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Docetaxel with Prednisone Or Prednisolone for the Treatment of Prostate Cancer ISSN 1366-5278 Feedback Your Views About This Report
Health Technology Assessment Health Technology Health Technology Assessment 2007; Vol. 11: No. 2 2007; 11: No. 2 Vol. Docetaxel with prednisone or prednisolone for the treatment of prostate cancer A systematic review and economic model of the clinical effectiveness and cost-effectiveness of docetaxel in combination with prednisone or prednisolone for the treatment of hormone-refractory metastatic prostate cancer Feedback The HTA Programme and the authors would like to know R Collins, E Fenwick, R Trowman, R Perard, your views about this report. The Correspondence Page on the HTA website G Norman, K Light, A Birtle, S Palmer (http://www.hta.ac.uk) is a convenient way to publish and R Riemsma your comments. If you prefer, you can send your comments to the address below, telling us whether you would like us to transfer them to the website. We look forward to hearing from you. January 2007 The National Coordinating Centre for Health Technology Assessment, Mailpoint 728, Boldrewood, Health Technology Assessment University of Southampton, NHS R&D HTA Programme Southampton, SO16 7PX, UK. HTA Fax: +44 (0) 23 8059 5639 Email: [email protected] www.hta.ac.uk http://www.hta.ac.uk ISSN 1366-5278 HTA How to obtain copies of this and other HTA Programme reports. An electronic version of this publication, in Adobe Acrobat format, is available for downloading free of charge for personal use from the HTA website (http://www.hta.ac.uk). A fully searchable CD-ROM is also available (see below). Printed copies of HTA monographs cost £20 each (post and packing free in the UK) to both public and private sector purchasers from our Despatch Agents. -
COMMENTARY Possible New Mechanism of Cortisol Action In
211 COMMENTARY Possible new mechanism of cortisol action in female reproductive organs: physiological implications of the free hormone hypothesis C Yding Andersen Laboratory of Reproductive Biology, Section 5712, University Hospital of Copenhagen, DK-2100 Copenhagen, Denmark (Requests for offprints should be addressed to C Yding Andersen; Email: [email protected]) Abstract The so-called free hormone hypothesis predicts that the cortisol to cortisone, while 11-HSD type 1 reverses this biological activity of a given steroid correlates with the free reaction. As a result, a high concentration of cortisol protein-unbound concentration rather than with the total available for biological action is present in the preovulatory concentration (i.e. free plus protein-bound). Cortisol is a follicle just prior to ovulation and it has been suggested that glucocorticoid with many diverse functions and the free cortisol may function to reduce the inflammatory-like hormone hypothesis seems to apply well to the observed reactions occurring in connection with ovulation. effects of cortisol. The ovaries express glucocorticoid This paper suggests (1) that the function of the oviduct receptors and are affected by cortisol, but lack the neces- is also affected by the high levels of free cortisol released in sary enzymes for cortisol synthesis. Ovarian follicles modu- preovulatory follicular fluid at ovulation and (2) that late the biological activity of cortisol by (1) follicular formation and function of the corpus luteum benefits from production of especially progesterone and 17-hydroxy- a high local concentration of free cortisol, whereas the progesterone which, within the follicle, reach levels that surrounding developing follicles may experience negative displace cortisol from its binding proteins, in particular, effects. -
Prednisolone Versus Dexamethasone for Croup: a Randomized Controlled Trial Colin M
