End-stage renal disease was defined as initiation of maintenance dialysis or renal transplantation. Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision.
Note: Patients with a history of hepatitis were eligible provided these limits were not exceeded. Evidence of active inflammatory muscle disease e. Note: Patients who were temporarily taking such drugs could have been re-screened for participation in the study when they discontinued them, if appropriate.
These contraindicated drugs included: HMG-CoA reductase inhibitor "statin" ; fibric acid derivative "fibrate" ; nicotinic acid; macrolide antibiotic erythromycin, clarithromycin ; systemic use of imidazole or triazole antifungals e. Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its ClinicalTrials.
More Information. The effects of lowering LDL cholesterol with simvastatin plus ezetimibe in patients with chronic kidney disease Study of Heart and Renal Protection : a randomised placebo-controlled trial. Epub Jun Am J Kidney Dis. Sharp Collaborative Group. Study of Heart and Renal Protection SHARP : randomized trial to assess the effects of lowering low-density lipoprotein cholesterol among 9, patients with chronic kidney disease.
Am Heart J. Epub Sep Can J Kidney Health Dis. Cost-effectiveness of lipid lowering with statins and ezetimibe in chronic kidney disease. Kidney Int. Epub Mar A policy model of cardiovascular disease in moderate-to-advanced chronic kidney disease.
As we noted in November, the SHARP steering committee sought to change the primary endpoint from first major vascular event to first major atherosclerotic event and the planned statistical analysis of the trial to avoid producing a false negative result. The trial sponsor, Merck, did not endorse their plan.
However, the point is somewhat moot now as the two analyses yielded very similar results. Furthermore, last November I expressed concern about 2 press releases that were issued about the SHARP trial, one from Merck , the much-maligned and criticized manufacturer of Vytorin the combination of ezetimibe and simvastatin , and one from the group running the trial, the highly-respected Clinical Trials Service Unit CTSU at Oxford.
Surprisingly, compared to the Oxford press reelease, the Merck release was a paragon, fully disclosing important details about the trial.
The Oxford release was also a paragon, but of a different type. Click here to read my article about the 2 press releases. Sadly, it appears that the CTSU authors have continued to embrace their position, once again hyping the trial results.
Around a quarter of all heart attacks, strokes, and operations to open blocked arteries could be avoided in people with chronic kidney disease by using the combination of ezetimibe and simvastatin to lower blood cholesterol levels. Comment and further background to this paper published in The Lancet 9 th June People with this disease are in desperate need of new treatments not only to combat the disease itself, but also to reduce pain and suffering, such as heart attacks and strokes, due to side effects of the illness.
We now know there is something we can do about this — and I believe this study will have a positive impact on the lives of many millions of people currently being treated for chronic kidney disease in the UK and around the world.
Professor Baigent has a personal interest because he developed kidney disease 30 years ago and needed dialysis before receiving a kidney transplant. Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. No effect on mortality. The number needed to treat for heart attack and cardiovascular death exceeds for 5 years.
This is shocking underperformance. Notify me of new posts by email. Enter your email address to subscribe to this blog and receive notifications of new posts by email. Email Address. Sign me up! CardioBrief One-stop source for cardiology news and links. Home About. More importantly, Stein emphasized that the study sheds no light at all on whether ezetimibe provides any additional benefits when given on top of simvastatin: … this study does not answer the question of whether or not they would have gotten the same result if they used simvastatin alone ie, if ezetimibe had anything to do with the observed results or if ezetimibe is safe, since a short study of individuals with advanced kidney disease is not the right context to study drug safety.
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At the mid-point of the study 2. Patients no longer taking study medication were included in all lipid measurements. The primary endpoint for the study was time to first major vascular event, defined as the composite of non-fatal heart attack or cardiac death, stroke or revascularization procedure in the two groups assigned to VYTORIN or placebo at study initiation.
This analysis did not include patients initially randomized to simvastatin alone for the first year. In the primary intent-to-treat analysis, The SHARP study design precluded drawing conclusions about the independent contribution of either ezetimibe or simvastatin to the observed effect on major vascular events. Myopathy sometimes takes the form of rhabdomyolysis with or without acute renal failure secondary to myoglobinuria, and rare fatalities have occurred.
The risk of myopathy, including rhabdomyolysis, is dose related. The risk of myopathy, including rhabdomyolysis, is greater in patients taking simvastatin 80 mg compared with other statin therapies with similar or greater LDL cholesterol lowering efficacy, and with lower doses of simvastatin. Please read Warnings and Precautions in the Prescribing Information for additional information. In such patients, higher doses should be used with caution and close monitoring.
See Dosage and Administration in the Prescribing Information for additional information. Cases of myopathy, including rhabdomyolysis, have been reported with simvastatin coadministered with colchicine, and caution should be used when prescribing VYTORIN with colchicine.
Due to the unknown effects of the increased exposure to ezetimibe in patients with moderate or severe hepatic impairment, VYTORIN is not recommended in these patients.
Persistent elevations in hepatic transaminase can occur. Liver function tests should be performed at treatment initiation and thereafter when clinically indicated.
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