Formulary Watch |

California court: Wyeth accountable for harms caused by generic metoclopramide

On November 7, the First District Court of Appeal in San Francisco, California, overturned a previous ruling in the case of Conte v Wyeth and ruled that Wyeth, the manufacturer of Reglan (metoclopramide), should be held responsible for harm caused to Elizabeth Conte, who developed tardive dyskinesia after taking generic metoclopramide for nearly 4 years. The court upheld the previous ruling in favor of Purepac, Pliva, and Teva, manufacturers of generic metoclopramide.

Pneumonia mortality rates lower for statin users

In a large, population-based cohort study published in the Archives of Internal Medicine, current use of statins by patients hospitalized with pneumonia was associated with a decreased risk of death after hospital admission compared with nonusers of statins.

Metformin moderately protective against CV risk in type 2 diabetics

Compared with biguanides, thiazolidinediones, meglitinides, and second-generation sulfonylureas, metformin is the sole oral therapy associated with a decreased risk of cardiovascular (CV) mortality in patients with type 2 diabetes, according to a meta-analysis published in the Archives of Internal Medicine.

Diabetes treatment becoming more complex, more expensive

In a survey of trends in diabetes treatment from 1994 to 2007, investigators observed an increasing incidence of diabetes, a greater variety of drugs and combinations available for treatment, and a marked increase in the annual cost of diabetes medications.

Pre-emption case of Wyeth v Levine in hands of US Supreme Court

On November 3, the US Supreme Court heard arguments in the case of Wyeth v Levine; the ultimate decision of the Court on this case may set a precedent on the issue of pre-emption, a tenet that FDA actions regarding drug approvals and medication safety supersede state laws.

Conflicts of interest under investigation as policies begin to change

Development of rimonabant and CP-945,598 for obesity is discontinued

One month after Merck announced that the company was discontinuing development of taranabant, an investigational selective blocker of the cannabinoid-1 (CB-1) receptor that was being studied for the treatment of obesity, Sanofi-Aventis and Pfizer announced that they were also halting the development of their investigational CB-1 receptor antagonists (rimonabant and CP-945,598, respectively).

Conte v Wyeth: Name-brand drug maker accountable for alleged harm caused by generic drug

On November 7, 2008, a California Intermediate Appellate Court in San Francisco held that the "common-law duty [of Wyeth] to use due care in formulating its product warnings extends to patients whose doctors foreseeably rely on its product information when prescribing metoclopramide, whether the prescription is written for and/or filled with Reglan or its generic equivalent."

Development of atacicept for lupus in patients with SLE is discontinued

A phase 2/3 trial of atacicept in combination with mycophenolate mofetil and corticosteroids for the treatment of lupus nephritis in patients with systemic lupus erythematosus has been discontinued.

Microalbuminuria associated with development and progression of coronary calcium

New Orleans-Subjects without symptoms of heart disease who have microalbuminuria are more likely to have coronary artery calcium and are more likely to have progression of coronary artery calcium over time than those without microalbuminuria, says Andrew P. DeFilippis, MD.

New stent entices progenitor cells, has low rate of thrombosis

New Orleans-A new type of stent coated with an antibody that binds circulating endothelial progenitor cells (EPCs) is associated with a low rate of stent thrombosis and requires only 1 month of dual antiplatelet therapy. Drug-eluting stents require at least 6 months of dual antiplatelet therapy to reduce the risk of stent thrombosis.

Studies assess decisions to seek care among patients with chest pain

New Orleans-Early reperfusion is crucial to maintaining cardiac myocytes in patients suffering a heart attack yet many patients refuse to seek medical care until hours after symptom onset, if at all.

ARB ineffective in HF with preserved ejection fraction

New Orleans-The use of irbesartan for heart failure with preserved ejection fraction (HFPEF) failed to improve outcomes compared to placebo, says Barry Massie, MD, investigator for the Irbesartan in Heart Failure with Preserved EF (I-PRESERVE) trial. These results are consistent with two previous trials (CHARM PRESERVED, PEP-CHF) that failed to show a positive effect with an angiotensin-receptor blocker (ARB) for these patients, explains Dr. Massie, University of California, San Francisco.

Exercise may be the prescription for heart failure

New Orleans-An aerobic exercise program modestly reduces death and hospitalization in patients with chronic heart failure, according to results from a study funded by the National Heart, Lung, and Blood Institute.

‘Vascular age’ of obese children similar to that of middle-aged men

New Orleans-Obese children, particularly those with elevated triglycerides, have a “vascular age” similar to those of 45-year-old white men, says Geetha Raghuveer, MD, University of Missouri-Kansas City School of Medicine. “I think this is a wake up call,” she says. “These children may need intensive management including pharmacological management of risk factors.

MR-proADM strong short-term prognosticator of mortality in heart failure

New Orleans-Mid-regional pro-adrenomedullin (MR-proADM) is a better biomarker for predicting short-term mortality in patients presenting with shortness of breath who are diagnosed with heart failure, according to results of the Biomarkers in the Assessment of Congestive Heart Failure (BACH) trial. Use of this marker was significantly more accurate than brain natriuretic peptide (BNP) or N-terminal prohormone BNP (NT-proBNP) in detecting which heart failure patients were likely to die.

