New Study Reveals Promise Of Linezolid For Diabetic Infections
In the wake of increasing threats of resistant bacteria strains such as MRSA, new data presented at the 40th Annual Meeting of the Infectious Diseases Society of America provides some hope. Researchers revealed that linezolid may have promise in treating diabetic foot infections caused by bacteria such as Staphylococcus aureus. According to the results of the study, which involved over 350 patients at U.S. and European sites, 81.3 percent of the linezolid patients were “clinically cured,” compared to 71.3 percent of patients who received a standard aminopenicillin combination. Benjamin A. Lipsky, MD, a principal investigator for the study, says it indicates linezolid is effective in treating these infections and is at least as effective as the most commonly used antibiotics, ampicillin/sulbactam (IV) and amoxicillin/clavulanate (oral). He says he is encouraged by these findings. “(The findings) suggest that linezolid (Zyvox, Pharmacia) may be an important addition to currently available treatments for diabetic foot infections, particularly those caused by the MRSA that are becoming increasingly common,” explains Dr. Lipsky, a Professor of Medicine at the University of Washington School of Medicine. An Oral And Outpatient Alternative? Adam Landsman, DPM, PhD, also believes that linezolid has potential in the treatment of these patients. “In particular, diabetic foot ulcer patients with infected ulcers will benefit from the availability of an IV strength medication given on an oral and outpatient basis,” says Dr. Landsman, a member of the adjunct faculty at the Northwestern University School of Medicine. “The best way to prevent serious infections with organisms like MRSA is to avoid potential exposure to nosocomial infections.” Dr. Lipsky says the study also showed oral therapy with both linezolid and the aminopenicillins/beta-lactamase inhibitors was as effective as intravenous and that outpatient therapy was as effective as inpatient. When patients have a suspected or proven infection with resistant gram-positive organisms, especially methicillin-resistant Staph aureus, linezolid would be an appropriate choice, according to Dr. Lipsky, the Director of the General Internal Medicine Clinic of the VA Puget Sound Health Care System in Seattle. According to Pharmacia, Zyvox is indicated for complicated skin and skin structure infections caused by Staphylococcus aureus (both methicillin-resistant and -susceptible strains), Streptococcus pyogenes and Streptococcus agalactiae. Dr. Landsman uses linezolid for patients whom he is on the fence about in regard to admission vs. outpatient treatment. When a patient presents with a red, swollen foot but does not clearly need surgical debridement, Dr. Landsman says he will attempt three to four days of treatment on an outpatient basis with linezolid. “If they respond, I keep them out of the hospital and continue with oral treatment,” notes Dr. Landsman. “If they don’t, then I admit them for surgical debridement. Our success rate using this approach has been outstanding.” There are some caveats to keep in mind. According to the study, more Zyvox-treated patients had drug-related adverse events, although researchers noted that these were mostly hematologic and gastrointestinal in nature, were mild to moderate in intensity and reversible. Addressing The Resistance Issue Dr. Lipsky also notes that while “linezolid appears to be relatively resistant to the development of resistance,” there have been a couple of cases. He says these patients are typically those who have underlying immune deficiencies, co-morbidities (e.g., renal failure), foreign bodies in place (e.g., indwelling catheters or prostheses) or those who have received prolonged therapy. Overall, the rise of resistant bacteria strains continues to be a major problem, according to Drs. Lipsky and Landsman. The Centers for Disease Control and Prevention (CDC) recently announced the discovery of a second case of VRSA and Dr. Lipsky calls MRSA “an increasing problem all over the world.” Dr. Lipsky notes that, in many locations, 30 to 50 percent of S. aureus isolates are now methicillin-resistant. In his hospital, the number is 50 percent and 50 to 60 percent are also resistant to erythromycin and clindamycin. Further, Dr. Lipsky adds that some data suggest infections with MRSA are associated with higher rates of amputation than those caused by other organisms. “Only vigorous efforts at controlling inappropriate antibiotic use and promoting infection control (like the CDC’s 12-step program unveiled earlier this year) can slow down the inexorable tide of antibiotic resistance,” maintains Dr. Lipsky. Study Emphasizes Value Of Exercise For Elderly The benefits of low-impact physical activity among elderly patients are highlighted in a new study that was recently published in The New England Journal Of Medicine. Researchers found that a physical therapy combination of daily balance exercises and three days a week of muscle