Nephro Trial Files Throwback Thursday: Telmisartan vs. Ramipril vs. Both in Vascular Disease, Treating Isolated Systolic HTN, and Early Correction of Anemia in CKD
Telmisartan, Ramipril, or Both in Patients at High Risk for Vascular Events
The ONTARGET Investigators. NEJM (April 2008)
Bottom Line: This randomized, double-blind clinical trial compared the effects of the ACE inhibitor ramipril, the ARB telmisartan, and combination therapy in patients with vascular disease or high-risk diabetes without heart failure. The primary outcome of death from cardiovascular causes, myocardial infarction, stroke, or hospitalization for heart failure was similar between the ramipril and telmisartan groups, with a lower risk of angioedema in the telmisartan group. Combination therapy did not provide additional benefit and was associated with more adverse events. The study was conducted over a median follow-up of 56 months and included a sample size of 25620 patients. Overall, telmisartan was found to be equivalent to ramipril in reducing mortality and morbidity in this patient population.
Effect of Treating Isolated Systolic Hypertension on the Risk of Developing Various Types and Subtypes of Stroke (SHEP)
Perry Jr HM et al. JAMA (July 2000)
Bottom Line: The SHEP study was a randomized, double-blind, placebo-controlled trial that aimed to investigate the effects of antihypertensive drug treatment on stroke incidence in older patients with isolated systolic hypertension. The study included 4736 participants and had an average follow-up of 4.5 years. The intervention group received 12.5 mg/d of chlorthalidone with the option to add either 25 mg/d of atenolol or 0.05 mg/d of reserpine, while the comparator group received placebo. The primary outcome was the incidence of stroke by type and subtype, timing of strokes, case-fatality rates, stroke residual effects, and relationship of attained systolic blood pressure to stroke incidence. The results showed a significant reduction in the incidence of both hemorrhagic and ischemic (including lacunar) strokes in the intervention group compared to the control group. The treatment was well-tolerated with no significant adverse effects reported. The study concluded that antihypertensive drug treatment can effectively reduce stroke incidence when specific systolic blood pressure goals are attained.
Normalization of Hemoglobin Level in Patients with Chronic Kidney Disease and Anemia
Drüeke TB et al. NEJM (November 2006)
Bottom Line: This randomized clinical trial evaluated whether early correction of anemia in patients with stage 3 or 4 chronic kidney disease would improve cardiovascular outcomes. The study included 603 patients with mild-to-moderate anemia and an estimated glomerular filtration rate of 15.0 to 35.0 ml per minute per 1.73 m2. Patients were randomly assigned to a target hemoglobin value in the normal range (13.0 to 15.0 g per deciliter) or the subnormal range (10.5 to 11.5 g per deciliter) with subcutaneous erythropoietin (epoetin beta) initiated at randomization or only after the hemoglobin level fell below 10.5 g per deciliter. The primary outcome was a composite of eight cardiovascular events evaluated over 3 years. Results showed that complete correction of anemia did not affect the likelihood of a first cardiovascular event, left ventricular mass index remained stable, and there was no significant difference in the progression of chronic kidney disease between the two groups. However, dialysis was required in more patients in the intervention group. Quality-of-life scores improved significantly in the intervention group compared to the comparator group. Safety outcomes showed no significant difference in the combined incidence of adverse events between the two groups, but hypertensive episodes and headaches were more prevalent in the intervention group. In conclusion, early complete correction of anemia in patients with chronic kidney disease did not reduce the risk of cardiovascular events.
Nephro Trial Files Issue #NPH-2025-03
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