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News Article | April 24, 2017
Site: www.eurekalert.org

CHICAGO - Patients undergoing spinal fusion surgery who are treated with methadone during the procedure require significantly less intravenous and oral opioids to manage postoperative pain, reports a new study published in the May issue of Anesthesiology, the peer-reviewed medical journal of the American Society of Anesthesiologists (ASA). "This is a new application for an old pain medication that offers hope for reducing the development of acute pain in the first few days after surgery, as well as chronic postoperative pain and the need for opioid medications following discharge from the hospital," said Glenn S. Murphy, M.D., lead study author and physician anesthesiologist at NorthShore University Health System in Evanston, Illinois. "There is currently an opioid crisis in the United States, and intraoperative methadone offers promise as a drug that can reduce the need for these pain medications during recovery." Methadone is a unique long-acting opioid that is typically used to relieve severe pain in people who are in need of medication around the clock for extended periods of time, and in those who cannot be treated with other medications. It is also used to prevent withdrawal symptoms in patients addicted to opiate drugs, specifically heroin. "Appropriate pain control is essential for enhancing recovery," said Dr. Murphy. "Inadequate postoperative pain relief is associated with the development of a variety of adverse events, including cardiac and pulmonary complications, chronic postsurgical pain, decreased patient satisfaction, and increased morbidity and mortality." Severe pain in the early postoperative period remains a common, yet underestimated and undertreated problem. Despite advances in pain management strategies, patients undergoing surgery often experience severe pain during the first three postoperative days. Acute pain after spinal fusion surgery, which includes herniated disc repair, treatment for narrowing of the spinal canal, etc., may be particularly difficult to manage. Patients undergoing complex spinal surgery often have chronic nerve pain and are dependent on oral opioid medication, which puts them at risk of addiction and other complications. The study included 115 patients who were randomly assigned to receive either methadone or placed in a control group to receive hydromorphone, a standard opioid administered during operations, at the start of surgery or during surgical closure, respectively. Hydromorphone, which is also commonly used as a pain medication after surgery, was also given to the patients studied following surgery to treat pain. To evaluate how effective methadone was in reducing post-surgical pain, researchers measured how much hydromorphone patients took during the first three days after surgery. They also measured patients' pain scores and satisfaction with pain management during that period. In the methadone group, patients required a median of 5 mg of hydromorphone to treat acute pain on the first day after surgery, compared to 10 mg in the control group. On the second day, patients in the methadone group required less than 1 mg of hydromorphone, compared to 3 mg in the control group. On the third day, patients in the methadone group didn't require hydromorphone, compared to less than 1 mg in the control group. Overall, patients given methadone required significantly less intravenous and oral opioid medication after surgery, reported lower pain scores, and had improved global satisfaction with pain management, compared to patients who were given hydromorphone during surgery. No differences in opioid-related or other adverse events in either group were found, the authors note. Founded in 1905, the American Society of Anesthesiologists (ASA) is an educational, research and scientific society with more than 52,000 members organized to raise and maintain the standards of the medical practice of anesthesiology. ASA is committed to ensuring that physician anesthesiologists evaluate and supervise the medical care of patients before, during, and after surgery to provide the highest quality and safest care that every patient deserves. For more information on the field of anesthesiology, visit the American Society of Anesthesiologists online at asahq.org. To learn more about the role physician anesthesiologists play in ensuring patient safety, visit asahq.org/WhenSecondsCount.


