The aim of the study was to quantify patient preferences for outcomes associated with oral antidiabetic medications (OAMs) in Sweden and Germany through a discrete-choice experiment.
Adults taking OAMs who had a self-reported physician's diagnosis of type 2 diabetes mellitus (T2DM) made a series of nine choices between pairs of hypothetical profiles. Each profile had a predefined range of attributes: blood glucose control, frequency of mild-to-moderate hypoglycaemia, annual severe hypoglycaemic events, annual weight gain, pill burden and frequency of administration, and cost. Choice questions were based on an experimental design with known statistical properties. Bivariate probit analysis estimated the probabilities of choice of medication administration from patient characteristics and, conditional on that choice, preferences for treatment outcomes.
The final sample consisted of 188 Swedish and 195 German patients. For both countries, weight gain was the most important attribute, followed by blood glucose control. Avoiding a 5-kg weight gain was 1.5 times more important in Sweden and 2.3 times more important in Germany than achieving moderate blood glucose control, thereby, suggesting that blood glucose control is relatively more important to Swedish than to German patients. Least important outcomes were the number of daily pills (Sweden) and frequency of mild-to-moderate hypoglycaemia (Germany).
Patients in both Sweden and Germany preferred OAMs not associated with weight gain.
As more studies report on patient preferences for diabetes treatment, identifying diabetes outcomes other than glycated hemoglobin (HbA1c) to describe effectiveness is warranted to understand patient-relevant, benefit-risk tradeoffs.
The aim of the study was to evaluate how preferences differ when effectiveness (glycemic control) is presented as long-term sequela (LTS) risk mitigation rather than an asymptomatic technical marker (HbA1c).
People with type 2 diabetes and using insulin (n = 3160) were randomly assigned to four self-administered, discrete-choice experiments that differed by their presentation of effectiveness. Epidemiologic reviews were conducted to ensure a close approximation of LTS risk relative to HbA1c levels. The relative importance of treatment benefit-risk characteristics and maximum acceptable risk tradeoffs was estimated using an error-component logit model. Log-likelihood ratio tests were used to compare parameter vectors.
In total, 1031 people responded to the survey. Significantly more severe hypoglycemic events were accepted for a health improvement in terms of LTS mitigation versus HbA1c improvement (0.7 events per year; 95% confidence interval [CI]: 0.4-1.0 vs. 0.2 events per year 95% CI: -0.02 to 0.5) and avoidance of treatment-related heart attack risk (1.4 severe hypoglycemic events per year; 95% CI: 0.8-1.9 vs. 1 event per year; 95% CI: 0.6-1.3). This finding is supported by a log-likelihood test that rejected at the 0.05 level that respondent preference structures are similar across the different experimental arms of the discrete-choice experiment.
We found evidence that benefit descriptions influence elicited preferences for the benefit-risk characteristics of injectable diabetes treatment. These findings argue for using carefully defined effectiveness measures to accurately take account of the patient perspective in benefit-risk assessments.
Continuous subcutaneous insulin infusion (CSII) was introduced in the outpatient diabetes clinic in Fredericia, Denmark, in 2005. The aim of this study was to evaluate the quality of metabolic control and patient satisfaction in type 1 diabetic patients treated with CSII.
In 2009-2010, a database with registration of metabolic variables and patient satisfaction was established. The collected material is a combination of retrospective and prospective data. Patient satisfaction was measured by use of the Diabetes Treatment Satisfaction Questionnaire Status (DTSQs) and change (DTSQc) versions.
