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The Cochrane Database of Systematic... 2000To determine therapeutically equivalent doses of inhaled versus oral steroids for adults with chronic asthma. (Review)
Review
OBJECTIVES
To determine therapeutically equivalent doses of inhaled versus oral steroids for adults with chronic asthma.
SEARCH STRATEGY
The Cochrane Airways Group trials register was searched using the terms: (drug delivery systems OR ((nebuli* OR inhal* OR MDI) AND oral*)) AND ( steroid* OR corticosteroid* OR glucocorticoid* OR beclomethasone OR betamethasone OR fluticasone OR cortisone OR dexamethasone OR hydrocortisone OR prednisolone OR prednisone OR triamcinolone).
SELECTION CRITERIA
Randomised controlled trials were selected of at least 4 weeks duration and included patients over the age of 15 years with chronic asthma. Trials compared inhaled steroids and oral prednisolone or prednisone; where the maximum dose for inhaled steroids was 2000 mcg/day and prednisolone 60 mg (on alternate days).
DATA COLLECTION AND ANALYSIS
Two independent reviewers screened 1285 titles and abstracts from the electronic search, bibliography searches and other contacts. Of these, 10 trials met previously defined inclusion criteria. Two reviewers independently extracted study characteristics, and outcome measures.
MAIN RESULTS
All trials were small and no data could be pooled. Carry-over effects were present in at least one cross-over trial. Data from six trials produced the same pattern, in which prednisolone 7.5-12 mg/day appeared to be as effective as inhaled steroid 300-2000 mcg/day. In two trials, inhaled steroid 300-400 mcg/day was more effective than prednisolone 5 mg/day. All doses of inhaled steroid appeared to be more effective than alternate day doses of prednisolone up to 60 mg on alternate days. Side-effect data were reported too variably to permit comparisons. A 30% incidence was reported in one study in patients receiving prednisolone 5 mg/day, none were reported in patients on inhaled steroids.
REVIEWER'S CONCLUSIONS
A daily dose of prednisolone 7.5-10 mg/day appears to be equivalent to moderate-high dose inhaled corticosteroids. Side-effects may be present on low doses, so if there is no alternative to oral steroids, the lowest effective dose should be prescribed.
Topics: Administration, Inhalation; Administration, Oral; Adult; Asthma; Chronic Disease; Glucocorticoids; Humans; Prednisolone; Prednisone
PubMed: 10796683
DOI: 10.1002/14651858.CD002160 -
Polskie Archiwum Medycyny Wewnetrznej Jun 2008Polymyalgia rheumatica (PMR) is a common disease of the elderly. It is characterized by pain and stiffness in the neck, shoulders and the pelvic girdle. In most cases... (Review)
Review
Polymyalgia rheumatica (PMR) is a common disease of the elderly. It is characterized by pain and stiffness in the neck, shoulders and the pelvic girdle. In most cases erythrocyte sedimentation rate and C-reactive protein levels are highly elevated. Polymyalgia rheumatica is frequently associated with giant cell arteritis. Steroids are the standard treatment for PMR but their dosage requires adjustment depending on clinical picture, co-morbid conditions and adverse effects. The most prominent features of the disease as well as the main principles of treatment are presented.
Topics: Blood Sedimentation; C-Reactive Protein; Diagnosis, Differential; Glucocorticoids; Humans; Polymyalgia Rheumatica; Prednisone
PubMed: 18619195
DOI: No ID Found -
Neurology(R) Neuroimmunology &... Jan 2023We report a case of chronic lymphocytic inflammation with pontine perivascular enhancement responsive to steroids (CLIPPERS) who achieved durable and steroid-free...
OBJECTIVE
We report a case of chronic lymphocytic inflammation with pontine perivascular enhancement responsive to steroids (CLIPPERS) who achieved durable and steroid-free remission after IV cladribine.
METHODS
A 25 year-old man presented with progressively worsening headaches, polydipsia, dysarthria, diplopia and vertigo, and obtundation requiring respiratory support. CSF revealed lymphocytosis, and MRI revealed a perivascular pattern of punctate enhancement involving the pons. An extensive workup for inflammatory, autoimmune, infective, and malignant explanations was unrevealing. He responded dramatically to steroids, compatible with CLIPPERS as a diagnosis of exclusion. Attempts to wean prednisone over the ensuing year resulted in 2 clinical relapses and persistent punctate enhancement. Given significant steroid side effects, steroid-sparing agents were considered.