News Article | November 17, 2016
Site: globenewswire.com

MIAMI, Nov. 17, 2016 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (Nasdaq:OPK), announced that data on RAYALDEE (calcifediol) extended-release capsules as a treatment for secondary hyperparathyroidism (SHPT) in stage 3 and 4 chronic kidney disease patients with vitamin D insufficiency will be presented later today in a poster presentation at the American Society of Nephrology Kidney Week Meeting, underway in Chicago, IL.  The data showed that RAYALDEE has similar effectiveness and safety in controlling SHPT in both African-American (AA) and non-African-American (nAA) patients with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency (defined as serum total 25-hydroxyvitamin D levels less than 30 ng/mL).  Serum total 25-hyrdroxyvitamin D levels showed a similar increase in both patient populations beyond the target of 30 ng/mL, a level considered sufficient for CKD patients in published clinical practice guidelines, despite the well established tendency for lower levels in AA patients. Plasma intact parathyroid hormone (iPTH) levels were effectively suppressed by RAYALDEE in AA patients and nAA patients versus placebo treatment. OPKO’s poster presentation entitled “Extended-release Calcifediol is Effective in African-American and Non-African-American Patients with Stage 3-4 CKD, Secondary Hyperparathyroidism and Vitamin D Insufficiency,” will be presented by senior author Stuart M. Sprague, DO, Chief, Division of Nephrology and Hypertension, NorthShore University Health System - University of Chicago, Pritzker School of Medicine. RAYALDEE (calcifediol) extended-release capsules is approved by the U.S. Food and Drug Administration (FDA) for the treatment of SHPT in adult patients with stage 3 or 4 CKD and serum total 25-hydroxyvitamin D levels less than 30 ng/mL.  RAYALDEE is not indicated for the treatment of secondary hyperparathyroidism in patients with stage 5 chronic kidney disease or end-stage renal disease on dialysis.  RAYALDEE has a patented formulation and is designed to raise serum total 25-hydroxyvitamin D (prohormone) concentrations to targeted levels (at least 30 ng/mL) and to reduce elevated iPTH.  OPKO expects to launch RAYALDEE in the U.S. through its dedicated renal sales force in November 2016. The full prescribing information for RAYALDEE is available at www.rayaldee.com. Potential side effects of RAYALDEE include hypercalcemia (elevated serum calcium), which can also lead to digitalis toxicity, and adynamic bone disease with subsequent increased risk of fractures if intact PTH levels are suppressed by RAYALDEE to abnormally low levels.  Severe hypercalcemia may require emergency attention; symptoms of hypercalcemia may include feeling tired, difficulty thinking clearly, loss of appetite, nausea, vomiting, constipation, increased thirst, increased urination, and weight loss.  Digitalis toxicity can be potentiated by hypercalcemia of any cause.  Excessive administration of RAYALDEE can cause hypercalciuria, hypercalcemia, hyperphosphatemia, or oversuppression of iPTH.  Common symptoms of vitamin D overdosage may include constipation, decreased appetite, dehydration, fatigue, irritability, muscle weakness, or vomiting.  Patients concomitantly taking cytochrome P450 inhibitors, thiazides, cholestyramine, phenobarbital or other anticonvulsants may require dose adjustments and more frequent monitoring. The most common adverse reactions in clinical trials (≥3% and more frequent than placebo) were anemia, nasopharyngitis, increased blood creatinine, dyspnea, cough, congestive heart failure and constipation. CKD is a condition characterized by a progressive decline in kidney function.  The kidney is normally responsible for excreting waste and excess water from the body, and for regulating various hormones.  CKD is classified in five stages — mild (stage 1) to severe (stage 5) disease — as measured by the kidney's glomerular filtration rate.  