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PubMed2004

An open-label randomized trial of the safety and efficacy of sirolimus vs. azathioprine in living related renal allograft recipients receiving cyclosporine and prednisone combination.

BACKGROUND: The ability of sirolimus (SRL), in combination with reduced exposure of cyclosporine, was investigated to prevent acute rejection and associated side effects. METHODS: Between June 1999 and February 2000, 70 recipients of primary one-haplotype living-related donor renal allografts were randomized to receive SRL (2 mg/d) or azathioprine (AZA) (2 mg/kg/d) combined with cyclosporine and prednisone. The primary end-point was a composite of first occurrence of biopsy-confirmed acute rejection, graft loss, or death during the first 3 months after transplantation. RESULTS: From week 4 to month 12, SRL patients received lower cyclosporine (week 4: 364 mg/d vs. 455 mg/d, p = 0.004; month 12: 195 mg/d vs. 255 mg/d, p = 0.038) doses and showed lower cyclosporine concentrations (week 4: 247 ng/mL vs. 309 ng/mL, p = 0.04; month 12: 143 ng/mL vs. 188 ng/mL, p = 0.045). Compared with AZA, SRL patients showed reduced 3-month primary end point (0% vs. 17.1%, p = 0.025), and reduced incidence of biopsy-confirmed acute rejection at 3 months (0% vs. 14.3%, p = 0.01) but not at 12 months (11.4% vs. 14.3%, NS). Mean creatinine at 12 months were not different (1.8 +/- 0.6 vs. 1.6 +/- 0.6, p = 0.23). Hyperlipidemia was the only adverse event more frequent among SRL patients (49% vs. 17%, p = 0.01). There were no differences in infections and no malignancies in both groups. CONCLUSIONS: The combination of 2 mg fixed doses of SRL, reduced cyclosporine exposure and prednisone was associated with a low incidence of acute rejection and did not result in significantly impaired graft function compared with patients receiving AZA, standard doses of cyclosporine and prednisone.

Adult↗
PubMed2006

Prednisone withdrawal in pediatric kidney transplant recipients on tacrolimus-based immunosuppression: four-year data.

Corticosteroids have been used in renal transplant immunosuppression for over 40 yr. Despite their adverse effects, steroid therapy continues to be part of early as well as maintenance immunosuppression in most pediatric renal transplant centers. The association of steroids with growth retardation, weight gain, and acne may be particularly distressing during the critical years of adolescence and young adulthood, increasing the risk of medication non-adherence. This study reviews the outcomes of pediatric renal transplant patients treated with low-dose tacrolimus, mycophenolate mofetil, or azathioprine, and planned prednisone withdrawal. Thirty-seven pediatric renal transplant recipients were withdrawn from steroids. The mean follow-up after steroid withdrawal was 42+/-19 months. Graft and patient survival were 100%. The mean serum creatinine levels and calculated creatinine clearances remained stable throughout the period of observation. The mean creatinine clearance was 96+/-24 mL/min/1.73 m2 at steroid withdrawal and 93+/-20 mL/min/1.73 m2 at the latest follow-up. Five patients restarted prednisone; in four (11%) it was for suspected or confirmed acute rejection. Improvements were observed in serum lipid profiles, blood pressure, and body mass index. Most patients experienced catchup or stable growth after prednisone withdrawal. Four patients developed viral infections; all were successfully treated. The potential benefits of steroid withdrawal in pediatric renal transplantation are supported by our results.

Adolescent↗
PubMed1984

Ovarian function after renal transplantation: comparison of cyclosporin A with azathioprine and prednisone combination regimens.

Ovarian function was assessed in 24 women after renal transplantation who were treated either with cyclosporin A (10 patients) or with a combination of azathioprine and prednisone (14 patients) as immunosuppressive therapy. The different regimens were not associated with any differences in clinical or endocrine indices of ovarian function (LH, FSH, prolactin, testosterone, oestradiol, dehydroepiandrosterone sulphate). Excessive hair growth was common in both treatment groups. Levels of testosterone and dehydroepiandrosterone were higher in cyclosporin-treated women but this was due to prednisone-induced suppression of adrenal androgen output in the azathioprine- and prednisone-treated women. Excessive hair growth was present in postmenopausal women on both treatments suggesting that hypertrichosis is a consequence of renal transplantation and is not a specific side-effect of cyclosporin A therapy.

