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Tuesday, May 1, 2018

Community Health posts surprise profit as costs fall

Hospital operator Community Health Systems Inc reported a surprise first-quarter profit on Tuesday, helped by lower operating costs.
The company’s shares rose about 7 pct to $4.25 in after-market trading. Total operating costs fell 21 percent to $3.48 billion.
Community Health decided to sell six of its hospitals in the quarter and said it is continuing with its divestiture plans to pay off long-term debt, which stood at $13.86 billion.
The company’s net loss attributable to shareholders narrowed to $25 million, or 22 cents per share, in the quarter ended March 31, from $199 million, or $1.79 per share, a year earlier.
Excluding items, the hospital operator earned 13 cents per share, compared with analysts’ expectations of a loss of 22 cents per share, according to Thomson Reuters I/B/E/S.
On a same-store basis, hospital admissions in the quarter decreased 2.4 percent from a year earlier.
Net operating revenue fell to $3.69 billion from $4.49 billion.
Larger rival HCA Healthcare reported a better-than-expected quarterly profit and revenue on Tuesday due to an increase in admission of patients needing advanced care to its hospital.

HCA Healthcare quarterly profit rises 73.6%

HCA Healthcare Inc, the largest U.S. publicly traded hospital company, reported a 76.3 pct rise in quarterly profit on Tuesday, helped in part by gains from the sale of its Oklahoma facilities.
Net income attributable to HCA was $1.14 billion, or $3.18 per share, in the first quarter ended March 31, compared with $659 million, or $1.74 per share, a year earlier.
The company’s revenue rose 7.5 percent to $11.42 billion.

Intermittent fasting may have ‘profound health benefits’

Intermittent fasting has been gaining popularity among people looking to shed extra kilograms and maintain a healthy weight. Researchers argue that this type of diet may also slow down aging and disease.
colorful measuring tapes
Intermittent fasting can help with weight management, but might it also bring other health benefits?
In intermittent fasting, what essentially takes place in the body is that one source of energy — which can facilitate the accumulation of body fat — is switched for another.
Our bodies run on glucose, or simple sugar, but when we fast for a longer period of time, that energy source becomes unavailable.
Our system needs to identify a different kind of “fuel.” That is when the body begins to convert certain types of body fat into fatty acids, which are easily absorbed by the blood.
Fatty acids, in turn, produce molecules called ketones, which the body uses as its new source of energy.
Stephen Anton, a researcher at the University of Florida College of Medicine in Gainesville, calls this process “flipping the metabolic switch.”
“This switch,” explains Anton, “can happen after a certain period of time fasting. It’s a gradation in which your metabolism over time shifts to use higher and higher amounts of ketones for energy.”
He and his team were interested to learn more about how this switch occurs, and whether it could bring other health benefits, alongside weight management.
For this purpose, they reviewed numerous recent studies focused on the mechanisms and benefits of intermittent fasting.
The team’s review, published in the journal Obesity, suggests that intermittent fasting may be more healthful than other dieting strategies, as ketones put less stress on cells than the byproducts of other dieting styles.

Significant weight loss regardless of style

Anton and his colleagues explain that the switch usually begins to take place after 8–12 hours of fasting, though in the case of individuals who practice intermittent fasting, the fasting strategies vary.
The researchers focused on the two most common types of intermittent fasting diets, the first of which is based on time restrictions for eating.
In it, the dieter may fast for a number of hours per day — for instance, 16 hours — while allowing themselves to eat anything they’d like over the remaining hours.
For the second type of intermittent fasting, dieters may choose to alternate days of total fasting, with days when no food is off limits.
Or they may simply alternate days of frugal eating — when individuals limit themselves to foods that equal only about 500 calories in all — with days of unrestricted eating, or “feasting days.” “Of course,” Anton notes, “we recommend healthy food [during the feasting times].”
The team’s review of existing studies revealed that, all in all, any type of intermittent fasting diets are associated with significant weight loss.
In all 10 clinical trials assessing the effects of alternate-day fasting, the results conclusively pointed to this strategy’s effectiveness when it came to shedding extra kilos. And, 3 out of the 4 studies focused on the restricted timing type of intermittent fasting had similar results.
“So in my mind, it’s not a question of whether it works for producing fat loss,” says Anton. What’s more interesting and more important is what kind of tissue is lost through intermittent fasting.

Additional potential health benefits

Most of the studies reviewed by Anton and team revealed that, while participants did lose body fat, no significant amount of lean tissue — which includes organ tissue, muscular tissue, and bone tissue — was lost.
This is important, since lean tissue allows our bodies to keep on functioning well, and other types of dieting strategies, Anton notes, lead to significant loss of both fat and lean tissue, which may affect health in the long run.
Studies into the effect of the switch from glucose-driven energy to ketone-driven energy in rodents and other animals suggests that intermittent fasting could also have other health benefits, the scientists say.
The researchers say that it could help to prolong the lifespan, improve the functioning of metabolic processes, protect cognitive function, enhance physical performance, reduce harmful instances of inflammation, and shield against cardiovascular diseases.
An important takeaway is that we all have the ability to switch our metabolism from glucose to ketone utilization. And that switch has the potential to have profound health benefits for us, in addition to the positive changes in body composition.”
Stephen Anton
Still, the authors warn against starting intermittent fasting without first asking for a doctor’s advice. This dieting style may not be equally beneficial for everyone, and in some cases it could do more harm than good, he cautions.

