Characteristics of undiagnosed diabetes in community-dwelling French elderly: the 3C study.

We aimed to assess clinical and socio-demographic characteristics of undiagnosed diabetes, including glucose control, in French community-living elderly people. Diagnosed and undiagnosed diabetes, impaired fasting glucose (IFG) and characteristics of subjects were assessed by interview, clinical examination and fasting blood glucose measures at the baseline visit of the Three-City (3C) study including 9294 people over 65 in three urban areas in France. In the Bordeaux sample, HbA1c was measured in diabetic and IFG subjects and in a sub-sample of non-diabetic subjects. The proportion of diagnosed diabetes, undiagnosed diabetes and IFG was, respectively, 8.2%, 1.4% and 3.6%. Diabetic and IFG subjects were more likely to be men, to suffer from hypertension and to be overweight. They were less likely to have a high income and more likely to have a lower educational level. These factors were unrelated to knowledge of diabetic status. In the Bordeaux sub-sample, 19.6% of the diagnosed diabetic subjects and 16.1% of those undiagnosed had an HbA1c greater than 8%. Prevalence of ischemic heart disease was more common in diagnosed than in undiagnosed diabetic subjects (P=.021). A significant number of undiagnosed elderly had poor glucose control suggesting a potential benefit for diabetes screening in the elderly.

Relationship between body mass index and different domains of disability in older persons: the 3C study.

OBJECTIVE: To study the relationships between body mass index (BMI) and different domains of disability in elderly subjects from the French 3C study. SETTING: Three cities in France: Bordeaux (South-West), Dijon (North-East) and Montpellier (South-East). DESIGN: Cross-sectional study. SUBJECTS: A sample of 8966 elderly community dwellers (age: 65-101 y). MAIN OUTCOME MEASURES: BMI, continence, basic and Instrumental Activities of Daily Living (ADL and IADL) and mobility. Adjustment variables: age, educational level, lifestyle, cognitive functioning, smoking and drinking history, depression, dyspnea, diabetes and indicator of cardiovascular disease. RESULTS: Obesity (BMI> or =30 kg/m2) was significantly associated with disability in each domain for women. The relationship tended to be linear for ADL and for continence; whereas for IADL, underweight women (BMI <21 kg/m2) were also at higher risk of disability. In men, relationships were weaker since BMI was only associated with mobility restriction, with a higher risk for both underweight and obese subjects. CONCLUSION: These results are in favor of a strong association between obesity and the three domains of disability and incontinence. Weaker relationships between underweight and disability were observed. Results suggest that maintaining a BMI in the healthy range could contribute to independence in activities of daily living.

Efficacy of Daflon 500 mg in venous leg ulcer healing: a double-blind, randomized, controlled versus placebo trial in 107 patients.

The objective of this study was to evaluate the efficacy of Daflon 500 mg (Dios)* in venous ulcers. A multicenter, double-blind, randomized, controlled versus placebo (Plac) trial was conducted, with stratification according to the size of ulcer (< or = 10 cm and > 10 cm). The protocol called for a two-month treatment with Dios (one tablet = 450 mg micronized purified Diosmin) or a placebo, two tablets/day, in addition to compression therapy. Evaluations were performed every fifteen days, from D0 to D60. The primary endpoint, in accordance with Alexander House group requirements were: percentage of patients with complete ulcer healing, ie, comparison between Dios and Plac group at D60, and comparison of survival curves in each group between D0 and D60 (log rank test). Secondary endpoints included ulcer surface area assessed by computerized planimetric measurements, qualitative evaluation of ulcers, and symptoms. The patients were 105 men and women ranging in age from eighteen to eighty-five years, with standard compression stocking, who were undergoing standardized local care of ulcer and had no significant arterial disease (ankle/arm systolic pressure index > 0.8). Fifty-three patients received Dios, and 52 received Plac. The 2 groups were well matched for age (m +/- 1 SD = seventy-one +/- eleven years), gender, ulcer size, and associated disorders. Among patients with ulcer size < or = 10 cm (Dios = 44, Plac = 47) a significantly larger number of patients had a complete ulcer healing at two months in the Dios group (n = 14) in comparison with the Plac group (n = 6) (32% vs 13%, P = 0.028) with a significantly shorter time duration of healing (P = 0.037). No difference was shown for the secondary criteria, except for sensation of heavy legs (P = 0.039) and a less atonic aspect of ulcer (P = 0.030) in favor of Dios. Among the 14 patients with ulcer size > 10 cm (Dios = 9, Plac = 5), subjected to a descriptive analysis only, no ulcer healed. This study showed that a two-month course of Daflon 500 mg at a daily dose of two tablets, in addition to conventional treatment, is of benefit in patients with venous ulcer < or = 10 cm by accelerating complete healing.

