Deltasone (Prednisone) - Summary

DELTASONE SUMMARY

Deltasone tablets contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract.

Prednisone tablets are indicated in the following conditions:

1. Endocrine Disorders:

Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance).

Congenital adrenal hyperplasia.

Hypercalcemia associated with cancer.

Nonsuppurative thyroiditis.

2. Rheumatic Disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:

Psoriatic arthritis.

Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy).

Ankylosing spondylitis.

Acute and subacute bursitis.

Acute nonspecific tenosynovitis.

Acute gouty arthritis.

Post-traumatic osteoarthritis.

Synovitis of osteoarthritis.

Epicondylitis.

3. Collagen Diseases: During an exacerbation or as maintenance therapy in selected cases of:

Systemic lupus erythematosus.

Systemic dermatomyositis (polymyositis).

Acute rheumatic carditis.

4. Dermatological Diseases:

Pemphigus.

Bullous dermatitis herpetiformis.

Severe erythema muliforme (Stevens-Johnson syndrome).

Exfoliative dermatitis.

Mycosis fungoides.

Severe psoriasis.

Severe seborrheic dermatitis.

5. Allergic States: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:

Seasonal or perennial allergic rhinitis.

Bronchial asthma.

Contact dermatitis.

Atopic dermatitis.

Serum sickness.

Drug hypersensitivity reactions.

6. Ophthalmic Diseases: Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:

Allergic corneal marginal ulcers.

Herpes zoster ophthalmicus.

Anterior segment inflammation.

Diffuse posterior uveitis and choroiditis.

Sympathetic ophthalmia.

Allergic conjunctivitis.

Keratitis.

Chorioretinitis.

Optic neuritis.

Iritis and iridocyclitis.

7. Respiratory Diseases:

Symptomatic sarcoidosis.

Loeffler's syndrome not manageable by other means.

Berylliosis.

Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy.

Aspiration pneumonitis.

8. Hematologic Disorders:

Idiopathic thrombocytopenic purpura in adults.

Secondary thrombocytopenia in adults.

Acquired (autoimmune) hemolytic anemia.

Erythroblastopenia (RBC anemia).

Congenital (erythroid) hypoplastic anemia.

9. Neoplastic Diseases: For palliative management of:

Leukemias and lymphomas in adults.

Acute leukemia of childhood.

10. Edematous States:

To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus.

11. Gastrointestinal Diseases: To tide the patient over a critical period of the disease in:

Ulcerative colitis.

Regional enteritis.

12. Nervous System:

Acute exacerbations of multiple sclerosis.

13. Miscellaneous:

Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy.

Trichinosis with neurologic or myocardial involvement.

DELTASONE NEWS HIGHLIGHTS

Published Studies Related to Deltasone (Prednisone)

Combination therapy of prednisone and ACE inhibitor versus ACE-inhibitor therapy alone in patients with IgA nephropathy: a randomized controlled trial. [2009.01]
BACKGROUND: Recent studies have shown that both steroids and angiotensin-converting enzyme (ACE) inhibitors improve kidney survival and decrease proteinuria in patients with immunoglobulin A nephropathy. In this study, we aim to investigate whether the addition of steroids to ACE-inhibitor therapy produces a more potent antiproteinuric effect and better protection of kidney function than an ACE inhibitor alone... CONCLUSIONS: Our results suggest that the addition of steroid to ACE-inhibitor therapy provided additional benefit compared with an ACE inhibitor alone. However, this was a pilot study with a small number of participants achieving the end points, and thus further validation is necessary.

Efficacy of 1-4 mg per day of prednisone in patients with rheumatoid arthritis: a randomized, double-blind, placebo-controlled withdrawal clinical trial. [2008.12.15]
OBJECTIVE: A randomized double-blind placebo-controlled withdrawal clinical trial of prednisone [generic for Deltasone] versus placebo in patients with rheumatoid arthritis (RA), treated in usual clinical care with 1-4 mg prednisone per day, withdrawn to the same dose of 1 mg prednisone or identical placebo tablets... CONCLUSION: Efficacy of 1-4 mg prednisone was documented. Evidence of statistically significant differences with only 31 patients may suggest a robust treatment effect.

