Identification of patients with gout: elaboration of a questionnaire for epidemiological studies.

OBJECTIVES: In France, the prevalence of gout is currently unknown. We aimed to design a questionnaire to detect gout that would be suitable for use in a telephone survey by non-physicians and assessed its performance. METHODS: We designed a 62-item questionnaire covering comorbidities, clinical features and treatment of gout. In a case-control study, we enrolled patients with a history of arthritis who had undergone arthrocentesis for synovial fluid analysis and crystal detection. Cases were patients with crystal-proven gout and controls were patients who had arthritis and effusion with no monosodium urate crystals in synovial fluid. The questionnaire was administered by phone to cases and controls by non-physicians who were unaware of the patient diagnosis. Logistic regression analysis and classification and regression trees were used to select items discriminating cases and controls. RESULTS: We interviewed 246 patients (102 cases and 142 controls). Two logistic regression models (sensitivity 88.0% and 87.5%; specificity 93.0% and 89.8%, respectively) and one classification and regression tree model (sensitivity 81.4%, specificity 93.7%) revealed 11 informative items that allowed for classifying 90.0%, 88.8% and 88.5% of patients, respectively. CONCLUSIONS: We developed a questionnaire to detect gout containing 11 items that is fast and suitable for use in a telephone survey by non-physicians. The questionnaire demonstrated good properties for discriminating patients with and without gout. It will be administered in a large sample of the general population to estimate the prevalence of gout in France.

Use of bosentan for digital ulcers related to systemic sclerosis: a real-life retrospective French study of 89 patients treated since specific approval.

OBJECTIVES: Ischaemic digital ulcers (DUs) are a common complication of systemic sclerosis (SSc). This study aimed to characterize patients with SSc and ongoing DUs treated with the endothelin receptor antagonist bosentan in clinical practice in France. METHOD: An observational, retrospective, longitudinal study was conducted in 10 French expert centres. Medical records from randomly selected adult SSc patients who received treatment with bosentan for DU prevention from March 2007 to December 2010 were analysed. The primary objective was to determine the profile of patients at treatment initiation. Secondary objectives were to monitor bosentan dosing, treatment schedule, and reasons for treatment termination. RESULTS: The study included 89 patients (mean age 52 years, 69% female, 44% diffuse cutaneous SSc). At bosentan treatment initiation, the mean duration of Raynaud's phenomenon was 15 ± 12 years, and the mean time since first episode with DU was 6.5 ± 7 years. Most patients had a history of at least two episodes with DUs, separated by < 12 months (61%), and had received intravenous iloprost (63%). Previous DU complications included auto-amputation (8%), surgical amputation (6%), osteitis (6%), and gangrene (4.5%). Active smokers (25%) had a history of significantly more surgical amputation (p = 0.004) and osteitis (p = 0.004) than non-smokers. At least one active DU at bosentan initiation was detected in 82% of patients. Bosentan was used according to prescription guidelines and was well tolerated; six patients (7%) withdrew from treatment because of raised liver enzymes. CONCLUSIONS: Patients treated with bosentan for DU prevention in France have severe, refractory, ongoing ulcerative disease. Active smoking was correlated to a history of DU complications. Tolerance of bosentan was comparable to previous studies.

Vertebral fractures in Gaucher disease type I: data from the French "Observatoire" on Gaucher disease (FROG).

UNLABELLED: Gaucher disease type 1 (GD1), results in a range of skeletal complications including osteopenia, osteoporosis, and osteonecrosis, but there is little published information regarding vertebral fractures. Findings from this observational study indicated that the prevalence of vertebral fractures in a cohort of adult French GD1 patients is approximately 15%. INTRODUCTION: The aim of the study was to assess the prevalence and characteristics of vertebral fractures in a cohort of adult patients with GD1. METHODS: This study was performed in adult patients with GD1 based on a detailed and complete clinical examination. For all patients for whom vertebral fractures were reported, a specific questionnaire was sent to physicians, and imaging data were collected, when available, for centralized analysis. RESULTS: Data were collected from a total of 105 adult GD1 patients. Bone complications were reported in 85% of patients, among whom vertebral fractures were diagnosed in 16 (15%); seven women and nine men (mean age, 45 years). We observed five patients with multiple vertebral fractures and one patient in whom the T3 vertebra was fractured. Most of these patients did not report fracture-related back pain. CONCLUSIONS: The prevalence of vertebral fractures in this cohort of adult patients with GD1 was 15%. Greater awareness of the natural history of vertebral fractures in GD1, and rigorous monitoring of bone fragility and spine involvement in affected patients, should allow earlier detection and initiation of treatment tailored toward improving bone status.

