Capsaicin 8% dermal patch in clinical practice: an expert opinion.

INTRODUCTION: Neuropathic pain (NP) is caused by a lesion or disease of the somatosensory system, which can severely impact patients' quality of life. The current-approved treatments for NP comprise of both centrally acting agents and topical drugs, including capsaicin 8% dermal patches, which is approved for the treatment of peripheral NP. AREAS COVERED: The authors summarize literature data regarding capsaicin use in patients who suffer from NP and discuss the clinical applications of this topical approach. EXPERT OPINION: Overall, the capsaicin 8% dermal patch is as effective in reducing pain intensity as other centrally active agents (i.e. pregabalin). Some studies have also reported fewer systemic side effects, a faster onset of action and superior treatment satisfaction compared with systemic agents. In our opinion, capsaicin 8% dermal patches also present additional advantages, such as a good systemic tolerability, the scarcity of adverse events, the possibility to combine it with other agents, and a good cost-effective profile. It is important to note that, as the mechanism of action of capsaicin 8% is the 'defunctionalization' of small afferent fibers through interaction with TRPV1 receptors, the peripheral expression of this receptor on nociceptor fibers, is crucial to predict patient's response to treatment.

The restore rechargeable, implantable neurostimulator: handling and clinical results of a multicenter study.

BACKGROUND: Spinal cord stimulation is an effective therapy for chronic, neuropathic pain refractory to medication. Use of a rechargeable neurostimulation system (Restore, Medtronic Inc) could provide greater longevity in the treatment of complex pain. However, patients' ability to successfully recharge a neurostimulation system has not yet been demonstrated. PRIMARY OBJECTIVE: Ability of patients to recharge the neurostimulator. SECONDARY OBJECTIVES: Patient and physician satisfaction with the system, pain relief, quality of life, functional status, adverse events. METHODS: Prospective, open-label, multicenter, European study in patients with long-term refractory neuropathic pain. Recharging ability was assessed 1-month postimplant. Patient and physician satisfaction, pain relief, quality of life, and functional status were assessed at scheduled follow-up visits through 12 months. Adverse events were monitored throughout. RESULTS: Primary end point: 100% of patients (n=41) successfully recharged the neurostimulator. Secondary end points at 1 month: 78.6% of patients found recharging easy. At 12 months: physicians were satisfied with the system for 92.7% of patients; pain intensity decreased significantly (P<0.001); mean self-reported pain relief was 62%; 80.5% of patients had more than 50% pain relief; quality of life and functional status improved significantly (P<0.001); 98% of patients would recommend spinal cord stimulation to others. Overall, 41 device-related complications (23 patients) were observed. CONCLUSIONS: Twelve-month experience indicates that the rechargeable neurostimulation system (Restore) was easy to use, with 100% of patients able to recharge successfully. Patient and physician satisfaction was high, with significant improvements in pain, quality of life, and functional status. Complications were comparable to prior experience with this therapy.

Spinal cord stimulation in hemodialysis patients with critical lower-limb ischemia.

BACKGROUND: Spinal cord stimulation (SCS) has been proposed for the treatment of ischemic pain and the prevention or delay of amputation in patients with peripheral arterial occlusive disease (PAOD) who are unsuitable for vascular reconstruction. PAOD is common in patients with end-stage renal disease and is associated with substantial morbidity and mortality. Furthermore, many patients are not candidates for limb-sparing procedures and have to undergo primary amputation. METHODS: We report our experience with SCS in 8 hemodialysis patients with chronic lower-limb ischemia and not suitable for either primary surgical or angioplastic intervention or reintervention. Intensity of ischemic pain, quality of life, use of analgesic medications, limb survival, and outcome of skin ischemic lesions were evaluated before implantation of an SCS device and after 6 and 12 months of follow-up. RESULTS: No complications from SCS device implantation occurred. Both intensity of pain and quality of life significantly improved during follow-up. SCS allowed a decrease in pain medication intake in all patients. Limb survival at 1 year was 75%. Ischemic skin lesions before implantation of an SCS device did not ameliorate during the follow-up period, but the appearance of new lesions was not observed. CONCLUSION: Implantation of an SCS device in patients with end-stage renal disease with critical limb ischemia dramatically improves quality of life and pain relief. In patients assessed at Leriche-Fontaine stage 2 or 3, the treatment might delay the appearance of ischemic skin lesions and amputation. At these stages, presumed long-term benefits could justify the cost of SCS.