Randomized, Double-Blind Six-Month Trial of Prednisone in Duchenne's Muscular Dystrophy
We performed a randomized, double-blind, controlled six-month trial of prednisone in 103 boys with Duchenne's muscular dystrophy (age, 5 to 15 years). The patients were assigned to one of three regimens: prednisone, 0.75 mg per kilogram of body weight per day (n = 33); prednisone, 1.5 mg per ki...
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| Veröffentlicht in: | The New England journal of medicine 1989-06, Vol.320 (24), p.1592-1597 |
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| creator | Mendell, J.R Moxley, R.T Griggs, R.C Brooke, M.H Fenichel, G.M Miller, J.P King, W Signore, L Pandya, S Florence, J Schierbecker, J Robison, J Kaiser, K Mandel, S Arfken, C Gilder, B |
| description | We performed a randomized, double-blind, controlled six-month trial of prednisone in 103 boys with Duchenne's muscular dystrophy (age, 5 to 15 years). The patients were assigned to one of three regimens: prednisone, 0.75 mg per kilogram of body weight per day (n = 33); prednisone, 1.5 mg per kilogram per day (n = 34); or placebo (n = 36). The groups were initially comparable in all measures of muscle function.
Both prednisone groups had significant improvement of similar degree in the summary scores of muscle strength and function. Improvement began as early as one month and peaked by three months. At six months the high-dose prednisone group, as compared with the placebo group, had improvement in the time needed to rise from a supine to a standing position (3.4 vs. 6.2 seconds), to walk 9 m (7.0 vs. 9.7 seconds), and to climb four stairs (4.0 vs. 7.1 seconds), in lifting a weight (2.1 vs. 1.2 kg), and in forced vital capacity (1.7 vs. 1.5 liters) (P |
| doi_str_mv | 10.1056/NEJM198906153202405 |
| format | Article |
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Both prednisone groups had significant improvement of similar degree in the summary scores of muscle strength and function. Improvement began as early as one month and peaked by three months. At six months the high-dose prednisone group, as compared with the placebo group, had improvement in the time needed to rise from a supine to a standing position (3.4 vs. 6.2 seconds), to walk 9 m (7.0 vs. 9.7 seconds), and to climb four stairs (4.0 vs. 7.1 seconds), in lifting a weight (2.1 vs. 1.2 kg), and in forced vital capacity (1.7 vs. 1.5 liters) (P<0.001 for all comparisons). There was an increase in urinary creatinine excretion (261 vs. 190 mg per 24 hours), which suggested an increase in total muscle mass. However, the prednisone-treated patients who had required long-leg braces (n = 5) or wheelchairs (n = 11) continued to require them. The most frequent side effects were weight gain, cushingoid appearance, and excessive hair growth.
We conclude from this six-month study that prednisone improves the strength and function of patients with Duchenne's muscular dystrophy. However, further research is required to identify the mechanisms responsible for these improvements and to determine whether prolonged treatment with corticosteroids may be warranted despite their side effects. (N Engl J Med 1989; 320:1592–7.)
DUCHENNE'S muscular dystrophy is an inexorably progressive disease that results in severe disability by the age of 10 to 12 years and in death in early adulthood. Despite recent major advances in the understanding of the molecular genetic defect,
1
2
3
4
5
6
no treatment improves or even slows the disorder. We recently observed an increase in muscle strength after six months of prednisone treatment (1.5 mg per kilogram of body weight per day) in an open therapeutic trial in 33 patients with Duchenne's muscular dystrophy.
