BACKGROUND

Liraglutide is an analog of human glucagon-like peptide-1 (GLP-1) and acts as a GLP-1 receptor agonist. Liraglutide is presently used in the treatment of selected patients with type 2 diabetes mellitus (T2DM).

OBJECTIVE

To assess efficacy and safety of liraglutide in, overweight and obese Indian patients with T2DM.

METHODS

A single center, prospective, open-labeled, single-arm, observational study for 24 weeks in a real-world setting. Fourteen overweight and obese patients with T2DM who were clinically suitable for liraglutide therapy received liraglutide injections. The starting dose of liraglutide (Victoza) injection was 0.6 mg/day for 3 days followed by 1.2 mg for next 10 days and finally 1.8 mg/day for 22 weeks. Patients were evaluated at baseline and after 12 and 24 weeks of therapy. Adverse events (AE) noted during course of therapy were recorded. A repeated measure analysis of variance was performed to assess statistical significance.

RESULTS

Fourteen patients were studied for 24 weeks. After 24 weeks of liraglutide therapy, mean fasting and postprandial plasma glucose decreased by 48.5 mg/dL and 66.71 mg/dL, respectively (P = 0.002 and P = 0004 over 24 weeks, respectively). A mean reduction of 2.26% of glycosylated hemoglobin was noted (P < 0.001 over 24 weeks). Mean decrease in body weight of 8.65 kg and mean decrease in body mass index of 3.26 kg/m(2) was noted (P < 0.001 over 24 weeks for each parameter). Systolic blood pressure was reduced by 15.15 mm of Hg (P = 0.004). Significant improvement in total cholesterol, low-density lipoprotein, triglycerides, and serum creatinine was noted. Nine patients reported AEs. The AEs noticed were nausea (n = 6), feeling of satiety (n = 3), and vomiting (n = 1). No serious AE or hypoglycemic episodes were observed.

CONCLUSIONS

Liraglutide once a day improved overall glycemic control and was well tolerated. Clinically significant reduction in body weight, systolic blood pressure and improvement in lipid profile were noticed with liraglutide therapy in addition to glycemic control.

OBJECTIVE

This study aimed to compare 6-month adherence to therapy with exenatide once weekly (Bydureon(®)) vs liraglutide once daily (Victoza(®)) in patients with type 2 diabetes under primary care in Germany.

METHODS

A nationwide longitudinal prescription database (LRx), (between January 2011 and September 2014) was used to analyze adherence to therapy. The proportion of days covered (PDC) by prescription was used as a measure of adherence in the 6-month postindex period. Logistic regression analyses were performed to investigate the associations between glucagon-like peptide-1 receptor agonist therapy adjusting for age, sex, and cotherapy.

RESULTS

Therapy was initiated in 5,449 patients with exenatide once weekly (age: 59.7±11.8 years; 51.4% were male) and in 24,648 patients with liraglutide once daily (age: 59.4±11.4 years; 49.7% were male). The median PDC was 0.88 for exenatide once weekly and 0.77 for liraglutide once daily (P<0.05). Once-weekly exenatide was associated with significantly higher adherence. Odds ratio (95% confidence interval) for having a PDC of ≥0.80 was 1.78 (1.62-1.96) for exenatide once weekly compared with liraglutide once daily after adjusting for age, sex, and cotherapy.

CONCLUSIONS

Adherence to treatment with exenatide once weekly was significantly increased compared to that with liraglutide once daily over 6 months in patients with type 2 diabetes.

BACKGROUND

Many patients with type 2 diabetes mellitus (T2DM) are not able to maintain adequate HbA(1c) control (<7.0%), even at maximal dosage levels of one or two oral agents, and are at increased risk for diabetes-related complications.

OBJECTIVE

To estimate the cost-effectiveness of a once-daily GLP-1 analog Victoza [Novo Nordisk] versus a thiazolidinedione (TZD), rosiglitazone in patients with T2DM. Both treatment groups included background therapy with glimepiride.

