RESUMO
PURPOSE: Peripheral neuropathy (PN) is common in multiple myeloma (MM) patients. More insight has been gained concerning the role of vitamin D in preventing PN. However, studies evaluating the effects of vitamin D3 supplementation on PN are lacking. The aims of this study are to (1) evaluate the effectiveness of a vitamin D3 regimen on achieving adequate vitamin D levels in deficient MM patients and to (2) exploratively evaluate the effect of vitamin D3 supplementation on PN. METHODS: Thirty-nine MM patients with inadequate (< 75 nmol/L [= 30 ng/mL]) 25-hydroxyvitamin D (25(OH)D) levels were included in this multicenter, prospective, single-arm study, of whom 35 patients completed the study. They received oral vitamin D3 for 6 months according to a dose escalation regimen that consisted of one or two loading doses of 200,000 international units (IU), and maintenance doses of 800, 1600, or 3200 IU/day depending on the 25(OH)D level. A validated questionnaire was used to measure PN. RESULTS: Median 25(OH)D increased from 38 (IQR 32-52) nmol/L at baseline to 77 (IQR 72-87) nmol/L after 6 months (P < 0.001). Adequate 25(OH)D levels were achieved by 66% of the subjects, and 34% were within the range of 50-75 nmol/L. Furthermore, in 37% of the participants, PN severity decreased (P = 0.007). CONCLUSION: The use of substantially higher vitamin D3 doses than recommended in current guidelines resulted in a significant increase in vitamin D levels in MM patients. Furthermore, evaluation of PN showed a significant decrease in PN grading. However, this exploratory evaluation needs further confirmatory research.
Assuntos
Mieloma Múltiplo , Doenças do Sistema Nervoso Periférico , Deficiência de Vitamina D , Humanos , Estudos Prospectivos , Mieloma Múltiplo/complicações , Mieloma Múltiplo/tratamento farmacológico , Suplementos Nutricionais , Deficiência de Vitamina D/tratamento farmacológico , Vitamina D/uso terapêutico , Vitaminas , Colecalciferol/uso terapêutico , Colecalciferol/farmacologia , Doenças do Sistema Nervoso Periférico/tratamento farmacológico , Doenças do Sistema Nervoso Periférico/etiologiaRESUMO
RATIONALE: While treatment strategies for multiple myeloma have evolved radically over the last decades, little is known about the risk of fractures for symptomatic multiple myeloma patients over time. OBJECTIVE: To determine the effect of different treatment periods (1996-2000, 2001-2006 and 2007-2011) on the risk of fractures in patients with multiple myeloma. METHODS: This retrospective case-control study included patients with multiple myeloma in Denmark, using the Danish National Health Service. Cases were defined as patients who had sustained a fracture between 1996 and 2011, and controls were those without a fracture. Exposure was defined as an ICD code for multiple myeloma. Vertebral fractures, gender, and age were considered in secondary analyses. Conditional logistic regression was used to estimate odd ratios (ORs) of fracture risk, and the analyses were adjusted for comorbidities and recent drug use. RESULTS: The study population consisted of 925,341 cases, and the same number of matched controls, of whom 1334 patients with multiple myeloma. Among cases, the risk of any fracture was higher in multiple myeloma patients compared to patients without multiple myeloma (any fracture: ORadj[95% CI] 1996-2000: 1.7[1.3-2.3]; 2001-2006: 1.3[1.1-1.6]; 2007-2011: 1.7[1.4-2.2]). Although fractures were mainly non-vertebral, the risk of vertebral fractures in particular was higher in multiple myeloma patients (vertebral fracture: ORadj[95% CI] 1996-2000: 3.5[1.4-8.6]; 2001-2006: 4.0[1.9-8.2]; 2007-2011: 3.0[1.6-5.7]). CONCLUSIONS: Despite new treatment strategies and improved supportive care, this study showed no decreased fracture risk for multiple myeloma patients over time. New treatment strategies, even if they have a positive impact on overall survival, offer no guarantee for a corresponding reduction in bone lesions.
Assuntos
Mieloma Múltiplo , Fraturas da Coluna Vertebral , Estudos de Casos e Controles , Dinamarca/epidemiologia , Humanos , Mieloma Múltiplo/complicações , Mieloma Múltiplo/epidemiologia , Estudos Retrospectivos , Fatores de Risco , Fraturas da Coluna Vertebral/complicações , Fraturas da Coluna Vertebral/epidemiologia , Medicina EstatalRESUMO
Rationale When patients are using carbasalate calcium or acetylsalicylic acid (ASA), it is recommended to prescribe a proton pump inhibitor (PPI) in order to prevent gastrointestinal (GI) bleeding. Should this recommendation also be followed for patients who are using clopidogrel in monotherapy, which is increasingly the case in practice? Method In a systematic literature review of the occurrence of GI bleeding when using clopidogrel versus ASA, we included 9 studies that compared the risk of GI bleeding when using ASA with clopidogrel monotherapy. Results These 9 studies on clopidogrel and ASA show that the risk of GI bleeding is also elevated when using clopidogrel monotherapy and that it is comparable with the risk of GI bleeding when using ASA. Conclusion Based on the current literature, we recommend prescribing pantoprazole to patients who are using clopidogrel monotherapy and have additional risk factors for GI bleeding, in accordance with the procedure for low-dose ASA. The risk of GI bleeding must be weighed against the disadvantages of using PPIs.
Assuntos
Clopidogrel/efeitos adversos , Hemorragia Gastrointestinal/prevenção & controle , Úlcera Péptica/prevenção & controle , Inibidores da Bomba de Prótons/efeitos adversos , Aspirina/efeitos adversos , Clopidogrel/administração & dosagem , Interações Medicamentosas , Feminino , Gastroenteropatias , Hemorragia Gastrointestinal/induzido quimicamente , Humanos , Masculino , Úlcera Péptica/induzido quimicamente , Inibidores da Agregação Plaquetária/efeitos adversos , Inibidores da Bomba de Prótons/administração & dosagem , Fatores de RiscoAssuntos
Antineoplásicos/uso terapêutico , Bortezomib/uso terapêutico , Mieloma Múltiplo/complicações , Mieloma Múltiplo/tratamento farmacológico , Diálise Renal , Insuficiência Renal/etiologia , Insuficiência Renal/terapia , Antineoplásicos/farmacologia , Bortezomib/farmacologia , Humanos , Mieloma Múltiplo/epidemiologia , Mieloma Múltiplo/mortalidade , Vigilância da População , Modelos de Riscos Proporcionais , Insuficiência Renal/epidemiologiaRESUMO
Renal impairment (RI) in patients with multiple myeloma (MM) is associated with poor prognosis. In this population-based cohort study, we assessed the effects of renal response, evaluated according to the IMWG-criteria, on overall survival (OS) in patients with newly diagnosed MM with RI at presentation. All included patients were diagnosed between January 2005 and January 2014 with MM and RI in Friesland, a province of the Netherlands. Of the 131 included patients, 61% achieved renal response. Using a time-varying exposure Cox model, no difference in OS between renal response and non-response was observed (HR = 1.08, 95% CI = 0.67-1.74, p = .76). In multivariable analysis, baseline eGFR <30 ml/min (HR = 1.71), age >70 yrs (HR = 1.77), hypercalcemia (HR = 2.73), lambda Bence-Jones (HR= 1.76), and initial treatment regimen (HR = 0.89 for thalidomide, HR = 1.95 in treatment regimens without novel agents and HR = 3.60 for no chemotherapy, all vs. bortezomib) were associated with decreased OS. In conclusion, achieving renal response was not associated with improved OS.