Real-world glycemic, blood pressure, and weight control in patients with type 2 diabetes mellitus treated with canagliflozin—an electronic health-record-based study

Abstract

Background: Canagliflozin (CANA) has been shown to improve HbA1c, blood pressure (BP), and weight in patients with type 2 diabetes mellitus (T2DM) in clinical trials. This study describes HbA1c, BP, and weight in T2DM patients treated with CANA in a real-world setting.

Methods: Adults with ≥1 diagnosis for T2DM and ≥12 months of clinical activity before the first CANA prescription (index) were identified in the IMS Health Real-World Data Electronic Medical Records - US database. Patient quality measures were described at baseline and 3, 6, 9, and 12 months post-index. Selected goals were HbA1c <7% (<53 mmol/mol), <8% (<64 mmol/mol), and >9% (>75 mmol/mol, poor control), BP <140/90 mmHg, and weight loss ≥5%.

Results: In total, 16,163 patients were identified (mean age = 58.5 years; 47.9% female; 75.8% white). At baseline, 90.4% of patients used ≥1 anti-hyperglycemic agent. Among patients with baseline HbA1c ≥7% (n = 10,478; 64.8%; mean HbA1c = 8.8%), 21.2%, 59.5%, and 17.6% had an HbA1c <7%, <8%, and >9% after 3 months, respectively; these proportions remained stable through 12 months. Among patients with baseline BP ≥140/90, 60.0% and 75.6% attained systolic BP <140 mmHg and diastolic BP <90 mmHg after 3 months, respectively; proportions remained stable through 12 months. Weight loss ≥5% was observed in 13.3% of patients at 3 months and the proportion increased to 25.8% at 12 months.

Limitations: This study relied on prescription data, which does not necessarily indicate that the medication was taken as prescribed. Some patients were also treated with other anti-hyperglycemics, anti-hypertensives, and weight loss medications during the follow-up, which may have contributed to the effects reported.

Conclusions: Most patients with inadequate HbA1c and BP levels at baseline achieved respective goals after 3 months of CANA, and the proportions of responders remained stable through 12 months. Weight loss ≥5% was increasingly observed over time.

Keywords:

• Blood pressure
• canagliflozin
• HbA1c
• type 2 diabetes mellitus
• weight

Transparency

Declaration of funding

This research was funded by Janssen Scientific Affairs, LLC, Raritan, NJ. Employees of Janssen were involved in the study design, data collection, data analysis, manuscript preparation, and publication decisions.

Declaration of financial/other relationships

Patrick Lefebvre, Dominic Pilon, and Marie-Hélène Lafeuille are employees of Groupe d’analyse, Ltée, a consulting company which has received research grants from Janssen Scientific Affairs, LLC. At the time the study was conducted, Marie-Noëlle Robitaille was an employee of Groupe d’analyse, Ltée. Wing Chow and Michael Pfeifer are employees of Janssen Scientific Affairs, LLC. Mei Sheng Duh is employed by Analysis Group, Inc., a consulting company that has received research grants from Janssen Scientific Affairs, LLC. CMRO Peer Reviewers on this manuscript have received an honorarium from CMRO for their review work. Peer Reviewer 1 has disclosed that he has received grants from Boehringer Ingelheim, Eli Lilly, and MSD. Peer Reviewer 2 has disclosed that he has been a consultant to Janssen, Astra, and Boehringer Ingelheim. Peer Reviewer 3 has disclosed that he has been a consultant to Novo Nordisk, Eli Lilly, Boehringer Ingelheim, and Merck. He has also served on the Speakers’ Bureau of Eisai, Genentech, Janssen, AstraZeneca, Novo Nordisk, Eli Lilly, Boehringer Ingelheim, and Merck. Peer Reviewer 4 has no relevant financial or other relationships to disclose.

Acknowledgment

Previous presentation—International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 20th Annual International Meeting, May 16–20, 2015, Philadelphia, PA.