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Nitrolingual (Nitroglycerin Lingual Spray) - Summary

 
 



NITROLINGUAL SUMMARY

Nitrolingual Pumpspray

Nitroglycerin, an organic nitrate, is a vasodilator which has effects on both arteries and veins. The chemical name for nitroglycerin is 1,2,3-propanetriol trinitrate (C3 H5 N3 O9).

Nitrolingual® Pumpspray is indicated for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease.


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NEWS HIGHLIGHTS

Published Studies Related to Nitrolingual (Nitroglycerin Spray)

Standard versus low-dose transdermal nitroglycerin: differential effects on the development of tolerance and abnormalities of endothelial function. [2010.10]
We compared standard (0.6 mg/h) versus low-dose (0.05 mg/h) transdermal nitroglycerin (TGTN) on acute hemodynamic parameters, the development of tolerance, and endothelial function. Study 1 randomized six healthy volunteers to receive 0.6 mg/h or 0.05 mg/h TGTN in a crossover design study (6-day washout period) with measurements of heart rate, blood pressure, radial artery waveforms, and aortic augmentation index taken at baseline and 1, 2, and 3 hours after initial TGTN application...

Short head-up tilt test potentiated with oral nitroglycerine: comparison with a conventional test using isoproterenol. [2004.08]
Conventional tilt test protocols are time consuming and there is no consensus regarding the optimal duration of the test and the provocative drug to be used. This study evaluated the diagnostic power of a short nitroglycerine test against a conventional isoproterenol protocol... For evaluating unexplained syncope the short tilt test protocol with nitroglycerine is less time consuming, easier to perform, and has a higher rate of positive response than a conventional isoproterenol protocol.

Sublingual nitroglycerin versus intravenous ritodrine as tocolytic for external cephalic version: a double-blinded randomized trial. [2003.06]
OBJECTIVE: The purpose of this study was to compare the efficacy of sublingual nitroglycerin with that of intravenous ritodrine as a tocolytic agent for external cephalic version in nulliparous women... CONCLUSION: When compared with intravenous ritodrine, sublingual nitroglycerin was associated with a higher rate of headache, lower blood pressure, and a trend toward a lower rate of successful external cephalic version.

Sublingual nitroglycerine as a tocolytic in external cephalic version: a comparative study. [2003.03]
OBJECTIVE: To study the effect of sublingual nitroglycerine as a tocolytic on the success rate of external cephalic version (ECV) in nulliparous and parous women... CONCLUSION: Although the success rate of ECV has increased in recent years, the use of sublingual nitroglycerine as a tocolytic was not associated with this higher success rate. A randomized, controlled trial is needed.

Methodology of head-up tilt testing potentiated with sublingual nitroglycerin in unexplained syncope. [2000.04.15]
Shortened head-up tilt testing (HUT) potentiated with sublingual nitroglycerin (60 degrees passive standing for 20 minutes followed, if negative, by 400 microg of sublingual nitroglycerin spray with the test continuing for another 20 minutes) differs from conventional nitroglycerin HUT for a shorter drug-free phase (20 vs 45 minutes)...

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Clinical Trials Related to Nitrolingual (Nitroglycerin Spray)

MQX-503 vs Nitroglycerin Ointment: A Pharmacokinetic Comparison in Normal Subjects [Completed]
The purpose of the study is to measure how much nitroglycerin or its metabolites may be found in the bloodstream when MQX-503 or an FDA approved Nitroglycerin ointment 2% USP is applied to the skin of healthy subjects.

Nitroglycerin in Non-small Cell Lung Cancer [Recruiting]
Nitroglycerin is a nitric oxide donor which is mainly known as a vasodilating agent used in ischemic heart disease. It has also been shown to increase tumor blood flow in animal and human tumors.

The addition of nitroglycerin to chemotherapy in non small cell lung cancer has been shown to generate very favorable response rates with respect to standard treatment schedules[5]. Theoretically nitroglycerin might reduce resistance to chemotherapy via a plethora of different effects: better tumor perfusion, direct effects of NO on cancer cells, increase in activated p53 protein and via an increased blood flow in the tumour with as consequence a higher drug concentration in the tumor [6] .

