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EASD: Lidocaine Patch Beats Pregabalin for Diabetic Nerve Pain

Posted: Wednesday, October 07, 2009

A dermal patch containing 5% lidocaine (Lidoderm) proved as effective as pregabalin (Lyrica) in relieving neuropathic pain in diabetic patients with dramatically fewer side effects.

Only 3.8% of patients treated with the patch suffered drug-related adverse events, compared with 36.2% of those taking oral pregabalin in a 210-patient, four-week randomized trial (P<0.0001).

Nearly identical proportions of patients met the study's primary pain relief endpoint, defined as either a reduction of at least two points in pain scores on the 11-point Numerical Rating Scale III or a final score of no more than four, according to Ingrid Tacken, PhD, who presented the results at the European Association for the Study of Diabetes meeting.

The lidocaine patch -- formulated in a clear hydrogel -- is currently FDA-approved for postherpetic neuralgia but not for other forms of neuropathic pain. Pregabalin is approved for diabetic neuralgia.

On an intent-to-treat basis, 68.0% of patients receiving the lidocaine patch and 68.3% of the pregabalin group were classed as responders. There was no meaningful difference in response rates in the per-protocol analysis (66.7% and 69.1%, respectively), which excluded 11 patients who did not comply with the study requirements.

Patients were included in the study if they had experienced diabetic peripheral neuropathy with significant leg or foot pain for at least three months, including at least two of the following symptoms: burning sensations, tingling or prickling, paresthesias, or painful responses to heat or cold. Those assigned to the patch could use up to four each day, for no more than 12 hours, applied to the area of maximum pain.

Pregabalin was given at a starting dose of 75 mg twice a day, titrated up to 300 mg/day during the second week and up to 600 mg/day during the third week, according to pain responses.

Baseline pain scores averaged 6.9 (SD 1.3) in those assigned to the lidocaine patch and 6.6 (SD 1.2) among those taking pregabalin. Patients reported that peripheral nerve pain had lasted approximately five years.

Tacken reported that NRS-III scores decreased by a mean of 2.5 points from baseline to week four in both treatment groups. Allodynia -- painful responses to light touch or heat/cold -- also improved about equally with both drugs. It was in safety that the treatments differed, according to Tacken.

Overall adverse effects, whether or not the investigators considered them drug-related, were reported in 16.2% of patients using the patches versus 43.8% of the pregabalin group (P<0.0001).

Discontinuations because of adverse effects also were significantly more common with pregabalin: 21.9% of the group, compared with 1.9% of patch users. Tacken said patients using the patches did not report numbness in the treated limbs.

Two cases each of application-site irritation and headache were the only drug-related adverse effects reported for the patch.

Nicolaas Schaper, MD, a clinical endocrinologist at Maastricht University in the Netherlands, said the patch -- which is not currently available in his country -- might be an attractive treatment option but he would like to see additional data. He said the familiarity of lidocaine and the local application were pluses for the patch.

But, Schaper said, "The lack of a placebo control [in the study] is a problem." He said neuropathic pain trials usually show a very strong placebo effect, making it unclear in this trial whether either treatment was actually effective. Another concern, he said, was whether the patch could be used on the plantar surface of the foot -- a common location for diabetic limb pain -- without causing or aggravating ulceration.

He also commented that four weeks was too short to fully evaluate treatments for this condition. "I would like to see longer-term data," Schaper said.

Tacken indicated that the four-week, parallel-group trial reported here was followed by eight weeks of combination treatment in which all consenting patients received both pregabalin and the lidocaine patch. Results from that phase will be reported elsewhere, she said.
Practice Pearls:

Explain to interested patients that severe pain in the legs and feet, accompanied by burning or tingling sensations, is a complication of diabetes related to nerve damage.

Explain that the lidocaine patch used in the study is not FDA approved for this purpose.

Explain that this was a randomized, controlled trial, a relatively strong form of research, although lack of a placebo group warrants caution in interpreting the efficacy results.
Diabetologia: Baron R, et al "5% lidocaine medicated plaster vs pregabalin in patients with painful diabetic polyneuropathy (DPN): Efficacy and tolerability results from a randomized, controlled trial"

Source: Diabetes In Control: Diabetologia 52: S452.

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