were also receiving information electronically from long-term care sites.¹

“This bidirectional exchange, in particular, can make it easier to share information across provider organizations electronically and, in turn, improve care delivery,” says Ms. Cross, who authored an accepted paper on the subject in the Journal of Post-Acute and Long-Term Medicine.

6. Hospitalists can work with providers in PAC settings to improve transitions.

Despite improvements in the electronic transfer of medical information, gaps still exist and can cause problems. One chasm when discharging patients to a PAC facility, is when a hospital IT system is incapable of communicating with the PAC facility system. In this instance, Dr. Nazir says, the hospitalist “can help bridge the gap.”

“[We] can verbally relay relevant information to physicians at PAC facilities so they understand the patient’s status, needs, and expectations,” he says. “Furthermore, hospitalists and a PAC facility’s administration can brainstorm methods to improve the systems of care so the patient receives more effective and timely care.”
 

7. Hospitalists switching to the PAC setting should have formal training.

The two main obstacles for hospitalists who change from working in a hospital to a PAC facility are the lack of exposure to PAC work in training and the assumption that it requires the same skills sets of a typical hospitalist, according to Manoj K. Mathew, MD, SFHM, national medical director of Los Angeles–based Agilon Health. The PAC setting has quite a number of differences compared with a hospital setting. For example, some regulations apply specifically to PAC facilities. In addition to formal training, hospitalists can benefit from using SHM’s Post-Acute Care Transitions Toolkit, having a mentor, or using resources from other organizations that function in this space such as The Society for Post-Acute and Long-Term Care Medicine, Dr. Nazir says.

Dr. Manoj K. Mathew

8. A variety of payors and payment models are in play.

Commercial insurers continue to be major payors for PAC, especially for individuals younger than 65 years. Medicare and Medicaid, administered by the Centers for Medicare & Medicaid Services, are the primary payors for patients aged 65 years and older.

Reference

Cross DA, Adler-Milstein J. Investing in post-acute care transitions: electronic information exchange between hospitals and long-term care facilities [published online ahead of print Sept. 14, 2016]. JAMDA. doi: http://dx.doi.org/10.1016/j.jamda.2016.07.024.

Whether you’re a hospitalist who works only in a hospital, a hospitalist who works only in a post-acute care (PAC) setting, or a hospitalist who works in both types of facilities, knowing about current trends at PAC facilities and what the future may hold can help you excel in your current capacity and, ultimately, improve patient care.

The Hospitalist tapped experts in the post-acute space to tell us what they thought HM should know about working in PAC – which, in many ways, is quite different from the hospital setting. Here’s a compilation of their top eight must-knows.

1. PAC settings rely more on mid-level medical staff than hospitals do.

PAC facilities employ more mid-level providers, such as nurse practitioners and physician assistants, because they can support the level of medical complexity and decision making 95% of the time, says James D. Tollman, MD, FHM, president of Essex Inpatient Physicians in Boxford, Mass. Further, they are more heavily staffed by licensed practical nurses than are acute-care settings.

2. Testing takes longer, and options are limited.

Access to some acute urgent resources such as laboratory testing, imaging tests, and pharmacy products is more challenging at PAC facilities because most of these resources are not on-site. Consequently, there is a time lag between ordering tests and new medications and implementing these orders.

“If a patient needs something performed diagnostically immediately, they usually have to be transported to the emergency room or a facility with the necessary testing equipment,” Dr. Tollman says.

3. Patient populations mainly include rehab and terminally ill patients.

Patients are typically sent to a PAC facility either to recover from an illness or injury or because they are chronically ill and have exhausted treatment options. Regarding the latter, “They are mostly there for palliation; we don’t perform daily tests or prescribe aggressive medications on these patients,” Dr. Nazir says.

Dr. Cummings explains that PAC clinicians go through “the dying process with the patient.”

