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A telephone survey investigating comedication rates of aspirin, acetaminophen, or nonaspirin NSAIDs (ibuprofen and naproxen) among long-term cyclooxygenase 2 (COX-2) inhibitor users (at least a 90-day supply of a COX-2 inhibitor) (N=325, mean age 71, 67% female) revealed that 50% used aspirin concurrently despite its apparent GI adverse effects. Aspirin use was higher for those aged ?56 years (50%) than for those aged 37 to 55 years (25%) (P=.03).

The Warfarin/Aspirin Study in Heart Failure provided no evidence that aspirin is effective or safe in heart failure patients.

A study presented on August 25 at the 20th International Conference on Pharmacoepidemiology & Therapeutic Risk Management in Bordeaux, France, revealed that higher-dose rofecoxib (>25 mg/d) was associated with a greater risk of acute myocardial infarction (AMI) and sudden cardiac death (SCD) compared to other NSAIDs. The risk of AMI and SCD was also increased with lower-dose rofecoxib (25 mg/d) when compared with celecoxib. The maximum recommended daily doses of rofecoxib in the management of pain associated with osteoarthritis, rheumatoid arthritis, primary dysmenorrhea, and migraine attacks with or without aura are 25, 25, 50, and 50 mg/d, respectively.

A study presented on August 25 at the 20th International Conference on Pharmacoepidemiology & Therapeutic Risk Management in Bordeaux, France, revealed that higher-dose rofecoxib (>25 mg/d) was associated with a greater risk of acute myocardial infarction (AMI) and sudden cardiac death (SCD) compared to other NSAIDs. The risk of AMI and SCD was also increased with lower-dose rofecoxib (25 mg/d) when compared with celecoxib. The maximum recommended daily doses of rofecoxib in the management of pain associated with osteoarthritis, rheumatoid arthritis, primary dysmenorrhea, and migraine attacks with or without aura are 25, 25, 50, and 50 mg/d, respectively.

Once-daily injections of liraglutide, a long-acting, acylated, glucagon-like peptide 1 analog, have proven to be effective in the treatment of patients with type 2 diabetes.

Investigators in the Trial of Atorvastatin in Rheumatoid Arthritis (TARA) assessed whether statins would reduce inflammatory symptoms in patients with RA. Patients with RA (N=116) were randomized in the double-blind, placebo-controlled trial to receive 40 mg of atorvastatin or placebo in addition to their current disease-modifying antirheumatic drug (DMARD) therapy.

Epilepsy therapy approved for migraine prophylaxis

SSNRI approved for the treatment of major depressive disorder

Current treatment options for acute coronary syndromes as well as chronic stable angina often include the use of percutaneous coronary intervention (PCI) with routine stenting. The clear benefits of stents have lead to their routine use for prevention of restenosis. However, the benefits of stenting demonstrated on some aspects of restenosis are compromised by the induction of restenosis by neointimal hyperplasia that is stimulated by standard bare metal stents. FDA has approved 2 drug-eluting stents (DES). DES create a local delivery system at the vascular site to reduce restenosis by neointimal hyperplasia. Multiple clinical trials have demonstrated the safety and efficacy of the use of DES. This article reviews the use of PCI in coronary artery disease, the evolution and pathophysiology of restenosis, and multiple aspects of DES technology. While DES may not be a direct pharmacy and therapeutics committee responsibility, committee members are being called upon to provide insights into pathway processes for medical technology review committees evaluating DES since these products contain a key pharmacologic component. There are also important adjunctive antiplatelet therapy protocols that need to be developed and adhered to in conjunction with DES in order to ensure optimal outcomes.

Although statins have been shown to reduce LDL-C and coronary heart disease (CHD) morbidity and mortality, it is not uncommon for patients to fail to reach the treatment goals recommended by the National Cholesterol Education Program (NCEP) guidelines. Some statins cannot lower LDL-C sufficiently in FDA-approved doses; other statins cannot be titrated optimally due to potential drug interactions and adverse effects. Ezetimibe/simvastatin(Vytorin, Merck/Schering-Plough) is an intestinal cholesterol absorption inhibitor and statin combination product that received FDA approval in July 2004. The combination has been found to reduce LDL-C and triglycerides by an additional 22% and17%, respectively, and to increase HDL-C by up to 5% compared to statin monotherapy. The 40 mg simvastatin/10 mg ezetimibe dose of the combination product is one of onlya few cholesterol-lowering regimens that can reduce LDL-C >55% and is also one of the most economical. Adding ezetimibe to a statin does not reduce tolerability. Since ezetimibelacks cytochrome P450 isoenzyme interactions, the additional drug interaction risk with combination therapy is low.

Pride, as they say, is difficult to swallow-but it will go down. Love us or hate us, Americans certainly have plenty of self-confidence, so on those occasions when we have to eat our words, it can be quite a feast.

An asset sale by an insurance company or a health maintenance organization typically involves the transfer of a block of business and generally is accomplished by an "assumption" or "portfolio" reinsurance transaction (when risk is transferred from one insurer to another) covering part or all of the seller's existing business.