Efficacy of Daflon 500 mg in the treatment of lymphedema (secondary to conventional therapy of breast cancer).

To assess the activity of a purified, micronized, flavonoidic fraction (Dios; Daflon 500 mg*) on upper limb lymphedema occurring after breast cancer therapy, a monocenter, randomized, double-blind, parallel group vs placebo (Plac) trial was carried out. One hundred and four women with lymphedema were included; 94 completed the study (46 Dios, 48 Plac). A subset of 24 patients with more severe lymphedema (10 Dios, 14 Plac) was subjected to a separate analysis. Treatment consisting of Dios or Plac was given two tablets daily over a six-month period. A radionuclide lymphoscintigraphy using technetium-99m was performed at inclusion and at the end of the treatment. The upper limb volume was measured every two months. In the overall population the evolution of parameters was not different between Dios and Plac. In the 24 patients with a more severe lymphedema, the lymphoscintigraphic parameters (m +/- sd) were as follows: lymphatic migration speed was significantly improved by Dios in comparison with Plac (delta Speed cm/minute: 0.84 +/- 0.6 vs 0.14 +/- 0.26, P = 0.005). The half-life of the colloidal compound was significantly improved over time in the Dios group (delta half-life = 10.3 +/- 13.07 minute, P = 0.034) but not in the Plac group (delta half-life = 0.53 +/- 15.51 minute, P = 0.086). The change over time of colloidal clearance was close to significance in the Dios group (delta clearance microL/minute: 2.18 +/- 3.10, P = 0.054) but not in the Plac group (0.11 +/- 2.26, P = 0.86). No significant difference was found for evolution of lymphedema volume, despite a tendency in favor of Dios. This can be related to wide distribution of volume values and small numbers of patients. In conclusion, these results suggest a beneficial therapeutic activity of Dios at the usual dose of two tablets/day in patients affected with more severe lymphedema. The clear improvement of the lymphatic speed illustrates its known lymphokinetic activity. Further studies with a higher dosage could confirm the beneficial activity of this drug in secondary lymphedema.

[Effects of rilmenidine (hyperium) on lipid balance in hyperlipidemic hypertensive patients. Randomized, controlled, double-blind 8-week study vs. captopril in parallel groups]. / Effets de la rilmenidine (hyperium) sur l'équilibre lipidique des patients hypertendus hyperlipidémiques. Etude randomisée à double insu et en groupes parallèles, contrôlée contre captopril, pendant 8 semaines.

Rilmenidine (dose of 1 mg once or twice a day) is the first oxazoline compound with antihypertensive properties. Its effects on lipid parameters [total cholesterol, HDL and LDL fractions, triglycerides, apolipoprotein A1 and B, lipoprotein (a)] were compared under double-blind conditions and in parallel groups to those of captopril (50 to 100 mg per day, in 2 divided doses) over a period of 8 weeks, in 51 hyperlipidaemic hypertensive patients [age: 56.3 +/- 1.5 years, systolic and diastolic blood pressure (SBP/DBP): 165.1 +/- 2.0/99.1 +/- 0.6 mmHg, LDL cholesterol: 5.38 +/- 0.16 mmol/L]. No significant difference was demonstrated between the groups on inclusion for any of the clinical parameters (SBP, DBP, heart rate (HR)) and laboratory parameters, apart from apolipoprotein A1, for which the mean value was higher in the rilmenidine group than in the captopril group (p < 0.05). No difference between the groups was demonstrated during the 8 weeks of treatment for the course of blood pressure: SBP and DBP decreased by 20.5 and 13.9 mmHg, respectively, in the rilmenidine group and by 21.3 and 13.1 mmHg in the captopril group (no significant difference: NS). HR decreased by 0.3 beats per minute (bpm) in the rilmenidine group and by 4.1 bpm in the captopril group (NS). No statistically significant difference in lipid parameters was observed between the two groups. No clinically significant variation in any of the lipid parameters was observed after 8 weeks of treatment with rilmenidine or captopril. These results confirm the antihypertensive efficacy and neutrality of rilmenidine on lipid metabolism over a period of 8 weeks. Rilmenidine therefore represents a useful alternative in the first-line treatment of hypertension in hyperlipidaemic hypertensive patients.

