PHARMACY

Study: Pirfenidone may improve lung function among IPF patients

BY Alaric DeArment

BRISBANE, Calif. — An investigational drug made by InterMune improved breathing in patients with a rare and fatal lung disease, according to results of a late-stage clinical trial published online in The Lancet last week.

InterMune is investigating the drug pirfenidone as a treatment for idiopathic pulmonary fibrosis, which affects more than 200,000 patients in the European Union and the United States combined. Only 20% of patients with IPF survive after five years.

“These newly published data document the favorable risk-benefit profile of pirfenidone in patients with IPF, consistent with the recent approval by the European Medicines Agency of pirfenidone for these patients,” lead study author and Duke University professor of medicine Paul Noble said. “Although the results of Study 004 and 006 were not identical, and only Study 004 achieved the primary endpoint, the totality of the data provides compelling evidence of a clinically meaningful treatment effect of pirfenidone, together with a favorable safety profile of patients with IPF.”

Trial results showed that the drug reduced the decline in patients’ forced vital capacity, or FVC, an important measure of lung function, compared with placebo, and also reduced the decline in the distance patients could walk in six minutes, another measure of lung function.

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MinuteClinic announces discounted camp, sports physicals

BY Antoinette Alexander

WOONSOCKET, R.I. — CVS Caremark’s MinuteClinic is looking to make it easier and more affordable for campers to get the physicals they need in order to participate in activities by offering discounts on camp and sports physicals through July 31.

Now through July 31, camp and sports physicals at MinuteClinic are $39, a $20 savings off the standard price of $59. The pre-participation physicals are offered seven days a week, including weekday evening hours, at MinuteClinic locations across the country. No appointment is necessary. An additional $5 savings is available when camp leaders complete an online enrollment form and register their group or team of 12 or more.

"Camper health and safety starts at home, which is why many camps require a pre-participation physical," stated Paulette Thabault, MinuteClinic chief nurse practitioner officer. "So it’s important for parents to be aware of camp health requirements and to obtain a physical in May or June before the kids’ bags are packed."

During a camp physical, MinuteClinic family nurse practitioners or physician assistants measure height and weight, review health and immunization history, perform a simple exam, help with any required registration paperwork and provide safety and education tips. Once a camper is cleared to participate in activities, the practitioner stamps any required forms and references the results provided on the official patient summary. Copies of the summary can be transmitted by electronic record, fax or mail to a primary care provider with patient permission. This typically occurs within 24 hours. Thabault added that pre-participation physicals should not replace an annual wellness visit with a primary care provider.

Insurance is not accepted for any pre-participation physical exams. Payment is due at the time of the visit (additional lab charges may apply), according to MinuteClinic. Requirements for physicals vary by state.

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FDA advisory committee to discuss safety, efficacy of Trilipix

BY Alaric DeArment

SILVER SPRING, Md. — A Food and Drug Administration panel will discuss findings in a clinical trial that has raised concerns about the safety and efficacy of Abbott’s cholesterol-lowering drug when it’s combined with similar drugs, according to an FDA announcement.

The FDA Endocrinologic and Metabolic Drugs Advisory Committee will discuss results of the “ACCORD Lipid” study, which examined Abbott’s drug Trilipix (fenofibric acid) delayed-release capsules, which belongs to the drug class known as fibrates, in combination with the drug simvastatin in patients with Type 2 diabetes.

According to the announcement, the trial found no significant difference between patients treated with Trilipix and simvastatin vs. placebo and simvastatin in terms of the proportion that experienced heart attacks. In addition, an analysis of female patients found that those who took Trilipix and simvastatin experienced more heart attacks than those in the placebo group, but the announcement stated that the clinical significance of the finding was unclear.

The committee will vote on whether to maintain the drug’s approval for use with a statin, change the labeling to include information from the study or withdraw the approval. FDA advisory committee rulings are not considered binding, but the FDA takes them into consideration and usually follows them.

“We believe that the body of evidence clearly supports the use of fibrate treatment in appropriate patients … and that the data from ‘ACCORD Lipid’ is supportive of the indication for co-administration with a statin,” Abbott spokeswoman Elizabeth Hoff told Drug Store News.

Trilipix also is approved for use as a stand-alone therapy.

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