Patient-reported frequency, awareness and patient-physician communication of hypoglycaemia in Belgium.

OBJECTIVES: Limited data exist on the frequency of non-severe hypoglycaemic events in patients with insulin-treated diabetes outside of clinical trial settings. Our study investigated the rates of self-reported non-severe events in a sample of Belgian patients. We also investigated self-reported awareness of the symptoms of hypoglycaemia and communication about hypoglycaemia between patients and their physicians. METHODS: Patients aged >15 years with Type 1 (T1DM) and insulin-treated Type 2 (T2DM) diabetes were recruited via existing panels in Belgium to complete four questionnaires at weekly intervals. In addition to demographics, data on frequency of non-severe hypoglycaemic events (7-day recall), severe hypoglycaemic events (1-year recall), awareness of hypoglycaemia and reporting of hypoglycaemia to physicians were recorded. RESULTS: In total, 412 patients (44% T1DM, 56% T2DM) completed 1148 patient-week records. Mean insulin-treatment duration was 11 years, mean HbA(1c) 7·7%. Mean reported non-severe hypoglycaemic events per patient-week were 2·3 in T1DM patients, 0·3 in T2DM patients receiving basal-only therapy, 0·7 in T2DM patients receiving basal-bolus therapy and 0·8 in T2DM patients receiving another form of insulin. Mean reported annual frequencies of severe hypoglycaemic events were 0·9 in T1DM and 0·4 in T2DM. Impaired awareness or unawareness of hypoglycaemia was reported by 70% of T1DM patients, 55% of T2DM patients receiving basal-only therapy, 61% of T2DM patients receiving basal-bolus therapy and 73% of T2DM patients receiving another form of insulin. Overall, 60% of T1DM patients and 46% of T2DM patients rarely/never discuss hypoglycaemia with their GP/specialist. In addition, 10% of T1DM patients and 13% of T2DM patients stated that GPs/specialists did not ask them about their hypoglycaemia in routine appointments. CONCLUSION: Hypoglycaemic events and unawareness of these events are common in Belgian insulin-treated diabetes patients. Patients often fail to report hypoglycaemic events to their physician and many physicians do not inquire about hypoglycaemia, meaning the current burden of hypoglycaemic events may be underestimated.

Naftidrofuryl in quality of life (NIQOL). A Belgian study.

BACKGROUND: Using a disease specific questionnaire, the Claudication Scale (CLAU-S), we undertook a double blind, placebo controlled study in patients with intermittent claudication (IC) to determine whether the increase in the pain-free walking distance, previously demonstrated with naftidrofuryl, is reflected as an improvement in the patients' quality of life. METHODS: Following an initial one month placebo run-in 235 patients, with stable IC for at least 3 months, were randomized to either naftidrofuryl (Praxilene), at a dosage of 200 mg three times daily, or matching placebo, for 6 months. All patients completed the self-administered CLAU-S questionnaire which is divided into 6 dimensions, before the start of treatment, at 3 and at 6 months. Statistical analysis was undertaken on an intention-to-treat (ITT) basis which included all patients known to have taken at least one dose of the drug and to have provided key data on at least one occasion after baseline. For each of the CLAU-S dimensions the two groups were compared in respect to difference between the initial and final values. RESULTS: Two hundred and twenty patients (108 naftidrofuryl, 112 placebo) were eligible for the ITT analysis. Significant improvements, in favour of the active medication, were seen for the dimensions Daily living, Pain and Social life (all p<0.01). For the dimensions complaints, disease specific fears and mood, there were no significant differences between naftidrofuryl and placebo. A multivariate analysis of covariance, which took into account such factors as initial score, age and sex confirmed the global superiority of naftidrofuryl (p=0.047). CONCLUSIONS: In this placebo controlled study, using a disease specific questionnaire, naftidrofuryl has been shown to significantly improve several aspects of the quality of life of patients with IC.

Lack of cardiovascular side effects of the new tricyclic antidepressant tianeptine. A double-blind, placebo-controlled study in young healthy volunteers.

In a double-blind, placebo-controlled, crossover study, the effects of therapeutic doses of the new tricyclic antidepressant tianeptine on cardiovascular function were closely monitored in 21 healthy volunteers during a 2-week treatment period. Blood pressure measurements, ECG recording, 24-h Holter monitoring, and echocardiography were carried out at 1-week intervals. Isotopic ventriculography was measured twice under each treatment. Tianeptine did not produce orthostatic hypotension or increase heart rate. No ECG changes could be observed and the cardiac conduction time remained unchanged. One subject presented with an increase in frequency of ventricular premature beats that could not be definitely attributed to the drug. Cardiac output assessed at rest and after a bicycle exercise stress test was not altered. The present study suggests that tianeptine is a tricyclic antidepressant endowed with less cardiac toxicity than classical tricyclic antidepressants.

