An empirically derived short form of the Hypoglycaemia Fear Survey II.

AIMS: To develop an empirically derived short version of the Hypoglycaemia Fear Survey II that still accurately measures fear of hypoglycaemia. METHODS: Item response theory methods were used to generate an 11-item version of the Hypoglycaemia Fear Survey from a sample of 487 people with Type 1 or Type 2 diabetes mellitus. Subsequently, this scale was tested on a sample of 2718 people with Type 1 or insulin-treated Type 2 diabetes taking part in DIALOG, a large observational prospective study of hypoglycaemia in France. RESULTS: The short form of the Hypoglycaemia Fear Survey II matched the factor structure of the long form for respondents with both Type 1 and Type 2 diabetes, while maintaining adequate internal reliability on the total scale and all three subscales. The two forms were highly correlated on both the total scale and each subscale (Pearson's R > 0.89). CONCLUSIONS: The short form of the Hypoglycaemia Fear Survey II is an important first step in more efficiently measuring fear of hypoglycaemia. Future prospective studies are needed for further validity testing and exploring the survey's applicability to different populations.

Insulin initiation in type 2 diabetic patients admitted in hospital in France and follow-up at 1 year.

OBJECTIVES AND METHODS: The IDAHO 2 epidemiological survey was conducted in departments of diabetology in insulin-naïve type 2 diabetics for whom insulin was initiated. The objective was to assess the patients' profile, the treatments proposed during hospital stay and after one year. RESULTS: 797 patients were analysed. Their characteristics were: age 64+/-12 years, 49% males, weight: 78+/-17 kg, BMI: 29+/-6 kg/m2, diabetes duration 11 years, prevalence of complications: 68%, fasting blood glucose 13+/-6 mmol/l, HbA1c: 10+/-2.2%; treatment prior to insulin comprised: at least 2 OHA: 71% of cases, one: 21%, no OAD: 8%. At hospital discharge, 54% of the patients used basal insulin. After 1 year, 670 continued on insulin. The insulin initiation was accompanied by a decrease in the FBG level (baseline: 13+/-6 mmol/l; final: 8.5+/-2.75 mmol/l; P<0.0001) and a HbA1c improvement (baseline: 10+/-2.2%; final: 7.9+/-1.4%; P<0.0001). This was observed du-ring the first 6 months (HbA1c: 7.8%, P<0.0001 versus baseline). 80% of the patients remained on the same insulin regimen after 1 year: 35% had 1 injection/day, 44% had 2, 12% had 3 and 9% had a complex regimen. The weight gain, the final daily dose and hypoglycaemias increased with the number of injections. The mean daily insulin dose was 33 U/day (24 U with 1 injection/day). CONCLUSION: The IDAHO study shows that insulin is effective in type 2 diabetics however, management is inadequate with insulin therapy being initiated too late and at doses which are low after one year.

High risk hypertensives: pre-hospital management of acute myocardial infarction--results from the French nationwide registry USIC 2000.

OBJECTIVE: To assess the use of mobile coronary care units (MCU) in hypertensive patients previously treated for cardiovascular diseases in comparison with those with no history of cardiovascular disease and to estimate the influence of the use of MCU on cardiovascular outcome in this population. PATIENTS: We used a nationwide prospective registry of all patients admitted for AMI in French intensive care units in 2000. Patients without history of hypertension or patients admitted with pulmonary oedema or cardiogenic shock were excluded. Men (N = 514) and women (N = 291) were analysed separately. RESULTS: The proportion of patients with history of myocardial infarction, peripheral artery disease and stroke was not significantly higher in subjects who used physician-staffed MCU as compared with patients with no history of myocardial infarction, peripheral artery disease or stroke. In each sex, revascularization (pre hospital fibrinolysis, in hospital fibrinolysis or coronary angioplasty) were more frequent in patients who used MCU. Also, one year cardiovascular mortality was lower in men who used MCU. CONCLUSION: Known high risk hypertensive patients did not use physician-staffed MCU more than subjects free of such condition. Education of hypertensive patients at risk during routine visits is required to increase of the use of physician-staffed MCU in case of symptoms suggestive of AMI.

Treatment of acute myocardial infarction by primary coronary angioplasty or intravenous thrombolysis in the "real world": one-year results from a nationwide French survey.

