Hypotension News and Research

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Antibiotics with blood pressure medications may cause hypotension

Mixing commonly used antibiotics with common blood pressure medications may cause hypotension and induce shock in older patients, requiring hospitalization, according to a study published in CMAJ.

18 Jan 2011

Combination therapy initially, best for blood pressure control: ACCELERATE study

A new study published online Jan. 13 in The Lancet shows that patients with high blood pressure respond better to a combination drug therapy than those on monotherapy. Also patients who undergo the two-drug treatment after taking the single-drug therapy also experience better blood pressure outcomes, though not at the same level as those who began with the combination treatment, according to research.

13 Jan 2011

Chelsea completes successful NORTHERA pre-NDA assessment with FDA

Chelsea Therapeutics International, Ltd. announced it has completed a pre-NDA assessment with the U.S. Food and Drug Administration (FDA) and intends to accelerate its new drug application (NDA) for NORTHERA™(droxidopa) for the treatment of symptomatic, neurogenic orthostatic hypotension (NOH), a chronic and potentially debilitating drop in blood pressure upon standing commonly associated Parkinson's disease, multiple system atrophy and pure autonomic failure.

20 Dec 2010

Phase 1 study results of Aduro BioTech's CRS-207 presented at AACR Conference on Tumor Immunology

Aduro BioTech, a clinical-stage immunotherapy company, is pleased to announce the presentation of the CRS-207 Phase 1 study at the AACR Special Conference on Tumor Immunology in Miami, Florida by the Principal Investigator, Dr. Dung Le of the Johns Hopkins Kimmel Cancer Center. Dr. Le reported that CRS-207 intravenous administration was well tolerated in subjects with advanced, treatment-refractory cancers. Dr. Le also reported evidence of immune activation and that 6 out of 17 end-stage cancer patients lived 15 months or longer.

7 Dec 2010

Positive interim data from Phase I/II trial of CYT387 in myelofibrosis presented at ASH Annual Meeting

YM BioSciences Inc. today announced positive interim data from the first 60 patients enrolled in the Phase I/II trial for its JAK1/JAK2 inhibitor, CYT387, in myelofibrosis. The results were reported today in an oral presentation at the 52nd American Society of Hematology Annual Meeting being held in Orlando, Florida.

7 Dec 2010

AMAG updates product label of Feraheme Injection

AMAG Pharmaceuticals, Inc. today announced that the company has reached agreement with the U.S. Food and Drug Administration (FDA) regarding an update to the product label for Feraheme (ferumoxytol) Injection for intravenous (IV) use.

29 Nov 2010

New Canadian Cardiovascular Society guidelines support clinicians in practicing evidence-based medicine

Summaries of a number of new Canadian Cardiovascular Society guidelines and position statements offering the most up to date information to support clinicians in practicing evidence-based medicine were released at the Canadian Cardiovascular Congress 2010 this week.

25 Oct 2010

RHUCIN clinical trial results published in JACI journal

Santarus, Inc., a specialty biopharmaceutical company, today announced the publication of an integrated analysis of two randomized placebo-controlled clinical trials with RHUCIN (recombinant human C1 inhibitor, or rhC1INH), in the October issue of the peer reviewed Journal of Allergy and Clinical Immunology (JACI).

5 Oct 2010

Chelsea Therapeutics' Phase III NORTHERA Study 301 meets primary endpoint

Chelsea Therapeutics International, Ltd. announced that preliminary analyses of its Phase III NORTHERA™ Study 301 met its primary endpoint. Treatment with Northera provided clinically meaningful and statistically significant improvement.

20 Sep 2010

FDA updates Shire's ProAmatine medicine for symptomatic orthostatic hypotension treatment

Shire, the global specialty biopharmaceutical company, announces that the United States Food and Drug Administration today posted an update on its website related to ProAmatine (known generically as midodrine), a medicine approved for the treatment of symptomatic orthostatic hypotension.

13 Sep 2010

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