title: Blood pressure-lowering effect of the sodium glucose co-transporter-2 inhibitor ertugliflozin, assessed via ambulatory blood pressure monitoring in patients with type 2 diabetes and hypertension.
abstract: This study compared the blood pressure-lowering effect of ertugliflozin (1, 5, 25 mg), hydrochlorothiazide (HCTZ; 12.5 mg) and placebo in 194 patients with type 2 diabetes mellitus and hypertension for 4 weeks using ambulatory blood pressure monitoring. Endpoints (change from baseline to week 4) were: 24-h mean systolic blood pressure (SBP; primary); daytime, night-time, seated predose SBP, 24-h, daytime, night-time, seated predose diastolic blood pressure, 24-h urinary glucose excretion and fasting plasma glucose (FPG; secondary). Safety and tolerability were monitored. Significant decreases in placebo-corrected 24-h mean SBP (-3.0 to -4.0 mmHg) were recorded for all doses of ertugliflozin (for HCTZ, this was -3.2 mmHg). Daytime, but not night-time SBP was consistently reduced. Ertugliflozin produced dose-dependent significant decreases in FPG and increases in urinary glucose excretion. No notable changes in plasma renin activity or urinary aldosterone were seen. The most common adverse events were urinary tract infection, genital fungal infection, upper respiratory tract infection and musculoskeletal pain.
authors.affiliation: Pfizer Worldwide Research and Development, Pfizer, Cambridge, MA, USA.
authors.forename: N B
authors.initials: NB
authors.lastname: Amin
authors.affiliation: Pfizer Worldwide Research and Development, Pfizer, Cambridge, MA, USA.
authors.forename: X
authors.initials: X
authors.lastname: Wang
authors.affiliation: Texas Center for Drug Development Inc, Houston, TX, USA.
authors.forename: J R
authors.initials: JR
authors.lastname: Mitchell
authors.affiliation: Pfizer Worldwide Research and Development, Pfizer, Cambridge, MA, USA.
authors.forename: D S
authors.initials: DS
authors.lastname: Lee
authors.affiliation: Pfizer Worldwide Research and Development, Pfizer, Cambridge, MA, USA.
authors.forename: G
authors.initials: G
authors.lastname: Nucci
authors.affiliation: Pfizer Worldwide Research and Development, Pfizer, Cambridge, MA, USA.
authors.forename: J M
authors.initials: JM
authors.lastname: Rusnak
mesh_terms: D000450:Aldosterone / Q000652:urine; D000959:Antihypertensive Agents / Q000627:therapeutic use*; D001786:Blood Glucose / Q000032:analysis; D001794:Blood Pressure / Q000187:drug effects*; D018660:Blood Pressure Monitoring, Ambulatory; D019086:Bridged Bicyclo Compounds, Heterocyclic / Q000627:therapeutic use*; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000150:complications* / Q000652:urine; D004305:Dose-Response Relationship, Drug; D005215:Fasting / Q000097:blood; D005260:Female; D006029:Glycosuria / Q000652:urine; D006339:Heart Rate / Q000187:drug effects; D006801:Humans; D006852:Hydrochlorothiazide / Q000627:therapeutic use; D006973:Hypertension / Q000188:drug therapy* / Q000209:etiology; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D008297:Male; D012083:Renin / Q000097:blood
chemical_list: D000959:Antihypertensive Agents; D001786:Blood Glucose; D019086:Bridged Bicyclo Compounds, Heterocyclic; D007004:Hypoglycemic Agents; D006852:Hydrochlorothiazide; D000450:Aldosterone; C570288:ertugliflozin; D012083:Renin
keywords: PF-04971729; ambulatory blood pressure monitoring; ertugliflozin; sodium-glucose co-transporter; type 2 diabetes mellitus