According to the National Kidney Foundation, CKD afflicts over 26 million people in the U.S., including more than 20 million patients with moderate (stages 3 or 4) and severe (stage 5) forms of CKD.  In stage 5 CKD, kidney function is minimal to absent and patients require regular dialysis or a kidney transplant for survival. RAYALDEE is only indicated for treating SHPT in patients with stage 3 or stage 4 CKD. SHPT is a condition commonly associated with CKD in which the parathyroid glands secrete excessive amounts of iPTH.  SHPT arises as a result of vitamin D insufficiency or impaired kidney function that prevents sufficient production of vitamin D hormone to properly regulate calcium and phosphorus metabolism, and PTH secretion.  Prolonged elevation of blood PTH causes excessive calcium and phosphorus to be released from bone, leading to elevated serum calcium and phosphorus, softening of the bones (osteomalacia) and calcification of vascular and renal tissues.  SHPT affects 40-60% of patients with moderate CKD and approximately 90% of patients with severe CKD. Vitamin D insufficiency is a condition in which the body has low vitamin D stores, characterized by inadequate blood levels of vitamin D prohormone, known as 25-hydroxyvitamin D.  An estimated 70-90% of CKD patients have vitamin D insufficiency, which can lead to SHPT and resultant debilitating bone diseases.  Vitamin D insufficiency has been associated with increased mortality in CKD. OPKO Health is a diversified healthcare company that seeks to establish industry-leading positions in large, rapidly growing markets. Our diagnostics business includes Bio-Reference Laboratories, the nation's third-largest clinical laboratory with a core genetic testing business and a 420-person sales force to drive growth and leverage new products, including the 4Kscore® prostate cancer test and the Claros® 1 in-office immunoassay platform. Our pharmaceutical business features RAYALDEE, an FDA-approved treatment for SHPT in stage 3-4 CKD patients with vitamin D insufficiency, VARUBI™ for chemotherapy-induced nausea and vomiting (oral formulation launched by partner TESARO and IV formulation PDUFA date: January 2017), TT401, a once or twice weekly oxyntomodulin for type 2 diabetes and obesity which is a clinically advanced drug candidate among the new class of GLP-1 glucagon receptor dual agonists, and TT701, an androgen receptor modulator for androgen deficiency indications.  Our biologics business includes hGH-CTP, a once-weekly human growth hormone injection (in phase 3 and partnered with Pfizer), a long-acting Factor VIIa drug for hemophilia (in phase 2a) and a long-acting oxyntomodulin for diabetes and obesity (in phase 1). We also have production and distribution assets worldwide, multiple strategic investments and an active business development strategy. More information is available at www.opko.com. This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), regarding product development efforts and other non-historical facts about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects, including statements regarding our ability to successfully launch and commercialize RAYALDEE, expectations about RAYALDEE, that RAYALDEE will effectively control secondary hyperparathyroidism in patients with stage 3 or 4 chronic kidney disease, whether RAYALDEE will be safe and effective in controlling SHPT in both African-American and non-African American patients, market potential for RAYALDEE, and the timing for launch of RAYALDEE. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in our filings with the Securities and Exchange Commission, as well as risks inherent in funding, developing and obtaining regulatory approvals of new, commercially-viable and competitive products and treatments, including the risks that others may develop products which are superior to RAYALDEE, and that RAYALDEE may not have advantages or prove to be superior over presently marketed products, including the currently used high monthly doses of prescription vitamin D2, activated vitamin D hormone and over-the-counter vitamin D supplements. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.


