Fixed-dose combination amlodipine–celecoxib for treatment of hypertension and osteoarthritis pain: an up-to-date evaluation

ABSTRACT

Introduction: A fixed-dose combination of amlodipine and celecoxib, branded in the USA as Consensi®, was recently granted a US Food and Drug Administration (FDA)-approved indication for treatment of comorbid hypertension and osteoarthritis.

Areas covered: A PubMed and Medline search was conducted for clinical trials published through December 2020 in the English language using keywords amlodipine, celecoxib, combination product, consensi, hypertension, osteoarthritis, and pill burden. Although no clinical trials have been published in the peer-reviewed literature, results from two phase 3 clinical trials reported to ClinicalTrials.gov suggest that amlodipine–celecoxib has similar short-term efficacy compared with amlodipine alone in reducing blood pressure and a comparable adverse event profile to the individual components administered alone.

Expert opinion: Despite the pill burden reduction and a body of evidence supporting the efficacy and safety of the individual drugs, the role of amlodipine–celecoxib in the management of patients with hypertension–osteoarthritis remains in question. This is in no small part because the combination product is very costly relative to the generic components, provides limited flexibility for dose-adjustment, and lacks long-term data on safety and efficacy.

KEYWORDS:

• Amlodipine
• celecoxib
• combination product
• Consensi
• hypertension
• osteoarthritis
• pill burden

Article highlight

• Consensi (amlodipine/celecoxib) is a fixed-dose combination product indicated for treatment of comorbid hypertension and osteoarthritis

• Based on limited data from short-term trials, efficacy and safety parameters of Consensi (amlodipine/celecoxib) appear similar to those of the individual agents

• Combination pills can reduce medication regimen complexity and improve adherence, but do not allow for flexible dosing, a potentially problematic issue for medications that treat osteoarthritic pain

• The cost of Consensi (amlodipine/celecoxib), approximately 15-20 times that of the generic components combined, may be prohibitive for many patients

Declaration of interest

S. Smith’s research in hypertension is funded by the National Health, Lung and Blood Institute and the Patient-Centered Outcomes Research Institute. However, this is not related to the topic of this manuscript. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer Disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This manuscript has not been funded.