Abstract:
Background:Iron chelation therapy (ICT) in patients with lower-risk myelodysplastic syndromes (MDS) has not been evaluated in randomized studies. Objective:To evaluate event-free survival (EFS) and safety of ICT in iron-overloaded patients with low- or intermediate-1-risk MDS. Design:Multicenter, randomized, double-blind, placebo-controlled trial (TELESTO). (ClinicalTrials.gov: NCT00940602). Setting:60 centers in 16 countries. Participants:225 patients with serum ferritin levels greater than 2247 pmol/L; prior receipt of 15 to 75 packed red blood cell units; and no severe cardiac, liver, or renal abnormalities. Intervention:Deferasirox dispersible tablets (10 to 40 mg/kg per day) (n = 149) or matching placebo (n = 76). Measurements:The primary end point was EFS, defined as time from date of randomization to first documented nonfatal event (related to cardiac or liver dysfunction and transformation to acute myeloid leukemia) or death, whichever occurred first. Results:Median time on treatment was 1.6 years (interquartile range [IQR], 0.5 to 3.1 years) in the deferasirox group and 1.0 year (IQR, 0.6 to 2.0 years) in the placebo group. Median EFS was prolonged by approximately 1 year with deferasirox versus placebo (3.9 years [95% CI, 3.2 to 4.3 years] vs. 3.0 years [CI, 2.2 to 3.7 years], respectively; hazard ratio, 0.64 [CI, 0.42 to 0.96]). Adverse events occurred in 97.3% of deferasirox recipients and 90.8% of placebo recipients. Exposure-adjusted incidence rates of adverse events (≥15 events per 100 patient treatment-years) in deferasirox versus placebo recipients, respectively, were 24.7 versus 23.9 for diarrhea, 21.8 versus 18.7 for pyrexia, 16.7 versus 22.7 for upper respiratory tract infection, and 15.9 versus 0.9 for increased serum creatinine concentration. Limitations:The protocol was amended from a phase 3 to a phase 2 study, with a reduced target sample size from 630 to 210 participants. There was differential follow-up between treatment groups. Conclusion:The findings support ICT in iron-overloaded patients with low- to intermediate-1-risk MDS, with longer EFS compared with placebo and a clinically manageable safety profile. Therefore, ICT may be considered in these patients. Primary Funding Source:Novartis Pharma AG.
journal_name
Ann Intern Medjournal_title
Annals of internal medicineauthors
Angelucci E,Li J,Greenberg P,Wu D,Hou M,Montano Figueroa EH,Rodriguez MG,Dong X,Ghosh J,Izquierdo M,Garcia-Manero G,TELESTO Study Investigators.doi
10.7326/M19-0916subject
Has Abstractpub_date
2020-04-21 00:00:00pages
513-522issue
8eissn
0003-4819issn
1539-3704pii
2763493journal_volume
172pub_type
杂志文章,多中心研究,随机对照试验abstract:PURPOSE:To evaluate the use of thyroid function tests to monitor therapy in patients taking levothyroxine. DATA IDENTIFICATION:Studies published between 1966 and January 1990 were identified through computer searches and references of identified studies. STUDY SELECTION:Studies that included a careful description of ...
journal_title:Annals of internal medicine
pub_type: 杂志文章,meta分析
doi:10.7326/0003-4819-113-6-450
更新日期:1990-09-15 00:00:00
abstract::A cohort of both active and retired older cotton textile workers was examined prospectively over a 6-year period to establish the nature and extent of chronic lung disease. Respiratory symptoms and lung function were studied in these workers and in a group of similarly aged controls. The cotton textile workers had hig...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-97-5-645
更新日期:1982-11-01 00:00:00
abstract:PURPOSE:To assess the data that support the use of coronary angiography and angioplasty after acute myocardial infarction, that identify the risks of these procedures, and that analyze their use and costs. DATA SOURCES:English-language articles published between 1970 and June 1995 identified through a search of the ME...
journal_title:Annals of internal medicine
pub_type: 杂志文章,评审
doi:10.7326/0003-4819-126-7-199704010-00007
更新日期:1997-04-01 00:00:00
abstract::Forty patients with systemic lupus erythematosus randomly received inactivated bivalent (A/NJ and A/Victoria) influenza vaccine or saline in a double-blind study. During 20 weeks of follow-up, no deterioration in major organ function or increase in disease flares was observed in the immunized group as compared with th...
journal_title:Annals of internal medicine
pub_type: 临床试验,杂志文章
doi:10.7326/0003-4819-88-6-729
更新日期:1978-06-01 00:00:00
abstract::Pyrimethamine-sulfadoxine has been associated with severe and fatal cutaneous reactions as well as transient liver damage. We report the case of a patient who died of progressive hepatic failure caused by pyrimethamine-sulfadoxine administration. In addition, we summarize reports made to the Food and Drug Administrati...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-106-3-393
更新日期:1987-03-01 00:00:00
abstract:BACKGROUND:Recently, liver transplantation has been used to treat patients with familial amyloid polyneuropathy (FAP). OBJECTIVE:To describe the clinical course of patients with FAP who received partial-liver transplantation from living donors. DESIGN:Case series. SETTING:University hospital in Matsumoto, Japan. PA...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-131-8-199910190-00008
更新日期:1999-10-19 00:00:00
abstract:BACKGROUND:Advice and exercise are widely recommended for subacute low back pain, but the effectiveness of these interventions is unclear. OBJECTIVE:To investigate the effectiveness of physiotherapist-prescribed exercise, advice, or both for subacute low back pain. DESIGN:Factorial randomized, placebo-controlled tria...
