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Primer on new medications offered at ACP Internal Medicine Meeting

SAN DIEGO — The limited number of new medications that would impact primary care that were approved in 2016 included agents intended for the treatment of asthma and gout, and drugs to be taken in combination with previously approved medications for hyperkalemia and bleeding risk, according to a speaker at the ACP Internal Medicine Meeting.

Gerald W. Smetana, MD, MACP, division of general medicine, Beth Israel Deaconess Medical Center and professor, Harvard University, focused his discussion on novel drugs relevant to primary care physicians that were not “me too” agents.

“Last year was a little disappointing in terms finding drugs that meet this criteria,” Smetana said.

Mepolizumab

Morbidity rates for asthma have not seen much improvement over the past 15 years, opening a window of opportunity for a medication that could help these patients.

“Existing therapy [for asthma] is imperfect,” Smetana said. “There was a potential for a new drug that could change our practice.”

Mepolizumab is designed for severe eosinophilic asthma and though some patients who took it experienced adverse events such as rare hypersensitivity and infusion reactions, the injectable drug reduced exacerbations by half and reduced the requirement for a corticosteroid, he said. The FDA approved dose is 100 mg subcutaneously every 4 weeks.

With a single dose costing approximately $2,700 a month, Smetana expressed concerns about how many people may actually benefit from it.

“Clearly the prior authorization process is going to be cumbersome on this one,” he said. “There will be significant barriers in getting this prescribed.”

Patiromer

“An advantage to [patriromer] is that it might allow continuation of angiotensin-converting enzyme inhibitors and angiotensin receptor blockers in patients with chronic kidney disease if there’s a compelling reason for that,” Smetana said.

The powdered medication is intended for non-life threatening hyperkalemia and should be taken in doses of 8.4 to 25.2 grams either 6 hours before or 6 hours after other medications to avoid interfering with the absorption of those drugs. The agent costs $595 for 30 packets.

Smetana said patriromer should not be taken if the patient has ileus after an operation, bowel obstruction or severe constipation, and added that adverse events were mostly minor and included hypersensitivity reactions, flatulence, abdominal discomfort, nausea, diarrhea, hypokalemia, hypomagnesemia and constipation.

Lesinurad

This drug lowers uric acid levels in patients with gout and is intended for patients who cannot achieve target levels on allopurinol alone, according to Smetana. Patients take a 200 mg dose of the drug once daily, and its average wholesale price is $350.

In combination with allopurinol, lesinurad was shown to lower gout levels more than allopurinol alone, reducing the number of gout attacks and reducing the burden of tophi in affected patients. According to Smetana, the pill should not be taken by patients with estimated glomerular filtration rates of less than 40 mL/min/1.73 m², and has a black box warning that indicates it should not be used as a monotherapy without allopurinol because of the potential for acute kidney injury.

Smetana added that lesinurad caused hypertension, headaches, myalgia and dizziness, as well as mild to moderate increases in creatinine levels, but otherwise was generally well tolerated.

Idarucizumab

This medication is intended to reverse the anticoagulation effects of dabigatran in patients who must undergo emergency or urgent surgery or similar procedure, particularly in those with life-threatening or uncontrolled bleeding, Smetana said.

Some clinicians and patients had been reluctant to use dabigatran because of the lack of lack of a reversal agent, and idarucizumab now addresses that limitation by achieving near complete reversal within minutes of infusion. Although primary care clinicians are unlikely to prescribe this agent, it is important for them to be able to discuss it with patients concerned about the lack of a reversal agent, Smetana told Healio Family Medicine.

This IV medicationcosts $3,500 a dose and represents a departure from the standard FDA approval process, he said.

“[Idarucizumab] was approved on an accelerated basis because of the opportunity to save lives with this treatment. The FDA took the unusual step of approving it while the trials were still ongoing.”

Smetana encouraged primary care physicians to search ‘new drug’ on the FDA’s website to get more information about the medications he discussed, as to remain up to date as other agents are approved. – by Janel Miller

Reference:

Smetana, GW. Session MTP 010. Presented at: ACP Internal Medicine Meeting; March 29-April 1, 2017; San Diego.

Disclosure: Smetana reports no relevant financial disclosures prior to publication.