First Consensus Guidelines for Diabetes-Related Pain

Newswise — Mayo Clinic Proceedings has published Consensus Guidelines for the treatment of diabetic peripheral neuropathic pain (DPNP) authored by the American Society of Pain Educators (ASPE), which for the first time provide healthcare professionals with a definitive, consistent treatment strategy for the management of pain associated with diabetes. The ASPE Consensus Guidelines for DPNP were developed to help improve treatment outcomes and minimize medical errors for the estimated 1 million people living with diabetes mellitus who suffer from chronic and debilitating DPNP.

According to ASPE Executive Director, B. Eliot Cole, M.D., M.P.A., "Until now, diabetic peripheral neuropathic pain has been an under-diagnosed and under-treated condition despite the growing public health issue with obesity and diabetes mellitus." Cole explained that the primary benefits to patients from the ASPE Consensus Guidelines include less or resolved pain and less likelihood of side effects from treatment. Physicians following the ASPE Consensus Guidelines for DPNP, with recently approved pharmacotherapies as recommended first-line treatment, may enable their patients to live a fuller, more independent life.

The Consensus Guidelines for DPNP, developed under an educational grant from Eli Lilly and Company, were jointly sponsored by the Johns Hopkins University School of Medicine and the American Society of Pain Educators. They were published as a continuing medical education (CME) supplement in the April 2006 issue of the Mayo Clinic Proceedings, a peer-reviewed medical journal of the Mayo Clinic College of Medicine (April 2006;81(4, suppl:S12-S25) http://www.mayoclinicproceedings.com).

Methodology & RecommendationsThe ASPE Consensus Guidelines were developed in 2005 over the course of a 2-day meeting of leading pain management specialists. Clinical trial outcomes were examined, strengths and weaknesses of trials assessed and the group's own experience with these various medications in real-world patient treatment situations was considered. This led to a ranking of the medications into first-tier and second-tier based upon demonstrated efficacy in randomized clinical trials. Those few medications with strong support for relieving DPNP were deemed first-tier, while those with strong support for the relief of other types of nerve damage pain, but not specifically DPNP, were deemed second-tier. First-tier agents include duloxetine, oxycodone controlled-release, pregabalin and all tricyclic antidepressants.

"The ASPE Consensus Guidelines for the treatment of diabetic peripheral neuropathic pain offer a positive alternative to the way patients are currently treated," said Cole. "In the absence of guidelines, physicians have relied on a combination of antidepressants, anticonvulsants and various analgesics based on their experience and comfort level. Now they have a clear consensus on how to help alleviate the pain of patients with DPNP."

Comorbid Conditions of DPN & DPNPAbout half of all people with diabetes mellitus have some form of neuropathy (nerve damage). The most common type is diabetic peripheral neuropathy (DPN), affecting the arms and legs. Symptoms may include numbness, tingling, muscle weakness and pain. DPN and DPNP are closely associated with a number of comorbid conditions, including diabetic retinopathy, depression and sleep disturbances, progressive muscle weakness and foot ulceration. DPN is the leading cause of foot ulcers, which, in turn, are a major cause of amputation in the United States. Other comorbidities in association with DPNP include those commonly associated with chronic pain, such as sleep disruption, depression and interference with activities of daily living.

"Pain is not a punishment for failing to comply with medications or diet regimens. Pain usually functions as an alarm, warning of injury or toxic effects, but in some cases " including DPNP " the alarm has broken and continues to go off when no injury is imminent," said Cole. He added: "When treating DPNP, it is critical that patients and caregivers become partners with their healthcare professionals to better manage their disease and more fully understand treatment options and outcomes."

High Cost of Treating DPNPThere are two key costs associated with treating DPNP:"¢ The actual average annual cost of pain medication per patient with DPNP is approximately $1,000. Patients who take two or more medications (as most do) have average annual medication costs of almost $1,600. "¢ People with painful neuropathies have annual healthcare costs almost three times higher than people without this condition.

About Diabetes MellitusDiabetes mellitus is a metabolic disorder caused by a deficiency of insulin and characterized by varying or persistent hyperglycemia (high blood sugar levels), especially after eating. It is the sixth leading cause of death and, after hypertension, the second largest silent killer of people in the United States, responsible for more than 73,000 deaths in 2002. The number of people with diabetes mellitus more than doubled between 1980 and 2004, from 5.8 million to 14.7 million. Prevalence of type 2 diabetes mellitus is expected to continue to increase as the U.S. population ages and a larger proportion of the population remains overweight.

Traditionally, diabetes mellitus has been a disease of people over 40 years, but current clinic-based reports and regional studies suggest it is becoming more common among children and adolescents, with an estimated 176,500 young people under 20 years of age diagnosed in 2005. "What few people understand is that diabetes plays out over 20 to 25 years. So while most people think diabetes is 'just an inconvenience,' in fact, it slowly destroys the body along with quality of life," said Cole.

The American Society of Pain Educators (www.paineducators.org) was founded in 2004 as the only organization to train healthcare professionals to serve as specialized resources for healthcare professionals, patients and caregivers as well as to educate their peers, patients, families and caregivers on ways to improve clinical outcomes and relieve pain by the safest means possible. Part of its mission is to identify pain-producing diseases and disorders for which there are no treatment guidelines and to develop needed diagnostic and treatment guidelines that improve treatment outcome and minimize medical errors for people with pain.