Announcer:
Welcome to ReachMD.
This medical industry feature titled “Recognizing and Diagnosing Painful Diabetic Peripheral Neuropathy” is sponsored by Averitas Pharma.
You’ll be hearing from Dr. Miroslav Backonja, Clinical Professor at the University of Washington Medical Center, UW Medical Center for Pain Relief.
Here’s Dr. Backonja.
Dr. Backonja:
It's my pleasure to present to you an Overview of Painful Diabetic Peripheral Neuropathy. Diabetic peripheral neuropathy is one of the main complications of diabetes, which comes as a result of nerve damage caused by diabetes. It is the most disabling and one of the most costly complications of diabetes, affecting approximately 60-70% of patients, Usually risk increases with age and duration of diabetes. So those who experience diabetes for 25 years or more are most affected, with the price tag of cost annually at $10 billion.
Mechanisms that lead to development of Diabetic Peripheral Neuropathy are complex, and at the core of them are oxidative stress and inflammation - starting with hyperglycemia, dyslipidemia and insulin resistance, which contribute dysregulation of metabolic pathways and cause imbalance in the mitochondrial [state]. This then translates into excessive formation of reactive oxygen species, which then lead to loss of axonal energy stores and axonal injury, and ultimately manifesting as peripheral neuropathy. The earliest affected C fibers are those that communicate messages, information about pain.
Symptoms of diabetic neuropathy range in everything from neuronal loss, sensory loss to hypersensitivity and pain. And usually this symptom onset is gradual, starting distally & moving up proximally, leading to the development of what is known as stocking and glove distribution - initially could be with the pain, but frequently pain might be the presenting symptom. And these are known as the characteristics of a neuropathic pain of diabetes.
We can view symptoms of diabetic neuropathy in terms of negative sensory phenomena - which is loss of function in patient reported numbness, "dead feeling" and hypoalgesia and hypoaesthesia. On the other hand, they have a positive sensory phenomena - such as dull and burning pain, as well as electrical shocks, and allodynia and hyperalgesia.
Diabetic neuropathy occurs in approximately 30% of patients with diabetes, and half of those proceed to develop painful symptoms - which is painful diabetic neuropathy or neuropathic pain of diabetic neuropathy. The epidemiological estimates are that 5 million Americans experience those symptoms and it is projected that by 2030, the number will go up to 8.2 million.
Patients describe their symptoms in a variety of terms, everything from numbness and tingling all the way to sharp shooting pains, and on a histopathological analysis, it has been recognized that the reduction in the density of epidermal nerve fibers are associated with development of painful diabetic neuropathy symptoms.
When patients talk about their symptoms, as the intensity of their pain increases to moderate to severe, they experience a whole host of unpleasant experiences described in various terms.
All of these have a very negative impact on patients quality of life, as well as everyday activities in work, as well as on mood and sleep, resulting in need to treat the patients with specific interventions and medications to ameliorate those problems as well.
Announcer:
Select Safety Information
- Do not dispense QUTENZA to patients for self-administration or handling. Only physicians or healthcare professionals under the close supervision of a physician are to administer and handle QUTENZA.
- Unintended exposure to capsaicin can cause severe irritation of eyes, mucous membranes, respiratory tract, and skin in healthcare providers and others. When administering QUTENZA, it is important to follow the procedures in the Important Dosage and Administration Instructions in the USPI.
- In patients treated for neuropathic pain associated with diabetic peripheral neuropathy, a careful examination of the feet should be undertaken prior to each application of QUTENZA to detect skin lesions related to underlying neuropathy or vascular insufficiency.
Contraindications
Warnings and Precautions
- Aerosolization of capsaicin can occur upon rapid removal of QUTENZA. Therefore, remove QUTENZA gently and slowly by rolling the adhesive side inward. Inhalation of airborne capsaicin can result in coughing or sneezing. If irritation of airways occurs, remove the affected individual from the vicinity of QUTENZA. Provide supportive medical care if shortness of breath develops.
- If skin not intended to be treated is exposed to QUTENZA, apply Cleansing Gel for one minute and wipe off with dry gauze. After the Cleansing Gel has been wiped off, wash the area with soap and water.
- Patients may experience substantial procedural pain and burning upon application and following removal of QUTENZA. Prepare to treat acute pain during and following the application procedure with local cooling (such as a cold pack) and/or appropriate analgesic medication.
- Transient increases in blood pressure may occur during and shortly after the QUTENZA treatment. Blood pressure changes were associated with treatment-related increases in pain. Monitor blood pressure and provide adequate support for treatment-related pain. Patients with unstable or poorly controlled hypertension, or a recent history of cardiovascular or cerebrovascular events, may be at an increased risk of adverse cardiovascular effects. Consider these factors prior to initiating QUTENZA treatment.
- Reductions in sensory function have been reported following administration of QUTENZA. Decreases in sensory function are generally minor and temporary. All patients with pre-existing sensory deficits should be clinically assessed for signs of sensory deterioration or loss prior to each application of QUTENZA. If sensory deterioration or loss is detected or pre-existing sensory deficit worsens, continued use of QUTENZA treatment should be reconsidered.
Adverse Reactions
- In all controlled clinical trials, adverse reactions occurring in ≥5% of patients in the QUTENZA group and at an incidence at least 1% greater than in the control group were application site erythema, application site pain, and application site pruritus.
For additional information, please see the full Prescribing Information, including Patient Information.
You’ve been listening to ReachMD. This program was sponsored by Averitas Pharma. If you missed any part of this discussion, visit www.ReachMD.com/IndustryFeature. This is ReachMD. Be part of the knowledge.
QUTENZA® is a registered trademark of Averitas Pharma, Inc.
© 2020 Averitas Pharma, Inc. All rights reserved.
M-QZA-US-10-20-0020 October 2020
