Navigation Links
ECLIPSE data on effects of Otsuka's investigational novel treatment, Tolvaptan
Date:9/19/2007

PRINCETON, N.J., Sept. 19, 2007 -- A single dose of Otsukas investigational oral medication tolvaptan, a vasopressin receptor antagonist, resulted in favorable changes in hemodynamics associated with a significant increase in urine output in patients with advanced heart failure (ADHF) who participated in the international trial the EffeCt of ToLvaptan on HemodynamIc Parameters in Subjects with HEart failure (ECLIPSE), presented at the late breaking trials symposium of the Heart Failure Society of Americas Annual Scientific Meeting (HFSA).

These ECLIPSE data are the first to clarify the hemodynamic effects of orally dosed tolvaptan in patients with advanced heart failure due to systolic dysfunction. Such details of the mechanism of action of tolvaptan help us further understand its clinical effects, said investigator James Udelson M.D., associate chief of the Division of Cardiology at the Tufts-New England Medical Center and associate professor of medicine at Tufts University School of Medicine.

In the ECLIPSE study, 180 patients with symptomatic heart failure (New York Heart Association class III and IV) were randomized to double-blind treatment with tolvaptan at a single oral dose of 15, 30, 60 mg or placebo. All three doses of tolvaptan examined in ECLIPSE significantly changed the primary outcome variable, pulmonary capillary wedge pressure (PCWP), compared to placebo treatment (tolvaptan 15 mg -6.38 0.62 mmHg, tolvaptan 30 mg- 5.67 0.70 mmHg, tolvaptan 60 mg -5.71 0.65 mmHg, placebo -4.16 0.67 mmHg; p vs. placebo less than 0.05 for each tolvaptan group). The primary statistical analysis comparing the effects across the placebo group and two higher doses of tolvaptan approach statistical significance (p=0.0563). PCWP provides information about two aspects of lung and heart function: an estimate of the lung capillary pressure, which is the fluid pressure that plays a role in pulmonary edema, and an estimate of the filling pressures of the left side of the heart.

Compared with placebo, each dose of tolvaptan significantly increased urine volume at 3 hours after dose was given (p<0.0001). Also, during the three to eight hour interval after tolvaptan administration, mean reductions of the pressure in the pulmonary artery that carries venous blood from the right ventricle of the heart to the lungs, a secondary endpoint, were observed and were statistically greater (p<0.05) in all tolvaptan groups than in the placebo group. Over the same time period, mean reductions in pressure within the hearts right atrium were also observed, and those were statistically greater in the tolvaptan 15 mg and 30 mg groups than in the placebo group. None of the other secondary outcome measures, including cardiac output (the amount of blood the hearts left ventricle ejects into the circulation in one minute), cardiac index (cardiac output indexed to a patient's body size), systemic vascular resistance (the resistance to blood flow by all of the blood vessels, excluding those in the lungs), heart rate, and blood pressure, showed significantly different changes in the tolvaptan and placebo groups.

Overall, 77 (42.5%) subjects experienced at least one treatment-emergent adverse event during the trial. The incidence of these events was highest in the tolvaptan 60 mg group (54.3%) and lowest in the placebo group (33.3%). Most common adverse events (greater than 3% and more frequent than placebo) associated with tolvaptan were dry mouth, thirst, back pain, headache, anxiety, and haematuria. No treatment-emergent adverse event occurred in more than 10% of the patients in any of the groups. No deaths occurred during study drug administration. Two patients died during the 7-day follow-up period (originally assigned to tolvaptan 30 mg and 60 mg, respectively). Both of those patients died from complications resulting from worsening of underlying disease.


'/>"/>

Contact: Debra Kaufmann
debra.kaufmann@otsuka.com
240-683-3568
Porter Novelli
Source:Eurekalert

Related medicine news :

1. The Science of Solar Eclipse
2. Acupuncture May Help Chemotherapy Side Effects
3. Just spice it up!!!!! Anti bacterial effects of spices unraveled in the West
4. Protective effects of tomatoes in prostate cancer
5. The Effects Of Delaying A Delivery Questioned
6. Side Effects Of Some Common Drugs
7. Toxic effects common with AIDS treatments
8. Contraceptives have dual effects
9. Cooling decreases heart attack effects
10. Heart Drug has grave side effects
11. Chemotherapy Pill Has Fewer Side Effects Than IV
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/20/2017)... ... January 20, 2017 , ... “Christmas in Suffolk”: a ... author, Sara Seymour, who lives in Lafayette, Indiana where she works in a daycare ... coffees and writes. , Published by Christian Faith Publishing, Sara Seymour’s new book is ...
(Date:1/20/2017)... ... January 20, 2017 , ... “Knowledge is God’s Lighthouse”: ... by faith. “Knowledge is God’s Lighthouse” is the creation of published author, Gene Gaapf, ... and poetry collections. , “I have been writing since high school and have ...
(Date:1/20/2017)... ... 20, 2017 , ... “God's Miracle Man: Against All Odds”: an inspiring ... published author, Keith C. A. Tucker, son of Minister Delores Pinnock and a Jamaican ... Reverend Mark Hardy , “While sitting up in bed, I felt a pounding headache. ...
(Date:1/19/2017)... (PRWEB) , ... January 19, ... ... introducing the Aerolib Learning Management System: an On-demand E-learning system for Clinical ... and Hospital Administration that is based on Aerolib`s successful education methodology of ...
(Date:1/19/2017)... ... 2017 , ... Wells Pharmacy Network announced the completion of ... pharmacy located in Ocala, Florida. , Meeting the Needs of a Growing ... States for high-quality human anti-aging and wellness compounded medications, Wells Pharmacy ...
Breaking Medicine News(10 mins):
(Date:1/19/2017)... -- Incretin Mimetics/GLP-1 Agonists, SNDRIs, Lipase Inhibitors, Serotonin Receptor ... global anti-obesity drugs market is expected to grow at a ... and CAGR of 38.7% in the second half of the forecast ... 32.8% from 2016 to 2027. The market is estimated at $1,058 ... 2027. ...
(Date:1/19/2017)... 2017  Abaxis, Inc. (NasdaqGS: ABAX ), ... and consumables for the medical and veterinary markets worldwide, ... results for the third quarter fiscal year 2017, ended ... p.m. ET on Thursday, January 26, 2017.  The Company ... year 2017 after the market closes on Thursday, January ...
(Date:1/19/2017)... -- ViewRay, Inc. (Nasdaq: VRAY) announced today that the German ... Germany , has purchased a MRIdian ... Clinic Heidelberg as part of its initiative for MRI-based ... be headed by Medical Director and Professor Jürgen Debus, ... German Cancer Research Center (DKFZ), the Heidelberg Heavy Ion ...
Breaking Medicine Technology: