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The Trial of Reduction of End points with Aranesp Therapy (TREAT) is an ongoing large-scale, randomized, double-blind, and placebo-controlled study including 4,000 anemic patients with type 2 diabetes and CKD (50).
For example in the Reduction of End Points in Non-insulin Dependent Diabetes Mellitus with the Angiotensin II Antagonist Losartan (RENAAL trial), LVH was associated with an increased risk of death, end-stage renal disease and doubling of serum creatinine (hazard ratio 1.41; p < 0.001) in patients with type 2 diabetes, clinical nephropathy and no known cardiovascular disease [ 23].
On an individual basis, the Reduction of End Points in Type 2 Diabetes With Angiotensin II Antagonist Losartan (RENAAL) study showed that treatment with losartan reduced the number of ESRD days by 33.6 per patient over 3.5 years, resulting in a net savings of $3,522 per patient (5).
In contrast to conventional MN tests, the neutralization of infection in the H5pp test was detected by measuring the reduction of end-point chemoluminescent signal compared to controls done in absence of sera (equivalent to 0% neutralization) and in absence of H5pp (equivalent to 100% neutralization), respectively.
The PROACTIVE prospective study showed a modest reduction of cardiovascular end points associated with pioglitazone [ 156] especially in patients with no peripheral artery disease [ 157].
In these patients, thrombolysis is associated with a reduction in mortality or recurrent PE, with a nonsignificant reduction in mortality [odds ratio (OR) 0.48, 95%% CI 0.20 1.15], a significant reduction in PE-related mortality (OR 0.15, 95%% CI 0.03 0.78) and a significant reduction of the end-point of death or treatment escalation (OR 0.18, 95%% CI 0.04 0.79) [15].
In the multivariate Cox proportional hazards model, combined therapy was associated with a reduction of the combined end point of all-cause mortality or cardiovascular hospitalization (hazard ratio 0.2, 95% confidence interval [0.1 0.6]; P < 0.001).
In a subsequent report, in which the diagnosis of diabetes was modified to include the new criteria of fasting plasma glucose ≥ 126 mg/dL, the total cohort of diabetic patients was increased to 769 and there was a 32% risk reduction of the composite end point of CHD death, stroke, or MI (P = 0.004) [ 20].
Several new anti-diabetes agents were approved for treatment due to their glucose lowering effect, but without proof of reduction of hard end-points, such as major adverse cardiovascular events (MACE).
Crowther et al reported a significant reduction of a combined end point consisting of perinatal death, shoulder dystocia, bone fracture, or nerve palsy associated with treatment for gestational diabetes.
The insulin lispro group showed an absolute reduction from baseline to end point of 9.7 ± 2.9 to 7.1 ± 1.8 mmol/l corresponding to −1.8 ± 2.3 mmol/l, which was also highly significant (P < 0.0001).
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com