training with elastic resistance bands resulted in a “45 percent reduction in disability” for frail elderly patients living at home. Researchers noted that implementing physical therapy programs of this kind could reduce the costs of health care and nursing homes for the elderly. The study also found reductions in nursing home use among the physical therapy participants and fewer fall-related injuries. Joseph C. D’Amico, DPM, who specializes in elderly care, agrees with the study’s recognition of cost reduction. He believes “more nursing homes are realizing that an active ‘pre’ as well as rehabilitation program not only makes good health sense but good business sense.” He adds that a “good percentage of the healthcare providers serving the elderly are already incorporating these concepts into their management protocols.” Tamara Fishman, DPM, raises the question of who will pay for elderly prehabilitation programs. She notes many nursing homes are understaffed and cost remains a high concern at the home care level. Drs. Fishman and D’Amico agree that physical activity in the elderly improves strength, reduces functional decline and minimizes falls. Dr. D’Amico encourages his elderly patients to begin home prehabilitation programs but emphasizes patient understanding of the program objectives. He outlines a proper exercise program with a presentation of its purpose and anticipated outcome for his elderly patients. Dr. D’Amico begins his patients with lower extremity motion exercises and progresses to balance and conditioning training. He incorporates posterior tibial and quadriceps strengthening followed by ankle weights. Additional studies have shown “that weight training improves strength and conditioning in the elderly,” offers Dr. D’Amico. Dr. D’Amico also points to a recent study conducted at a senior community center of over 200 adults 70 years and older where the practice of Tai Chi was incorporated. Dr. D’Amico notes Tai Chi “improves balance, flexibility, coordination, strength and lessens the likelihood of multiple falls.” In contrast to Dr. D’Amico’s patients whom he says are “eager” to begin a physical therapy program, in Dr. Fishman’s experience, her elderly patients are “not receptive” to therapy. She believes her elderly patients would benefit if someone came to the home everyday to assist them in the exercises but, again, cost is a concern. Dr. Fishman warns of the “many hurdles the elderly must overcome, especially if they are alone, where decline is much faster and more severe.” She suggests a group setting such as a neighborhood senior center or adult day care center where patients would be more inclined toward group activity. Overall, Dr. D’Amico says the study is an “important step in recognizing the benefits, possibilities and importance of fitness training in the elderly.” – Gina DiGironimo Production Editor Gifts From Drug Makers To Get Federal Scrutiny The federal government will give increased scrutiny to the thorny issue of pharmaceutical companies providing gifts or gratuities to doctors. In July, the Executive Committee of the Pharmaceutical Research and Manufacturers of America (PhRMA), which represents research-based pharmaceutical and biotechnology companies, adopted a new marketing code to govern the pharmaceutical industry’s relationships with physicians and other healthcare professionals. Although adherence to the code is voluntary, the Department of Health and Human Services is urging pharmaceutical companies to abide by it. The Office of the Inspector General (OIG) of Health and Human Services called the code “a good starting point for compliance,” according to a recent draft of a compliance plan guidance posted in the Federal Register. “The OIG recommends pharmaceutical manufacturers, at a minimum, comply with the standards set by the PhRMA Code,” according to a statement in the draft. “Arrangements that fail to meet the minimum standards set out in the code are likely to receive increased scrutiny from government authorities.” The PhRMA Code on Interactions with Healthcare Professionals permits industry representatives and others to offer informational presentations and discussions that provide valuable scientific and educational benefits. Reasonable meals are permissible when in connection with presentations but spouses and guests are not permitted to attend, and offering recreational and entertainment events is forbidden, according to the code. “The new (PhRMA) code makes it crystal clear that the interactions of company sales representatives with healthcare professionals are to benefit patients and enhance the practice of medicine,” says PhRMA President Alan F. Holmer. “It explicitly spells out that all interactions should be focused on informing healthcare professionals about products, providing scientific and educational information, and supporting medical research and education.” The code says token consulting or advisory arrangements should not be used to justify compensating healthcare professionals for their time or their