journal_title:Annals of internal medicine
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.7326/0003-4819-146-11-200706050-00007
更新日期:2007-06-05 00:00:00
abstract:BACKGROUND:Neurologic complications of endocarditis can influence diagnosis, therapeutic plans, and prognosis. OBJECTIVE:To describe how early cerebral magnetic resonance imaging (MRI) affects the diagnosis and management of endocarditis in hospitalized adults. DESIGN:Single-center prospective study between June 2005...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-152-8-201004200-00006
更新日期:2010-04-20 00:00:00
abstract:OBJECTIVE:To determine the most effective and safe dose of enoxaparin to prevent deep venous thrombosis in high-risk surgical patients. DESIGN:A double-blind, randomized, multicenter clinical trial. SETTING:Private, university, and government hospitals in the United States. PATIENTS:572 patients having elective hip ...
journal_title:Annals of internal medicine
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
doi:10.7326/0003-4819-121-2-199407150-00001
更新日期:1994-07-15 00:00:00
abstract::Research participants require ongoing protection of the kind already established in law and regulation. However, "special scrutiny" for certain types of research is also needed. Three criteria for special scrutiny are 1) research that involves initial experiences of translating new scientific advances into humans, esp...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-140-3-200402030-00013
更新日期:2004-02-03 00:00:00
abstract:PURPOSE:To review the radiofrequency ablation method, describe the technique, and discuss the indications, results, and limitations of its use in patients with cardiac tachyarrhythmias. DATA SOURCES:Peer-reviewed reports in the literature by clinical investigators who use radiofrequency catheter ablation as identified...
journal_title:Annals of internal medicine
pub_type: 杂志文章,评审
doi:10.7326/0003-4819-121-6-199409150-00010
更新日期:1994-09-15 00:00:00
abstract:OBJECTIVE:To determine the role of B19 parvovirus in red cell aplasia of patients infected with human immunodeficiency virus type 1 (HIV-1). DESIGN:Uncontrolled clinical trial, with assay of serum, peripheral blood cells, and bone marrow for virus using DNA hybridization and immunocytochemistry techniques; these assay...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-113-12-926
更新日期:1990-12-15 00:00:00
abstract::Methylation of DNA is a biochemical modification that can influence gene expression and is involved in inactivating one of the two X chromosomes in women. Evidence that has accumulated in the past 10 years suggests that cancer cells usurp this physiologic mechanism and use it to their benefit by inactivating tumor sup...
journal_title:Annals of internal medicine
pub_type: 杂志文章,评审
doi:10.7326/0003-4819-134-7-200104030-00011
更新日期:2001-04-03 00:00:00
abstract:BACKGROUND:Visits to physicians for genital herpes simplex virus (HSV) infection continue to increase. Most patients with symptomatic infections have recurrences, but no studies of the long-term clinical course of genital herpes are available. OBJECTIVE:To determine whether the frequency of HSV recurrences decreases o...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-131-1-199907060-00004
更新日期:1999-07-06 00:00:00
abstract:OBJECTIVE:To examine, from the perspective of primary care physicians, the value of mental status findings and ancillary tests in diagnosing dementia or its causes. DATA SOURCES:Studies identified using MEDLINE and bibliographies of pertinent articles. STUDY SELECTION:Selection based on availability of information on...
journal_title:Annals of internal medicine
pub_type: 杂志文章,评审
doi:10.7326/0003-4819-115-2-122
更新日期:1991-07-15 00:00:00
abstract::A patient with bladder carcinoma metastatic to lung and brain died of pneumonia. Autopsy examination showed a confluent bronchopneumonia with several small abscesses and acute pyelonephritis with abscess formation. Legionella pneumophila, serogroup 4, was isolated in pure culture from lung tissue postmortem and was al...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-93-6-835
更新日期:1980-12-01 00:00:00
abstract::We prospectively studied the evaluation of dementia in 107 unselected outpatients; 83 had so-called "irreversible" dementias, including 74 who had an Alzheimer-type dementia. Fifteen patients had potentially reversible dementias, of which hypothyroidism and drug toxicity were the commonest causes. Distinguishing featu...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-100-3-417
更新日期:1984-03-01 00:00:00
abstract::Communication in the delivery of health care services occurs along 2 axes: between providers and patients and among several providers. In primary care, a principle objective in the provider-patient relationship is facilitating whole-person care, which is care provided in the context of family and community. In additio...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-142-8-200504190-00039
更新日期:2005-04-19 00:00:00
abstract:Background:The 2013 cholesterol management guidelines from the American College of Cardiology and American Heart Association (ACC/AHA) recommend lipid screening in all adults older than 20 years to identify those at increased risk for atherosclerotic cardiovascular disease (ASCVD). Statins may be considered for patient...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/M16-2052
更新日期:2017-06-20 00:00:00
abstract:DESCRIPTION:Update of the 2009 U.S. Preventive Services Task Force (USPSTF) recommendation on screening for breast cancer. METHODS:The USPSTF reviewed the evidence on the following: effectiveness of breast cancer screening in reducing breast cancer-specific and all-cause mortality, as well as the incidence of advanced...