By 31 December 2010, the database contained data from 68 active patients. Compared with before the initiation of CSII, glycohaemoglobin (HbA1c) had decreased significantly from 8.0% (5.8-13.7%) to 7.6% (6.1-9.5%). The improved glycaemic control was maintained each year until = 4 years after initiation of CSII (p 9% had decreased from 18% to 3%, and the number of serious attacks of hypoglycaemia had decreased (p
Concerns have been raised as to the safety of using pivaloyl-conjugated beta-lactam antibiotics during pregnancy as they cause carnitine depletion. Restrictions have been recommended in some Scandinavian countries as drug-induced carnitine depletion could constitute a risk to the developing foetus. One of these drugs, pivmecillinam, is widely used against urinary tract infections but few data exist concerning its safety in pregnancy. In a cohort study, we compared the prevalences of congenital abnormalities, pre-term delivery, low birth weight, low Apgar score and neonatal hypoglycaemia in the offspring of 414 women who had at least 1 prescription for pivmecillinam redeemed during pregnancy with those of the offspring of 7472 pregnant women for whom no drugs were prescribed during pregnancy. The prevalence of congenital abnormalities was 1.7% among 119 infants exposed in the first trimester and 3.7% among the reference group [odds ratio (OR) 0.46; 95% confidence interval (CI) 0.11-1.86]. We found no significantly increased risks in either pre-term delivery (OR 0.91, 95% CI 0.11-1.86), low birth weight (OR 0.57, 95%, CI 0.23-1.41), low Apgar score (OR 2.32, 95% CI 0.30-18.16) or hypoglycaemia (OR 0.73, 95% CI 0.18-3.00) that were induced by carnitine depletion. No significantly increased risk in adverse birth outcome was therefore found in women treated with pivmecillinam.
We retrospectively reviewed our 10-year experience with the management of sulfonylurea overdose. There were 40 overdoses in 37 patients aged 1 to 78 years, with two deaths and one patient being left in a chronic vegetative state. Blood sugar levels ranged from normal to severe recalcitrant hypoglycemia. Maximal duration of recurrent hypoglycemia was 82 hours. In 21 of 31 patients with hypoglycemia, response to hypertonic glucose therapy was poor, resulting in recurrent hypoglycemia. Six of these patients were treated with intravenous diazoxide and had prompt correction. Overdose of sulfonylurea drugs may produce severe, protracted hypoglycemia poorly responsive to hypertonic glucose therapy. Treatment with diazoxide is rational and effective and may be lifesaving.
Comparison of biphasic insulin aspart 30 given three times daily or twice daily in combination with metformin versus oral antidiabetic drugs alone in patients with poorly controlled type 2 diabetes: a 16-week, randomized, open-label, parallel-group trial conducted in russia.
Modern premixed insulins offer a flexible approach to the initiation of insulin therapy in patients with poorly controlled type 2 diabetes. A disadvantage of twice-daily regimens of biphasic insulin aspart 30 (BIAsp 30) is that lunchtime control (when no insulin is administered) can be suboptimal. Therefore, it is possible that administering BIAsp 30 thrice daily might further optimize glycemic control and offer an option for patients in whom metformin (MET) is contraindicated.
This study evaluated the efficacy and safety profiles of 2 different regimens of BIAsp 30 compared with a regimen consisting of oral antidiabetic drugs (OADs) alone.
In this multicenter, randomized, open-label, parallel-group trial, insulin-naive patients with poorly controlled type 2 diabetes (baseline glycosylated hemoglobin [HbA(1c) > or =8.0%) who were taking OADs (a sulfonylurea or meglitinide with/without MET or MET only) were randomized to receive BIAsp 30 TID, BIAsp 30 BID + MET, or continuation of their current OAD therapy for 16 weeks. The primary end point was HbA(1c) at the end of the study. Secondary end points included reductions in HbA(1c), mean blood glucose (BG), prandial increment, mean 7-point self-monitored BG profile, weight changes, tolerability (hypoglycemia, adverse events), and satisfaction/quality of life (derived from 2 questionnaires completed at weeks 0, 8, and 16).
The study enrolled 308 insulin-naive patients with type 2 diabetes (78.9% female; mean age, 58.3 years; body mass index, 29.4 kg/m(2); HbA(1c), 10.3%). Both BIAsp 30 TID and BIAsp 30 BID + MET were associated with significantly greater mean (SD) reductions in HbA(1c) relative to OADs alone (absolute percent reduction: 2.9% [1.5%], 3.0% [1.6%], and 2.1% [1.4%], respectively; P
The majority of individuals with type 1 diabetes do not meet recommended glycemic targets.
To evaluate the effects of continuous glucose monitoring in adults with type 1 diabetes treated with multiple daily insulin injections.
