Diabetes Guidelines Don’t Include Specific Pharmacotherapy Advise
By Annette M. Boyle
WASHINGTON —The VA and DoD Evidence-Based Practice Work Group has recently released five updated clinical practice guidelines.
They cover common conditions such as Type 2 diabetes, which affects 25% of veterans, and lower back pain as well as post-traumatic stress disorder and lower limb amputation, which occur more frequently among individuals who have served in the military. In addition, the updates address the current state of research and understanding of the risks of opioid therapy for chronic pain.
The diabetes update differs from previous guidelines because it does not make explicit recommendations for pharmacotherapy.
“Because it is such a rapidly changing field, in a year or two the recommendations could be out of date,” explained James L. Sall, PhD, clinical program specialist, Evidence-Based Practice Program in the VA’s Office of Quality, Safety and Value. Instead, the guidelines encourage clinicians to “refer to the criteria for use published by the VA Pharmacy Benefits Management program and the Department of Defense Pharmacy and Therapeutics Committee.”
While recognizing that new medications and studies will be released during the lifetime of the guideline, the authors did make a few overarching recommendations for pharmacotherapy. They advised starting patients on insulin and non-pharmacological therapy if they have marked symptoms, ketosis, Type 1 diabetes or severe hyperglycemia. Metformin is recommended as a first-line agent in other circumstances unless there are contraindications. The guidelines also note that adding a second agent from another class is typically better than substituting a new agent as dual therapy reduces hyperglycemia through different mechanisms, although clinicians should be careful to combine drugs that have been tested and shown to work well together.
The update also makes strong new recommendations regarding the general approach to Type 2 diabetes care. “The diabetes update emphasized shared decision-making with patients. Research shows that when you involve the patient, while goals may not seem as aggressive, you have more success because the patient feels they have a bigger stake in the goals and in the long haul you have better management of the disease,” Sall told U.S. Medicine. The guideline also advises clinicians to offer patients ongoing self-management education “via various modalities tailored to their preferences, learning needs and abilities.”
Low Back Pain
The impact of the update on care and treatment of veterans and servicemembers could be substantial. The guideline notes that about a third of veterans reported significant back pain in the prior three months in a VA survey. It also reports that lower back pain prompted more than six million outpatient visits and 25,000 hospitalizations of active duty forces between 2010 and 2014.
The updated low back pain clinical practice guideline focuses on axial, nonradiating pain. Like the diabetes guideline, it strongly recommends patient education on self-care, the need to remain active and the expected course of their condition. Discussions should be culturally appropriate, empathetic and non-judgmental and tailored to the patient’s level of education and cognizant of any disabilities.
The updated low back pain guideline expanded the recommendations for nonpharmacologic/noninvasive therapy and pharmacological therapy, compared to the 2007 guideline. Strongly recommended therapies included cognitive behavioral therapy for chronic pain and nonsteroidal anti-inflammatory drugs (NSAIDs) for acute or chronic pain. The guidelines also urge against use of benzodiazepines, systemic corticosteroids (oral or intramuscular) and long-term opioids or acetaminophen for chronic pain. Spinal epidural steroid injections are not recommended for reduction of radicular low back pain, nonradicular low back pain or spinal stenosis.
The update suggests that some therapies might be useful for chronic low back pain, including mindfulness-based stress reduction, clinician-directed exercises, acupuncture, exercise programs such as yoga, Pilates and tai chi and duloxetine. Insufficient evidence was found to support any recommendations regarding dietary supplements, topical preparations or short-term acetaminophen or opioid therapy, although the authors emphasized that the risk of opioid therapy must be considered in all patients.
The update to the clinical practice guideline for opioid therapy for chronic pain reflects the “growing recognition of an epidemic of opioid misuse and opioid use disorder in Americans, including among America’s Veterans” as well as the “mounting body of research detailing the lack of benefit and severe harms” of long-term opioid therapy. The guideline emphasizes the “biopsychosocial model of pain [which] recognizes pain as a complex multidimensional experience that requires multimodal and integrated care approaches.”
This fundamental shift in the approach to pain and use of opioids led to a thorough rewrite of the 2010 guideline. Most notably, where the 2010 guideline prioritized pain treatment, the 2017 update emphasizes safety in light of the hazards of opioid use. Consequently, the update strongly recommends against the initiation of long-term opioid therapy for chronic pain and strongly advocates using alternatives such as self-management strategies, nonpharmacological treatments and nonopioid medications when pharmacological therapies are prescribed for chronic pain.
The guideline specifically discourages use of opioids in specific patient groups. For patients under the age of 30, the guidelines strongly recommend against long-term use of opioid therapy “secondary to higher risk of opioid use disorder and overdose.” It also strongly urges clinicians not to prescribe opioids to patients with untreated substance use disorder or concurrently with benzodiazepines. If a patient has been taking long-term opioid therapy, is under age 30, has a substance use disorder or is taking benzodiazepines and is also currently prescribed opioids, the update recommends close monitoring, risk mitigation strategies and consideration of tapering.
