A double‐blind study of deflazacort and prednisone in patients with chronic inflammatory disorders

Gray, Richard E.; Doherty, S. M.; Galloway, J.; Coulton, Les; Broe, Marc De; Kanis, JA

doi:10.1002/art.1780340306

Cited by 70 publications

(30 citation statements)

References 28 publications

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“…Four were placebocontrolled (21)(22)(23)52) and the other 5 were active drugcontrolled studies comparing prednisone to another agent, which included deflazacort (24,25), chloroquine (26), and aspirin (27,28). The 2 studies that used deflazacort as the "control" therapy were not included in the standard meta-analysis, although they were included in the comparative meta-analysis.…”

Section: Resultsmentioning

confidence: 99%

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Low‐dose corticosteroids in rheumatoid arthritis. A meta‐analysis of their moderate‐term effectiveness

Saag

Criswell

Sems

et al. 1996

Arthritis & Rheumatism

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Objective. To perform a systematic literature review and meta-analysis of the effectiveness of lowdose corticosteroids in the treatment of rheumatoid arthritis (RA).Methods. After identifying all relevant studies meeting preselected inclusion criteria, we performed 2 meta-analyses. First, we compared the effectiveness of prednisone to placebo and active drug controls (aspirin, chloroquine, or deflazacort) using standard metaanalysis methods for continuous data. Then, to compare the relative effectiveness of prednisone to second-line agents, we used methods similar to prior meta-analyses of second-line agents for RA treatment. Outcomes assessed were the number of tender and swollen joints, grip strength, and the erythrocyte sedimentation rate (ESR).Results. Very few studies directly assessed the effectiveness of corticosteroids for RA treatment, and many were of poor methodologic quality. Only 9 of 34 studies identified by our search met criteria for inclusion. The results of our standard meta-analysis indicated that corticosteroids appeared to be more effective than either placebo or active drug controls in improving most conventional outcome measures (effect size 0.90 for the number of tender joints, 1.05 for the number of swollen joints, and 1.20 for the ESR). In our second comparative meta-analysis, corticosteroids were nearly Submitted for publication January 9, 1996; accepted in revised form June 3, 1996. equivalent to second-line agents previously examined in meta-analyses (combined effect size 0.82).Conclusion. Based on the limited data available, during moderate-term treatment periods averaging slightly over 7 months, corticosteroids appeared to be as effective or more effective than alternative therapies in improving several common RA disease activity measures.

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Section: Resultsmentioning

confidence: 99%

“…Quality ratings performed using Chalmers' method yielded only 2 studies that exceeded a quality rating of 50% (21,26). Of note and reflected in the quality ratings, only 5 of the 9 studies used a doubleblind design (21,(23)(24)(25)52). The 9 studies were published between 1955 and 1995.…”

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confidence: 99%

Low‐dose corticosteroids in rheumatoid arthritis. A meta‐analysis of their moderate‐term effectiveness

Saag

Criswell

Sems

et al. 1996

Arthritis & Rheumatism

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“…We can not explain the bone-sparing effect of deflazacort in terms of osteoclast formation based on our study. Glucocorticoids, including deflazacort, affect multiple parameters of mineral metabolism (19)(20)(21). All these studies assumed that the potency of prednisone relative to deflazacort was 1.2.…”

Section: Discussionmentioning

confidence: 99%

Deflazacort Increases Osteoclast Formation in Mouse Bone Marrow Culture and the Ratio ofRANKL/OPGmRNA Expression in Marrow Stromal Cells

et al. 2001

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Information on precise effects of deflazacort on bone cell function, especially osteoclasts, is quite limited. Therefore, the present study was undertaken to test effects of deflazacort on osteoclast-like cell formation in mouse bone marrow cultures and on the regulation of osteoprotegerin (OPG) and its ligand (RANKL) mRNA expressions by RT-PCR in the ST2 marrow stromal cells. TRAP-positive mononuclear cells increased after the treatment of deflazacort at 10(-9) to 10(-7) M alone for 6 days in a dose-dependent manner. Number of TRAP-positive multi-nucleated cells (MNCs) increased significantly with combined treatment of deflazacort at 10(-7) M and 1,25-(OH)2D3 at 10(-9) M compared to that of cultures treated with 1,25-(OH)2D3 alone (p<0.05). Exposure to deflazacort at 10(-7) M in the presence of 1,25-(OH)2D3 at 10(-9) M in the last 3-day culture had greater stimulatory effect on osteoclast-like cell formation than that of the first 3-day culture did. Deflazacort at 10(-10) -10(-6) M downregulated OPG and upregulated RANKL in mRNA levels in a dose-dependent manner. These observations suggest that deflazacort stimulate osteoclast precursor in the absence of 1,25-(OH)2D3 and enhance differentiation of osteoclasts in the presence of 1,25-(OH)2D3. These effects are, in part, thought to be mediated by the regulation of the expression of OPG and RANKL mRNA in marrow stromal cells.

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“…Thus studies have demonstrated less marked hypercalciuria (85,86), lesser effects on intestinal calcium absorption (85), reduced bone loss (87)(88)(89)(90) and less growth retardation in children treated with deflazacort (91,92). However, all these studies assumed that the potency of prednisone relative to deflazacort was 1.2.…”

Section: Bone-sparing Glucocorticoidsmentioning

confidence: 99%

Glucocorticoid osteoporosis--mechanisms and management

Reid

1997

European Journal of Endocrinology

249

148

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Glucocorticoids are potent osteopenic agents, producing negative calcium and bone balance via actions at many sites. The most significant adverse effects of glucocorticoid drugs on the skeleton are probably a direct inhibition of matrix synthesis by the osteoblast, reductions in calcium absorption in both the gut and the renal tubule, and the production of hypogonadism, particularly in men. Reductions in bone density of 10-40% result, the loss being more marked in trabecular bone and in patients receiving a high cumulative dose of the steroid. Fractures occur in about 30% of individuals who take these drugs for an average of 5 years. Bone loss is reversible when glucocorticoid treatment is withdrawn. Bone density can also be increased by sex hormone replacement in those with demonstrable deficiency, by bisphosphonates, and possibly by vitamin D metabolites. All patients treated with glucocorticoids for more than 6 months should be considered for bone densitometry and be offered appropriate drug treatment if values are towards the lower end of the young normal range or if there is already evidence of fractures occurring after minimal trauma. With this approach, the significant morbidity associated with steroid osteoporosis might be substantially avoided.

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A double‐blind study of deflazacort and prednisone in patients with chronic inflammatory disorders

Cited by 70 publications

References 28 publications

Low‐dose corticosteroids in rheumatoid arthritis. A meta‐analysis of their moderate‐term effectiveness

Low‐dose corticosteroids in rheumatoid arthritis. A meta‐analysis of their moderate‐term effectiveness

Deflazacort Increases Osteoclast Formation in Mouse Bone Marrow Culture and the Ratio ofRANKL/OPGmRNA Expression in Marrow Stromal Cells

Glucocorticoid osteoporosis--mechanisms and management

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