7
That study, which used historical controls,
8
suggested that patients with this disorder received a short-term benefit. However, that . . .</description><identifier>ISSN: 0028-4793</identifier><identifier>EISSN: 1533-4406</identifier><identifier>DOI: 10.1056/NEJM198906153202405</identifier><identifier>PMID: 2657428</identifier><language>eng</language><publisher>United States: Massachusetts Medical Society</publisher><subject>Adolescent ; Body weight ; Body weight gain ; Child ; Child, Preschool ; Clinical Trials as Topic ; Corticosteroids ; Creatinine ; Double-Blind Method ; Double-blind studies ; Duchenne's muscular dystrophy ; Evidence-based medicine ; Excretion ; Gene expression ; Humans ; Laboratories ; Lactose ; Male ; Muscle strength ; Muscles - drug effects ; Muscles - physiopathology ; Muscular Dystrophies - drug therapy ; Muscular Dystrophies - physiopathology ; Muscular dystrophy ; Musculoskeletal system ; Patients ; Prednisone ; Prednisone - administration & dosage ; Prednisone - adverse effects ; Prednisone - therapeutic use ; Protein synthesis ; Proteins ; Random Allocation ; Research centers ; Side effects ; Urine</subject><ispartof>The New England journal of medicine, 1989-06, Vol.320 (24), p.1592-1597</ispartof><rights>Copyright Massachusetts Medical Society Jun 15, 1989</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c415t-d4e4b1a0e41c97a7931e621441bcadc21d5ed7b72fb7be56ad77d397c675b7922</citedby><cites>FETCH-LOGICAL-c415t-d4e4b1a0e41c97a7931e621441bcadc21d5ed7b72fb7be56ad77d397c675b7922</cites></display><links><openurl>$$Topenurl_article</openurl><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>776</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/2657428$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Mendell, J.R</creatorcontrib><creatorcontrib>Moxley, R.T</creatorcontrib><creatorcontrib>Griggs, R.C</creatorcontrib><creatorcontrib>Brooke, M.H</creatorcontrib><creatorcontrib>Fenichel, G.M</creatorcontrib><creatorcontrib>Miller, J.P</creatorcontrib><creatorcontrib>King, W</creatorcontrib><creatorcontrib>Signore, L</creatorcontrib><creatorcontrib>Pandya, S</creatorcontrib><creatorcontrib>Florence, J</creatorcontrib><creatorcontrib>Schierbecker, J</creatorcontrib><creatorcontrib>Robison, J</creatorcontrib><creatorcontrib>Kaiser, K</creatorcontrib><creatorcontrib>Mandel, S</creatorcontrib><creatorcontrib>Arfken, C</creatorcontrib><creatorcontrib>Gilder, B</creatorcontrib><title>Randomized, Double-Blind Six-Month Trial of Prednisone in Duchenne's Muscular Dystrophy</title><title>The New England journal of medicine</title><addtitle>N Engl J Med</addtitle><description>We performed a randomized, double-blind, controlled six-month trial of prednisone in 103 boys with Duchenne's muscular dystrophy (age, 5 to 15 years). The patients were assigned to one of three regimens: prednisone, 0.75 mg per kilogram of body weight per day (n = 33); prednisone, 1.5 mg per kilogram per day (n = 34); or placebo (n = 36). The groups were initially comparable in all measures of muscle function.
Both prednisone groups had significant improvement of similar degree in the summary scores of muscle strength and function. Improvement began as early as one month and peaked by three months. At six months the high-dose prednisone group, as compared with the placebo group, had improvement in the time needed to rise from a supine to a standing position (3.4 vs. 6.2 seconds), to walk 9 m (7.0 vs. 9.7 seconds), and to climb four stairs (4.0 vs. 7.1 seconds), in lifting a weight (2.1 vs. 1.2 kg), and in forced vital capacity (1.7 vs. 1.5 liters) (P<0.001 for all comparisons). There was an increase in urinary creatinine excretion (261 vs. 190 mg per 24 hours), which suggested an increase in total muscle mass. However, the prednisone-treated patients who had required long-leg braces (n = 5) or wheelchairs (n = 11) continued to require them. The most frequent side effects were weight gain, cushingoid appearance, and excessive hair growth.
We conclude from this six-month study that prednisone improves the strength and function of patients with Duchenne's muscular dystrophy. However, further research is required to identify the mechanisms responsible for these improvements and to determine whether prolonged treatment with corticosteroids may be warranted despite their side effects. (N Engl J Med 1989; 320:1592–7.)
DUCHENNE'S muscular dystrophy is an inexorably progressive disease that results in severe disability by the age of 10 to 12 years and in death in early adulthood. Despite recent major advances in the understanding of the molecular genetic defect,
1
2
3
4
5
6
no treatment improves or even slows the disorder. We recently observed an increase in muscle strength after six months of prednisone treatment (1.5 mg per kilogram of body weight per day) in an open therapeutic trial in 33 patients with Duchenne's muscular dystrophy.
