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Fulltext Risk of all-cause and CHD mortality in women versus men with type 2 diabetes: a systematic review and meta-analysis

Xu G, You D, Wong L, Duan D, Kong F, Zhang X, et al.

Eur J Endocrinol, 2019 Apr;180(4):243-255.
PMID: 30668524 DOI: 10.1530/EJE-18-0792

Objective: Previous studies have shown sex-specific differences in all-cause and CHD mortality in type 2 diabetes. We performed a systematic review and meta-analysis to provide a global picture of the estimated influence of type 2 diabetes on the risk of all-cause and CHD mortality in women vs men.
Methods: We systematically searched PubMed, EMBASE and Web of Science for studies published from their starting dates to Aug 7, 2018. The sex-specific hazard ratios (HRs) and their pooled ratio (women vs men) of all-cause and CHD mortality associated with type 2 diabetes were obtained through an inverse variance-weighted random-effects meta-analysis. Subgroup analyses were used to explore the potential sources of heterogeneity.
Results: The 35 analyzed prospective cohort studies included 2 314 292 individuals, among whom 254 038 all-cause deaths occurred. The pooled women vs men ratio of the HRs for all-cause and CHD mortality were 1.17 (95% CI: 1.12-1.23, I2 = 81.6%) and 1.97 (95% CI: 1.49-2.61, I2 = 86.4%), respectively. The pooled estimate of the HR for all-cause mortality was approximately 1.30 in articles in which the duration of follow-up was longer than 10 years and 1.10 in articles in which the duration of follow-up was less than 10 years. The pooled HRs for all-cause mortality in patients with type 2 diabetes was 2.33 (95% CI: 2.02-2.69) in women and 1.91 (95% CI: 1.72-2.12) in men, compared with their healthy counterparts.
Conclusions: The effect of diabetes on all-cause and CHD mortality is approximately 17 and 97% greater, respectively, for women than for men.

Matched MeSH terms: Diabetes Mellitus, Type 2/mortality*
Renal impairment and all-cause mortality in cardiovascular disease: effect modification by type 2 diabetes mellitus

Selvarajah S, Uiterwaal CS, Haniff J, van der Graaf Y, Visseren FL, Bots ML, et al.

Eur J Clin Invest, 2013 Feb;43(2):198-207.
PMID: 23301500 DOI: 10.1111/eci.12035

BACKGROUND:
Renal impairment and type 2 diabetes mellitus (DM) are well-known independent risk factors for mortality. The evidence of their combined effects on mortality is unclear, but of importance because it may determine aggressiveness of treatment. This study sought to assess and quantify the effect modification of diabetes on renal impairment in its association with mortality.

MATERIALS AND METHODS:
Patients with cardiovascular disease or at high risk, recruited in the Second Manifestations of ARTerial disease cohort study, were selected. A total of 7135 patients were enrolled with 33 198 person-years of follow-up. Renal impairment was defined by albuminuria status and estimated glomerular filtration rate (eGFR). Outcome was all-cause mortality.

RESULTS:
Mortality increased progressively with each stage of renal impairment, for both albuminuria status and eGFR, for diabetics and non-diabetics. There was no effect modification by diabetes on mortality risk due to renal impairment. The relative excess risk due to interaction (RERI) for DM and microalbuminuria was 0·21 (-0·11, 0·52), for overt proteinuria -1·12 (-2·83, 0·59) and for end-stage renal failure (ESRF) 0·32 (-3·65, 4·29). The RERI for DM with eGFR of 60-89 mL/min/1·73 m(2) was -0·31(-0·92, 0·32), for eGFR of 30-59 mL/min/1·73 m(2) -0·07 (-0·76, 0·62) and for eGFR of < 30 mL/min/1·73 m(2) 0·38 (-0·85, 1·61).

CONCLUSIONS:
Type 2 diabetes mellitus does not modify nor increase the risk relation between all-cause mortality and renal impairment. These findings suggest that the hallmark for survival is the prevention and delay in progression of renal impairment in patients with cardiovascular disease.

Matched MeSH terms: Diabetes Mellitus, Type 2/mortality*
Fulltext Gender Differences and Risk Factors of Recurrent Stroke in Type 2 Diabetic Malaysian Population with History of Stroke: The Observation from Malaysian National Neurology Registry

Aziz S, Sheikh Ghadzi SM, Abidin NE, Tangiisuran B, Zainal H, Looi I, et al.

