Claim: FDA advisory panel rejects J&J drug for acute coronary syndrome.
Verdict: SUPPORTS

Retrieved passages:
title: Management of acute coronary syndrome
text: favorable action on hemodynamic parameters and cardiac oxygen consumption. However, in patients presenting without ST elevation, morphine has been shown to have adverse events potential, and its use is considered acceptable only after inadequate pain relief by medication specific against angina. Non-steroidal anti-inflammatory drugs are contraindicated for both categories of patients. All patients with acute coronary syndrome must immediately receive antiplatelet therapy, including aspirin and generally a second oral antiplatelet agent. Bleeding is the most important side-effect of antiplatelets. Aspirin inhibits platelet aggregation and formation of blood clots. It is effective across the entire spectrum of acute coronary syndromes, and

title: Acute coronary syndrome
text: 2006, there was a 17% reduction in hospital admissions for acute coronary syndrome. 67% of the decrease occurred in non-smokers. People with presumed ACS are typically treated with aspirin, clopidogrel or ticagrelor, nitroglycerin, and if the chest discomfort persists morphine. Other analgesics such as nitrous oxide are of unknown benefit. Angiography is recommended in those who have either new ST elevation or a new left bundle branch block on their ECG. Unless the person has low oxygen levels additional oxygen does not appear to be useful. If the ECG confirms changes suggestive of myocardial infarction (ST elevations in specific leads,

title: Management of acute coronary syndrome
text: which includes coronary angiography and, if necessary, revascularization with percutaneous coronary intervention or coronary artery bypass surgery. Medical therapy for acute coronary syndromes is based on drugs that act against ischemia and resultant angina and limit the infarct size (i.e., the area of myocardium that is affected), as well as drugs that inhibit clot formation. The latter include antiplatelet agents, which block the activation and aggregation of platelets (cellular blood components that contribute to clot formation), and anticoagulant agents (which attenuate the coagulation cascade). Long-term therapy in acute coronary syndrome survivors is targeted against recurrence and long term complications (secondary

title: Acute coronary syndrome
text: Cocaine associated ACS should be managed in a manner similar to other patients with acute coronary syndrome except beta blockers should not be used and benzodiazepines should be administered early. The TIMI risk score can identify high risk patients in non-ST segment elevation MI ACS and has been independently validated. Based on a global registry of 102,341 patients, the GRACE score estimates in-hospital, 6 months, 1 year, and 3 year mortality risk after a heart attack. GRACE Score 2.0 Calculator. The Killip classification consists of 4 classes based on clinical symptoms. It predicts 30-day mortality after myocardial infarction. The aim

title: Management of acute coronary syndrome
text: treated with fibrinolysis and those who do not undergo reperfusion treatment only clopidogrel is indicated. Prasugrel must not be given to patients with a history of ischemic stroke or aged 75 years or older. In patients with non-ST elevation acute coronary syndrome current guidelines also recommend immediate administration of dual antiplatelet therapy upon diagnosis; clopidogrel and ticagrelor are indicated in this setting, with ticagrelor considered superior for patients undergoing early invasive strategy (see later). However, emerging evidence questions this strategy. As with aspirin, it is necessary to administer a loading dose. Glycoprotein IIb/IIIa inhibitors are a class of intravenous antiplatelet

title: JNJ-42165279
text: of severe adverse events, including a death. In response, Janssen announced that it was temporarily suspending dosing in its two Phase II clinical trials with JNJ-42165279, describing the decision as "precautionary measure follows safety issue with different drug in class". Janssen was emphatic that no serious adverse events had been reported in any of the clinical trials with JNJ-42165279 to date. The suspension is to remain in effect until more information is available about the BIA 10-2474 study. JNJ-42165279 JNJ-42165279 is a drug developed by Janssen Pharmaceutica which acts as a potent and selective inhibitor of the enzyme fatty acid