The Centers for Disease Control and Prevention cites pain as the number one cause of disability in America. It's a widespread, complex affliction that significantly increases healthcare costs and decreases work force productivity. With more than 50 million Americans either partially or completely disabled by pain and nearly two-thirds of full-time workers with painful conditions, health plans and employers now shoulder a greater burden of the pain.

The relationship between providers and payers really hasn’t changed since HIPAA.

MORPHINE, the first and best-known of the opioid analgesics, is a natural substance produced from the opium poppy, papaver somniferum. It's been used to relieve pain since ancient times; Hippocrates prescribed poppy juice as a narcotic. Today many different semisynthetic opioid analgesics are used to relieve moderate to severe pain, but morphine remains the standard of comparison used to describe their effectiveness.

AS AN ANONYMOUS but perceptive comedian once said, "Money talks, but all mine ever says is goodbye." The healthcare industry has been saying the same thing since long before managed care arrived on the scene, so it's no surprise that its less-than-sparkling financial history has led some experts to look for solutions that have nothing to do with economics.

The Administrative Simplification section of HIPAA consists of a trioof regulations that address privacy, transactions and security. Implementationof the final Security Rule and its mandated security practices must be ineffect as of April 20, 2005, for most covered entities. Although the PrivacyRule requires the presence of "adequate safeguards" for ProtectedHealth Information (PHI), the Security Rule details more than 40 separateaudit points within the categories of technical, administrative and physicalsafeguards. While the Security regulation addresses what must be done, itdoes not provide a road map for how to do it.

The decision to seek HR and payroll outsourcing services for SomerfordCorp.'s 13 assisted living facilities was directly related to growth. Theacquisition of a California-based healthcare provider in October, 2001,doubled Somerford's employee population and added six facilities to thecompany, and also increased the complexity of HR management.

In the highest-enrollment states, not only are there higher populations generally, but the population also is more concentrated, and HMOs operated there successfully for longer periods before the anti-managed care movement began to really get legs, according to one expert.

Top 20 States by HMO enrollment

New combinations

Trimming the fat in your business--Obesity costs U.S. companies more than $13 billion a year in medical fees and lost productivity, along with 39 million lost workdays. What can your company do about it? Don't just sit around...

Another activity that will support FDA's e-labeling initiative is the establishment of a "paperless label" system.

Two studies evaluating the efficacy and long-term safety of the inhalable, rapid-acting dry powder insulin formulation (Exubera, Pfizer/Aventis) demonstrate that the drug was able to sustain glycemic control and pulmonary function in patients with type 2 diabetes

Etanercept/anakinra combination therapy for the treatment of rheumatoid arthritis (RA) provides no added benefit and has an increased risk compared to etanercept alone, according to a study published in Arthritis & Rheumatism, the journal of the American College of Rheumatology (ACR).

Four commonly prescribed antidepressants carry an equal risk of quadrupling the chance of suicidal behavior during the first 9 days of treatment, according to a study from the United Kingdom published in the Journal of the American Medical Association. The authors cautioned, however, that the risk is likely only temporary and may be attributed to the time period in which the drugs have not yet taken effect in those patients already considering suicide.

FDA's paperless e-labeling initiative will allow manufacturers to transmit labeling information electronically to prescribers, pharmacists, and patients.

Although the mechanism of action of imiquimod is unknown, an open-label study suggests that the drug may act by increasing the filtration of lymphocytes, dendritic cells, and macrophages into the tumor lesion. Imiquimod was approved on July 14, 2004, for an expanded indication to include the treatment of biopsy-confirmed, primary superficial basal cell carcinoma (sBCC) in immunocompetent adults.

A newly released update to the National Cholesterol Education Program's (NCEP) guidelines on cholesterol management recommend that clinicians consider more intensive treatment options for patients at high and moderately high risk for heart attack. These evidence-based recommendations include setting lower treatment goals for low-density lipoprotein cholesterol (LDL-C) and initiating cholesterol-lowering drug therapy at lower LDL thresholds.

Although warfarin is an effective drug in the treatment and prevention of thromboembolism, dosing complexities and drug interactions have led to its underutilization and a desire for an alternative agent. Ximelagatran (Exanta, AstraZeneca) is a novel oral anticoagulant that can be taken in standardized doses without the use of periodic blood monitoring to determine the level of anticoagulation. Large prospective clinical trials have shown ximelagatran to be similar in efficacy compared to the standard of therapy in the prevention and treatment of thromboembolism with similar or lower rates of bleed. Of concern, however, is the fact that that ximelagatran may elevate hepatic enzymes. An NDA was filed for ximelagatran on December 23, 2003, and FDA’s Cardiovascular and Renal Drugs Advisory Committee is scheduled to review the drug for the prevention of stroke and thromboembolism at a meeting on September 10, 2004. This article reviews ximelagatran’s chemistry and pharmacology, pharmacokinetics, clinical trials, adverse effects, drug interactions, and dosage and administration.