title: Impact of Empagliflozin on Blood Pressure in Patients With Type 2 Diabetes Mellitus and Hypertension by Background Antihypertensive Medication.
abstract: In the EMPA-REG BP trial, empagliflozin 10 mg and 25 mg once daily reduced glycohemoglobin, blood pressure (BP), and weight versus placebo in patients with type 2 diabetes mellitus and hypertension. Patients received placebo (n=271), empagliflozin 10 mg (n=276), or empagliflozin 25 mg (n=276) for 12 weeks (n=full analysis set). This present analysis investigated changes from baseline to week 12 in mean 24-hour systolic BP (SBP) and diastolic BP (DBP) in patients receiving 0, 1, or ≥2 antihypertensive medications and patients receiving/not receiving diuretics or angiotensin-converting enzyme inhibitors/angiotensin receptor blockers. Compared with placebo, empagliflozin 10 mg and 25 mg reduced mean 24-hour SBP/DBP in patients receiving 0 (10 mg: -3.89/-2.58 mm Hg; 25 mg: -3.77/-2.45 mm Hg), 1 (10 mg: -4.74/-1.97 mm Hg; 25 mg: -4.27/-1.81 mm Hg), or ≥2 (10 mg: -2.36/-0.68 mm Hg; 25 mg: -4.17/-1.54 mm Hg) antihypertensives. The effect of empagliflozin was not significantly different between subgroups by number of antihypertensives for changes in SBP (interaction P value 0.448) or DBP (interaction P value 0.498). Empagliflozin reduced 24-hour mean SBP/DBP irrespective of diuretic or angiotensin-converting enzyme inhibitor/angiotensin receptor blocker use, with no significant difference between subgroups by use/no use of diuretics (interaction P values 0.380 [systolic]; 0.240 [diastolic]) or angiotensin-converting enzyme inhibitors/angiotensin receptor blockers (interaction P values 0.900 [systolic]; 0.359 [diastolic]). In conclusion, in patients with type 2 diabetes mellitus and hypertension, empagliflozin for 12 weeks reduced SBP and DBP versus placebo, irrespective of the number of antihypertensives and use of diuretics or angiotensin-converting enzyme inhibitors/angiotensin receptor blockers.
  
  
  
  URL: https://clinicaltrials.gov. Unique identifier: NCT01370005.
authors.affiliation: From the University of Milano-Bicocca, Milan, Italy (G.M.); Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, and Harvard Clinical Research Institute, Boston, MA (C.P.C.); Abdominal Center, Nephrology, Helsinki University Hospital, University of Helsinki and Minerva Institute for Medical Research, Finland (I.T.); Biostatistics and Data Sciences (C.Z.), Medicine, Medical Affairs Germany (L.L.), Medicine, Therapeutic Area Metabolism (H.J.W., U.C.B.), Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany; and Medicine, Human Pharma, Boehringer Ingelheim Norway KS, Asker, Norway (O.E.J.). giuseppe.mancia@unimib.it.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Mancia
authors.affiliation: From the University of Milano-Bicocca, Milan, Italy (G.M.); Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, and Harvard Clinical Research Institute, Boston, MA (C.P.C.); Abdominal Center, Nephrology, Helsinki University Hospital, University of Helsinki and Minerva Institute for Medical Research, Finland (I.T.); Biostatistics and Data Sciences (C.Z.), Medicine, Medical Affairs Germany (L.L.), Medicine, Therapeutic Area Metabolism (H.J.W., U.C.B.), Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany; and Medicine, Human Pharma, Boehringer Ingelheim Norway KS, Asker, Norway (O.E.J.).
authors.forename: Christopher P
authors.initials: CP
authors.lastname: Cannon
authors.affiliation: From the University of Milano-Bicocca, Milan, Italy (G.M.); Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, and Harvard Clinical Research Institute, Boston, MA (C.P.C.); Abdominal Center, Nephrology, Helsinki University Hospital, University of Helsinki and Minerva Institute for Medical Research, Finland (I.T.); Biostatistics and Data Sciences (C.Z.), Medicine, Medical Affairs Germany (L.L.), Medicine, Therapeutic Area Metabolism (H.J.W., U.C.B.), Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany; and Medicine, Human Pharma, Boehringer Ingelheim Norway KS, Asker, Norway (O.E.J.).
