Hypotension News and Research

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Adoption of standby intra-aortic balloon pump strategy during high-risk PCI needed: Study

High-risk patients undergoing a coronary procedure such as placement of a stent who electively received an intra-aortic balloon pump (a device that can help improve blood flow) prior to the procedure did not experience a significantly lower overall rate of events such as heart attack, revascularization or death, according to a study in the August 25 issue of JAMA.

25 Aug 2010

Hospira Japan receives approval for long term use of Precedex IV sedative

Hospira Japan Co., Ltd. today announced it has received an approval for the long-term (greater than 24 hour) use of the sedative "Precedex IV™200ug" (generic name: dexmedetomidine hydrochloride). This approval follows Hospira's first launches earlier this year of Precedex in Canada and in South Korea, important milestones for Hospira as the company continues to build the molecule's global presence.

23 Aug 2010

Chelsea Therapeutics announces new investigator to conduct phase II clinical study of Droxidopa

Chelsea Therapeutics International, Ltd. announced that a new investigator-led phase II clinical study of Droxidopa, an oral synthetic precursor of norepinephrine, has been initiated in chronic fatigue syndrome (CFS).

20 Aug 2010

FDA issues Proposal to Withdraw Marketing Approval for orthostatic hypotension drug midodrine hydrochloride

The U.S. Food and Drug Administration today proposed to withdraw approval of the drug midodrine hydrochloride, used to treat the low blood pressure condition orthostatic hypotension, because required post-approval studies that verify the clinical benefit of the drug have not been done.

17 Aug 2010

Ikaria announces voluntary recall of INOMAX DS drug-delivery system in US and Canada

Ikaria, Inc. announced today that its INOMAX® DS drug-delivery systems in the United States are being voluntarily recalled due to the potential failure of a pressure switch which may have an impact on the administration of INOMAX® (nitric oxide) for inhalation to patients. This potential failure was identified by Ikaria as part of its ongoing quality monitoring and review processes. This class I recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA). All INOMAX DS systems in Canada also are being voluntarily recalled.

10 Aug 2010

Research examines effects of orthostatic hypotension in adults, children

A simple variation to the tried and true method of checking blood pressure can reveal startling information about both older and younger persons, new research suggests.

4 Aug 2010

GE Healthcare Medical Diagnostics reintroduces Optison ultrasound contrast agent for echocardiograms

GE Healthcare Medical Diagnostics today announced the market reintroduction of Optison™ (Perflutren Protein-Type A Microspheres Injectable Suspension, USP), a diagnostic ultrasound contrast agent for use in select echocardiograms. Optison is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricle and to improve the delineation of the left ventricular endocardial borders. The safety and efficacy of Optison with exercise stress or pharmacologic stress testing have not been established.

12 Jul 2010

Jasmine can be used instead of sleeping pills or mood enhancers: Study

Instead of a sleeping pill or a mood enhancer, a nose full of jasmine from Gardenia jasminoides could also help: in collaboration with Dr. Olga Sergeeva and Prof. Helmut Hass from the Heinrich Heine University in Düsseldorf, researchers from Bochum led by Prof. Dr. Dr. Dr. Hanns Hatt have discovered that the two fragrances Vertacetal-coeur (VC) and the chemical variation (PI24513) have the same molecular mechanism of action and are as strong as the commonly prescribed barbiturates or propofol.

9 Jul 2010

Study results of triple combination therapy in patients with diabetes and hypertension presented at ADA 2010

Preliminary results of a pre-specified subgroup study analysis of patients with diabetes and hypertension demonstrated that the investigational triple combination therapy of olmesartan medoxomil / amlodipine / hydrochlorothiazide (40/10/25 mg) resulted in a statistically significant greater Least Squares mean reduction in blood pressure from baseline at week 12 (37.9/22.0 mm Hg versus 26.4-28.0/14.7-17.6 mm Hg, P less than or equal to 0.0013) as compared to corresponding dual combination therapy [olmesartan medoxomil (40 mg) / amlodipine (10 mg); olmesartan medoxomil (40 mg) / hydrochlorothiazide (25 mg); or amlodipine (10 mg) and hydrochlorothiazide (25 mg)].