title: Eteplirsen
text: 2015 for drisapersen and February 26, 2016 for eteplirsen. Following FDA rejection of drisapersen, the agency announced a three-month time extension for its review of eteplirsen. The FDA panel decision was controversial because the FDA staff and the panel used a stricter standard of evidence than Sarepta and patient groups used. The FDA panel said that it was required by law to apply the standard of “substantial evidence” of effectiveness. This required randomized, controlled trials showing effectiveness of a meaningful clinical outcome, such as the ability to function in daily life. Sarepta and the patient groups wanted to use the

title: Acute coronary syndrome
text: angina and acute coronary syndrome is therefore empirical treatment with aspirin, a second platelet inhibitor such as clopidogrel, prasugrel or ticagrelor, and heparin (usually a low-molecular weight heparin), with intravenous nitroglycerin and opioids if the pain persists. The heparin-like drug known as fondaparinux appears to be better than enoxaparin. A blood test is generally performed for cardiac troponins twelve hours after onset of the pain. If this is positive, coronary angiography is typically performed on an urgent basis, as this is highly predictive of a heart attack in the near-future. If the troponin is negative, a treadmill exercise test or

title: Anticoagulant
text: drugs argatroban and dabigatran. An oral direct thrombin inhibitor, ximelagatran (Exanta) was denied approval by the Food and Drug Administration (FDA) in September 2004 and was pulled from the market entirely in February 2006 after reports of severe liver damage and heart attacks. In November 2010, dabigatran was approved by the FDA to treat atrial fibrillation. With regards to NOAC medication and invasive dental treatments, there has not been enough clinical evidence and experience to prove any reliable side-effects, relevance or interaction between these two. Further clinical prospective studies on NOACs are required to investigate the bleeding risk and haemostasis

title: Management of acute coronary syndrome
text: for use in acute coronary syndromes, clopidogrel, ticagrelor and prasugrel; all reduce platelet aggregation by inhibiting the P2Y receptor, a type of adenosine phosphate receptor, on the surface of platelets. Not all three of them are equally indicated in all types of acute coronary syndromes. In patients with ST elevation the choice of P2Y inhibitor depends on reperfusion strategy; for patients undergoing primary percutaneous coronary intervention ticagrelor and prasugrel are considered superior to clopidogrel, as they are more potent and have more rapid onset of action, at the cost of some increase in bleeding risk; for STEMI patients who are

title: Ticagrelor
text: quality evidence for the use of ticagrelor before percutaneous coronary intervention (PCI) in non-ST elevation acute coronary syndrome. The FDA indication for ticagrelor is reduction of the rate of cardiovascular death, myocardial infarction (MI), and stroke in people with acute coronary syndrome or history of myocardial infarction. AHA/ACC Guidelines (09/2014) state: "It is reasonable to choose ticagrelor over clopidogrel for P2Y12 inhibition treatment in patients with NSTE-ACS treated with early invasive strategy and/or coronary stenting". Ticagrelor was found to be comparable to acetylsalicylic acid in people with acute ischemic stroke or transient ischemic attack. Contraindications for ticagrelor are: active pathological

title: Vorapaxar
text: acute coronary syndrome comparing the medication and a placebo. Vorapaxar is eliminated primarily by metabolism by the CYP3A enzymes. It is best to avoid any strong CYP3A4 inhibitors(ex: ketoconazole, itraconazole, posaconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, boceprevir, telaprevir, telithromycin, and conivaptan). CYP3A4 inducers(Carbamazepine, rifampin, St. John's Wort, and Phenytoin) should also be avoided. No dose adjustment is required in persons with renal impairment. No dose adjustment is required in persons with mild and moderate hepatic impairment. If the person has severe hepatic impairment, vorapaxar is not recommended due to the risk of bleeding. Vorapaxar is a new anti-platelet drug

title: Management of acute coronary syndrome
text: proved to reduce the size of infarcted heart muscle, the risk of arrhythmias, and the proportion of patients with acute coronary syndrome who actually evolve STEMI. However, they have also been shown to increase the risk of acute heart failure. Their early use is contraindicated if there are signs of congestive heart failure (e.g., Killip class II or above) or hypotension, along with other contraindications to beta blockers (slow heart rate, atrioventricular block); in the absence of contraindications beta blocker therapy should begin in the first 24 hours. It may be prudent to prefer oral rather than intravenous forms. Initial

