Researchers examined 4,063 patients aged 65 and older in the Veterans Health Administration ( VHA ). There were 5,226 indications for 4,062 carotid ultrasounds . Overall , the researchers identified six main clinical themes for ordering the imaging : vascular indications , |
near-syncope / syncope indications , neuropsychiatric indications , earrelated indications , ocular indications , and imaging and part of preoperative evaluation . The most common indication was carotid bruit , accounting for one third of all indications . Follow-up for carotid disease in patients with |
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carotid stenosis was second . Together , these indications accounted for half of all imaging in this group .
Each indication was rated and researchers found that only 5.4 % of images were appropriate while 83.4 % were uncertain and 11.3 % were inappropriate . While most of the
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appropriate indications were related to ocular disease , the most common appropriate indication was follow-up for carotid intervention . Carotid bruit and follow-up for established carotid disease were the most prevalent uncertain indications . Dizziness / vertigo , syncope , and blurred / change in vision |
TRITON-TIMI 38 : Greater reductions in thrombotic CV events and stent thrombosis with Effient + ASA vs clopidogrel + ASA *
Thrombotic CV events ( primary composite of CV death , nonfatal Stent thrombosis RRR in STEMI-PCI patients was 42 %
MI , nonfatal stroke ) relative risk reduction ( RRR ) in STEMI-PCI through 450 days ( 1.6 % Effient + ASA vs 2.8 % clopidogrel + patients was 21 % through 450 days ( 9.8 % Effient + ASA vs ASA , P = 0.02 ) 5
12.2 % clopidogrel + ASA , P = 0.02 ) 1 SELECTED SAFETY : Effient increased the risk of TIMI
— RRR was 30 % through 7 days ( 5.5 % Effient + ASA vs major or minor bleeding vs clopidogrel
7.8 % clopidogrel + ASA , P = 0.008 ) and 32 % through 30 days Effient can cause significant , sometimes fatal , bleeding .
( 6.5 % Effient + ASA vs 9.4 % clopidogrel + ASA , P = 0.002 ) 2 , 3 Overall rates of non-CABG TIMI major or minor bleeding
Difference in treatments was primarily driven by a significant were significantly higher with Effient + ASA ( 4.5 %) compared reduction in nonfatal MIs , with no significant difference in with clopidogrel + ASA ( 3.4 %). The rates of fatal bleeding were
CV death or nonfatal stroke 1 0.3 % with Effient + ASA and 0.1 % with clopidogrel + ASA . In
— In the overall study population , approximately 40 % of MIs patients who underwent CABG ( N = 437 ), the rates of CABGrelated TIMI major or minor bleeding were 14.1 % with Effient + occurred periprocedurally and were detected solely by changes in CK-MB
ASA and 4.5 % with clopidogrel + ASA
Stent thrombosis ( secondary endpoint ) RRR in ACS-PCI
* In TRITON-TIMI 38 , the LD of clopidogrel was delayed relative to the patients was 52 % through 450 days ( 1.1 % Effient + ASA vs placebo-controlled trials that supported its approval for ACS . 1
2.2 % clopidogrel + ASA , P < 0.0001 ) 4
Effient is indicated to reduce the rate of thrombotic cardiovascular ( CV ) events ( including stent thrombosis ) in patients with acute coronary syndrome ( ACS ) who are to be managed with percutaneous coronary intervention ( PCI ) as follows : [ 1 ] patients with unstable angina ( UA ) or non – ST-elevation myocardial infarction ( NSTEMI ); [ 2 ] patients with ST-elevation myocardial infarction ( STEMI ) when managed with primary or delayed PCI .
The loading dose ( LD ) of Effient is 60 mg and the maintenance dose ( MD ) is 10 mg once daily . Effient is available in 5-mg and 10-mg tablets .
IMPORTANT SAFETY INFORMATION
WARNING : BLEEDING RISK
Effient ® ( prasugrel ) can cause significant , sometimes fatal , bleeding .
Do not use Effient in patients with active pathological bleeding or a history of transient ischemic attack or stroke .
In patients ≥75 years of age , Effient is generally not recommended , because of the increased risk of fatal and intracranial bleeding and uncertain benefit , except in high-risk situations ( patients with diabetes or a history of prior myocardial infarction [ MI ]) where its effect appears to be greater and its use may be considered .
Do not start Effient in patients likely to undergo urgent coronary artery bypass graft surgery ( CABG ). When possible , discontinue Effient at least 7 days prior to any surgery .
Additional risk factors for bleeding include : body weight < 60 kg propensity to bleed
concomitant use of medications that increase the risk of bleeding ( eg , warfarin , heparin , fibrinolytic therapy , chronic use of nonsteroidal anti-inflammatory drugs [ NSAIDs ])
Suspect bleeding in any patient who is hypotensive and has recently undergone coronary angiography , percutaneous coronary intervention ( PCI ), CABG , or other surgical procedures in the setting of Effient .
If possible , manage bleeding without discontinuing Effient . Discontinuing Effient , particularly in the first few weeks after acute coronary syndrome , increases the risk of subsequent cardiovascular events .
Please see Brief Summary of Prescribing Information , including Boxed Warning regarding bleeding risk , on subsequent pages .
CONTRAINDICATIONS
Effient is contraindicated in patients with active pathological bleeding , such as from a peptic ulcer or intracranial hemorrhage ( ICH ), or a history of transient ischemic attack ( TIA ) or stroke , and in patients with hypersensitivity to prasugrel or any component of the product
WARNINGS AND PRECAUTIONS
Patients who experience a stroke or TIA while on Effient generally should have therapy discontinued . Effient should also be discontinued for active bleeding and elective surgery
Premature discontinuation of Effient increases risk of stent thrombosis , MI , and death
Thrombotic thrombocytopenic purpura ( TTP ), a rare but serious condition that can be fatal , has been reported with Effient , sometimes after a brief exposure (< 2 weeks ), and requires urgent treatment , including plasmapheresis
Hypersensitivity , including angioedema , has been reported in patients receiving Effient , including patients with a history of hypersensitivity reaction to other thienopyridines
ADVERSE REACTIONS
Bleeding , including life-threatening and fatal bleeding , is the most commonly reported adverse reaction
TRITON-TIMI 38 TRIAL DESIGN
TRITON-TIMI 38 was a head-to-head study comparing Effient ( 60-mg LD followed by a 10-mg once-daily MD ) plus aspirin ( ASA ) with clopidogrel ( 300-mg LD followed by a 75-mg once-daily MD ) plus ASA in 13,608 patients with ACS managed with PCI ( median duration 14.5 months ). 1 , 6
References : 1 . Effient ® ( prasugrel ) prescribing information . Daiichi Sankyo , Inc . and Eli Lilly and Company . 2 . Data on file : # EFF20130920a : DSI / Lilly . 3 . Data on file : # EFF20080929c : DSI / Lilly . 4 . Data on file : # EFF20091204b : DSI / Lilly . 5 . Data on file : # EFF20100129c : DSI / Lilly . 6 . Wiviott SD , Braunwald E , McCabe CH , et al ; for the TRITON-TIMI 38 Investigators . N Engl J Med . 2007 ; 357:2001-2015 .