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Somavert
Clinical Pharmacology
Somavert
Table 2 shows the effect of treatment with SOMAVERT on ring size (standard jeweler's sizes converted to a numeric score ranging from 1 to 63), and on both the total and individual scores for signs and symptoms of acromegaly. Each individual score (for soft-tissue swelling, arthralgia, headache, perspiration and fatigue) was based on a nine-point ordinal rating scale (0 = absent and 8 = severe and incapacitating), and the total score was derived from the sum of the individual scores. Mean baseline scores were as follows: ring size = 47.1; total signs and symptoms = 15.2; soft tissue swelling = 2.5; arthralgia = 3.2; headache = 2.4; perspiration = 3.3; and fatigue = 3.7.
Table 1. Mean Percent Change from Baseline in IGF-I at Week
12 for Intent-to- Treat Population
| SOMAVERT | Placebo n=31 |
|||
| 10 mg/day n=26 |
15 mg/day n=26 |
20 mg/day n=28 |
||
| Mean percent change from baseline in IGF-I (SD) | -27 (28) | -48 (26) | -63 (21) | -4.0 (17) |
| SOMAVERT minus Placebo (95% CI for treatment difference) | -23* | -44* | -59* | |
| (-35, -11) | (-56, -33) | (-68, -49) | ||
| * P<0.01 | ||||
Table 2. Mean Change from Baseline (SD) at Week 12 for Ring
Size and Signs and Symptoms of Acromegaly
| SOMAVERT | Placebo n=30 |
|||
| 10 mg/day n=26 |
15 mg/day n=24-25 |
20 mg/day n=26-27 |
||
| Ring size | -0.8 (1.6) | -1.9 (2.0) | -2.5 (3.3) | -0.1 (2.3) |
| Total score for signs and symptoms of acromegaly | -2.5 (4.3) | -4.4 (5.9) | -4.7 (4.7) | 1.3 (6.0) |
| Soft-tissue swelling | -0.7 (1.6) | -1.2 (2.3) | -1.3 (1.3) | 0.3 (2.3) |
| Arthralgia | -0.3 (1.8) | -0.5 (2.5) | -0.4 (2.1) | 0.1 (1.8) |
| Headache | -0.4 (1.6) | -0.3 (1.4) | -0.3 (2.0) | 0.1 (1.7) |
| Perspiration | -0.6 (1.6) | -1.1 (1.3) | -1.7 (1.6) | 0.1 (1.7) |
| Fatigue | -0.5 (1.4) | -1.3 (1.7) | -1.0 (1.6) | 0.7 (0.5) |
Ring size at week 12 was smaller (improved) in the groups treated with 15 or 20 mg of SOMAVERT, compared with placebo. The mean total score for signs and symptoms at week 12 was lower (improved) in each of the groups treated with SOMAVERT, compared with the group treated with placebo.
Generic Name: Pegvisomant
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