Effectiveness and Persistence of Liraglutide Treatment Among Patients with Type 2 Diabetes Treated in Primary Care and Specialist Settings: A Subgroup Analysis from the EVIDENCE Study, a Prospective, 2-Year Follow-up, Observational, Post-Marketing Study

Luc Martinez, Alfred Penfornis, Jean-Francois Gautier, Eveline Eschwège, Guillaume Charpentier, Amira Bouzidi, Pierre Gourdy, Luc Martinez, Alfred Penfornis, Jean-Francois Gautier, Eveline Eschwège, Guillaume Charpentier, Amira Bouzidi, Pierre Gourdy

Abstract

Introduction: The objective of this subgroup analysis is to investigate the effectiveness of liraglutide in people with type 2 diabetes (T2D) treated within the primary care physician (PCP) and specialist care settings.

Methods: EVIDENCE is a prospective, observational study of 3152 adults with T2D recently starting or about to start liraglutide treatment in France. We followed patients in the PCP and specialist settings for 2 years to evaluate the effectiveness of liraglutide in glycemic control and body weight reduction. Furthermore, we evaluated the changes in combined antihyperglycemic treatments, the reasons for prescribing liraglutide, patient satisfaction, and safety of liraglutide in these two treatment settings.

Results: After 2 years of follow-up, 477 out of 1209 (39.0%) of PCP and 297 out of 1398 (21.2%) of specialist-treated patients still used liraglutide and maintained the glycated hemoglobin (HbA1c) target of <7.0%. Significant reductions from baseline were observed in both PCP- and specialist-treated cohorts in mean HbA1c (-1.22% and -0.8%, respectively), fasting plasma glucose (FPG) concentration (-39 and -23 mg/dL), body weight (-4.4 and -3.8 kg), and body mass index (BMI) (-1.5 and -1.4 kg/m2), all p < 0.0001. Reductions in HbA1c and FPG were significantly greater among PCP- compared with specialist-treated patients, p < 0.0001 for both. Patient treatment satisfaction was also significantly increased in both cohorts. Reported gastrointestinal adverse events were less frequent among PCP-treated patients compared with specialist-treated patients (4.5% vs. 16.1%).

Conclusion: Despite differences in demography and clinical characteristics of patients treated for T2D in PCP and specialty care, greater reduction in HbA1c and increased glycemic control durability were observed with liraglutide in primary care, compared with specialist care. These data suggest that liraglutide treatment could benefit patients in primary care by delaying the need for further treatment intensification.

Trial registration: ClinicalTrials.gov identifier, NCT01226966.

Funding: Novo Nordisk A/S.

Keywords: GLP-1 receptor agonist; Liraglutide; Observational study; Primary care; Type 2 diabetes; Weight management.

Figures

Fig. 1
Fig. 1
Patients still treated with liraglutide achieving primary endpoint of HbA1c <7.0% at 2 years of treatment. 95% confidence intervals shown. Analysis based on population for primary endpoint analysis (PEA). HbA1c glycated hemoglobin, PCP primary care physician

