Abstract
Objectives
The glycaemic goals for older patients with type 2 diabetes mellitus (DM) are recommended to avoid an HbA1c levels <7%. The purpose of this study was to analyse the glycaemic control and therapeutic management of older adults (≥65 years) with type 2 DM.
Design
Pooled analysis of patients enrolled in three Spanish cross-sectional epidemiological studies.
Setting
The study was conducted between 2009 and 2011 by primary care or specialist physicians.
Participants
A total of 7,269 patients aged ≥65 years with type 2 DM.
Measurements
Sociodemographic, medical history, lifestyle habits, biochemical laboratory parameters, comorbidities, type 2 DM complications, and pharmacological treatment data collected from medical records.
Results
In total, data from 7,269 patients were analysed (mean age 73.4 years old; 48.4% male). A total of 10.9% of patients had HbA1c levels ≥8.5% and 43.2% <7%. The most common comorbidities were hypertension (82.0%) and dyslipidaemia (76.6%). The microvascular complications were mainly diabetic nephropathy (23.6%) and retinopathy (19.3%). Oral antidiabetic drugs (OADs) were taken by 70.5% of patients (sulphonylureas 65.3%), 4.1% were taking insulin alone and 25.4% took both insulin and an OAD. Half of the patients (51.0%) were taking a combination of OADs.
Conclusion
In conclusion, more than half of older patients with type 2 DM had unsatisfactory management: approximately one in ten had inadequate glycaemic control (HbA1c ≥8.5%) despite hypoglycaemic drugs and four in ten were potentially overtreated (HbA1c <7%).
Key words: Diabetes mellitus, glycaemic control, management, older adults, type 2 diabetes
Introduction
Type 2 diabetes mellitus (DM) is a highly prevalent metabolic disease among older people (1). After the publication in 2011 of the European Diabetes Working Party for Older People 2011 clinical guidelines for type 2 diabetes mellitus (2) and in 2012 of the American Diabetes Association (ADA) and American Geriatrics Society (AGS) consensus report on diabetes in older adults (≥65 years) (3), different glycaemic goals for this population were proposed that recommended avoiding haemoglobin A1c (HbA1c) levels of less than 7% (4).
More recently, the global guideline for managing older people with type 2 DM, published by the International Diabetes Federation (IDF) (1, 5), recommended that glycaemic control targets should be individualized by taking into account distinct characteristics such as functional status, presence of comorbidities or type 2 DM complications, or risk of hypoglycaemia. Since the incidence of hypoglycaemia is higher in older type 2 DM patients compared to younger patients, even at comparable glycaemic control (6), antidiabetic therapies with high risk of hypoglycaemia are not recommended for the elderly population (7).
Recently, a US study based on a sample of older adults indicated that a substantial proportion of elderly patients with type 2 DM may be overtreated in clinical practice increasing the risk of serious hypoglycaemia and its consequences such as falls, cognitive impairment, or cardiovascular disease among others (8). In this line, the purpose of our study was to analyse the glycaemic control and the adequacy of treatment patterns in older adults with type 2 DM in Spain.
Methods
We present a pooled analysis of a subgroup of patients (≥65 years) enrolled in three cross-sectional, epidemiological and multicentre studies conducted in Spain between 2009 and 2011 (HIPOQoL (9), OBEDIA (10) and PATHWAYS (11) studies). The overall population of these three studies included 14,266 adult patients (≥18 years) with type 2 DM who attended a primary care physician or specialist; 7,269 patients were ≥65 years old. The OBEDIA study (10) had body mass index (BMI) ≥25 kg/m2 (i.e. overweight or obese patients) as an additional inclusion criterion.
Sociodemographic, medical history, lifestyle habits, biochemical laboratory parameters, comorbidities, type 2 DM complications, and pharmacological treatment data were collected from medical records. The HIPOQoL study did not collect treatment data.
Body mass index was calculated by dividing the body weight by the height squared (kg/m2). Abdominal obesity was defined as waist circumference >102 cm for men and >88 cm for women, according to ADA metabolic syndrome criteria. Systolic and diastolic blood pressures were measured after the individual had been sitting for several minutes. A smoker was defined as either a current smoker or a subject who had stopped smoking within the previous 12 months. A sedentary person was defined as a subject who walked less than half hour per day. Glomerular filtration rate (GFR) was estimated using the abbreviated (four-variable) Modified Diet in Renal Disease (MDRD-4) equation (12): estimated GFR (ml/min/1.73 m2) = 186 x (serum creatinine)-1.154 x (age)-0.203 x (0.742 if female) x (1.210 if black).
