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Outcome Trials (outcome + trials)
Selected AbstractsTreatment of isolated systolic hypertension in diabetes mellitus type 2DIABETES OBESITY & METABOLISM, Issue 4 2006Ingrid Os Age-related arterial stiffness is more pronounced in diabetics compared to non-diabetics, which could explain the prevalence of isolated systolic hypertension (ISH, systolic blood pressure ,140 mmHg and diastolic blood pressure <90 mmHg) being approximately twice that of the general population without diabetes. Large-scale interventional outcome trials have also shown that diabetics usually have higher pulse pressure and higher systolic blood pressure than non-diabetics. Advanced glycation end-product formation has been implicated in vascular and cardiac complications of diabetes including loss of arterial elasticity, suggesting possibilities for new therapeutic options. With increasing age, there is a shift to from diastolic to systolic blood pressure and pulse pressure as predictors of cardiovascular disease. This may affect drug treatment as different antihypertensive drugs may have differential effects on arterial stiffness that can be dissociated from their effects on blood pressure. While thiazide diuretics are associated with little or no change in arterial stiffness despite a robust antihypertensive effect, angiotensin converting enzyme inhibitors, angiotensin II receptor blockers and calcium-channel blockers have been shown to reduce arterial stiffness. However, combination therapy is nearly always necessary to obtain adequate blood pressure control in diabetics. There are no randomized controlled trials looking specifically at treatment of ISH in diabetics. Recommendations regarding treatment of ISH in diabetes mellitus type 2 are based on extrapolation from studies in non-diabetics, post-hoc analyses and prespecified subgroup analysis in large-scale studies, and metaanalysis. These analyses have clearly demonstrated that blood pressure lowering in ISH confers improved prognosis and reduced cardiovascular and renal outcomes in both diabetics and non-diabetics. [source] Cardiovascular Events in Hypertension Trials of Angiotensin-Converting Enzyme InhibitorsJOURNAL OF CLINICAL HYPERTENSION, Issue 2005William J. Elliott MD Angiotensin-converting enzyme inhibitors are widely-prescribed drugs for hypertension and are supported by clinical trials in which they reduce cardiovascular events. In the high-risk patients in the Heart Outcomes Prevention Evaluation, the Perindopril Protection Against Recurrent Stroke Study, and European Trial of Reduction of Cardiac Events With Perindopril in Stable Coronary Artery Disease, ramipril and perindopril showed impressive benefits. One reason trandolapril did somewhat less well in the Prevention of Events With Angiotensin-Converting Enzyme Inhibition trial may be that its patients were very well treated with other effective modalities. In the Antihypertensive and Lipid Lowering to Prevent Heart Attack Trial, lisinopril-treated patients had a slightly lower incidence of myocardial infarction, despite much poorer control of blood pressure, perhaps because a second-line diuretic was prohibited by protocol. Although angiotensin-converting enzyme inhibitors can cause cough and angioedema (more common among blacks), angiotensin receptor blockers are currently more expensive and have fewer outcome trials to support their use. [source] Special Issue: KDIGO Clinical Practice Guideline for the Care of Kidney Transplant RecipientsAMERICAN JOURNAL OF TRANSPLANTATION, Issue 2009Article first published online: 14 OCT 200 Abstract The 2009 Kidney Disease: Improving Global Outcomes (KDIGO) clinical practice guideline on the monitoring, management, and treatment of kidney transplant recipients is intended to assist the practitioner caring for adults and children after kidney transplantation. The guideline development process followed an evidence-based approach, and management recommendations are based on systematic reviews of relevant treatment trials. Critical appraisal of the quality of the evidence and the strength of recommendations followed the Grades of Recommendation Assessment, Development, and Evaluation (GRADE) approach. The guideline makes recommendations for immunosuppression, graft monitoring, as well as prevention and treatment of infection, cardiovascular disease, malignancy, and other complications that are common in kidney transplant recipients, including hematological and bone disorders. Limitations of the evidence, especially on the lack of definitive clinical outcome trials, are discussed and suggestions are provided for future research. [source] Nutraceuticals in Cardiovascular Prevention: Lessons from Studies on Endothelial FunctionCARDIOVASCULAR THERAPEUTICS, Issue 4 2010Cinzia Zuchi An "unhealthy" diet is considered as a main cause of increased atherosclerotic cardiovascular