News Article | April 28, 2016
Site: www.technologyreview.com

Customized, printed orthopedic implants could be the future. In the meantime, the new manufacturing method is helping companies cut costs. Orthopedic surgeons are relying more and more on 3-D printing to build replacements for their patients’ defective or worn out bones. This year surgeons around the world will implant tens of thousands of 3-D printed replacements parts for hips, knees, ankles, parts of the spine, and even sections of the skull. Most of them look a lot like their conventionally made titanium counterparts. But the first few 3-D printed implants tailored specifically to an individual’s anatomy may hint at a future in which customized bone replacements are commonplace. Printed parts represent only a small fraction of the overall market for orthopedic implants, but for two important reasons that share could grow quickly in the coming years. First, an aging population is getting more joint replacement operations. The number of annual hip replacements in the U.S. doubled between 2000 and 2010. Second, in recent years engineers have gotten much better at using additive manufacturing technology—as 3-D printing is also called—to make titanium implants. Leading orthopedic implant makers are investing substantially in the development of the technology; earlier this year Stryker announced plans to build a $400 million additive manufacturing facility. Companies hope to cut costs by simplifying the production process for these implants, which are often geometrically complicated assemblies of multiple metal pieces. Building them layer by layer allows companies to consolidate many pieces into one, and save material that would be wasted in traditional subtractive manufacturing processes like forging and casting (see “10 Breakthrough Technologies 2013: Additive Manufacturing”). But perhaps the biggest potential benefit is the ability to design implants that are specific to an individual patient’s body, by using data from magnetic resonance imaging or computerized tomography scans. That’s especially true for parts of the skeleton that have complicated geometries that can be very unique to an individual, like the pelvis, says Jason Koh, an orthopedic surgeon at NorthShore University Health System and director of the NorthShore Orthopaedic Institute. Koh says customized total joint replacements could also have substantial benefits for patients. In the U.S., a few printed, custom implants have already received clearance from the Food and Drug Administration, including a total knee replacement and a craniofacial plate. It’s still very early days for custom implants. Less than 1 percent of the implants made on the electron beam melting machines sold by market-leader Arcam are patient-specific, says the company’s CEO Magnus René. René estimates that at least half of today’s additively manufactured orthopedic implants are made using Arcam’s machines. But more custom implants are under development. One hurdle might be uncertainty over how the FDA will ultimately choose to approach this new class of implants, according to Greg Kowalczyk, president of a startup called Additive Orthopaedics, which is developing a custom product. So far the agency has cleared new printed implants that it determined pose no more risk than a product already on the market, but those devices have mostly been made out of materials and based on designs familiar to the FDA. The medical value of custom implants could be “tremendous,” says Koh. But he says the technology will likely face design hurdles as well, especially in cases where the implants need to bear substantial bodyweight, such as in a hip replacement. A challenge will be identifying the specific areas in which additive manufacturing is uniquely valuable to the overall health-care system, says Koh.


News Article | April 27, 2016
Site: www.technologyreview.com

Customized, printed orthopedic implants could be the future. In the meantime, the new manufacturing method is helping companies cut costs. Orthopedic surgeons are relying more and more on 3-D printing to build replacements for their patients’ defective or worn out bones. This year surgeons around the world will implant tens of thousands of 3-D printed replacements parts for hips, knees, ankles, parts of the spine, and even sections of the skull. Most of them look a lot like their conventionally made titanium counterparts. But the first few 3-D printed implants tailored specifically to an individual’s anatomy may hint at a future in which customized bone replacements are commonplace. Printed parts represent only a small fraction of the overall market for orthopedic implants, but for two important reasons that share could grow quickly in the coming years. First, an aging population is getting more joint replacement operations. The number of annual hip replacements in the U.S. doubled between 2000 and 2010. Second, in recent years engineers have gotten much better at using additive manufacturing technology—as 3-D printing is also called—to make titanium implants. Leading orthopedic implant makers are investing substantially in the development of the technology; earlier this year Stryker announced plans to build a $400 million additive manufacturing facility. Companies hope to cut costs by simplifying the production process for these implants, which are often geometrically complicated assemblies of multiple metal pieces. Building them layer by layer allows companies to consolidate many pieces into one, and save material that would be wasted in traditional subtractive manufacturing processes like forging and casting (see “10 Breakthrough Technologies 2013: Additive Manufacturing”). But perhaps the biggest potential benefit is the ability to design implants that are specific to an individual patient’s body, by using data from magnetic resonance imaging or computerized tomography scans. That’s especially true for parts of the skeleton that have complicated geometries that can be very unique to an individual, like the pelvis, says Jason Koh, an orthopedic surgeon at NorthShore University Health System and director of the NorthShore Orthopaedic Institute. Koh says customized total joint replacements could also have substantial benefits for patients. In the U.S., a few printed, custom implants have already received clearance from the Food and Drug Administration, including a total knee replacement and a craniofacial plate. It’s still very early days for custom implants. Less than 1 percent of the implants made on the electron beam melting machines sold by market-leader Arcam are patient-specific, says the company’s CEO Magnus René. René estimates that at least half of today’s additively manufactured orthopedic implants are made using Arcam’s machines. But more custom implants are under development. One hurdle might be uncertainty over how the FDA will ultimately choose to approach this new class of implants, according to Greg Kowalczyk, president of a startup called Additive Orthopaedics, which is developing a custom product. So far the agency has cleared new printed implants that it determined pose no more risk than a product already on the market, but those devices have mostly been made out of materials and based on designs familiar to the FDA. The medical value of custom implants could be “tremendous,” says Koh. But he says the technology will likely face design hurdles as well, especially in cases where the implants need to bear substantial bodyweight, such as in a hip replacement. A challenge will be identifying the specific areas in which additive manufacturing is uniquely valuable to the overall health-care system, says Koh.