J Diabetes Res, 2019;2019:1794267.
PMID: 31886276 DOI: 10.1155/2019/1794267

Background and Purpose: Diabetes mellitus has been reported as a strong independent risk factor for stroke recurrence. Data on the modifiable factors contributing to the recurrence of stroke in type 2 diabetic Malaysian population with a history of stroke stratified by genders are lacking, and this supports the importance of this study.
Method: The data of 4622 patients with T2DM who had a history of stroke was obtained from the Malaysian National Stroke Registry. Univariate analysis was performed to differentiate between genders with and without stroke recurrence in terms of demographics, first stroke attack presentations, and other clinical characteristics. The significant factors determined from the univariate analysis were further investigated using logistic regression.
Results: Ischemic heart diseases were found significantly associated with the stroke recurrence in males (OR = 1.738; 95% CI: 1.071-2.818) as well as female (OR = 5.859; 95% CI: 2.469-13.752) diabetic patients. The duration of hypertension, as well as the duration of diabetes, has been associated with the recurrence in both male and female subjects (p value < 0.05). Smoking status has an impact on the stroke recurrence in male subjects, while no significant association was observed among their peers.
Conclusions: Most of the predictive factors contributing to the recurrence of stroke in type 2 diabetic Malaysian population with a history of stroke are modifiable, in which IHD was the most prominent risk factor in both genders. The impact of optimizing the management of IHD as well as blood glucose control on stroke recurrence may need to be elucidated. No major differences in recurrent stroke predictors were seen between genders among the Malaysian population with type 2 diabetes mellitus who had a previous history of stroke.

Matched MeSH terms: Diabetes Mellitus, Type 2/mortality
Long-Term Cost-Effectiveness of Insulin Glargine Versus Neutral Protamine Hagedorn Insulin for Type 2 Diabetes in Thailand

Permsuwan U, Chaiyakunapruk N, Dilokthornsakul P, Thavorn K, Saokaew S

Appl Health Econ Health Policy, 2016 Jun;14(3):281-92.
PMID: 26961276 DOI: 10.1007/s40258-016-0228-3

BACKGROUND: Even though Insulin glargine (IGlar) has been available and used in other countries for more than a decade, it has not been adopted into Thai national formulary. This study aimed to evaluate the long-term cost effectiveness of IGlar versus neutral protamine Hagedorn (NPH) insulin in type 2 diabetes from the perspective of Thai Health Care System.
METHODS: A validated computer simulation model (the IMS CORE Diabetes Model) was used to estimate the long-term projection of costs and clinical outcomes. The model was populated with published characteristics of Thai patients with type 2 diabetes. Baseline risk factors were obtained from Thai cohort studies, while relative risk reduction was derived from a meta-analysis study conducted by the Canadian Agency for Drugs and Technology in Health. Only direct costs were taken into account. Costs of diabetes management and complications were obtained from hospital databases in Thailand. Both costs and outcomes were discounted at 3 % per annum and presented in US dollars in terms of 2014 dollar value. Incremental cost-effectiveness ratio (ICER) was calculated. One-way and probabilistic sensitivity analyses were also performed.
RESULTS: IGlar is associated with a slight gain in quality-adjusted life years (0.488 QALYs), an additional life expectancy (0.677 life years), and an incremental cost of THB119,543 (US$3522.19) compared with NPH insulin. The ICERs were THB244,915/QALY (US$7216.12/QALY) and THB176,525/life-year gained (LYG) (US$5201.09/LYG). The ICER was sensitive to discount rates and IGlar cost. At the acceptable willingness to pay of THB160,000/QALY (US$4714.20/QALY), the probability that IGlar was cost effective was less than 20 %.
CONCLUSIONS: Compared to treatment with NPH insulin, treatment with IGlar in type 2 diabetes patients who had uncontrolled blood glucose with oral anti-diabetic drugs did not represent good value for money at the acceptable threshold in Thailand.

Matched MeSH terms: Diabetes Mellitus, Type 2/mortality
Safety and effectiveness of biphasic insulin aspart 30 in type 2 diabetes: results from the ASEAN cohort of the A₁chieve study

Lim-Abrahan MA, Jain AB, Bebakar WM, Seah D, Soewondo P

Diabetes Res Clin Pract, 2013 Apr;100 Suppl 1:S3-9.
PMID: 23647715 DOI: 10.1016/S0168-8227(13)70003-2

AIM:
To determine the safety and effectiveness of biphasic insulin aspart 30 (BIAsp 30) in the ASEAN cohort of the A₁chieve study.