7
That study, which used historical controls,
8
suggested that patients with this disorder received a short-term benefit. However, that . . .</description><subject>Adolescent</subject><subject>Body weight</subject><subject>Body weight gain</subject><subject>Child</subject><subject>Child, Preschool</subject><subject>Clinical Trials as Topic</subject><subject>Corticosteroids</subject><subject>Creatinine</subject><subject>Double-Blind Method</subject><subject>Double-blind studies</subject><subject>Duchenne's muscular dystrophy</subject><subject>Evidence-based medicine</subject><subject>Excretion</subject><subject>Gene expression</subject><subject>Humans</subject><subject>Laboratories</subject><subject>Lactose</subject><subject>Male</subject><subject>Muscle strength</subject><subject>Muscles - drug effects</subject><subject>Muscles - physiopathology</subject><subject>Muscular Dystrophies - drug therapy</subject><subject>Muscular Dystrophies - physiopathology</subject><subject>Muscular dystrophy</subject><subject>Musculoskeletal system</subject><subject>Patients</subject><subject>Prednisone</subject><subject>Prednisone - administration & dosage</subject><subject>Prednisone - adverse effects</subject><subject>Prednisone - therapeutic use</subject><subject>Protein synthesis</subject><subject>Proteins</subject><subject>Random Allocation</subject><subject>Research centers</subject><subject>Side effects</subject><subject>Urine</subject><issn>0028-4793</issn><issn>1533-4406</issn><fulltext>false</fulltext><rsrctype>article</rsrctype><creationdate>1989</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BEC</sourceid><sourceid>BENPR</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNp9kN1LHDEUxYNUdLX-BVIICPqgY3MzyWTmUV3rB25b_KCPQya5y84yk6zJDrj-9U3ZpQ9Fel_uhfO7h8Mh5BDYOTBZfP1-fT-BqqxYATLnjAsmt8go3XkmBCs-kRFjvMyEqvJdshfjnKUBUe2QHV5IJXg5Ir8etbO-b9_RntGxH5oOs8uudZY-tW_ZxLvljD6HVnfUT-nPgNa10TukraPjwczQOTyJdDJEM3Q60PEqLoNfzFafyfZUdxEPNnufvHy7fr66zR5-3NxdXTxkRoBcZlagaEAzFGAqpVNSwIKDENAYbQ0HK9GqRvFpoxqUhbZK2bxSplCyURXn--R47bsI_nXAuKz7NhrsOu3QD7EGKaAopUrg0T_g3A_BpWw1lCVPXA55ovI1ZYKPMeC0XoS212FVA6v_lF5_UHr6-rLxHpoe7d-fTctJP13rfR9rh_P-v26_AY4Rh8Q</recordid><startdate>19890615</startdate><enddate>19890615</enddate><creator>Mendell, J.R</creator><creator>Moxley, R.T</creator><creator>Griggs, R.C</creator><creator>Brooke, M.H</creator><creator>Fenichel, G.M</creator><creator>Miller, J.P</creator><creator>King, W</creator><creator>Signore, L</creator><creator>Pandya, S</creator><creator>Florence, J</creator><creator>Schierbecker, J</creator><creator>Robison, J</creator><creator>Kaiser, K</creator><creator>Mandel, S</creator><creator>Arfken, C</creator><creator>Gilder, B</creator><general>Massachusetts Medical Society</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>0TZ</scope><scope>7RV</scope><scope>7X7</scope><scope>7XB</scope><scope>8AO</scope><scope>8C1</scope><scope>8FE</scope><scope>8FH</scope><scope>8FI</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AN0</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BEC</scope><scope>BENPR</scope><scope>BHPHI</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>HCIFZ</scope><scope>K0Y</scope><scope>LK8</scope><scope>M0R</scope><scope>M0T</scope><scope>M1P</scope><scope>M2M</scope><scope>M2O</scope><scope>M2P</scope><scope>M7P</scope><scope>MBDVC</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>PSYQQ</scope><scope>Q9U</scope><scope>7U7</scope><scope>C1K</scope></search><sort><creationdate>19890615</creationdate><title>Randomized, Double-Blind Six-Month Trial of Prednisone in Duchenne's Muscular Dystrophy</title><author>Mendell, J.R ; Moxley, R.T ; Griggs, R.C ; Brooke, M.H ; Fenichel, G.M ; Miller, J.P ; King, W ; Signore, L ; Pandya, S ; Florence, J ; Schierbecker, J ; Robison, J ; Kaiser, K ; Mandel, S ; Arfken, C ; Gilder, B</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c415t-d4e4b1a0e41c97a7931e621441bcadc21d5ed7b72fb7be56ad77d397c675b7922</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>1989</creationdate><topic>Adolescent</topic><topic>Body