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Keywords: prostate, androgen, antiandrogen, pharmacokinetics, pharmacodynamics Prostate function is an important indicator of androgen status in toxicological studies, making desirable predictive systems modeling. A biologically based model for endogenous hormone kinetics and dynamics in intact and castrate rats and prostate perturbation by antiandrogen exposure has been developed. Antiandrogens act in two ways. Androgen antagonists, such as the fungicide vinclozolin, are competitive ligands for the androgen receptor AR ; . Enzyme inhibitors, such as the therapeutic drug finasteride, inhibit the enzyme 5-reductase 5-R ; from metabolizing testosterone T ; to the more potent dihydrotestosterone DHT ; . Each mode of action results in decreased DHT levels and hence decreased prostate size. A model describing the kinetics of T, DHT, luteinizing hormone LH ; , and antiandrogens was linked to a pharmacodynamic model describing the androgen-controlled gene regulation of the prostate in the adult male rat. The resulting system model simulates time-dependent prostatic changes. The model describes the metabolism of T to DHT by 5-R with feedback loops for the positive regulation of T synthesis by LH and negative regulation of LH by and DHT. The generegulated processes involved in prostate maintenance, including cell proliferation, apoptosis, fluid production, and 5-R activity, are each controlled in the model by the occupancy of a single gene by androgen-AR dimerized complexes. The model accurately captures the dynamics of the prostate after castration vs. daily doses of finasteride, compared with experimental data. Castration leads to nearly total removal of T and DHT from the body, resulting in acute, substantial prostate regression. Daily dosing of finasteride results in substantially decreased levels of DHT and raised levels of T due to feedback. The result is approximately 60 percent prostate regression after 21 days compared to over 90 percent regression due to castration. This model provides a framework for extension from the adult to the more sensitive pubertal developmental period by including growth and changes in hormone synthesis and metabolism. This work was reviewed by U.S. EPA and approved for publication but does not necessarily reflect official Agency policy. Point of Contact: Hugh Barton Toxicologist U.S. EPA ORD NCCT 109 T.W. Alexander Drive Research Triangle Park, NC 27711 919-541-1995 barton.hugh epa.gov and vasodilan.
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Coronary disease, measured in term of involved vessels, was detected.50 This was consistent with the results of a more recent study on 453 Yorkshire patients, classified at angiography as having normal vessels or single-vessel or multivessel coronary disease, that showed only a borderline significant P 0.06 ; relation between PAI-1ag level and coronary artery stenoses.45 Thus, at the present time there is no conclusive evidence of a relation between PAI-1ag plasma level and the extent of coronary atherosclerosis, and further studies are needed. No relation between coronary atherosclerosis and the 4G 5G polymorphism was found, 45 despite the contention that the 4G homozygotes would have the highest PAI-1 plasma levels. This would also challenge the hypothesis of a role for PAI-1 plasma levels in the development of coronary atherosclerotic lesions, and might suggest that the increased PAI-1 plasma levels in patients with CAD may simply be a consequence of the presence of atheroma.45 However, it must be emphasized that it is not known whether the 4G 5G polymorphism has any relation with the local arterial wall ; levels of PAI-1 and whether the increased plasma levels of PAI-1 reflect an enhanced release of the inhibitor from endothelial cells. Thus, although it has been hypothesized that an increase in local levels of PAI-1 might contribute to the pathogenesis of atherosclerosis, it is still unclear whether the increase in PAI-1 plasma levels observed in this pathological condition represents cause, effect, or both. In our view, the cause effect relation must be demonstrated in prospective studies of healthy populations before PAI-1 can be considered a risk factor for coronary atherosclerosis, because it is evident that PAI-1 can play an ambivalent role, either by contributing plaque stabilization or by enhancing the risk of thrombosis after plaque rupture.