The neurological manifestations of Gaucher disease type 1: the French Observatoire on Gaucher disease (FROG).

BACKGROUND: Gaucher disease (GD), the most prevalent inherited lysosomal storage disorder, is caused by deficient glucocerebrosidase activity. Type 1 GD (GD1), the most common variant, is classically considered non-neuronopathic. METHODS: We performed a national cross-sectional observational survey-the French Observatoire on Gaucher Disease (FROG)-in patients with GD1 between March 2005 and September 2006. The study included all patients over 18 years of age with confirmed GD1 who attended participating centers for regular follow-up. RESULTS: One hundred and five patients were included, in whom we studied the prevalence and characteristics of relevant neurological symptoms associated with the neuraxis. Of these, 51 (49%) GD1 patients presented at least one neurological symptom. Four patients (4%) had Parkinson disease and 22 (21%) presented with at least one parkinsonian sign or at least one sign frequently associated with Parkinson disease. Five patients (5%) had a previous diagnosis of peripheral neuropathy. Other central nervous system symptoms were recorded in 20 (19%) patients and other peripheral nervous system symptoms in 39 (37%) patients. CONCLUSIONS: These data challenge the current classification of GD, and suggest that the three forms of GD each involve a different profile of neurological manifestations.

[Pneumo-Quest: A standardised self-questionnaire to be completed at home before a first appointment at a respiratory clinic]. / Pneumo-Quest, auto-questionnaire standardisé à compléter au domicile avant une première consultation en pneumologie : étude de validation.

The Pneumo-Quest self-questionnaire was developed to standardize the practice of recollection when welcoming a new patient. It consists of 82 main questions and 34 subsidiary questions to be completed at home by the patients before their first visit to a pulmonologist. This evaluation was carried out on the basis of 137 returned questionnaires. The feasibility (main criterion) was good with 93±5% of the questions answered and an average completion time of 15.1±9.8minutes (mean±SD). The reliability of the responses (secondary criterion) was good with the agreement between the patient's response and the doctor's opinion being excellent or good for the majority of medical histories and treatments, as evidenced by the high values of the kappa coefficient (>0.90; <0.90; <0.75). Patient and physician perception of the questionnaire was good with 99% and 90% positive ratings, respectively. The use of the questionnaire was unhelpful in the course of the consultation in only 2% of cases. Doctors found the tool useful for obtaining a comprehensive history in 87% of cases and patients declared that it helped them "forgot nothing" in 93% of the cases. The questionnaire helped the doctor to identify the patient's problems rapidly in 71% of cases and saved time in 64%. These positive results encourage a wide dissemination of the questionnaire (www.pneumo-quest.com).

Evaluation of cardiac abnormalities by Doppler echocardiography in a large nationwide multicentric cohort of patients with systemic sclerosis.

OBJECTIVES: There is increasing concern about heart and pulmonary vascular involvement in systemic sclerosis (SSc). One of the most severe complications of SSc is pulmonary arterial hypertension (PAH). There has been an increased awareness of left ventricular (LV) diastolic abnormalities in SSc patients. However, previous studies have generally been conducted in small populations. The aims of this study were to prospectively screen for PAH and to describe echocardiographic parameters in a large group of SSc patients. METHODS: This prospective study was conducted in 21 centres for SSc in France. Patients without severe pulmonary function abnormalities, severe cardiac disease and known PAH underwent Doppler echocardiography performed by a reference cardiologist. RESULTS: Of the 570 patients evaluated, PAH was suspected in 33 patients and was confirmed in 18 by right heart catheterisation. LV systolic dysfunction was rare (1.4%). LV hypertrophy was found in 22.6%, with LV diastolic dysfunction in 17.7%. These LV abnormalities were influenced by age, gender and blood pressure. We identified a small group of 21 patients with a restrictive mitral flow pattern in the absence of any other cardiopulmonary diseases, suggesting a specific cardiac involvement in SSc. CONCLUSIONS: Left and right heart diseases, including PAH, LV hypertrophy and diastolic dysfunction, are common in SSc. However, a small subset of patients without any cardiac or pulmonary diseases have a restrictive mitral flow pattern that could be due to primary cardiac involvement of SSc. The prognostic implications of the LV abnormalities will be evaluated in the 3-year follow-up of this cohort.

