-
Something wrong with this record ?
Studie TREAT s darbepoetinem alfa u diabetiků 2. typu s chronickou chorobou ledvin
[Trial of darbepoetin alfa in type 2 diabetes and chronic kidney disease]
Pfeffer MA, Burdmann AE, Chen C-Y, et al.
Language Czech Country Czech Republic
Document type Multicenter Study
- MeSH
- Anemia etiology drug therapy MeSH
- Stroke epidemiology chemically induced MeSH
- Renal Insufficiency, Chronic complications blood MeSH
- Kidney Failure, Chronic epidemiology prevention & control MeSH
- Diabetes Mellitus, Type 2 complications MeSH
- Double-Blind Method MeSH
- Erythropoietin analogs & derivatives adverse effects therapeutic use MeSH
- Financing, Organized MeSH
- Hematinics adverse effects therapeutic use MeSH
- Hemoglobins analysis MeSH
- Kaplan-Meier Estimate MeSH
- Cardiovascular Diseases mortality prevention & control MeSH
- Middle Aged MeSH
- Humans MeSH
- Neoplasms mortality MeSH
- Randomized Controlled Trials as Topic MeSH
- Aged MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Multicenter Study MeSH
Anemia is associated with an increased risk of cardiovascular and renal events among patients with type 2 diabetes and chronic kidney disease. Although darbepoetin alfa can effectively increase hemoglobin levels, its effect on clinical outcomes in these patients has not been adequately tested. METHODS: In this study involving 4038 patients with diabetes, chronic kidney disease, and anemia, we randomly assigned 2012 patients to darbepoetin alfa to achieve a hemoglobin level of approximately 13 g per deciliter and 2026 patients to placebo, with rescue darbepoetin alfa when the hemoglobin level was less than 9.0 g per deciliter. The primary end points were the composite outcomes of death or a cardiovascular event (nonfatal myocardial infarction, congestive heart failure, stroke, or hospitalization for myocardial ischemia) and of death or end-stage renal disease. RESULTS: Death or a cardiovascular event occurred in 632 patients assigned to darbepoetin alfa and 602 patients assigned to placebo (hazard ratio for darbepoetin alfa vs. placebo, 1.05; 95% confidence interval [CI], 0.94 to 1.17; P=0.41). Death or end-stage renal disease occurred in 652 patients assigned to darbepoetin alfa and 618 patients assigned to placebo (hazard ratio, 1.06; 95% CI, 0.95 to 1.19; P=0.29). Fatal or nonfatal stroke occurred in 101 patients assigned to darbepoetin alfa and 53 patients assigned to placebo (hazard ratio, 1.92; 95% CI, 1.38 to 2.68; P<0.001). Red-cell transfusions were administered to 297 patients assigned to darbepoetin alfa and 496 patients assigned to placebo (P<0.001). There was only a modest improvement in patient-reported fatigue in the darbepoetin alfa group as compared with the placebo group. CONCLUSIONS: The use of darbepoetin alfa in patients with diabetes, chronic kidney disease, and moderate anemia who were not undergoing dialysis did not reduce the risk of either of the two primary composite outcomes (either death or a cardiovascular event or death or a renal event) and was associated with an increased risk of stroke. For many persons involved in clinical decision making, this risk will outweigh the potential benefits. (ClinicalTrials.gov number, NCT00093015.) 2009 Massachusetts Medical Society
Trial of darbepoetin alfa in type 2 diabetes and chronic kidney disease
- 000
- 00000naa 2200000 a 4500
- 001
- bmc10004713
- 003
- CZ-PrNML
- 005
- 20111210160528.0
- 008
- 100224s2009 xr e cze||
- 009
- AR
- 040 __
- $a ABA008 $b cze $c ABA008 $d ABA008 $e AACR2
- 041 0_
- $a cze $b eng
- 044 __
- $a xr
- 100 1_
- $a Pfeffer, Marc A.
- 245 10
- $a Studie TREAT s darbepoetinem alfa u diabetiků 2. typu s chronickou chorobou ledvin / $c Pfeffer MA, Burdmann AE, Chen C-Y, et al.