All study participants provided informed written consent prior to study enrolment. The three studies were reviewed and approved by the ethics committee at Hospital Clínic of Barcelona (Spain).
Statistical analysis
Categorical and continuous variables were summarised as percentages and mean ± standard deviation (SD), respectively. Missing values were not included in the count. Qualitative variables were analysed by the Chi-square test or the Fisher exact test, as appropriate, and quantitative variables were analysed using the t-test or the Mann-Whitney test. A p-value <0.05 was considered statistically significant. Statistical analyses were performed using the SAS® statistical package for Windows (version 9.2, SAS Institute Inc., Cary, NC, USA).
Results
A total of 7,269 older patients with type 2 DM were included in the analysis. Males accounted for 50.7% of the population between 65-74 years old, and 44.9% of the population aged over 75 years old. The mean age was 73.4 ± 6.0 years and the mean time since type 2 DM diagnosis was 10.9 ± 7.7 years. Table 1 lists the main demographic and clinical characteristics of the study sample. The overall mean BMI value was in the obese range (≥30 kg/m2). Either obesity, as defined by the BMI, or abdominal obesity were significantly lower with increasing age (p<0.05 for both). People aged 75 years or more were less likely to smoke compared to patients between 65 and 74 years and were more likely to exhibit sedentary behaviour (p<0.05 for both).
Table 1.
Demographic, clinical and lifestyle characteristics of older patients with type 2 diabetes mellitus in Spain
| Variable | 65-74 years n=4,408 | ≥75 years n=2,861 | Overall (≥65 years) n=7,269 |
|---|---|---|---|
| Demographic characteristics: | |||
| Age (years), mean ± SD | 69.3 ± 2.8* | 79.6 ± 3.7* | 73.4 ± 6.0 |
| Gender (male), n (%) | 2224 (50.7)* | 1277 (44.9)* | 3501 (48.4) |
| Anthropometric characteristics: | |||
| BMI (kg/m2), mean ± SD | 30.7 ± 4.7 | 30.2 ± 4.8 | 30.5 ± 4.7 |
| BMI (kg/m2)*, n (%): | |||
| <25 | 326 (7.4) | 330 (11.5) | 656 (9.0) |
| 25-<30 | 1813 (41.1) | 1177 (41.1) | 2990 (41.1) |
| ≥30 | 2269 (51.5) | 1354 (47.3) | 3623 (49.8) |
| Abdominal obesity (yes), n (%) | 2736 (70.1)* | 1655 (67.5)* | 4391 (69.1) |
| Vital signs: | |||
| SBP (mmHg), mean ± SD | 139.0 ± 15.0 | 139.3 ± 15.7 | 139.1 ± 15.3 |
| DBP (mmHg), mean ± SD | 80.7 ± 9.9 | 78.9 ± 10.6 | 80.0 ± 10.2 |
| History of diabetes: | |||
| Time since diagnosis (years), mean ± SD | 10.1 ± 7.1* | 12.2 ± 8.5* | 10.9 ± 7.7 |
| Time since diagnosis (years)*, n (%) | |||
| <5 | 1030 (23.9) | 534 (19.2) | 1564 (22.1) |
| 5-<10 | 1455 (33.8) | 803 (28.8) | 2258 (31.8) |
| 10-<15 | 1000 (23.2) | 607 (21.8) | 1607 (22.7) |
| ≥15 | 821 (19.1) | 844 (30.3) | 1665 (23.5) |
| Lifestyle habits: | |||
| Smoking (yes), n (%) | 600 (13.7)* | 222 (7.8)* | 822 (11.4) |
| Sedentary (yes), n (%) |
2695 (65.3)* |
2027 (75.5)* |
4722 (69.3) |
SD: standard deviation; BMI: body mass index; SBP: systolic blood pressure; DBP: diastolic blood pressure
p<0.05
Approximately two thirds (65.8%) of older adults with type 2 DM had HbA1c levels less than 7.5% and 43.2% less than 7% (Figure 1). Around one out of ten patients (10.9%) had HbA1c level greater than or equal to 8.5%. The mean HbA1c was approximately 7% (55 mmol/mol) and the mean fasting glucose level was 145 mg/dl (8.0 mmol/l) [Table 2].
Figure 1.
Glycaemic control (HbA1c [%]) in older patients with type 2 diabetes mellitus in Spain (n=7,269)
Table 2.
