Author + information
- Jack Ishak,
- Michael Rael,
- Henry Punzi,
- Alan Gradman,
- Lynn M. Anderson,
- Mehul D. Patel,
- Sanjida Ali,
- William Ferguson and
- Joel Neutel
Background: The single-pill combination (SPC) comprising nebivolol (5 mg), a vasodilatory β1-selective antagonist/ β3 agonist, and valsartan (80 mg), an angiotensin receptor blocker, is the only FDA-approved β-blocker/renin-angiotensin-aldosterone system (RAAS) inhibitor SPC for hypertension. Additive effects of nebivolol/valsartan SPCs were compared with other antihypertensive SPCs.
Methods: Data from 5 FDA-approved, non-β-blocker/RAAS inhibitor SPCs were abstracted from Drugs@FDA; data for 4 nebivolol/valsartan SPCs (nebivolol 5 mg/valsartan 80 mg, 5/160, 10/160, 10/320) came from a published Phase 3 trial. Additivity for all SPCs is the ratio of placebo-adjusted SPC BP reduction to the sum of placebo-adjusted monotherapy component BP reductions. A weighted average of comparator scores was also quantified and compared vs nebivolol/valsartan SPCs. An additivity score of 1 denotes complete additivity, <1 is partial, and >1 is synergistic.
Results: Nebivolol/valsartan SPCs additivity scores (range diastolic BP: 0.735-0.866; systolic BP: 0.717-0.822) were similar to the weighted average of comparator scores (DBP 0.837, SBP 0.825; Figure 1). Among nebivolol/valsartan SPCs, 5/80 mg had the greatest additivity (DBP 0.866, SBP: 0.822). Contributions of monotherapy components to BP reduction were similar for the nebivolol/valsartan 5/80 SPC.
Conclusions: Additivity scores of nebivolol/valsartan and select non-β-blocker/RAAS inhibitor SPCs are comparable.
Poster Hall, Hall C
Friday, March 17, 2017, 10:00 a.m.-10:45 a.m.
Session Title: Assessing the Clinical Impact of Blood Pressure Lowering Therapies
Abstract Category: 33. Prevention: Hypertension
Presentation Number: 1105-038
- 2017 American College of Cardiology Foundation