If a clinician decides to prescribe opioids, the update urges a short duration of the lowest dose, noting that “there is no absolutely safe dose of opioids.” The authors strongly recommend against the use of long-acting opioids. Doses over 90 mg morphine equivalent daily are not advised, and patients on high doses should be evaluated for tapering or discontinuation. Clinicians should implement risk mitigation strategies and conduct a suicide risk assessment for all patients on initiation or continuation of long-term opioid therapy. The risks and benefits of continued opioid use should be evaluated every three months.
The guideline strongly recommends “alternatives to opioids for mild-to-moderate acute pain” and the use of multimodal pain care, when opioids are used. Take-home opioids should be limited to immediate-release formulations prescribed at the lowest effective dose with a reassessment within three to five days.
Post-Traumatic Stress Disorder
Improved recognition of the complex nature of acute stress reaction, acute stress disorder and post-traumatic stress disorder (PTSD) “has led to the adoption of new or refined strategies to manage and treat patients with these conditions” notes the 2017 update to the post-traumatic stress disorder guideline.
In addition, changes in the diagnostic criteria for PTSD between the fourth and fifth edition of the Diagnostic and Statistical Manual (DSM) raised questions the authors of the update sought to address, particularly as patients will now be diagnosed based on DSM-5 criteria, but all the clinical trials used to prepare the evidence-based guideline relied on DSM-4 criteria. By some estimates, the authors wrote, up to 50% of individuals would be diagnosed with PTSD under one set of criteria, but not the other.
Generally, patients diagnosed with PTSD using the DSM-4 criteria who continue to exhibit symptoms of PTSD but do meet the criteria for PTSD under the DSM-5 criteria could safely be treated using the updated guidelines. Patients who did not meet DSM-4 criteria but do meet DSM-5 criteria for PTSD may rely on the guideline as the “best available projection of effective treatments for DSM-5 PTSD.” Clinicians may choose to reevaluate patients who have some symptoms of PTSD but do not meet the criteria for the disorder using DSM-5 criteria, those with subthreshold PTSD, under the DSM-4 criteria to assist in making a decision about the applicability of evidence-based treatment developed for patients meeting that definition of the disorder.
The Work Group strongly recommended the use of “individual trauma-focused psychotherapy that includes a primary component of exposure and/or cognitive restructuring” in patients with acute stress disorder to prevent the development of PTSD. For patients with PTSD, the update strongly preferred this kind of trauma-focused psychotherapy over pharmacologic or other non-pharmacologic treatments. If individual trauma-focused psychotherapy is not available, either pharmacological or non-trauma focused psychotherapy should be utilized, with no recommendation of one over the other.
Among the pharmacological therapies, the update advocates using sertraline, paroxetine, fluoxetine or venlafaxine if a patient is unable to access or does not want trauma-focused psychotherapy. In contrast, the guidelines strongly urges clinicians to not use divalproex, tiagabine, guanfacine, risperidone, benzodiazepines, ketamine, hydrocortisone, D-cycloserine and cannabis or its derivatives as monotherapy for PTSD based on their known risks, side effects and lack of evidence showing their effectiveness. A wide range of other therapies were found to lack sufficient evidence to recommend for or against them and a large number were weakly recommended or discouraged. Clinicians should consult the guideline for specifics.
The Work Group found no therapies with adequate evidence to recommend augmentation therapy. They strongly recommended against atypical antipsychotics, benzodiazepines and divalproex as augmentation for other therapies and discouraged use of D-cycloserine, topiramate, baclofen, prazosin and pregabalin on this basis. The guideline authors strongly encouraged identification and treatment of co-occurring disorders, particularly substance use disorders, sleep disorders and insomnia.
Lower Limb amputation
Since the last guideline was issued on lower limb amputation, “improved recognition of the complex nature of this condition has led to the adoption of new strategies for rehabilitation.” Still, the update had only four strong recommendations. They encouraged providers to “consider the patient’s birth sex and self-identified gender identity in developing individualized treatment plans” throughout all amputation processes.
In addition, they advised training interventions in the perioperative period that use “open and closed chain exercises and progressive resistance to improve gait, mobility, strength, cardiovascular fitness and activities of daily living performance.” During the prosthetic training period, clinicians should use valid and responsive functional outcome measures. The Work Group also strongly recommended evaluating patients for factors that could lead to worse outcomes including smoking, comorbidities, psychosocial function and pain, and implementing interventions when appropriate.
With pharmacists from across the DoD and VA clamoring for spots in the Clinical Pharmacy Course at Army Medical Department Center and School (AMEDDCS) in Fort Sam Houston, TX, organizers offered back-to-back programs this spring, with another scheduled for August.
Most people looking at a hospital room will see an environment specifically designed to keep human beings alive through even the most traumatic circumstances.