Analytical values of older patients with type 2 diabetes mellitus in Spain
| Parameter, mean ± SD | 65-74 years n=4,408 | ≥75 years n=2,861 | Overall (≥65 years) n=7,269 |
|---|---|---|---|
| HbA1c (%) | 7.3 ± 1.2 | 7.2 ± 1.1 | 7.2 ± 1.2 |
| Fasting glucose (mg/dl) | 145.4 ± 43.1 | 144.0 ± 43.7 | 144.8 ± 43.4 |
| Serum albumin (g/dl) | 4.5 ± 1.1 | 4.4 ± 1.1 | 4.5 ± 1.1 |
| Serum creatinine (mg/dl) | 1.0 ± 0.5* | 1.1 ± 0.4* | 1.1 ± 0.4 |
| Urine albumin/ creatinine ratio (mg/g) | 4.8 ± 2.5 | 4.5 ± 2.1 | 4.7 ± 2.3 |
| LDL-cholesterol (mg/dl) | 119.4 ± 36.5 | 114.7 ± 34.1 | 117.6 ± 35.6 |
| HDL-cholesterol (mg/dl) | 51.4 ± 18.6 | 50.7 ± 16.0 | 51.1 ± 17.6 |
| Total cholesterol (mg/dl) | 199.0 ± 42.4 | 192.8 ± 39.1 | 196.4 ± 41.2 |
| Triglycerides (mg/dl) | 155.7 ± 86.9 | 145.7 ± 66.3 | 151.6 ± 79.3 |
| eGFR (ml/min/1.73 m2) | 76.2 ± 50.2* | 68.0 ± 45.7* | 72.9 ± 48.6 |
| eGFR (ml/min/1.73 m2)*, n (%) | |||
| <15 | 17 (0.8) | 4 (0.3) | 21 (0.6) |
| 15-<30 | 35 (1.6) | 44 (2.9) | 79 (2.1) |
| 30-<60 | 572 (25.4) | 581 (38.0) | 1153 (30.5) |
| 60-<90 | 1185 (52.6) | 723 (47.3) | 1908 (50.4) |
| ≥90 |
446 (19.8) |
176 (11.5) |
622 (16.4) |
SD: standard deviation; LDL: low-density lipoprotein; HDL: high-density lipoprotein; eGFR: estimated glomerular filtration rate
p<0.05
Table 2 shows additional biochemical laboratory parameters. Serum albumin, urine albumin/creatinine ratio and lipid levels were similar between age groups. However, estimated GFR (eGFR) decreased with increasing age (p<0.05). There was a higher proportion of patients with an eGFR below 60 ml/ min/1.73 m2 (41.2% vs. 27.8%, p<0.05) or below 30 ml/min/1.73 m2 (3.2% vs. 2.4%, p<0.05) after the age of 75.
Furthermore, there was a high proportion of hypertension, dyslipidaemia and history of coronary artery disease among older patients with type 2 DM (Table 3). The vast majority of patients received concomitant treatment (93.9%), the most common being antihypertensive therapies (82.2%) and lipidlowering medications (73.1 %) [Table 4]. The prevalence of microvascular complications is reported in Table 3 (mainly diabetic nephropathy 23.6% and retinopathy 19.3%). The occurrence of comorbidities and type 2 DM complications increased with age.
Table 3.
Comorbidities and diabetes complications in older patients with type 2 diabetes mellitus in Spain
| Disorder, n (%) | 65-74 years n=4,408 | ≥75 years n=2,861 | Overall (≥65 years) n=7,269 |
|---|---|---|---|
| Hypertension | 2478 (79.9)* | 1798 (85.1)* | 4276 (82.0) |
| Dyslipidaemia | 2413 (77.1) | 1612 (75.9) | 4025 (76.6) |
| Coronary artery disease | 988 (32.6)* | 889 (43.5)* | 1877 (37.0) |
| Cerebrovascular disease | 254 (6.3)* | 340 (12.8)* | 594 (8.8) |
| Peripheral artery disease | 509 (12.5)* | 435 (16.4)* | 944 (14.0) |
| Diabetic retinopathy | 725 (17.8)* | 570 (21.4)* | 1295 (19.3) |
| Diabetic nephropathy | 880 (21.7)* | 705 (26.5)* | 1585 (23.6) |
| Diabetic foot |
223 (5.5) |
176 (6.6) |
399 (5.9) |
p<0.05
Table 4.
