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PubMed1991

A comparison of daily and alternate-day prednisone therapy in the treatment of Duchenne muscular dystrophy.

We previously reported the results of a randomized, double-blind 6-month trial of prednisone therapy in which 102 boys aged 5 to 15 years with Duchenne muscular dystrophy received daily doses of 1.5 and 0.75 mg/kg per day and were compared with those receiving placebo. The strength and function in both prednisone-treated groups improved equally and were significantly better than in the placebo group. To compare alternate-day and daily dosing of prednisone with respect to benefits and adverse side effects, the placebo group was started on alternate-day prednisone therapy, and the treatment group regimens were changed to equivalent doses of alternate-day prednisone without breaking the double-blind nature. At the end of 6 months, the group that was changed from daily to alternate-day therapy had declined in strength back to levels observed 12 months previously, at the start of daily therapy. The group in which alternate-day therapy was started showed a significant improvement in strength at 3 months, similar in magnitude to the response of boys treated with daily therapy. However, their strength declined significantly in the subsequent 3 months compared with boys who received daily therapy. The frequency of side effects was not significantly different for alternate-day therapy compared with daily therapy. We conclude that alternate-day prednisone therapy effectively increases strength but does not sustain the improvement to the same extent as daily therapy or mitigate side effects.

Adolescent↗
PubMed1996

Oral prednisone as a risk factor for infections in children with asthma.

OBJECTIVE: To determine whether the frequency of acute infections in children with asthma is associated with the number of doses of prednisone received for asthma attacks. DESIGN: A cohort study. SETTING: Primary care clinic and emergency department of an inner-city teaching hospital from March 31, 1992, to May 31, 1993. PATIENTS: Convenience sample of clinic enrollees aged 2 to 14 years who had made two or more outpatient visits for acute asthma in the preceding year. Eighty-six children were enrolled. Seventy-eight (91%) completed the study. MAIN OUTCOME MEASURES: The independent variable was cumulative prednisone dose received during the study period. Outcome variables were episodes of acute infections. RESULTS: The mean (+/-SD) number of doses of prednisone (2 mg/kg to a maximum of 60 mg) received was 9.5 +/- 11.8 doses (range, 0 to 57 doses). Ninety-four episodes of acute infection occurred in 50 children. No difference was observed in the mean number of doses of prednisone received by those with the infection compared with those without the infection. No correlation was observed between the number of doses of prednisone received and the number of episodes of each infection. CONCLUSIONS: The administration of prednisone as short courses for acute asthma is not associated with an increase in the number of episodes of common acute infections.

Acute Disease↗
PubMed1981

Vindesine and prednisone for remission induction in children with acute lymphocytic leukemia.

Vinca alkaloids are effective anticancer agents. Vindesine is a recent vinca alkaloid derivative with anti-tumor effects shown in in vitro systems and in patients with acute lymphocytic leukemia (ALL). The present study was designed to investigate the therapeutic effectiveness and toxicity of vindesine in combination with prednisone for remission induction in late stage ALL in children. Sixteen children with late-stage ALL were treated with vindesine 4.0 mg/m2/week intravenously and prednisone 60 mg/m2/day orally in four divided doses for minimum of three weeks. Thirteen children were evaluable. Of these patients, four had complete remission and four had partial response. Toxicity was well tolerated and consisted of bone pain, paresthesias, loss of deep tendon reflexes, leukopenia, and thrombocytopenia primarily. Abnormal liver function tests and fever were also noted in some patients. All patients had received vincristine and prednisone prior to vindesine prednisone combination. All patients had been resistant to vincristine prednisone combination prior to vindesine prednisone treatment. This study suggests effectiveness of vindesine in late stage ALL and lack of cross-resistance of vindesine and vincristine.

Adolescent↗
PubMedDate not supplied

A pilot study on the effects of prednisone withdrawal on serum hepatitis B virus DNA and HBeAg in chronic active hepatitis B.

