Use of Liraglutide in the Real World and Impact at 36 Months on Metabolic Control, Weight, Lipid Profile, Blood Pressure, Heart Rate, and Renal Function

Maurizio Rondinelli, Antonio Rossi, Alessandra Gandolfi, Fabio Saponaro, Loredana Bucciarelli, Guido Adda, Chiara Molinari, Laura Montefusco, Claudia Specchia, Maria Chiara Rossi, Marco Scardapane, Maura Arosio, Stefano Genovese

Research output: Contribution to journalArticle

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Abstract

Purpose An observational retrospective study was conducted by 2 diabetes clinics in Italy to assess patterns of use and long-term effectiveness of liraglutide on established and emerging parameters. Methods Data from 261 patients with type 2 diabetes who started treatment with liraglutide between 2010 and 2014 were collected. Hierarchical linear regression models were applied to assess trends over time of clinical parameters. Factors associated with higher likelihood of dropout were identified through multivariate logistic analysis. Findings Liraglutide was initiated as a switch in 42.5% of patients and as an add-on in 49.8%; in 7.7% of the patients initiation of liraglutide was associated with a reduction in the number of pharmacologic agents. A statistically significant reduction after 36 months was found for the following parameters (mean change [95% CIs]): glycosylated hemoglobin (HbA1c; –1.01% [1.34% to –0.68%]), fasting blood glucose (–27.5 [–40.6 to –14.4] mg/dL), weight (–2.9 [–4.5 to –1.3] kg), body mass index (–1.13 [–1.76 to –0.50] kg/m2), waist circumference (–1.74 [–3.85 to –0.37] cm), and LDL-C (–24.7 [–36.67 to –12.8] mg/dL). Improvements in systolic (–3.5 mm Hg) and diastolic (–2.3 mm Hg) blood pressures were observed at 24 months. Albuminuria was reduced by –16.6 mg/L during 36 months, although statistical significance was not reached. Glomerular filtration rate and heart rate were unchanged. Reductions in HbA1c between –0.6% and –1.3% were obtained in specific subgroups. Treatment was effective also in patients with >20 years of diabetes duration, although the likelihood of dropout was 6% higher for each additional year of disease duration (RR = 1.06; 95% CI, 1.01–1.12). The likelihood of dropout was almost four times higher for subjects treated with insulin (RR = 3.82; 95% CI, 1.22–11.96) and more than twice for those treated with sulfonylureas (RR = 2.39; 95% CI, 1.16–4.94) compared with patients not treated with these agents. Implications Liraglutide used in routine clinical conditions maintains its effectiveness on metabolic control and weight after 3 years. Improvements in terms of metabolic control were found when liraglutide was used as both switch and add-on treatment. In addition, improvements were sustained when liraglutide replaced sulfonylureas or insulin. Diabetes duration had no impact on drug efficacy. Long-term benefits relative to blood pressure and LDL-C were also found, which could not be entirely explained by antihypertensive/lipid-lowering treatment intensification. No major effect on renal parameters was documented. Diabetes duration and some concomitant treatments were associated with a higher likelihood of liraglutide discontinuation. These data can contribute to improve appropriateness and cost-effectiveness profile of liraglutide.

Original languageEnglish
Pages (from-to)159-169
Number of pages11
JournalClinical Therapeutics
Volume39
Issue number1
DOIs
Publication statusPublished - Jan 1 2017

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Heart Rate
Blood Pressure
Kidney
Lipids
Weights and Measures
Linear Models
Insulin
Therapeutics
Liraglutide
Albuminuria
Glycosylated Hemoglobin A
Waist Circumference
Glomerular Filtration Rate
Type 2 Diabetes Mellitus
Antihypertensive Agents
Italy
Cost-Benefit Analysis
Observational Studies
Blood Glucose
Fasting

Keywords

  • effectiveness
  • liraglutide
  • real world
  • type 2 diabetes

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)

Cite this

Use of Liraglutide in the Real World and Impact at 36 Months on Metabolic Control, Weight, Lipid Profile, Blood Pressure, Heart Rate, and Renal Function. / Rondinelli, Maurizio; Rossi, Antonio; Gandolfi, Alessandra; Saponaro, Fabio; Bucciarelli, Loredana; Adda, Guido; Molinari, Chiara; Montefusco, Laura; Specchia, Claudia; Chiara Rossi, Maria; Scardapane, Marco; Arosio, Maura; Genovese, Stefano.

