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001-es BibID:BIBFORM073187
035-os BibID:(WoS)000425013600005 (Scopus)85030632365
Első szerző:Rosenstock, Julio
Cím:Effect of ertugliflozin on glucose control, body weight, blood pressure and bone density in type 2 diabetes mellitus inadequately controlled on metformin monotherapy (VERTIS MET) / Julio Rosenstock, Juan Frias, Dénes Páll, Bernard Charbonnel, Raluca Pascu, Didier Saur, Amanda Darekar, Susan Huyck, Harry Shi, Brett Lauring, Steven G. Terra
Dátum:2018
ISSN:1462-8902
Megjegyzések:Introduction: We evaluated efficacy and safety of ertugliflozin, an SGLT2 inhibitor, in type 2diabetes mellitus (T2DM) inadequately controlled (HbA1c, 7.0?10.5%) on metforminmonotherapy (?1500 mg/day for ?8 weeks).Methods: Double-blind, 26-week, multicentre study with ongoing 78-week extension; 621participants randomized 1:1:1 to placebo, ertugliflozin 5 or 15 mg/day. Primary endpoint:change from baseline in HbA1c at week 26. Secondary efficacy endpoints: change frombaseline at week 26 in fasting plasma glucose (FPG), body weight, systolic/diastolic bloodpressure (SBP/DBP); participants with HbA1c <7.0% (53 mmol/mol). Pre-specified adverseevents (AEs) of special interest and percent change from baseline in bone mineral density(BMD) were also assessed at week 26.Results: At week 26, the placebo-adjusted least-squares mean change from baselineHbA1c (8.1%) was ?0.7% and ?0.9% for ertugliflozin 5 and 15 mg, respectively (both P <0.001), to final means of 7.3% and 7.2%, respectively. The odds of HbA1c <7.0% weresignificantly greater in both ertugliflozin groups vs placebo. Ertugliflozin significantly reducedFPG, body weight, SBP and DBP vs placebo. Incidence of genital mycotic infections wasincreased in ertugliflozin groups (females: placebo, 0.9%; ertugliflozin 5 mg, 5.5%; 15 mg,6.3% [P = 0.032]; males: 0; 3.1%; 3.2%), as was incidence of urinary tract infections andsymptomatic hypoglycaemia. Incidence of hypovolaemia AEs was similar across groups.Ertugliflozin had no adverse impact on BMD at week 26.Conclusions: Ertugliflozin added to metformin in inadequately controlled T2DM improvedglycaemic control, reduced body weight and BP, but increased genital mycotic infections.ClinicalTrials.gov identifier: NCT02033889.
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
folyóiratcikk
bone mineral density
ertugliflozin
SGLT2 inhibitor
type 2 diabetes mellitus
Megjelenés:Diabetes Obesity & Metabolism. - 20 : 3 (2018), p. 520-529. -
További szerzők:Frias, Juan Páll Dénes (1967-) (belgyógyász, kardiológus) Charbonnel, Bernard Pascu, Raluca Saur, Didier Darekar, Amanda Huyck, Susan Shi, Harry Lauring, Brett Terra, Steven G.
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