Open-label crossover randomized clinical trial conducted in 15 diabetes outpatient clinics in Sweden between February 24, 2014, and June 1, 2016 that included 161 individuals with type 1 diabetes and hemoglobin A1c (HbA1c) of at least 7.5% (58 mmol/mol) treated with multiple daily insulin injections.
Participants were randomized to receive treatment using a continuous glucose monitoring system or conventional treatment for 26 weeks, separated by a washout period of 17 weeks.
Difference in HbA1c between weeks 26 and 69 for the 2 treatments. Adverse events including severe hypoglycemia were also studied.
Among 161 randomized participants, mean age was 43.7 years, 45.3% were women, and mean HbA1c was 8.6% (70 mmol/mol). A total of 142 participants had follow-up data in both treatment periods. Mean HbA1c was 7.92% (63 mmol/mol) during continuous glucose monitoring use and 8.35% (68 mmol/mol) during conventional treatment (mean difference, -0.43% [95% CI, -0.57% to -0.29%] or -4.7 [-6.3 to -3.1 mmol/mol]; P?
Comment In: JAMA. 2017 Jan 24;317(4):363-36428118435
Exposure and clinical data concerning cases of toxic convulsions and hypoglycemia due to tetramethyl succinonitrile (TMSN) exposure are reported.
Forty-four workers exposed to TMSN in the PVC production plant participated in occupational health medical check-ups including medical history, clinical examination and clinical chemistry. A 4-year follow-up was performed. To evaluate occupational exposure, measurements of TMSN in the ambient air as well as personal air sampling were conducted.
Four workers suffered from convulsions with reversible pathologic EEG and 16 other persons were hypoglycemic. Other frequent symptoms included headaches, dizziness and unpleasant taste sensations. TMSN levels had been clearly above the Swiss occupational exposure limit value (MAK). Occupational hygiene interventions resulted in a reduction of the TMSN concentration below the MAK value. TMSN related symptoms have not been observed anymore in the 4-year follow-up.
TMSN is a convulsive substance which in humans has also a hypoglycemic effect.
To assess the cost-effectiveness of insulin detemir compared with Neutral Protamine Hagedorn (NPH) insulin when initiating insulin treatment in people with type 2 diabetes mellitus (T2DM) in Denmark, Finland, Norway, and Sweden.
Efficacy and safety data were derived from a 20-week multi-centre randomized controlled head-to-head clinical trial comparing insulin detemir and NPH insulin in insulin naïve people with T2DM, and short-term (1-year) cost effectiveness analyses were performed. As no significant differences in HbA1c were observed between the two treatment arms, the model was based on significant differences in favour of insulin detemir in frequency of hypoglycaemia (Rate-Ratio?=?0.52; CI?=?0.44-0.61) and weight gain (??=?0.9?kg). Model outcomes were measured in Quality Adjusted Life Years (QALYs) using published utility estimates. Acquisition costs for insulin and direct healthcare costs associated with non-severe hypoglycaemic events were obtained from National Health Service public sources. One-way and probabilistic sensitivity analyses were performed.
Based on lower incidence of non-severe hypoglycaemic events and less weight gain, the QALY gain from initiating treatment with insulin detemir compared with NPH insulin was 0.01 per patient per year. Incremental cost-effectiveness ratios for the individual countries were: Denmark, Danish Kroner 170,852 (€22,933); Finland, €28,349; Norway, Norwegian Kroner 169,789 (€21,768); and Sweden, Swedish Krona 226,622 (€25,097) per QALY gained. Possible limitations of the study are that data on hypoglycaemia and relative weight benefits from a clinical trial were combined with hypoglycaemia incidence data from observational studies. These populations may have slightly different patient characteristics.
The lower risk of non-severe hypoglycaemia and less weight gain associated with using insulin detemir compared with NPH insulin when initiating insulin treatment in insulin naïve patients with type 2 diabetes provide economic benefits in the short-term. Based on cost/QALY threshold values, this represents good value for money in the Nordic countries. Using a short-term modelling approach may be conservative, as reduced frequency of hypoglycaemia and less weight gain may also have positive long-term health-related implications.