References

    1. Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of hyperglycaemia in type 2 diabetes, 2015: a patient-centred approach. Update to a position statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetologia. 2015;58:429–442. doi: 10.1007/s00125-014-3460-0.
    1. Garber AJ, Abrahamson MJ, Barzilay JI, et al. Consensus statement by the American Association of Clinical Endocrinologists and American College of Endocrinology on the comprehensive type 2 diabetes management algorithm—2016 executive summary. Endocr Pract. 2016;22:84–113. doi: 10.4158/EP151126.CS.
    1. Buse JB, Rosenstock J, Sesti G, et al. Liraglutide once a day versus exenatide twice a day for type 2 diabetes: a 26-week randomised, parallel-group, multinational, open-label trial (LEAD-6) Lancet. 2009;374:39–47. doi: 10.1016/S0140-6736(09)60659-0.
    1. Croom KF, McCormack PL. Liraglutide: a review of its use in type 2 diabetes mellitus. Drugs. 2009;69(14):1985–2004. doi: 10.2165/11201060-000000000-00000.
    1. Garber A, Henry R, Ratner R, et al. Liraglutide versus glimepiride monotherapy for type 2 diabetes (LEAD-3 Mono): a randomised, 52-week, phase III, double-blind, parallel-treatment trial. Lancet. 2009;373:473–481. doi: 10.1016/S0140-6736(08)61246-5.
    1. Marre M, Shaw J, Brandle M, et al. Liraglutide, a once-daily human GLP-1 analogue, added to a sulphonylurea over 26 weeks produces greater improvements in glycaemic and weight control compared with adding rosiglitazone or placebo in subjects with Ttype 2 diabetes (LEAD-1 SU) Diabet Med. 2009;26:268–278. doi: 10.1111/j.1464-5491.2009.02666.x.
    1. Nauck M, Frid A, Hermansen K, et al. Efficacy and safety comparison of liraglutide, glimepiride, and placebo, all in combination with metformin, in type 2 diabetes: the LEAD (liraglutide effect and action in diabetes)-2 study. Diabetes Care. 2009;32:84–90. doi: 10.2337/dc08-1355.
    1. Russell-Jones D, Vaag A, Schmitz O, et al. Liraglutide vs insulin glargine and placebo in combination with metformin and sulfonylurea therapy in type 2 diabetes mellitus (LEAD-5 met+ SU): a randomised controlled trial. Diabetologia. 2009;52:2046–2055. doi: 10.1007/s00125-009-1472-y.
    1. Zinman B, Gerich J, Buse JB, et al. Efficacy and safety of the human glucagon-like peptide-1 analog liraglutide in combination with metformin and thiazolidinedione in patients with type 2 diabetes (LEAD-4 Met + TZD) Diabetes Care. 2009;32:1224–1230. doi: 10.2337/dc08-2124.
    1. Marso SP, Daniels GH, Brown-Frandsen K, et al. Liraglutide and cardiovascular outcomes in type 2 diabetes. N Engl J Med. 2016;375:311–322. doi: 10.1056/NEJMoa1603827.
    1. MacMahon S, Collins R. Reliable assessment of the effects of treatment on mortality and major morbidity, II: observational studies. Lancet. 2001;357:455–462. doi: 10.1016/S0140-6736(00)04017-4.
    1. Yang W, Zilov A, Soewondo P, Bech OM, Sekkal F, Home PD. Observational studies: going beyond the boundaries of randomized controlled trials. Diabetes Res Clin Pract. 2010;88(Suppl 1):S3–S9. doi: 10.1016/S0168-8227(10)70002-4.
    1. Gautier JF, Martinez L, Penfornis A, et al. Effectiveness and persistence with liraglutide among patients with type 2 diabetes in routine clinical practice—EVIDENCE: a prospective, 2-year follow-up, observational, post-marketing study. Adv Ther. 2015;32:838–853. doi: 10.1007/s12325-015-0245-x.
    1. Kesavadev J, Shankar A, Krishnan G, Jothydev S. Liraglutide therapy beyond glycemic control: an observational study in Indian patients with type 2 diabetes in real world setting. Int J Gen Med. 2012;5:317–322. doi: 10.2147/IJGM.S27886.
    1. Inoue K, Maeda N, Fujishima Y, et al. Long-term impact of liraglutide, a glucagon-like peptide-1 (GLP-1) analogue, on body weight and glycemic control in Japanese type 2 diabetes: an observational study. Diabetol Metab Syndr. 2014;6:95. doi: 10.1186/1758-5996-6-95.
    1. Buysschaert M, D’Hooge D, Preumont V, Roots Study Group ROOTS: a multicenter study in Belgium to evaluate the effectiveness and safety of liraglutide (Victoza®) in type 2 diabetic patients. Diabetes Metab Syndr. 2015;9:139–142. doi: 10.1016/j.dsx.2015.05.001.
    1. Ponzani P, Scardapane M, Nicolucci A, Rossi MC. Effectiveness and safety of liraglutide after three years of treatment. Minerva Endocrinol. 2016;41:35–42.
    1. Ostawal A, Mocevic E, Kragh N, Xu W. Clinical effectiveness of liraglutide in type 2 diabetes treatment in the real-world setting: a systematic literature review. Diabetes Ther. 2016;7:411–438. doi: 10.1007/s13300-016-0180-0.
    1. Thong K, Walton C, Ryder R. Safety and efficacy of liraglutide 1.2 mg in patients with mild and moderate renal impairment: the ABCD nationwide liraglutide audit. Pract Diabetes. 2013;30:71-6b.
    1. Thong K, Gupta PS, Cull ML, et al. GLP-1 receptor agonists in type 2 diabetes-NICE guidelines versus clinical practice. Br J Diabetes. 2014;14:52–59. doi: 10.15277/bjdvd.2014.015.
    1. Lee WC, Dekoven M, Bouchard J, Massoudi M, Langer J. Improved real-world glycaemic outcomes with liraglutide versus other incretin-based therapies in type 2 diabetes. Diabetes Obes Metab. 2014;16:819–826. doi: 10.1111/dom.12285.
    1. Montanya E, Fonseca V, Colagiuri S, Blonde L, Donsmark M, Nauck MA. HbA improvement evaluated by baseline BMI: a meta-analysis of the liraglutide phase 3 clinical trial programme. Diabetes Obes Metab. 2015;18:707–710. doi: 10.1111/dom.12617.
    1. Khunti K, Wolden ML, Thorsted BL, Andersen M, Davies MJ. Clinical inertia in people with type 2 diabetes: a retrospective cohort study of more than 80,000 people. Diabetes Care. 2013;36:3411–3417. doi: 10.2337/dc13-0331.
    1. Nyeland ME, Ploug UJ, Richards A, et al. Evaluation of the effectiveness of liraglutide and sitagliptin in type 2 diabetes: a retrospective study in UK primary care. Int J Clin Pract. 2015;69:281–291. doi: 10.1111/ijcp.12575.
    1. Mezquita-Raya P, Reyes-Garcia R, Moreno-Perez O, et al. Clinical effects of liraglutide in a real-world setting in Spain: eDiabetes-Monitor SEEN Diabetes Mellitus Working Group Study. Diabetes Ther. 2015;6:173–185. doi: 10.1007/s13300-015-0112-4.

Source: PubMed

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