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FältnamnIndikatorerMetadata
00006137naa a2200889 4500
001oai:DiVA.org:uu-156228
003SwePub
008110718s2011 | |||||||||||000 ||eng|
0247 a https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-1562282 URI
0247 a https://doi.org/10.1016/S0140-6736(11)60739-32 DOI
040 a (SwePub)uu
041 a engb eng
042 9 SwePub
072 7a ref2 swepub-contenttype
072 7a art2 swepub-publicationtype
1001 a Baigent, Colin4 aut
2451 0a The effects of lowering LDL cholesterol with simvastatin plus ezetimibe in patients with chronic kidney disease (Study of Heart and Renal Protection) :b a randomised placebo-controlled trial
264 1c 2011
338 a print2 rdacarrier
520 a Background Lowering LDL cholesterol with statin regimens reduces the risk of myocardial infarction, ischaemic stroke, and the need for coronary revascularisation in people without kidney disease, but its effects in people with moderate-to-severe kidney disease are uncertain. The SHARP trial aimed to assess the efficacy and safety of the combination of simvastatin plus ezetimibe in such patients. Methods This randomised double-blind trial included 9270 patients with chronic kidney disease (3023 on dialysis and 6247 not) with no known history of myocardial infarction or coronary revascularisation. Patients were randomly assigned to simvastatin 20 mg plus ezetimibe 10 mg daily versus matching placebo. The key prespecified outcome was first major atherosclerotic event (non-fatal myocardial infarction or coronary death, non-haemorrhagic stroke, or any arterial revascularisation procedure). All analyses were by intention to treat. This trial is registered at ClinicalTrials.gov, NCT00125593, and I SRCTN54137607. Findings 4650 patients were assigned to receive simvastatin plus ezetimibe and 4620 to placebo. Allocation to simvastatin plus ezetimibe yielded an average LDL cholesterol difference of 0.85 mmol/L (SE 0.02; with about two-thirds compliance) during a median follow-up of 4.9 years and produced a 17% proportional reduction in major atherosclerotic events (526 [11.3%] simvastatin plus ezetimibe vs 619 [13.4%] placebo; rate ratio [RR] 0.83, 95% CI 0.74-0.94; log-rank p=0.0021). Non-significantly fewer patients allocated to simvastatin plus ezetimibe had a non-fatal myocardial infarction or died from coronary heart disease (213 [4.6%] vs 230 [5.0%]; RR 0.92,95% CI 0.76-1.11; p=0.37) and there were significant reductions in non-haemorrhagic stroke (131 [2.8%] vs 174 [3.8%]; RR 0.75,95% CI 0.60-0.94; p=0.01) and arterial revascularisation procedures (284 [6.1%] vs 352 [7.6%]; RR 0.79, 95% CI 0.68-0.93; p=0.0036). After weighting for subgroup-specific reductions in LDL cholesterol, there was no good evidence that the proportional effects on major atherosclerotic events differed from the summary rate ratio in any subgroup examined, and, in particular, they were similar in patients on dialysis and those who were not. The excess risk of myopathy was only two per 10 000 patients per year of treatment with this combination (9 [0.2%] vs 5 [0.1%]). There was no evidence of excess risks of hepatitis (21 [0.5%] vs 18 [0.4%]), gallstones (106 [2.3%] vs 106 [2.3%]), or cancer (438 [9.4%] vs 439 [9.5%], p=0.89) and there was no significant excess of death from any non-vascular cause (668 [14.4%] vs 612 [13.2%], p=0.13). Interpretation Reduction of LDL cholesterol with simvastatin 20 mg plus ezetimibe 10 mg daily safely reduced the incidence of major atherosclerotic events in a wide range of patients with advanced chronic kidney disease.
650 7a MEDICIN OCH HÄLSOVETENSKAPx Medicinska och farmaceutiska grundvetenskaperx Farmaceutiska vetenskaper0 (SwePub)301012 hsv//swe
650 7a MEDICAL AND HEALTH SCIENCESx Basic Medicinex Pharmaceutical Sciences0 (SwePub)301012 hsv//eng
653 a PHARMACY
653 a FARMACI
7001 a Landray, Martin J.4 aut
7001 a Reith, Christina4 aut
7001 a Emberson, Jonathan4 aut
7001 a Wheeler, David C.4 aut
7001 a Tomson, Charles4 aut
7001 a Wanner, Christoph4 aut
7001 a Krane, Vera4 aut
7001 a Cass, Alan4 aut
7001 a Craig, Jonathan4 aut
7001 a Neal, Bruce4 aut
7001 a Jiang, Lixin4 aut
7001 a Hooi, Lai Seong4 aut
7001 a Levin, Adeera4 aut
7001 a Agodoa, Lawrence4 aut
7001 a Gaziano, Mike4 aut
7001 a Kasiske, Bertram4 aut
7001 a Walker, Robert4 aut
7001 a Massy, Ziad A.4 aut
7001 a Feldt-Rasmussen, Bo4 aut
7001 a Krairittichai, Udom4 aut
7001 a Ophascharoensuk, Vuddidhej4 aut
7001 a Fellström, Bengtu Uppsala universitet,Institutionen för medicinska vetenskaper4 aut0 (Swepub:uu)bengfell
7001 a Holdaas, Hallvard4 aut
7001 a Tesar, Vladimir4 aut
7001 a Wiecek, Andrzej4 aut
7001 a Grobbee, Diederick4 aut
7001 a de Zeeuw, Dick4 aut
7001 a Gronhagen-Riska, Carola4 aut
7001 a Dasgupta, Tanaji4 aut
7001 a Lewis, David4 aut
7001 a Herrington, William4 aut
7001 a Mafham, Marion4 aut
7001 a Majoni, William4 aut
7001 a Wallendszus, Karl4 aut
7001 a Grimm, Richard4 aut
7001 a Pedersen, Terje4 aut
7001 a Tobert, Jonathan4 aut
7001 a Armitage, Jane4 aut
7001 a Baxter, Alex4 aut
7001 a Bray, Christopher4 aut
7001 a Chen, Yiping4 aut
7001 a Chen, Zhengming4 aut
7001 a Hill, Michael4 aut
7001 a Knott, Carol4 aut
7001 a Parish, Sarah4 aut
7001 a Simpson, David4 aut
7001 a Sleight, Peter4 aut
7001 a Young, Alan4 aut
7001 a Collins, Rory4 aut
7102 a Uppsala universitetb Institutionen för medicinska vetenskaper4 org
7730 t The Lancetg 377:9784, s. 2181-2192q 377:9784<2181-2192x 0140-6736x 1474-547X
8564 8u https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-156228
8564 8u https://doi.org/10.1016/S0140-6736(11)60739-3

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