Prednisolone Versus Dexamethasone for Croup: a Randomized Controlled Trial Colin M. Parker, MBChB, DCH, MRCPCH, FACEM,a,b Matthew N. Cooper, BCA, BSc, PhDc OBJECTIVES: The use of either prednisolone or low-dose dexamethasone in the treatment of abstract childhood croup lacks a rigorous evidence base despite widespread use. In this study, we compare dexamethasone at 0.6 mg/kg with both low-dose dexamethasone at 0.15 mg/kg and prednisolone at 1 mg/kg. METHODS: Prospective, double-blind, noninferiority randomized controlled trial based in 1 tertiary pediatric emergency department and 1 urban district emergency department in Perth, Western Australia. Inclusions were age .6 months, maximum weight 20 kg, contactable by telephone, and English-speaking caregivers. Exclusion criteria were known prednisolone or dexamethasone allergy, immunosuppressive disease or treatment, steroid therapy or enrollment in the study within the previous 14 days, and a high clinical suspicion of an alternative diagnosis. A total of 1252 participants were enrolled and randomly assigned to receive dexamethasone (0.6 mg/kg; n = 410), low-dose dexamethasone (0.15 mg/kg; n = 410), or prednisolone (1 mg/kg; n = 411). Primary outcome measures included Westley Croup Score 1-hour after treatment and unscheduled medical re-attendance during the 7 days after treatment. RESULTS: Mean Westley Croup Score at baseline was 1.4 for dexamethasone, 1.5 for low-dose dexamethasone, and 1.5 for prednisolone. Adjusted difference in scores at 1 hour, compared with dexamethasone, was 0.03 (95% confidence interval 20.09 to 0.15) for low-dose dexamethasone and 0.05 (95% confidence interval 20.07 to 0.17) for prednisolone. -
Penetration of Synthetic Corticosteroids Into Human Aqueous Humour
Eye (1990) 4, 526--530 Penetration of Synthetic Corticosteroids into Human Aqueous Humour C. N. 1. McGHEE,1.3 D. G. WATSON, 3 1. M. MIDGLEY, 3 M. 1. NOBLE, 2 G. N. DUTTON, z A. I. FERNl Glasgow Summary The penetration of prednisolone acetate (1%) and fluorometholone alcohol (0.1%) into human aqueous humour following topical application was determined using the very sensitive and specific technique of Gas Chromatography with Mass Spec trometry (GCMS). Prednisolone acetate afforded peak mean concentrations of 669.9 ng/ml within two hours and levels of 28.6 ng/ml in aqueous humour were detected almost 24 hours post application. The peak aqueous humour level of flu orometholone was S.lng/ml. The results are compared and contrasted with the absorption of dexamethasone alcohol (0.1%), betamethasone sodium phosphate (0.1 %) and prednisolone sodium phosphate (0.5%) into human aqueous humour. Topical corticosteroid preparations have been prednisolone acetate (1.0%) and fluorometh used widely in ophthalmology since the early alone alcohol (0.1 %) (preliminary results) 1960s and over the last 10 years the choice of into the aqueous humour of patients under preparations has become larger and more going elective cataract surgery. varied. Unfortunately, data on the intraocular penetration of these steroids in humans has SUbjects and Methods not paralleled the expansion in the number of Patients who were scheduled to undergo rou available preparations; indeed until recently, tine cataract surgery were recruited to the estimation of intraocular penetration has study and informed consent was obtained in been reliant upon extrapolation of data from all cases (n=88), Patients with corneal disease animal models (see Watson et ai., 1988, for or inflammatory ocular conditions which bibliography). -
Part I Biopharmaceuticals
1 Part I Biopharmaceuticals Translational Medicine: Molecular Pharmacology and Drug Discovery First Edition. Edited by Robert A. Meyers. © 2018 Wiley-VCH Verlag GmbH & Co. KGaA. Published 2018 by Wiley-VCH Verlag GmbH & Co. KGaA. 3 1 Analogs and Antagonists of Male Sex Hormones Robert W. Brueggemeier The Ohio State University, Division of Medicinal Chemistry and Pharmacognosy, College of Pharmacy, Columbus, Ohio 43210, USA 1Introduction6 2 Historical 6 3 Endogenous Male Sex Hormones 7 3.1 Occurrence and Physiological Roles 7 3.2 Biosynthesis 8 3.3 Absorption and Distribution 12 3.4 Metabolism 13 3.4.1 Reductive Metabolism 14 3.4.2 Oxidative Metabolism 17 3.5 Mechanism of Action 19 4 Synthetic Androgens 24 4.1 Current Drugs on the Market 24 4.2 Therapeutic Uses and Bioassays 25 4.3 Structure–Activity Relationships for Steroidal Androgens 26 4.3.1 Early Modifications 26 4.3.2 Methylated Derivatives 26 4.3.3 Ester Derivatives 27 4.3.4 Halo Derivatives 27 4.3.5 Other Androgen Derivatives 28 4.3.6 Summary of Structure–Activity Relationships of Steroidal Androgens 28 4.4 Nonsteroidal Androgens, Selective Androgen Receptor Modulators (SARMs) 30 4.5 Absorption, Distribution, and Metabolism 31 4.6 Toxicities 32 Translational Medicine: Molecular Pharmacology and Drug Discovery First Edition. Edited by Robert A. Meyers. © 2018 Wiley-VCH Verlag GmbH & Co. KGaA. Published 2018 by Wiley-VCH Verlag GmbH & Co. KGaA. 4 Analogs and Antagonists of Male Sex Hormones 5 Anabolic Agents 32 5.1 Current Drugs on the Market 32 5.2 Therapeutic Uses and Bioassays -
