OBJECTIVEInsulin degludec (IDeg) is a basal insulin that forms soluble multihexamers after subcutaneous injection, resulting in an ultra-long action profile. We assessed the efficacy and safety of IDeg formulations administered once daily in combination with mealtime insulin aspart in people with type 1 diabetes.RESEARCH DESIGN AND METHODSIn this 16-week, randomized, open-label trial, participants (mean: 45.8 years old, A1C 8.4%, fasting plasma glucose [FPG] 9.9 mmol/L, BMI 26.9 kg/m2) received subcutaneous injections of IDeg(A) (600 μmol/L; n = 59), IDeg(B) (900 μmol/L; n = 60), or insulin glargine (IGlar; n = 59), all given once daily in the evening. Insulin aspart was administered at mealtimes.RESULTSAt 16 weeks, mean A1C was comparable for IDeg(A) (7.8 ± 0.8%), IDeg(B) (8.0 ± 1.0%), and IGlar (7.6 ± 0.8%), as was FPG (8.3 ± 4.0, 8.3 ± 2.8, and 8.9 ± 3.5 mmol/L, respectively). Estimated mean rates of confirmed hypoglycemia were 28% lower for IDeg(A) compared with IGlar (rate ratio [RR]: 0.72 [95% CI 0.52–1.00]) and 10% lower for IDeg(B) compared with IGlar (RR: 0.90 [0.65–1.24]); rates of nocturnal hypoglycemia were 58% lower for IDeg(A) (RR: 0.42 [0.25–0.69]) and 29% lower for IDeg(B) (RR: 0.71 [0.44–1.16]). Mean total daily insulin dose was similar to baseline. The frequency and pattern of adverse events was similar between insulin treatments.CONCLUSIONSIn this clinical exploratory phase 2 trial in people with type 1 diabetes, IDeg is safe and well tolerated and provides comparable glycemic control to IGlar at similar doses, with reduced rates of hypoglycemia.
The New Zealand Cot Death Study, a multicentre case-control study, was set up to identify risk factors associated with sudden infant death syndrome (SIDS). In the 3 years of the study there were 485 infant deaths classified as SIDS in the study areas and 1800 infants who were randomly selected as controls. Data were collected by parent interviews and from obstetric notes. A full set of data for this analysis was available from 356 cases and 1529 control infants. The relationship between length of any breastfeeding and SIDS was examined: 92% of the controls were initially breastfed compared to 86% of the cases. As time went by, cases stopped breastfeeding sooner than controls: by 13 weeks, 67% controls were breastfed versus 49% cases. A reduced risk for SIDS in breastfed infants persisted during the first 6 months after controlling for confounding demographic, maternal and infant factors. Infants exclusively breastfed 'at discharge from the obstetric hospital' (odds ratio [OR] = 0.52, 95% confidence interval (CI): 0.35-0.71) and during the last 2 days (OR = 0.65, 95% CI: 0.46-0.91) had a significantly lower risk of SIDS than infants not breastfed after controlling for potential confounders. We have shown a substantial association of breastfeeding with a lowered risk for SIDS. This supports the need for more positive promotion and active community support to further enhance the level and length of exclusive breastfeeding.
OBJECTIVE -We sought to evaluate the effects of muraglitazar, a dual (␣/␥) peroxisome proliferator-activated receptor (PPAR) activator within the new glitazar class, on hyperglycemia and lipid abnormalities. RESULTS -Analyses were conducted at week 24 for HbA 1c (A1C) and at week 12 for lipid parameters. Mean A1C at baseline was 8.12 and 8.13% in muraglitazar and pioglitazone groups, respectively. At week 24, muraglitazar reduced mean A1C to 6.98% (Ϫ1.14% from baseline), and pioglitazone reduced mean A1C to 7.28% (Ϫ0.85% from baseline; P Ͻ 0.0001, muraglitazar vs. pioglitazone). At week 12, muraglitazar and pioglitazone reduced mean plasma triglyceride (Ϫ28 vs. Ϫ14%), apolipoprotein B (Ϫ12 vs. Ϫ6%), and non-HDL cholesterol (Ϫ6 vs. Ϫ1%) and increased HDL cholesterol (19 vs. 14%), respectively (P Ͻ 0.0001 vs. pioglitazone for all comparisons). At week 24, weight gain (1.4 and 0.6 kg, respectively) and edema (9.2 and 7.2%, respectively) were observed in the muraglitazar and pioglitazone groups; at week 50, weight gain and edema were 2.5 and 1.5 kg, respectively, and 11.8 and 8.9%, respectively. At week 50, heart failure was reported in seven patients (five with muraglitazar and two with pioglitazone), and seven deaths occurred: three from sudden death, two from cerebrovascular accident, and one from pancreatic cancer in the muraglitazar group and one from perforated duodenal ulcer in the pioglitazone group.
RESEARCH DESIGN AND METHODSCONCLUSIONS -We found that 5 mg muraglitazar resulted in greater improvements in A1C and lipid parameters than a submaximal dose of 30 mg pioglitazone when added to metformin. Weight gain and edema were more common when muraglitazar was compared with a submaximal dose of pioglitazone.
A prospective study of 167 consecutive patients admitted to a general hospital following an episode of deliberate self-harm was carried out; 102 patients were interviewed by computer and then by a psychiatrist who was blind to the results of the computer interview. The computer interview consisted of a self-rating modification of the Hamilton Rating Scale for Depression and a novel questionnaire developed to assess suicidal ideation. This article explores the preliminary findings in these patients and suggests that not only is the computer interview acceptable to the majority of patients but the data suggest, in line with previous studies, that the patients are prepared to confide information to the computer that they may be unwilling to tell the clinician. Further the data also suggest a significant pathoplastic effect of the personality of the patient on the perception of the psychopathology by the clinician. The computer appeared to be a better predictor of suicidality than the interview by the clinician.
Glycemic control is maintained with insulin detemir during long-term treatment. At equivalent glycemic control to NPH insulin, insulin detemir is associated with a lack of weight gain and a trend towards a reduced risk of nocturnal hypoglycemia when used in basal-bolus therapy with mealtime soluble human insulin.
ObjectiveTo investigate death rates in schizophrenia and related psychoses.DesignData from two epidemiologically complete cohorts of patients presenting for the first time to mental health services in North Wales for whom there are at least 1, and up to 10-year follow-up data have been used to calculate survival rates and standardised death rates for schizophrenia and related psychoses.SettingThe North Wales Asylum Denbigh (archived patient case notes) and the North West Wales District General Hospital psychiatric unit.PopulationCohort 1: The North Wales Asylum Denbigh (archived patient case notes). Of 3168 patients admitted to the North Wales Asylum Denbigh 1875–1924, 1074 had a schizophrenic or related psychosis. Cohort 2: Patients admitted between 1994 and 2010 to the North West Wales District General Hospital psychiatric unit, of whom 355 had first admissions for schizophrenia or related psychoses.ResultsWe found a 10-year survival probability of 75% in the historical cohort and a 90% survival probability in the contemporary cohort with a fourfold increase in standardised death rates in schizophrenia and related psychoses in both historical and contemporary periods. Suicide is the commonest cause of death in schizophrenia in the contemporary period (SMR 35), while tuberculosis was the commonest cause historically (SMR 9). In the contemporary data, deaths from cardiovascular causes arise in the elderly and deaths from suicide in the young.ConclusionsContemporary death rates in schizophrenia and related psychoses are high but there are particular hazards and windows of risk that enable interventions. The data point to possible interventions in the incident year of treatment that could give patients with schizophrenia a normal life expectancy.
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