September 16th 2023
Even though committee members voted in support of Onpattro for patients with cardiomyopathy related to transthyretin-mediated amyloidosis, there were questions about whether it provided a clinically meaningful benefit. The FDA set an action date of Oct. 8, 2023.
Anticoagulant bridging: Prosthetic heart valves, labeling changes, and limiting issues of liability
September 1st 2002With enoxaparin?s recent labeling change regarding its use in patients with prosthetic valves, clinicians may have several questions about appropriate anticoagulant selection. Specifically, what evidence prompted the labeling change, which patients are affected, what are the options and limitations for bridging patients, what?s the evidence supporting the role of low molecular weight heparins (LMWHs) in bridge therapy, and how can liability be limited should clinicians choose to use LMWH therapy? The authors of this commentary offer their insight on these issues.
Few CHF patients achieve target dosages of beta blockers, risking hospitalizations and death
June 1st 2002Albert Einstein Healthcare Network, Philadelphia-What are the real-world consequences of inadequate beta blocker therapy in patients with congestive heart failure (CHF)? That is what this group of clinicians at Prestige Health-a 50,000 member managed care organization in Philadelphia-set out to determine.
Milrinone for acute exacerbations of CHF: Routine use not recommended
May 1st 2002Ratherthan shortening the hospital stay and improving clinical outcomes, a 48-hour infusion of milrinone was associated with increased early treatment failure-particularly due to the development of arrhythmias and hypotension-in patients hospitalized with acute exacerbations of chronic heart failure (CHF).
Longer is better for thromboembolism prophylaxis after cancer surgery
May 1st 2002Enoxaparin (Lovenox) is typically used during hospitalization after orthopedic or abdominal surgery. Recent studies of its use after orthopedic surgery have shown that extending administration of the low-molecular-weight heparin after hospital discharge significantly reduces the frequency of deep-vein thrombosis (DVT). A new study confirms this is also the case for abdominal surgery for cancer, which carries a high risk of this complication.
No advantage to omapatrilat over enalapril in heart failure . . .
May 1st 2002The investigational vasopeptidase inhibitor omapatrilat is as effective as enalapril in preventing major adverse cardiac outcomes in patients with moderate to severe heart failure, but failed to show superiority, said Milton Packer, MD.
Cardiac events: Losartan beats beta blocker in patients with diabetes,HTN, & LVH
May 1st 2002Therapy starting with the angiotensin receptor blocker (ARB) losartansignificantly reduced the risk of cardiovascular outcomes and new-onsetdiabetes compared with a beta blocker in older high-risk hypertensive patients,said Björn Dahlöf, MD. The improved outcomes with losartan occurredeven after adjusting for small differences in blood pressure reduction betweenthe two study drugs.
Outcomes in ACS: GP IIb/IIIa inhibitor plus LMWH superior to GPs plus unfractionated heparin
May 1st 2002Atlanta-The low-molecular-weight heparin enoxaparin improves outcomes compared with currently recommended therapy in patients with non-ST-segment elevation acute coronary syndromes (ACS) who are being treated with a glycoprotein (GP) IIb/IIIa inhibitor, said Shaun Goodman, MD.
Lercanidipine: A long-acting dihydropyridine calcium channel blocker for treatment of hypertension
May 1st 2002Lercanidipine is currently under FDA review for the management of hypertension. In comparative clinical trials, lercanidipine has shown antihypertensive efficacy comparable to that of slow-release nifedipine, amlodipine, nitrendipine, verapamil, captopril, and atenolol. Its side effect profile is similar or superior to these agents. This Focus article reviews those trials as well as lercanidipine?s pharmacologic properties and addresses the agent?s potential role in patients with comorbid conditions.
Simple physician-prompting intervention drastically improves outcomes in CHD
April 1st 2002Creighton University, Omaha, NE-Despite the evidence that lipid-lowering drug therapy-especially with HMG-CoA reductase inhibitors (statins)-is known to save lives and help prevent subsequent events in coronary heart disease (CHD) patients, utilization of this class of drugs is erratic.
Rosuvastatin: A new HMG0CoA reductase inhibitor for hypercholesterolemia (PDF)
April 1st 2002Rosuvastatin is an investigational HMG-CoA reductase inhibitor expected to gain FDA approval later this year for treatment of hypercholesterolemia. It has significantly exceeded atorvastatin, pravastatin, and simvastatin in reducing LDL cholesterol in clinical trials. This Focus article reviews those trials as well as rosuvastatin's pharmacologic and safety profiles in an effort to delineate its likely role in cholesterol-reducing therapy.
Success of a P & T policy for use of a second ACE inhibitor before switching to an ARB (PDF)
February 1st 2002VA Medical Center, Miami-ACE inhibitor therapy is recognized as the gold standard treatment for congestive heart failure (CHF) as well as diabetic nephropathy due to its effect on the morbidity and mortality associated with these conditions.
Huge meta-analysis refines role of antiplatelet therapy in high-risk patients
February 1st 2002This 287-study meta-analysis aimed to address unanswered questions about antiplatelet therapy in patients at high risk for occlusive vascular events. It yielded several new findings or clarifications, including these: (1) Antiplatelets protect against vascular events in patients with unstable angina, intermittent claudication, and atrial fibrillation. (2) Antiplatelet therapy can be started promptly during acute ischemic stroke and continued long-term. (3) Daily aspirin doses of 75 to 150 mg seem to be as effective as higher doses for long-term treatment.
Study cautions against overtreatment when adopting new NCEP III guidelines
February 1st 2002Clinicians must use caution in adopting newly revised national guidelines for treating elevated cholesterol, concludes a new study from the University of Maryland Pharmaceutical Health Services Research Department.
Success of a P & T policy for use of a second ACE inhibitor before switching to an ARB
February 1st 2002VA Medical Center, Miami-ACE inhibitor therapy is recognized as the gold standard treatment for congestive heart failure (CHF) as well as diabetic nephropathy due to its effect on the morbidity and mortality associated with these conditions.
Automatic interchange of the ACE inhibitors: Decision-making process and initial results (PDF)
January 1st 2002Clinicians at Nebraska Methodist Hospital, a not-for-profit acute care facility, developed and implemented an automatic interchange program for the ACE inhibitor class of drugs. This article presents the ACE inhibitor review upon which the formulary decisions were based as well as the initial clinical and economic results of the interchange program. (This pdf version includes an appendix that was not included in the print issue)
Focus On: Fondaparinux: A novel synthetic antithrombotic for prevention of venous thromboembolism
December 1st 2001Fondaparinux, the first in a new class of antithrombotics that selectively target factor Xa, has been deemed approvable by the FDA for prevention of venous thromboembolism following orthopedic surgery. Four phase III trials have suggested that it may be more effective than enoxaparin in this setting with little to no additional bleeding risk. This Focus review examines data from these trials and others in an effort to sketch out this pending agent's likely therapeutic role.