Prospective randomized study comparing docetaxel, estramustine, and prednisone with docetaxel and prednisone in metastatic hormone-refractory prostate cancer. [2008.11.10]
PURPOSE: To assess the efficacy and toxicity of the addition of estramustine to docetaxel (D) for the treatment of metastatic hormone-refractory prostate cancer... CONCLUSION: The addition of estramustine to weekly D does not provide any clinically relevant advantage. Both regimens are well tolerated, although the toxicity profile favors D without estramustine.

Combination Therapy of Prednisone and ACE Inhibitor Versus ACE-Inhibitor Therapy Alone in Patients With IgA Nephropathy: A Randomized Controlled Trial. [2008.10.17]
BACKGROUND: Recent studies have shown that both steroids and angiotensin-converting enzyme (ACE) inhibitors improve kidney survival and decrease proteinuria in patients with immunoglobulin A nephropathy. In this study, we aim to investigate whether the addition of steroids to ACE-inhibitor therapy produces a more potent antiproteinuric effect and better protection of kidney function than an ACE inhibitor alone... CONCLUSIONS: Our results suggest that the addition of steroid to ACE-inhibitor therapy provided additional benefit compared with an ACE inhibitor alone. However, this was a pilot study with a small number of participants achieving the end points, and thus further validation is necessary.

Oral melphalan, prednisone, and thalidomide in elderly patients with multiple myeloma: updated results of a randomized controlled trial. [2008.10.15]
The initial analysis of the oral combination melphalan, prednisone [generic for Deltasone], and thalidomide (MPT) in newly diagnosed patients with myeloma showed significantly higher response rate and longer progression-free survival (PFS) than did the standard melphalan and prednisone (MP) combination and suggested a survival advantage... New agents in the management of relapsed disease could explain this finding.

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Clinical Trials Related to Deltasone (Prednisone)

Prednisone Timed-Release Tablet (TRT) Study: TRT Formulation of Prednisone Compared to Standard Prednisone in Patients With Rheumatoid Arthritis [Completed]
The objective of this study is to investigate if low doses of prednisone TRT, given at night and, with active drug release at 2 am, are more effective in controlling joint stiffness, and other disease symptoms of rheumatoid arthritis than standard prednisone given in the morning. Treatment duration per patient takes 12 months (the double-blind comparative study takes 3 months; 9 months subsequent open treatment on the TRT-medication).

Prednisone-Placebo vs Prednisone-Valacyclovir in Bell´s Palsy [Completed]
Since steroids carry a moderate beneficial effect in Bell's palsy, and to address this question, valacyclovir was added to prednisone for the treatment of this condition.

Comparison of Melphalan-Prednisone (MP) to MP Plus Thalidomide in the Treatment of Newly Diagnosed Very Elderly Patients (> 75 Years) With Multiple Myeloma [Terminated]
In multiple myeloma, combination chemotherapy with melphalan plus prednisone has been usedsince the 1960s and is regarded as the standard of care in very elderly patients. We assess whether the addition of thalidomide at 100 mg/day to this combination would improve survival.

Study of Irofulven in Patients With Hormone-Refractory Prostate Cancer [Active, not recruiting]
Irofulven is an investigational chemotherapeutic agent being studied in a variety of solid tumors. The purpose of this study is to assess the efficacy and safety of irofulven-based regimens compared to mitoxantrone plus prednisone in patients with hormone-refractory prostate cancer (HRPC) whose disease has progressed following Taxotere® based regimens. Upon determination of eligibility, patients will randomly be assigned to receive one of three treatment arms:

- Irofulven + prednisone

- Irofulven + capecitabine (Xeloda®) + prednisone

- Mitoxantrone + prednisone

For every five patients randomized, two will receive treatment number 1 (irofulven + prednisone), two patients will receive treatment number 2 (irofulven + capecitabine (Xeloda®) + prednisone), and one patient will receive treatment number 3 (mitoxantrone + prednisone). This is not a blinded study, so both the patient and doctor will know which treatment has been assigned.

Mitoxantrone, Prednisone Plus Sorafenib in Taxane-Refractory Metastatic Hormone Refractory Prostate Cancer (HRPC) [Active, not recruiting]
The purpose of this research study is to determine if the combination of mitoxantrone, prednisone and sorafenib will improve the time to progression of advanced stage metastatic hormone-refractory prostate cancer.

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