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Aims: We aimed to assess trends in glycosylated hemoglobin A1c (HbA1c) and systolic blood pressure (SBP) thresholds at initiation of glucose- and blood pressure-lowering medication among patients with type 2 diabetes and assess the influence of age and sex on these trends. Materials and Methods: We used the Groningen Initiative to ANalyze Type 2 diabetes Treatment (GIANTT) primary care database. Patients initiating a first non-insulin glucose-lowering or any blood pressure-lowering medication between 2015 and 2020 with an HbA1c or SBP measurement in the 120 days before initiation were included. We used multilevel regression analyses adjusted for potential confounders to assess the influence of calendar year, age or sex, and the interaction between calendar year and age or sex on trends in HbA1c and SBP thresholds at initiation of medication. Results: We included 2,671 and 2,128 patients in the analyses of HbA1c and SBP thresholds, respectively. The overall mean HbA1c threshold at initiation of glucose-lowering medication significantly increased from 7.4% in 2015 to 8.0% in 2020 (p < 0.001), and particularly in the younger age groups. Compared to patients ≥80 years, patients aged 60–69 years initiated medication at lower levels mainly in the early years. Patients <60 years and between 70–79 years initiated medication at similar levels as patients ≥80 years. Females initiated medication at lower levels than males throughout the study period (p < 0.001). The mean SBP threshold at initiation of blood pressure-lowering medication varied from 145 to 149 mmHg without a clear trend (p = 0.676). There were no differences in SBP thresholds between patients of different ages or sex. Conclusion: The rising trend in the HbA1c threshold for initiating glucose-lowering medication in the lower age groups was unexpected and requires further investigation. Males appear to receive less timely initiation of glucose-lowering medication than females. The lack of higher thresholds for the oldest age group or lower thresholds for the youngest age group in recent years is not in line with the age-related recommendations for personalized diabetes care and calls for health systems interventions. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the associations between different types of diabetes distress and health-related quality of life (HRQOL) among patients with type 2 diabetes (T2DM) using antihypertensive and/or antihyperlipidemic medications in Indonesia and to explore the differences between those using only antihypertensive, only antihyperlipidemic, or both medications.Methods: A multicenter cross-sectional study was conducted in Community Health Centers in three cities in Indonesia among patients with T2DM aged at least 18 years who were using antihypertensive and/or antihyperlipidemic medications. Diabetes distress subscales (emotional, regimen-related, interpersonal, and physician-related distress) and HRQOL were assessed using a validated diabetes distress scale-17 and EQ-5D-5L scale, respectively. Multiple linear regression models were used to evaluate the associations between different types of diabetes distress and HRQOL adjusting for confounders.Results: Most of the 503 participants were females (67.6%) and aged 60-69 years (40.8%). Emotional distress was negatively associated with HRQOL among the whole group of patients (β: -0.08; 95% confidence interval (CI): -0.10, -0.05; p < 0.001). This association was similar across all therapeutic subgroups. Regimen-related distress (β: -0.06; 95% CI: -0.09, -0.03; p < 0.001) and interpersonal distress (β: -0.02; 95% CI: -0.05, -0.01; p = 0.022) were negatively associated, whereas physician-related distress (β: 0.04; 95% CI: 0.01, 0.07; p = 0.037) was positively associated with HRQOL among the whole group. These associations were also observed among those using only antihypertensive medication.Conclusion: Emotional distress affects HRQOL in T2DM patients treated for cardiovascular comorbidities, independent of antihypertensive and/or antihyperlipidemic medication use. [ABSTRACT FROM AUTHOR]

