VA/DoD CLINICAL PRACTICE GUIDELINE FOR OPIOID THERAPY FOR CHRONIC PAIN

VA/DoD Clinical Practice Guideline for Opioid Therapy for Chronic Pain
above. Evidence on the safety of tapentadol was reviewed for this guideline update. In long-term studies,
there is low quality evidence that, when compared to placebo, patients experience more adverse events
when taking tapentadol. Some severe adverse events experienced by a small portion of patients receiving
tapentadol included chest pain,[150,151] coronary artery disease,[151] and severe upper abdominal pain
possibly related to the study drug.[150] There was one death due to myocardial ischemia but this was not
likely related to tapentadol. In one study comparing tapentadol versus placebo, minor adverse events
observed in patients treated with tapentadol included nausea and vomiting in 21.1% and 12.7% of
patients, respectively.[151] In short-term studies, there is overall low to very low quality evidence that,
when compared to placebo, patients receiving tapentadol experience more adverse events (e.g., vomiting,
tiredness, dry mouth, dizziness, sweating, constipation, nausea) and drop out of treatment more often
than the placebo groups.[146,152-154]
Buprenorphine for Pain
There is insufficient evidence to recommend buprenorphine over other opioids for the treatment of
chronic pain. Transdermal buprenorphine was found to be efficacious and well-tolerated for the shortterm
treatment of chronic, moderate-to-severe low back pain.[155] In patients with chronic, moderate-tosevere
osteoarthritis (OA) pain of the hip and/or knee, short-term use of seven-day low-dose
buprenorphine patches were an effective and well-tolerated analgesic.[156] Furthermore, during a 28-day
assessment period, seven-day low-dose transdermal buprenorphine patches were as effective as
sublingual (SL) buprenorphine, with a better tolerability profile.[157] In terms of dosing, transdermal
buprenorphine provides effective analgesia with an acceptable tolerability profile when initiated at 10
micrograms (mcg)/hour (hr) and titrated upward to a maximum of 40 mcg/hr.[158] One study suggested
efficacy for two-thirds of elderly OA patients (whose pain responds to opioids) at a seven-day low-dose
buprenorphine patch at 5-20 mcg/hr when surgery was not possible and when NSAIDs were not
recommended. Focus on and management of side effects is necessary.[159]
Buprenorphine has several properties that make it a potentially desirable as an analgesic. It is a synthetic
opioid analgesic with partial mu opioid agonist and kappa opioid antagonist properties.[157] It has high
affinity to the opiate receptor and a long duration of action (24-72 hr). Buprenorphine is a partial agonist
agent and as such may be associated with less euphoria and easier withdrawal. Buprenorphine should not
be added to patients that are on a full mu agonist as it will precipitate withdrawal. In addition, caution
should be exercised when adding full mu agonists to patients on buprenorphine as the efficacy and side
effect profiles may vary.
Pregnancy and liver disease require consideration of monotherapy (buprenorphine without naloxone).
Other considerations for buprenorphine may be found in the VA/DoD SUD CPG. 10 Consideration should be
given to specialty consultation when patients on buprenorphine have acute or post-operative pain
10 See the VA/DoD Clinical Practice Guideline for the Management of Substance Use Disorders. Available at:
http://www.healthquality.va.gov/guidelines/mh/sud/index.asp
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