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Eligard
Clinical Pharmacology
Eligard
Serum PSA decreased in all patients in all studies whose Baseline values were elevated above the normal limit. Refer to Table 4 for a summary of the effectiveness of ELIGARD® in reducing serum PSA values.
Table 4 - Effect of ELIGARD® on Patient Serum PSA Values
| ELIGARD® | 7.5 mg | 22.5 mg | 30 mg | 45 mg |
| Mean PSA Reduction at Study Conclusion | 94% | 98% | 86% | 97% |
| Patients with Normal PSA at Study Conclusion* | 94% | 91% | 93% | 95% |
| *Among patients who presented with elevated levels at Baseline | ||||
Other secondary efficacy endpoints evaluated included WHO performance status, bone pain, urinary pain and urinary signs and symptoms. Refer to Table 5 for a summary of these endpoints.
Table 5 - Secondary Efficacy Endpoints
| ELIGARD® 7.5 mg |
ELIGARD® 22.5 mg |
ELIGARD® 30 mg |
ELIGARD® 45 mg |
||
| Baseline | WHO Status = 01 | 88% | 94% | 90% | 90% |
| WHO Status = 12 | 11% | 6% | 10% | 7% | |
| WHO Status = 23 | 3% | ||||
| Mean Bone Pain4 (range) | 1.22 (1-9) | 1.20 (1-9) | 1.20 (1-7) | 1.38 (1-7) | |
| Mean Urinary Pain(range) |
1.12 (1-5) | 1.02 (1-2) | 1.01 (1-2) | 1.22 (1-8) | |
| Mean Urinary Signs and Symptoms (range) |
Low | 1.09 (1-4) | Low | Low | |
| Number of Patients with Prostate Abnormalities | 102 (85%) | 96 (82%) | 66 (73%) | 89 (80%) | |
| Month 6 | Month 6 | Month 8 | Month 12 | ||
| Follow- up | WHO Status = 0 | Unchanged | 96% | 87% | 94% |
| WHO Status = 1 | Unchanged | 4% | 12% | 5% | |
| WHO Status = 2 | 1% | 1% | |||
| Mean Bone Pain (range) | 1.26 (1-7) | 1.22 (1-5) | 1.19 (1-8) | 1.31 (1-8) | |
| Mean Urinary Pain (range) | 1.07 (1-8) | 1.10 (1-8) | 1.00 (1-1) | 1.07 (1-5) | |
| Mean Urinary Signs and Symptoms (range) | Modestly Decreased | 1.18 (1-7) | Modestly Decreased | Modestly Decreased | |
| Number of Patients with Prostate Abnormalities | 77 (64%) | 76 (65%) | 54 (60%) | 60 (58%) | |
| 1. WHO Status = 0 classified as “fully active.” 2. WHO Status = 1 classified as “restricted in strenuous activity but ambulatory and able to carry out work of a light or sedentary nature.” 3. WHO Status = 2 classified as “ambulatory but unable to carry out work activities.” 4. Pain score scale: 1 (no pain) to 10 (worst pain possible). |
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REFERENCE
1 Sennello LT et al. Single-dose pharmacokinetics of leuprolide in humans following intravenous and subcutaneous administration. J Pharm Sci 1986; 75(2): 158-160.
2 MacLeod TL et al. Anaphylactic reaction to synthetic luteinizing hormone releasing hormone. Fertil Steril 1987 Sept; 48(3): 500-502.
Generic Name: Leuprolide Acetate
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