RESULTS
IV cladribine IV (0.0875 mg/kg adjusted body weight daily × 4 days at 0, 4, 8, and 16 months) was selected, given its favorable side effect profile including lower risks of malignancy and infertility and the potential for long-lasting effects. The only side effect was short-term fatigue at the time of infusion. At 20 months after cladribine initiation, he was able to wean-off prednisone altogether. Now at 33 months, he remains in clinical and MRI remission.
DISCUSSION
Cladribine is a rational candidate steroid-sparing treatment for presumed neurologic autoimmune conditions such as CLIPPERS.
CLASSIFICATION OF EVIDENCE
This study provides Class IV evidence that cladribine is a steroid-sparing treatment consideration in CLIPPERS.
Topics: Male; Humans; Adult; Cladribine; Central Nervous System Diseases; Prednisone; Pons; Magnetic Resonance Imaging
PubMed: 36396449
DOI: 10.1212/NXI.0000000000200060 -
Immunity, Inflammation and Disease Mar 2023Lupus nephritis (LN) is one of the most severe manifestations of systemic lupus erythematosus (SLE). The chronic graft versus host disease (cGVHD) mouse model is a...
Lupus nephritis (LN) is one of the most severe manifestations of systemic lupus erythematosus (SLE). The chronic graft versus host disease (cGVHD) mouse model is a well-established model of SLE. LC3-associated autophagy plays a critical role in extracellular particle clearance, including pathogens and apoptotic cells. Lupus Recipe (LR) is a Chinese herbal compound that has been proven to be effective in treating SLE. In the study, we investigated the protective effects of LR or LR combined with prednisone on cGVHD mouse model and LC3-associated autophagy in the kidney. The mice were subjected to six groups. The LR treatment group received LR at the dosage of 1.15 and 2.3 g/kg/day, respectively. The corticosteroid treatment group received prednisone at a dosage of 5 mg/kg/day. The combination treatment group received LR at a dosage of 2.3 g/kg/day, and prednisone at 2.5 mg/kg/day. LR treatment reduced proteinuria and serum triglyceride levels, as well as spleen weight. LR also alleviated pathologic damage and immunoglobulin G deposition in the kidney. LR combined with a low dose of prednisone significantly improved kidney function and decreased serum triglyceride, total cholesterol, and spleen weight. In addition, combination treatment relieved kidney injury more effectively than LR alone. Western blot revealed that LR treatment or LR combined with prednisone increased the LC3-associated autophagy protein of Rubicon and Nox2, as well as LC3I levels in the kidney tissues. In conclusion, LR inhibited the manifestation of cGVHD-induced LN, which may attribute to the increased levels of LC3-associated autophagy.
Topics: Mice; Animals; Lupus Nephritis; Prednisone; Kidney; Lupus Erythematosus, Systemic; Autophagy; Bronchiolitis Obliterans Syndrome; Triglycerides
PubMed: 36988251
DOI: 10.1002/iid3.815 -
Nigerian Journal of Clinical Practice Dec 2023There was no sufficient clinical evidence on the relationship between auto-immune hepatitis (AIH) and risk of eye illness, except 11 uveitis cases where related AIH is... (Observational Study)
Observational Study
BACKGROUND
There was no sufficient clinical evidence on the relationship between auto-immune hepatitis (AIH) and risk of eye illness, except 11 uveitis cases where related AIH is reported currently.
AIM
To determine the relationship between choroidal thickness (ChT) and liver damage in simple AIH patients without ocular symptoms after oral prednisone treatment.
PATIENTS AND METHODS
This prospective observational study included simple AIH patients. The patients' ChT was measured by swept-source (SS)-optical coherence tomography (OCT), and the liver damage was evaluated by alanine aminotransferase (ALT) and aspartate aminotransferase (AST). ChT and liver functions were assessed prior to and after treatment. Then comparisons were made prior to and post treatment. The relationships between biochemical indexes of liver injury and ChT were evaluated after a mean (SD) of 24 (1.28) weeks of regular oral prednisone.