We investigated the efficacy of a short course of prednisone therapy in 20 patients with histologic evidence of chronic active hepatitis B. Sixteen of 20 prednisone-treated patients who were initially serum hepatitis B virus DNA-positive had a transient elevation of their serum ALT activity on withdrawal of prednisone. Subsequently, 14 of these 16 patients (87.5%) became persistently negative for serum hepatitis B virus DNA, and 10 also lost their HBeAg. In addition, there was a significant fall in serum ALT levels and HBsAg titers up to 12 months of follow-up in the prednisone-treated group. Five of 20 (25%) prednisone-treated patients experienced a transient episode of hepatic decompensation coinciding with the peak of enzyme elevation. To contrast, only 3 of 15 (20%) initially hepatitis B virus DNA-positive matched untreated patients followed during the same time period became negative for serum hepatitis B virus DNA, and no significant changes in serum ALT values or HBsAg titers were noted over the 12-month study period. Thus, patients with chronic active hepatitis B appear to be responsive to immunologic manipulation with prednisone as indicated by a pronounced rebound immune response and clearance of hepatitis B virus DNA with improvement in liver disease activity.

Adult↗
PubMed1979

High-pressure liquid chromatographic evaluation of aqueous vehicles for preparation of prednisolone and prednisone liquid dosage forms.

A high-pressure liquid chromatographic method was developed that separates prednisolone from prednisone, prednisone from methylprednisolone succinate sodium, and hydrocortisone from hydrocortisone acetate or cortisone acetate. The common liquid dosage preservatives methylparaben, propylparaben, and sodium benzoate do not interfere with quantitative prednisolone, prednisone, and hydrocortisone determinations. The method was used to study prednisolone and prednisone stability in five aqueous vehicles (water, citrate buffer USP, 50% glycerin, 50% sorbitol, and 50% sucrose) containing 10% (v/v) ethanol. Prednisone crystallized out in all vehicles except glycerin, in which it appeared to be stable for at least 92 days. Prednisolone did not crystallize in any vehicle but decomposed quickly in citrate buffer. Sorbitol and glycerin appeared to be the best vehicles for prednisolone. The developed method was applied successfully to the quantitative determinations of prednisolone, prednisone, and hydrocortisone in commercial tablets.

Chromatography, High Pressure Liquid↗
PubMed1975

The use of low-dose prednisone and melphalan in the treatment of poor-risk patients with multiple myeloma.

A study was designed to evaluate the effectiveness of prednisone therapy in poor-risk patients with multiple myeloma. Patients were treated with melphalan alone or in combination with prednisone at doses of either 0.6 mg/kg or 0.3 mg/kg. The group of patients receiving melphalan and prednisone 0.6 mg/kg had significantly improved responses in hemoglobin, lowering of the M-protein concentration, and reduction of azotemia. Significant benefits attributable to prednisone were not demonstrated in the group receiving 0.3 mg/kg. Good responses have been shown to produce improved survival. The combination of melphalan and prednisone is effective in producing good responses, but the dose of steroids is important. A dose of prednisone of 0.6 mg/kg in gradually decreasing doses has been found to be effective in production of good responses, especially in the uremic patient.

Dose-Response Relationship, Drug↗
PubMed1999

Use of low-dose oral prednisone to prevent paclitaxel-induced arthralgias and myalgias.

OBJECTIVES: The aim of this study was to examine the clinical utility of low-dose oral prednisone in preventing severe paclitaxel-associated arthralgias and myalgias. METHODS: Patients treated with paclitaxel in the gynecologic oncology program of the Cleveland Clinic Foundation who developed arthralgias/myalgias which were uncontrolled through the use of nonsteroidal anti-inflammatory medications received low-dose oral prednisone (10 mg B.I.D. starting 24 h after the completion of chemotherapy and continuing for a total of 5 days) with their next paclitaxel course. RESULTS: Of 46 patients meeting the criteria for treatment with the oral prednisone regimen (i.e., subjective feeling of unacceptable discomfort despite the use of nonsteroidal anti-inflammatory agents), 39 (85%) experienced substantial relief of symptoms. All but one of the responding patients requested continuation of the oral prednisone regimen with subsequent paclitaxel treatment cycles. There were no significant toxicities noted in any patient receiving prednisone. CONCLUSION: This low-dose oral prednisone regimen results in substantial improvement in the majority of patients experiencing significant paclitaxel-associated arthralgias/myalgias.