In: Clinical Therapeutics, Vol. 39, No. 1, 01.01.2017, p. 159-169.

Research output: Contribution to journalArticle

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abstract = "Purpose An observational retrospective study was conducted by 2 diabetes clinics in Italy to assess patterns of use and long-term effectiveness of liraglutide on established and emerging parameters. Methods Data from 261 patients with type 2 diabetes who started treatment with liraglutide between 2010 and 2014 were collected. Hierarchical linear regression models were applied to assess trends over time of clinical parameters. Factors associated with higher likelihood of dropout were identified through multivariate logistic analysis. Findings Liraglutide was initiated as a switch in 42.5{\%} of patients and as an add-on in 49.8{\%}; in 7.7{\%} of the patients initiation of liraglutide was associated with a reduction in the number of pharmacologic agents. A statistically significant reduction after 36 months was found for the following parameters (mean change [95{\%} CIs]): glycosylated hemoglobin (HbA1c; –1.01{\%} [1.34{\%} to –0.68{\%}]), fasting blood glucose (–27.5 [–40.6 to –14.4] mg/dL), weight (–2.9 [–4.5 to –1.3] kg), body mass index (–1.13 [–1.76 to –0.50] kg/m2), waist circumference (–1.74 [–3.85 to –0.37] cm), and LDL-C (–24.7 [–36.67 to –12.8] mg/dL). Improvements in systolic (–3.5 mm Hg) and diastolic (–2.3 mm Hg) blood pressures were observed at 24 months. Albuminuria was reduced by –16.6 mg/L during 36 months, although statistical significance was not reached. Glomerular filtration rate and heart rate were unchanged. Reductions in HbA1c between –0.6{\%} and –1.3{\%} were obtained in specific subgroups. Treatment was effective also in patients with >20 years of diabetes duration, although the likelihood of dropout was 6{\%} higher for each additional year of disease duration (RR = 1.06; 95{\%} CI, 1.01–1.12). The likelihood of dropout was almost four times higher for subjects treated with insulin (RR = 3.82; 95{\%} CI, 1.22–11.96) and more than twice for those treated with sulfonylureas (RR = 2.39; 95{\%} CI, 1.16–4.94) compared with patients not treated with these agents. Implications Liraglutide used in routine clinical conditions maintains its effectiveness on metabolic control and weight after 3 years. Improvements in terms of metabolic control were found when liraglutide was used as both switch and add-on treatment. In addition, improvements were sustained when liraglutide replaced sulfonylureas or insulin. Diabetes duration had no impact on drug efficacy. Long-term benefits relative to blood pressure and LDL-C were also found, which could not be entirely explained by antihypertensive/lipid-lowering treatment intensification. No major effect on renal parameters was documented. Diabetes duration and some concomitant treatments were associated with a higher likelihood of liraglutide discontinuation. These data can contribute to improve appropriateness and cost-effectiveness profile of liraglutide.",
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T1 - Use of Liraglutide in the Real World and Impact at 36 Months on Metabolic Control, Weight, Lipid Profile, Blood Pressure, Heart Rate, and Renal Function