1 Jul 2010

Chelsea completes enrollment in Northera Phase III Study 301 for neurogenic orthostatic hypotension

Chelsea Therapeutics International, Ltd. has successfully reached its target enrollment of 150 patients in its Northera™ (Droxidopa) pivotal Phase III Study 301 for the treatment of symptomatic, neurogenic orthostatic hypotension (NOH). Results from the trial are expected in September 2010 and the full registration program is on track to initiate a new drug application (NDA) in the first half of 2011.

30 Jun 2010

Chelsea initiates NORTHERA Phase III trial for symptomatic NOH associated with PD

Chelsea Therapeutics International, Ltd. announced the initiation of Study 306, a pivotal Phase III trial evaluating the efficacy of NORTHERA™, an oral synthetic precursor of norepinephrine, for the treatment of symptomatic neurogenic orthostatic hypotension (NOH) associated with Parkinson's disease.

29 Jun 2010

Chelsea presents Northera study data at International Congress on Parkinson's Disease and Movement Disorders

Chelsea Therapeutics International, Ltd. announced that data from its pivotal studies of Northera™ (droxidopa) in symptomatic neurogenic orthostatic hypotension was presented during a poster session and featured in a symposium highlighting the role of norepinephrine (NE) deficiency in Parkinson's disease at the 14th International Congress on Parkinson's Disease and Movement Disorders in Buenos Aires, Argentina.

17 Jun 2010

Phase II study results of riociguat for CTEPH and PAH published online

Bayer HealthCare Pharmaceuticals, Inc. today announced that the study "Riociguat for chronic thromboembolic pulmonary hypertension and pulmonary arterial hypertension: a phase II study" was published online this week by the European Respiratory Journal. Results of this study to assess the safety, tolerability and the feasibility of individual dose titration of riociguat were previously presented at the 2009 International Conference of the American Thoracic Society.

11 Jun 2010

Update on Phase II clinical study of CH-4051 in rheumatoid arthritis

Chelsea Therapeutics International, Ltd. announced that during a teleconference yesterday, the U.S. Food and Drug Administration requested that the company delay the initiation of its proposed Phase II clinical study of CH-4051 in rheumatoid arthritis and indicated that the agency is requesting additional detail from the preclinical studies previously submitted as part of the company's investigational new drug application.

9 Jun 2010

Masimo PVI identifies patients at high risk for developing severe hypotension during anesthesia induction

Masimo, the inventor of Pulse CO-Oximetry and Measure-Through Motion and Low Perfusion pulse oximetry, announced today that a new clinical study published in the May 2010 issue of Acta Anaesthesiologica Scandinavica shows that Masimo pleth variability index can be used to help clinicians assess risk for mean arterial pressure decreases and subsequent hypotension during anesthesia administration.

25 May 2010

Malnutrition presents a serious social problem in Bulgaria

According to a strategic document published by the World Bank (2006), malnutrition leads to indirect losses in productivity from poor cognitive development and schooling.

24 May 2010

Eli Lilly to present results of two Phase II trials evaluating ALIMTA in combination with chemotherapy, radiation

Results of two Phase II trials evaluating ALIMTA (pemetrexed for injection) in combination with a platinum chemotherapy and radiation for patients with locally advanced non-small cell lung cancer will be presented by Eli Lilly and Company at the 46th Annual Meeting of the American Society of Clinical Oncology in Chicago, Ill., on June 6, 2010.

21 May 2010

Medinox, Orient Europharma form partnering agreement for NOX-100 anti-hypotensive drug

Medinox, Inc. in Carlsbad, California and Orient Europharma in Taiwan announce today that they have entered into a partnering agreement to develop and market NOX-100, a new anti-hypotensive drug. Under the terms of the agreement, Orient Europharma holds the exclusive distribution rights of NOX-100 in Taiwan, China, Korea, Australia, New Zealand and Southeast Asia. Medinox retains the marketing rights in the United States, Japan and Europe.

12 Apr 2010

Team of neurologists from the U.S. face Canadian neurologists in annual "Neurobowl"

In a competition modeled after TV quiz shows, a team of neurologists from the United States will face Canadian neurologists in the annual "Neurobowl®" on April 11.