Administration, Oral↗
PubMed1992

Treatment of mesangiocapillary glomerulonephritis with alternate-day prednisone--a report of the International Study of Kidney Disease in Children.

It has been claimed that long-term prednisone treatment ameliorates the course of children with mesangiocapillary glomerulonephritis (MCGN). The International Study of Kidney Disease in Children conducted a randomized, double-blinded, placebo-controlled clinical trial in 80 children with idiopathic MCGN, including 42 patients with type I disease, 14 with type II disease, 17 with type III disease, and 7 with nontypable disease. Criteria for admission included heavy proteinuria and a glomerular filtration rate of greater than or equal to 70 ml/min per 1.73 m2. Prednisone or lactose, 40 mg/m2, was given every other day as a single morning dose. The mean duration of treatment was 41 months, renal failure being the most common reason for termination of therapy. Treatment failure was defined as an increase from baseline of 30% or more in serum creatinine, or more than 35 mumol/l. Overall, treatment failure occurred in 55% of patients treated with lactose, compared with 40% in the prednisone group. Life-table analysis showed a renal survival rate (i.e., stable renal function) at 130 months of 61% among patients receiving prednisone and 12% among patients receiving lactose (P = 0.07). Of patients with type I or III MCGN, 33% treated with prednisone were treatment failures, compared with 58% in the lactose group. Long-term treatment with prednisone appears to improve the outcome of children with MCGN.

Adolescent↗
PubMed1990

Nonlinear pharmacokinetics and interconversion of prednisolone and prednisone in rats.

The pharmacokinetics of prednisolone and prednisone were examined in 32 rats at four intravenous doses (5, 10, 25, and 50 mg/kg). Each rat was given one dose of either intravenous prednisolone or prednisone, and plasma concentrations of both compounds were measured by HPLC. Mammillary moment analysis showed the apparent clearance and volume of distribution of prednisolone and the apparent clearance of prednisone to be dose-dependent. Further diagnostic analysis using a linear interconversion model revealed modest interconversion between the two steroids and at least two saturable clearance processes: the conversion of prednisolone to prednisone and the irreversible elimination of prednisone. A comprehensive model which incorporates the nonlinear clearances of prednisolone and prednisone plus the additional feature of nonlinear tissue distribution of prednisolone was then constructed. Four differential equations describing the rate of change of each steroid in each compartment were used to numerically fit by nonlinear least squares analysis all plasma concentration-time profiles simultaneously. The final estimates from the full model only partly agreed with the results from the two moment analyses but confirmed the general structure of the model. The nonlinear tissue distribution of prednisolone was reinforced by assay of muscle tissue. This study demonstrates the utility of the model-building process where simpler models yield insights into more elaborate schemes with complex nonlinear features.

Analysis of Variance↗
PubMed1993

Long versus standard prednisone therapy for initial treatment of idiopathic nephrotic syndrome in children. Arbeitsgemeinschaft für Pädiatrische Nephrologie.

Two regimens of steroid treatment for the initial attack of idiopathic nephrotic syndrome (NS) in children were compared in a controlled prospective multi-centre study. Long prednisone therapy consisted of 60 mg/m2 per 24 h for 6 weeks, followed by alternate day 40 mg/m2 per 48 h for 6 weeks. The standard prednisone therapy was 60 mg/m2 per 24 h for 4 weeks, followed by 40 mg/m2 per 48 h for 4 weeks. A total of 71 children with an initial attack of idiopathic NS were allocated at random to the two groups. The cumulative rate of patients with sustained remissions after 2 years was significantly higher after the long course than after the standard treatment (49% vs 19%, P = 0.0079). The mean relapse rate per patient at intervals of 3, 6 and 12 months was lower in the long-course prednisone group than in the standard prednisone group, and the proportion of children with frequent relapses during any subsequent 6 months period was lower in the long-course group than in the standard group (29% vs 57%, P = 0.03). Mild side-effects of corticosteroid therapy were observed more frequently after long-course prednisone treatment. It is concluded that long-course prednisone therapy of the initial attack of steroid responsive NS is preferable to the standard regimen because it reduces the rate of subsequent relapses without increasing the risk for severe steroidal side-effects.