weight</topic><topic>Body weight gain</topic><topic>Child</topic><topic>Child, Preschool</topic><topic>Clinical Trials as Topic</topic><topic>Corticosteroids</topic><topic>Creatinine</topic><topic>Double-Blind Method</topic><topic>Double-blind studies</topic><topic>Duchenne's muscular dystrophy</topic><topic>Evidence-based medicine</topic><topic>Excretion</topic><topic>Gene expression</topic><topic>Humans</topic><topic>Laboratories</topic><topic>Lactose</topic><topic>Male</topic><topic>Muscle strength</topic><topic>Muscles - 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The patients were assigned to one of three regimens: prednisone, 0.75 mg per kilogram of body weight per day (n = 33); prednisone, 1.5 mg per kilogram per day (n = 34); or placebo (n = 36). The groups were initially comparable in all measures of muscle function.
Both prednisone groups had significant improvement of similar degree in the summary scores of muscle strength and function. Improvement began as early as one month and peaked by three months. At six months the high-dose prednisone group, as compared with the placebo group, had improvement in the time needed to rise from a supine to a standing position (3.4 vs. 6.2 seconds), to walk 9 m (7.0 vs. 9.7 seconds), and to climb four stairs (4.0 vs. 7.1 seconds), in lifting a weight (2.1 vs. 1.2 kg), and in forced vital capacity (1.7 vs. 1.5 liters) (P<0.001 for all comparisons). There was an increase in urinary creatinine excretion (261 vs. 190 mg per 24 hours), which suggested an increase in total muscle mass. However, the prednisone-treated patients who had required long-leg braces (n = 5) or wheelchairs (n = 11) continued to require them. The most frequent side effects were weight gain, cushingoid appearance, and excessive hair growth.
We conclude from this six-month study that prednisone improves the strength and function of patients with Duchenne's muscular dystrophy. However, further research is required to identify the mechanisms responsible for these improvements and to determine whether prolonged treatment with corticosteroids may be warranted despite their side effects. (N Engl J Med 1989; 320:1592–7.)
DUCHENNE'S muscular dystrophy is an inexorably progressive disease that results in severe disability by the age of 10 to 12 years and in death in early adulthood. Despite recent major advances in the understanding of the molecular genetic defect,
1
2
3
4
5
6
no treatment improves or even slows the disorder. We recently observed an increase in muscle strength after six months of prednisone treatment (1.5 mg per kilogram of body weight per day) in an open therapeutic trial in 33 patients with Duchenne's muscular dystrophy.
7
That study, which used historical controls,
8
suggested that patients with this disorder received a short-term benefit. However, that . . .</abstract><cop>United States</cop><pub>Massachusetts Medical Society</pub><pmid>2657428</pmid><doi>10.1056/NEJM198906153202405</doi><tpages>6</tpages></addata></record> |
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| subjects | Adolescent Body weight Body weight gain Child Child, Preschool Clinical Trials as Topic Corticosteroids Creatinine Double-Blind Method Double-blind studies Duchenne's muscular dystrophy Evidence-based medicine Excretion Gene expression Humans Laboratories Lactose Male Muscle strength Muscles - drug effects Muscles - physiopathology Muscular Dystrophies - drug therapy Muscular Dystrophies - physiopathology Muscular dystrophy Musculoskeletal system Patients Prednisone Prednisone - administration & dosage Prednisone - adverse effects Prednisone - therapeutic use Protein synthesis Proteins Random Allocation Research centers Side effects Urine |
| title | Randomized, Double-Blind Six-Month Trial of Prednisone in Duchenne's Muscular Dystrophy |
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