Session Information
Date: Tuesday, November 10, 2015
Title: Fibromyalgia, Soft Tissue Disorders, Regional and Specific Clinical Pain Syndromes Poster II
Session Type: ACR Poster Session C
Session Time: 9:00AM-11:00AM
Background/Purpose:
Pregabalin has
demonstrated efficacy and safety for the treatment of pain associated with fibromyalgia
(FM) and is approved by the US Food and Drug Administration for this
indication. Although pregabalin has been shown to be well tolerated in subjects
with moderate or severe baseline pain, no studies have assessed whether its
safety and tolerability differs by baseline pain severity. In this analysis, we
evaluated data from subjects from 5 pooled clinical trials using pregabalin for
FM-related pain to determine whether safety profiles were different in subjects
with moderate versus severe baseline pain severity.
Methods:
Safety data were pooled
from 5, Phase III, placebo-controlled, clinical trials using pregabalin (8–15
weeks; 300 or 450 mg/day) for treatment of
FM-related pain (study numbers 1008105, A0081056, A0081077, A0081100,
A0081208). Subjects had FM diagnoses (1990 ACR criteria), were aged ≥18
years, had mean baseline pain scores ≥4, and had scores ≥40 mm on
the Visual Analog Scale of Short-form McGill Pain Questionnaire. Descriptive
statistics were used to classify adverse event (AE) profiles after 12 weeks of treatment
categorized by baseline moderate (pain scores ≥4-<7) or severe
(≥7-10) pain severity.
Results:
Overall, the incidences
of treatment-emergent AEs, treatment-related AEs, serious AEs (SAEs), and
discontinuations were comparable between subjects with baseline moderate and severe
pain who received the same treatment (Table
1).
|
Table 1. Safety and tolerability of pregabalin across all five clinical trials. |
||||
|
Number (%) of Subjects with AEsa |
Pregabalin (300 or 450 mg/day) |
Placebo |
||
|
|
Moderate (n = 785) |
Severe (n = 820) |
Moderate (n = 504) |
Severe (n = 425) |
|
Subjects with treatment-emergent AEs |
694 (88.4) |
725 (88.4) |
371 (73.6) |
312 (73.4) |
|
Subjects with treatment-related AEs |
588 (74.9) |
613 (74.8) |
234 (46.4) |
192 (45.2) |
|
Subjects with SAEs |
7 (0.9) |
20 (2.4) |
5 (1.0) |
6 (1.4) |
|
Subjects with severe intensity treatment-emergent AEs |
87 (11.1) |
117 (14.3) |
36 (7.1) |
34 (8.0) |
|
Subjects who permanently discontinued due to treatment-emergent AEs |
134 (17.1) |
130 (15.9) |
44 (8.7) |
35 (8.2) |
|
Subjects with dose reduction or temporary discontinuation due to treatment-emergent AEs |
52 (6.6) |
47 (5.7) |
19 (3.8) |
11 (2.6) |
|
aAEs defined by Medical Dictionary of Regulatory Activities (MedDRA) Preferred Terms. |
||||
The incidences of the most common
treatment-emergent AEs were also comparable between subjects within the same
treatment group who had moderate and severe baseline pain severity (Table 2).
|
Table 2. Most common treatment-emergent AEs (≥5% incidence in any treatment group) across five pregabalin clinical trials. |
||||
|
Number (%) of Subjects with AEsa |
Pregabalin (300 or 450 mg/day) |
Placebo |
||
|
|
Moderate (n = 785) |
Severe (n = 820) |
Moderate (n = 504) |
Severe (n = 425) |
|
Constipation |
66 (8.4) |
57 (7.0) |
27 (5.4) |
8 (1.9) |
|
Diarrhea |
29 (3.7) |
37 (4.5) |
24 (4.8) |
29 (6.8) |
|
Dizziness |
282 (35.9) |
302 (36.8) |
53 (10.5) |
34 (8.0) |
|
Dry mouth |
59 (7.5) |
54 (6.6) |
8 (1.6) |
6 (1.4) |
|
Fatigue |
54 (6.9) |
61 (7.4) |
19 (3.8) |
18 (4.2) |
|
Headache |
85 (10.8) |
104 (12.7) |
56 (11.1) |
47 (11.1) |
|
Nasopharyngitis |
51 (6.5) |
57 (7.0) |
51 (10.1) |
27 (6.4) |
|
Nausea |
56 (7.1) |
52 (6.3)
|
35 (6.9) |
36 (8.5) |
|
Edema peripheral |
46 (5.9) |
42 (5.1) |
9 (1.8) |
6 (1.4) |
|
Somnolence |
189 (24.1) |
185 (22.6) |
47 (9.3) |
29 (6.8) |
|
Vision blurred |
48 (6.1) |
49 (6.0) |
5 (1.0) |
5 (1.2) |
|
Weight increased |
96 (12.2) |
94 (11.5) |
16 (3.2) |
10 (2.4) |
|
aAEs defined by Medical Dictionary of Regulatory Activities (MedDRA) Preferred Terms. |
||||
Conclusion:
No notable differences
in the safety or tolerability of pregabalin were observed between subjects with
moderate and severe baseline pain severity. The treatment-emergent AEs and
their incidence rates were consistent with the known safety profile of pregabalin.
To cite this abstract in AMA style:
Clair A, Emir B. Safety of Pregabalin for Treatment of Fibromyalgia Is Comparable Between Subjects with Moderate or Severe Baseline Widespread Pain [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/safety-of-pregabalin-for-treatment-of-fibromyalgia-is-comparable-between-subjects-with-moderate-or-severe-baseline-widespread-pain/. Accessed .« Back to 2015 ACR/ARHP Annual Meeting
ACR Meeting Abstracts - https://acrabstracts.org/abstract/safety-of-pregabalin-for-treatment-of-fibromyalgia-is-comparable-between-subjects-with-moderate-or-severe-baseline-widespread-pain/