Background: To develop targeted and tailored interventions for addressing medication non-adherence, it is important to identify underlying factors. Objective: To identify factors associated with non-adherence as well as subtypes of non-adherence to antihypertensive or antihyperlipidemic drugs among patients with type 2 diabetes in Indonesia. Design: An observational multicenter cross-sectional survey. Participants: Patients with type 2 diabetes using either antihypertensive or antihyperlipidemic drugs in four regions in Indonesia. Main Measures: Non-adherence and its subtypes of intentional and unintentional non-adherence were assessed using the Medication Adherence Report Scale. Necessity and concern beliefs were assessed with the Beliefs about Medicines Questionnaire. We applied binary and multinomial logistic regression to assess associations of medication beliefs, sociodemographic factors, and clinical-related factors to non-adherence and report odds ratios (OR) with 95% confidence intervals (CI). Key Results: Of 571 participating patients (response rate 97%), 45.5% and 52.7% were non-adherent to antihypertensive and antihyperlipidemic drugs, respectively. Older age was associated with non-adherence to antihypertensive drugs (60–69 years) (OR, 5.65; 95% CI, 2.68–11.92), while higher necessity beliefs (OR, 0.92; 95% CI, 0.88–0.95) were associated with less non-adherence. Factors associated with non-adherence to antihyperlipidemic drugs were female gender (OR, 1.84; 95% CI, 1.03–3.27) and higher concern beliefs (OR, 1.10; 95% CI, 1.03–1.18), while higher necessity beliefs (OR, 0.89; 95% CI, 0.83–0.96) were associated with less non-adherence. Conclusions: The main factors associated with non-adherence to antihypertensive and antihyperlipidemic drugs are modifiable. In general, beliefs about the necessity of the drug are important but for antihyperlipidemic drugs concerns are important as well. Healthcare providers should pay attention to identify and address medication beliefs during patient counselling. [ABSTRACT FROM AUTHOR]

Background: Adherence to antihypertensive drugs in patients with diabetes is important. To support adherence, attention should be paid to the dynamic process of implementation, persistence and reinitiation of these drugs. We assessed non-adherence, non-persistence and reinitiation patterns for antihypertensive drugs in patients on oral diabetes drugs and identified pharmacy-based predictors of these processes. Methods: We conducted a cohort study in patients on oral diabetes drugs who initiated antihypertensive drugs between 1995–2015, as registered in the IADB.nl pharmacy database. Non-adherence was defined as a medication possession ratio < 80% and non-persistence as a gap > 180 days. We defined reinitiation as the dispensing of an antihypertensive drug within one year following discontinuation. We provide descriptive statistics for different time periods and applied logistic and Cox regressions to assess associations with sociodemographic and drug-related factors. Results: Of 6,669 initiators, non-adherence rates in persistent patients decreased from 11.0% in the first year to 8.5% and 7.7% in the second and third years, respectively. Non-persistence rates decreased from 18.0% in the first year to 3.7% and 2.9% in the second and third years, respectively. Of the 1,201 patients who discontinued in the first year, 22.0% reinitiated treatment within one year. Non-adherence and non-persistence rates were lower in the more recent time period. Predictors of non-adherence were secondary prevention (OR: 1.45; 95% CI: 1.10–1.93) and diuretics as initial drug class (OR: 1.37; 95% CI: 1.08–1.74). Predictors of non-persistence were female gender (HR: 1.18; 95% CI: 1.05–1.32), older age (HR: 1.33; 95% CI: 1.08–1.63) and diuretics, beta-blocking agents or calcium channel blockers as initial drug class. Longer duration of persistence was a predictor of reinitiation. Conclusions: Adherence to antihypertensive drugs in patients on oral diabetes drugs has improved over time. The first year after initiation is the most crucial with regard to non-adherence and non-persistence, and the risk groups are different for both processes. Early non-persistence is a risk factor for not reinitiating treatment. [ABSTRACT FROM AUTHOR]