Concomitant treatments in older patients with type 2 diabetes mellitus in Spain
| Treatment, n (%) | 65-74 years n=4,408 | ≥75 years n=2,861 | Overall (≥65 years) n=7,269 |
|---|---|---|---|
| Any treatment | 2954 (92.8)* | 2068 (95.4)* | 5022 (93.9) |
| Antihypertensives | 2389 (80.9)* | 1737 (84.0)* | 4126 (82.2) |
| Lipid-lowering medications | 2209 (74.8)* | 1460 (70.6)* | 3669 (73.1) |
| Anticoagulants/ antiplatelets | 1648 (55.8)* | 1313 (63.5)* | 2961 (59.0) |
| Gastrointestinal drugs | 908 (40.3)* | 711 (46.1)* | 1619 (42.6) |
| Antidepressants |
575 (19.5) |
424 (20.5) |
999 (19.9) |
p<0.05; Data not available for the HIPOQoL study
Oral antidiabetic drugs (OADs) were prescribed in 70.5% of cases (metformin in 93.0%, sulphonylureas for 65.3%, and dipeptidyl peptidase-4 [DPP4] inhibitors in 56.3%) while 4.1% of patients were taking insulin alone and 25.4% were being treated with both insulin and an OAD (Table 5). A total of 51.0% of patients were on free or fixed-dose OAD combinations. The proportion of patients on insulin was significantly higher with increasing age (27.4% in patients between 65-74 years vs. 32.6% in patients ≥75 years) while OADs such as DPP4 inhibitors (59.3% vs. 51.0%) or thiazolidinediones (29.6% vs. 22.3%) decreased with age (p<0.05 for all).
Table 5.
Diabetes treatment patterns in older patients with type 2 diabetes mellitus in Spain
| 65-74 years n=4,408 | ≥75 years n=2,861 | Overall (≥65 years) n=7,269 | |
|---|---|---|---|
| Type of therapy*, n (%): | |||
| OAD | 2286 (72.6) | 1428 (67.4) | 3714 (70.5) |
| Insulin | 105 (3.3) | 111 (5.2) | 216 (4.1) |
| Insulin + OAD | 756 (24.0) | 580 (27.4) | 1336 (25.4) |
| Type of OAD, n (%): | |||
| Monotherapy | 1074 (47.2) | 753 (52.0) | 1827 (49.0) |
| Free or fixed-dose combination | 1204 (52.9) | 696 (48.0) | 1900 (51.0) |
| Type of OAD, n (%): | |||
| Metformin | 1926 (94.0)* | 1177 (91.3)* | 3103 (93.0) |
| Sulphonylureas | 722 (64.0) | 534 (67.3) | 1256 (65.3) |
| DPP4 inhibitors | 650 (59.3)* | 319 (51.0)* | 969 (56.3) |
| Thiazolidinediones | 222 (29.6)* | 102 (22.3)* | 324 (26.8) |
| Meglitinides | 143 (21.3) | 107 (23.6) | 250 (22.2) |
| Alpha-glucosidase inhibitors | 59 (9.6) | 36 (9.0) | 95 (9.3) |
| GLP-1 receptor agonists |
55 (9.1) |
32 (8.3) |
87 (8.8) |
OAD: oral antidiabetic drug; DPP4: dipeptidyl peptidase-4; GLP-1: glucagon-like peptide 1
p<0.05; Data not available for the HIPOQoL study
Discussion
The present study allows to accurately describing the characteristics and management of a large cohort of older patients with type 2 DM in Spain. It is worth noting that the glycaemic control of our study population was tighter than required by current guidelines (3). Our study shows that more than half of patients (54%) had unsatisfactory management: 11% had inadequate glycaemic control (HbA1c greater than or equal to 8.5% despite hypoglycaemic agents) and 43% were potentially overtreated (HbA1c less than 7%). Although there is a general agreement that avoiding tight glycaemic control minimizes the risk of hypoglycaemia (1), and that it is not indicated in older people (13), these results highlight the elevated percentage of tight glycaemic control among older subjects with type 2 DM increasing the risk of iatrogenic hypoglycaemia, an important challenge for health professionals nowadays (14).