METHODS

The CORE Diabetes Model (CDM) was used to project and compare 35-year clinical and economic outcomes associated with liraglutide 1.2 mg + glimepiride and liraglutide 1.8 mg + glimepiride versus rosiglitazone 4 mg + glimepiride. Baseline cohort characteristics (HbA(1c) (8.4%), age, duration of disease, sex, body-mass index (BMI), blood pressure, and lipids) were based on the Liraglutide Effect and Action in Diabetes-1 (LEAD-1) trial.

RESULTS

Primary outcomes included life expectancy (LE), quality-adjusted life-years (QALYs), total costs and incremental cost-effectiveness ratios (ICERs). results: When compared to rosiglitazone, liraglutide 1.2 mg and 1.8 mg increased mean LE by 0.968 and 1.041 years, and QALYs by 0.764 and 0.837, respectively. Total lifetime costs increased by $26,094 for liraglutide 1.2 mg versus rosiglitazone, and by $47,041 for liraglutide 1.8 mg versus rosiglitazone. ICERs for liraglutide 1.2 mg versus rosiglitazone and 1.8 mg versus rosiglitazone were $34,147 and $56,190, respectively.

CONCLUSIONS

Compared to rosiglitazone 4 mg plus glimepiride, liraglutide (particularly at the 1.2-mg dose) plus glimepiride is a cost-effective treatment option for improving glucose control in T2DM. Limitations include the projection of short term efficacy results from randomized control trials to longer time horizons. In addition, clinical acceptance and overall use of rosiglitazone in the treatment of diabetes has continued to fall since publication of the clinical trial upon which this modeling analyses was based.

Liraglutide (Victoza®) is a subcutaneously administered glucagon-like peptide-1 (GLP-1) receptor agonist produced by recombinant DNA technology and used as an adjunct to diet and exercise in the treatment of adults with type 2 diabetes mellitus. This article reviews the clinical efficacy and tolerability of liraglutide in adults with type 2 diabetes, and provides a summary of its pharmacological properties. Recently published pharmacoeconomic studies of liraglutide are also reviewed. Administered subcutaneously, liraglutide (usually 1.2 or 1.8 mg once daily) generally produced greater improvements in glycaemic control than active comparators or placebo when administered as monotherapy or in combination with one or two oral antidiabetic drugs (OADs) to adults with type 2 diabetes in numerous randomized, controlled phase III trials. These included six trials in the LEAD trial programme that was designed to evaluate the efficacy and safety of liraglutide across a continuum of antihyperglycaemic management for patients with type 2 diabetes. Liraglutide was generally well tolerated, with a low risk of hypoglycaemia evident, in the phase III trials. The most common adverse events were gastrointestinal and included nausea and diarrhoea; most events were mild to moderate in severity and decreased in incidence over time. In conclusion, liraglutide has an important place in the management of adults with type 2 diabetes across a continuum of care. As well as providing effective glycaemic control, liraglutide improves pancreatic β-cell function and leads to bodyweight loss, thereby addressing some of the unmet needs of patients treated with traditional OADs.

Subcutaneous liraglutide (Victoza(®)), a glucagon-like peptide 1 receptor agonist, is approved for the treatment of adult patients with type 2 diabetes mellitus. Once-daily liraglutide, as monotherapy or add-on therapy to other antidiabetic agents (including basal insulin), was an effective and generally well tolerated treatment in adult patients with type 2 diabetes in several well-designed phase III trials and in the real world clinical practice setting. In addition to improving glycaemic control, liraglutide had beneficial effects on bodyweight, systolic blood pressure and surrogate measures of β-cell function in clinical trials, with these benefits maintained during long-term treatment (≤2 years). Liraglutide has a convenient once-daily administration regimen, a low potential for drug-drug interactions and low propensity to cause hypoglycaemia. Thus, liraglutide continues to be a useful option for the management of type 2 diabetes. This article reviews the therapeutic use of liraglutide in adult patients with type 2 diabetes and summarizes its pharmacological properties.