Gilead reaffirms 2018 sales outlook $20B-$21B, consensus $21.29B

Reaffirms 2018 Product Gross Margin outlook 85%-87%. The company still sees the diluted EPS impact of acquisition-related, up-front collaboration, stock-based compensation and other expenses at $1.41 – $1.51 .

Aetna upped to buy by Cantor

from neutral.

https://bit.ly/2HGIT5d

Neurologic Effects of ‘Revolutionary’ Cancer Drugs May Be Severe, Fatal

Checkpoint inhibitors, a novel class of agents promising in the treatment of a wide range of cancers, have been tied to serious neurologic, immune-related adverse events, new research shows.
Checkpoint inhibitors are used to treat melanoma, non-small cell lung cancer, kidney cancer, bladder cancer, and head and neck cancers, among others. Their neurotoxic effects can be severe, even fatal, warranting increased vigilance and rapid treatment when they are administered, researchers caution.
“I’m a neuromuscular specialist but I have a niche in cancer and chemotherapy. Over the last year and a half I’ve had eight cases with really rapidly progressive neurotoxicity,” study investigator Kelsey Juster-Switlyk, MD, assistant professor in the Division of Neuromuscular Medicine, Department of Neurology, University of Utah Medical Center in Salt Lake City, told Medscape Medical News.
“The neurologic immune-related adverse events are a lot more severe, refractory, and prolonged compared to the non-neurologic,” she added during a poster presentation here at the American Academy of Neurology (AAN) 2018 Annual Meeting.

20% Mortality Rate

One patient treated with the checkpoint inhibitor pembrolizumab (Keytruda, Merck) developed autoimmune myositis and myasthenia gravis. Electromyography and muscle biopsy confirmed the diagnoses. In this case, the patient died despite treatment with high-dose corticosteroids, Juster-Switlyk noted.
“The key case I wrote up, the fatal case of myositis, was tragic,” she said.
Juster-Switlyk noted that the literature does not offer any consensus on how to reverse these adverse events.
“There are no prospective studies on how to treat these cases. There are only case reports. I have a patient right now. She’s 25 and she has lymphoma. She’s been on nivolumab [Opdivo, Bristol-Myers Squibb] for about a year, and it’s the only thing that has kept her cancer at bay. I think it’s causing a really aggressive, immune-related neuropathy, a Guillain-Barré–like neuropathy. It’s really hard to tell her, ‘Maybe we need to stop this for good.'”
With little more than case reports to go by, Juster-Switlyk and colleague Nicholas Johnson, MD, performed a systematic review of the literature. They identified 65 studies with 73 patients reported in PubMed through May 2017.
They found a wide range of neurologic immune-related adverse events associated ipilimumab (Yervoy, Bristol-Myers Squibb), nivolumab, or pembrolizumab. The most common of these adverse effects were neuropathy in 29% of patients, myositis in 25%, and myasthenia gravis in 19%.
Despite use of immunotherapy in 95% of patients, only 32% of patients made a full recovery and approximately 1 in 5 patients died.
“Interestingly, there has been more interest at the AAN and several courses I’ve been to recently on checkpoint inhibitors, but still not a ton of answers,” Juster-Switlyk said.
“My big question, which this [report] does not answer, is can you ever re-expose patients to checkpoint inhibitors?”
In addition, she said, there is a need for prospective studies to understand whether concurrent intravenous immunoglobulin (IVIG) added to corticosteroids improves treatment of these adverse effects and/or whether IVIG and rituximab work better than prednisone alone.
Juster-Switlyk also wants to increase awareness of the adverse effects of these agents so oncologists know how to recognize these neurotoxicities.
“They have patients who have a lot of muscle pain, maybe a CK [creatine kinase] elevation or muscle cramping, and they don’t always think it’s immune-mediated.”

Revolutionizing Cancer Treatment

Commenting on the study for Medscape Medical News, Avi Fellner, MD, professor in the Department of Neurology at Rabin Medical Center in Petah Tikva, Israel, noted that the field of immunotherapy in cancer is rapidly evolving and immune checkpoint inhibitors have “revolutionized” cancer treatment in recent years.
Nevertheless, he said, the growing use of these agents is associated with an increasing number of reports on neurologic immune-related adverse effects, the diagnosis of which may at times can be “very challenging.”
“This study emphasizes the need to keep in mind the possibility of immune checkpoint inhibitors–related neurological adverse effects and the importance of early recognition and aggressive treatment in these cases,” said Fellner, lead author of a similar study that reported nine cases of neurologic complications associated with use of checkpoint inhibitors.
His report includes patients who developed meningoencephalitis, limbic encephalitis, polyradiculitis, cranial polyneuropathy, and myasthenic syndrome (J Neurooncol2018;137:601-609).
Fellner and colleagues also pointed to the heterogeneity and seriousness of the presentations, two of which proved fatal.
Other specialties outside of neurology are also reporting conditions associated with use of checkpoint inhibitors, including new-onset connective tissue diseases and inflammatory arthritis. The American Society of Oncology and the National Comprehensive Cancer Network, recognizing the adverse events associated with these agents, released joint guidelines for treating checkpoint inhibitor toxicities in February 2018.
Juster-Switlyk and Fellner have disclosed no relevant financial relationships.
American Academy of Neurology (AAN) 2018 Annual Meeting. Abstract P4.161. Presented April 25, 2018.

