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1、VALUE and MATCH: An era of comparative clinical trials,Eric J Topol MD Provost and Chief Academic Officer Chairman, Department of Cardiovascular Medicine Cleveland Clinic Foundation Cleveland, OH Robert M Califf MD Professor of Medicine Associate Vice Chancellor for Clinical Research Director, Duke
2、Clinical Research Institute Duke University Medical Center Durham, NC,VALUE Valsartan Antihypertensive Long-Term Use Evaluation MATCH Management of Atherothrombosis with Clopidogrel in High-Risk Patients with Recent Transient Ischemic Attacks or Ischemic Stroke,Topics,Valsartan Antihypertensive Long
3、-Term Use Evaluation VALUE,VALUE: Goal,Trial designed to compare two treatment strategies: amlodipine (Norvasc, Pfizer) and valsartan (Diovan, Novartis). (Lancet 2004 Jun 19; 363:2022-31.) STUDY AIM If similar blood-pressure control could be achieved with both drugs, would there be any beneficial ef
4、fect on cardiac end points with valsartan beyond blood-pressure lowering alone? Primary end point a composite of cardiac morbidity or mortality,VALUE: Design,Trial involved 15 245 hypertensive patients with at least one high-risk feature, including CAD, previous stroke or TIA, peripheral vascular di
5、sease, or diabetes Patients randomized to valsartan 80 mg or amlodipine 5 mg Patients already on BP-lowering medications “rolled over“ to either amlodipine or valsartan At one month, if target BP not 140/90 mm Hg, patients up-titrated to valsartan 160 mg and amlodipine 10 mg; hydrochlorothiazide add
6、ed in increasing doses if control not achieved,VALUE: Primary composite end point,Lancet 2004; 363,VALUE: Systolic BP over time by treatment group,Lancet 2004; 363,VALUE: Secondary and prespecified end points,Lancet 2004; 363,VALUE: Califfs conclusions,“Bringing blood pressure down quickly is import
7、ant.“ Early differences in BP lowering does make a difference Amlodipine, if anything, looks better as monotherapy Diabetes finding will affect some clinicians,Califf,VALUE: Topols thoughts,“Usually I dont find hypertension so interesting, but this is a very interesting trial.“ Control of BP with am
8、lodipine better up front and throughout the trial MI, stroke, and all-cause death better with amlodipine in the first three months,Topol,VALUE: Topols thoughts,Overall, the trade-off appears to be less stroke, fewer infarcts with amlodipine, but more new-onset diabetes Unsure how to interpret HF dat
9、a “To me, it looks pretty favorable for amlodipine, even though the trial appears to be spun to support a lack of differences.“,Topol,VALUE: Blood-pressure control,Amlodipine, in this environment, does get the nod over valsartan Results related to early difference in BP control Pfizer continues to c
10、ome out on top despite doing the “wrong trials“ Valsartan still a valuable drug, considering its low side-effect profile,Califf,VALUE: Drug or BP lowering?,But a 19% increase in fatal and nonfatal MIs and a 15% increase in fatal and nonfatal strokes? That doesnt speak well for valsartan. - Topol I d
11、ont see that as a huge rap on valsartan. Its a rap on not getting the blood pressure down. - Califf,VALUE: Results after adjusting for BP differences,Lancet 2004; 363,VALUE: Admitting bias,This trial was sponsored by Novartis, and people, being wise to the ways of the world, will know it was spun a
12、little bit. - Califf Im glad you admit that. - Topol,VALUE: Admitting bias,“I think some of the trials weve done, weve taken on the sponsor. Its important for investigators to stand up for what the findings are.“ In VALUE, key end points dont look good for valsartan but you wouldnt have known that f
13、rom investigators quoted in press releases,Topol,VALUE: Data out there,Savvy clinicians should be able to look at the data and know the CV results are heading in the wrong direction Need for both drugssuppress diabetes and protect against MI and stroke Trials continue to support renin- angiotensin-s
14、ystem blockade to protect against diabetes,Topol,VALUE: Making an impact,Major message from this trial is to get the BP down and to keep it down By lowering BP 5 to 10 mm Hg through a combination of diuretic, ACE inhibitor, or CCB, one could reduce the number of morbid events and hospital admissions
15、 Big opportunities in hypertension management,Califf,VALUE: Decision,“This is a very rigorous, solid trial, and I would give it two thumbs up.“ - Topol “I would also give it two thumbs up, with one caveat . . .“ Should the trial have been stopped at six months due to the discrepancy in systolic BP?
16、- Califf,VALUE: Results,“The adage is dont ever stop a trial, unless its something so highly compelling.“ - Topol “We probably need to move to a new standard for how we monitor trials.“ - Califf,Management of Atherothrombosis with Clopidogrel in High-Risk Patients with Recent Transient Ischemic Attacks or Ischemic Stroke MATCH,MATCH: Design,Cerebrovascular trial presented at the 13th European Stroke Conference in Germany 7500 high-risk patients who had a recent T