RESULTS
A total of 35 patients (31 females, aged 45.66 ± 11.62 years) were included. After treatment, ChT was significantly increased in all sectors (including the center sector, superior inner sector, inner nasal sector, inferior inner sector, inner temporal sector, superior outer sector, outer nasal sector, inferior outer sector, and outer temporal sector) (all P < 0.001). After treatment, both ALT (51.34 ± 44.16 vs 255.06 ± 107.84, P < 0.001) and AST (38.66 ± 27.12 vs 164.89 ± 85.58, P < 0.001) were significantly decreased. The increase of ChT in all sectors was significantly related to the decrease of ALT and AST (all P < 0.001).
CONCLUSION
The improvement of ChT might reflect the remission of liver damage in simple AIH patients without ocular symptoms during oral prednisone treatment.
Topics: Female; Humans; Prednisone; Choroid; Prospective Studies; Hepatitis
PubMed: 38158360
DOI: 10.4103/njcp.njcp_435_23 -
Blood Advances Jan 2022Standard initial therapy of chronic graft vs. host disease (cGVHD) with glucocorticoids results in suboptimal response. Safety and feasibility of therapy with ofatumumab...
Standard initial therapy of chronic graft vs. host disease (cGVHD) with glucocorticoids results in suboptimal response. Safety and feasibility of therapy with ofatumumab (1000 mg IV on days 0 and 14) and prednisone (1 mg/kg/day) was previously established in our phase I trial (n = 12). We now report the mature results of the phase II expansion of the trial (n = 38). The overall NIH severity of cGVHD was moderate (63%) or severe (37%) with 74% of all patients affected by the overlap subtype of cGVHD and 82% by prior acute cGVHD. The observed 6 month clinician-reported and 2014 NIH-defined overall response rates (ORR = complete + partial response [CR/PR]) of 62.5% (1-sided lower 90% confidence interval=51.5%) were not superior to pre-specified historic benchmark of 60%. Post-hoc comparison of 6 month NIH response suggested benefit compared to more contemporaneous NIH-based benchmark of 48.6% with frontline sirolimus/prednisone (CTN 0801 trial). Baseline cGVHD features (organ involvement, severity, initial immune suppression agents) were not significantly associated with 6-month ORR. The median time to initiation of second-line therapy was 5.4 months (range 0.9-15.1 months). Failure-free survival (FFS) was 64.2% (95% CI 46.5-77.4%) at 6 months and 53.1% (95% CI 35.8-67.7%) at 12 months, whereas FFS with CR/PR at 12 months of 33.5% exceeded a benchmark of 15% in post-hoc analysis, and was associated with greater success in steroid discontinuation by 24 months (odds ratio 8 (95% CI 1.21-52.7). This single-arm phase II trial demonstrated acceptable safety and potential efficacy of the upfront use of ofatumumab in combination with prednisone in cGVHD. This trial was registered at www.clinicaltrials.gov as #NCT01680965.
Topics: Antibodies, Monoclonal, Humanized; Drug Therapy, Combination; Graft vs Host Disease; Humans; Immunosuppression Therapy; Prednisone
PubMed: 34649279
DOI: 10.1182/bloodadvances.2021005552 -
Alternating-day cyclosporine and prednisone for treatment of high-risk chronic graft-v-host disease.Blood Aug 1988Therapy of chronic graft-v-host disease (GVHD) has been unsatisfactory in patients with platelet counts less than 100,000/microL. Survival at 5 years after marrow...
Therapy of chronic graft-v-host disease (GVHD) has been unsatisfactory in patients with platelet counts less than 100,000/microL. Survival at 5 years after marrow transplant is only 26% in such patients treated with trimethoprim-sulfamethoxazole (TMP-SMX) and every other day with prednisone. Since October 1982, 61 patients with high-risk extensive chronic GVHD were treated with a new alternating-day regimen of prednisone (1 mg/kg every other day) and oral cyclosporine (6 mg/kg every 12 hours every other day) with one double-strength TMP-SMX tablet twice daily. Forty patients (group I) received primary treatment of thrombocytopenic chronic GVHD (median platelet count 35 [range 7 to 87] x 10(3)/microL). Twenty-one patients (group II) received salvage treatment after failing initial prednisone +/- azathioprine. Twenty-one patients in group I and 15 in group II survive with a minimum of 2 years and a median of 3.7 years follow-up. At 4 years after transplant, actuarial survival is 51% (group I) and 67% (group II). Causes of death included interstitial pneumonia (six), relapse (five), GVHD without infection (five), infection (four), organ failure (three), and hemorrhage (two). Mortality increased with the progressive type onset of chronic GVHD and treatment failure. Toxicity included hypertension (13), nephrotoxicity (nine), nausea (seven), aseptic necrosis (five), neurologic abnormalities (four), and diabetes (three). Median cyclosporine levels at four and 36 hours were 296 and 64 ng/mL, respectively. Four patients required permanent discontinuation of cyclosporine, but none required renal dialysis. Karnofsky performance scores for 25 survivors are 90% to 100%, scores for six survivors are 70% to 89%, and scores for five survivors are less than 70%. Alternating-day cyclosporine and prednisone has acceptable toxicity and appears to improve survival in patients with high-risk chronic GVHD.