OBJECTIVE

The ROOTS study was an observational study to evaluate the effectiveness and safety of liraglutide (Victoza(®)), a GLP-1 receptor analog, in a cohort of patients with type 2 diabetes with inadequate glycaemic control despite conventional antihyperglycaemic dual therapy. The primary objective was to assess glycaemic control while using liraglutide under normal clinical practice conditions. The primary endpoint was to estimate the proportion of patients achieving improved glycaemic control defined as a HbA1c<7% or with a decrease of ≥1% after 12 months.

METHODS

The study included 245 subjects. They received liraglutide in addition to their usual dual therapy (metformin and sulfonylureas or pioglitazone). Age and duration (mean±SD) of diabetes were 58±10 and 9±5 years respectively. Body mass index was 33.9±6.2 kg/m(2).

RESULTS

HbA1c decreased from 9.12%±1.28 at baseline to 7.54%±1.12 after one year follow-up (p<0.001). The primary endpoint was achieved in 66.5% of patients. In parallel, we observed a reduction of BMI from baseline 33.9±6.2 to 32.8±6.3 kg/m(2) (p<0.001). At 12 months, 64.6% of the patients received liraglutide at a dosage of 1.2 mg/day, 32.7% received 1.8 mg and 2.7% 0.6 mg. Adverse drug reactions were present in 24% of subjects, most frequently gastrointestinal disorders (11.4%), mainly nausea (6.9%) and no pancreatic events.

CONCLUSIONS

Treatment with liraglutide was associated with a marked improvement in glycaemic control in daily routine practice as well as with a reduction of weight, without major side effects.

BACKGROUND

Glucagon-like peptide (GLP-1) is a neuroendocrine hormone that increases blood glucose and is a drug target for treatment of type 2 diabetes. Liraglutide, a subcutaneous, once-daily GLP-1 agonist, is approved for the treatment of type 2 diabetes in the United States and Europe. It also has been studied for weight loss.

OBJECTIVE

The purpose of this article is to review all of the relevant literature on the chemistry, pharmacology, pharmacokinetics, metabolism, clinical trials, safety, drug interactions, cost, and place in therapy of liraglutide.

METHODS

Literature searches of MEDLINE between 1969 and September 2010, International Pharmaceutical Abstracts between 1970 and September 2010, American Diabetes Association Meeting abstracts (2008-2010), and European Association for the Study of Diabetes abstracts (2008-2010) were performed using liraglutide, Victoza, and NN2211 as key terms.

RESULTS

Thirteen randomized controlled trials were identified and summarized. Liraglutide has been shown to increase glucose-dependent insulin release by 34% to 118% and reduce postprandial glucagon levels by 20%. Studies showed that liraglutide, as monotherapy and in combination with glimepiride, metformin, and/or rosiglitazone, lowers glycosylated hemoglobin (HbA(1c)) between 0.84% and 1.5%. Transient nausea was reported by 7% to 40% of subjects. Severe hypoglycemia-glucose <55 mg/dL-was observed by 2.5% of subjects in 1 trial.

CONCLUSIONS

Liraglutide safely and effectively reduces HbA(1c) in patients with type 2 diabetes. The most recent American Diabetes Association guidelines recommended a GLP-1 agonist along with metformin as a second-tier therapy for type 2 diabetes. Although the American Association of Clinical Endocrinologists/American College of Endocrinologists' guidelines recommended it for first-line monotherapy in patients with HbA(1c) between 6.5% and 7.5% and with metformin if HbA(1c) is between 7.6% and 8.5%, liraglutide should be considered for patients who cannot tolerate first-line agents or if an additional agent is needed to help reach target HbA(1c) goals.