BACKGROUND: Recent randomized trials comparing primary coronary angioplasty and intravenous thrombolysis at the acute stage of myocardial infarction have shown a limited but definite advantage for primary angioplasty. The aim of this study was to document 1-year outcome in patients receiving either thrombolysis or primary angioplasty for acute myocardial infarction in the "real world." METHODS AND RESULTS: We used a nationwide prospective registry of all patients admitted for acute myocardial infarction in French intensive care units in November 1995. Of the 721 patients who received reperfusion therapy, 152 were treated with primary angioplasty and 569 received intravenous thrombolysis. The two groups were remarkably similar with respect to all baseline descriptors, except that a higher proportion of patients in the angioplasty group had a history of cerebrovascular accident (10% versus 2%, P<0.01). In-hospital outcome was not different in the 2 groups. One-year survival was 85.5% in the angioplasty group and 89. 5% in the thrombolysis group (P=0.18). Multivariate analysis showed that older age, anterior location of infarction, female sex, and history of heart failure were related to 1-year mortality. In patients alive on day 5, the use of primary angioplasty and higher Killip class were additional adverse prognostic indicators. CONCLUSIONS: The results of this large registry of real-world practice indicate no survival benefit for patients treated with primary angioplasty compared with those who received thrombolytic therapy.

Management of acute myocardial infarction in intensive care units in 1995: a nationwide French survey of practice and early hospital results.

OBJECTIVES: This survey sought to determine actual practices in the management of acute myocardial infarction on a nationwide scale. BACKGROUND: Few data are available regarding the adoption of clinical trial results of treatment of myocardial infarction into "real-world" clinical practice. METHODS: Of 501 intensive care units in France, 373 (74%) collected data from all patients with myocardial infarction admitted within 48 h of symptom onset during November 1995. RESULTS: Data from 2,563 patients (71% men; mean age [+/-SD] 67 +/- 14 years) were included. Time from symptom onset to admission was <6 h in 1,467 patients (62%). Thrombolysis was used in 822 patients (32%) and primary angioplasty in 330 (13%). The use of reperfusion therapy decreased markedly with age. During the first 5 days, heparin was prescribed in 96% of patients, aspirin in 89%, nitrates in 87%, beta-adrenergic blocking agents in 64%, angiotensin-converting enzyme inhibitors in 46% and calcium antagonists in 17%. Coronary angiography was performed in 33% of patients, and 58% had echocardiographic assessment of left ventricular ejection fraction (LVEF). Median LVEF was 50%. The 5-day mortality rate was 7.7% compared with 12.1% in a previous French survey carried out in 1984. By multivariate analysis, independent predictors of mortality were age, anterior infarction, history of stroke and heart failure and, when added to the model, Killip class and LVEF. CONCLUSIONS: This survey shows that the results of therapeutic trials have largely translated to clinical practice, resulting in improved early outcome compared with the early 1980s. However, continuous efforts should be made to shorten the time delay before hospital admission and to increase the proportion of elderly patients receiving reperfusion therapy.

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.

[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.

Benefits of electronic pillboxes in evaluating treatment compliance of patients with mild to moderate hypertension.

OBJECTIVE: This study was designed to assess the compliance of hypertensive patients with a once-daily regimen of the angiotensin converting enzyme (ACE) inhibitor trandolapril and to evaluate the antihypertensive efficacy of the drug in relation to the time interval between taking the final dose and measuring the blood pressure (BP). DESIGN: After a 2-week wash-out period, hypertensive patients, recruited by cardiologists, received trandolapril 2 mg once daily in the morning for 4 weeks. METHODS: In order to assess compliance, each patient's supply of trandolapril capsules was presented in a pillbox that incorporated in its lid a microprocessor that recorded the date and time of each occasion that it was opened. BP was measured using validated semi-automatic devices, at the end of both the wash-out and the treatment period. RESULTS: A total of 590 patients entered the study. Compliance data were evaluable for 501 patients. Overall compliance, defined as the ratio of the number of openings recorded to the number of doses prescribed was less than 80, 80-100, and more than 100% in 17, 63 and 20% of patients, respectively. The average number (+/- SD) of missed doses was 4.5 +/- 8 (median 2). The average interval between successive openings was 25 h 07 min mean +/- 13 h (median 24 h). The average number of delayed doses (a delayed dose being defined as the box being opened 25-36 h after the previous occasion) was 5.6 +/- 3 (median 6). Patients living in the Paris area had more forgotten and delayed doses than those living in the provinces (7.9 versus 3.8 forgotten; P<0.0001 and 6.3 versus 5.5 delayed; P<0.005). Doses were forgotten and delayed more often during weekends than on weekdays. The greatest number of delayed doses occurred in those patients under 60 years of age (6.0 versus 5.2; P<0.01). Decreases in systolic blood pressure (SBP and diastolic blood pressure (DBP) were 20.3/12.8 mmHg, for patients whose final drug was taken on the same day as the BP measurement, and 18.9/11.2 mmHg for patients whose final dose was taken on the previous day. CONCLUSIONS: Electronic compliance monitoring allows refined analysis of the behaviour of hypertensive patients. In this study doses were missed and delayed frequently during the first month of treatment, depending on the patient's lifestyle.