Steroid Use in Prednisone Allergy Abby Shuck, Pharmd Candidate
Steroid Use in Prednisone Allergy Abby Shuck, PharmD candidate 2015 University of Findlay If a patient has an allergy to prednisone and methylprednisolone, what (if any) other corticosteroid can the patient use to avoid an allergic reaction? Corticosteroids very rarely cause allergic reactions in patients that receive them. Since corticosteroids are typically used to treat severe allergic reactions and anaphylaxis, it seems unlikely that these drugs could actually induce an allergic reaction of their own. However, between 0.5-5% of people have reported any sort of reaction to a corticosteroid that they have received.1 Corticosteroids can cause anything from minor skin irritations to full blown anaphylactic shock. Worsening of allergic symptoms during corticosteroid treatment may not always mean that the patient has failed treatment, although it may appear to be so.2,3 There are essentially four classes of corticosteroids: Class A, hydrocortisone-type, Class B, triamcinolone acetonide type, Class C, betamethasone type, and Class D, hydrocortisone-17-butyrate and clobetasone-17-butyrate type. Major* corticosteroids in Class A include cortisone, hydrocortisone, methylprednisolone, prednisolone, and prednisone. Major* corticosteroids in Class B include budesonide, fluocinolone, and triamcinolone. Major* corticosteroids in Class C include beclomethasone and dexamethasone. Finally, major* corticosteroids in Class D include betamethasone, fluticasone, and mometasone.4,5 Class D was later subdivided into Class D1 and D2 depending on the presence or 5,6 absence of a C16 methyl substitution and/or halogenation on C9 of the steroid B-ring. It is often hard to determine what exactly a patient is allergic to if they experience a reaction to a corticosteroid. -
PROMETRIUM® (Progesterone, USP) Capsules 200 Mg WARNING
PROMETRIUM® (progesterone, USP) Capsules 100 mg Capsules 200 mg WARNING: CARDIOVASCULAR DISORDERS, BREAST CANCER AND PROBABLE DEMENTIA FOR ESTROGEN PLUS PROGESTIN THERAPY Cardiovascular Disorders and Probable Dementia Estrogens plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia. (See CLINICAL STUDIES and WARNINGS, Cardiovascular disorders and Probable dementia.) The Women's Health Initiative (WHI) estrogen plus progestin substudy reported increased risks of deep vein thrombosis, pulmonary embolism, stroke and myocardial infarction in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral conjugated estrogens (CE) [0.625 mg] combined with medroxyprogesterone acetate (MPA) [2.5 mg], relative to placebo. (See CLINICAL STUDIES and WARNINGS, Cardiovascular disorders.) The WHI Memory Study (WHIMS) estrogen plus progestin ancillary study of the WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with daily CE (0.625 mg) combined with MPA (2.5 mg), relative to placebo. It is unknown whether this finding applies to younger postmenopausal women. (See CLINICAL STUDIES and WARNINGS, Probable dementia and PRECAUTIONS, Geriatric Use.) Breast Cancer The WHI estrogen plus progestin substudy also demonstrated an increased risk of invasive breast cancer. (See CLINICAL STUDIES and WARNINGS, Malignant neoplasms, Breast Cancer.) In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and MPA, and other combinations and dosage forms of estrogens and progestins. Progestins with estrogens should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman. -
Oral Contraceptives and Endocrine Changes* 0
