FDA OKs Consensi for Osteoarthritis Pain and Hypertension

The US Food and Drug Administration (FDA) yesterday approved a combination of amlodipine besylate and the nonsteroidal anti-inflammatory drug (NSAID) celecoxib (Consensi, Kitov Pharma) for individuals with osteoarthritis pain and hypertension.

The company says that although celecoxib —  a cyclooxygenase 2 inhibitor — does not reduce blood pressure when given alone, it appears to act synergistically with the antihypertensive calcium channel blocker amlodipine besylate to enhance amlodipine besylate's blood pressure–lowering ability.

"Consensi provides a safe and effective combination treatment option for the millions of Americans who suffer from osteoarthritis pain and hypertension," J. Paul Waymack, MD, ScD, chairman of Kitov's board and chief medical officer, said in a company news release.

Amlodipine and celecoxib are already approved individually by the FDA.

The combo will be available in three dosage forms, in line with the currently approved dosages of both drugs. Each will have 200 mg of celecoxib; however, the dosages of amlodipine besylate will be 2.5, 5, and 10 mg. Consensi is intended to be taken once daily.

"Over 50 million Americans suffer from osteoarthritis. About 1 of 3 U.S. adults or about 75 million people have high blood pressure, known as the 'silent killer' due to the absence of noticeable symptoms. As a result, patients' adherence to the hypertension treatment regimen is low. We believe that Consensi, as a single pill combination treatment for osteoarthritis and hypertension, presents a unique value proposition of potentially increasing treatment adherence," Isaac Israel, chief executive officer, Kitov, said in the news release.

The approval follows the FDA's consideration of data from a phase 3 clinical trial that met its primary endpoint of demonstrating that the combination medication lowers daytime systolic blood pressure by 50% or more of that achieved in patients who took amlodipine besylate only (P = .001).

The company also reported results from its randomized, double-blind, placebo-controlled renal function phase 3/4 trial, which it claims validated the primary efficacy endpoint met in the phase 3 clinical trial. Patients who took the combination pill experienced a statistically significant reduction of serum creatinine from its value at baseline (P = .0005). The reduction of serum creatinine shows the medication improves renal function, the researchers say. Serum creatinine did not significantly decrease in those who received either amlodipine besylate alone or placebo.

Source: Medscape

Podcast: Professor Giuseppe Mancia talks about the role of beta-blockers in the overall treatment of hypertension

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Is the new BP guideline good for Asians?

Whether the 2017 ACC/AHA* blood pressure (BP) guidelines should be adopted in Asian countries was the topic of a much-anticipated discussion here at the Asian Pacific Society of Cardiology (APSC) Congress 2018 in Taiwan last week.

With the release of the new BP guideline, more people are immediately labelled as “hypertensive” since the BP threshold for hypertension diagnosis has been lowered to ≥130/80 mm Hg, said Professor Peera Buranakitjaroen from Siriraj Hospital in Bangkok, Thailand. “In the US for example, the number of hypertensive patients increased from 32 percent to 48 percent [with the new BP definition].” [APSC 2018, session S022-03]

In addition, those with a systolic BP of 140 mm Hg, previously the hypertension diagnostic cut-off in the JNC7 guideline, are now considered as having stage 2 hypertension under the new classification. The new BP threshold for drug treatment of hypertension is also lower now, noted Buranakitjaroen. [J Am Coll Cardiol 2018;71:2199-2269]

However, implementing the new BP guideline will bring about some issues. With more people being labelled as hypertensive and requiring treatment, more drugs are needed to further lower their BP, according to Buranakitjaroen.

Also, many more elderly will have serious adverse events (SAEs) from intensive BP lowering, since certain conditions that predispose one to develop SAEs are also more common in the elderly, including comorbidites (such as stroke, chronic kidney disease, and coronary artery disease), white coat effect, autonomic nervous system dysfunction, pill burden, and frailty.

“Huge budget will be needed to cope with such demand [from implementation of the new guidelines], while we have not [yet] done well in terms of prevention, early detection, and treatment of hypertension including BP control to target using the present guidelines,” said Buranakitjaroen.

“[Therefore,] the 2017 ACC/AHA guidelines should not be adopted immediately in Asian countries. While we await more clinical data, our limited resources should be used efficiently to improve the rate of awareness, detection, and treatment to target BP across the country using our own guidelines,” he stated.

As of present, the recommended BP threshold for hypertension diagnosis remains at <140/90 mm Hg in the national guideline by Thai Hypertension Society, except for certain subgroups of population, according to Buranakitjaroen. Subgroups which are exceptions to the rule include very elderly patients (age >80 years) who are recommended a BP threshold of <150/90 mm Hg; nonelderly patients (age <50 years), BP <130/80 mm Hg; and CKD patients with micro- and macro-albuminuria, BP <130/80 mm Hg.

Noting that less than 2 percent of the study population in SPRINT** — which the 2017 ACC/AHA BP guidelines are largely based on — are Asians, to project the guideline on the Asian population in the absence of data presents a unique challenge, commented Dr Eugene Yang of the University of Washington, Seattle, Washington, US, who is also a member of the ACC Cardiovascular Prevention Council and Official Reviewer for the new BP guideline.

When asked about how the Asian communities tackle the issue and derive the guidelines for their respective countries, Buranakitjaroen said the current national Thai recommendations are based on consensus expert opinion from different subspecialties.

“In the Philippines, we are creating a position statement on the 2017 BP guidelines,” added Session Chair Dr Jorge Sison of Makati Medical Center, Manila, the Philippines. He explained that in real-world clinical practice in the country, BP readings are mostly based on office BP measurement, although they are also beginning to emphasize on home BP monitoring now. As such, the position statement emphasizes two levels of recommendations — a threshold of 140/90 mm Hg for office BP and 130/80 mm Hg for home BP monitoring.

*ACC/AHA: American College of Cardiology and the American Heart Association
**SPRINT: Systolic PRessure INtervention Trial

Source: MIMS