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Why are older patients with type 2 diabetes treated for dyslipidemia but not for hyperglycaemia?
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CANADIAN JOURNAL OF DIABETES
T2D treatments available for this special population. This meta-analysis of the six phase 3 trials for liraglutide (Liraglutide Effect and Action in Diabetes [LEAD]) investigated changes in HbA1c, body weight (BW), systolic blood pressure (SBP) and hypoglycaemia from baseline to 26 weeks in elderly (>65 years) vs young (<65 years) patients with T2D receiving liraglutide 1.8 mg/day or placebo. Materials and methods: HbA1c, BW and SBP data from the 6 trials were stratified by age, >65 years (n=474) and <65 years (n=2276). The changes in HbA1c and body weight were analysed by age group using ANCOVA. results: Reduction in HbA1c from baseline was significantly greater after 26 weeks with liraglutide 1.8 mg vs placebo for both age groups (p<0.0001). Reductions in HbA1c with liraglutide 1.8 mg were similar between <65-years vs >65-year age groups: -1.39 vs -1.32%, respectively. These reductions in HbA1c with liraglutide brought a high number of subjects below the American Diabetes Association HbA1c target of 7%: 68% in the age group <65 years and 60% in the age group >65 years. BW reduced significantly from baseline with liraglutide 1.8 mg in <65-year and >65-year age groups (-1.71 and -2.17kg, respectively; both p<0.0001 vs baseline) whereas reductions seen with placebo, for both age groups, were not significant (-0.51 and -0.70 kg, respectively; p=NS vs baseline). No significant differences in BW change, between age groups, with liraglutide and placebo were observed. Reductions in SBP from baseline, with liraglutide 1.8 mg, was significant in age group <65y (-2.96; p<0.001). Improvements in SBP with liraglutide 1.8 mg were more pronounced in the <65-year age group vs >65-year age group (-0.86 mmHg: difference of -2.09 mmHg, p<0.05) but not with placebo (+0.39 mmHg: difference of -0.71, p=NS). The proportion of subjects reporting minor hypoglycaemia was low and similar between age groups with liraglutide 1.8 mg (13.4% [<65 years] and 13.9% [>65 years]) and placebo (8.3% [<65 years] and 8.0% [>65 years]). Adverse events were predominantly gastrointestinal in nature, that is, nausea. The proportion of subjects experiencing nausea with liraglutide 1.8 mg was 11.3% (<65 years) vs 14.7% (>65 years), respectively. conclusions: These data show that the efficacy of liraglutide with respect to HbA1c and weight is independent of age in T2D, and that liraglutide is well-tolerated in patients <65 years or >65 years with low risk of hypoglycaemia. Diabetes in the elderly, in-patients, and other special groups
patients who currently received lipid lowering therapy. results: 441 patients (57.3% of 770 older patients with untreated T2DM) were receiving treatment for dyslipidemia; mean (SD) age was 71.4 (5.7) years, 52.6% were male, mean BMI was 30.3 (4.9), and average duration of diabetes was 21.1 (24.0) months. Most recent mean measures were 6.8% (0.6) for HbA1c (with 32.6% not at goal <7%), and 7.1 mmol/L (1.5) for FPG (44.6% were >=7.0 mmol/L). Macrovascular complications were reported in 24.9% of patients, and microvascular in 17.2%. 46.3% of patients had an estimated glomerular filtration rate <60 mL/min/1.73m2. 79.1% were being treated with an antihypertensive. Median number of current medications used was 4. The distribution of the first ranked physician reasons for not initiating AHA therapy was “try diet and exercise first (D&E)” 53.9%, “mild hyperglycemia” 25.6%, “patient’s concerns” 14.8%, “concerns related to AHAs” 3.2%, and “issues with comorbidity and polypharmacy” 2.5%. However, the corresponding proportions of patients with HbA1c >=7% were 27.5%, 25.0%, 59.4%, 50.0%, and 45.5%, respectively. Based on most recent measures, HbA1c had increased since diagnosis in 16.4% of all patients and 26.0% of patients