Is the gap between guidelines and clinical practice in heart failure treatment being filled? Insights from the IMPACT RECO survey.

BACKGROUND: Recent registries have shown that recommended drugs for the treatment of chronic heart failure (CHF) are under-prescribed in daily practice. AIMS: To determine prescription rates of CHF drugs, and to assess predictive factors for drug prescription using data from a large panel of French cardiologists. METHODS AND RESULTS: We included 1919 outpatients, with NYHA class II-IV heart failure and a left ventricular ejection fraction <40%. The most frequently prescribed drugs were diuretics (83%), angiotensin converting enzyme inhibitors (ACE-I) (71%), beta-blockers (65%), spironolactone (35%) and angiotensin receptor blockers (ARB) (21%); 61% of patients received a combination of a beta-blocker and an ACE-I or ARB. Target doses were reached in 49% of the patients for ACE-I, but in only 18% for beta-blockers and in 9% for ARBs. Multivariate analyses showed that age >75 years was an independent factor associated with under-prescription of ACE-I-ARBs, beta-blockers or spironolactone. Renal failure was associated with a lower prescription of ACE-I-ARB and spironolactone, and asthma was a predictor of under-prescription of beta-blockers. CONCLUSIONS: In this contemporary survey, prescription rates of CHF drugs were higher than previously reported. However, dosages were lower than those recommended in guidelines. Age remained an independent predictor of under-prescription of CHF drugs.

[First-intent monotherapy: persistence rate of antihypertensive treatment is better with angiotensin receptor blockers. Ol'métrise Cardio survey results]. / Monothérapie de première intention: le traitement antihypertenseur est plus souvent poursuivi, seul ou combiné, quand il s'agit d'un ARA II. Enquête Ol'métrise Cardio.

OBJECTIVES: To describe, according to the type of first-line antihypertensive monotherapy (FLAM) the persistence rate and the cumulative probability of its potential given up to the advantage of another antihypertensive class (rotation) in the following 3 years. METHODS: retrospective survey (to avoid any "survey effect" undertaken by 551 French cardiologists, in treated hypertensive patients. The survey described the FLAM, patients characteristics when FLAM was introduced, when given up in case of rotation and at the inclusion visit, as well as the dates of introduction, rotation and visit. STATISTICAL ANALYSIS: Kaplan Meier's method, Cox model. RESULTS: One thousand nine hundred and fifty five patients (62 +/- 11 years, males 57%, diabetes 13%, coronary disease 11%, LVH 20%) were analysed. At the end of 2.1 +/- 0.7 years, 1407 patients (72%) continued the FLAM alone (N=738, 52%) or combined (N=669, 48%). Survival analysis shows i) that the probability of rotation is roughly constant over time whatever the FLAM ii) that the probability of rotation against time is different according to the FLAM (p<0.0001, log rank) and lesser with ARB. These results are confirmed by the multivariate analysis (Cox model adjusted on age, sex and comorbidities).

[Gastroesophageal reflux and sleep position of infants. A survey conducted in France by 493 pediatricians]. / Reflux gastro-œsophagien et position de couchage des nourrissons. Enquête de pratique menée en France auprès de 493 pédiatres.

