| A phase II clinical trial does not show that high dose simvastatin has beneficial effect on markers of bone turnover in multiple myeloma. | |
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MedLine Citation:
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PMID: 18668701 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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Several studies have evaluated the impact of low dose statin (20-80 mg/day) on bone metabolism with inconclusive results despite promising data of preclinical studies. In this study, we investigated the effect of high dose simvastatin (HD-Sim) on biochemical markers of bone turnover and disease activity in six heavily pretreated patients with multiple myeloma (MM). These patients were treated with simvastatin (15 mg/kg/day) for 7 days followed by a rest period of 21 days in two 4-week cycles. Endpoints were changes in the level of biochemical markers of (i) osteoclast activity (tartrate resistant acid phosphatase, TRACP); (ii) bone resorption (collagen fragments CTX and NTX); (iii) bone formation (osteocalcin and aminoterminal propeptide of type I collagen PINP); (iv) cholesterol; (v) regulators of bone metabolism [osteoprotegerin (OPG) and Dickkopf-1 (DKK-1)] and (vi) disease activity (monoclonal proteins or free light chains in serum). TRACP activity in serum and levels of collagen fragments (NTX) in urine increased for all patients temporarily during the 7 days of treatment with HD-Sim indicating that osteoclasts may have been stimulated rather than inhibited. The other markers of bone metabolism showed no change. None of the patients showed any reduction in free monoclonal light chains or monoclonal proteins in serum during treatment with HD-Sim. In spite of the fact that bone turn over effects of HD-Sim may have been blunted by concomitant treatment of patients with other drugs we observed a transient increase in markers of osteoclast activity. This sign of a transient stimulation of osteoclast activity suggests that HD-Sim may be harmful rather than beneficial for MM patients. For this reason and because of gastro-intestinal side effects the study was stopped prematurely. |
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Authors:
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T E Sondergaard; P T Pedersen; T L Andersen; K Søe; T Lund; B Ostergaard; P Garnero; J-M Delaisse; T Plesner |
Publication Detail:
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Type: Clinical Trial, Phase II; Journal Article; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: Hematological oncology Volume: 27 ISSN: 1099-1069 ISO Abbreviation: Hematol Oncol Publication Date: 2009 Mar |
Date Detail:
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Created Date: 2009-03-03 Completed Date: 2009-04-27 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 8307268 Medline TA: Hematol Oncol Country: England |
Other Details:
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Languages: eng Pagination: 17-22 Citation Subset: IM |
Copyright Information:
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Copyright 2009 John Wiley & Sons, Ltd. |
Affiliation:
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Department of Clinical Cell Biology, IRS-CSFU, University of Southern Denmark, Vejle Hospital, Vejle, Denmark. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Aged Aged, 80 and over Antilipemic Agents / therapeutic use, toxicity Bone and Bones / drug effects, metabolism* Drug Administration Schedule Drug Therapy, Combination Female Humans Male Middle Aged Multiple Myeloma / drug therapy*, metabolism* Osteoclasts / drug effects, metabolism Patient Selection Simvastatin / therapeutic use*, toxicity* |
| Chemical | |
Reg. No./Substance:
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0/Antilipemic Agents; 79902-63-9/Simvastatin |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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