Accuracy and reproducibility of left ventricular mass measurement by subcostal M-mode echocardiography in hypertensive patients and professional bicyclists.

In some patients, left ventricular (LV) mass cannot be evaluated by M-mode echocardiography because the parasternal long-axis view is not available. The aim of this study was to determine whether the subcostal view obtained by M-mode echocardiography under 2-dimensional guidance allows accurate and reproducible LV mass determination. Using the cube formula, LV mass was calculated, from parasternal and subcostal views in 96 subjects: 73 hypertensives and 23 professional bicyclists, covering a wide range of LV dimensions. M-mode tracings were read by 2 experienced echocardiographers and the interobserver variability was evaluated. With use of the subcostal view, the interobserver reproducibility, expressed as observer 1-observer 2, was excellent: -0.3 +/- 1.3 mm for LV diastolic diameter, -0.1 +/- 1.0 mm for ventricular diastolic septal thickness, 0.2 +/- 0.6 mm for diastolic free wall thickness and 0.03 +/- 16.7 g for LV mass. In 96% of cases, the difference in LV mass between the 2 observers did not exceed 30 g. With use of the parasternal and subcostal approaches, LV mass was not statistically different (202.6 +/- 2.2 g and 206.5 +/- 2.0 g, respectively) and the difference was < 52 g (clinically significant threshold) in 91 of 96 cases. It is concluded that, using the cube formula, LV mass calculation based on the subcostal view was accurate and not statistically different from that provided by the usual parasternal approach.

Comparison of three blood pressure measurement methods for the evaluation of two antihypertensive drugs: feasibility, agreement, and reproducibility of blood pressure response.

Our objective was to compare three different methods of blood pressure measurement through the results of a controlled study aimed at comparing the antihypertensive effects of trandolapril and losartan. Two hundred and twenty-nine hypertensive patients were randomized in a double-blind parallel group study. After a 3-week placebo period, they received either 2 mg trandolapril or 50 mg losartan once daily for 6 weeks. At the end of both placebo and active treatment periods, three methods of blood pressure measurement were used: a) office blood pressure (three consecutive measurements); b) home self blood pressure measurements (SBPM), consisting of three consecutive measurements performed at home in the morning and in the evening for 7 consecutive days; and c) ambulatory blood pressure measurements (ABPM), 24-h BP recordings with three measurements per hour. Of the 229 patients, 199 (87%) performed at least 12 valid SBPM measurements during both placebo and treatment periods, whereas only 160 (70%) performed good quality 24-h ABPM recordings during both periods (P < .0001). One hundred-forty patients performed the three methods of measurement well. At baseline and with treatment, agreement between office measurements and ABPM or SBPM was weak. Conversely, there was a good agreement between ABPM and SBPM. The mean difference (SBP/DBP) between ABPM and SBPM was 4.6 +/- 10.4/3.5 +/- 7.1 at baseline and 3.5 +/- 10.0/4.0 +/- 7.0 at the end of the treatment period. The correlation between SBPM and ABPM expressed by the r coefficient and the P values were the following: at baseline 0.79/0.70 (< 0.001/< .0001), with active treatment 0.74/0.69 (0.0001/.0001). Hourly and 24-h reproducibility of blood pressure response was quantified by the standard deviation of BP response. Compared with office blood pressure, both global and hourly SBPM responses exhibited a lower standard deviation. Hourly reproducibility of SBPM response (10.8 mm Hg/6.9 mm Hg) was lower than hourly reproducibility of ABPM response (15.6 mm Hg/11.9 mm Hg). In conclusion, SBPM was easier to perform than ABPM. There was a good agreement between these two methods whereas concordance between SBPM or ABPM and office measurements was weak. As hourly reproducibility of SBPM response is better than reproducibility of both hourly ABPM and office BP response, SBPM seems to be the most appropriate method for evaluating residual antihypertensive effect.