Background: Guideline-adherent prescribing for treatment of multiple risk factors in type 2 diabetes (T2D) patients is expected to improve clinical outcomes. However, the relationship to Health-Related Quality of Life (HRQoL) is not straightforward since guideline-adherent prescribing can increase medication burden. Objectives: To test whether guideline-adherent prescribing and disease-specific medication burden are associated with HRQoL in patients with T2D. Methods: Cross-sectional study including 1,044 T2D patients from the e-VitaDM/ZODIAC study in 2012 in the Netherlands. Data from the diabetes visit, such as laboratory and physical examinations and prescribed medication, and from two HRQoL questionnaires, the EuroQol 5 Dimensions 3 Levels (EQ5D-3L) and the World Health Organization Well-Being Index (WHO-5) were collected. Twenty indicators assessing prescribing of recommended glucose lowering drugs, statins, antihypertensives and renin-angiotensin-aldosterone system (RAAS)-inhibitors and potentially inappropriate drugs from a validated diabetes indicator set were included. Disease-specific medication burden was assessed using a modified version of the Medication Regimen Complexity Index (MRCI). Associations were tested with regression models, adjusting for age, gender, diabetes duration, comorbidity, body mass index and smoking. Results: The mean MRCI was 7.1, the median EQ5D-3L-score was 0.86 and the mean WHO-5 score was 72. Seven indicators included too few patients and were excluded from the analysis. The remaining thirteen indicators focusing on recommended start, intensification, current and preferred use of glucose lowering drugs, statins, antihypertensives, RAAS inhibitors, and on inappropriate prescribing of glibenclamide and dual RAAS blockade were not significantly associated with HRQoL. Finally, also the MRCI was not associated with HRQoL. Conclusions: We found no evidence for associations between guideline-adherent prescribing or disease-specific medication burden and HRQoL in T2D patients. This gives no rise to refrain from prescribing intensive treatment in T2D patients as recommended, but the interpretation of these results is limited by the cross-sectional study design and the selection of patients included in some indicators. [ABSTRACT FROM AUTHOR]

Aims: To assess variability in systolic blood pressure (SBP) and albuminuria (urinary albumin creatinine ratio [UACR]) responses in patients with type 2 diabetes mellitus initiating renin angiotensin aldosterone system (RAAS) inhibition, and to assess the association of response variability with cardiovascular outcomes. Material and Methods: We performed an observational cohort study in patients with type 2 diabetes who started RAAS inhibition between 2007 and 2013 (n = 1600). Patients were identified from general practices in the Netherlands. Individual response in SBP and UACR was assessed during 15 months’ follow‐up. Patients were categorized as: good responders (∆SBP <0 mm Hg and ∆UACR <0%); intermediate responders (∆SBP <0 mm Hg and ∆UACR >0% or ∆SBP >0 mm Hg and ∆UACR <0%); or poor responders (∆SBP >0 mm Hg and ∆UACR >0%). Multivariable Cox regression was performed to test the association between initial RAAS inhibition response and subsequent cardiovascular outcomes. Results: After starting RAAS inhibition, the mean SBP change was −13.2 mm Hg and the median UACR was −36.6%, with large between‐individual variability, both in SBP [5th to 95th percentile: 48.5‐20] and UACR [5th to 95th percentile: −87.6 to 171.4]. In all, 812 patients (51%) were good responders, 353 (22%) had a good SBP but poor UACR response, 268 (17%) had a good UACR but poor SBP response, and 167 patients (10%) were poor responders. Good responders had a lower risk of cardiovascular events than poor responders (hazard ratio 0.51, 95% confidence interval 0.30‐0.86; P = .012). Conclusions: SBP and UACR response after RAAS inhibition initiation varied between and within individual patients with type 2 diabetes treated in primary care. Poor responders had the highest risk of cardiovascular events, therefore, more efforts are needed to develop personalized treatment plans for these patients. [ABSTRACT FROM AUTHOR]

