What % of patients is on Duloxetine in the Cross Over Study?
32%
100
WHAT WAS THE DC RATE FOR ANY REASON FOR LYRICA VS PLACEBO
12.2% VS 12.4%
100
WHAT ARE THE DOSES USED IN THE CROFFORD STUDY?
300MG 450MG 600MG
100
WHAT IS THE LYRICA STARTING DOSE IN THE CROSSOVER STUDY
LYRICA 150MG (IN TWO DIVIDED DOSES) OR PLACEBO ( IN TWO DIVIDED DOSES)
100
WHAT ARE THE PATIENT DESCRIPTORS FOR THE FM PATIENT
UNRESOLVED AND DISRUPTIVE
200
WHAT MUST BE DISCUSSED PRIOR TO CROSSOVER
CROFFORD
200
WHAT IS THE DC RATE DUE TO AE'S FOR LYRICA VS PLACEBO
6.1% VS 3.4%
200
WHAT IS THE AMOUNT OF TIME A PATIENT NEEDED TO BE WASHED OUT WHO WERE PREVIOUSLY ON EITHER LYRICA OR GABA IN THE CROSSOVER STUDY?
7 DAY WASH OUT
200
WHAT IS THE SECONDARY EFFICACY ENDPOINT IN THE CROSSOVER STUDY
FUNCTIONAL STATUS USING FIQ
200
53% vs 33%
WHAT IS THE % OF LYRICA VS PLACEBO PATIENTS THAT STILL EXPERIENCED SIGNIFICANT PAIN RELIEF AT THE END OF THE CROFFORD STUDY
53% VS 33%
300
WHAT TOOL WS USED TO EVALUATE FUNCTIONAL STATUS AS A SECONDARY ENDPOINT
FIQ
300
WHAT MAKES THE PATIENTS IN THE CROFFORD STUDY HARD TO TREAT
PATIENTS HAD FM AVERAGE OF 10 YEARS, IN MODERATE TO SEVERE PAIN CATAGORY, NO DOSING CHANGES ALLOWED, AVERAGE 17 OUT OF 18 POSITIVE TENDERPOINTS, AVERAGE PAIN SCORE 78/100 ON THE VAS
300
WHAT IS THE % OF FM PATIENTS THAT EXPERIENCE CHRONIC WIDESPREAD PAIN
97%
300
WHAT IS THE BASELINE MEAN SCORE FOR THE PATIENTS IN THE CROSSOVER STUDY
6.7
300
WHAT IS THE SIGNIFICANT IMPROVED FUNCTION FOR LYRICA VS PLACEBO FM PATIENTS IN THE CROSSOVER STUDY
30% VS 20%
400
WHAT IS THE SIGNIFICANT REDUCTION MEAN PAIN SCORE PERCENTAGE FOR LYRICA VS PLACEBO
25% VS 16%
400
WHAT ARE THE 3 TYPES OF DEPRESSION PATIENTS HAD IN THE CROSSOVER STUDY
MDD, DYTHEMIA, NOS
400
WHAT IS THE PRIMARY ENDPOINT OF CROFFORD
TEST THE ABILITY OF LYRICA TO MAINTAIN PAIN RELIEF FOR 6 MONTHS.
LTR (LOSS OF THERAPUETIC RESPONSE)
400
WHAT DOSE OF A SSRI OR SNRI WERE PATIENTS ON FOR 3 MONTHS PRIOR TO THE CROSSOVER STUDY
STABLE
400
WHAT % OF PATIENTS ARE ON AN SSRI VS SNRI IN THE CROSSOVER STUDY
52% VS 47%
500
WHAT IS THE AVERAGE DOSE OF LYRICA PATIENTS TOOK IN THE CROSS OVER STUDY
380
500
WHERE IS AN EASY PLACE TO SEND DOCTORS AND STAFF TO OBTAIN LYRICA PA'S
WHAT IS THE % OF PATIENTS TAKING 300MG AND 450MG OF LYRICA IN THE CROSSOVER STUDY
21.5 AND 75.5
500
DESCRIBE THE TWO FM PATIENT PROFILES
PATIENT ON MEDICATION FOR COMORBID DEPRESSION
AND
PATIENT WITH IMPARIED FUNCTION
500
WHAT IS THE BENEFIT OF A CROSSOVER STUDY
PATIENTS SERVE AS THEIR OWN CONTROL, SUBJECT VARIABILITY IS MINIMIZED BECAUSE PATIENTS GET BOTH TREATMENTS. LESS PATIENTS ARE REQUIRED TO DEMONSTRATE A TREATMENT EFFECT