with recent HbA1c >=7%. Among 112 patients who were scheduled to be treated with AHA within a month as indicated by their physician, 57% had a current HbA1c above the threshold specified by their physician for medication initiation. conclusion: In these older patients treated for dyslipidemia, but not treated with AHA for >6 months since T2DM diagnosis, one third had HbA1c levels above goal and some already had macro-/micro-vascular complications. Reasons for non-treatment with AHA suggest there are substantial barriers to AHA use in real world practice, including physician’s perception of “mild hyperglycemia” and the HbA1c threshold for initiating AHA, which should be explored further. Diabetes in the elderly, in-patients, and other special groups Conflict of interest Stock ownership: Q. Zhang and L. Radican are owners of Merck stock Employee: Q. Zhang and L. Radican are employees of Merck & Co. Commercially-sponsored research: M. Feinglos receives research grant support from Merck & Co. Other substantive relationships: E. Marrett is a Merck funded research fellow.S. Narayanan has had a financial relationship with Merck & Co. (research support)
Conflict of interest Paid lecturing: B Bode, R Pratley: Novo Nordisk Employee: A Falahati, J Brett: Novo Nordisk Commercially-sponsored research: B Bode, R Pratley: Novo Nordisk Other substantive relationships: B Bode: Novo Nordisk (consultant)
P-1382
P-1354
1
Why are older patients with type 2 diabetes treated for dyslipidemia but not for hyperglycaemia? Q. Zhang1, E. Marrett1, L. Radican1, S. Narayanan2, M. Feinglos3 Merck & Co. Inc., Global Outcomes Research and Reimbursement, Whitehouse Station New Jersey, USA 2 TNS Healthcare, Global TPO & HEOR, New York New York, USA 3 Duke Univeristy Medical Center, Medicine/Endocrinology Metabolism & Nutrition, Durham North Carolina, USA
1
aims: Previous research has highlighted the need for earlier intervention in diabetes. This study examined older patients treated for dyslipidemia but not type 2 diabetes (T2DM) for >6 months after T2DM diagnosis, and assessed reasons for non-treatment with antihyperglycemic agents (AHA). Methods: A survey was conducted in Nov/Dec-2008 among a panel of U.S. primary care physicians. Patients aged >=65 years at time of T2DM diagnosis, who had not initiated AHA therapy for >=6 months after diagnosis, were selected by their physicians. Each physician provided data for 2 patients based on chart review and reasons for not initiating AHA therapy. In this analysis we focused on a subgroup of
changes in glycosylated haemoglobin levels among managed care dyslipidemia patients with type 2 diabetes treated with niacin extended-release plus statin versus other lipid therapies S. Balu1, R. Quimbo2, M. Cziraky2, R. Simko1 Abbott Laboratories, Global Health Economics & Outcomes Research, Abbott Park, USA 2 HealthCore Inc., Health Outcomes, Wilmington, USA
aim: To compare changes in glycemic regulation in patients with type II diabetes (T2D) and dyslipidemia treated with niacin extendedrelease + any statin (NER+S), ezetimibe + any statin (E+S), or statin monotherapy (SM) in a managed care setting. Methods: Retrospective analysis of the HealthCore Integrated Research Database was performed on patients aged =18 years, diagnosed with dyslipidemia and T2D, minimum of 12-month pre- and post-index health plan eligibility, and newly initiating NER+S, E+S, or SM therapy between 1/1/2000-6/30/2006 (index date). Comparisons included mean change in HbA1c level and percent (%) of patients achieving < 7% HbA1c from baseline (12 months prior to index date) to 1-year post-index between the study cohorts. Multivariate regression analysis estimated change in HbA1c level after adjusting for differences in age, gender, prior cardiovascular disease (CVD), hypertension, baseline HbA1c, and pre- and post-index average daily dose of insulin, oral and other injectable anti-diabetic medications (incretin mimetics). results: A total of 2,441 patients were identified, 204 NER+S, 343 E+S, and 1,894 SM. SM patients were significantly younger (51.7 ±
