Efficacy and safety of biphasic insulin aspart 70/30 in type 2 diabetes patients of different race or ethnicity (INITIATE<i>plus</i> trial)

Trippe, Bruce S.; Shepherd, M.; Coulter, Franklin C.; Bhargava, Anuj; Brett, Jason; Chu, Pei-Ling; Oyer, David

doi:10.1185/03007995.2012.686444

Cited by 5 publications

(10 citation statements)

References 23 publications

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“…This finding would be consistent with previous studies that showed significant reductions in hypoglycemia after patients were switched from NPH insulin to biphasic insulin aspart 30 [1, 14]. Others have reported that improved hyperglycemia and a lower proportion of people experiencing hypoglycemia can be achieved and maintained in patients receiving biphasic insulin aspart 30 who have optimized their insulin dosage [15]. As there was no control arm in the study, it is not possible to determine if the placebo effect due to participation in a clinical trial had any impact on the reduced incidence of hypoglycemia.…”

Section: Discussionsupporting

confidence: 91%

Safety and Effectiveness of Switching from a Basal-only to Biphasic Insulin Aspart 30 Insulin Regimen

et al. 2013

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PurposeThis sub-analysis of the A1chieve study evaluated the safety and effectiveness of changing from a basal-only insulin regimen to biphasic insulin aspart 30.MethodsA1chieve was an international, multicenter, prospective, open-label, non-interventional, 24-week study in people with type 2 diabetes mellitus starting/switching to therapy with biphasic insulin aspart 30, insulin detemir, or insulin aspart (alone/in combination) in routine clinical practice. This sub-analysis evaluated the safety and effectiveness of switching from basal insulin with either insulin glargine (GLA group) or insulin neutral protamine Hagedorn (NEU group) to biphasic insulin aspart 30.ResultsA total of 2,818 participants received biphasic insulin aspart 30 (1,395 in the GLA group and 1,423 in the NEU group). After 24 weeks of treatment, there were significant reductions in the proportion of patients with at least one hypoglycemia event: total [baseline vs. 24 weeks: 15.5% vs. 9.7% (p < 0.001) and 12.3% vs. 9.9% (p < 0.05), in NEU and GLA groups, respectively], major [2.5% vs. 0.08% (p < 0.001) and 1.2% vs. 0.08% (p < 0.001), in NEU and GLA groups, respectively] and nocturnal hypoglycemia [7.2% vs. 3.5% (p < 0.001) and 5.4% vs. 3.9% (p < 0.05), in NEU and GLA groups, respectively]. After 24 weeks of biphasic insulin aspart 30 there were statistically significant improvements from baseline in glycated hemoglobin, fasting plasma glucose, and post-prandial plasma glucose levels (p < 0.001) and in health-related quality of life (p < 0.001) in both groups.ConclusionsBiphasic insulin aspart 30 may benefit patients with poor glycemic control on basal insulin regimens who are seeking to change treatment.

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Section: Discussionsupporting

confidence: 91%

Safety and Effectiveness of Switching from a Basal-only to Biphasic Insulin Aspart 30 Insulin Regimen

et al. 2013

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“…Administrative claims data were the most common sources of primary ADE detection, used in 37.5 % (15/40) of studies [9][10][11][12][13][14][15][16][17][18][19][20][21][22][23]. Chart review was used as a primary ADE detection method in 35 % (14/40) of studies [8,[24][25][26][27][28][29][30][31][32][33][34][35][36], and survey or patient/ parent report was used in 27.5 % (11/40) of the studies [27,32,33,[37][38][39][40][41][42][43][44]. Direct documentation by research staff was used by three studies (7.5 %) [45][46][47].…”

Section: Resultsmentioning

confidence: 99%

“…Direct documentation by research staff was used by three studies (7.5 %) [45][46][47]. Three studies (7.5 %) used more than one method for ADE detection [27,32,33]; two of these studies that analyzed agreement between methods of ADE detection found that only 5-6 % of ADEs were detected by both chart review and patient report [27,33]. In contrast to using more than one method for ADE detection, an additional three studies utilized chart review as a secondary method only for ADE verification [14,20,42].…”

Section: Resultsmentioning

confidence: 99%

“…2). Two of these studies analyzed Hispanics as compared to non-Hispanics, including both blacks and whites in each group [17,32].…”

