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

Introduction: A fixed-dose combination of amlodipine and celecoxib, branded in the USA as Consensi (R), 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.