Subcutaneous liraglutide (Victoza(®), Novo Nordisk) was approved for the treatment of Type 2 diabetes mellitus (T2DM) in Europe in 2009 and in the USA in 2010. In December 2014, liraglutide 3.0 mg was approved by the Food and Drug Administration (FDA) and in March 2015 by the European Medicines Agency (EMA) for the treatment of chronic weight management under the brand name Saxenda(®) Novo Nordisk. Liraglutide causes a glucose-dependent increase in insulin secretion, decreases glucagon secretion and promotes weight loss by inhibiting appetite. Liraglutide probably induces satiety through activation of different areas in the hind brain and possibly by preserving free leptin levels. Recently, liraglutide has been suggested to protect against prediabetes and seems to prevent bone loss by increasing bone formation following diet-induced weight loss in obesity. This article not only covers the major clinical trials evaluating the effects of liraglutide in obesity and T2DM but also provides novel insights into the pharmacological mechanisms of liraglutide.

Albumin is one of the most extensively studied endogenous proteins which are used in the fabrication of drug delivery and diagnostic technologies during last 10 years. This review provides a summary of products involving the use of albumin as a drug delivery tool for getting better the pharmacokinetics of a drug by developing the targetted drug delivery systems and diagnosing the pathologies. Using albumin, following market approved products have been developed: Levemir and Victoza (antidiabetic product), Abraxane (antimetastatic breast cancer product), and Nanocoll and Albures (for lymphoscintigraphy and diagnosis of cancer and rheumatoid arthritis).

BACKGROUND

Heart failure is one of the most common cardiovascular complications of diabetes and the most disabling and deadly complication too. Many antidiabetic agents have been associated with increased morbidity and mortality in a subset of patients with chronic heart failure (CHF); thus, new treatment modalities are warranted. Interestingly, a beneficial effect of the incretin hormone, GLP-1, on cardiac function has been suggested in patients with diabetes and patients without diabetes. Liraglutide (Victoza) is a GLP-1 analogue developed for the treatment of type 2 diabetes (T2D); however, its impact on cardiac function has not previously been investigated in patients with CHF. This prompted us to investigate whether liraglutide treatment for 24 weeks improves left ventricular ejection fraction (LVEF) in patients with CHF with and without T2D compared with placebo treatment.

METHODS

An investigator-initiated, multicentre, randomised, double-blind, parallel, placebo-controlled intervention trial. In total, 240 patients with CHF (with and without T2D) with LVEF≤45% will be randomised to either subcutaneous injection of liraglutide 1.8 mg or matching placebo once daily for 24 weeks. The effect of liraglutide on left ventricular function will be evaluated by advanced echocardiography, including three-dimensional contrast echocardiography.

BACKGROUND

The study will be performed and monitored according to the Good Clinical Practice-International Conference on Harmonisation (GCP-ICH) regulations and conducted according to the principles of the Helsinki Declaration. The Danish Medicines Agency, the local Research Ethics Committee and the Danish Data Protection Agency have approved the study.

BACKGROUND

ClinicalTrials.gov Identifier: NCT01472640.

BACKGROUND

Glucagon-like peptide-1 (GLP-1) receptor agonists are a relatively recent addition to the treatment options for type 2 diabetes mellitus (T2DM) and are administered using prefilled pen devices.

METHODS

In this open-label task and interview-based pilot study, 3 GLP-1 receptor agonist pen devices-exenatide (Byetta®, Bristol-Myers Squibb/AstraZeneca), liraglutide (Victoza®, Novo Nordisk), and lixisenatide (Lyxumia®, Sanofi-Aventis)-were comparatively assessed in a randomized order in 30 participants with T2DM for ease of use, using a series of key performance measures (time taken to complete a series of tasks, number of user errors [successful performance], and user satisfaction rating). Linear and logistic regression analysis was conducted for the lixisenatide and liraglutide pens versus the exenatide pen. Participants' mean age was 60 years; 27% and 20% of the participants had visual impairments and reduced manual dexterity, respectively.