BACKGROUND AND AIMS: The supine sleeping position with the head higher than the legs has no impact on regurgitations in infants. Inclined ventral decubitus decreases regurgitations but is associated with an increased risk of sudden infant death syndrome (SIDS). The LUNE study aimed to evaluate the impact of regurgitations on the choice of sleeping position by pediatricians and parents. METHODS: Cross-sectional case-control study (ratio 1:1) conducted in France in 2013. A representative sample of pediatricians recruited 3-week to 4-month-old breast- or formula-fed infants. Cases and controls were defined by the presence or absence of regurgitations. Collected data included Vandenplas codification for regurgitations (VD, range 0-6), associated symptoms, and variations in sleeping position since maternity hospital discharge. RESULTS: A total of 1347 cases and 1346 controls were recruited by 493 pediatricians. Regurgitations were evaluated at VD1 (minor, 22 % of cases), VD2 (mild, 47 % of cases), or VD≥3 (moderate to severe, 31 % of cases). At the maternity hospital, the supine position was recommended to 96 % of parents for SIDS prevention. Since discharge, parents asked questions about the relationship between sleeping position and regurgitations (79 % of infants with GER versus 45 % of controls). The sleeping position was modified at least once since maternity discharge (42 % of infants with GER versus 35 % of controls). At inclusion, 86 % of infants with GER and 86 % of controls were sleeping on their back. Fifty-one percent of infants with GER and 28 % of controls slept in an inclined position. Pediatricians repeated the prescription of dorsal decubitus for 91 % of infants with GER and recommended an inclined position in 70 %. CONCLUSIONS: Regurgitations had no impact on supine sleeping position. The inclined supine sleeping position was more frequent in infants with regurgitations with pediatricians' assent, which is not in agreement with evidence-based medicine.

[Prevalence and mechanism of masked hypertension: the ol'mesures survey]. / Prevalence et mécanismes de l'hypertension masquée. Enquête OL'MESURES.

RATIONALE: Masked hypertension (MH) and uncontrolled hypertension (UCH) have both bad prognosis. The influence of measurement circumstances on MH prevalence and reproducibility are little known. OBJECTIVE: To evaluate the prevalence and reproducibility of MH after excluding confusing factors [method and time of blood pressure (BP) measurement, antihypertensive treatment] by a standardization procedure. METHODS: 2189 hypertensive patients (61+/- 12 years, men 57%) having been treated in monotherapy by an angiotensin II receptor inhibitor for at least 8 weeks Were evaluated in a French multicenter prospective observational survey. Three BP successive office measurements were performed by the GPs during 2 visits (V) at similar times 13 +/- 9 days apart (BP: V1 149 +/- 19 / 85 +/- 11 mmHg, V2 145 +/- 19/83 +/- 11 mmHg) and home BP self-measurements (HBPM) were performed morning and evening for 3 consecutive days (HBPM morning + evening : n=18 +/- 1; 142 +/- 16/81 +/- 9 mmHg) and at the time of the visit (daytime HBPM: n=9 +/- 1; 140 +/- 16/80 +/- 10 mmHg) by the patients (Omron-705CP). RESULTS: [table: see text]. CONCLUSION: the observed MH prevalence is similar to previous published studies and is independent of: treatment, BP measurement methods, measurements frequency and HBPM time but it depends on office BP values. Consequently, its reproducibility is directly dependent of the quality of office BP measurements.

[Pregnancies occurring during oral contraception: lessons from the GRECO study]. / Grossesses survenant sous contraception orale: les leçons de l'étude GRECO.

OBJECTIVES: The GRECO study has collected data on pregnancies, regardless of their outcome, that occurred in women taking an oral contraceptive. PATIENTS AND METHODS: The analysis concerned 551 women prospectively recruited in services of gynaecology or obstetrics, termination of pregnancy centres, family planning centres or consultations of gynaecology in France throughout 2002 and who were 12 weeks pregnant or less. RESULTS: Contraception used during the cycle of conception was an estroprogestative combination in 88% of cases, a microprogestative in 8.7%, a macroprogestative in 0.9% or another type of pill in 2.4%. Progestatives were levonorgestrel 59.0%, gestoden 17.2%, desogestrel 4.7%, norethisterone acetate 2.9%, norgestimate 1.8%, cyproterone acetate 2.0%, norgestrel 1.6%. When asked about the potential cause of the oral contraceptive failure, 76.9% of women reported events such as missed pills which were the most frequent cause of failure (60.8% of failures and 80.1% of events, 2.7+/-2.7 missed pills), followed by vomiting and diarrhoea. 81.5% of women chose to terminate their pregnancy. DISCUSSION AND CONCLUSION: The GRECO study, despite its limitations (retrospective collection of missed pills data, declaratory data) showed that missed pills, even once, were the most common reason for oral contraceptive failure. The most frequent decision was the termination of pregnancy.

Does the route of immunoglobin replacement therapy impact quality of life and satisfaction in patients with primary immunodeficiency? Insights from the French cohort "Visages".