Adult↗
PubMed1983

The influence of high-dose prednisone medication on autoantibody specific activity and on circulating immune complex level in cerebrospinal fluid of multiple sclerosis patients.

In agreement with the close correlation between intrathecal IgG production and anti-MBP (myelin basic protein) and anti-MAG (myelin-associated glycoprotein) antibody activity in the CSF of active MS cases, and parallel to the reduction of intrathecal IgG synthesis resulting from corticosteroids medication, we have found a significant reduction of anti-MBP and anti-MAG antibody activity expressed per 0.5 micrograms of CSF IgG in the same group of 40 MS patients subjected to high-dose prednisone therapy. Every patient received 3980 mg of prednisone over 54 days. In native CSF of 30% (21/70) of active MS cases, circulating immune complexes (CIC) were detected by C1q binding solid-phase RIA. There was no correlation between CIC level in the CSF or MS patients and 1. IgG index which was used as an indicator of intrathecal IgG synthesis, or 2. CSF anti-MBP specific antibody activity, or 3. CSF anti-MAG specific antibody activity. High-dose prednisone therapy resulted in a highly significant reduction of the CSF CIC level. CIC were also found in the CSF of patients affected with various chronic diseases of the CNS.

Adult↗
PubMed1985

Phase III study of intermittent 5-drug regimen (VBCMP) versus intermittent 3-drug regimen (VMP) versus intermittent melphalan and prednisone (MP) in myelomatosis.

A prospective randomized trial in 96 patients with previously untreated myelomatosis was performed comparing 3 regimens of chemotherapy: (i) Intermittent vincristine, BCNU, cyclophosphamide, melphalan, and prednisone (VBCMP) to (ii) intermittent vincristine, melphalan and prednisone (VMP) to (iii) intermittent melphalan and prednisone (MP). Induction response rates and survival were similar in all 3 regimens. An improvement in relapse-free survival was observed by adding vincristine to MP, but this did not achieve statistical difference (p = 0.10). Patients given VBCMP fared slightly worse than those given VMP. The haematologic toxicity was similar in all 3 regimens, but the tolerability of VBCMP was lower. Although showing no statistical differences between the 3 treatment regimens, the results support the view that a combination of MP 'standard' induction therapy in MM with frequently administered vincristine has a trend towards postponing treatment failure due to development of resistance to melphalan.

Adult↗
PubMed2005

Effects of short-term treatment with systemic prednisone on bone healing: an experimental study in rats.

Long-term systemic use of corticosteroids causes osteoporosis and increased risk of fracture. However, the effect of short-term use of corticosteroids on bone healing is not well defined. The aim of the present study was to test the influence of short-term systemic corticosteroid therapy on bone healing. Standardized bone defects (2 mm diameter) were formed in the middle of the femur in 40 male rats. Rats were divided into two groups; control group (n = 20) and prednisone-treated group (n = 20). Subcutaneous injection of either sterile normal saline (control) or 0.020 mg kg(-1) dose of prednisone was administered just before surgery and thereafter daily for 3 days. Histopathological cross sections were taken 1, 2, 3 and 4 weeks after surgery. There was no statistically significant difference between the prednisone group and the control group. No inhibitory effects were seen following short-term corticosteroid treatment.

Animals↗
PubMedDate not supplied

Response of canine mast cell tumors to treatment with oral prednisone.

Twenty-five dogs with naturally occurring mast cell tumors were treated with daily oral prednisone (1 mg/kg) for 28 days. Five dogs (20%) had reduction in tumor volume and were considered responders. Four of these underwent partial remission and one underwent complete remission. Survival times for the five responders were 3, 5, 6, 7.5, and greater than 28 months, respectively. We therefore conclude that prednisone is effective in some canine mast cell tumors. Further studies are indicated to determine the most effective dose of prednisone, the appropriate duration of treatment, and the efficacy in more benign mast cell tumors, and in combination with other forms of therapy.