Lipid profile and antihypertensive efficacy in hyperlipidemic hypertensive patients: comparison of rilmenidine and captopril.

In hypertensive patients with lipid abnormalities, an ideal antihypertensive agent would control blood pressure without interfering with lipid metabolism. The aim of the present study was to assess whether in addition to angiotensin-converting enzyme inhibitors, calcium antagonists, and alpha 1-antagonists, rilmenidine (RIL), the first antihypertensive drug that is selective to imidazoline receptors, fulfills these requirements. To assess the effects of RIL (daily doses of 1 mg o.d. or b.i.d.) in comparison to captopril (CAP) (doses of 25 or 50 mg b.i.d.), an 8-week, double-blind, randomized, parallel-group study was carried out. Fifty-one patients (mean age: 56.3 +/- 1.5 years) with mild-to-moderate hypertension (supine systolic/diastolic blood pressure, 165.1 +/- 2.0/99.1 +/- 0.6 mm Hg) and type 2a or 2b hyperlipidemia (low-density lipoprotein (LDL) cholesterol: 5.38 +/- 0.16 mmol/L) were included in the study, and they were followed by their general practitioner at 4-week intervals. Twenty-six patients received RIL, and 25 received CAP. The permanence of hypercholesterolemia was checked twice before inclusion into the study, at 3-week intervals, for patients who had already been on a hypocholesterolemic diet for 6 weeks. Plasma lipid evaluation included total, LDL and high-density lipoprotein (HDL) cholesterol, triglycerides, apolipoproteins A1 and B, lipoprotein (a), and, last, a uric acid assay. Assays were centralized at the Lipid Laboratory, CHU Pitié-Salpétrière, Paris. In each group, 1 patient withdrew from the study for personal reasons, and four patients required a dose adjustment (double dose) at the week 4 visit. After 8 weeks of therapy, systolic blood pressure decreased significantly in both groups, with no statistically significant difference between groups (RIL, 20.5 mm Hg; CAP, 21.3 mm Hg; NS). Diastolic blood pressure also decreased (RIL, 13.9 mm Hg; CAP, 15.1 mm Hg; NS). No difference between groups was observed on the changes of lipid parameters between week 0 and week 8 visits. No severe adverse event occurred other than an asymptomatic atrial fibrillation in a CAP group patient at week 8. This study provides evidence that over a follow-up period of 8 weeks, both RIL and CAP are efficient and well-tolerated drugs in the first-line treatment of hypertensive patients with lipid abnormalities.

Cardiovascular variability after rilmenidine challenge: assessment of acute dosing effects by means of spectral analysis.

Short-term fluctuations in blood pressure (BP) and heart rate (HR) were analysed in a group of twelve subjects with mild hypertension. Indirect finger BP was measured by a Finapres device. The effects of an oral dose of rilmenidine (1 mg) were studied in a double-blind cross-over placebo-controlled study. Compared with placebo, rilmenidine reduced the variability of standing BP after 2 hours as estimated from the standard deviation of systolic BP which diminished by 20%. Spectral analysis of fluctuations in BP showed this reduction predominated in the mid frequency (MF) region corresponding to 10-second period oscillations, which depend on the activity of the autonomic nervous system. The average reduction in MF component for standing systolic BP was 24%. In addition the MF component for HR was reduced by 17%. This frequency domain analysis demonstrates a modified BP and HR variability profile with an acute dosing of rilmenidine. This effect being limited to the MF fluctuations in standing position orients towards an effect of the drug on the sympathetic cardiovascular control.

Laser Doppler and transcutaneous oximetry: modern investigations to assess drug efficacy in chronic venous insufficiency.