Stratification beyond Framingham criteria is possible using coronary calcium score

Precisely defining intermediate cardiovascular-event risk using the Framingham Risk Score (FRS) is a challenge for clinicians. This is magnified when one considers that the number of patients who fall under the intermediate risk category outnumbers those considered low or high risk.

Electronic health records alone don’t improve care in heart failure

By itself, use of electronic health records (EHRs) does not improve the quality of care for heart failure, says Mary Norine Walsh, MD.

New anticoagulant is promising in treatment of ACS

An investigational oral anticoagulant-the factor Xa inhibitor rivaroxaban-performed well enough in a Phase II study in patients with acute coronary syndromes (ACS) to support a pivotal Phase III trial in patients with ACS, reports C. Michael Gibson, MD.

Anticoagulation can be maintained during invasive procedures

A patient on chronic warfarin is scheduled for a pacemaker implantation, so naturally you discontinue the warfarin several days prior to the procedure to reduce the chance of bleeding. That may not be necessary, says Peter H. Belott, MD, who contends that “we can keep the patient [at a] therapeutic INR [international normalized ratio] and will not incur any deleterious effects.”

Drug-eluting stents show increased safety in diabetics

Drug-eluting stents (DES) were associated with decreased rates of death, myocardial infarction (MI), and revascularization at 3 years of follow up in diabetic patients compared to bare-metal stents (BMS), according to results of a large observational study. “Our primary concern was to look at safety,” says Laura Mauri, MD (pictured) Brigham and Women’s Hospital and Harvard Medical School, Boston. “Considering the safety concerns surrounding DES recently, it was to our surprise that we found a significant difference in the opposite direction.

Lack of sleep associated with increased heart disease risk in elderly hypertensive patients

Getting less than 7.5 hours of sleep daily is a predictor of incident cardiovascular disease in elderly patients with hypertension, reports Kazuo Eguchi, MD, Jichi Medical University, Tochigi, Japan. “Reflecting changing lifestyles, people are sleeping less in modern societies,” he says.

Race affects hospitalization rates for AF in the United States

African Americans are half as likely to be hospitalized for atrial fibrillation (AF) as whites, according to Paul Tabereaux, MD, MPH, and colleagues.

Transition from pediatric to adult cardiac care should start early

The process of transitioning pediatric cardiology patients into adult cardiac care should begin in late childhood or early adolescence, says Arwa Saidi, MD (pictured) department of internal medicine and pediatric cardiology, University of Florida. The 2008 American College of Cardiology/American Heart Association guidelines recommend preparing young people for the transition beginning at age 12.

Human heart valve grown from stem cells offers hope for prenatal infants with defects

Researchers have successfully used umbilical cord stem cells to build a functional heart valve that may someday be perfected so that infants born with valve abnormalities could receive a new valve derived from their own stem cells, reports Philipp Schaefermeier, MD, University Hospital of Munich, Germany.

Resistant hypertension is multifactorial in etiology, requires combinations of drugs

A coalescence of factors usually conspires to cause resistant hypertension, which is defined as the failure to reach goal blood pressure in patients adhering to full doses of an appropriate three-drug antihypertensive treatment regimen, says Domenic Sica, MD.

No effect of B vitamins on vascular risk

The final nail has been driven into the homocysteine-lowering coffin as a means to prevent recurrent coronary events. The results from the homocysteine-lowering arm of the SEARCH (Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine) trial found no benefit to folic acid combined with vitamin B12

Mixed results with low-dose aspirin as primary prevention of vascular events in type 2 diabetes

Low-dose aspirin did not result in a significant reduction in first atherosclerotic events in patients with type 2 diabetes, reports Hisao Ogawa, MD, PhD (pictured), lead investigator of the Japanese Primary Prevention of Atherosclerosis with Aspirin for Diabetes (JPAD) trial.

Vitamin E and C show no cardiovascular benefit; vitamin E associated with increased hemorrhagic stroke

Neither vitamin C nor vitamin E is effective for primary prevention of cardiovascular events in men, according to results of the Physician’s Health Study II, which evaluated the risk and benefits of both vitamins as well as a multivitamin in preventing cardiovascular disease and cancer. Results relating to cancer prevention will be presented November 17 at the Frontiers in Cancer Prevention Research conference.

JUPITER: Rosuvastatin reduces events in patients without hyperlipidemia but with elevated hsCRP

Rosuvastatin treatment of patients with better than average lipid profiles but with elevated high-sensitivity C-reactive protein (hsCRP) resulted in a 44% relative risk reduction in cardiovascular events and a 20% reduction in all-cause mortality, reports Paul Ridker, MD (pictured), lead investigator for the JUPITER Trial Study Group. JUPITER was an investigator-initiated trial sponsored by AstraZeneca.