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Nitromist (Nitroglycerin Lingual Aerosol) - Summary

 



NITROMIST SUMMARY

Nitroglycerin, an organic nitrate, is a vasodilator which has effects on both arteries and veins.

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


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NEWS HIGHLIGHTS

Published Studies Related to Nitromist (Nitroglycerin)

Intravenous nitroglycerin for external cephalic version: a randomized controlled trial. [2009.09]
OBJECTIVE: To estimate whether treatment with intravenous nitroglycerin for uterine relaxation increases the chance of successful external cephalic version... CONCLUSION: Treatment with intravenous nitroglycerin increased the rate of successful external cephalic version in nulliparous, but not in multiparous, women. Treatment with intravenous nitroglycerin appeared to be safe, but our numbers were too small to rule out rare serious adverse effects. LEVEL OF EVIDENCE: I.

Transdermal nitroglycerin therapy may not prevent early postmenopausal bone loss. [2009.09]
CONTEXT: Osteoporosis is common among postmenopausal women; animal studies and human pilot studies support the concept of nitric oxide (NO) donors reducing bone mineral density loss. OBJECTIVE: The objective of the study was to evaluate whether NO donor, nitroglycerin, prevents postmenopausal bone loss... CONCLUSIONS: BMD changes did not substantially differ between postmenopausal women who received the dose of nitroglycerin tested, in comparison with a placebo. Once-daily dosing with 22.5 mg of transdermal-administered nitroglycerin was not effective (compliance adjusted dose was only approximately 16 mg/d); a sub-therapeutic dose.

Effects of nitroglycerin on sublingual microcirculatory blood flow in patients with severe sepsis/septic shock after a strict resuscitation protocol: A double-blind randomized placebo controlled trial. [2009.08.27]
OBJECTIVES:: Microcirculatory alterations have been associated with morbidity and mortality in human sepsis. Such alterations occur despite pressure-guided resuscitation. Earlier data suggested that impaired microcirculatory blood flow could be corrected with intravenous nitroglycerin in these patients. We tested this concept after fulfillment of preset systemic hemodynamic resuscitation end points in the early phase of sepsis... CONCLUSIONS:: In the context of a strict resuscitation protocol, based upon fulfillment of systemic hemodynamic end points in patients with early-phase severe sepsis or septic shock, we conclude that intravenous nitroglycerin does not promote sublingual microcirculatory blood flow.

The effect of nitroglycerin as an adjuvant to lidocaine in intravenous regional anesthesia. [2009.06]
PURPOSE: The disadvantages of intravenous regional anesthesia (IVRA) include slow onset, poor muscle relaxation, tourniquet pain, and rapid onset of pain after tourniquet deflation. In this randomized, double-blind study, we evaluated the effect of nitroglycerin (NTG) in quality improvement when added to lidocaine in IVRA... CONCLUSION: The NTG adding to lidocaine in intravenous regional anesthesia shortens onset times of sensory and motor block and decreases the tourniquet and postoperative pain, without any side effect.

Transdermal nitroglycerin as an adjuvant to patient-controlled morphine analgesia after total knee arthroplasty. [2009.03]
BACKGROUND: Nitroglycerin (NTG) has been shown to be a useful adjunct for pain treatment without increasing adverse side effects. The effects of NTG on postoperative morphine consumption after knee replacement were evaluated... CONCLUSIONS: The use of NTG patches conferred no advantage over the use of placebo in patients receiving patient-controlled morphine analgesia after total knee replacement. Two myocardial infarcts occurred in this group. Therefore, the safety of postoperative NTG patch use for pain control must be questioned.

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Clinical Trials Related to Nitromist (Nitroglycerin)

Radial Artery Dilation Study: The Effect of Topical Administration of Nitroglycerin and Lidocaine Versus Lidocaine Alone of the Radial Artery Diameter [Recruiting]
The radial artery, which is located on the outer side of the forearm, can be used in interventional procedures, such as cardiac catheterization, to provide access to the arterial blood supply. In order to facilitate successful catheterization of the artery, a dilated artery and one free of arterial spasm is desirable. The proposed study will randomize twenty three healthy subjects to determine the effect of topical nitroglycerin on radial artery vasodilation. In the first phase of the study, which is a dose escalation study, each subject will receive either one or two inches of nitroglycerin in a blinded manner on one wrist and placebo on the other. Radial artery diameter will be measured with ultrasound at regular intervals up to two hours. The subjects will then return at a later date at which point they will receive the alternate dose on one wrist and placebo on the other. In the second phase of the study, we will randomize the same patients to a mixture of topical nitroglycerin and lidocaine or topical lidocaine alone. Measurements of radial artery diameter will be performed as in the first study.

Dose Response to Topical Glyceryl Trinitrate in Patients With Raynaud's Phenomenon [Recruiting]
The purpose of this study is to evaluate the blood flow response to topical Glyceryl Trinitrate when applied to the skin of patient's fingers with Raynaud's Phenomenon.

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

Concurrent Chemotherapy and Radiotherapy With Nitroglycerin in Patients With Locally Advanced Non-Small Cell Lung Cancer [Recruiting]
Nitroglycerin will increase the effectiveness of treatment with induction chemotherapy and concurrent chemo-radiotherapy by reducing chemo-radio resistance through an increased oxygen pressure in tumoral tissue. The combination treatment of nitroglycerin and chemotherapy will result in longer disease-free and over-all survival in patients with locally advanced NSCLC

A Study to Determine the Effect of Nitroglycerin Ointment on the Pain Associated With Chronic Anal Fissures [Recruiting]
Anal fissure is a solitary ulcer in the squamous epithelium of the anus causing intense anal pain especially upon defecation and for one or two hours afterwards. There are no approved drugs in the US for this condition and surgery is often the treatment choice. Strakan is conducting this confirmatory study so the product can be submitted for regulatory approval in the US. Strakan currently markets this product throughout Europe.

To determine the effect of Cellegesic versus placebo on average pain intensity over every 24 hour period for up to 21 days of treatment in 250 patients.

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Page last updated: 2009-10-20

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