disease in the industrialized countries. There is a substantial interest in the potential cardiovascular protective effects of "nutraceuticals," that is food-derived substances that exert beneficial health effects. The correct understanding of cardiovascular effects of these compounds will have important implications for cardiovascular prevention strategies. Endothelial dysfunction is thought to play an important role in development and progression of atherosclerosis, and the characterization of the endothelial effects of several nutraceuticals may provide important insights into their potential role in cardiovascular prevention. At the same time, the analysis of the endothelial effects of nutraceuticals may also provide valuable insights into mechanisms of why certain nutraceuticals may not be effective in cardiovascular prevention, and it may aid in the identification of food-derived substances that may have detrimental cardiovascular effects. These findings further support the notion that nutraceuticals do need support from large clinical outcome trials with respect to their efficacy and safety profile for cardiovascular prevention, before their widespread use can be recommended. In fact, the term nutraceutical was coined to encourage an extensive and profound research activity in this field, and numerous large-scale clinical outcome trials to examine the effects of nutraceuticals on cardiovascular events have now been performed or are still ongoing. Whereas it is possible that single nutraceuticals may be effective in cardiovascular prevention, this field of research provides also valuable insights into which food components may be particularly important for cardiovascular prevention, to further advice the composition of a particularly healthy diet. The present review summarizes recent studies on the endothelial effects of several nutraceuticals, that have been intensely studied. [source] Renin Inhibitors in Chronic Heart Failure: The Aliskiren Observation of Heart Failure Treatment Study in ContextCLINICAL CARDIOLOGY, Issue 9 2010FESC, FRACP, Henry Krum PhD Renin-angiotensin aldosterone system (RAAS) activation is a key neurohormonal contributor to the progression of chronic heart failure. Strategies that block this activation have consistently demonstrated major beneficial impacts on morbidity and mortality in this setting. Direct renin inhibitors (DRIs) present a novel opportunity to block at an additional or alternative step in this pathway, that being conversion of angiotensinogen to angiotensin I. Theoretical benefits of blocking at the level of renin include: inhibition of the reflex activation of plasma renin activity induced by conventional downstream RAAS blockers. Minimization of angiotensin II and/or aldosterone escape and blocking upstream at the rate-limiting step of angiotensin I production. Preclinical and early-phase clinical studies have largely supported this hypothesis. In the Aliskiren Observation of Heart Failure Treatment study, patients with systolic chronic heart failure receiving background angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers and ,-blockers benefited from aliskiren in reduction vs placebo of plasma levels of brain natriuretic peptide, the primary efficacy endpoint of that study. Large-scale outcome trials are, however, required to definitively determine the benefits of a DRI strategy additional to, or as an alternative to, conventional approaches such as ACE inhibitors in the systolic chronic heart failure setting. Copyright © 2010 Wiley Periodicals, Inc. The authors have no funding, financial relationships, or conflicts of interest to disclose. [source] Clinical trial experience around the globe: Focus on calcium-channel blockersCLINICAL CARDIOLOGY, Issue S2 2003William B. White M.D. Abstract Although certain classes of drugs appear to possess benefits apart from their blood-pressure lowering capability, reduction of blood pressure remains the single most important action of antihypertensive therapy. Calcium-channel blockers (CCBs) have long been recognized as potent agents for hypertension therapy. This is especially true for the prevention of stroke in hypertensive patients as evidenced from the Systolic Hypertension in Europe (Syst-Eur) and Systolic Hypertension in China (Syst-China) trials with a long acting dihydropyridine CCB. The same can be said for beta blockers in patients post myocardial infarction. However, most recent clinical trials have underscored the necessity of multiple drug therapy to achieve the goals of blood pressure reduction coupled with outcomes reduction. For example, the many recent large-scale clinical trials have required an average of three or more agents to achieve goal. Thus, the paradigm for hypertension management has been altered to determine the best treatment regimen rather than the best initial agent. While response rates to individual agents across a