Patients experiencing chronic pain have shown a significant improvement upon treatment with Lyrica (pregabalin) compared to placebo treated patients, according to a new study analysis.
The orally administrated drug is approved by the U.S. Food and Drug Administration (FDA) and European Medicine Agencies (EMA) to treat chronic pain conditions including fibromyalgia (FM), neuropathic pain associated with diabetic peripheral neuropathy (DPN), postherpetic neuralgia (PHN), and spinal cord injury (SCI). Its effectiveness for improving pain intensity has been demonstrated in many placebo-controlled trials.
Patients with chronic pain often characterize their pain as mild, moderate, or severe, which usually also reflect the degree of pain interference in the patient’s function. In many situations, because the pain categories and function relationship is not linear, scientist believe it is important to understand if treatments that bring about meaningful pain relief can be related to clinically significant changes in function.
The analysis report, “Improvement in pain severity category in clinical trials of pregabalin,” published in the Journal of Pain Research, intended to better understand the overall clinical benefit of Lyrica in all FDA-approved chronic pain conditions.
Researchers analyzed pain category data collected from 23 placebo-controlled trials of Lyrica therapy for patients with FM (1,623 treated with Lyrica, 937 with placebo), DPN/PHN (2,867 treated with Lyrica, 1,532 with placebo), or SCI (181 treated with Lyrica, 175 with placebo).
The team found that regardless of the Lyrica dose prescribed – 300 or 450 mg/day for FM patients, and 300 or 600 mg/day for DPN/PHN patients – all treated patients demonstrated a significant improvement in pain category compared to placebo.
Among both FM and DPN/PHN patients, a flexible-dose therapy with Lyrica (adjusted to the patients’ overall therapy response) showed better results in improving pain category, compared to a fixed-dose therapy.
In patients with SCI, researchers observed that upon flexible-dose Lyrica treatment, patients also presented a “much improved” pain category change (from moderate to mild, or severe to moderate), as compared to placebo-treated patients.
For all groups of patients, Lyrica treatment was more efficient among patients who were classified as severely in pain at the beginning of the study.
The team also analyzed the overall health status, progress, and outcome of FM patients through the Fibromyalgia Impact Questionnaire (FIQ). No significant improvement was observed compared to placebo-treated patients, but a trend toward a greater proportion of patients shifting from severe to mild pain classification after single-dose Lyrica therapy did become apparent.
The study concluded that Lyrica is not only relevant for controlling pain, but also in improving patients’ pain assessment. The study also revealed that pain category changes can be considered as clinically meaningful and can reflect a real impact in the patient’s ability to function in life.
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