ACR: One-Year Results from an Active Comparator-Controlled Trial of Rofecoxib (Vioxx) in Patients with Rheumatoid Arthritis

[Guest guest]

ACR: One-Year Results from an Active Comparator-Controlled Trial of

Rofecoxib in Patients with Rheumatoid Arthritis

By Bruce Sylvester

Special to DG News

NEW ORLEANS, LA -- October 30, 2002 -- Rofecoxib, 25 mg once daily, is the

optimal dosage for treatment of the signs and symptoms of rheumatoid

arthritis, researchers report.

This study finding was presented here at the annual meeting of the American

College of Rheumatology

" We describe results of a 40-week active comparator-controlled continuation

period (Part II) following a 12-week placebo and

active-comparator-controlled pivotal efficacy study (Part I) in RA, " the

authors, from Merck Research Labs in Rahway, New Jersey, United States,

wrote.

Six hundred and fifty three patients of the 889 subjects enrolled in Part I

entered into Part II. The investigators assessed the safety and maintenance

of clinical efficacy with 25 and 50mg rofecoxib once daily versus naproxen

500 mg twice daily in this second part of the study.

They administered 25 or 50mg rofecoxib or naproxen, pre-assigned at original

(Part I) dosing level to the patients who completed Part I.

Placebo subjects from Part I received rofecoxib 25 mg or naproxen in Part

II. Subjects using rofecoxib 12.5 mg in Part I received rofecoxib 25 mg in

Part II. Half the patients receiving 25 mg in Part I received 50 mg in Part

II. All remaining subjects continued on their same therapy in Part II.

The investigators used all components of the ACR core set for their

assessments. They pre-specified four primary endpoints plus patient and

investigator global assessments of disease activity and counts of tender and

swollen joints.

Safety evaluations were made based on adverse experiences reported by

investigators who were blinded to study treatment, and by laboratory and

vital sign measurements.

The investigators found that the active treatments indicated similar degrees

of improvement relative to Part I baseline, and from the first efficacy

measurement in Part II (week 14) through the last evaluation (week 52).

The improvements included a 17 to 19-joint reduction in tender joints (total

68 joints), a 8 to 10-joint reduction in swollen joints (total 66 joints), a

33 to 37-mm improvement on the patient global assessment for pain (100 mm

Visual Analog Scale/ VAS) and a 1.4-unit reduction on the investigator

global assessment (0 to 4 Likert scale).

Subjects who received one therapy for up to a year sustained their achieved

therapeutic effects.

The investigators reported no added therapeutic benefit for rofecoxib 50

mg/day treatment versus 25 mg/day treatment.

" In this study, improvements with 25 mg rofecoxib were similar to those with

50 mg rofecoxib and naproxen 500 mg twice daily and sustained for up to one

year. All treatments were generally well tolerated. These findings support

the use of 25 mg rofecoxib as the optimal dose for treating the signs and

symptoms of RA, " the authors wrote.

The study was supported by Merck.

[Guest guest]

Interesting study, a.

I can only say that when I took 50 mg. of Vioxx, as compared to 25 mg., I

sure felt good! (I had been given some samples which is how I first came to

try the 50 mg. strength.) When I told my rheumy how great I felt when I

took that dosage, he smiled, told me all his patients told him that, then

severely warned me not to take that dosage! That it was not safe to take it

more than a few days at a time at that dosage. This was before I started

mtx or prednisone and was having a lot of pain.

Suzanne in NW FL

[ ] ACR: One-Year Results from an Active

Comparator-Controlled Trial of Rofecoxib (Vioxx) in Patients with Rheumatoid

Arthritis

> ACR: One-Year Results from an Active Comparator-Controlled Trial of

> Rofecoxib in Patients with Rheumatoid Arthritis

>

> By Bruce Sylvester

> Special to DG News

>

> NEW ORLEANS, LA -- October 30, 2002 -- Rofecoxib, 25 mg once daily, is the

> optimal dosage for treatment of the signs and symptoms of rheumatoid

> arthritis, researchers report.

>

> This study finding was presented here at the annual meeting of the

American

> College of Rheumatology

>

> " We describe results of a 40-week active comparator-controlled

continuation

> period (Part II) following a 12-week placebo and

> active-comparator-controlled pivotal efficacy study (Part I) in RA, " the

> authors, from Merck Research Labs in Rahway, New Jersey, United States,

> wrote.

>

> Six hundred and fifty three patients of the 889 subjects enrolled in Part

I

> entered into Part II. The investigators assessed the safety and

maintenance

> of clinical efficacy with 25 and 50mg rofecoxib once daily versus naproxen

> 500 mg twice daily in this second part of the study.

>

> They administered 25 or 50mg rofecoxib or naproxen, pre-assigned at

original

> (Part I) dosing level to the patients who completed Part I.

>

> Placebo subjects from Part I received rofecoxib 25 mg or naproxen in Part

> II. Subjects using rofecoxib 12.5 mg in Part I received rofecoxib 25 mg in

> Part II. Half the patients receiving 25 mg in Part I received 50 mg in

Part

> II. All remaining subjects continued on their same therapy in Part II.

>

> The investigators used all components of the ACR core set for their

> assessments. They pre-specified four primary endpoints plus patient and

> investigator global assessments of disease activity and counts of tender

and

> swollen joints.

>

> Safety evaluations were made based on adverse experiences reported by

> investigators who were blinded to study treatment, and by laboratory and

> vital sign measurements.

>

> The investigators found that the active treatments indicated similar

degrees

> of improvement relative to Part I baseline, and from the first efficacy

> measurement in Part II (week 14) through the last evaluation (week 52).

>

> The improvements included a 17 to 19-joint reduction in tender joints

(total

> 68 joints), a 8 to 10-joint reduction in swollen joints (total 66 joints),

a

> 33 to 37-mm improvement on the patient global assessment for pain (100 mm

> Visual Analog Scale/ VAS) and a 1.4-unit reduction on the investigator

> global assessment (0 to 4 Likert scale).

>

> Subjects who received one therapy for up to a year sustained their

achieved

> therapeutic effects.

>

> The investigators reported no added therapeutic benefit for rofecoxib 50

> mg/day treatment versus 25 mg/day treatment.

>

> " In this study, improvements with 25 mg rofecoxib were similar to those

with

> 50 mg rofecoxib and naproxen 500 mg twice daily and sustained for up to

one

> year. All treatments were generally well tolerated. These findings support

> the use of 25 mg rofecoxib as the optimal dose for treating the signs and

> symptoms of RA, " the authors wrote.

>

> The study was supported by Merck.

[Guest guest]

I¹ve never taken 50mgs, but it¹s interesting to know that it¹s so good if I

need extra help on a bad day. I feel much better about taking Vioxx after

reading the study that it¹s safe in lower doses.

a

> Interesting study, a.

>

> I can only say that when I took 50 mg. of Vioxx, as compared to 25 mg., I

> sure felt good! (I had been given some samples which is how I first came to

> try the 50 mg. strength.) When I told my rheumy how great I felt when I

> took that dosage, he smiled, told me all his patients told him that, then

> severely warned me not to take that dosage! That it was not safe to take it

> more than a few days at a time at that dosage. This was before I started

> mtx or prednisone and was having a lot of pain.

>

> Suzanne in NW FL