Melatonin for Migraine Headache Prophylaxis

Question

Is melatonin effective for reducing the frequency of migraine headaches?
Response from Philip J. Gregory, PharmD
Drug Information Consultant
Interest in using melatonin for headache disorders has been developing for decades. Over the years, several clues have emerged to suggest that melatonin plays a role in a variety of headache disorders, including migraine, cluster, and tension. One of these clues is that melatonin levels are altered in patients suffering from some types of headaches. In patients with migraine headaches, for instance, some research shows that melatonin levels are lower on days when migraines occur compared with the days when they do not. Patients with chronic migraine also appear to have lower melatonin levels than those with episodic migraine.[1] Nighttime melatonin levels are also lower in patients with migraine compared with those without.[1,2]
Imaging studies provide additional evidence for melatonin’s role in migraine prevention. During migraine attacks, the hypothalamus is activated. Given the presence of melatonin receptors within the suprachiasmatic nucleus of the hypothalamus, it is conceivable that melatonin’s binding and action in the hypothalamus could play a role in these headaches.[1]
The role of melatonin in migraine headaches could also be related to its impact on sleep. Melatonin levels are increased at night, inducing the onset of sleep. Lack of sleep can be a migraine trigger, while adequate sleep can reduce migraine attacks.[1]
Melatonin might also affect headaches through direct effects on pain and inflammation.[1] Animal studies show that melatonin can reduce pain perception in models of inflammation and neuropathic pain, possibly by binding receptors in the spinal cord or through a variety of other pathways.[3]
Clinical research evaluating melatonin in patients with migraine headaches has focused on migraine prophylaxis. Most studies have found beneficial effects from melatonin on headache frequency; however, some of these studies also have serious methodologic limitations. Several uncontrolled studies found that taking melatonin over a period of 2-6 months significantly reduced migraine headache frequency in both adults and children. In these studies, about 62%-78% of patients had a greater than 50% reduction in migraine frequency at the end of the trial compared with at the beginning.[4,5,6,7,8]
Three placebo-controlled clinical trials assessing the use of melatonin for migraine prevention have been published.
Alstadhaug and colleagues[9] compared extended-release melatonin 2 mg 1 hour before bed versus placebo in a crossover trial with 46 adults who experienced two to seven migraine headaches per month. After a 4-week run-in phase, participants were randomly assigned to receive melatonin or placebo for 8 weeks. Treatments were switched following a 6-week washout period. No significant difference was detected between melatonin and placebo for migraine headache frequency.
Ebrahimi-Monfared and colleagues[10] compared melatonin with sodium valproate and placebo in a randomized, double-blind, placebo-controlled trial. In this study, 105 adults with chronic migraine were allocated to receive melatonin 3 mg 30 minutes before bed, sodium valproate 200 mg daily, or placebo for 2 months. All patients also received nortriptyline 25 mg and propranolol 20 mg daily. Melatonin and sodium valproate reduced migraine headache frequency and duration to a similar degree, and each significantly more than placebo (< .001). Melatonin reduced migraine attack frequency by about 40% and migraine duration by about 56% compared with baseline.
Gonçalves and colleagues[11] conducted the most rigorous trial to date. In this randomized, double-blind, placebo-controlled trial, 196 adults with migraine headaches occurring two to eight times per month were allocated to receive melatonin 3 mg, amitriptyline 25 mg, or placebo at bedtime for 12 weeks. Melatonin reduced the number of migraine headache days by 2.7 compared with 2.2 with amitriptyline (= .19) and 1.1 with placebo (= .009). In terms of responder rate, melatonin was significantly more effective than amitriptyline. In the melatonin group, 54.4% of patients had a > 50% reduction in migraine frequency compared with 39.1% in the amitriptyline group (< .05). Both melatonin and amitriptyline also significantly reduced migraine headache intensity and duration compared with placebo (
In all clinical trials, melatonin was well tolerated, with sleepiness being the most commonly reported side effect. Less common side effects included fatigue, dizziness, constipation, stomach upset, and dry mouth. In the placebo-controlled trials, side effects were comparable to those of placebo and less common compared with either amitriptyline or sodium valproate.[9,10,11]
Overall, the evidence supporting melatonin for migraine prevention is promising but still preliminary. Nonetheless, given the favorable tolerability and low risk for side effects, melatonin is an option that may be worth considering for reducing migraine frequency, severity, and duration in patients with frequent migraine headaches.