[Trimetazidine versus betahistine in vestibular vertigo. A double blind study]. / Trimétazidine contre bétahistine dans les vertiges vestibulaires. Etude en double aveugle.

The efficacy of trimetazidine (60 mg/day) in vertigo was compared with that of betahistine (24 mg/day) in a three-month double-blind study. Included in the study were only patients with peripheral vertigo associated or not with tinnitus or hearing loss, and excluded were those presenting with symptoms related to retrocochlear or central disease. Out of the 40 patients enrolled, 20 suffered from Meniere's disease; 4 patients either dropped out of the study or were non-compliant to therapy and could not be taken into account in the final analysis, which bore on 36 patients (18 treated by trimetazidine and 18 with betahistine). There were no dropouts in the Meniere's disease subgroup (10 receiving trimetazidine and 10 receiving betahistine). Results revealed a better response to therapy with trimetazidine in patients suffering from vertigo, and this was particularly true of the Meniere's disease subgroup (p less than 0.025). Moreover, in the latter subgroup, all patients treated with trimetazidine fully recovered from vertigo spells, while these disappeared completely only in 4 of the patients administered betahistine (p less than 0.005). There was no noticeable difference between the two treatment groups as regards the evolution of the accompanying symptoms and the audiometric or vestibular test results. Clinical acceptability was equally excellent in both treatment groups. Overall, this study allowed to confirm the therapeutical efficacy of trimetazidine in the management of vertigo, as well as establishing the clinical advantage of trimetazidine over betahistine in patients suffering from Meniere's disease.

Transfer from purified porcine insulins to semisynthetic human insulins decreases insulin antibodies and circulating immune complexes in diabetic children and adolescents. A two-year follow-up.

In this long-term prospective study, including 45 diabetic children and adolescents under the age of 20 years, insulin antibodies and other immunological factors (circulating immune complexes, autoantibodies, etc.) were compared before and during a two-year follow-up after a switch-over from monocomponent porcine insulins to monocomponent semisynthetic human insulins. IgG insulin antibodies were detected in 21 children out of 45 (47%) at a mean level of 0.96 mU/ml (0.77-1.15). A significant and important decrease of both the number of patients having insulin antibodies and the level of insulin antibodies was observed 18 months after the switch-over. After 24 months, IgG insulin antibodies were only present in 5 patients (11%) at a mean level reduced by half (0.53 mU/ml; p less than 0.05). Four patients out of the five (80%) had HLA-DR3 DR4 antigens while this phenotype was only prevalent in 26% of the initial patient cohort. On the other hand, 3 months after the transfer, there was a significant and persistent decrease (by half) of non-specific immune complexes (39% of the patients with porcine insulins) which did not appear to correlate with the level of insulin antibodies. The prevalence of autoantibodies and of antinuclear factors showed no significant variations. The practical implication of these findings is that the use of semisynthetic human insulins could be of interest in patients previously treated by porcine insulins.

Normalization of complement activation and consumption in diabetic children and adolescents after switch-over from porcine to semisynthetic human insulin.

As the use of human insulin could possibly modify the immunogenicity of insulin, the present prospective study compares complement evaluation (CH50, C3, C3d/C3, C4) as well as other immunological factors (insulin antibodies, autoantibodies, ...), metabolic control (HbA1, lipids, ...) and clinical data (insulin dose/kg, number of hypoglycaemic episodes, ...), before and after a switch-over from monocomponent porcine insulins (Actrapid MC, Monotard MC) to human semisynthetic insulins (Actrapid HM, Protaphane HM). Forty-six type I diabetic children and adolescents (mean age +/- SD: 14.3 +/- 3.8 years) participated in the trial. The duration of diabetes ranged from 1.0 to 16.9 years (mean +/- SD: 7.3 +/- 3.7). The study protocol consisted of a 9 month period during which, at monthly intervals, the subjects were assessed clinically and blood samples taken for measurement of biological data. After 3 months, porcine insulins were switched to human insulins. The main results were as follows: 1) The insulin dose/kg was increased after the switch-over (porcine insulin: 0.90 +/- 0.03 U/kg; human insulin: 0.98 +/- 0.03 U/kg; p less than 0.001). This can perhaps be explained by the different bioavailabilities of Monotard MC and Protaphane HM. 2) The objective degree of metabolic control (HbA1), as well as the HDL-cholesterol level and the apo A1/B ratio, were not statistically different before and after the switch-over. 3) IgG insulin antibody binding was not statistically different on transfer from porcine insulin to semisynthetic insulin. 4) Mean level of total IgE and IgE specific insulin antibodies, determined before and after the switch-over, were not different. 5) Autoantibodies and antinuclear factor were unchanged.(ABSTRACT TRUNCATED AT 250 WORDS)