Bull. Org. mond. Sante 1972, 46, 443-450 Bull. Wid HIth Org. Oral contraceptives and endocrine changes* 0. J. LUCIS1 & R. LUCIS In groups of women taking oral contraceptives and in control groups ofwomen, the serum levels ofcortisol, protein-bound iodine, and total thyroxine were measured together with the T3 binding index. The daily excretion in the urine offree cortisol, 17-hydroxycorticoste- roids, 17-ketosteroids, pregnanediol, pregnanetriol, total oestrogens, total catecholamines, and 4-hydroxy-3-methoxymandelic acid was also assayed. The frequency distribution of the values obtained indicates that oral contraceptives have a marked influence on the endocrine environment. The smallest deviations were observed in urinary excretion of total catecholamines and of 4-hydroxy-3-methoxymandelic acid. In some individuals the hor- mone assays were continued throughout the menstrual cycle. The morning and afternoon levels of serum cortisol tended to increase during the period when the oral contraceptive was being taken. According to the estimates of the Advisory Com- to prescription, and had been doing so for at least mittee on Obstetrics and Gynecology (1969) of the 2 months. The types of oral contraceptive prepara- United States Food and Drug Administration, tions taken are shown in Table 1. 18.5 million women are using oral contraceptives. The urinary excretion of hormones and their The hormonal balance in these women may show metabolites was determined on 24-hour urine spe- deviations from that seen in normally menstruating cimens. The quantity of free cortisol in the urine was women and this problem was investigated in our assayed by the method of protein displacement bind- laboratory in order to establish the values for com- ing (Murphy, 1967) using newborn calf serum and monly used endocrine assays in women with spon- corticosterone-3H as reagents. -
Pharmacokinetics of Ophthalmic Corticosteroids
British Journal ofOphthalmology 1992; 76: 681-684 681 MINI REVIEW Br J Ophthalmol: first published as 10.1136/bjo.76.11.681 on 1 November 1992. Downloaded from Pharmacokinetics of ophthalmic corticosteroids Corticosteroids have been used by ophthalmologists with an identical vehicle, the aqueous humour concentrations of increasing frequency over the past 30 years, with the these steroids are almost identical.'9 None the less it is concomitant development of a diverse range of drop, essential when considering such empirical data, to recall that ointment, subconjunctival, and oral preparations. Though the systemic anti-inflammatory effect of both betamethasone the clinical benefits and side effects of such corticosteroid and dexamethasone is five to seven times that of predniso- preparations have been well documented, their basic lone.39"' The local anti-inflammatory potency of ocular pharmacokinetics in the human eye have yet to be fully steroids has yet to be fully investigated and whilst early work established. Indeed most of our pharmacokinetic knowledge suggested that prednisolone acetate 1% had the greatest anti- of these drugs has been elucidated by extrapolation of data inflammatory effect in experimental keratitis,'7 later studies obtained from rabbit experiments.1-26 These results can be demonstrated that fluorometholone acetate in a 1% formu- significantly disparate from human data because of the lation was equally efficacious in the same model.26 However, thinner rabbit cornea, lower rabbit blink rate, effect of prednisolone -
Characteristics of Binding to Estrogen, Androgen, Progestin, And
[CANCER RESEARCH 40. 1612-1622, May 1980] 0008-5472/80/0040-OOOOS02.00 Characteristics of Binding to Estrogen, Androgen, Progestin, and Glucocorticoid Receptors in 7,12-Dimethylbenz(a)anthracene- induced Mammary Tumors and Their Hormonal Control1 Jacques Asselin,2 RéjeanMelançon,Gilbert Moachon, and Alain Bélanger Laboratory of Molecular Endocrinology, Le Centre Hospitalier de I UniversitéLaval, Quebec G1V4G2, Quebec. Canada ABSTRACT induced mammary tumors in the rat. Moreover, as revealed by hypophysectomy, adrenalectomy, and ovariectomy, the levels In order to perform simultaneous measurement of binding of of the progesterone and glucocorticoid receptors are under four classes of steroids and facilitate study of their mechanism different hormonal control. of action in 7,12-dimethylbenz(a)anthracene-induced mam mary tumors in the rat, we have investigated in detail the binding characteristics of 17/3-[2,4,6,7,16,17-3H]estradiol INTRODUCTION (17/8-[3H]estradiol), 17,21 -[6,7-3H]dimethyl-19-norpregna- 4,9-diene-3,20-dione ([3H]R5020), [3H]dexamethasone (DEX), Treatment of human breast cancer by endocrine manipula and 5a-[3H]dihydrotestosterone (DHT) in cytosol prepared from tion has shown that a certain proportion of these tumors are hormone dependent. This is supported by the presence of these tumors. Following assessment of optimal buffer compo steroid and peptide receptors in these tumors. In fact, estrogen sition, separation of bound and free steroids was achieved with (16, 23, 27, 41, 45), progesterone (38, 41, 45), and androgen dextran-coated charcoal, protamine sulfate, or hydroxylapatite. (31, 39) receptors have been reported in cytosol prepared Using the same buffer and the optimal method of separation from human breast cancer biopsies. -
Ophthalmic Steroids Reference Number: OH.PHAR.PPA.100 Effective Date: 01/01/2021 Revision Log Last Review Date: 11.20 Line of Business: Medicaid
Clinical Policy: Ophthalmic Agents: Ophthalmic Steroids Reference Number: OH.PHAR.PPA.100 Effective Date: 01/01/2021 Revision Log Last Review Date: 11.20 Line of Business: Medicaid See Important Reminder at the end of this policy for important regulatory and legal information. Description Ophthalmic Agents: Ophthalmic Steroids NO PA REQUIRED “PREFERRED” PA REQUIRED “NON-PREFERRED” DEXAMETHASONE SODIUM PHOSPHATE ALREX® (loteprednol etabonate) DUREZOL® (difluprednate) FLAREX® (fluorometholone acetate) FLUOROMETHOLONE INVELTYS® (loteprednol etabonate) FML FORTE® (fluorometholone) LOTEMAX® (loteprednol etabonate) FML S.O.P. ® (fluorometholone) LOTEMAX® SM (loteprednol etabonate) PRED MILD® (prednisolone acetate) LOTEPREDNOL PREDNISOLONE ACETATE MAXIDEX® (dexamethasone sodium phosphate) PREDNISOLONE SODIUM PHOSPHATE FDA approved indication(s) Alrex is indicated for: • Temporary relief of the signs and symptoms of seasonal allergic conjunctivitis Durezol is indicated for: • Treatment of postoperative ocular pain and postoperative ocular inflammation • Treatment of endogenous anterior uveitis Flarex, fluorometholone, FML Forte, and FML S.O.P are indicated for: • Treatment of corticosteroid-responsive ophthalmic disorders including allergic conjunctivitis, ocular burns or trauma due to corneal injury resulting from chemical, thermal or penetration trauma, giant papillary conjunctivitis (GPC), keratitis, postoperative ocular inflammation, vernal keratoconjunctivitis, and chronic anterior uveitis Inveltys is indicated for: • Treatment of postoperative -
Hydrocortisone Tablets Contain Lactose Monohydrate
New Zealand Data Sheet 1. PRODUCT NAME Hydrocortisone 5 mg Tablets Hydrocortisone 20 mg Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each Hydrocortisone 5 mg Tablet contains 5 mg of hydrocortisone. Each Hydrocortisone 20 mg Tablet contains 20 mg of hydrocortisone. Excipient(s) with known effect Hydrocortisone Tablets contain lactose monohydrate. For the full list of excipients, see Section 6.1. 3. PHARMACEUTICAL FORM Hydrocortisone 5 mg Tablet: white, round, biconvex tablet having a diameter of 6.5 mm. Hydrocortisone 20 mg Tablet: white, round, biconvex tablet having a diameter of 7.94 mm, breakline on one face and dp logo on the other. The score line on Hydrocortisone 20 mg Tablet is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4. CLINICAL PARTICULARS 4.1. Therapeutic indications • Replacement therapy in Addison’s disease or chronic adrenocortical insufficiency secondary to hypopituitarism. • Inhibition of the secondary increase in ACTH secretion when aminoglutethimide is administered for breast or prostatic cancer. 4.2. Dose and method of administration Dose As replacement therapy The normal requirement is 10‐30 mg daily (usually 20 mg in the morning and 10 mg at night to mimic the circadian rhythm of the body). 1 | Page As combination therapy with aminoglutethimide A dosage of 40 mg daily, given as 10 mg with breakfast, 10 mg with dinner and 20 mg at bedtime is usually recommended. Special populations Elderly population Steroids should be used cautiously in the elderly, since adverse effects are enhanced in old age, see Section 4.4. When long term treatment is to be discontinued, the dose should be gradually reduced over a period of weeks or months, depending on dosage and duration of therapy, see Section 4.4.