authors.forename: Ilkka
authors.initials: I
authors.lastname: Tikkanen
authors.affiliation: From the University of Milano-Bicocca, Milan, Italy (G.M.); Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, and Harvard Clinical Research Institute, Boston, MA (C.P.C.); Abdominal Center, Nephrology, Helsinki University Hospital, University of Helsinki and Minerva Institute for Medical Research, Finland (I.T.); Biostatistics and Data Sciences (C.Z.), Medicine, Medical Affairs Germany (L.L.), Medicine, Therapeutic Area Metabolism (H.J.W., U.C.B.), Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany; and Medicine, Human Pharma, Boehringer Ingelheim Norway KS, Asker, Norway (O.E.J.).
authors.forename: Cordula
authors.initials: C
authors.lastname: Zeller
authors.affiliation: From the University of Milano-Bicocca, Milan, Italy (G.M.); Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, and Harvard Clinical Research Institute, Boston, MA (C.P.C.); Abdominal Center, Nephrology, Helsinki University Hospital, University of Helsinki and Minerva Institute for Medical Research, Finland (I.T.); Biostatistics and Data Sciences (C.Z.), Medicine, Medical Affairs Germany (L.L.), Medicine, Therapeutic Area Metabolism (H.J.W., U.C.B.), Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany; and Medicine, Human Pharma, Boehringer Ingelheim Norway KS, Asker, Norway (O.E.J.).
authors.forename: Ludwin
authors.initials: L
authors.lastname: Ley
authors.affiliation: From the University of Milano-Bicocca, Milan, Italy (G.M.); Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, and Harvard Clinical Research Institute, Boston, MA (C.P.C.); Abdominal Center, Nephrology, Helsinki University Hospital, University of Helsinki and Minerva Institute for Medical Research, Finland (I.T.); Biostatistics and Data Sciences (C.Z.), Medicine, Medical Affairs Germany (L.L.), Medicine, Therapeutic Area Metabolism (H.J.W., U.C.B.), Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany; and Medicine, Human Pharma, Boehringer Ingelheim Norway KS, Asker, Norway (O.E.J.).
authors.forename: Hans J
authors.initials: HJ
authors.lastname: Woerle
authors.affiliation: From the University of Milano-Bicocca, Milan, Italy (G.M.); Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, and Harvard Clinical Research Institute, Boston, MA (C.P.C.); Abdominal Center, Nephrology, Helsinki University Hospital, University of Helsinki and Minerva Institute for Medical Research, Finland (I.T.); Biostatistics and Data Sciences (C.Z.), Medicine, Medical Affairs Germany (L.L.), Medicine, Therapeutic Area Metabolism (H.J.W., U.C.B.), Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany; and Medicine, Human Pharma, Boehringer Ingelheim Norway KS, Asker, Norway (O.E.J.).
authors.forename: Uli C
authors.initials: UC
authors.lastname: Broedl
authors.affiliation: From the University of Milano-Bicocca, Milan, Italy (G.M.); Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, and Harvard Clinical Research Institute, Boston, MA (C.P.C.); Abdominal Center, Nephrology, Helsinki University Hospital, University of Helsinki and Minerva Institute for Medical Research, Finland (I.T.); Biostatistics and Data Sciences (C.Z.), Medicine, Medical Affairs Germany (L.L.), Medicine, Therapeutic Area Metabolism (H.J.W., U.C.B.), Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany; and Medicine, Human Pharma, Boehringer Ingelheim Norway KS, Asker, Norway (O.E.J.).
authors.forename: Odd Erik
authors.initials: OE
authors.lastname: Johansen
mesh_terms: D000959:Antihypertensive Agents / Q000008:administration & dosage*; D001559:Benzhydryl Compounds / Q000008:administration & dosage*; D001786:Blood Glucose / Q000187:drug effects; D001795:Blood Pressure Determination; D015897:Comorbidity; D003924:Diabetes Mellitus, Type 2 / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology*; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D005960:Glucosides / Q000008:administration & dosage*; D006801:Humans; D006973:Hypertension / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology*; D007004:Hypoglycemic Agents / Q000008:administration & dosage; D008297:Male; D011446:Prospective Studies; D012016:Reference Values; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D000959:Antihypertensive Agents; D001559:Benzhydryl Compounds; D001786:Blood Glucose; D005960:Glucosides; D007004:Hypoglycemic Agents; C570240:empagliflozin
keywords: SGLT2 inhibitor; antihypertensive; blood pressure; diuretic; empagliflozin; hypertension; type 2 diabetes mellitus