Home self blood pressure measurement in general practice. The SMART study. Self-measurement for the Assessment of the Response to Trandolapril.

The SMART study (Self-Measurement for the Assessment of the Response to Trandolapril) was performed in general practice and enrolled 1710 patients in order to assess on a large scale the feasibility and informative value of self-measurement of blood pressure at home (SMBP), define home blood pressure (BP) levels in comparison to office readings, and determine the number of home measurements necessary to provide an accurate and precise BP value. After a 2-week washout period, patients with office diastolic blood pressure within the range 95 to 119 mm Hg received 2 mg trandolapril once daily in the morning for 4 weeks. Four days of SMBP were performed both at the end of the washout period and the end of the treatment period, with an automatic printer-equipped oscillometric device (A&D UA751). The first day values were not analyzed. Thus, the maximum number of BP measurements obtained per patient and per period was 18. Four hundred and twenty-four patients (25%) did not perform any measurements. One thousand one hundred and nine patients (65%) performed at least 4 measurements. Among them, 619 (36%) correctly performed all 18 measurements. A preference for digits 0 and 5 was detected in physicians' measurements (three consecutive values, during a single office visit). This digit preference was not found with the semiautomatic device. When the number of measurements selected for analysis was increased from 1 to 18, in the 604 patients who provided all recordings and fullfilled all protocol criteria, the standard deviation of the mean BP of the cohort was reduced by 17% for SBP and by 23% for DBP. Eighty-five percent of this reduction was already achieved by six home measurements taken at random. BP was significantly lower at home than at the office by 13 +/- 15 mm Hg for systolic BP (SBP), and 8 +/- 10 mm Hg for diastolic BP (DBP). This difference was independent of age, more marked in women (P < .001 for SBP and P < .05 for DBP), and had a Gaussian distribution. Under treatment, office SBP/DBP decreased from 166.4 +/- 14.8/101.4 +/- 5.7 mm Hg to 144.7 +/- 14.2/86.1 +/- 8.3 mm Hg, while SMBP decreased from 153.2 +/- 17.8/93.8 +/- 10.1 mm Hg to 139.4 +/- 16.4/85.1 +/- 9.5 mm Hg (all P < .0001). A major aim in research studies and individual care is to reduce BP measurements variability. This study demonstrates the ability to evaluate baseline SMBP level in two-thirds of patients previously unfamiliar with the method, the ability to evaluate treatment effect in about one-half of the patients, the improvement in the measurement precision obtained with the repetition of measures (at least six home measurements), and the absence of bias of SMBP as compared to office measurements.

Use of electronic pill boxes to assess risk of poor treatment compliance: results of a large-scale trial.

The objective of the present study was to determine the predictive factors of treatment compliance in hypertensive patients. This was an open large-scale multicenter study where mild to moderate essential hypertensive patients received trandolapril (2 mg) once daily for 30 to 60 days in addition to their usual treatment. Trandolapril was packed in electronic pill boxes that registered date and time of each opening. The main compliance parameters were the percentage of missed doses, the percentage of delayed doses, and the percentage of correct dosing periods. Predictive factors of poor compliance (correct dosing periods < 80%) were determined using a multivariate stepwise logistic regression analysis. Two thousand one hundred seventy-three patients aged 60 +/- 12 years were analyzed. Of the total patients 37% were poor compliers; 29% of patients forgot more than 10% of doses and 36% of patients delayed more than 10% of doses. Ranked predictive factors of poor compliance were: age < 60 years (odds ratio [OR], 1.80 [1.49 to 2.17], P = .0001), the Paris area (OR, 1.70 [1.32 to 2.19], P = .0001), smokers (OR, 1.65 [1.29 to 2.11], P = .0001), monotherapy (OR, 1.40 [1.14 to 1.72], P = .0012), and baseline diastolic blood pressure > or = 100 mm Hg (OR, 1.21 [1.01 to 1.46], P = .044). Therefore, we conclude that young hypertensives, large city dwellers, and smokers are more likely to be poor compliers. The presence of some of these characteristics might incite the physician either to encourage patient compliance or to prescribe antihypertensive drugs that have an effect that persists even beyond 24 h.