RESULTS

Tasks were completed faster (P < .001) and with higher successful performance (P = .001) with the lixisenatide pen than with the exenatide pen, whereas the liraglutide pen was not statistically significant versus the exenatide pen on these parameters. Overall, user satisfaction was statistically higher for the lixisenatide and liraglutide pens versus the exenatide pen (P < .001 for both).

CONCLUSIONS

Lixisenatide and liraglutide pens are associated with higher user satisfaction compared with the exenatide pen. In addition, the lixisenatide pen is faster and results in fewer errors than its comparator (exenatide). The lixisenatide pen may therefore be a suitable choice for patients with T2DM, including older and pen device-naïve patients, and those with visual impairments and reduced manual dexterity.

Liraglutide (Victoza-Novo Nordisk), a glucagon-like peptide-1 (GLP-1) receptor agonist given by subcutaneous injection, has been approved by the FDA for treatment of patients with type 2 diabetes. It can be used alone or in addition to oral antidiabetic drugs such as metformin (Glucophage, and others) or glimepiride (Amaryl, and others). Liraglutide is not recommended for first-line therapy and is not approved for use with insulin.

OBJECTIVE

To evaluate the efficacy and safety of the available glucagon-like peptide-1 receptor agonists (GLP-1 RAs) exenatide and liraglutide (marketed as Byetta * and Victoza † , respectively) in first- or second-line pharmacotherapy for type 2 diabetes (T2D), described here as 'early use'.

METHODS

MEDLINE, EMBASE and Google Scholar databases were queried for clinical trial reports using the terms incretin, GLP-1, exenatide and liraglutide. Relevant articles were those that employed these agents in treatment-naïve patients with T2D and in patients who had failed on metformin monotherapy. Additional targeted searches were conducted on diabetes treatment guidelines and on the range of physiological responses to GLP-1 RAs. Most evidence is level I and II.

RESULTS

Effective therapy for T2D should be implemented early in the course of this progressive disease. The recently revised 2013 Canadian Diabetes Association (CDA) guidelines now identify the GLP-1 RAs among various injected and oral agents recommended for the management of T2D. The rationale for early use of GLP-1 RAs in T2D management is manifold: these agents offer effective management of hyperglycemia in early-stage T2D, minimal risk of hypoglycemia, weight loss, improvement in multiple non-glycemic cardiovascular risk factors, and potential enhancement of patient adherence to antihyperglycemic treatment. Available data from clinical trials support second-line use of GLP-1 RAs among patients who fail on metformin, as well as first-line use of these agents in a subset of T2D patients.

CONCLUSIONS

The ability to achieve glycemic targets using GLP-1 RAs while simultaneously avoiding hypoglycemia and weight gain could provide substantial reassurance to physicians and patients who might otherwise resist the transition to injected therapies. Exenatide and liraglutide represent appropriate second-line choices for pharmacological treatment of T2D, as indicated in the 2013 CDA guidelines.

An obese lady of 51 year with Type 2 Diabetes Mellitus for 13 years was prescribed Liraglutide, a glucagon like peptide (GLP-1) analogue (Victoza) for glycaemic control and reduction of weight. She was on gliclazide and Insulin prior to initiation of Liraglutide. Eight weeks after initiation of GLP -1 analogue, she developed severe abdominal pain, nausea and vomiting. She was admitted to a private hospital and evaluated. Biochemical tests and CT scan revealed presence of pancreatitis and she was treated for acute pancreatitis. Liraglutide was withdrawn and symptoms subsided. Subsequent follow-up showed that pancreatic enzyme levels were normal.

BACKGROUND

GLP-1 analogues has established role in the management of type 2 diabetes mellitus (T2DM). Liraglutide, a human GLP-1 analogue is used as an adjunct to diet and exercise in adults with T2DM for improvement of glycemic control.

OBJECTIVE

To assess the efficacy and safety of liraglutide in Indian patients with T2DM in real-world setting.