Administration, Oral↗
PubMed1984

Representation and quantitation of the binding interaction between prednisone, prednisolone and corticosteroid binding globulin.

The interaction between prednisone and prednisolone (0-500 ng ml-1) for binding sites on corticosteroid binding globulin (CBG) in rabbit plasma has been investigated. The fraction unbound of each steroid rose markedly with increasing concentration at low concentrations (250 ng ml-1), tending to a plateau (0.29 prednisone, 0.15 prednisolone) at the higher concentrations (250-500 ng ml-1), indicating both saturation of CBG and the importance of binding to albumin in higher concentrations. A method is proposed of representing graphically the prednisone-prednisolone-protein interaction in three dimensions.

Animals↗
PubMed2000

Prednisone and aspirin improve pregnancy rate in patients with reproductive failure and autoimmune antibodies: a prospective study.

PROBLEM: The study was conducted to investigate the efficacy of prednisone and aspirin in autoantibody seropositive patients with repeated in vitro fertilization embryo transfer (IVF ET) failure. METHODS OF STUDY: The study group comprised 52 consecutive patients seropositive for non-organ-specific autoantibodies, i.e., anti-cardiolipin antibodies (ACA), anti-nuclear antibodies (ANA), anti-double-stranded (ds) DNA, rheumatoid factor (RF), and lupus anti-coagulant (LAC). These patients were treated with prednisone, 10 mg per day, and aspirin, 100 mg per day, starting 4 weeks before induction of ovulation in 52 IVF cycles. RESULTS: The clinical pregnancy rate per cycle was 32.7% (17/52). No increased incidence of pregnancy complications, including premature labor, gestational diabetes mellitus, and pregnancy-induced hypertension, were found. CONCLUSIONS: Combined treatment of prednisone for immunosuppression and aspirin as an anti-thrombotic agent, starting before ovulation induction, may improve pregnancy rate in autoantibody seropositive patients who have had repeated IVF-ET failures.

Antibodies, Anticardiolipin↗
PubMed1975

Haemangioma with coagulopathy: sustained response to prednisone.

Two cases of giant haemangioma with thrombocytopenia are described. A satisfactory and sustained response to prednisone was achieved in respect of both coagulation abnormalities and tumour size. It is proposed that prednisone is effective by enhancement of thrombosis and reduction of fibrinolysis within the tumour, thus promoting a natural form of resolution. It is suggested that prednisone therapy should be first-choice treatment of complicated haemangiomas.

Abdominal Muscles↗
PubMed1975

Prednisone for chronic active liver disease: dose titration, standard dose, and combination with azathioprine compared.

Among 120 consecutive patients with chronic active liver disease (CALD) randomized to different treatments, those receiving maintenance doses of prednisone 20 mg daily (Pred), prednisone in doses given on alternate days and titrated to secure resolution of clinical and biochemical abnormalities (Pred-Titrad), or a combination of prednisone 10 mg and azathioprine 50 mg daily (Comb) survived and underwent resolution of clinical and biochemical features of disease more often than a control group receiving placebo or azathioprine 100 mg daily. Histological remission occurred significantly more often with Pred and Comb than with other regimens. Major side-effects of therapy were commoner with Pred than with Comb or Pred-Titrad, which did not differ. We conclude that Comb is the initial treatment of choice for CALD, since clinical, biochemical, and histological resolution of disease activity occurs as often as with Pred, whereas early side-effects are significantly less frequent.

Adolescent↗
PubMed1990

Acquired von Willebrand disease associated with free lambda light chain monoclonal gammopathy, normal bleeding time and response to prednisone.

We report a case of acquired von Willebrand's syndrome with severe gastrointestinal bleeding and associated free monoclonal lambda light chains. The patient had a rapid sustained clinical and laboratory response to the administration of prednisone. Of note in this patient was the occurrence of angiodysplasia which has previously been reported in association with acquired von Willebrand's syndrome. No inhibitors of VWF:Ag, VWF:RCoF, or factor VIII:C were detected by mixing studies and the bleeding time was normal. Very few high molecular weight von Willebrand multimers were present prior to prednisone; however, the pattern reverted to a normal distribution following treatment. In appropriate patients with acquired von Willebrand's syndrome and monoclonal para-proteins, a trial of prednisone may be indicated.