Aims: To evaluate statin non-persistence and non-adherence as discrete processes in diabetes patients, and identify pharmacy-based predictors of these processes in the first year after statin initiation.Methods: We conducted a retrospective cohort study of statin initiators using a pharmacy database. Persistence and adherence were measured in the first, second and third year. Non-persistence was defined as a gap >180 days. Non-adherence was calculated in persistent patients and defined as a medication possession ratio <80%. Cox regression hazard ratios (HRs) and logistic regression odds ratios (ORs) were assessed for sociodemographic and medication-related factors as possible predictors.Results: Of 12,741 initiators, 20.0% were non-persistent in the first year, while 9.0% and 7.5% were non-persistent in the second and third years. Non-adherence in persistent patients increased from 13.4% in the first to 15.6% and 18.1% in the second and third years. Predictors of non-persistence were female gender (HR: 1.10; 95% CI: 1.01-1.19), older age (HR: 1.52; 95% CI: 1.31-1.75), primary prevention (HR: 1.10; 95% CI: 1.00-1.20), initiating on low dose (HR: 1.44; 95% CI: 1.07-1.94) or standard dose (HR: 1.56; 95% CI: 1.16-2.10), and no cardiovascular co-medication (HR: 1.19; 95% CI: 1.07-1.33), while patients with four or more other medications were more likely to be persistent. Age <50 years (OR: 1.47; 95% CI: 1.22-1.77), low socioeconomic status (OR: 1.27; 95% CI: 1.12-1.45) and primary prevention (OR: 1.21; 95% CI: 1.07-1.38) were predictors of non-adherence, while females were more likely to be adherent (OR: 0.87; 95% CI: 0.77-0.98).Conclusion: Non-persistence was the foremost problem in the first year after statin initiation, while non-adherence in persistent patients increased in the second and third years. Pharmacy-based predictors of statin non-persistence were different from predictors of non-adherence among persistent patients. [ABSTRACT FROM AUTHOR]

Objectives: To assess whether patients’ willingness to add a blood pressure-lowering drug and the importance they attach to specific treatment characteristics differ among age groups in patients with type 2 diabetes. Materials and Methods: Patients being prescribed at least an oral glucose-lowering and a blood pressure-lowering drug completed a questionnaire including a discrete choice experiment. This experiment contained choice sets with hypothetical blood pressure-lowering drugs and a no additional drug alternative, which differed in their characteristics (i.e. effects and intake moments). Differences in willingness to add a drug were compared between patients <75 years (non-aged) and ≥75 years (aged) using Pearson χ2-tests. Multinomial logit models were used to assess and compare the importance attached to the characteristics. Results: Of the 161 patients who completed the questionnaire, 151 (72%) could be included in the analyses (mean age 68 years; 42% female). Aged patients were less willing to add a drug than non-aged patients (67% versus 84% respectively; P = 0.017). In both age groups, the effect on blood pressure was most important for choosing a drug, followed by the risk of adverse drug events and the risk of death. The effect on limitations due to stroke was only significant in the non-aged group. The effect on blood pressure was slightly more important in the non-aged than the aged group (P = 0.043). Conclusions: Aged patients appear less willing to add a preventive drug than non-aged patients. The importance attached to various treatment characteristics does not seem to differ much among age groups. [ABSTRACT FROM AUTHOR]

The article offers information on a study conducted by the authors related type 2 diabetes patients agreeing to undergo statin treatment after having a cardiovascular event. Topics discussed include patients willing to take statin after cardiovascular event, more use of nitrates and calcium antagonists during start of statin treatment and data related to medicines given during hospitalization not part of the study.

Aims: To estimate the efficacy of standard and intensive statin treatment in the secondary prevention of major cardiovascular and cerebrovascular events in diabetes patients. Methods: A systematic search was conducted in Medline over the years 1990 to September 2013. Randomized, double-blind, clinical trials comparing a standard-dose statin with placebo or a standard-dose statin with an intensive-dose statin for the secondary prevention of cardiovascular and cerebrovascular events in diabetes patients were selected. Trial and patient characteristics were extracted independently by two researchers. The combined effect on the composite primary endpoint was measured with a fixed-effect model. Potential publication bias was examined with a funnel plot. Results: Five trials were included in the analysis comparing standard-dose statins with placebo with a total of 4 351 participants. Four trials were included for comparing standard-dose with intensive-dose statins, including 4 805 participants. Compared with placebo, standard-dose statin treatment resulted in a significant relative risk (RR) reduction of 15% in the occurrence of any major cardiovascular or cerebrovascular event (RR 0.85, 95% CI 0.79–0.91). Compared with standard-dose statin treatment, intensive-dose statin treatment resulted in an additional 9% relative risk reduction (RR 0.91, 95% CI 0.84–0.98). Conclusion: Treatment with standard-dose statins to prevent cardiovascular or cerebrovascular events in diabetes patients with manifest cardiovascular disease results in an estimated 15% relative risk reduction and intensive-dose statin treatment adds 9%. If proven cost-effective, more intensive statin treatment should be recommended for diabetes patients at high cardiovascular risk. [ABSTRACT FROM AUTHOR]

