Lyrica (Pregabalin) - Summary

LYRICA SUMMARY

LYRICA (pregabalin) binds with high affinity to the alpha₂-delta site (an auxiliary subunit of voltage-gated calcium channels) in central nervous system tissues. Although the mechanism of action of pregabalin is unknown, results with genetically modified mice and with compounds structurally related to pregabalin (such as gabapentin) suggest that binding to the alpha₂-delta subunit may be involved in pregabalin's antinociceptive and antiseizure effects in animal models. In vitro, pregabalin reduces the calcium-dependent release of several neurotransmitters, possibly by modulation of calcium channel function.

LYRICA is indicated for:

Management of neuropathic pain associated with diabetic peripheral neuropathy

Management of postherpetic neuralgia

Adjunctive therapy for adult patients with partial onset seizures

Management of fibromyalgia

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NEWS HIGHLIGHTS

Published Studies Related to Lyrica (Pregabalin)

Efficacy and tolerability of pregabalin in essential tremor: a randomized, double-blind, placebo-controlled, crossover trial. [2009.10.15]
We performed a double-blind, crossover-design study to assess the tolerability and efficacy of pregabalin (PGB) in patients with essential tremor (ET). Twenty patients (11 women; mean age of 62.2+/-12.7 years, mean ET duration of 25.5+/-14.9 years) with ET were randomized for treatment with PGB (150-600 mg/day) or placebo, titrated over 6 weeks...

An evaluation of perioperative pregabalin for prevention and attenuation of postoperative shoulder pain after laparoscopic cholecystectomy. [2009.10]
Postlaparoscopic shoulder pain (PLSP) frequently follows laparoscopic surgery. In this placebo-controlled study, we evaluated the efficacy of two perioperative doses of pregabalin 300 mg 12 h apart for preventing and attenuating PLSP after laparoscopic cholecystectomy... However, the 2-h postoperative incidence of oversedation was higher with pregabalin.

Rapid onset of seizure suppression with pregabalin adjunctive treatment in patients with partial seizures. [2009.08]
PURPOSE: To determine the time at which pregabalin demonstrates seizure-suppressing activity when given as adjunctive treatment to patients with refractory partial seizures. METHODS: Data from four similar 12-week, randomized, double-blind, placebo-controlled, parallel-group trials in patients with refractory partial seizures were pooled to provide an adequate sample to compare the proportion of patients free of seizures on each study day between pregabalin (combined 150-600 mg/day groups) and placebo (combined groups)...

The effects of pregabalin on sleep disturbance symptoms among individuals with fibromyalgia syndrome. [2009.06]
OBJECTIVES: Sleep disturbances are common in patients with fibromyalgia (FM). The objective of this analysis was to evaluate the effects of pregabalin on sleep in patients with FM... CONCLUSIONS: These data demonstrate improvement in FM-related sleep dysfunction with pregabalin therapy. The majority of this benefit was a direct effect of pregabalin on the patients' insomnia, while the remainder occurred through the drug's analgesic activity.

The effect of pregabalin on preoperative anxiety and sedation levels: a dose-ranging study. [2009.04]
BACKGROUND: Pregabalin is a gabapentinoid compound, which has been alleged to possess anxiolytic, analgesic, and anticonvulsant properties. We hypothesized that premedication with oral pregabalin would produce dose-related reductions in acute (state) anxiety and increases in sedation (sleepiness) before induction of general anesthesia. A secondary objective was to determine if premedication with pregabalin would reduce postoperative pain... CONCLUSION: Preoperative pregabalin administration (75-300 mg po) increased perioperative sedation in a dose-related fashion, but failed to reduce preoperative state anxiety, postoperative pain, or to improve the recovery process after minor elective surgery procedures.

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Clinical Trials Related to Lyrica (Pregabalin)

A Placebo-Controlled Trial of Pregabalin (Lyrica) for Irritable Bowel Syndrome [Not yet recruiting]
This study is being done to see if Lyrica helps people with irritable bowel syndrome, otherwise known as "IBS". Lyrica is the trade name for pregabalin, which was first approved by the FDA in June 2005 and has been available through prescription since fall 2005, and is marketed by Pfizer. Lyrica is known to have clinical efficacy treating pain disorders including IBS-related conditions such as fibromyalgia.

PharmacofMRI of Anxiolytic Medications (Pregabalin) [Recruiting]
The purpose of this study is to use functional magnetic resonance imaging (fMRI) in healthy controls to examine the acute effects of certain anxiolytic medications on brain function. In this case, the medication pregabalin will be used. We hypothesize that pregabalin (at doses of 50 mg and 200 mg, versus placebo) will yield a reduction in amygdala and insula activity (in a dose-dependent fashion) during emotion processing using fMRI.