BACKGROUND: IgG replacement therapy (IgRT) in primary immunodeficiencies (PID) is a lifelong treatment which may be administered intravenously (IVIg) or subcutaneously (SCIg), at hospital or at home. The objective of the VISAGE study was to investigate if route and/or place for IgRT impact patients' satisfaction regarding IgRT and quality of life (QoL) in real-life conditions. METHODS: The study enrolled PID patients at least 15 years old receiving IgRT for at least 3 months. Satisfaction and QoL were evaluated at enrollment and over a 12-month follow-up period by Life Quality Index (LQI) which measures 3 dimensions of satisfaction: treatment interference, therapy related problems and therapy settings (factors I, II and III) and SF-36 v2 questionnaire. RESULTS: The study included 116 PID patients (mean age 42 ± 18 years, 44 % males, 58 % with scholar or professional occupation) receiving IgRT for a mean of 8.5 ± 8.4 years. At enrollment they were receiving either home-based SCIg (51 %), hospital-based IVIg (40 %) or home-based IVIg (9 %). Patients exhibited a high degree of satisfaction regarding IgRT whatever the route and place for administration. LQI factor I was higher for home-based SCIg (86 ± 2) than for hospital-based IVIg (81 ± 3) and home-based IVIg (73 ± 5; p = 0.02 versus home-based SCIg); no difference was found for LQI factor II; LQI factor III was higher for home-based SCIg (92 ± 2) than for hospital-based IVIg (87 ± 5) and hospital-based IVIg (82 ± 3; p = 0.005 versus home-based SCIg). By contrast, every dimension of QoL was impaired. Over the follow-up period, 10 patients switched from hospital-based IVIg to home-based SCIg and improved LQI factor I (p = 0.004) and factor III (p = 0.02), while no change was noticed in LQI factors II and QoL. Meanwhile, no change in satisfaction or QoL was found in patients with stable route of IgRT. When asked on their preferred place of treatment all but one patient with home-based treatment would choose to be treated at home and 29 % of patients treated at hospital would prefer home-based IgRT. CONCLUSION: PID patients expressed a high degree of satisfaction regarding IgRT, contrasting with impaired QoL. In real-life conditions awareness of patient's expectations regarding the route or place of IgRT may be associated with further improvement of satisfaction.

Electronic pill-boxes in the evaluation of oral hypoglycemic agent compliance.

OBJECTIVE: To compare compliance in type 2 diabetic patients treated with glimepiride once daily or glibenclamide twice to three times daily. METHODS: Poorly controlled type 2 diabetic patients aged 35-65 years were randomized to glimepiride 1 mg once daily or to glibenclamide 1.25 mg twice daily. During initial titration, doses ranged from 1 to 6 mg once daily (glimepiride) and from 1.25 mg twice daily to 5 mg 3 times daily (glibenclamide) to achieve fasting blood glucose < 126 mg/dL. The final titration phase doses were continued during the maintenance phase. Both treatments were packed in electronic pill-boxes fitted with a microprocessor to record dates and times of each opening. Compliance was assessed in terms of mean daily compliance (MDC) and the ratio of days with adequate compliance (DAC). Glycemic control was assessed in terms of the adjusted mean final HbA1c, and the incidence of hypoglycemia. Patient satisfaction was evaluated using the Diabetes Treatment Satisfaction Questionnaire. RESULTS: Compliance over the whole study was generally good, but the MDC was significantly better with glimepiride (87+/-16%) than with glibenclamide (80+/-17%;P < 0.0001). The ratios of DAC for glimepiride and glibenclamide were 87+/-16% and 67+/-24% respectively (P < 0.0001). The adjusted final HbA1c, and the incidence of hypoglycemia were similar in the two groups. Treatment satisfaction on the DTSQc was greater with glimepiride than with glibenclamide (P = 0.0034). CONCLUSIONS: Patient compliance and treatment satisfaction with once-daily glimepiride were significantly better than with glibenclamide 2 to 3 times daily.

Is "isolated home" hypertension as opposed to "isolated office" hypertension a sign of greater cardiovascular risk?