In mice, nitric oxide donors such as isosorbide dinitrate have been shown to decrease tumor hypoxia by better tumor perfusion, which could enhance radiotherapy responses [7].

To date these combined effects have not been tested in humans. In this trial we would like to demonstrate the effect of nitroglycerin on tumor perfusion and hypoxia in non small cell lung cancer (using DCE and HX4 scanning), providing a rationale for further study and to test the effect of combining nitroglycerine to standard treatment of NSCLC (radiotherapy/chemotherapy).

GTN Therapy on Biomarkers of Immune Escape in Men With Biochemical Recurrence of Prostate Cancer After Primary Therapy [Recruiting]
Prostate cancer is the most commonly diagnosed cancer in men in Canada. Over 30% of men over the age of fifty have histological evidence of prostate cancer on biopsy. Despite the stage migration afforded by early detection with serum prostate specific antigen (PSA) testing and an apparent trend toward improved survival over the past several years, prostate cancer remains a significant cause of morbidity and mortality. Biochemical failure after primary therapy (surgery or radiation) remains a significant health care burden and strategies to delay clinical prostate cancer progression and prolong the interval from treatment failure to systemic therapy would be of significant clinical benefit for those men suffering from a finding of PSA recurrence.

PSA is widely accepted as the most useful prognostic marker of prostate cancer progression, particularly after primary therapy with radical surgery or radiation. 5 Despite improved cancer control rates with definitive management of early stage prostate cancer, a PSA recurrence is unfortunately a common occurrence (25-50%) in most large case series.

Microenvironmental factors have been demonstrated to play a pivotal role in the selection of neoplastic cell subpopulations expressing more malignant phenotypes and contributing to the progression of localized and metastatic disease. Very low levels of O2 (< 10 mmHg) has been well described in many solid tumours (including prostate cancer) and the extent of hypoxia has been demonstrated to represent an independent marker of a poor prognosis for patients with various types of cancers. Tumour hypoxia contributes to numerous adaptive phenotypes including increased invasion and metastasis, as well as evasion of immune cell surveillance increased resistance to radiotherapy and chemotherapy. Although cellular adaptive responses to hypoxia are likely mediated by various mechanisms, our previous preclinical studies suggest that decreased nitric oxide (NO)-dependent signalling plays a significant role in this progression of a malignant phenotype.

Treatment of Suspected Cholelithiasis With Nitroglycerin [Not yet recruiting]
ABSTRACT: Sublingual nitroglycerin has been advocated for the treatment of acute pain from suspected symptomatic cholelithiasis. There is, however, no clinical studies that validate its use. This study is designed to evaluate the efficacy of nitroglycerine in relieving acute pain of suspected biliary tract origin.

Nitroglycerin is a potent smooth muscle relaxant used for biliary tract dilation during ERCP, (Chelly, J) and has been recommended for treatment of biliary colic based on anecdotal experience and small case reports. Nitroglycerin effect is a result of the nitric oxide component of the medication which acts as a smooth muscle relaxant in vascular, bronchial, esophageal and biliary smooth muscles. [McGowan(1936), Chelly (1979),Toyoyama (2001)] The typical dose of nitroglycerin is 0. 4 mg given sublingually in pill form or, more recently, in a metered spray form. In a case series reported by Hassel (1993), positive response times ranged from 20 to 60 seconds with duration of action of two to twelve hours. Sublingual nitroglycerin is most commonly used for treatment of chest pain related to insufficient cardiac perfusion. It has also been noted to relieve the pain of esophageal spasms. Nitroglycerin has an excellent safety profile if used in patients with adequate pretreatment blood pressures. [Newberry (2005), Nitroglycerine (2011), Nitro (2011), Wolters (2009)] This study proposes to compare sublingual 0. 4 mg doses of nitroglycerin to placebo for the initial treatment of acute pain from suspected symptomatic cholelithiasis

MQX-503 Applied to the Hand Versus Nitroglycerin Ointment Applied to the Chest: A Pharmacokinetic Comparison [Recruiting]

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Page last updated: 2011-12-09

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