Bleeding Time↗
PubMed2003

Resolution of multiple severe nonsteroidal anti-inflammatory drug-induced colonic strictures with prednisone therapy: a case report and review of the literature.

A 69-year-old woman on nonsteroidal anti-inflammatory drugs (NSAIDs) was admitted to a university hospital with abdominal pain, profound anemia and melena stools. Duodenal ulceration and subsequent healing were documented. Colonoscopy revealed haustral ulceration and NSAID-induced colonic diaphragm disease. Discontinuation of NSAID therapy did not result in endoscopic change, but a 20-week course of prednisone was followed by complete resolution. This is the first case describing prednisone monotherapy for such strictures, and only the second in which endoscopic resolution has been documented. With further supporting experience, prednisone may be considered in addition to NSAID discontinuation for patients with this rare but serious complication.

Aged↗
PubMed2004

Results of a multicenter randomized phase II trial of thalidomide and prednisone maintenance therapy for multiple myeloma after autologous stem cell transplant.

We report a multicenter, randomized phase II trial conducted to assess the tolerability of combined thalidomide and prednisone maintenance in multiple myeloma. Eligibility required administration of melphalan (200 mg/m2) with blood stem cell support within 1 year of treatment onset and initiation of maintenance within 60 to 100 days after stem cell infusion. All patients received 50 mg of prednisone by mouth on alternate days and thalidomide at a starting dose of either 200 or 400 mg daily by mouth. The primary end point was the incidence of dropout or dose reduction due to treatment toxicity within 6 months. Sixty-seven patients were enrolled. Median follow-up is 36.8 months. The primary end point was reached by 31% of patients on the 200 mg of thalidomide arm and 64% of patients on the 400 mg of thalidomide arm. Allowing for dose reduction, 76% of patients assigned to the 200 mg of thalidomide arm and 41% of patients assigned to the 400 mg of thalidomide arm remained on any maintenance therapy 18 months after registration. Eighty-eight percent of all patients dose-reduced thalidomide and 72% of all patients dose-reduced prednisone within 2 years of beginning maintenance. The median progression-free survival post-transplant is 32.3 months, or 42.2 months from diagnosis. Only the 200 mg of thalidomide arm of this trial met our definition of a tolerable maintenance therapy, defined as no dose reductions or discontinuation due to toxicity in at least 65% of patients for a minimum of 6 months, thus establishing a dosing schedule for phase III trials.

Aged↗
PubMed1999

Control of cytomegalovirus disease in renal transplant patients treated with prednisone, azathioprine and cyclosporine using intensive monitoring and decreased immunosuppression.

BACKGROUND: The aim of this trial was to study the effectiveness of intensive monitoring, together with an early decrease in immunosuppression, in reducing the prevalence of CMV disease in renal transplant recipients treated with prednisone, azathioprine and cyclosporine. METHODS: From 1/95 to 11/97 a prospective, longitudinal study was conducted among 146 consecutive, unselected, renal transplant patients in our unit. Only 96 patients whose immunosuppressive regimens consisted of prednisone, azathioprine and cyclosporine and whose follow-up period was greater than 4 months were included in the study. Preemptive therapy was administered to 27 high-risk patients. CMV antigenemia (CMV-AG) and other virological tests were performed weekly for the first 4 posttransplant months. The immunosuppression was decreased when the first positive CMV-AG was detected. Azathioprine was completely withdrawn when the CMV-AG count was greater than 10 cells per 10(5) PBLs. The cyclosporine dose was gradually decreased in the next 4 weeks, but it was not withdrawn in any patient. The prednisone dose was modified according to the immunosuppressive protocol. RESULTS: 53% (51/96) of the patients had positive CMV-AG on at least one occasion. The dose of azathioprine was decreased after CMV-AG detection in 41/51 (80.4%) patients and it was completely withdrawn in 23 of these (45%). The mean decrease in the dose of azathioprine was 73 +/- 31 (25-175) mg, a mean percentage decrease of 76 +/- 27% (25-100%). The dose of cyclosporine was progressively decreased during the 4 weeks after detection of the first CMV-AG (mean cyclosporine levels: 210 +/- 66, 196 +/- 54 and 164 +/- 36 ng/ml at the time of first CMV-AG detection, 2 and 4 weeks respectively, p < 0.0001, repeated measures analysis of variance). None of the 45 patients without CMV-AG and only 2 of 51 (3.9%) patients with CMV-AG developed symptomatic CMV disease (2% of the total). CMV disease was of moderate intensity in both patients. Only 3/51 (5.8%) patients developed acute rejection after the first CMV-AG detection in the 4 posttransplant months. CONCLUSION: The results of this study suggest that intensive monitoring and an early reduction of immunosuppression, together with preemptive therapy in high-risk patients, is effective in diminishing the prevalence and severity of CMV disease.