Section: Resultsmentioning

confidence: 99%

“…2 Percent of studies that included specified racial/ethnic groups in the analysis of adverse drug events (N=40) Due to the number of studies, confidence intervals were not included for this category. Confidence intervals can be found in Online Resource Table S3 c Hispanic tracked as an ethnicity, inclusive of whites/blacks in two studies [17,32] disparity was lower than that for Asians [14,45]. Six studies analyzed ADEs in the inpatient setting and two studies analyzed outpatient settings, and results were variable across clinical settings (Online Resource Table S2).…”

Section: Anticoagulant-related Adverse Drug Eventsmentioning

confidence: 99%

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Racial and Ethnic Disparities in Adverse Drug Events: A Systematic Review of the Literature

Baehr

Peña

2015

J. Racial and Ethnic Health Disparities

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The 2014 National Action Plan for Adverse Drug Event Prevention has recognized adverse drug events (ADEs) as a national priority in order to facilitate a nationwide reduction in patient harms from these events. Throughout this effort, it will be integral to identify populations that may be at particular risk in order to improve care for these patients. We have undertaken a systematic review to evaluate the evidence regarding racial or ethnic disparities in ADEs with particular emphasis on anticoagulants, diabetes agents, and opioids due to the clinical significance and preventability of ADEs associated with these medication classes. From an initial search yielding 3302 studies, we identified 40 eligible studies. Twenty-seven of these included studies demonstrated the presence of a racial or ethnic disparity. There was no consistent evidence for racial or ethnic disparities in the eight studies of ADEs in general. Asians were most frequently determined to be at higher risk of anticoagulant-related ADEs, and black patients were most frequently determined to be at higher risk for diabetes agents-related ADEs. Whites were most frequently identified as at increased risk for opioid-related ADEs. However, few of these studies were specifically designed to evaluate racial or ethnic disparities, lacking a standardized approach to racial/ethnic categorization as well as control for potential confounders. We suggest the need for targeted interventions to reduce ADEs in populations that may be at increased risk, and we suggest strategies for future research.

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Safety and Effectiveness of Biphasic Insulin Aspart 30 in Different Age-Groups: A1chieve Sub-Analysis

et al. 2013

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IntroductionEffective management of type 2 diabetes requires sustained glycemic control over many years, which can be particularly challenging for elderly people. This sub-analysis of the A1chieve study evaluated the clinical safety and effectiveness of biphasic insulin aspart 30 in 3 age-groups (≤40, >40–65, and >65 years) of previously insulin-experienced and insulin-naïve people with type 2 diabetes.MethodsA1chieve was an international, multicenter, prospective, open-label, non-interventional, 24-week study in people with type 2 diabetes who had been receiving anti-diabetes medication before starting, or switching to, therapy with biphasic insulin aspart 30, insulin detemir or insulin aspart (alone or in combination) in routine clinical practice. This sub-analysis evaluated clinical safety and effectiveness of biphasic insulin aspart 30 (±oral glucose-lowering drugs) in different age-groups.ResultsData on 40,122 participants were included. In all age-groups, the proportion of participants experiencing any hypoglycemia, major hypoglycemia or nocturnal hypoglycemia was significantly reduced from baseline, except for the following in insulin-naïve patients: a significant increase in any hypoglycemia in patients aged >65 years; no change in any hypoglycemia, major hypoglycemia, and nocturnal hypoglycemia in patients aged >40–65, ≤40, and >65 years, respectively. Significant improvements at 24 weeks vs. baseline were observed in insulin-experienced and insulin-naïve participants for: glycated hemoglobin (change from baseline ranged from −1.8% to −2.4%); fasting plasma glucose (from −3.0 to −4.3 mmol/l); post-breakfast post-prandial plasma glucose (from −4.1 to −6.5 mmol/l); and health-related quality of life (HRQoL). Sixteen serious adverse drug reactions were reported.ConclusionAfter 24-week treatment with biphasic insulin aspart 30, all age-groups of insulin-experienced and insulin-naïve patients experienced significantly improved glycemic control and HRQoL; incidence of hypoglycemia was generally reduced. The tolerability and effectiveness of biphasic insulin aspart 30 may benefit all age-groups.

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Efficacy and safety of biphasic insulin aspart 70/30 in type 2 diabetes patients of different race or ethnicity (INITIATEplus trial)

Cited by 5 publications

References 23 publications

Safety and Effectiveness of Switching from a Basal-only to Biphasic Insulin Aspart 30 Insulin Regimen

Safety and Effectiveness of Switching from a Basal-only to Biphasic Insulin Aspart 30 Insulin Regimen

Racial and Ethnic Disparities in Adverse Drug Events: A Systematic Review of the Literature

Safety and Effectiveness of Biphasic Insulin Aspart 30 in Different Age-Groups: A1chieve Sub-Analysis

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