LTC Bulletin Board—June 2011
FDA News
FDA Approves New Fecal Incontinence Treatment
On May 27, 2011, the FDA approved Solesta (dextranomer in stabilized hyaluronic acid), a sterile, injectable gel to treat fecal incontinence in patients ≥18 years of age who have received no relief from other therapies. Approximately 40% to 50% of nursing home residents have fecal incontinence, which has numerous etiologies and can be difficult to treat. “This approval provides a minimally invasive treatment option for patients with fecal incontinence that does not respond to conservative therapies,” said Christy Foreman, director, Office of Device Evaluation, Center for Devices and Radiological Health, in an FDA statement. Solesta gel is a bulking agent that is injected into the layer of tissue beneath the anal mucosa, helping to build tissue in that area. By growing the surrounding tissue, the opening of the anus narrows, potentially allowing for better muscle control, the statement noted. The FDA’s approval of Solesta was based on the results of a clinical trial that randomized 206 patients to receive Solesta (n = 136) or sham treatment (n = 70). Of those receiving Solesta, 52% (n = 71) had a ≥50% reduction in the number of incontinence episodes, compared with 31% of patients (n = 22) who received the sham treatment. The investigators reported 128 treatment-related adverse events with Solesta, of which two were serious, including one rectal abscess and one prostatic abscess. The most commonly observed adverse events included pain at the injection sites and bleeding. Inflammation and infection of anal tissue were also observed, but these occurred less commonly. “[Solesta] is a significant new treatment option for the many underserved patients who fail conservative therapy and face a life of potential social humiliation and the possibility of severe invasive treatment such as surgery,” said David S. Tierney, president and chief operating officer, Oceana Therapeutics Inc, one of Solesta’s developers, in a press release. To ensure patients have access to the treatment as soon as possible, the company is pushing hard for a third quarter launch in the United States, Tierney noted.
FDA News
FDA Approves New Treatment for HIV-1 Infection
On May 20, 2011, the FDA approved Edurant (rilpivirine) in combination with other antiretroviral drugs for the treatment of HIV-1 infection in treatment-naïve adults (ie, individuals whose HIV infection has never been treated). Edurant belongs to a class of HIV drugs called non-nucleoside reverse transcriptase inhibitors (NNRTI), which block HIV viral replication. “Patients may respond differently to various HIV drugs or experience varied side effects. FDA’s approval of Edurant provides an additional treatment option for patients who are starting HIV therapy,” said Edward Cox, MD, MPH, director, Office of Antimicrobial Products, Center for Drug Evaluation and Research, in an FDA statement. 
Edurant is approved to be used as part of a highly active antiretroviral therapy (HAART) regimen that is designed to suppress the amount of viral load in the blood. Its safety and efficacy was established in two 48-week phase 3 clinical trials that included almost 1400 adults with HIV infection, and in a 96-week (with extension to 192 weeks) trial that included 368 adults. Patients enrolled in these trials had not received prior HIV therapy and were selected to receive treatment with Edurant or efavirenz, another FDA-approved NNRTI. Both Edurant and efavirenz were given in combination with other antiretroviral drugs. Edurant was as effective as efavirenz in lowering viral load. In the Edurant and efavirenz groups, 83% and 80% of subjects, respectively, had undetectable amounts of HIV in their blood after 48 weeks of treatment. Patients receiving Edurant who had a higher viral load at the start of therapy were more likely not to respond to the drug than individuals with a lower viral load at the start of therapy. In addition, persons who failed therapy with Edurant developed more drug resistance than patients who failed efavirenz. The most commonly reported side effects in patients taking Edurant included depression, insomnia, headache, and rash. Fewer patients on Edurant stopped taking the drug due to side effects as compared with patients taking efavirenz.
FDA News
FDA Approves New Treatment for Clostridium difficile-Associated Diarrhea
On May 27, 2011, the FDA approved Dificid (fidaxomicin) tablets, a macrolide antibiotic, for the treatment of Clostridium difficile-associated diarrhea (CDAD), which is one of the most common causes of diarrhea among nursing home residents. “In recent years, many in the infectious disease community have seen an increase in the number of cases of people with a C. difficile infection,” said Edward Cox, MD, MPH, director, Office of Antimicrobial Products, Center for Drug Evaluation and Research, in an FDA statement, which noted that other individuals can contract the infection by touching surfaces that have been contaminated by the bacteria and then touching their mouths. Because C. difficile infections often spread rapidly and their complications can result in significant morbidity and mortality, prevention and timely treatment are imperative. The FDA’s approval of Dificid was based on the safety and efficacy observed with the drug in two trials that cumulatively included 564 patients with CDAD and randomized them to receive Dificid or vancomycin, an antibiotic commonly used to treat C. difficile infections. Although the clinical response was similar between the Dificid and vancomycin groups, fewer patients receiving Dificid experienced a recurrence 3 weeks after completing treatment. At 25-day follow-up, sustained clinical response was observed in 70% and 72% of patients receiving Dificid in the first and second trials, respectively, compared with 57% of those receiving vancomycin in both trials. The most common side effects reported with Dificid included nausea, vomiting, headache, abdominal pain, and diarrhea. “Dificid is an effective new treatment option for patients who develop Clostridium difficile-associated diarrhea,” said Cox. However, to maintain effectiveness of the drug and prevent the development of drug-resistant bacteria, the FDA statement warned that the drug should be used only to treat infections that are proven or strongly suspected to be caused by C. difficile.
