Amlodipine & Celecoxib Combo Pill Approved for Patients with Hypertension and Arthritis | FDA

The US FDA has approved an amlodipine besylate and celecoxib combination pill (Consensi®, Kitov) for the treatment of patients with hypertension and osteoarthritis-related pain.

Amlodipine & Celecoxib Combination Pill

  • Amlodipine besylate – calcium channel blocker, antihypertensive
  • Celecoxib – COX-2 inhibitor, non-steroidal anti-inflammatory agent (NSAID)
  • Three dosages approved (200 mg of celecoxib; 2.5, 5, or 10 mg amlodipine) PO QD
  • Combination therapy appears to lower serum creatinine (amlodipine/celecoxib monotherapy do not)
  • NSAIDs increase risk of potentially fatal cardio/cerebrovascular events and GI bleeding
  • Adverse events (common):  headache, edema, GI distress, URI, fatigue
  • Adverse events (severe): GI ulceration/perforation, hypersensitivity reactions, MI/stroke
  • Contraindications: peri-CABG or NSAID/sulfonamide sensitivity
  • Cost likely to be significantly higher than individual prescription of generics

Evidence

  • Phase III (antihypertensive efficacy) & Phase III/IV (renoprotective efficacy) clinical trials; data not published
  • Amlodipine approved since 1990, celecoxib approved since 1998 as individual drugs

What is Comorbid Hypertension and Osteoarthritis?

Over 50 million Americans suffer from osteoarthritis and approximately 1/3 U.S. adults (75 million people) have high blood pressure.  A large number of people are estimated to have simultaneous osteoarthritis and hypertension.

What is combination amlodipine and celecoxib?

Amlodipine besylate is a calcium-channel blocker with anti-hypertensive properties.  It works by inhibiting vascular L-type calcium channels (CaV1.2), resulting in smooth muscle relaxation and decreased systemic vascular resistance.  Celecoxib is a non-steroidal anti-inflammatory agent commonly prescribed for pain associated with arthritis.  It works by selectively inhibiting the cyclooxygenase-2 enzyme, avoiding some of the GI toxicity observed with COX-1/COX-2 non-selective NSAIDS.

References

1. Kitov Pharma Ltd. FDA Approves Kitov’s Consensi™ for Treatment of Osteoarthritis Pain and Hypertension. GlobeNewswire News Room. https://globenewswire.com/news-release/2018/05/31/1515108/0/en/FDA-Approves-Kitov-s-Consensi-for-Treatment-of-Osteoarthritis-Pain-and-Hypertension.html. Published May 31, 2018. Accessed June 4, 2018.

2. Consensi (amlodipine/celecoxib) dosing, indications, interactions, adverse effects, and more. Medscape Drugs & Diseases – Comprehensive peer-reviewed medical condition, surgery, and clinical procedure articles with symptoms, diagnosis, staging, treatment, drugs and medications, prognosis, follow-up, and pictures. https://reference.medscape.com/drug/consensi-amlodipine-celecoxib-1000251#0. Published June 1, 2018. Accessed June 4, 2018.

 

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