BACKGROUND: The SHEAF (Self-Measurement of Blood Pressure at Home in the Elderly: Assessment and Follow-up) study is an observational study (from February 1998 to early 2002) designed to determine whether home blood pressure (BP) measurement has a greater cardiovascular prognostic value than office BP measurement among elderly (> or =60 years) French patients with hypertension. The objective of this present work is to describe the baseline characteristics of the treated patients in the SHEAF study from February 1998 to March 1999, placing special emphasis on "isolated office" and "isolated home" hypertension. METHODS: Baseline office BP measurement was assessed using a mercury sphygmomanometer. Home BP measurement was performed over a 4-day period. A 140/90-mm Hg threshold was chosen to define office hypertension, and a 135/85-mm Hg threshold to define home hypertension. RESULTS: Of the 5211 hypertensive patients in the SHEAF study with a valid home BP measurement, 4939 received treatment with at least 1 antihypertensive drug. Patients with isolated office hypertension represented 12.5% of this population, while patients with isolated home hypertension represented 10.8%. The characteristics of the patients with isolated office hypertension were similar to those of patients with controlled hypertension. However, patients with isolated office hypertension had fewer previous cardiovascular complications. In contrast, rates of cardiovascular risk factors and history of cardiovascular disease in patients with isolated home hypertension resembled those in patients with uncontrolled hypertension. CONCLUSIONS: This retrospective analysis suggests that patients with isolated home hypertension belong to a high-risk subgroup. The 3-year follow-up of these patients will provide prospective data about the cardiovascular prognosis of these subgroups.

[Is masked hypertension an artefact due to the blood pressure measurement method and threshold effects?]. / L'hypertension masquée est-elle un artéfact lié à méthode de mesure et à un effet seuil?

UNLABELLED: From results of office and home measurements of blood pressure (BP), patients can be classified as "hypertensive (HT)", "normotensive (NT)", "office hypertensive (OH)" or "masked hypertensive (MH)" by crossing the classifications obtained from each method. It seems that 9 to 20% of patients could be MH with a prognosis close to HT (SHEAF study). OBJECTIVES: To test the hypothesis that at least one part of the prevalence of MH would be an artefact due to the difference between the methods of measurements (shygmomanometer vs semi-automatic device) and/or due to different definitions of office hypertension (OHT). To determine the impact of different definitions of OHT on the prevalence of MH. METHODS: During the course of a phase IV study, BP was measured with the same semi-automatic device (OMRON 705CP) both at doctor's office (3 measurements at 1-minute intervals) and at home, by the patient himself (3 measurements in the morning and in the evening at 1-minute intervals over the 7 days before the visit). Following definitions were used: Office HT: SBP > or =140 mmHg, DBP > or =90 mmHg, SBP > or =140 mmHg or DBP > or =90 mmHg; Home HT: SBP > or =135 mmHg, DBP> or =85 mmHg, SBP > or =135 mmHg or DBP > or =85 mmHg. Another definition of office HT was used SBP > or =135 mmHg, DBP > or =85 mmHg SBP > or =135 mmHg or DBP > or =85 mmHg. RESULTS: 575 patients were analysed. Results from the two methods of measurements are closed but significantly different (difference for SBP: 3.2 +/- 16.5 mmHg; p < 0.0001; difference for DBP: 1.4 +/- 10.3 mmHg; p = 0.002)

[Management of patients admitted for acute myocardial infarction in France from 1995 to 2000: time to admission dependent improvement in outcome]. / Prise en charge de l'infarctus du myocarde en France dans les études USIK 1995 et USIC 2000: amélioration pronoslique et rôle du délai d'admission.

The in-hospital management and short- and long-term outcomes was assessed in 2 registries of consecutive patients admitted for acute myocardial infarction, 5 years apart, in France. The 2000 cohort was younger and with a less frequent history of cardiac diseases, but was more often diabetic and with anterior infarcts. Time to admission was actually longer in 2000 than in 1995 (median 5.25 hours vs 4.00 hours). Overall, reperfusion therapy was used in 43% of the patients in both registries. However, the use of reperfusion therapy increased from 1995 to 2000 in patients admitted within 6 hours of symptom onset (64 vs 58%), with an increasing use of primary angioplasty (from 12 to 30%). Five-day mortality significantly improved from 7.7 to 6.1% (p < 0.03) and one-year survival was also less in the most recent period (85 vs 81%, p < 0.01). Multivariate analyses showed that the period of inclusion (2000 vs 1995) was an independent predictor of both short- and long-term mortality in patients admitted within 6 hours of symptom onset. Thus, in the real world setting, a continued decline in one-year mortality was observed in patients admitted to intensive care units for recent acute myocardial infarction, especially for patients admitted early. This goes along with a shift in reperfusion therapy towards a broader use of primary angioplasty, and with an increased use of the early prescription of recognised secondary prevention medications.