Ciric I.S.,NorthShore University Health System
World Neurosurgery | Year: 2013

Background: This report was conceived as a contribution to the national debate regarding U.S. health care (HC) and as a means of explaining the challenges facing U.S. HC to the international readers of WORLD NEUROSURGERY. Methods: The basic economic concepts pertinent to health care, including fundamentals of economic theories, gross domestic product (GDP), U.S. revenues and expenditures and the U.S. federal deficit and national debt, are discussed at the outset of this study. This is followed by a review of the U.S. health insurance paradigms and a detailed analysis of the escalating cost of U.S. health care. Finally, the efforts designed to reverse the paradigm of escalating health care costs will be discussed. Results: This study reveals that should the U.S. HC cost continue to escalate at the same rate, HC would consume the entire gross domestic product by 2070. The root causes for this trend are overutilization of HC, inappropriate allocation of HC costs at the end of life, defensive medicine, high-end technology and prescription drugs, failure of competitive market forces, and administrative costs, inefficiency, and waste. The proposed means of reversing this paradigm, including the Patient Protection and Affordable Care Act, are discussed in light of their economic and social impact. Conclusions: The reversal of the current paradigm of escalating cost of U.S. HC will require extraordinary leadership across the entire spectrum of HC delivery. It is concluded that neither the Affordable Care Act nor the Path to Prosperity will succeed unless the escalating cost of U.S. HC is reversed. It is hoped that this report contributes to that end. © 2013 Elsevier Inc. All rights reserved.


Freedman N.,Northshore University Health System
F1000Prime Reports | Year: 2014

Obstructive sleep apnea (OSA) is common and is associated with a number of adverse outcomes, including an increased risk for cardiovascular disease. Typical treatment approaches, including positive airway pressure, oral appliances, various upper airway surgeries, and/or weight loss, can improve symptoms and reduce the severity of disease in select patient groups. However, these approaches have several potential limitations, including suboptimal adherence, lack of suitability for all patient groups, and/or absence of adequate outcomes data. Emerging potential therapeutic options, including nasal expiratory positive airway pressure (PAP), oral negative pressure, upper airway muscle stimulation, and bariatric surgery, as well as improvements in existing treatments and the utilization of improving technologies are moving the field forward and should offer effective therapies to a wider group of patients with OSA. © 2014 Faculty of 1000 Ltd.


Alshayeb H.M.,University of Chicago | Josephson M.A.,University of Chicago | Sprague S.M.,NorthShore University Health System
American Journal of Kidney Diseases | Year: 2013

Kidney transplantation, the most effective treatment for the metabolic abnormalities of chronic kidney disease (CKD), only partially corrects CKD-mineral and bone disorders. Posttransplantation bone disease, one of the major complications of kidney transplantation, is characterized by accelerated loss of bone mineral density and increased risk of fractures and osteonecrosis. The pathogenesis of posttransplantation bone disease is multifactorial and includes the persistent manifestations of pretransplantation CKD-mineral and bone disorder, peritransplantation changes in the fibroblast growth factor 23-parathyroid hormone-vitamin D axis, metabolic perturbations such as persistent hypophosphatemia and hypercalcemia, and the effects of immunosuppressive therapies. Posttransplantation fractures occur more commonly at peripheral than central sites. Although there is significant loss of bone density after transplantation, the evidence linking posttransplantation bone loss and subsequent fracture risk is circumstantial. Presently, there are no prospective clinical trials that define the optimal therapy for posttransplantation bone disease. Combined pharmacologic therapy that targets multiple components of the disordered pathways has been used. Although bisphosphonate or calcitriol therapy can preserve bone mineral density after transplantation, there is no evidence that these agents decrease fracture risk. Moreover, bisphosphonates pose potential risks for adynamic bone disease. © 2013 National Kidney Foundation, Inc.