title: Anticoagulant
text: and more recently letaxaban (TAK-442) from Takeda and eribaxaban (PD0348292) from Pfizer. The development of darexaban was discontinued in September 2011: in a trial for prevention of recurrences of myocardial infarction in top of dual antiplatelet therapy (DAPT), the drug did not demonstrate effectiveness and the risk of bleeding was increased by approximately 300%. The development of letaxaban was discontinued for acute coronary syndrome in May 2011 following negative results from a Phase II study. Another type of anticoagulant is the direct thrombin inhibitor. Current members of this class include the bivalent drugs hirudin, lepirudin, and bivalirudin; and the monovalent

title: Isosorbide dinitrate/hydralazine
text: ACE inhibitors) than caucasians. The new patent and the old patent were licensed to a company called NitroMed, which ran a clinical called the African-American Heart Failure Trial (A-HeFT), the results of which were published in 2004 in the New England Journal of Medicine. The clinical trial was stopped early because the drug worked so well; it reduced mortality by 43%, reduced hospitalizations by 39%, and improved quality of life markers in African-American patients with CHF. On the basis of A-HeFT, the FDA approved BiDil in June 2005. In 2006, the Heart Failure Society of America included the use of

title: History of invasive and interventional cardiology
text: "off label" coronary artery lesions, which would otherwise go untreated or for bypass surgery. The FDA advisory board reiterated the ACC guidelines that clopidogrel should be continued for 12 months after drug eluting stent placement in individuals who are at low risk for bleeding. History of invasive and interventional cardiology The history of invasive and interventional cardiology is complex, with multiple groups working independently on similar technologies. Invasive and interventional cardiology is currently closely associated with cardiologists (physicians who treat the diseases of the heart), though the development and most of its early research and procedures were performed by diagnostic

title: Management of acute coronary syndrome
text: glyceryl trinitrate spray, aspirin, or opioid painkillers), an AED, and oxygen. Pilots may divert the flight to land at a nearby airport. Cardiac monitors are being introduced by some airlines, and they can be used by both on-board and ground-based physicians. Management of acute coronary syndrome Management of acute coronary syndrome is targeted against the effects of reduced blood flow to the afflicted area of the heart muscle, usually because of a blood clot in one of the coronary arteries, the vessels that supply oxygenated blood to the myocardium. This is achieved with urgent hospitalization and medical therapy, including drugs

title: Lorcaserin
text: panel voted 19-4-1 to recommend lorcaserin to the FDA. The FDA stated that the weight loss data passed FDA standards for efficacy and that the drug did not have cancer risks based on clarifications in the data. The FDA panelist recommended that postmarketing studies regarding potential heart valve issues be completed. The FDA has not stated one way or the other whether they believe this is necessary at this time although no related safety markers have been indicated during clinical studies. On 27 June 2012, the FDA officially approved lorcaserin for use in the treatment of obesity for some adults.

title: Icos
text: acute respiratory distress syndrome. Rovelizumab, trade-named LeukArrest and also known as Hu23F2G, was developed to treat patients suffering from hemorrhagic shock, which is caused by massive blood loss. The drug is a monoclonal antibody that inhibits the recruitment of white blood cells to the site of inflammation. During testing, few patients were given the drug, because LeukArrest had to be administered within four hours of the injury and informed consent was required; patients were often unconscious, and relatives had to be reached to give consent. In June 1998, Icos and many medical centers asked the FDA to waive consent requirements

title: Rovelizumab
text: States Food and Drug Administration (FDA) to waive consent requirements in situations where the patient was at high risk of dying and relatives could not be reached. While some medical ethicists opposed waiving consent, the FDA approved the proposal in August 1998 for five medical centers. Development of rovelizumab was halted in April 2000 when interim data from phase III clinical trials did not meet Icos's goals. The company's goals for rovelizumab included reducing the chance of multiple organ failure and reducing the death-rate from shock at 28 days. Rovelizumab was also being tested for treating heart attack, multiple sclerosis,