Template:Side effects of combined androgen blockade with nonsteroidal antiandrogens
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References
- ^ McLeod DG (1997). "Tolerability of Nonsteroidal Antiandrogens in the Treatment of Advanced Prostate Cancer". Oncologist. 2 (1): 18–27. doi:10.1634/theoncologist.2-1-18. PMID 10388026.
In the double-blind, comparative study of flutamide plus LHRH-A versus bicalutamide plus LHRH-A, elevated transaminases occurred in slightly more patients in the flutamide group than in the bicalutamide group (10% versus 6%; p = 0.07). This increased incidence was also seen for patients with greatly elevated (>5× normal) transaminase values (2% [2.5%] versus 0.5%) [22, 46].
- ^ Kolvenbag GJ, Blackledge GR (January 1996). "Worldwide activity and safety of bicalutamide: a summary review". Urology. 47 (1A Suppl): 70–9, discussion 80–4. doi:10.1016/S0090-4295(96)80012-4. PMID 8560681.
[...] In the combination study,9 the incidence of hepatic adverse events was lower in bicalutamide plus LHRH-A group than in the flutamide plus LHRH-A group (6.7% versus 12%; P = 0.07). [...] In the clinical trial program, evaluation of biochemistry assessments showed that increases in the liver function test values for serum glutamic oxaloacetic transaminase (SGOT; aspartate aminotransferase) and serum glutamic pyruvic transaminase (SGPT; alanine aminotransaminase) occurred with greater frequency in the flutamide plus LHRH-A group than in the bicalutamide plus LHRH-A group (49 [12.0%] and 28 [7.0%] patients, respectively). The difference between groups was observed for both test results that were less than twice the upper limit of normal (ULN) and for test results that were greater than two times the ULN. [\n\n] In the combination study, 77 patients (28 [7.0%], bicalutamide plus LHRH-A; 49 [12.0%], flutamide plus LHRH) had at least one liver enzyme test result (SGOT or SGPT) that exceeded twice the ULN. For these patients, there was no clear pattern to distinguish between SGOT versus SGPT changes as drug induced; changes were observed for both enzymes (either alone or together) while patients received study therapy. Of these 77 patients, 52 had an increase in SGOT and/or SGPT levels >2 ✕ ULN on only one occasion. [\n\n] Drug-induced changes were more likely when liver function test values were above the ULN at more than one assessment. This finding was observed more often for flutamide-treated patients than for bicalutamide-treated patients (17 [4.2%] vs 8 [2.0%]). Liver function test values >5 ✕ ULN (SGOT >325 U/L [patients >65 years]; SGPT >265 U/L) after the start of therapy were more frequently observed for patients who received flutamide plus LHRH-A (10 of 407 patients) [2.5%] than patients who received bicalutamide plus LHRH-A (2 of 401 patients) [0.5%].
- ^ Schellhammer P, Sharifi R, Block N, Soloway M, Venner P, Patterson AL, Sarosdy M, Vogelzang N, Jones J, Kolvenbag G (January 1996). "Maximal androgen blockade for patients with metastatic prostate cancer: outcome of a controlled trial of bicalutamide versus flutamide, each in combination with luteinizing hormone-releasing hormone analogue therapy. Casodex Combination Study Group". Urology. 47 (1A Suppl): 54–60, discussion 80–4. doi:10.1016/s0090-4295(96)80010-0. PMID 8560679.
The tolerability evaluation included 808 patients (401 in the bicalutamide plus LHRH-A group and 407 in the flutamide plus LHRH-A group) and was performed after a median follow-up of 49 weeks. Five patients refused therapy; 88 patients (32 [8.0%] in the bicalutamide plus LHRH-A group and 56 [13.8%] in the flutamide plus LHRH-A group) had study therapy withdrawn because of safety reasons (Table II). [...] TABLE II. Adverse events leading to withdrawal: [...] Liver function abnormalities: Bicalutamide plus LHRH-A (n = 401): 6 [1.5%]; Flutamide plus LHRH-A (n = 407): 8 [2.0%]. [...]
- ^ "Casodex Product Monograph" (PDF). Retrieved 24 September 2018.
Table 1 Incidence of Adverse Reactions (≥ 5% in Either Treatment Group) Regardless of Causality [...] Increased Liver Enzyme Test: [...] [Number of Patients (%)] [...] CASODEX Plus LHRH Analog (n=401): 30 (7 [7.5%) [...] Flutamide Plus LHRH Analog (n=407): 46 (11 [11.3%]).
- ^ "NU-Bicalutamide Product Monograph" (PDF). Retrieved 24 September 2018.
Adverse event reports of abnormal liver function test results occurred in 7% of patients. These changes were frequently transient and rarely severe, resolving or improving with continued therapy or following cessation of therapy. Hepatic failure and interstitial lung disease (see WARNINGS AND PRECAUTIONS) have been observed in post-marketed data and fatal outcomes have been reported for both. [...] The most common adverse events leading to withdrawal of study medication were abnormal liver function tests (1.5%) [...] Table 1 Incidence Of Adverse Events (≥ 5% In Either Treatment Group) Regardless Of Causality [...] Increased Liver Enzyme Testb [Number of Patients (%)] [...] CASODEX Plus LHRH Analogue (n=401): 30 (7 [7.5%]) [...] Flutamide Plus LHRH Analogue (n=407): 46 (11 [11.3%]) [...] During the first few months of use, you may be monitored by your physician for signs of changes in your liver function. In approximately 2.0% of patients, such changes may lead to withdrawal of therapy.
- ^ Blackledge GR (1996). "Clinical progress with a new antiandrogen, Casodex (bicalutamide)". Eur. Urol. 29 Suppl 2: 96–104. doi:10.1159/000473847. PMID 8717470.
Casodex has been administered to over 3,900 subjects and patients and, in general, has been well tolerated. [...] Elevations of liver transaminases have been seen with Casodex, but these are usually transient, resolving either on continued therapy or on temporary cessation of therapy. In a randomised comparison with flutamide, elevations of transaminases were both less frequent and less severe than with flutamide. No cases of fulminant hepatic failure or death due to hepatic failure have been seen with Casodex in any of the clinical trials.