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Glycosuria Weight loss Dry mouth Tingling of extremities Because most of these data are from long-term studies up to 40 weeks of treatment ; , it is probable that many of the adverse experiences reported are due to causes other than the drug. Approximately 10% of patients given indapamide discontinued treatment in long-term trials because of reactions either related or unrelated to the drug. Hypokalemia with concomitant clinical signs or symptoms occurred in 3% of patients receiving indapamide 2.5 mg q.d. and 7% of patients receiving indapamide 5 mg q.d. In long-term controlled clinical trials comparing the hypokalemic effects of daily doses of indapamide and hydrochlorothiazide, however, 47% of patients receiving indapamide 2.5 mg, 72% of patients receiving indapamide 5 mg, and 44% of patients receiving hydrochlorothiazide 50 mg had at least one potassium value out of a total of 11 taken during the study ; below 3.5 mEq L. In the indapamide 2.5 mg group, over 50% of those patients returned to normal serum potassium values without intervention. In clinical trials of six to eight weeks, the mean changes in selected values were as shown in the tables below. Mean Changes from Baseline after 8 Weeks of Treatment 1.25 mg Serum Electrolytes mEq L ; Serum Uric Acid BUN Potassium Sodium Chloride mg dL ; mg dL ; Indapamide 1.46 0.69 0.28 mg n 255-257 ; Placebo n 263-266 ; 0.00 0.11 0.21 0.06 No patients receiving indapamide 1.25 mg experienced hyponatremia considered possibly clinically significant 125 mEq L ; . Indapamide had no adverse effects on lipids. Mean Changes from Baseline after 40 Weeks of Treatment 2.5 mg and 5.0 mg Serum Electrolytes mEq L ; Serum Uric Acid BUN Potassium Sodium Chloride mg dL ; mg dL ; Indapamide 0.4 0.6 3.6 mg n 76 ; Indapamide 0.6 0.7 5.1 mg n 81 ; The following reactions have been reported with clinical usage of Lozol: jaundice intrahepatic cholestatic jaundice ; , hepatitis, pancreatitis and abnormal liver function tests. These reactions were reversible with discontinuance of the drug. Also reported are erythema multiforme, Stevens-Johnson Syndrome, bullous eruptions, purpura, photosensitivity, fever, pneumonitis, anaphylactic reactions, agranulocytosis, leukopenia!
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The possibility that changes in the level of PKA activity in U. maydis result in resistance to vinclozolin was explored by examining previously characterized mutant strains that are defective in the regulatory subunit of PKA due to disruption of the ubc1 gene Gold et al., 1994; Durrenberger et al., 1998 ; . These strains are expected to have high levels of constitutive PKA activity due to loss of the inhibitory influence of the regulatory subunit. As shown in Fig. 2, a strain with a defect in ubc1 displayed more robust growth in the presence of a concentration of vinclozolin 25 g ml ; that inhibited the growth of the wild-type strain. We also tested isolates with disruption mutations in uac1 encoding adenylyl cyclase; Gold et al., 1994 ; and adr1 Durrenberger et al., 1998 ; in similar growth assays on solid medium and found that these strains were sensitive to growth inhibition by vinclozolin data not shown ; . These mutants would be expected to have low PKA activity and thus be more sensitive to vinclozolin than wild-type cells. Unfortunately, these mutants grow with a filamentous morphology and this phe.
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Concerning Question 3, there were varying degrees of enthusiasm to pursue smoked marijuana for several indications. This enthusiasm was tempered by the fact that, for many of these disorders, effective alternative treatments are already available. Given the general consensus among the experts that the number, design and documentation of studies performed to date with smoked marijuana did not provide definitive answers, it was difficult to compare marijuana with products that had received regulatory approval under more rigorous experimental conditions. This does not mean, however, that the issue should be foreclosed. It simply means that in order to evaluate various hypotheses concerning the potential utility of marijuana in various therapeutic areas, more and better studies would be needed. In the words of Dr. William Beaver, Professor of Pharmacology and Anesthesia, Georgetown University School of Medicine, who 4.
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