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.

Ambulatory blood pressure and urinary albumin excretion in diabetic (non-insulin-dependent and insulin-dependent) hypertensive patients: relationships at baseline and after treatment by the angiotensin converting enzyme inhibitor trandolapril.

The aim of the present study was to examine the relationships between ambulatory blood pressure (ABPM) and urinary albumin excretion (UAE) in diabetic (non-insulin dependent [NIDDM] and insulin-dependent [IDDM]) hypertensives at baseline and after treatment by an angiotensin converting enzyme (ACE) inhibitor. After a 3-week placebo period, patients were treated for 16 weeks with trandolapril, 2 to 4 mg/day. The UAE and blood pressure (mercury sphygmomanometer and 24-h ABPM) were measured at baseline and repeated on trandolapril. Predictive factors of abnormal UAE (24-h UAE > or = 30 mg) were determined using univariate and multivariate analysis (logistic regression). Predictors of UAE decrease were also searched. One hundred seventy-one patients entered the analysis. Baseline office BP was 164+/-14 / 97+/-6 mm Hg and 24-h BP was 142+/-17 / 83+/-10 mm Hg. Seventy-four patients (43%) had UAE > or = 30 mg. Independent risk factors for abnormal UAE were nighttime diastolic BP (odds ratio [OR] = 4.1, confidence interval [CI] = 2.0 to 8.6, P = .0001), diabetes duration (OR = 2.4, CI = 1.1 to 5.0, P = .025), and presence of retinopathy (OR = 3.2, CI = 1.0 to 10.0, P = .047). Conversely, office BP level was not significantly related to UAE. On treatment, office BP levels decreased to 143+/-13 / 82+/-8 mm Hg (P < .0001) and 24-h BP levels to 134+/-17 / 78+/-9 mm Hg (P < .0001). In the abnormal UAE group, UAE significantly decreased from 76 to 50 mg/day (P = .006). After treatment, independent predictive factors of abnormal UAE were: on-drug fasting plasma glucose (OR = 3.5, CI = 1.7 to 7.4, P = .0009) and on-drug nighttime diastolic BP (OR = 3.5, CI = 1.7 to 7.4, P = .001). The only predictor of UAE decrease was a 24-h systolic BP decrease (OR = 2.3, CI = 1.3 to 4.3, P = .007). We conclude that in diabetic hypertensives with abnormal UAE, trandolapril exhibited a sustained 24-h antihypertensive effect and provided a consistent reduction of microalbuminuria. This study confirmed the superiority of ABPM over clinical BP to predict target organ damage.

Short-term effects of withdrawing angiotensin converting enzyme inhibitor therapy on home self-measured blood pressure in hypertensive patients.

The aim of this study was to compare blood pressure rise after interruption of two angiotensin converting enzyme (ACE) inhibitors in hypertensive patients. After a 2-week placebo run-in period, hypertensive patients were treated with either trandolapril 2 mg once daily or perindopril 4 mg once daily for 4 weeks in a double-blind design. A placebo was then administered for 1 week. Three periods of 1-week home self-measured blood pressure (SMBP) were programmed: end of placebo run-in period, end of treatment period, and final withdrawal placebo period. Every day, three consecutive measurements were requested both in the evening and in the morning. Individual reversion to baseline BP level was studied in the subgroup of patients responding to therapy (evening diastolic SMBP decrease > or =6 mm Hg). The ratio (R) of mean post-drug DBP lowering (residual effect) over evening on-drug DBP lowering (full effect) was used to study reversion to baseline. Patients exhibiting a lower value than the median of this ratio were called Reverters, whereas others were called Nonreverters. One hundred-nineteen patients entered the analysis. During the treatment period, mean SMBP decreased significantly, from 150 +/- 14/97 +/- 7 mm Hg to 139 +/- 15/91 +/- 9 mm Hg (all P < .001). The on-drug BP level was similar in the evening in the two treatment groups. However, both systolic and diastolic morning SMBP levels were significantly lower in the trandolapril group. After drug discontinuation, the mean BP level significantly rose to 144 +/- 14/94 +/- 9 mm Hg (all P = .01) but remained lower than the baseline BP values (P = .003 for SBP and P = .002 for DBP). The post-drug BP level was significantly lower in the trandolapril group than in the perindopril group. Seventy-four patients were responders to therapy. In this subgroup, the median of the R ratio used to analyze reversion to baseline after drug discontinuation was 44%. Nonreverters were characterized by a sustained on-drug BP decrease, compared to Reverters. We therefore conclude that ACE inhibitor treatment withdrawal is accompanied by a rapid rise in BP (within 48 h), followed by a 5-day BP plateau that is lower than the initial level. Reverters to baseline after drug discontinuation were more likely to be insufficiently controlled during therapy, particularly in the morning. The longer duration of action of trandolapril was associated with a lower BP level during both the morning during the active treatment phase and the 1-week posttreatment phase.