FDA News
FDA Approves Two New Treatments for Hepatitis C
In May 2011, the FDA approved two new treatments for adults with chronic hepatitis C infection: Victrelis (boceprevir) to treat patients who have some liver function and have not been previously treated with drug therapy or have failed such treatment, and Incivek (telaprevir) to treat individuals who have not received interferon-based drug therapy for their infection or have not responded adequately to prior therapies. Hepatitis C places patients at risk of requiring liver transplantation and developing cirrhosis, and hepatocellular carcinoma, increasing the risk of mortality. The current standard of care for patients with chronic hepatitis C infection is peginterferon alfa and ribavirin taken for 48 weeks, but <50% of patients respond to this therapy. On May 13, the FDA approved the first drug, Victrelis, for use in combination with peginterferon alfa and ribavirin. The safety and efficacy of Victrelis was established in two phase 3 clinical trials that included 1500 adults. In these trials, patients were randomized to receive Victrelis plus standard care or standard care alone. Of the patients receiving Victrelis, two-thirds experienced a significantly increased sustained virologic response, with no trace of the virus detected in blood tests performed at 24 weeks after stopping treatment. The most commonly reported side effects in patients receiving Victrelis in combination with pegylated interferon and ribavirin included fatigue, anemia, nausea, headache, and taste distortion. On May 23, the FDA approved the second drug, Incivek, also for use in combination with peginterferon alfa and ribavirin. The safety and efficacy of Incivek was evaluated in three phase 3 clinical trials that included approximately 2250 adult patients who were previously untreated or had received prior drug therapy. In all three studies, patients were randomized to receive Incivek plus standard care or standard care alone. Of previously untreated patients, 79% of those receiving Incivek experienced a sustained virologic response, with no sign of hepatitis C infection in blood tests performed 24 weeks after stopping treatment. Across all studies and patient groups, sustained virologic response was found to be 20% to 45% higher when Incivek was added to peginterferon alfa and ribavirin. In addition, similar to Victrelis, Incivek shortened treatment duration from 48 weeks to 24 weeks in most patients. Of the previously untreated patients receiving Incivek, 60% achieved an early response by 24 weeks, with 90% of these individuals demonstrating a sustained virologic response. The most commonly reported side effects in patients receiving Incivek in combination with peginterferon alfa and ribavirin included rash, anemia, nausea, fatigue, headache, diarrhea, pruritus, and anal or rectal irritation and pain. The FDA statement noted that rash can be serious enough to require stopping Incivek or the entire treatment regimen in some patients. “With the approval of Incivek, there are now two important new treatment options for hepatitis C that offer a greater chance at a cure for some patients with this serious condition,” said Edward Cox, MD, MPH, director, Office of Antimicrobial Products, Center for Drug Evaluation and Research, in an FDA statement. “The availability of new therapies that significantly increase responses while potentially decreasing the overall duration of treatment is a major step forward in the battle against chronic hepatitis C infection.” {C}
Medical News
Study Sheds Light on Vitamin D’s Ability to Regenerate Muscle
A recent Dutch study presented during ENDO 2011—the Annual Meeting of the Endocrine Society—found that activated vitamin D stimulates expression of the androgen receptor in skeletal muscle cells. The researchers also found that nandrolone, the active metabolite of the anabolic steroid nandrolon decanoate, stimulates expression of the vitamin D receptor in skeletal muscle cells and that the combination of nandrolone and hydroxylated vitamin D (NDD) has a synergistic effect on the in-vitro proliferation of human skeletal muscle cells. “We found that both compounds stimulate expression of their own and each other’s receptors in human skeletal muscle. This has never been published before and could help unravel the mechanism of action of muscle regeneration,” said Lenus Kloosterboer, PhD, one of the study’s lead researchers in a press statement. What makes this study unique is that both young and aged human skeletal muscle cells were used; however, the receptor expression was greater in the aged muscle cells. The statement noted that it is likely that the number of both the androgen receptors and vitamin D receptors on human skeletal muscle decline as people age, which may slow down muscle regeneration. “It is really promising that we were able to demonstrate that the proliferation of satellite cells, also known as new skeletal muscle cells, can be triggered by the active metabolites of NDD,” said Kloosterboer. Muscle mass plays a key role in recovery from illness or trauma and in preventing falls and fractures. Hospitalized elderly patients can lose up to 10% of lean leg muscle mass in only 3 days, and there remains a substantial unmet medical need to support the recovery of these patients. “The results of this study may help us understand the underlying mechanisms of human muscle regeneration and bring us closer to offering a clinical solution,” concluded Kloosterboer. 