wide spectrum of patients vary little, not all drugs are equally suited as companion products. In this article, we discuss the most recent outcome trials with the long acting CCBs alone or in combination with other drugs. The evidence shows that calcium antagonists remain an important part of hypertension management, including in those individuals at risk of cardiac and cerebrovascular events. [source] Pathophysiology of Target-Organ Disease: Does Angiotensin II Remain the Key?JOURNAL OF CLINICAL HYPERTENSION, Issue 2007Ronald G. Victor MD Basic research provides an increasingly compelling rationale for renin-angiotensin system (RAS) blockade in hypertension treatment and cardiovascular risk reduction. Clinical trials addressing blood pressure-independent effects of angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers, however, have yielded mixed results, in part because of incomplete RAS blockade. Animal studies have shed new light on the complexity of RAS pathways involved in the induction of target-organ damage. New outcomes trials are under way to explore the full potential of more complete RAS blockade with regard to cardiovascular target-organ protection. [source] Pharmacotherapy Review: Calcium Channel BlockersJOURNAL OF CLINICAL HYPERTENSION, Issue 1 2006Domenic A. Sica MD As a drug class, calcium channel blockers encompass a heterogeneous group of compounds with distinctive structures and pharmacologic characteristics. These agents are widely used in the treatment of hypertension, chronic coronary ischemia, and/or supraventricular arrhythmias. Much of the early debate alluding to increased cardiovascular risk associated with calcium channel blocker use has been silenced by an array of outcomes trials that show these drugs to be both safe and effective in reducing hard cardiovascular end points. The most common side effects associated with calcium channel blockers are vasodilatory in nature and include a non-volume-dependent form of peripheral edema, flushing, and headache. Despite the sometimes discomforting side effects seen with calcium channel blocker therapy, their robust blood pressure-lowering effect makes them an important component of most multidrug regimens used for blood pressure control. [source] Glycaemic control and metabolic risk: getting the extra mile from diabetes controlPRACTICAL DIABETES INTERNATIONAL (INCORPORATING CARDIABETES), Issue 6 2008M Devers MBChB, MRCP Specialist Registrar Abstract Cardiometabolic risk is an emerging term which has been used to denote the cluster of risk factors defined by the metabolic syndrome and, in addition, to include the newer risk factors which are now recognised to occur in association with dysglycaemia and abdominal obesity. Interventions for diabetes can have effects on cardiometabolic risk factors beyond lowering of hyperglycaemia, and may be an explanation for the reductions in cardiovascular events that are seen with some but not all antidiabetic drugs. Newer antidiabetic agents and the weight-reducing drug, rimonabant, have demonstrated favourable effects on cardiometabolic risk factors and on glycaemia, and should be further studied in long-term cardiovascular outcomes trials. Copyright © 2008 John Wiley & Sons. [source] 2154: Are all glaucoma drugs equally effective?ACTA OPHTHALMOLOGICA, Issue 2010L SCHMETTERER Purpose It is only in the recent years that we have got evidence that reducing intraocular pressure (IOP) is beneficial in terms of preventing glaucoma progression in all types of glaucomatous disease. Nowadays we do have numerous data from large clinical outcomes trials clearly indicating that the lower the IOP the better the visual field preservation. There is, however, less data available comparing outcomes of different pharmacological regimen. Methods Only few head-to-head comparisons of two drugs that are equally effective in lowering IOP have been published. It is generally assumed that such trials would yield similar results in visual field preservation with both regimen. Looking into the literature there is, however, some evidence for the opposite. Results One clinical trial indicates that betaxolol may be superior to timolol in terms of visual field perservation. Another trial indicates that a combination of dorzolamide and timolol is assocaited with less visual field detoriation than a combination of brinzolamide and timolol. In this study the risk of disease progression was closely linked to low blood velocities in retrobulbar vessels. Conclusion In light of these results and the lessons we have learned from other fields there is a need for further studies comparing the outcomes of different antiglaucoma drugs head-to-head. Given that the pathophysiology of glaucoma is only poorly understood it can not generally be expected that all glaucoma drugs are equally effective in perserving visual fields. Commercial interest [source] | ||||||||||||||||||||||