METHODS:
Type 2 diabetes patients from Indonesia, Malaysia, Philippines and Singapore prescribed BIAsp 30 therapy were included. The primary outcome was evaluation of serious adverse drug reactions including major hypoglycaemia over 24 weeks. Secondary outcomes were changes in hypoglycaemic events, serious adverse events (SAEs) and effectiveness parameters.

RESULTS:
This sub-analysis included 2798 patients (insulin-naive, 1903; insulin-experienced, 895) with mean age ± SD, 55.3 ± 10.8 years, BMI, 24.9 ± 4.6 kg/m(2) and diabetes duration, 7.5 ± 5.9 years. Baseline HbA1c in the entire cohort was poor (9.9%, 85 mmol/mol). A total of 15 SAEs were reported in 7 insulin-experienced patients (1 moderate event was related to BIAsp 30). Overall hypoglycaemia at Week 24 was 0.88 events/patient-year compared to 1.71 events/patient-year reported at baseline (change in proportion of patients affected, p < 0.0001). No major hypoglycaemia was reported at Week 24. BIAsp 30 significantly improved glucose control (HbA1c, fasting plasma glucose and postprandial plasma glucose, p < 0.001) at Week 24. The proportion of patients achieving HbA1c <7.0% at Week 24 was 35.3% compared to 3.5% at baseline. The lipid profile and systolic blood pressure also improved significantly (p < 0.001). Quality of life was positively impacted (mean change in visual analogue scores from EQ-5D = 10.6 ± 13.8 points, p < 0.001).

CONCLUSION:
BIAsp 30 was well-tolerated and improved glucose control while decreasing the risk of hypoglycaemia.

Matched MeSH terms: Diabetes Mellitus, Type 2/mortality
Switching from biphasic human insulin to biphasic insulin aspart 30 in type 2 diabetes: results from the ASEAN subgroup of the A₁chieve study

Hussein Z, Lim-Abrahan MA, Jain AB, Goh SY, Soewondo P

Diabetes Res Clin Pract, 2013 Apr;100 Suppl 1:S24-9.
PMID: 23647714 DOI: 10.1016/S0168-8227(13)70006-8

Aim: To evaluate the safety and effectiveness of biphasic insulin aspart 30 (BIAsp 30) in ASEAN type 2 diabetes (T2D) patients switched from biphasic human insulin (BHI) in the non-interventional 24-week A₁chieve study.

Methods: Indonesian, Malaysian, Filipino and Singaporean patients switched from BHI to BIAsp 30 at their physicians' discretion were included. The incidence of serious adverse drug reactions (SADRs), including major hypoglycaemia was the primary endpoint. Changes in hypoglycaemia, glycated haemoglobin A1c (HbA1c), fasting plasma glucose (FPG), postprandial plasma glucose (PPPG), lipids, body weight and systolic blood pressure were also evaluated. Quality of life (QoL) was measured using the EQ-5D questionnaire.

Results: For the 465 patients included (mean ± SD age: 56 ± 10.3 years, diabetes duration: 9.7 ± 7.1 years, baseline HbA1c: 9.4 ± 1.8%), the mean pre-study BHI dose was 0.62 ± 0.28 IU/kg and 63.4% were dosing BHI twice daily (bid). The mean baseline BIAsp 30 dose was 0.65 ± 0.27 U/kg, titrated up to 0.71 ± 0.28 U/kg over 24 weeks, and most patients continued bid dosing. No SADRs or major hypoglycaemic episodes were reported. The proportion of patients reporting overall hypoglycaemia decreased significantly from 10.8% at baseline to 3.4% at Week 24 (p < 0.0001). Significant improvements in glycaemic control were noted (HbA1c: -1.4 ± 1.7%, FPG: -56.7 ± 72.5 mg/dL, post-breakfast PPPG: -84.8 ± 82.8 mg/dL, p < 0.001). Mean QoL improved by +6.6 ± 14.6 points (p < 0.001).

Conclusion: BIAsp 30 was well-tolerated and significantly increased glycaemic control in this ASEAN subgroup poorly controlled on BHI.