CANADIAN JOURNAL OF DIABETES
T2D treatments available for this special population. This meta-analysis of the six phase 3 trials for liraglutide (Liraglutide Effect and Action in Diabetes [LEAD]) investigated changes in HbA1c, body weight (BW), systolic blood pressure (SBP) and hypoglycaemia from baseline to 26 weeks in elderly (>65 years) vs young (<65 years) patients with T2D receiving liraglutide 1.8 mg/day or placebo. Materials and methods: HbA1c, BW and SBP data from the 6 trials were stratified by age, >65 years (n=474) and <65 years (n=2276). The changes in HbA1c and body weight were analysed by age group using ANCOVA. results: Reduction in HbA1c from baseline was significantly greater after 26 weeks with liraglutide 1.8 mg vs placebo for both age groups (p<0.0001). Reductions in HbA1c with liraglutide 1.8 mg were similar between <65-years vs >65-year age groups: -1.39 vs -1.32%, respectively. These reductions in HbA1c with liraglutide brought a high number of subjects below the American Diabetes Association HbA1c target of 7%: 68% in the age group <65 years and 60% in the age group >65 years. BW reduced significantly from baseline with liraglutide 1.8 mg in <65-year and >65-year age groups (-1.71 and -2.17kg, respectively; both p<0.0001 vs baseline) whereas reductions seen with placebo, for both age groups, were not significant (-0.51 and -0.70 kg, respectively; p=NS vs baseline). No significant differences in BW change, between age groups, with liraglutide and placebo were observed. Reductions in SBP from baseline, with liraglutide 1.8 mg, was significant in age group <65y (-2.96; p<0.001). Improvements in SBP with liraglutide 1.8 mg were more pronounced in the <65-year age group vs >65-year age group (-0.86 mmHg: difference of -2.09 mmHg, p<0.05) but not with placebo (+0.39 mmHg: difference of -0.71, p=NS). The proportion of subjects reporting minor hypoglycaemia was low and similar between age groups with liraglutide 1.8 mg (13.4% [<65 years] and 13.9% [>65 years]) and placebo (8.3% [<65 years] and 8.0% [>65 years]). Adverse events were predominantly gastrointestinal in nature, that is, nausea. The proportion of subjects experiencing nausea with liraglutide 1.8 mg was 11.3% (<65 years) vs 14.7% (>65 years), respectively. conclusions: These data show that the efficacy of liraglutide with respect to HbA1c and weight is independent of age in T2D, and that liraglutide is well-tolerated in patients <65 years or >65 years with low risk of hypoglycaemia. Diabetes in the elderly, in-patients, and other special groups
patients who currently received lipid lowering therapy. results: 441 patients (57.3% of 770 older patients with untreated T2DM) were receiving treatment for dyslipidemia; mean (SD) age was 71.4 (5.7) years, 52.6% were male, mean BMI was 30.3 (4.9), and average duration of diabetes was 21.1 (24.0) months. Most recent mean measures were 6.8% (0.6) for HbA1c (with 32.6% not at goal <7%), and 7.1 mmol/L (1.5) for FPG (44.6% were >=7.0 mmol/L). Macrovascular complications were reported in 24.9% of patients, and microvascular in 17.2%. 46.3% of patients had an estimated glomerular filtration rate <60 mL/min/1.73m2. 79.1% were being treated with an antihypertensive. Median number of current medications used was 4. The distribution of the first ranked physician reasons for not initiating AHA therapy was “try diet and exercise first (D&E)” 53.9%, “mild hyperglycemia” 25.6%, “patient’s concerns” 14.8%, “concerns related to AHAs” 3.2%, and “issues with comorbidity and polypharmacy” 2.5%. However, the corresponding proportions of patients with HbA1c >=7% were 27.5%, 25.0%, 59.4%, 50.0%, and 45.5%, respectively. Based on most recent measures, HbA1c had increased since diagnosis in 16.4% of all patients and 26.0% of patients with recent HbA1c >=7%. Among 112 patients who were scheduled to be treated with AHA within a month