Adult↗
PubMed2006

The multicenter trial SAKK 37/95 of cladribine, cyclophosphamide and prednisone in the treatment of chronic lymphocytic leukemias and low-grade non-Hodgkin's lymphomas.

A multicenter trial was performed to confirm the therapeutic efficacy and the toxicity profile of the combination of cladribine, cyclophosphamide and prednisone in low-grade non-Hodgkin's lymphoma (NHL) and chronic lymphocytic leukemia (CLL). Twenty-three adults with previously treated (61%) or untreated (39%) NHL International Working Formulation A or Binet B and C CLL were administered cladribine 0.1 mg/kg/day as a subcutaneous bolus for 5 days, intravenous cyclophosphamide 500 mg/m2 on day 1, and oral prednisone 40 mg/m2 on days 1-5, every 4 weeks. Unexpected early hematological toxicities led to dose modifications for pretreated patients who received cladribine for 3 days only up to a maximum of five courses. Responses were observed in 75%, with 7 patients obtaining a complete clinical and hematological response. Median duration of complete response was 9 months. Median time to progression or relapse was 31 months. Myelosuppression and infections were dose limiting whereas posttreatment complications, including fatalities, resulted from infections. Median overall survival time from trial entry was 60 months. Activity of the combination of cladribine, cyclophosphamide and prednisone was confirmed. However, in the specific setting of a multicenter trial, unexpected fatal infectious episodes occurred in pretreated patients. Great caution is thus required in these susceptible patients and the routine use of corticosteroids should probably be abandoned.

Aged↗
PubMedDate not supplied

A pilot study of prednisone in Alzheimer's disease.

Preliminary to a multicenter trial, an open-label study was conducted of prednisone treatment in Alzheimer's disease. Prednisone was given at an initial dose of 10 mg (part 1) or 20 mg (part 2) and tapered over 7 weeks. There were no serious adverse events attributed to the medication, and there were no significant changes in either mean cognitive or behavioral assessment scores with treatment during either part. Serum levels of the acute phase proteins alpha-1-antichymotrypsin and C-reactive protein did not change significantly during part 1, but were suppressed by the higher dose given in part 2. Thus, a prednisone regimen with an initial dose of 20 mg is tolerable and results in suppression of the acute phase response in Alzheimer's disease.

Acute-Phase Proteins↗
PubMed1979

Effect of high-dose prednisone on renal hemodynamics of normal and transplanted dog kidneys.

The effect of prednisone therapy on renal hemodynamics was studied in normal, autotransplanted as well as homotransplanted dog kidneys. After intravenous administration of prednisone (8 and 16 mg/kg/min) the total blood flow decreased and vascular resistance increased significantly. This effect was more pronounced if the drug was directly injected into the arteria renalis. The same changes were observed in autotransplanted and homotransplanted kidneys and in kidneys in rejection. Our results suggest that high dosage of prednisone decreases the renal blood flow and this adverse effect has to be considered in the therapy. The administration of the drug directly into the arteria renalis may have to be avoided.

Animals↗