Our results are consistent with that reported by Barrot-de la Puente et al (15) who found a high percentage of patients with an HbA1c level less than 7% among older type 2 DM patients (between 54-61% in men or women older than 65 years). Lipska et al also found a high percentage of patients (62%) with a tight glycaemic control (HbA1c ≤7%) among US older adults with diabetes (8). Furthermore, another study conducted in French long-term-care homes also reported a tight glycaemic control in elderly patients with diabetes. In particular, they described a total of 32% of subjects with an HbA1c value of ≤6.5% (16).
Antidiabetic therapies such as sulphonylureas or human insulin are not recommended in the elderly (4, 7, 17). However, a large proportion of older patients with type 2 DM were receiving sulphonylureas (65%) or insulin (30%) despite the associated risk of hypoglycaemia (by comparison 27% were receiving thiazolidinediones, 9% received alpha-glucosidase inhibitors , and 9% glucagon-like peptide 1 [GLP-1] receptor agonists). Aside from this, half of the patients were on free or fixed-dose OAD combinations. These treatment patterns were generally consistent with previous studies that reported a high percentage of older diabetic adults receiving insulin (between 27-34%) or sulphonylureas (40-56%) (8, 18). Conversely, the proportion of patients who were prescribed DPP4 inhibitors, a glucose-lowering agent with a low risk of hypoglycaemia, was higher in our European sample compared to older US patients with type 2 DM (56% vs. 12%) (18).
In our sample, there was a high rate of hypertension and dyslipidaemia, common comorbidities among older adults with diabetes (3). According to current IDF guidelines (1), the LDL-cholesterol level was clearly outside the target (<80 mg/dl) regardless of lipid-lowering medications. The prevalence of some microvascular and macrovascular complications was higher in this study than that reported by Souza et al (19) among Brazilian older patients with type 2 DM: nephropathy 24% versus 13%, retinopathy 19% versus 12%, coronary artery disease 37% versus 13%, and peripheral artery disease 14% versus 9%. On the other hand, the prevalence of diabetic foot or cerebrovascular disease was lower in our study compared to Brazilian population (6% vs.12% and 9% vs. 12%, respectively) (19). As expected, the incidence of both microvascular and macrovascular complications increased with age.
The main strength of the present study is the large sample size, representative of routine clinical practice in Spain. However, the study has also several limitations. First, its crosssectional design does not allow the determination of causal relationships between treatments and degree of glycaemic control. Second, as the HIPOQoL study did not collect any treatment data, a percentage of patients may be undertaking diet and exercise regimen. Therefore, the percentage of overtreated patients may be slightly overestimated. Moreover, we could not exclude those patients with HbA1c level less than 7% who were on diet and exercise only and thus, not overtreated. In addition, as a functional assessment of subjects was not performed, we cannot define the degree of glycaemic control with absolute precision. Finally, patients who were overweight or obese were overrepresented in this study as one of the studies had this condition as an inclusion criterion.
In summary, the results of this pooled analysis show that the glycaemic control and therapeutic management of older patients with type 2 DM in Spain is inadequate, mainly due to overtreatment with drugs with high risk of hypoglycaemia. These findings emphasise the need for better management of type 2 DM in older adults and for changing the targets now recommended by several local guidelines of practice.
Key conclusions
• The glycaemic control of older patients with type 2 DM in Spain is inadequate
• Patients are overtreated with drugs with high risk of hypoglycaemia
• There is a need for better management of type 2 DM in older adults in Spain
Acknowledgements: Manuscript writing and editorial support was provided by Eva Mateu from TFS Develop.
Funding: Financial support was provided by Novartis Farmacéutica, S.A., Barcelona, Spain.
Conflict of interest: Dr. Francesc Formiga has received speaking and/or advisory board honoraria from Boehringer-Ingelheim and Lilly, Glaxo SmithKline, Jansen, Novartis and Novo Nordisk. Dr. Josep Franch-Nadal has received speaking and/or advisory board honoraria related to this subject from Novartis, Boehringer-Ingelheim and Lilly, MSD and Jansen. Dr. Leocadio Rodríguez has received grants from Novartis, Lilly, Servier and Sanofi for making research projects or for giving lectures. Dr. Luis Ávila Lachica has received honoraria for collaboration with this subject from Novartis, Novo, Boehringer- Ingelheim, Lilly, MSD, Janssen, Astra Médica, Esteve, Servier and Glaxo. Dr. Eva Fuster is employee of Novartis.
Ethical standard: This study was conducted in accordance with the guidelines in the Declaration of Helsinki and the three studies were reviewed and approved by the ethics committee at Hospital Clínic of Barcelona (Spain). All study participants provided informed written consent prior to study enrolment.
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