Topics: Adolescent; Adult; Bone Marrow Transplantation; Child; Child, Preschool; Chronic Disease; Cyclosporins; Drug Administration Schedule; Drug Therapy, Combination; Female; Graft vs Host Disease; Humans; Infant; Infections; Male; Middle Aged; Prednisone; Thrombocytopenia
PubMed: 3042042
DOI: No ID Found -
PloS One 2023Despite the widespread use of glucocorticoids in inflammatory and autoimmune disorders, there is uncertainty about the safe cessation of long-term systemic treatment, as...
Glucocorticoid withdrawal and glucocorticoid-induced adrenal insufficiency: Study protocol of the randomized controlled «TOASST" (Taper Or Abrupt Steroid STop) multicenter trial.
BACKGROUND
Despite the widespread use of glucocorticoids in inflammatory and autoimmune disorders, there is uncertainty about the safe cessation of long-term systemic treatment, as data from prospective trials are largely missing. Due to potential disease relapse or glucocorticoid-induced hypocortisolism, the drug is often tapered to sub-physiological doses rather than stopped when the underlying disease is clinically stable, increasing the cumulative drug exposure. Conversely, the duration of exposure to glucocorticoids should be minimized to lower the risk of side effects.
METHODS
We designed a multicenter, randomized, triple-blinded, placebo-controlled trial to test the clinical noninferiority of abrupt glucocorticoid stop compared to tapering after ≥28 treatment days with ≥420 mg cumulative and ≥7.5 mg mean daily prednisone-equivalent dose. 573 adult patients treated systemically for various disorders will be included after their underlying disease has been stabilized. Prednisone in tapering doses or matching placebo is administered over 4 weeks. A 250 mg ACTH-test, the result of which will be revealed a posteriori, is performed at study inclusion; all patients are instructed on glucocorticoid stress cover dosing. Follow-up is for 6 months. The composite primary outcome measure is time to hospitalization, death, initiation of unplanned systemic glucocorticoid therapy, or adrenal crisis. Secondary outcomes include the individual components of the primary outcome, cumulative glucocorticoid doses, signs and symptoms of hypocortisolism, and the performance of the ACTH test in predicting the clinical outcome. Cox proportional hazard, linear, and logistic regression models will be used for statistical analysis.
CONCLUSION
This trial aims to demonstrate the clinical noninferiority and safety of abrupt treatment cessation after ≥28 days of systemic glucocorticoid therapy in patients with stabilized underlying disease.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT03153527; EUDRA-CT: 2020-005601-48 https://clinicaltrials.gov/ct2/show/NCT03153527?term=NCT03153527&draw=2&rank=1.
Topics: Adult; Humans; Adrenal Insufficiency; Adrenocorticotropic Hormone; Glucocorticoids; Multicenter Studies as Topic; Neoplasm Recurrence, Local; Prednisone; Prospective Studies; Randomized Controlled Trials as Topic; Withholding Treatment
PubMed: 37018188
DOI: 10.1371/journal.pone.0281585 -
RMD Open 2019Glucocorticoids have anti-inflammatory, transrepression-mediated effects, although adverse events (AEs; transactivation-mediated effects) limit long-term use in patients... (Randomized Controlled Trial)
Randomized Controlled Trial
OBJECTIVES
Glucocorticoids have anti-inflammatory, transrepression-mediated effects, although adverse events (AEs; transactivation-mediated effects) limit long-term use in patients with rheumatoid arthritis (RA). We evaluated the efficacy and safety of fosdagrocorat (PF-04171327), a dissociated agonist of the glucocorticoid receptor, versus prednisone or placebo.