Electronic pill-boxes in the evaluation of antihypertensive treatment compliance: comparison of once daily versus twice daily regimen.

The objective was to compare the compliance of hypertensive patients treated with captopril twice daily or trandolapril once daily. After a 2-week placebo period, hypertensive patients (diastolic BP 95-115 mm Hg) were randomly allocated to trandolapril 2 mg once daily or to captopril 25 mg twice daily for 6 months. Trandolapril and captopril were packed in electronic pill-boxes equipped with a microprocessor that recorded date and time of each opening (MEMS). Patients' compliance was assessed both by standard pill-count and by electronic monitoring. Blood pressure was measured using a validated semi-automatic device at the end of the placebo period and of the treatment period. One hundred sixty-two patients entered the study. Compliance data were evaluable for 133 patients (62 in the captopril group and 71 in the trandolapril group). Treatment groups were comparable at baseline except for age (P = .046). Using electronic pill-box, overall compliance was 98.9% in the trandolapril group and 97.5% in the captopril group (P = .002). The percentage of missed doses was 2.6% in the trandolapril group and 3.3% in the captopril group (P = .06). The percentage of delayed doses was 1.8% in the trandolapril group and 11.7% in the captopril group (P = .0001). The percentage of correct dosing periods, ie, a period with only one correct recorded opening, was 94.0% in the trandolapril group and 78.1% in the captopril group (P = .0001). Results were unchanged when adjusted for age. At the end of the study, 41% of patients in the trandolapril group and 27% in the captopril group (NS) had their blood pressure normalized (systolic BP <140 and diastolic BP <90 mm Hg). In this 6-month study, the electronic pill-box allowed refined analysis of compliance of hypertensive patients. Patients' compliance with once daily trandolapril was higher than with twice daily captopril. The between-group difference is mainly explained by an increase in delayed doses in the twice daily group.

Control of diabetes and cardiovascular risk factors in patients with type 2 diabetes: a nationwide French survey.

OBJECTIVES: To evaluate in France in 2001 the therapeutic management and control of diabetes and of modifiable cardiovascular risk factors in patients with type 2 diabetes receiving specialist care. METHODS: The study was proposed to 575 diabetologists across France. The first 8 consecutive ambulatory patients with type 2 diabetes treated by oral antidiabetic drugs (OADs) and/or insulin attending for consultation with a diabetologist were eligible for inclusion in the survey. The following data were collected: demographics, diabetic and cardiovascular history, cardiovascular risk factors, blood pressure, last recorded measurements of HbA(1c) and LDL cholesterol, and details of diabetes medication and cardiovascular medication. RESULTS: 4, 930 patients (53% men) aged 62 +/- 11 years were recruited by 410 specialists in diabetes care. The mean duration of diabetes was 12 +/- 9 years. 71% of patients were treated with OADs, 18% with an OAD + insulin and 9% with insulin alone. Mean HbA(1c) was 7.6 +/- 1.6%; HbA(1c) was<=6.5% in 27% of patients, between 6.6% and 8% in 39% of patients, and > 8% in 34% of patients. Mean blood pressure was 140 +/- 16/80 +/- 9 mmHg. In the study population as a whole the target blood pressure (systolic BP<140 mmHg and diastolic BP<80 mmHg) was attained by 29% of patients. Among the 3, 085 patients (63%) treated for hypertension, this target was attained in only 23% of patients; 40% of patients treated for hypertension received one single antihypertensive treatment, 36% received 2 treatments and 24% received 3 treatments or more. Among the 1, 845 patients considered by the investigators as not having hypertension, the target blood pressure was attained by 39%. A measurement for LDL cholesterol was available in 4, 036 patients (82%). 58% of these patients had LDL cholesterol<1.3 g/l, 29% had values between 1.3 and 1.6 g/l, and 13% had values > 1.6 g/l. 52% of patients were not receiving any lipid-lowering agents, 28% were treated with statins, 19% with fibrates, and 1% with statins + fibrates. LDL cholesterol was<1.3 g/l in only 66% of the 646 patients with associated coronary heart disease. CONCLUSION: According to this large nationwide survey, the prevalence of cardiovascular risk factors remains high. Control of glycaemia, blood pressure and LDL cholesterol does not appear to be optimal. This is due in part to the severity of diabetes in these patients seen by specialists in diabetes care; however, both awareness and application of published recommendations need to be reinforced.