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.

Effects of clinical audit on the quality of care in patients with type 2 diabetes: results of the DIABEST pilot study.

OBJECTIVE: To improve the quality of diabetes care in general practice by the use of audit. MATERIAL AND METHODS: A prospective multicenter pilot study. Thirty-five groups of ten general practitioners (GPs) have been set up throughout France on a voluntary basis. These groups were led by a steering committee that includes a diabetologist and a GP. Each group established a consensus on healthcare standards and carried out 2 data collections over a 12-month period, with adoption of corrective measures between these 2 collections. RESULTS: 309 (90.4%) of the 342 practitioners completed the first data collection, assessing the management of 3,125 patients over a year. Less than half the groups have reached the 80% reference threshold for quality of care with regard to foot examination, microalbuminuria, ECG, fundoscopy and assessment of diet. The audit also found no intervention within one year in case of poor glucose control for 47% of patients, unsatisfactory quality of HbA(1c) measurement and insufficient resources for diet and education. 226 (66.1%) practitioners completed the second data collection assessing the management of 2,248 patients. Comparison between the two phases of the audit showed significant improvements for all the indicators of the process of care (p<0.001). Quality of HbA(1c) measurement and diet assessment by GPs progressed (p<0.01). Outcomes of care also improved with respect to the proportion of patients with HbA(1c)<=8% (p=0.007), fasting glycaemia<1.40 g/l (p=0.05) and SBP<140 mmHg (p=0.02). CONCLUSIONS: This pilot study confirms the feasibility of using clinical audit at the national level. It seems to be an effective measure to improve the management of patients with type 2 diabetes in primary care. It is intended that the large-scale DIABEST study will address this issue.

Predictors of response to glimepiride in patients with type 2 diabetes mellitus.

OBJECTIVE: The purpose of DIAMETRE (DIabète et Amarel en Monothérapie. Etude de Titration pour la définition des Répondeurs) was to identify factors predictive of response to glimepiride monotherapy in type 2 diabetic patients in the setting of a prospective multicentre open study. MATERIAL AND METHODS: Patients aged 35-70 years with poorly controlled diabetes [fasting plasma glucose (FPG) > or =1,40 g/l and < 3 g/l at baseline] were treated with glimepiride for 6 months, with dosage titrated from 1-6 mg daily, depending on the monthly FPG measurement. Responders were defined as patients with a) FPG < 7.78 mmol/l (1.40 g/l) and HbA(1c) < 7.5% at endpoint, or b) decrease in FPG > or = 20% and/or HbA1c > or = 10%. Stepwise logistic regression analysis was used to identify factors predictive of response. RESULTS: Of 849 patients evaluable for efficacy, 483 (56.9%) were responders. The response was independently influenced by prior treatment with OADs [OR: 0.399 (0.290-0.549), p=0.0001] and diabetes duration [OR: 0.912 (0.877-0.948), p=0.0001]. Ninety patients (9.2%) experienced 124 episodes of symptomatic hypoglycaemia. Multivariate analysis revealed that a high level of HbA(1c) decreased the risk of symptomatic hypoglycaemia [OR: 0.734 (0.628; 0.858), p=0.0001] whereas a family history of type 2 diabetes doubled this risk [OR: 1.956 (1.246; 3.072), p=0.003]. CONCLUSION: This large-scale study, conducted under conditions approximating to current medical practice, confirms that glimepiride has a favourable risk-benefit ratio in type 2 diabetes mellitus. Diabetes duration and previous treatment with OADs reduced the likelihood of being a responder to treatment.