METHODS
In this 12-week, phase II, randomised controlled trial, 323 patients with moderate to severe RA were randomised 1:1:1:1:1:1:1 to fosdagrocorat (1 mg, 5 mg, 10 mg or 15 mg), prednisone (5 mg or 10 mg) or placebo, once daily. The primary endpoints (week 8) were American College of Rheumatology 20% improvement criteria (ACR20) responses, and percentage changes from baseline in biomarkers of bone formation (procollagen type 1 N-terminal peptide [P1NP]) and resorption (urinary N-telopeptide to urinary creatinine ratio [uNTx:uCr]). Safety was assessed.
RESULTS
ACR20 responses with fosdagrocorat 10 mg and 15 mg were superior to placebo, and fosdagrocorat 15 mg was non-inferior to prednisone 10 mg (week 8 model-predicted ACR20 responses: 47%, 61%, 69% and 73% vs 51%, 71% and 37% with fosdagrocorat 1 mg, 5 mg, 10 mg and 15 mg vs prednisone 5 mg, 10 mg and placebo, respectively). Percentage changes from baseline in P1NP with fosdagrocorat 1 mg, 5 mg and 10 mg met non-inferiority criteria to prednisone 5 mg. Corresponding changes in uNTx:uCr varied considerably. All fosdagrocorat doses reduced glycosylated haemoglobin levels. AEs were similar between groups; 63 (19.5%) patients reported treatment-related AEs; 9 (2.8%) patients reported serious AEs. No patients had adrenal insufficiency, treatment-related significant infections or laboratory abnormalities. No deaths were reported.
CONCLUSION
In patients with RA, fosdagrocorat 10 mg and 15 mg demonstrated efficacy similar to prednisone 10 mg and safety similar to prednisone 5 mg.
TRIAL REGISTRATION NUMBER
NCT01393639.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Antirheumatic Agents; Arthritis, Rheumatoid; Biomarkers; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Organophosphates; Phenanthrenes; Prednisone; Treatment Outcome; Young Adult
PubMed: 31168411
DOI: 10.1136/rmdopen-2018-000889 -
JAMA Cardiology Oct 2018Cardiac dysfunction is a leading cause of morbidity and mortality in Duchenne muscular dystrophy (DMD). This case highlights the importance of steroids in treating...
IMPORTANCE
Cardiac dysfunction is a leading cause of morbidity and mortality in Duchenne muscular dystrophy (DMD). This case highlights the importance of steroids in treating cardiac complications of DMD and the dangers of discontinuing or switching between steroid classes.
OBJECTIVE
To recognize the presentation of acute myocardial inflammation, or dystrophinitis, in DMD, which presents as myocarditis and to treat the myocardial inflammation and dilated cardiomyopathy associated with DMD through guideline-directed medical therapy, steroids, and serial surveillance for cardiac dysfunction.
DESIGN, SETTING, AND PARTICIPANT
A case report of an 18-year-old patient with DMD and with steroid withdrawal-induced myocarditis followed up for 3 years to observe for cardiac function recovery and the natural history of cardiomyopathy in DMD, who was hospitalized in the cardiac care unit and followed up between November 3, 2016, and March 27, 2017.
EXPOSURES
Switching from deflazacort to underdosed prednisone for 7 days.
MAIN OUTCOMES AND MEASURES
Increased myocardial inflammation, edema, and fibrosis after stopping deflazacort abruptly.
RESULTS
An 18-year-old male patient with DMD presented to the emergency department with acute-onset chest pain. Ischemic changes were present on electrocardiogram, and elevated cardiac enzymes were detected. Depressed cardiac function and potential evidence of inflammation were seen on cardiac magnetic resonance (CMR) imaging, characterized by elevated T2 values and late gadolinium enhancement. These findings were all consistent with acute myocarditis but without a viral prodrome. Several days prior to presentation, the patient's deflazacort was abruptly discontinued and converted to an equivalent dose of prednisone. After restarting deflazacort, his symptoms improved, and subsequent CMR showed resolution of myocardial edema and improved left ventricular function.
CONCLUSIONS AND RELEVANCE
This case highlights adverse effects associated with changing between corticosteroid classes in DMD cardiomyopathy and also demonstrates the utility of CMR in detecting myocardial inflammation and monitoring response to treatment.
Topics: Adolescent; Drug Substitution; Emergency Service, Hospital; Humans; Male; Muscular Dystrophy, Duchenne; Myocarditis; Prednisone; Pregnenediones; Steroids
PubMed: 30167630
DOI: 10.1001/jamacardio.2018.2695