Adolescent↗
PubMed1984

Mineral loss in cortical and trabecular bone during high-dose prednisone treatment.

To evaluate the effect of prednisone and triple treatment (sodium fluoride, calcium, and vitamin D) on trabecular and cortical bone serial bone mineral content (BMC) measurements were made at a metaphyseal (BMCD) and diaphyseal (BMCP) site on the forearm on 31 consecutive and previously bone-healthy patients scheduled for at least 24 weeks high-dose prednisone treatment. The patients were randomized into two further treatment groups: group I (n = 16) received prednisone plus triple treatment and group II (n = 15) received only prednisone. The two groups were similar with regard to age, sex, prednisone dose, and initial BMC. During 24 weeks treatment, BMCD (partially representing trabecular bone) and BMCP (mainly representing cortical bone) fell significantly and similarly, demonstrating that there is no preventive effect on bone mineral loss on the triple regimen. The BMC fall after 12 weeks was significantly more pronounced for metaphyseal (partially trabecular) than for diaphyseal (cortical) bone, whereas the values did not differ significantly after 24 weeks; this indicates a greater sensitivity to the hormone treatment of trabecular bone. In the entire group, the fall in BMC correlated positively with individual prednisone dose, significant at the diaphyseal site (r = 0.39, P less than 0.05), but not at the metaphyseal site (r = 0.31, P = 0.08). It is concluded that corticosteroid-induced osteopenia is a diffuse bone disease which affects trabecular as well as cortical bone, suggesting that BMC measured on the forearm reflects changes in bone mineral at other locations.

Adult↗
PubMed1996

The effect of long-term prednisone treatment on growth hormone and insulin-like growth factor-1.

Due to a lack of longitudinal data the precise effect of long-term corticosteroid treatment on serum levels of the anabolic hormones Growth Hormone (GH) and Insulin-like Growth Factor-1 (IGF-1) is unknown. Therefore, we prospectively followed GH and IGF-1 levels over a six month period in 18 euthyroid patients with Graves' ophthalmopathy. Ten patients were treated with a three month course of prednisone; eight patients receiving retrobulbar irradiation served as controls. Baseline serum GH and IGF-1 levels were similar in both groups. Whereas no changes were seen in controls, prednisone induced a rapid increase in serum IGF-1 levels, which was sustained during the entire treatment period: 18.2 +/- 5.2 at baseline vs 24.1 +/- 6.7 nmol/l after 12 weeks of treatment (p < 0.001). After discontinuation of prednisone IGF-1 returned to baseline levels. Basal GH levels were frequently undetectable, but during treatment GH values were lower in the prednisone group (median of detectable values 4.0 mU/L [range 2.0-26.0]) than in controls (11.8 [2.8-44.0]; p < 0.01). In conclusion, long-term prednisone treatment is associated with suppressed GH levels and with an increase in total IGF-1 levels. This suggests that prednisone can disrupt the GH/IGF 1 axis.

Adult↗
PubMed1998

Immunosuppression without prednisone after liver transplantion is safe and associated with normal early graft function: preliminary results of a randomized study.

