PHARMACY

Study: Dapagliflozin added to existing glimepiride therapy helps Type 2 diabetics reduce blood-glucose levels

BY Allison Cerra

DUBAI — A study conducted by Bristol-Myers Squibb and AstraZeneca found that adding an investigational compound to an existing Type 2 diabetes treatment may help reduce blood-glucose levels among patients.

The drug makers said that in its phase-3 study — which was conducted over a 24-week period and consisted of 592 adults (ages 18 years and older) with Type 2 diabetes — a mean change in blood-glucose levels was recorded in patients that had dapagliflozin (2.5 mg, 5 mg or 10 mg per day) added to their glimepiride (4 mg/day) therapy, compared with placebo added to glimepiride. The study period then was extended by an additional 24 weeks — 519 of 546 patients initially enrolled completed the extension — to measure the efficacy of dapagliflozin over a longer period of time. Bristol and AstraZeneca found that in addition to maintaining reductions in blood-sugar levels, the 48-week study reported that patients taking dapagliflozin added to glimepiride maintained reductions in fasting plasma glucose levels, post-prandial glucose and total body weight.

The data were presented at the International Diabetes Federation 2011 World Diabetes Congress in Dubai last week.

“Given that patients with Type 2 diabetes often need multiple therapies to help manage blood-sugar levels over the course of this progressive disease, it is important to assess the ability of new compounds to work in combination with commonly prescribed anti-diabetic treatments,” said Krzysztof Strojek of the department of internal diseases, diabetology and nephrology at Silesian Medical University (Poland). “This study demonstrated that the addition of dapagliflozin to existing glimepiride therapy maintained reductions in blood-sugar levels over 48 weeks.”

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PHARMACY

NACDS aims to set record straight regarding PBM testimony at Senate hearing

BY Michael Johnsen

ALEXANDRIA, Va. — The National Association of Chain Drug Stores on Wednesday challenged some of Express Scripts’ and Medco’s testimony during last week’s hearing before the Senate Judiciary Subcommittee on Antitrust, Competition Policy and Consumer Rights, most notably that PBMs are subject to state regulation in all states and that as a PBM the two companies have no influence on the design of prescription drug benefits.

In comments submitted to subcommittee chair Sen. Herb Kohl, D-Wis., NACDS president and CEO Steve Anderson emphasized ways in which the PBM executives attempted to downplay the potentially harmful impact of the proposed merger.

“We believe that these witnesses obfuscated facts in an effort to portray their companies in a better light, downplaying many of their companies’ objectionable activities that would certainly worsen if the two companies were allowed to merge,” he noted.

According to the retail pharmacy association, PBMs have successfully opposed overall efforts at state regulation, leaving only a "couple of states" and "the regulation in those states is weak, at best."

As to assertions made by Express Scripts CEO George Paz and Medco CEO David Snow on their lack of control over the design of prescription drug benefits, Anderson countered, "PBMs design the benefit plans and determine the costs. Because of that, it is our view PBMs steer the health plans and employers toward the items they most want to sell," such as mail order or pharmaceutical brands with large rebates.

Express Scripts and Medco executives also made the case that the number of retail pharmacies continues to rise. "Actually, the number of pharmacies is shrinking relative to the number of prescriptions filled by retail pharmacies," Anderson noted. "In 2000, there were about 19 pharmacies for every one million prescriptions, but by 2010, there were only about 16 pharmacies per one million prescriptions."

And Anderson questioned several other areas of concern based on Paz’s and Snow’s comments, including the level of savings that PBMs actually achieve and transparency regarding rebates and discounts from manufacturers. This point has taken on tremendous significance amid the controversy surrounding the merger, as consumer groups and elected officials alike have voiced concern and skepticism that a new mega-PBM would pass along any purported savings to consumers, employers and health plans.

“If this merger is allowed to proceed, patients will be faced with reduced access to retail pharmacies and pharmacy services as the combined entity shifts patients to mail order and dominates specialty pharmacy,” Anderson reiterated. “We believe that you should consider the testimony of Mr. Paz and Mr. Snow as illustrative of how their respective companies presently conduct themselves, which would only be exacerbated by a merger.”

A copy of the NACDS comments for the record can be found here.

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FDA advisory committee recommends approval for schizophrenia, bipolar disorder drug

BY Alaric DeArment

MOUNTAIN VIEW, Calif. — A Food and Drug Administration panel has voted to recommend approval for a psychiatric drug made by Alexza Pharmaceuticals.

Alexza said the FDA’s Pychopharmalogic Drugs Advisory Committee voted 9-8 with one abstention to recommend approval of Adasuve (loxapine) for treating agitation in patients with schizophrenia and bipolar mania. The drug is administeredusing Alexza’s proprietary Staccato inhaler technology. The FDA plans to decide whether or not to approve the drug in February. While the agency takes advisory committee recommendations into account when deciding whether to approve a drug, it is not bound by them but will usually follow them nonetheless.

"We view the recommendations by the PDAC today as another step forward in the development of Adasuve," Alexza president and CEO Thomas King said. "We appreciate the advisory committee’s recognition of agitation as a serious and underappreciated symptom of schizophrenia and bipolar disorder."

More than 90% of patients with the disorders experience agitation, which starts with patients feeling uncomfortable, tense and reckless and can escalate into potentially violent behavior.


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