Sprague S.M.,NorthShore University Health System | Sprague S.M.,University of Chicago
Clinical Journal of the American Society of Nephrology | Year: 2014

Calciphylaxis, also referred to as calcific uremic arteriolopathy, is a relatively rare but well described syndrome that occurs most commonly in patients with late stage CKD. It is characterized by very painful placques or subcutaneous nodules and violaceous, mottled skin lesions that may progress to nonhealing ulcers, tissue necrosis, and gangrene with a 1-year mortality rate >50%. The pathogenesis of calciphylaxis is poorly understood. Risk factors include female sex, obesity, hyperphosphatemia, hypercalcemia, hyperparathyroidism, longer dialysis vintage, hypercoagulable states, and use of calcium-containing phosphate binders and warfarin. Treatment strategies for calciphylaxis are limited by inadequate understanding of its pathophysiology. Therapy is generally focused on correcting disturbances of calcium, phosphorus, and parathyroid hormone metabolism. Additional therapy focuses on decreasing inflammation and on dissolution of tissue calcium deposits with sodium thiosulfate and/or bisphosphonates. Successful treatment generally results in improvement of pain and healing of the lesions within 2-4 weeks, but the disorder generally takes many months to completely resolve. © 2014 by the American Society of Nephrology.


Goldstein J.L.,NorthShore University Health System | Cryer B.,University of Texas Southwestern Medical Center
Drug, Healthcare and Patient Safety | Year: 2015

Nonsteroidal anti-inflammatory drugs (NSAIDs) are effective anti-inflammatory and analgesic agents and are among the most commonly used classes of medications worldwide. However, their use has been associated with potentially serious dose-dependent gastrointestinal (GI) complications such as upper GI bleeding. GI complications resulting from NSAID use are among the most common drug side effects in the United States, due to the widespread use of NSAIDs. The risk of upper GI complications can occur even with short-term NSAID use, and the rate of events is linear over time with continued use. Although gastroprotective therapies are available, they are underused, and patient and physician awareness and recognition of some of the factors influencing the development of NSAID-related upper GI complications are limited. Herein, we present a case report of a patient experiencing a gastric ulcer following NSAID use and examine some of the risk factors and potential strategies for prevention of upper GI mucosal injuries and associated bleeding following NSAID use. These risk factors include advanced age, previous history of GI injury, and concurrent use of medications such as anticoagulants, aspirin, corticosteroids, and selective serotonin reuptake inhibitors. Strategies for prevention of GI injuries include anti-secretory agents, gastroprotective agents, alternative NSAID formulations, and nonpharmacologic therapies. Greater awareness of the risk factors and potential therapies for GI complications resulting from NSAID use could help improve outcomes for patients requiring NSAID treatment. © 2015 Goldstein and Cryer.


Freedman N.,NorthShore University Health System
Chest | Year: 2015

The data support the use of an ambulatory management strategy in patients with a high clinical suspicion of moderate to severe OSA in the absence of comorbid medical conditions. Th is approach results in similar outcomes and reduced costs for testing and treatment compared with a management strategy primarily based on PSG. Th us, an out-of-center approach utilizing HST as the first line of testing should be considered for most patients with a high clinical suspicion of OSA as long as the managing clinicians are adequately trained in how to interpret and manage the data from these technologies. © 2015 AMERICAN COLLEGE OF CHEST PHYSICIANS.

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