A 6-month, double-blind, placebo-controlled trial with pregabalin

[Guest guest]

FYI...

Source: Pain. 2008 Apr 7 [Epub ahead of print]

(via co-cure)

NOTE: When you see " double-blind (DB), placebo-controlled study " , that is

usually reliable, unbiased information.

To translate one interesting fact in the last paragraph... at the end of

the study, 61% of the placebo patients had loss of response (LTR) of the

treatment, compared to 32% of pregabalin patients. Meaning the treatment

was working for more of the people receiving the real medication.

Also, notable, 17% of the participants left the study due to " adverse

events " (more than placebo patients). From AFFTER's study, along with

comments from many in our groups, we notice a lot of people have experienced

side affects - some severe.

Shari Ferbert

www.affter.org

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Fibromyalgia relapse evaluation and efficacy for durability of

meaningful relief (FREEDOM): A 6-month, double-blind,

placebo-controlled trial with pregabalin.

Pain. 2008 Apr 7 [Epub ahead of print]

Crofford LJ, Mease PJ, Simpson SL, Young JP Jr, SA, Haig GM, Sharma

U.

University of Kentucky, Internal Medicine, Room J-503 Kentucky

Clinic, 740 S. Limestone Street, Lexington, KY 40536-0284, USA.

PMID: 18400400

This was a multicenter, double-blind (DB), placebo-controlled,

randomized discontinuation trial to evaluate the efficacy of

pregabalin monotherapy for durability of effect on fibromyalgia (FM) pain.

The trial included a 6-week open-label (OL) pregabalin-treatment

period followed by 26-week DB treatment with placebo or pregabalin.

Adults with FM and 40-mm score on 100-mm pain visual analog scale

(VAS) were eligible. During OL weeks 1-3, patients received

escalating dosages of pregabalin to determine their optimal dosages.

During OL weeks 4-6, patients received their optimal fixed dosages

(300, 450, 600mg/d). To be randomized, patients must have had 50%

decrease in pain VAS and a self-rating of " much " or " very much "

improved on Patient Global Impression of change (PGIC) at the end of

OL. Double-blind treatment was with placebo or the patient's optimal

fixed dosage of pregabalin. Primary outcome was time to loss of

therapeutic response (LTR), defined as <30% reduction in pain (from

OL baseline) or worsening of FM. A total of 1051 patients entered OL;

287 were randomized to placebo, 279 to pregabalin.

Time to LTR was longer for pregabalin versus placebo (P<.0001).

Kaplan-Meier estimates of time-to-event showed half the placebo group

had LTR by Day 19; half the pregabalin group still had not lost

response by trial end. At the end of DB, 174 (61%) placebo patients

met LTR criteria versus 90 (32%) pregabalin patients. Pregabalin was

well tolerated, though 178 (17%) discontinued during OL for

treatment-related adverse events (AE), and more pregabalin than

placebo patients discontinued for AEs during DB.

In those who respond, pregabalin demonstrated durability of effect

for relieving FM pain.