Abstract: Background: Statins are lipid-lowering drugs that reduce the risk of cardiovascular events in patients with diabetes. Objectives: The objective of this study was to determine whether statin treatment for primary prevention in newly diagnosed type 2 diabetes is cost-effective, taking nonadherence, baseline risk, and age into account. Methods: A cost-effectiveness analysis was performed by using a Markov model with a time horizon of 10 years. The baseline 10-year cardiovascular risk was estimated in a Dutch population of primary prevention patients with newly diagnosed diabetes from the Groningen Initiative to Analyse Type 2 Diabetes Treatment (GIANTT) database, using the United Kingdom Prospective Diabetes Study risk engine. Statin adherence was measured as pill days covered in the IADB.nl pharmacy research database. Cost-effectiveness was measured in costs per quality-adjusted life-year (QALY) from the health care payers’ perspective. Results: For an average patient aged 60 years, the base case, statin treatment was highly cost-effective at €2245 per QALY. Favorable cost-effectiveness was robust in sensitivity analysis. Differences in age and 10-year cardiovascular risk showed large differences in cost-effectiveness from almost €100,000 per QALY to almost being cost saving. Treating all patients younger than 45 years at diabetes diagnosis was not cost-effective (weighted cost-effectiveness of almost €60,000 per QALY). Conclusions: Despite the nonadherence levels observed in actual practice, statin treatment is cost-effective for primary prevention in patients newly diagnosed with type 2 diabetes. Because of large differences in cost-effectiveness according to different risk and age groups, the efficiency of the treatment could be increased by targeting patients with relatively higher cardiovascular risk and higher ages. [Copyright &y& Elsevier]

Objective: To assess whether quality indicators for treatment of cardiovascular and renal risk factors are associated with short-term outcomes in patients with diabetes. Design: A prospective cohort study using linear regression adjusting for confounders. Setting: The GIANTT database (Groningen Initiative to Analyse Type 2 Diabetes Treatment) containing data from primary care medical records from The Netherlands. Participants: 15 453 patients with type 2 diabetes mellitus diagnosed before 1 January 2008. Mean age 66.5 years, 47.5% men. Exposure: Quality indicators assessing current treatment (CT) status or treatment intensification (TI) for patients with diabetes with elevated cardiovascular or renal risk factors. Main outcome measures: Low-density lipoprotein cholesterol (LDL-C), systolic blood pressure (SBP), and albumin:creatinine ratio (ACR) before and after assessment of treatment quality. Results: Use of lipid-lowering drugs was associated with better LDL-C levels (-0.41 mmol/ litre; 95%CI -0.48 to -0.34). Use of blood pressure-lowering drugs and use of renin- angiotensin system inhibitors in patients with elevated risk factor levels was not associated with better SBP and ACR outcomes, respectively. TI was also associated with better LDL-C (-0.82 mmol/ litre; CI -0.93 to -0.71) in patients with elevated LDL-C levels, and with better SBP (-1.26 mm Hg; CI -2.28 to -0.24) in patients with two elevated SBP levels. Intensification of albuminuria-lowering treatment showed a tendency towards better ACR (-2.47 mmol/mg; CI -5.32 to 0.39) in patients with elevated ACR levels. Conclusions: Quality indicators of TI were predictive of better short-term cardiovascular and renal outcomes, whereas indicators assessing CT status showed association only with better LDL-C outcome. [ABSTRACT FROM AUTHOR]