METHODS

A prospective, open label, single arm, single centre, observational study of 24 weeks duration in a real-world setting. Subjects with T2DM with impaired glucose control despite of antidiabetic therapy and clinically suitable for liraglutide therapy were enrolled and managed. All subjects received liraglutide therapy in addition to their existing anti-diabetic therapy. Starting dose of liraglutide (Victoza) was 0.6 mg/day for 7 days followed by 1.2 mg/day for next 7 days and finally 1.8 mg/day for 22 weeks. Subjects were evaluated at baseline and at 24 weeks. Adverse events (AE) noted during course of therapy were recorded. Student t test (two tailed, dependent) was performed for assessment of statistical significance.

RESULTS

Total 195 subjects were studied over 24 weeks. Mean fasting plasma glucose (FPG) was decreased from 163.81 mg/dL to 111.6 (P<0.001); similarly HbA1c was reduced from 8.14% to 6.96% (P=0.006) at 24 weeks. At week 24, 49.23% and 41.03% subjects treated with liraglutide reached an HbA1c<7.0% and ≤6.5%, respectively. Mean weight was reduced from 86.41 kg to 82.37 kg (P<0.001). Additionally mean systolic and diastolic blood pressure was reduced from 129.31 and 76.18 mm of Hg to 119.59 (P=0.90) and 70.88 (P<0.001) mm of Hg, respectively. Serum cholesterol was reduced from 166.68 mg/dL to 124.86 mg/dL (P<0.001). Twenty-two (11.28%) subjects reported adverse events (AE), the most common AEs being vomiting, tiredness, loose motion and nausea. All AEs were mild to moderate in nature without any serious AE.

CONCLUSIONS

In 195 Indian patients with T2DM receiving anti-diabetic drugs, addition of liraglutide resulted in significant improvement in glycemic parameters and was well tolerated. Clinically significant reduction in weight, blood pressure and serum cholesterol were also noted.

Liraglutide (victoza, Novo Nordisk A/S) is human GLP-1 analogue developed by recombinant DNA technology. It is indicated along with diet and exercise in management of type 2 diabetes (T2DM) in adults. Liraglutide has been made available in India recently. Present review evaluates the efficacy and safety of liraglutide in T2DM and its comparison with other incretin based therapies. Liraglutide has been evaluated as monotherapy, in combination with one, two and three oral antidiabetic drugs similarly to routine clinical practice. These studies reported greater improvement in glycaemic control with liraglutide compared with comparators. Evaluation up to 2 years revealed sustained improvement in glycaemic control with liraglutide use. Liraglutide was well tolerated except for mild to moderate gastro-intestinal adverse events, which declined after continuation of therapy. Low risk of hypoglycaemia was reported with liraglutide therapy. Greater efficacy than other incretin based therapies was noted with liraglutide. Liraglutide has an important place in the management of T2DM. Apart from glycaemic control it also provides some important non-glycaemic benefits in terms of improving beta-cell function, weight reduction, and reduction in systolic blood pressure thereby overcoming the present therapeutic gap.

Liraglutide (Victoza) is a peptide produced by DNA recombinant technology, which presents 97% homology with human glucagon-like peptide-1 (GLP-1) but is resistant to dipeptidylpeptidase-4, the enzyme that degrades the natural hormone. It actives the GLP-1 receptor and exerts an incretin mimetic effect during at least 24 hours after a single subcutaneous injection. Besides a glucose-dependent stimulatory effect of insulin secretion, liraglutide inhibits glucagon secretion and retards gastric emptying. In patients with type 2 diabetes, it reduces glycated haemoglobin by at least 1%, without inducing hypoglycaemia. It also induces a moderate weight loss and a mild reduction in blood pressure. Gastrointestinal adverse events (nausea, vomiting) may occur during the initial phase of treatment, but rarely impose the interruption of the medication and usually diminish with time.Although indicated in combination with other glucose-lowering agents, liraglutide is currently reimbursed in Belgium only if administered in patients with type 2 diabetes not sufficiently controlled with a combination of metformin plus sulfonylurea or metformin plus a thiazolidinedione. Victoza is presented in prefilled pens and is injected subcutaneously once a day. Treatment will be initiated with 0.6 mg to improve digestive tolerance and the daily dose will be increased to 1.2 mg (usual dose) after at least one week, and up to 1.8 mg (maximal dose) if necessary.