Matched MeSH terms: Diabetes Mellitus, Type 2/mortality
Safety and effectiveness of insulin aspart in type 2 diabetic patients: results from the ASEAN cohort of the A₁chieve study

Bebakar WM, Lim-Abrahan MA, Jain AB, Seah D, Soewondo P

Diabetes Res Clin Pract, 2013 Apr;100 Suppl 1:S17-23.
PMID: 23647713 DOI: 10.1016/S0168-8227(13)70005-6

AIM:
To examine the clinical safety and effectiveness of insulin aspart (IAsp) therapy in type 2 diabetes (T2D) patients from the ASEAN cohort of the international, 24-week, non-interventional A₁chieve study.

METHODS:
T2D patients from Indonesia, Malaysia, Philippines and Singapore, who started IAsp therapy with or without oral glucose-lowering drugs, were included. The primary endpoint was the incidence of serious adverse drug reactions (SADRs), including major hypoglycaemic events. Secondary endpoints included hypoglycaemia, glycated haemoglobin A1c [HbA1c], fasting plasma glucose [FPG], postprandial plasma glucose [PPPG], systolic blood pressure [SBP], body weight and lipids. Quality of life (QoL) was assessed using the EQ-5D questionnaire.

RESULTS:
Overall, 312 T2D patients (222 insulin-naive and 90 insulin-experienced) with a mean ± SD age of 56.6 ± 11.2 years, BMI of 24.2 ± 3.9 kg/m(2) and diabetes duration of 7.0 ± 5.7 years were included. The mean daily IAsp dose was 0.51 ± 0.31 U/kg at baseline titrated up to 0.60 ± 0.29 U/kg at Week 24. No SADRs or major hypoglycaemic events were reported in the entire subgroup. The proportion of patients who reported overall hypoglycaemia decreased from baseline to Week 24 (7.1% vs. 0.3%, p < 0.0001). The mean HbA1c improved from 9.5 ± 1.6% at baseline to 7.6 ± 1.3% after 24 weeks (p < 0.001). The mean FPG, post-breakfast PPPG and SBP also improved (p < 0.001). Health-related QoL scores increased in the entire subgroup (mean increase: 9.8 ± 14.6 points, p < 0.001).

CONCLUSIONS:
Starting IAsp therapy was well-tolerated and was associated with significantly improved overall glycaemic control in the ASEAN cohort.

Matched MeSH terms: Diabetes Mellitus, Type 2/mortality
Safety and effectiveness of insulin detemir in type 2 diabetes: results from the ASEAN cohort of the A₁chieve study

Soewondo P, Mohamed M, Jain AB, Sy RA, Khoo CM

Diabetes Res Clin Pract, 2013 Apr;100 Suppl 1:S10-6.
PMID: 23647712 DOI: 10.1016/S0168-8227(13)70004-4

AIM:
To determine the safety and effectiveness of insulin detemir (IDet) in type 2 diabetes patients from the ASEAN cohort of the A1chieve study.

METHODS:
Patients from Indonesia, Malaysia, Philippines and Singapore prescribed IDet at the discretion of their physicians were included. The primary outcome was the incidence of serious adverse drug reactions including major hypoglycaemia over 24 weeks. Secondary endpoints included changes in the frequency of hypoglycaemia, serious adverse events and effectiveness assessments.

RESULTS:
This sub-analysis included 1540 patients (insulin-naive, 1239; insulin-experienced, 301) with mean age ± SD 56.4 ± 10.9 years, BMI 25.4 ± 4.6 kg/m(2) and diabetes duration 6.9 ± 5.3 years. Insulin-naive patients received a baseline IDet dose of 0.24 ± 0.11 U/kg titrated up to 0.37 ± 0.21 U/kg by Week 24. The pre-study insulin dose in insulin-experienced patients was 0.41 ± 0.25 U/kg and baseline IDet dose was 0.31 ± 0.24 U/kg titrated up to 0.40 ± 0.20 U/kg by Week 24. Overall hypoglycaemia decreased from 1.73 to 0.46 events/patient-year from baseline to Week 24 (change in proportion of patients affected, p < 0.0001). At Week 24, 1 major hypoglycaemic event was reported in 1 insulin-experienced patient. IDet significantly improved glucose control (p < 0.001) at Week 24. The lipid profile and systolic blood pressure improved (p < 0.001) and body weight did not change significantly. Quality of life was positively impacted (p < 0.001).

CONCLUSION:
IDet was well-tolerated and improved glycaemic control without increasing the risk of hypoglycaemia or weight gain.

Matched MeSH terms: Diabetes Mellitus, Type 2/mortality