travel, lodging and other out-of-pocket expenses. In addition, the code specifies items primarily for the benefit of patients may be offered to healthcare professionals if they are worth $100 or less. Drawing The Line On Ethics John McCord, DPM, is vocal on the subject of doctors accepting gifts from drug companies. “In my opinion, there is no way by any stretch of the imagination that a physician can consider accepting gifts from a medical equipment or pharmaceutical company ethical,” says Dr. McCord. “To the big companies, it’s just marketing. Unfortunately, nobody expects big corporations to be ethical, but the public does expect physicians and hospitals to be objective and be above letting gifts of any size sway their decision making on patient care matters.” Michael Hriljac, DPM, JD, says he doesn’t think it’s out of line for a pharmaceutical company to provide something like an informational seminar with a reasonably priced dinner. He acknowledges it is excessive to follow a 10-minute presentation with dinner at a five-star restaurant or for pharmaceutical companies to offer free golf, hotel, sports or theater tickets. Dr. Hriljac says he tries to push doctors to comply with federal programs regarding ethics. “It really comes down to the value,” explains Dr. Hriljac. “It’s a difficult area. It’s abused a lot and I’m not sure if it really induces the doctor to write a prescription based on a meal or nominal gift.” Dr. McCord also acknowledges accepting gifts from a drug company is a “fuzzy and gray” area. He does not disapprove of a doctor accepting trinkets like pens and notepads from companies but believes offices should set policies regarding gifts. Dr. McCord cites more egregious examples of a drug company giving a doctor a VCR on which to play a company video and another company paying for a doctor’s trip to Europe to learn to use a new ultrasound machine. Other Key Points To Keep In Mind The PhRMA code also emphasizes that companies should not provide grants, subsidies, consulting contracts or educational or practice-related items to a healthcare professional in exchange for prescribing products or for a commitment to continue prescribing products. “Nothing should be offered or provided in a manner or on conditions that would interfere with the independence of a healthcare professional’s prescribing practices,” the code states. The OIG warns that some arrangements made by drug companies to encourage referrals may implicate an anti-kickback statute. According to the OIG, these include entertainment, travel, meals or other benefits in association with information or marketing presentations. Also questionable are financing related to third-party educational conferences and meetings, grants for research and education and gifts and other business courtesies. The American Medical Association has had ethical guidelines since 1990 and is currently reviewing the draft compliance program guidelines for pharmaceutical manufacturers, according to its Web site. — B.M. Avandamet Garners FDA Approval If your patients suffer from type 2 diabetes, there is renewed hope to help them manage and control this disease. The U.S. Food and Drug Administration recently approved a new drug that combines two diabetes medications in one pill called Avandamet. Manufactured by GlaxoSmithKline, Avandamet contains rosiglitazone maleate and metformin HCI for type 2 diabetes patients when metformin alone does not control their blood sugar levels. The drug is also indicated for type 2 diabetes patients currently being treated with rosiglitazone and metformin in separate tablets. According to the manufacturer, Avandamet’s combination can significantly reduce A1C levels. The American Diabetes Association recommends that patients’ A1C levels should not exceed 7.0 percent in order to help reduce the frequency of diabetes complications. Hossein Gharib, MD, President of the American Association of Clinical Endocrinologists, comments that “more than 50 percent of people diagnosed with type 2 diabetes do not meet target A1C levels. … With every one percent above target A1C levels, a person’s risk for diabetes complications … increases.” Early management of diabetes and blood sugar levels are essential, according to Barry Goldstein, MD, PhD, the Director of the Division of Endocrinology, Diabetes and Metabolic Diseases at Jefferson Medical College of Thomas Jefferson University in Philadelphia. Dr. Goldstein believes there is a “movement underway to prescribe combinations of drugs to patients with type 2 diabetes earlier in the course of their treatment.” He emphasizes employing these combinations early will help patients manage their blood glucose levels better and the convenience of having the two medications in one pill will facilitate improved patient compliance. Dr. Goldstein hopes that “Medicare/Medicaid realize the potential benefits of compliance and lower overall cost with this drug combination, making it available and covered for patients where it seems to be an appropriate therapy.” — G.D.