Prednisone has been commonly considered the mainstay of immunosuppressive therapy after liver transplantation. Recent data suggest that prednisone withdrawal late after transplant reduces complications without affecting graft function. We report here the preliminary results of an open-label, randomized study aimed at investigating whether prednisone therapy can be completely avoided during the first 3 months after transplantation. Twenty-seven consecutive patients were randomized to receive double (group A: cyclosporine and azathioprine) or triple (group B: prednisone, cyclosporine, and azathioprine) immunosuppressive therapy after liver transplantation. Six patients died within the first 3 weeks in each group and were excluded from the calculations. The present results refer to 10 patients in group A and 11 in group B. The actuarial 1-year survival did not differ between the two groups (90.9% vs 88.8%). There were no differences with respect to infectious complications or episodes of histological acute graft rejections. Only one severe acute rejection occurred in group A and two in group B. During the first month after transplant, liver and kidney functions tended to be better in the group of patients treated without prednisone, although there were no differences in the mean cyclosporine blood levels. These data, though preliminary, indicate that early immunosuppression without the use of prednisone is safe and tends to be associated with improved liver and renal functions compared to conventional triple therapy.

Adult↗
PubMed2003

The effect of low-dose prednisone on bone mineral density in Peruvian rheumatoid arthritis patients.

OBJECTIVE: The aim of this study was to determine the difference between bone mineral density (BMD) of rheumatoid arthritis (RA) patients on low-dose prednisone and matched RA patients without prior systemic corticosteroid therapy. METHODS: Ninety patients attending our clinics and receiving 10 mg/day of prednisone or less for at least the previous 3 consecutive months were studied. The control group comprised 90 selected RA patients without corticosteroid therapy matched for age, race, gender, disease duration, use of methotrexate, postmenopause, and Health Assessment Questionnaire score. The BMD was measured using dual X-ray absorptiometry. RESULTS: Patients on prednisone had lower BMD than controls (0.94 +/- 0.17 vs 0.96 +/- 0.17 for L2-4 and 0.73 +/- 0.14 vs 0.76 +/- 0.16 for femoral neck), but these differences were not statistically significant (P > 0.05). In post hoc analysis, postmenopausal women on prednisone had more bone loss in femoral neck than controls (0.68 +/- 0.13 vs 0.74 +/- 0.15). CONCLUSION: Bone mineral density was not significantly reduced by low-dose prednisone in this diverse group of RA patients. A reduction in hip BMD was seen in postmenopausal women on prednisone.

Adrenal Cortex Hormones↗
PubMed1993

Recovery of the hypothalamic-pituitary-adrenal (HPA) axis in patients with rheumatic diseases receiving low-dose prednisone.

PURPOSE: To assess the status of the hypothalamic-pituitary-adrenal (HPA) axis in cortico-steroid-treated patients whose prednisone dose had been tapered to physiologic doses. PATIENTS AND METHODS: The design of the study was a retrospective chart review of 50 consecutive patients receiving 10 mg or less of prednisone daily at a university teaching hospital rheumatology clinic. Patients were given a rapid adrenocorticotropic hormone stimulation test, with cortisol levels obtained at baseline and after intravenous administration of cosyntropin. Charts were reviewed for duration of therapy, highest, current, and total cumulative steroid dose, and average daily steroid dose in each month of the preceding 2 years. RESULTS: Current steroid dose was the only significant indicator of HPA axis function. Patients receiving less than 5 mg of prednisone daily had a normal HPA axis response, whereas those receiving 5 mg or more had widely varied responses. Neither the total, the highest prednisone dose, nor the duration of therapy was a significant indicator of HPA axis recovery. CONCLUSIONS: Spontaneous recovery of the HPA axis is usual for patients who are taking prednisone at daily doses of 5 mg or less. Return of normal HPA axis function can be achieved without alternate-day therapy in patients whose disease allows tapering to daily prednisone doses of 5 mg or less.

Adult↗
PubMed1978

Minimum dose requirements of steroid-dependent asthmatic patients for aerosol beclomethasone and oral prednisone.