- 246 11
- $a Trial of darbepoetin alfa in type 2 diabetes and chronic kidney disease
- 314 __
- $a Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston mpfeffer@rics.bwh.harvard.edu
- 520 9_
- $a Anemia is associated with an increased risk of cardiovascular and renal events among patients with type 2 diabetes and chronic kidney disease. Although darbepoetin alfa can effectively increase hemoglobin levels, its effect on clinical outcomes in these patients has not been adequately tested. METHODS: In this study involving 4038 patients with diabetes, chronic kidney disease, and anemia, we randomly assigned 2012 patients to darbepoetin alfa to achieve a hemoglobin level of approximately 13 g per deciliter and 2026 patients to placebo, with rescue darbepoetin alfa when the hemoglobin level was less than 9.0 g per deciliter. The primary end points were the composite outcomes of death or a cardiovascular event (nonfatal myocardial infarction, congestive heart failure, stroke, or hospitalization for myocardial ischemia) and of death or end-stage renal disease. RESULTS: Death or a cardiovascular event occurred in 632 patients assigned to darbepoetin alfa and 602 patients assigned to placebo (hazard ratio for darbepoetin alfa vs. placebo, 1.05; 95% confidence interval [CI], 0.94 to 1.17; P=0.41). Death or end-stage renal disease occurred in 652 patients assigned to darbepoetin alfa and 618 patients assigned to placebo (hazard ratio, 1.06; 95% CI, 0.95 to 1.19; P=0.29). Fatal or nonfatal stroke occurred in 101 patients assigned to darbepoetin alfa and 53 patients assigned to placebo (hazard ratio, 1.92; 95% CI, 1.38 to 2.68; P<0.001). Red-cell transfusions were administered to 297 patients assigned to darbepoetin alfa and 496 patients assigned to placebo (P<0.001). There was only a modest improvement in patient-reported fatigue in the darbepoetin alfa group as compared with the placebo group. CONCLUSIONS: The use of darbepoetin alfa in patients with diabetes, chronic kidney disease, and moderate anemia who were not undergoing dialysis did not reduce the risk of either of the two primary composite outcomes (either death or a cardiovascular event or death or a renal event) and was associated with an increased risk of stroke. For many persons involved in clinical decision making, this risk will outweigh the potential benefits. (ClinicalTrials.gov number, NCT00093015.) 2009 Massachusetts Medical Society
- 650 _2
- $a randomizované kontrolované studie jako téma $7 D016032
- 650 _2
- $a financování organizované $7 D005381
- 650 _2
- $a senioři $7 D000368
- 650 _2
- $a anemie $x etiologie $x farmakoterapie $7 D000740
- 650 _2
- $a kardiovaskulární nemoci $x mortalita $x prevence a kontrola $7 D002318
- 650 _2
- $a diabetes mellitus 2. typu $x komplikace $7 D003924
- 650 _2
- $a dvojitá slepá metoda $7 D004311
- 650 _2
- $a erythropoetin $x analogy a deriváty $x škodlivé účinky $x terapeutické užití $7 D004921
- 650 _2
- $a ženské pohlaví $7 D005260
- 650 _2
- $a hematinika $x škodlivé účinky $x terapeutické užití $7 D006397
- 650 _2
- $a hemoglobiny $x analýza $7 D006454
- 650 _2
- $a lidé $7 D006801
- 650 _2
- $a Kaplanův-Meierův odhad $7 D053208
- 650 _2
- $a chronické selhání ledvin $x epidemiologie $x prevence a kontrola $7 D007676
- 650 _2
- $a mužské pohlaví $7 D008297
- 650 _2
- $a lidé středního věku $7 D008875
- 650 _2
- $a nádory $x mortalita $7 D009369
- 650 _2
- $a chronická renální insuficience $x komplikace $x krev $7 D051436
- 650 _2
- $a cévní mozková příhoda $x epidemiologie $x chemicky indukované $7 D020521
- 655 _2
- $a multicentrická studie $7 D016448
- 700 1_
- $a Burdmann, Emmanuel A.
- 700 1_
- $a Chen, Chao-Yin
- 773 0_
- $w MED00012709 $t Postgraduální nefrologie $g Roč. 7, č. 6 (2009), s. 95 $x 1214-178X
- 787 18
- $w bmc10004714 $i Recenze v: $t Komentář [k článku Studie TREAT s darbepoetinem alfa u diabetiků 2. typu s chronickou chorobou ledvin]
- 856 41
- $u https://www.postgradualninefrologie.cz/download/format/pdf/id/182/ $y plný text volně přístupný
- 910 __
- $a ABA008 $b B 2318 $c 893 $y 8
- 990 __
- $a 20100223151344 $b ABA008
- 991 __
- $a 20100503101509 $b ABA008
- 999 __
- $a ok $b bmc $g 714135 $s 577084
- BAS __
- $a 3
- BMC __
- $a 2009 $b 7 $c 6 $d 95 $i 1214-178X $m Postgraduální nefrologie $x MED00012709
- LZP __
- $a 2010-03/mkme