Background: Information on prescribing quality of diabetes care is required by health care providers, insurance companies, policy makers, and the public. Knowledge regarding the opinions and preferences of all involved parties regarding prescribing quality information is important for effective use of prescribing quality indicators. Methods: Between June and December 2009 we conducted semi structured interviews with 16 key-informants representing eight different organizations in the Netherlands involved in healthcare quality measurement and improvement. The interview guide included topics on participants' opinions and preferences regarding existing types of prescribing quality indicators in relation to their aim of using quality information. Content analysis methods were used to process the resulting transcripts following the framework of predetermined themes. Results: Findings from this qualitative study of stakeholder preferences showed that indicators focusing on undertreatment are found important by all participants. Furthermore, health care providers and policy makers valued prescribing safety indicators, insurance companies prioritized indicators focusing on prescribing costs, and patients' organization representatives valued indicators focusing on interpersonal side of prescribing. Representatives of all stakeholders preferred positive formulation of the indicators to motivate health care providers to participate in health improvement programs. A composite score was found to be most useful by all participants as a starting point of prescribing quality assessment. Lack of information on reasons for deviating from guidelines recommendations appeared to be the most important barrier for using prescribing quality indicators. According to the health care providers, there are many legitimate reasons for not prescribing the recommended treatment and these reasons are not always taken into account by external evaluators. The latter may cause mistrust of health care providers towards external stakeholders and limit the use of PQI in external quality improvement programs. Conclusion: Prescribing quality indicators are considered to be an important tool for assessing quality of provided diabetes care by all participants, although the preferences for specific types of indicators may differ by stakeholder depending on their user aim. Introduction of information systems to register the reasons for deviating from the recommended drug treatment may contribute to a more widespread use of PQI for assessment of provided health care quality to diabetic patents. This study identified the potential preferences regarding quality indicators for diabetes care, and this could be used for development of questionnaires to conduct a survey among a larger group of participants. [ABSTRACT FROM AUTHOR]

The article discusses research which investigated primary outcomes associated with patient-oriented treatment decision aid in establishing type 2 diabetes treatment goals. Topics explored include the random allocation of decision aid and usual care to participating patients in the Netherlands, the use of electronic health records for evaluating treatment, and the participation of diabetes nurse practitioners and specialists in the study.

Abstract: Objective: To assess the relationship of patients' medication beliefs and treatment complexity with unintentional and intentional non-adherence for three therapeutic groups commonly used by patients with type 2 diabetes. Methods: Survey data about adherence (Medication Adherence Report Scale) and beliefs about medicines (Beliefs about Medicines Questionnaire) were combined with prescription data from the Groningen Initiative to ANalyse Type 2 diabetes Treatment (GIANTT) database. Patients were classified as being adherent, mainly unintentional non-adherent, or partly intentional non-adherent per therapeutic group (glucose-, blood pressure-, and lipid-lowering drugs). Treatment complexity was measured using the Medication Regimen Complexity Index, which includes the dosage form, dosing frequency and additional directions of taking the drug. Analyses were performed using Kruskal–Wallis and Mann–Whitney U-tests. Results: Of 257 contacted patients, 133 (52%) returned the questionnaire. The patients had a mean age of 66years and 50% were females. Necessity beliefs were not significantly different between the adherers, mainly unintentional non-adherers, and partly intentional non-adherers (differences smaller than 5 points on a scale from 5 to 25). For blood pressure-lowering drugs, patients reporting intentional non-adherence had higher concern beliefs than adherers (8 point difference, P=0.01). Treatment complexity scores were lower for adherers but similar for mainly unintentional and partly intentional non-adherers to glucose- and blood pressure-lowering drugs. Conclusion: Treatment complexity was related to non-adherence in general. Beliefs about necessity were not strongly associated with non-adherence, while patients' concern beliefs may be associated with intentional non-adherence. However, the role of these determinants differs per therapeutic group. [Copyright &y& Elsevier]