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
- 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.
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.