During chronic venous insufficiency (CVI), microcirculatory changes, e.g. a decrease in transcutaneous oxygen pressure (tcpO2) and an increase in transcutaneous carbon dioxide pressure (tcpCO2), are implicated in the pathophysiology of trophic disorders leading ultimately to venous ulcers. Daflon 500 mg1, a micronized purified flavonoid fraction, has been shown to improve venous tone, capillary permeability and resistance, and lymphagogue activity at a daily dose of 2 tablets. To assess the effects of Daflon 500 mg on microcirculatory parameters by means of laser Doppler fluxmetry and transcutaneous oxiketry, a 3-month, double-blind, randomized, parallel-group study was carried out in 104 patients divided into 3 groups according to the daily dose: 1 tablet (group 1, n = 34), 2 tablets (group 2, n = 33), on 4 tablets (group 3, n = 37). All patients (mean age 43.7 +/- 13.1 years; 100 females, 4 males) included in the study were affected by mild CVI. They were followed for 90 days with visits at 1 month (day 28) and 3 months (day 90). At inclusion, there were no significant differences between groups as regards biometric data, mean tcpO2 (group 1, 62.7 +/- 4.5 mm Hg; group 2, 64.0 +/- 3.3 mm Hg; group 3, 64.1 +/- 3.5 mm Hg), mean tcpCO2 (group 1, 40.7 +/- 2.5 mm Hg; group 2, 39.3 +/- 2.9 mm Hg; group 3, 40.0 +/- 2.5 mm Hg) and laser Doppler parameters. Fourteen patients withdrew from the study (group 1, n = 4; group 2, n = 3; group 3, n = 7): 9 for reasons not related to treatment, 3 for adverse events, 2 because they were lost to follow-up. From day 0 to day 90, mean tcpO2 significantly increased (p < 0.001) in each group (group 1, 3.0 +/- 2.1 mm Hg; group 2, 2.9 +/- 2.1 mm Hg; group 3, 2.5 +/- 1.6 mm Hg), mean tcpCO2 significantly decreased (p < 0.001) in each group (group 1, 2.6 +/- 2.0 mm Hg; group 2, 1.7 +/- 1.9 mm Hg; group 3, 2.2 +/- 1.5 mm Hg). No significant differences were observed between groups. Laser Doppler parameters remained unchanged from day 0 to day 90 in the 3 groups. Symptoms (discomfort, pain, heaviness, burning sensation) and signs (oedema) of CVI as well as perimetric measurements of calf and supramalleolar area were significantly improved in the 3 groups. In conclusion, during this 3-month study, Daflon 500 mg improved oximetric measurements and did not alter laser Doppler parameters. These data suggest that Daflon 500 mg, at the early stages of CVI, acts favourably on the microcirculatory disturbances also involved in the pathophysiology of more severe stages of CVI.

Long-term control of blood pressure by rilmenidine in high-risk populations.

Efficacy and acceptability of rilmenidine in populations with high cardiovascular risk has been established in short- or mid-term studies (1.5-6 months) enrolling relatively small numbers of patients. The present open study was undertaken to compare, on a larger scale, the efficacy and acceptability of a 12-month rilmenidine treatment in high-risk outpatients versus the results obtained in the general population and to check for unexpected adverse events. A total of 2,635 hypertensive patients (supine diastolic blood pressure [SDBP] > 90 mm Hg) were enrolled, including a high-risk population with 1,591 patients aged > 60 (60.3%), 1,007 patients with dyslipidemia (38.2%), 393 with diabetes (14.9%), 328 with chronic renal failure (12.4%), 301 with angina pectoris (11.4%), and 84 with chronic heart failure (3.2%). All patients were treated by rilmenidine 1 mg/day during the first 6 weeks; then (at 1.5 months), if SDBP was > 90 mm Hg, dosage of rilmenidine was 1 mg twice daily during the following 6 weeks. From month 3 to month 12, any other antihypertensive drugs could be added if SDBP remained > 90 mm Hg. In comparison with the general population, the percentage of high-risk patients whose monotherapy normalized blood pressure (SDBP < or = 90 mm Hg) was slightly lower at month 1.5 (58-66%, according to the risk group, vs 68% in the general population) and month 3 (73-82% vs 85%). At month 12, all treatments taken as a whole (monotherapy and combination therapy) led to the normalization of blood pressure in 94% of patients in the general population and in populations at risk.(ABSTRACT TRUNCATED AT 250 WORDS)