Additivity of nebivolol/valsartan single-pill combinations versus other single-pill combinations for hypertension

J Clin Hypertens (Greenwich). 2018 Jan;20(1):143-149. doi: 10.1111/jch.13132. Epub 2017 Nov 5.

Abstract

The single-pill combination (SPC) comprising nebivolol (5 mg), a vasodilatory β1 -selective antagonist/β3 -agonist, and valsartan (80 mg), a renin-angiotensin-aldosterone system inhibitor, is the only Food and Drug Administration-approved β-blocker/renin-angiotensin-aldosterone system inhibitor SPC for hypertension. Additive effects of four nebivolol/valsartan SPC doses (5 mg/80 mg, 5/160 mg, 10/160 mg, 10/320 mg nebivolol/valsartan) were compared with five Food and Drug Administration-approved non-β-blocker/renin-angiotensin-aldosterone system inhibitor SPCs (aliskiren/hydrochlorothiazide, aliskiren/amlodipine, valsartan/amlodipine, aliskiren/valsartan, and telmisartan/amlodipine). Additivity is the ratio of placebo-adjusted SPC blood pressure (BP) reduction to the placebo-adjusted monotherapy component BP reduction sums. A weighted average of comparator scores was calculated and compared vs nebivolol/valsartan. Additivity ratio scores for nebivolol/valsartan SPCs (diastolic BP range: 0.735-0.866; systolic BP range: 0.717-0.822) were similar to the comparator weighted average (diastolic BP: 0.837; systolic BP: 0.825). Among the nebivolol/valsartan SPCs, 5/80 mg had the greatest additivity (diastolic BP: 0.866; systolic BP: 0.822). BP reduction contributions with monotherapy were similar for nebivolol/valsartan 5/80 mg SPC. Additivity scores for nebivolol/valsartan and select non-β-blocker/renin-angiotensin-aldosterone system inhibitor SPCs were comparable.

Keywords: antihypertensive agents; drug combination; efficacy; hypertension; nebivolol; valsartan.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adrenergic beta-1 Receptor Agonists / administration & dosage
  • Adrenergic beta-1 Receptor Agonists / adverse effects
  • Adrenergic beta-1 Receptor Agonists / pharmacokinetics
  • Aged
  • Angiotensin II Type 1 Receptor Blockers / administration & dosage
  • Angiotensin II Type 1 Receptor Blockers / adverse effects
  • Angiotensin II Type 1 Receptor Blockers / pharmacokinetics
  • Antihypertensive Agents / administration & dosage
  • Antihypertensive Agents / classification
  • Blood Pressure Determination / methods
  • Dose-Response Relationship, Drug
  • Drug Combinations
  • Drug Monitoring / methods
  • Drug Synergism
  • Female
  • Humans
  • Hypertension* / diagnosis
  • Hypertension* / drug therapy
  • Male
  • Middle Aged
  • Nebivolol* / administration & dosage
  • Nebivolol* / adverse effects
  • Nebivolol* / pharmacokinetics
  • Renin-Angiotensin System / drug effects*
  • Treatment Outcome
  • Valsartan* / administration & dosage
  • Valsartan* / adverse effects
  • Valsartan* / pharmacokinetics

Substances

  • Adrenergic beta-1 Receptor Agonists
  • Angiotensin II Type 1 Receptor Blockers
  • Antihypertensive Agents
  • Drug Combinations
  • Nebivolol
  • Valsartan