ProHealth health Vitamin and Natural Supplement Store and Health
Log In  |  My Account  |  View Cart  View Your ProHealth Vitamin and Supplement Shopping Cart
800-366-6056  |  Contact Us  |  Help

|
|
|
|

Trending News

New Science Destroys the Saturated Fat Myth

Ginger's Many Evidence-Based Health Benefits Revealed

Diet Affects Men’s and Women’s Gut Microbes Differently

New Lyme guidelines promote options and informed choice

Natural products from plants protect skin during cancer radiotherapy

Dangers of desert dust: new diagnostic tool for valley fever

Phases of clinical depression could affect treatment

“Worm pill” could ease autoimmune disease symptoms

Eating Baked or Broiled Fish Weekly Boosts Brain Health, Pitt Study Says

The Effect of d-Lenolate® on the Immune Parameters in Humans

 
Print Page
Email Article

Once-Daily Dose of Pregabalin (Lyrica) for Fibromyalgia Studied

  [ 4 votes ]   [ Discuss This Article ]
www.ProHealth.com • June 15, 2014


Editor's comment: Currently pregabalin, best known as Lyrica, is prescribed as a twice-a-day capsule. The clinical trial being reported here is for a controlled-release version of Lyrica that would only have to be taken once a day.

Once-daily controlled-release pregabalin in the treatment of patients with fibromyalgia: a Phase III, double-blind, randomized withdrawal, placebo-controlled study.

Abstract:

Objective: Safety and efficacy of a once-daily controlled-released (CR) formulation of pregabalin was evaluated in patients with fibromyalgia using a placebo-controlled, randomized withdrawal design.

Research design and methods: This multicenter study included 6-week single-blind pregabalin CR treatment followed by 13-week double-blind treatment with placebo or pregabalin CR. The starting dose of 165 mg/day was escalated during the first 3 weeks, up to 495 mg/day based on efficacy and tolerability. Patients with ?50% reduction in average daily pain score at the end of the single-blind phase were randomized to continue pregabalin CR at the optimized dose (330–495 mg/day) or to placebo. The primary endpoint was time to loss of therapeutic response (LTR), defined as <30% pain reduction relative to single-blind baseline or discontinuation owing to lack of efficacy or adverse event (AE). Secondary endpoints included measures of pain severity, global assessment, functional status, tiredness/fatigue, and sleep.

Results: 441 patients entered the single-blind phase, and 63 were randomized to pregabalin CR and 58 to placebo.
  • The median time to LTR (Kaplan-Meier analysis) was significantly longer in the pregabalin CR group than placebo (58 vs. 22 days, p=0.02).

  • By trial end, 34/63 (54.0%) pregabalin CR and 41/58 (70.7%) placebo patients experienced LTR.

  • Significantly more patients reported “benefit from treatment” (Benefit, Satisfaction, and Willingness to Continue Scale) in the pregabalin CR group; no other secondary endpoints were statistically significant.

  • Most AEs were mild-to-moderate in severity (most frequent: dizziness, somnolence).

  • The percentage of pregabalin CR patients discontinuing because of AEs was 12.2% and 4.8% in the single-blind and double-blind phases, respectively (placebo, 0%).

Conclusions: Time to LTR was significantly longer with pregabalin CR versus placebo in fibromyalgia patients who initially showed improvement with pregabalin CR, indicating maintenance of response. Pregabalin CR was well-tolerated in most patients. Generalizability may be limited by study duration and selective population.

Clinical Trial Registration: ClinicalTrials.gov NCT01271933

Source: Current Medical Research and Opinion, May 27, 2014. By Lesley M. Arnold, Pierre Arsenault, Cynthia Huffman, Jeffrey L. Patrick, Michael Messig, Marci L. Chew, Luis Sanin, Joseph M. Scavone, Lynne Pauer and Andrew G. Clair.



Please Discuss This Article:   Post a Comment 



[ Be the first to comment on this article ]




 
Free Chronic Fatigue Syndrome and Fibromyalgia Newsletters
Subscribe to
Our FREE
Newsletter
Subscribe Now!
Receive up-to-date ME/CFS & Fibromyalgia treatment and research news
 Privacy Guaranteed  |  View Archives

Immune Support Supplements

Featured Products

Mitochondria Ignite™ with NT Factor® Mitochondria Ignite™ with NT Factor®
Reduce Fatigue up to 45%
Energy NADH™ 12.5mg Energy NADH™ 12.5mg
Improve Energy & Cognitive Function
Optimized Curcumin Longvida® by ProHealth Optimized Curcumin Longvida® by ProHealth
Supports Cognition, Memory & Overall Health
Vitamin D3 Extreme™ by ProHealth Vitamin D3 Extreme™ by ProHealth
50,000 IU Vitamin D3 - Prescription Strength
FibroSleep™ by ProHealth FibroSleep™ by ProHealth
The All-in-One Natural Sleep Aid

Natural Remedies

How I Found My Long-Lost Energy How I Found My Long-Lost Energy
Preserving Cognitive Function with Aging Preserving Cognitive Function with Aging
More Weight Loss than Any Other Discovery in Supplement History More Weight Loss than Any Other Discovery in Supplement History
The Most Powerful Natural Antioxidant Discovered to Date - Hydroxytyrosol The Most Powerful Natural Antioxidant Discovered to Date - Hydroxytyrosol
IBS, Crohn’s Disease, Colitis, and Other Digestive Disorders IBS, Crohn’s Disease, Colitis, and Other Digestive Disorders

FIBROMYALGIA RESOURCES
What is Fibromyalgia?
Fibromyalgia 101
Fibromyalgia Symptoms
Fibromyalgia Treatments
| CFS RESOURCES
What is CFS?
ME/CFS 101
ME/CFS Symptoms
ME/CFS Treatments
| FORUMS
Fibromyalgia
ME/CFS
ADVANCED MEDICAL LABS
WHOLESALE  |  AFFILIATES
GUARANTEE
CONTACT US
PRIVACY
RSS
SITE MAP
ProHealth on Facebook  ProHealth on Twitter  ProHealth on Pinterest  ProHealth on Google Plus
Credit Card Processing