AU - Rondinelli, Maurizio

AU - Rossi, Antonio

AU - Gandolfi, Alessandra

AU - Saponaro, Fabio

AU - Bucciarelli, Loredana

AU - Adda, Guido

AU - Molinari, Chiara

AU - Montefusco, Laura

AU - Specchia, Claudia

AU - Chiara Rossi, Maria

AU - Scardapane, Marco

AU - Arosio, Maura

AU - Genovese, Stefano

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N2 - Purpose An observational retrospective study was conducted by 2 diabetes clinics in Italy to assess patterns of use and long-term effectiveness of liraglutide on established and emerging parameters. Methods Data from 261 patients with type 2 diabetes who started treatment with liraglutide between 2010 and 2014 were collected. Hierarchical linear regression models were applied to assess trends over time of clinical parameters. Factors associated with higher likelihood of dropout were identified through multivariate logistic analysis. Findings Liraglutide was initiated as a switch in 42.5% of patients and as an add-on in 49.8%; in 7.7% of the patients initiation of liraglutide was associated with a reduction in the number of pharmacologic agents. A statistically significant reduction after 36 months was found for the following parameters (mean change [95% CIs]): glycosylated hemoglobin (HbA1c; –1.01% [1.34% to –0.68%]), fasting blood glucose (–27.5 [–40.6 to –14.4] mg/dL), weight (–2.9 [–4.5 to –1.3] kg), body mass index (–1.13 [–1.76 to –0.50] kg/m2), waist circumference (–1.74 [–3.85 to –0.37] cm), and LDL-C (–24.7 [–36.67 to –12.8] mg/dL). Improvements in systolic (–3.5 mm Hg) and diastolic (–2.3 mm Hg) blood pressures were observed at 24 months. Albuminuria was reduced by –16.6 mg/L during 36 months, although statistical significance was not reached. Glomerular filtration rate and heart rate were unchanged. Reductions in HbA1c between –0.6% and –1.3% were obtained in specific subgroups. Treatment was effective also in patients with >20 years of diabetes duration, although the likelihood of dropout was 6% higher for each additional year of disease duration (RR = 1.06; 95% CI, 1.01–1.12). The likelihood of dropout was almost four times higher for subjects treated with insulin (RR = 3.82; 95% CI, 1.22–11.96) and more than twice for those treated with sulfonylureas (RR = 2.39; 95% CI, 1.16–4.94) compared with patients not treated with these agents. Implications Liraglutide used in routine clinical conditions maintains its effectiveness on metabolic control and weight after 3 years. Improvements in terms of metabolic control were found when liraglutide was used as both switch and add-on treatment. In addition, improvements were sustained when liraglutide replaced sulfonylureas or insulin. Diabetes duration had no impact on drug efficacy. Long-term benefits relative to blood pressure and LDL-C were also found, which could not be entirely explained by antihypertensive/lipid-lowering treatment intensification. No major effect on renal parameters was documented. Diabetes duration and some concomitant treatments were associated with a higher likelihood of liraglutide discontinuation. These data can contribute to improve appropriateness and cost-effectiveness profile of liraglutide.

AB - Purpose An observational retrospective study was conducted by 2 diabetes clinics in Italy to assess patterns of use and long-term effectiveness of liraglutide on established and emerging parameters. Methods Data from 261 patients with type 2 diabetes who started treatment with liraglutide between 2010 and 2014 were collected. Hierarchical linear regression models were applied to assess trends over time of clinical parameters. Factors associated with higher likelihood of dropout were identified through multivariate logistic analysis. Findings Liraglutide was initiated as a switch in 42.5% of patients and as an add-on in 49.8%; in 7.7% of the patients initiation of liraglutide was associated with a reduction in the number of pharmacologic agents. A statistically significant reduction after 36 months was found for the following parameters (mean change [95% CIs]): glycosylated hemoglobin (HbA1c; –1.01% [1.34% to –0.68%]), fasting blood glucose (–27.5 [–40.6 to –14.4] mg/dL), weight (–2.9 [–4.5 to –1.3] kg), body mass index (–1.13 [–1.76 to –0.50] kg/m2), waist circumference (–1.74 [–3.85 to –0.37] cm), and LDL-C (–24.7 [–36.67 to –12.8] mg/dL). Improvements in systolic (–3.5 mm Hg) and diastolic (–2.3 mm Hg) blood pressures were observed at 24 months. Albuminuria was reduced by –16.6 mg/L during 36 months, although statistical significance was not reached. Glomerular filtration rate and heart rate were unchanged. Reductions in HbA1c between –0.6% and –1.3% were obtained in specific subgroups. Treatment was effective also in patients with >20 years of diabetes duration, although the likelihood of dropout was 6% higher for each additional year of disease duration (RR = 1.06; 95% CI, 1.01–1.12). The likelihood of dropout was almost four times higher for subjects treated with insulin (RR = 3.82; 95% CI, 1.22–11.96) and more than twice for those treated with sulfonylureas (RR = 2.39; 95% CI, 1.16–4.94) compared with patients not treated with these agents. Implications Liraglutide used in routine clinical conditions maintains its effectiveness on metabolic control and weight after 3 years. Improvements in terms of metabolic control were found when liraglutide was used as both switch and add-on treatment. In addition, improvements were sustained when liraglutide replaced sulfonylureas or insulin. Diabetes duration had no impact on drug efficacy. Long-term benefits relative to blood pressure and LDL-C were also found, which could not be entirely explained by antihypertensive/lipid-lowering treatment intensification. No major effect on renal parameters was documented. Diabetes duration and some concomitant treatments were associated with a higher likelihood of liraglutide discontinuation. These data can contribute to improve appropriateness and cost-effectiveness profile of liraglutide.

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