journal_title:Annals of internal medicine
pub_type: 杂志文章,实务指引
doi:10.7326/M15-2886
更新日期:2016-02-16 00:00:00
abstract::Colony-stimulating factors are growth factors responsible for the proliferation and the maturation of bone marrow stem cells to fully differentiated granulocytes and monocytes. In addition to their effects on hematopoiesis, some colony-stimulating factors prime mature cells for enhanced chemotaxis, phagocytosis, and k...
journal_title:Annals of internal medicine
pub_type: 临床试验,杂志文章,评审
doi:10.7326/0003-4819-110-4-297
更新日期:1989-02-15 00:00:00
abstract:BACKGROUND:Lack of awareness of hypoglycemia is a major limiting factor in the management of type 1 diabetes. OBJECTIVE:To examine whether reduction in the number of episodes of hypoglycemia restores hypoglycemia awareness by influencing beta-adrenergic sensitivity in patients with type 1 diabetes. DESIGN:Controlled ...
journal_title:Annals of internal medicine
pub_type: 临床试验,杂志文章
doi:10.7326/0003-4819-134-9_part_1-200105010-00009
更新日期:2001-05-01 00:00:00
abstract:BACKGROUND:Women treated with therapeutic chest radiation may develop breast cancer. PURPOSE:To summarize breast cancer risk and breast cancer surveillance in women after chest radiation for pediatric or young adult cancer. DATA SOURCES:Studies from MEDLINE, EMBASE, the Cochrane Library, and CINAHL (1966 to December ...
journal_title:Annals of internal medicine
pub_type: 杂志文章,评审
doi:10.7326/0003-4819-152-7-201004060-00009
更新日期:2010-04-06 00:00:00
abstract::The mechanisms of flushing reactions are pharmacologically and physiologically heterogeneous. Flushing may result from agents acting directly on the vascular smooth muscle or may be mediated by vasomotor nerves. Vasomotor nerves may lead to flushing as a result of events at both peripheral and central sites. In suscep...
journal_title:Annals of internal medicine
pub_type: 杂志文章,评审
doi:10.7326/0003-4819-95-4-468
更新日期:1981-10-01 00:00:00
abstract::In studies of the cause of gastrointestinal symptoms in homosexual men, Campylobacter jejuni was recovered from 10 of 158 men with, and 2 of 75 men without, intestinal symptoms. In addition, a heterogeneous group of Campylobacter-like organisms was identified in 26 symptomatic and 6 asymptomatic homosexual men, but in...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-101-2-187
更新日期:1984-08-01 00:00:00
abstract::Protein S activity may be compromised in patients with the nephrotic syndrome and contribute to a thrombotic diathesis. Protein S is found in two forms in plasma as free and functionally active protein S, and complexed to C4b-binding protein. When compared with controls, patients with nephrotic syndrome had reduced fu...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-107-1-42
更新日期:1987-07-01 00:00:00
abstract:OBJECTIVE:To evaluate the incidence and symptoms of and risk factors for biliary sludge and gallstones during pregnancy and to assess the natural history of these conditions in the first year after delivery. DESIGN:Cohort study. PATIENTS:A total of 272 pregnant women recruited in the first trimester. MEASUREMENTS:Bi...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-119-2-199307150-00004
更新日期:1993-07-15 00:00:00
abstract::The competition for funds to conduct clinical research is intense, and only a minority of grant proposals receive funding. In particular, funding for patient-oriented research lags behind that allocated for basic science research. Grant writing is a skill of fundamental importance to the clinical researcher, and condu...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-142-4-200502150-00009
更新日期:2005-02-15 00:00:00
abstract::Adverse effects to D-penicillamine were studied prospectively over 3 years in 259 patients with rheumatoid arthritis. Ninety-five percent had had gold therapy previously, yet 70% benefited from D-penicillamine therapy. Of the 275 courses given, 160 (58%) were complicated by at least one reaction, including rashes (44%...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-92-1-24
更新日期:1980-01-01 00:00:00
abstract::The sharp rise in drug abuse in the past decade has led to the development of new sources of information on drug-abuse trends. These include surveys, drug-related emergencies, drug-abuse treatment, hepatitis rates, and various types of law enforcement information. This paper summarizes data currently available for her...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-83-3-402
更新日期:1975-09-01 00:00:00