as indicated by their physician, 57% had a current HbA1c above the threshold specified by their physician for medication initiation. conclusion: In these older patients treated for dyslipidemia, but not treated with AHA for >6 months since T2DM diagnosis, one third had HbA1c levels above goal and some already had macro-/micro-vascular complications. Reasons for non-treatment with AHA suggest there are substantial barriers to AHA use in real world practice, including physician’s perception of “mild hyperglycemia” and the HbA1c threshold for initiating AHA, which should be explored further. Diabetes in the elderly, in-patients, and other special groups Conflict of interest Stock ownership: Q. Zhang and L. Radican are owners of Merck stock Employee: Q. Zhang and L. Radican are employees of Merck & Co. Commercially-sponsored research: M. Feinglos receives research grant support from Merck & Co. Other substantive relationships: E. Marrett is a Merck funded research fellow.S. Narayanan has had a financial relationship with Merck & Co. (research support)
Conflict of interest Paid lecturing: B Bode, R Pratley: Novo Nordisk Employee: A Falahati, J Brett: Novo Nordisk Commercially-sponsored research: B Bode, R Pratley: Novo Nordisk Other substantive relationships: B Bode: Novo Nordisk (consultant)
P-1382
P-1354
1
Why are older patients with type 2 diabetes treated for dyslipidemia but not for hyperglycaemia? Q. Zhang1, E. Marrett1, L. Radican1, S. Narayanan2, M. Feinglos3 Merck & Co. Inc., Global Outcomes Research and Reimbursement, Whitehouse Station New Jersey, USA 2 TNS Healthcare, Global TPO & HEOR, New York New York, USA 3 Duke Univeristy Medical Center, Medicine/Endocrinology Metabolism & Nutrition, Durham North Carolina, USA
1
aims: Previous research has highlighted the need for earlier intervention in diabetes. This study examined older patients treated for dyslipidemia but not type 2 diabetes (T2DM) for >6 months after T2DM diagnosis, and assessed reasons for non-treatment with antihyperglycemic agents (AHA). Methods: A survey was conducted in Nov/Dec-2008 among a panel of U.S. primary care physicians. Patients aged >=65 years at time of T2DM diagnosis, who had not initiated AHA therapy for >=6 months after diagnosis, were selected by their physicians. Each physician provided data for 2 patients based on chart review and reasons for not initiating AHA therapy. In this analysis we focused on a subgroup of
changes in glycosylated haemoglobin levels among managed care dyslipidemia patients with type 2 diabetes treated with niacin extended-release plus statin versus other lipid therapies S. Balu1, R. Quimbo2, M. Cziraky2, R. Simko1 Abbott Laboratories, Global Health Economics & Outcomes Research, Abbott Park, USA 2 HealthCore Inc., Health Outcomes, Wilmington, USA
aim: To compare changes in glycemic regulation in patients with type II diabetes (T2D) and dyslipidemia treated with niacin extendedrelease + any statin (NER+S), ezetimibe + any statin (E+S), or statin monotherapy (SM) in a managed care setting. Methods: Retrospective analysis of the HealthCore Integrated Research Database was performed on patients aged =18 years, diagnosed with dyslipidemia and T2D, minimum of 12-month pre- and post-index health plan eligibility, and newly initiating NER+S, E+S, or SM therapy between 1/1/2000-6/30/2006 (index date). Comparisons included mean change in HbA1c level and percent (%) of patients achieving < 7% HbA1c from baseline (12 months prior to index date) to 1-year post-index between the study cohorts. Multivariate regression analysis estimated change in HbA1c level after adjusting for differences in age, gender, prior cardiovascular disease (CVD), hypertension, baseline HbA1c, and pre- and post-index average daily dose of insulin, oral and other injectable anti-diabetic medications (incretin mimetics). results: A total of 2,441 patients were identified, 204 NER+S, 343 E+S, and 1,894 SM. SM patients were significantly younger (51.7 ±