In 34 steroid-dependent asthma patients who improved markedly during 2 mo of treatment when progressively larger doses of beclomethasone aerosol were added to their oral prednisone regimen, we subsequently reduced both steroids to ascertain the minimum dose of each needed to prevent recurrence of significant asthmatic disability. After 80 wk of follow-up, 15 patients had successfully terminated oral prednisone; 19 were better controlled with a combination of aerosol plus oral steroid than with either drug alone; all patients previously unable to convert to alternate-day prednisone did so successfully during the combined therapy. The minimum effective maintenance dosage varied greatly among these patients-the median values being 2.5 mg prednisone and 1,200 microgram beclomethasone per day. The latter ranged from 200 to 1,8000 microgram. Only 4 patients were satisfactorily controlled without prednisone on 400 microgram beclomethasone per day or less. Seven needed extra intranasal beclomethasone to help control the nasal polyps which worsened after prednisone withdrawal. Suppression of plasma cortisol levels, apparently attributable to the beclomethasone, persisted in most patients, but on the average this was no worse than before commencing this treatment and valuable clinical improvement accrued. There were no other important complications of the regimen. In most of these patients with severe chronic asthma, optimum control of the disease required combined aerosol-oral therapy and maintenance doses of beclomethasone higher than those usually recommended. In some patients, effective control of chronic asthma by beclomethasone treatment may require acceptance of some persisting suppression of adrenal function as a considered risk.

Administration, Oral↗
PubMed1994

Analysis of induced sputum to examine the effects of prednisone on airway inflammation in asthmatic subjects.

To determine whether induced sputum samples might provide a useful means for evaluating the effects of therapy on airway mucosal inflammation, we examined induced sputum samples obtained before and after 6 days of treatment with prednisone (0.5 mg/kg/day) or placebo in a randomized, double-blind study of 24 asthmatic subjects. Induced sputum was analyzed for total and differential cell counts and for concentrations of eosinophil cationic protein, albumin, and mucin-like glycoprotein. We found that the mean (+/- SEM) percentage of eosinophils in sputum samples from the prednisone-treated group fell from 14.1% +/- 5.0% at baseline to 1.8% +/- 0.8% after treatment, a decrease significantly greater than in the placebo-treated group (from 10.3% +/- 4.9% to 11.1% +/- 4.0%; p = 0.002). The absolute number of eosinophils also decreased significantly more in the prednisone-treated group than in the placebo-treated group (p = 0.04). In addition, eosinophil cationic protein levels in induced sputum fell more in the prednisone-treated group than in the placebo-treated group (from 324 +/- 131 ng/ml to 144 +/- 84 ng/ml vs 173 +/- 50 ng/ml to 188 +/- 47 ng/ml; p = 0.002). Furthermore, prednisone treatment was associated with a significant increase in peak expiratory flow, an effect that was significantly correlated with the decrease in eosinophil percentage in induced sputum (rs = 0.64, p = 0.04). Prednisone treatment was not associated with any significant change in the concentrations of albumin or mucin-like glycoprotein. We conclude that analysis of induced sputum is a useful noninvasive method for studying the effects of asthma therapy on airway eosinophilic inflammation.

Adult↗
PubMed1985

Immunosuppressive activity of prednisone and prednisolone and their metabolic interconversion in the mixed lymphocyte reaction.

The immunosuppressive activities of prednisolone, prednisone and cortisol were assessed and compared using a modified micro-2-way mixed lymphocyte reaction (MLR) assay. As measured by the inhibition of the MLR on day 3, prednisolone was 2.40 +/- 0.98 times more potent than cortisol: The average EC50S for prednisolone and cortisol were 28.25 +/- 7.8 ng/ml and 63.25 +/- 16.88 ng/ml, respectively. Prednisone (10 - 1000 ng/ml) had little or no immunosuppressive activity and did not affect the inhibition due to prednisolone or cortisol. Although, prednisone was inactive in the MLR, it was slowly being converted to prednisolone by 11-hydroxylation. MLR cultures with starting prednisone concentrations of 100, 200, 500, 1000 and 2000 ng/ml, contained 28, 34, 46, 50 and 81 ng/ml of prednisolone, respectively, on day 3 of the culturing period. The reverse reaction, the conversion of prednisolone to prednisone, did not occur. The inactivity of prednisone despite a significant conversion to its biologically active 11-hydroxyl metabolite, prednisolone, suggests the importance of the duration and timing of prednisolone's presence to immunosuppressive activity in the MLR culture.

Dose-Response Relationship, Drug↗