July poll question: Should more alternative therapies (eg, acupuncture, massage) be made available to long-term care residents to complement traditional treatments? Vote online at https://www.annalsoflongtermcare.com/content/should-alternative-therapies-eg-acupuncture-massage-be-made-available-ltc-residents-complime
Did You Know…
Injuries Among Nurses
• The Bureau of Labor Statistics reports that nursing home staff are twice as likely as other workers to be injured on the job and that many of these injuries are serious. • Nursing ranks among the top 10 most hazardous occupations for injuries to the muscles and joints. • Nursing is ranked second after industrial work for physical workload intensity. • Of nurses who leave the profession, 12% leave due to back pain. • Over 52% of nurses have reported chronic back pain that has last more than 14 days over a 6-month period. • The cumulative weight lifted by a health caregiver in a typical 8-hour day is 1.8 tons. • In 2010, over 71,000 nurses suffered a back injury—but these are only the injuries that can be directly traced to work. • Although 48% of nurses have chronic back pain only 35% report the injury. • Nurses take approximately 30% more days off due to back pain than all other causes compared with 8% for the general population. • Nursing assistants have a rate of musculoskeletal injuries (injuries to the muscles and bones) that is seven times higher than for workers in other fields. Source: American Association for Long Term Care Nursing. For more information, visit https://ltcnursing.org/online-nursing-assistant-educators/protect-your-back.
Product Spotlight
3M Launches 3M™ Kind Removal Silicone Tape
Skin injury is a serious problem in healthcare settings, affecting at least 1.5 million US patients annually and costing facilities $20 to $50 per incident. To minimize the risk of skin injury, 3M Skin and Wound Care has recently introduced 3M Kind Removal Silicone Tape, which features a new, silicone-based, adhesive technology that provides good adhesion but is easy to remove or reposition. “This new tape represents the convergence of 3M’s 50 years of medical adhesive tape know-how, along with the ingenious use of our diverse advanced technology platform; it is virtually unmatched in the industry,” said Simon Fung, PhD, 3M senior product development specialist and inventor of 3M Kind Removal Silicone Tape, in a 3M press statement. “Medical tape touches almost every patient every day. We are confident that the clean, kind removal of this new tape will further our ultimate goal of improving the lives of patients worldwide.” 
The unique properties of the tape’s silicone adhesive work with skin in a different way than acrylate adhesives, which are used in most traditional medical tapes. This allows 3M Kind Removal Silicone Tape to be fastened securely, yet still be removed with minimal disruption of fragile skin layers or hair pulling. The skin-friendly characteristics of 3M Kind Removal Silicone Tape may be particularly important for patients with sensitive, compromised or at-risk skin, or those who may require repeat taping to anchor dressings or secure lightweight tubing. For more information on 3M Kind Removal Silicone Tape, visit www.3M.com/SiliconeTape.
Product Spotlight
MediHoney: Healing Diabetic Foot Ulcers With Honey
Approximately 3 million people with diabetes develop a foot ulcer annually. More than half of these ulcers will become infected, resulting in hospitalization, and 1 in 5 patients will require an amputation. A medical dressing incorporating honey may offer another way to treat diabetic foot ulcers in these patients, potentially preventing hospitalization and amputation. MediHoney dressings by Derma Sciences have been shown to heal and manage chronic and acute wounds, providing durable antimicrobial, anti-inflammatory, and immune system support. These dressings use active Leptospermum honey, which is derived from the pollen and nectar of Leptospermum plants in New Zealand and Australia and has been shown in randomized controlled studies to help heal wounds that have stalled under first-line treatment. Several mechanisms have been found to contribute to MediHoney’s efficacy: its ability to clean and debride wounds through its high osmolarity; its ability to lower overall wound pH; its promotion of a moisture-balanced environment; and its nontoxic profile, enabling extended wear times. The newest product in Derma Sciences’ line of honey dressings is MediHoney Gel, which is blended with natural-based gelling agents. The product is dispensed from a tube directly onto the wound site and maintains its physical integrity even in the presence of wound fluid and body heat. For more information on MediHoney dressings, visit www.medihoney.com.