Liraglutide is a human glucagon-like peptide-1 receptor agonist approved for treatment of adults with type 2 diabetes mellitus at a maximum dose of 1.8 mg/day (Victoza^®) and more recently at 3.0 mg/day for weight management (Saxenda^®). During the evaluation of liraglutide for approval in weight management, a minor imbalance in the numbers of reported breast neoplasms was observed, motivating the present study. Our objective was to quantify the association between liraglutide and incidence of breast cancer (BC) among women in a real-world setting.

Women initiating liraglutide or other antidiabetic therapies and who were enrolled in a large US health plan (2010-2014) were included. Comparisons of BC incidence rates were made between matched cohorts of initiators of liraglutide and cohorts of initiators of exenatide, metformin, pioglitazone, sulfonylureas, and dipeptidyl peptidase-4 inhibitors separately and as two "all comparators" groupings: with or without exenatide. Women with two or more claims with BC diagnosis codes within 61days of each other were identified as possible cases, with additional confirmation by clinician review of comprehensive claims listings. Propensity score matched intention-to-treat (ITT) and time-on-drug (TOD) analyses were completed via Poisson regression. A latency analysis was performed.Relative risks for BC for liraglutide vs comparators from the ITT analyses ranged from 0.90 (95% CI: 0.67-1.22) for both the "all comparator" and "all comparator except exenatide" cohorts to 1.46 (95% CI: 0.96-2.22) relative to exenatide. Latency analyses excluding the first year of follow-up yielded slightly attenuated point estimates. The TOD analyses of cumulative use of liraglutide suggested no increased risk of BC.Neither the ITT (overall or latency analysis) nor cumulative TOD analyses suggested an elevated risk of BC among liraglutide initiators. Short length of follow-up and the potential for confounding by unmeasured factors limit the full assessment of long-term risk.

OBJECTIVE

The objective was to compare the use of low-dose liraglutide (LD-L) (Victoza) to the other glucagon-like peptide-1 receptor agonists (GLP-1 RAs) in patients without a type 2 diabetes (T2D) diagnosis in the post approval period for high-dose liraglutide (HD-L) (Saxenda), which is not indicated for T2D.

METHODS

This was a retrospective, repeated cross-sectional, cohort study.

METHODS

Adult patients with T2D with more than 1 prescription for a GLP-1 RA in the Optum Humedica database between December 2014 and March 2016 were included. The proportions of patients without a T2D diagnosis who were prescribed L-DL versus the other GLP-1 RAs and within each cohort were computed. Logistic regression models estimated the predictive value of either treatment in those without a T2D diagnosis, controlling for multiple factors. To supplement these findings, administrative claims data were extracted from the Truven Health MarketScan database.

RESULTS

Analyses identified 11,245 patients prescribed LD-L and 4134 patients prescribed other GLP-1 RAs. For the entire study period, Humedica data revealed that patients without T2D accounted for 2.7% of the GLP-1 RA cohort and 17.5% of the LD-L cohort. Multivariable logistic regression analyses identified that patients receiving LD-L were more than 6 times likely to have no indication of T2D relative to patients taking other GLP-1 RAs. Claims data from MarketScan corroborated the Humedica results.

CONCLUSIONS

In patients without a T2D diagnosis, LD-L use was significantly greater than that with other GLP-1 RAs within 6 months after approval of HD-L; differences persisted until the end of the study. Increased payer scrutiny of appropriate LD-L use is warranted.