Efficacy and Safety of Imarikiren in Patients with Type 2 Diabetes and Microalbuminuria: A Randomized, Controlled Trial.

@article{Ito2019EfficacyAS,
  title={Efficacy and Safety of Imarikiren in Patients with Type 2 Diabetes and Microalbuminuria: A Randomized, Controlled Trial.},
  author={S. Ito and Tomoya Kagawa and Takuya Saiki and K. Shimizu and S. Kuroda and Yuhei Sano and Y. Umeda},
  journal={Clinical journal of the American Society of Nephrology : CJASN},
  year={2019},
  volume={14 3},
  pages={
          354-363
        }
}
BACKGROUND AND OBJECTIVES Imarikiren is a novel, potent, and selective direct renin inhibitor that has shown high oral availability during clinical development for the treatment of diabetic nephropathy. We evaluated the efficacy and safety of imarikiren in patients with type 2 diabetes mellitus and microalbuminuria. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS This was a randomized, multicenter, placebo-controlled, double-blind, phase 2, dose-finding trial. A total of 415 patients were… Expand
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References

SHOWING 1-10 OF 23 REFERENCES
Effects of verapamil added-on trandolapril therapy in hypertensive type 2 diabetes patients with microalbuminuria: the BENEDICT-B randomized trial
TLDR
In hypertensive type 2 diabetes patients with microalbuminuria, verapamil added-on trandolapril did not improve renal or cardiovascular outcomes and this translated into significant cardioprotection. Expand
Time course of antiproteinuric effect of aliskiren in arterial hypertension associated with type 2 diabetes and microalbuminuria
TLDR
Aliskiren has a greater and more prolonged antiproteinuric effect than R; it might partly be related to a higher degree of intrarenal renin–angiotensin–aldosterone system blockade. Expand
Cardiorenal end points in a trial of aliskiren for type 2 diabetes.
TLDR
The addition of aliskiren to standard therapy with renin-angiotensin system blockade in patients with type 2 diabetes who are at high risk for cardiovascular and renal events is not supported by these data and may even be harmful. Expand
Pharmacokinetics, Pharmacodynamics and Safety of a Single Dose of Imarikiren, a Novel Renin Inhibitor, in Healthy Male Subjects
TLDR
Plasma active renin concentration increased, reaching a maximum at approximately 6 hr, in a nearly dose‐dependent manner, and there was a generally linear relationship between dose and area under the plasma concentration–time curve (0 to infinity) or maximum plasma concentration of imarikiren. Expand
Telmisartan, ramipril, or both in patients at high risk for vascular events.
TLDR
Telmisartan was equivalent to ramipril in patients with vascular disease or high-risk diabetes and was associated with less angioedema and a increased risk of hypotensive symptoms. Expand
Microalbuminuria Reduction with Telmisartan in Normotensive and Hypertensive Japanese Patients with Type 2 Diabetes: A Post-Hoc Analysis of the Incipient to Overt: Angiotensin II Blocker, Telmisartan, Investigation on Type 2 Diabetic Nephropathy (INNOVATION) Study
The Incipient to Overt: Angiotensin II Blocker, Telmisartan, Investigation on Type 2 Diabetic Nephropathy (INNOVATION) study previously showed that treatment with telmisartan, an angiotensin IIExpand
Albuminuria and blood pressure, independent targets for cardioprotective therapy in patients with diabetes and nephropathy: a post hoc analysis of the combined RENAAL and IDNT trials.
TLDR
The SBP and albuminuria response to ARB therapy is variable and discordant, and therapies intervening in the renin-angiotensin-aldosterone system with the aim of improving cardiovascular outcomes may require a dual approach targeting both blood pressure andalbuminuria. Expand
Combined angiotensin inhibition for the treatment of diabetic nephropathy.
TLDR
Combination therapy with an ACE inhibitor and an ARB was associated with an increased risk of adverse events among patients with diabetic nephropathy and safety outcomes included mortality, hyperkalemia, and acute kidney injury. Expand
Factors associated with frequent remission of microalbuminuria in patients with type 2 diabetes.
TLDR
It is indicated that reduction in urinary AER occurs frequently in Japanese patients with type 2 diabetes and early detection of microalbuminuria and a multifactorial control may result in improved outcomes for diabetic nephropathy and cardiovascular events. Expand
Reduction in Microalbuminuria as an Integrated Indicator for Renal and Cardiovascular Risk Reduction in Patients With Type 2 Diabetes
TLDR
Clinical evidence is provided implying that a reduction of microalbuminuria in type 2 diabetic patients is an integrated indicator for renal and cardiovascular risk reduction. Expand
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