Role of Pregabalin in Treatment of Post-Op Pain in Fracture Patients [Recruiting]
This is a randomized, prospective, double-blind pilot study designed to evaluate the potential effectiveness of pregabalin in post-operative pain management for patients who have sustained a fracture.

A Randomized Double-Blind Study Testing the Effects of Pregabalin on Diabetic Neuropathy [Recruiting]
This study is designed to examine how pregabalin affects parameters of autonomic nerve regulation in correlation with change in pain, anxiety, and depressive symptoms in patients with diabetic neuropathy.

A Study of Pregabalin (Lyrica) Augmentation in Serotonin Reuptake Inhibitor-Refractory Obsessive Compulsive Disorder [Recruiting]
This study will examine the efficacy of pregabalin (Lyrica) added to SRI treatment in OCD for individuals who have not responded or only partially responded to an adequate trial of SRI. Although SRIs have demonstrated efficacy in OCD in numerous placebo-controlled trials, response rates have been as low as 40%. Augmentation strategies would be beneficial to maximize treatment response in OCD.

Pregabalin (Lyrica) is an anticonvulsant medication that appears to have a novel mechanism of action. It has been shown to enhance activity at gamma-amino-butyric acid (GABA) receptors as well as inhibit glutamate release. These two neurotransmitters systems have been implicated in the neurobiology of OCD.

The study will consist of patients who have not attained full response to an SRI. The patients will be randomized in a double-blind fashion to augmentation with pregabalin (Lyrica) or placebo. The dose of study medication will be flexible, starting at 75 mg/day and increasing in 75 mg increments to a maximum of 600 mg/day, based on efficacy and any side effects. Patients' response to treatment will be measured by the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS), the Montgomery Asberg Depression Rating Scale (MADRS), and the Clinical Global Impression Scale(CGI).

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PATIENT REVIEWS / RATINGS / COMMENTS

Lyrica review by 46 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		Fibromyalgia
Dosage & duration:		150mg taken 2x per day for the period of Still taking it
Other conditions:		None
Other drugs taken:		None
		Reported Results
Benefits:		Lyrica has made a huge difference with my fibromyalgia pain. I have had fibromyalgia for 13 plus years and was excited about the FDA finally approving Lyrica for fibromyalgia patients. I would recomend that anyone suffering from fibromyalgia try this medication, along with a healthy diet and exercise. Lyrica is not a cure, but I have improved probably 75% over this last year.
Side effects:		It took my body 3-4 weeks to get used to Lyrica. It did make me feel a little different "high" would probably be the best way to describe it. I have since adjusted and have had no further side effects.
Comments:		Started with 50 mg 2x a day (morning and afternoon), then gradually built up to 150mg 2x a day.

Lyrica review by 57 year old female patient
		Rating
Overall rating:
Effectiveness:		Marginally Effective
Side effects:		Moderate Side Effects
		Treatment Info
Condition / reason:		fibromyalgia
Dosage & duration:		100 mg. 3 X day taken 3x day for the period of 3months
Other conditions:		arthritis
Other drugs taken:		premarin, cataflam
		Reported Results
Benefits:		Very little benefits, may have had a slight lessening of pain but not much
Side effects:		I was told by my doctor that this drug had "no side effects". I had swelling of my hands and face, lethargy, drugged feeling but when I ran out of it over a weekend and had to go 3 days without it I experienced severe withdrawal symptoms, itching, skin crawling, insomnia, etc so I quit taking it
Comments:		100 mg. 3 X day for about 3 months for fibromyalgia

Lyrica review by 58 year old female patient
		Rating
Overall rating:
Effectiveness:		Ineffective
Side effects:		Severe Side Effects
		Treatment Info
Condition / reason:		neuropathic pain aand fibromyalgia
Dosage & duration:		300mg/day taken 150mg twice/day for the period of 2 months
Other conditions:		severe spasms, severe osteoarthritis, migraines
Other drugs taken:		Klonopin, Ultram
		Reported Results
Benefits:		None
Side effects:		Extreme swelling of face, hands and feet, as well as, raised welts on skin
Comments:		Patient was being weened off of 3600mg/day of Neurontin on to Lyrica. As the dosage taken of Neurontin lessened and that of Lyrica increased so did the side effects. Patient was taken totally off of Lyrica and, successfully, placed back on Neurontin.