Management and short-term outcome of diabetic patients hospitalized for acute myocardial infarction: results of a nationwide French survey.

OBJECTIVES: To compare management and short-term outcome of diabetic and non-diabetic patients hospitalized for acute myocardial infarction. METHODS: This was a prospective epidemiological survey. All patients admitted in coronary care units in France in November 2000 for confirmed acute myocardial infarction were eligible to enter the study. RESULTS: Of the 2320 patients recruited from 369 centers, 487 were diabetic (21%). Compared to non-diabetic patients, diabetic patients were 5 years older, more often female, obese and hypertensive; they had more often a history of cardiovascular disease; they had a lower ejection fraction and worse Killip class. Reperfusion therapy was less frequent among diabetic patients (39% versus 51%; p=0.0001), as was the use of beta-blockers (61% versus 72%; p=0.0001), aspirin (83% versus 89%; p=0.0001) and statins (52% versus 60%; p=0.001) during hospitalization. Conversely, the use of ACE-inhibitors was more frequent (54% versus 44%; p=0.0001). 58% of diabetic patients received insulin during hospitalization. Twenty-eight-day mortality was 13.1% in diabetic patients and 7.0% in non-diabetic patients (risk ratio: 1.87; p=0.001). Diabetes remained associated with increased mortality after adjustment for relevant risk factors including age and ejection fraction (risk ratio: 1.51; p=0.07). In patients treated with antidiabetic drugs (chiefly sulfonylureas) before admission, 28-day mortality was 10.4% compared with 19.9% in diabetic patients on diet alone or untreated (p=0.005). CONCLUSION: Despite higher cardiovascular risk and worse prognosis, in-hospital management of diabetic patients with acute myocardial infarction remains sub-optimal. Patients previously treated with antidiabetic drugs including sulfonylureas had a better prognosis than untreated diabetic patients.

Antihypertensive effects of trandolapril and nitrendipine in the elderly: a controlled trial with special emphasis on time effect profiles.

The aim of this double-blind randomized study was to compare the antihypertensive effects of trandolapril and nitrendipine in the elderly. After a 2-week placebo period, patients received either trandolapril 0.5 mg or nitrendipine 10 mg, once daily for 15 days. At the end of this period, according to a forced titration, the dose was increased to 2 mg of trandolapril or 20 mg of nitrendipine once daily for 2 months. Seventy-three hypertensive patients, aged 65 and over, entered the study. Demographic data and initial blood pressure (BP) level were comparable in the two groups. The antihypertensive effect, measured with a mercury sphygmomanometer, was assessed in 64 patients: SBP decreased by 18.6 +/- 12.1 mm Hg in the trandolapril (P < 0.001) and by 21.0 +/- 13.7 mm Hg in the nitrendipine group (P < 0.001); DBP decreased by 13.4 +/- 8.5 mm Hg in the trandolapril group (P < 0.001) and by 15.4 +/-8.2 mm Hg in the nitrendipine group (P < 0.001). No statistically significant difference was seen between the two treatment groups. A sub-group of 42 patients were evaluated by 24 h ambulatory BP monitoring. Mean 24 h ambulatory SBP/DBP decreases were 6.6 +/- 18.0/8.4 +/- 8.5 mm Hg in the trandolapril group (P < 0.001) and 5.7 +/- 11.1/7.2 +/-9.6 mm Hg in the nitrendipine group (P < 0.001). The differences between the two treatment groups were not statistically significant. The antihypertensive action of trandolapril was sustained throughout the 24 h period with a trough-to-peak ratio of 70.2% for SBP and 70.9% for DBP. Nitrendipine exerted its action mainly during the day, with a very modest antihypertensive effect during the night and early morning; its trough/peak ratio was 25.9% for SBP and 28% for DBP. The tolerance of both treatments were good; seven patients were withdrawn from the trial for adverse events (four in the nitrendipine group, three in the trandolapril group).