“They may or may not have assistance from hospice organizations,” she says, “and when they don’t, [hospitalists] take on the role of palliative-care providers.”

Dr. Cummings has seen an increase in psychiatric patients entering PAC facilities.

“Many patients with chronic psychological problems are aging, and there are fewer inpatient psychiatric beds available to those with concurrent medical and psychiatric problems,” she says. Much of this work is now being done in PAC settings.

4. You can build a relationship with your patient.

Because the pace of a PAC facility is slower and a patient typically stays in a PAC facility longer than at a hospital, there’s time for a hospitalist to have more in-depth conversations with patients and their families.

“Building a deeper relationship with a patient may give the hospitalist an opportunity to discover the cause of an acute problem,” Dr. Nazir says. “They can go in-depth into the psychosocial aspect of medicine and may be able to find out what led to the initial problem and the real root cause, which can help prevent future recurrences, such as repeat falls or forgetting to take a medication.”
 

5. Using EHRs can improve transitions.

Care transitions between a hospital and PAC facility can be compromised by a lack of information sharing, and they can affect the quality and safety of patient care, says Dori Cross, a doctoral candidate in health services organization and policy at the University of Michigan School of Public Health in Ann Arbor. Handoffs between providers require information continuity – information that is complete, timely, and in a usable format – to ensure appropriate medical decisions and to provide high-quality care during and after transition.

Electronic health records (EHRs) as well as health information exchanges (HIEs) allow providers to communicate and share patient information. For example, hospitals can send information electronically to PAC facilities (“push” exchange) or make information available online securely for PAC providers to log in and access (“pull” exchange). According to a 2014 survey data by the American Hospital Association, more than 50% of hospitals report sending structured summary-of-care records electronically to long-term care settings; a little less than half of those hospitals (23% of the total sample of hospitals) were also receiving information electronically from long-term care sites.¹

“This bidirectional exchange, in particular, can make it easier to share information across provider organizations electronically and, in turn, improve care delivery,” says Ms. Cross, who authored an accepted paper on the subject in the Journal of Post-Acute and Long-Term Medicine.

6. Hospitalists can work with providers in PAC settings to improve transitions.

Despite improvements in the electronic transfer of medical information, gaps still exist and can cause problems. One chasm when discharging patients to a PAC facility, is when a hospital IT system is incapable of communicating with the PAC facility system. In this instance, Dr. Nazir says, the hospitalist “can help bridge the gap.”

“[We] can verbally relay relevant information to physicians at PAC facilities so they understand the patient’s status, needs, and expectations,” he says. “Furthermore, hospitalists and a PAC facility’s administration can brainstorm methods to improve the systems of care so the patient receives more effective and timely care.”
 

7. Hospitalists switching to the PAC setting should have formal training.

The two main obstacles for hospitalists who change from working in a hospital to a PAC facility are the lack of exposure to PAC work in training and the assumption that it requires the same skills sets of a typical hospitalist, according to Manoj K. Mathew, MD, SFHM, national medical director of Los Angeles–based Agilon Health. The PAC setting has quite a number of differences compared with a hospital setting. For example, some regulations apply specifically to PAC facilities. In addition to formal training, hospitalists can benefit from using SHM’s Post-Acute Care Transitions Toolkit, having a mentor, or using resources from other organizations that function in this space such as The Society for Post-Acute and Long-Term Care Medicine, Dr. Nazir says.

Dr. Manoj K. Mathew

8. A variety of payors and payment models are in play.

Commercial insurers continue to be major payors for PAC, especially for individuals younger than 65 years. Medicare and Medicaid, administered by the Centers for Medicare & Medicaid Services, are the primary payors for patients aged 65 years and older.

Reference

Cross DA, Adler-Milstein J. Investing in post-acute care transitions: electronic information exchange between hospitals and long-term care facilities [published online ahead of print Sept. 14, 2016]. JAMDA. doi: http://dx.doi.org/10.1016/j.jamda.2016.07.024.