Biomedical subjects

L Vaur

Publications and source records attributed to L Vaur.

At least 37 records · Page 2Linked to original sources

PubMed2001

[Antihypertensive effect of valsartan 80 mg and hydrochlorothiazide 12.5 mg evaluated by ambulatory blood pressure monitoring].

OBJECTIVE: The aim of the study was to evaluate by ambulatory blood pressure measurement (ABPM) the 24 hours antihypertensive efficacy of the fixed combination therapy, valsartan 80 mg + hydrochlorothiazide 12.5 mg (V + H), once daily, after 6 weeks of treatment, in patients with mild to moderate hypertension. STUDY DESIGN: It was a French, multicenter, double blind, randomized trial in parallel groups comparing V + H and placebo. After an initial two weeks placebo period, patients were assigned to receive either V + H or placebo for six weeks. Were eligible those with clinical arterial blood pressure, measured by sphygmomanometer, between 160/95 and 209/114 mmHg after monotherapy. A 26 hours ABPM, with Spacelabs 90,207, was done at J0 and J42 (one measurement every 15 minutes, in day time and at night). Responders were defined as a fall in day diastolic blood pressure > or = 5 mmHg and/or day diastolic blood pressure < 90 mmHg with ABPM. RESULTS: 123 of the 138 randomized patients had two interpretative measurements. Their average age was 59 + 10 years. 57% (78) of them were males and their average ABPM before treatment was 143 +/- 15/88 +/- 11 mmHg. With V + H, the reduction of the systolic and the diastolic blood pressure measured by ABPM, was significantly more important than with placebo (SBP: -15.4 +/- 10.9 mmHg versus -0.6 +/- 7.7 mmHg, p < 0.001; DBP: -9.1 +/- 7 mmHg versus -0.4 +/- 5.4 mmHg, p < 0.001). Pulse pressure (PP) was also significantly reduced with the combination therapy V + H, but it was not modified with placebo (-6.3 + 5.5 mmHg versus -0.2 + 4.1 mmHg, p < 0.001). ABPM responder rate was 73% with V + H versus 24% with placebo (p < 0.001). Trough/peak ratio was 80.3% for systolic blood pressure and 57.3% for diastolic blood pressure. The combination V + H was as well tolerated as placebo. CONCLUSION: The fixed combination V + H used for treatment of hypertension, after failure of monotherapy, is very effective in reducing pulse pressure, systolic and diastolic blood pressure, over 24 hours, homogeneously, and is as well tolerated as placebo.

Aged↗

PubMed2001

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.

Adult↗

PubMed2001

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.

Albuminuria↗

PubMed2000

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.

Angiotensin-Converting Enzyme Inhibitors↗

PubMed2000

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.

Angiotensin-Converting Enzyme Inhibitors↗

PubMed2000

[The feasibility of at-home self-monitoring blood pressure in elderly hypertensive patients].

The goal of the SHEAF study is to determine whether self blood pressure measurement (SBPM) has a better cardiovascular prognostic value than office blood pressure (OBP) among French elderly (> or = 60 y) hypertensive patients (pts) followed-up by general practitioners. Baseline SBPM was performed over a 4-day period: every day a series of 3 consecutive measurements was requested in the morning (8:00 am) and in the evening (8:00 pm), using a validated device OMRON 705 CP. Measurements performed out of predefined morning and evening time (outside the 4:00-12:00 am range or the 4:00-12:00 pm range) were discarded as well as aberrant values. Pts were included in the study only if they exhibited at least 15 valid measurements with at least 6 in the morning and 6 in the evening. 5,649 pts were selected. 186 pts were excluded for age < 60 years. Thus SBPM analysis was performed for 5,463 pts: 2,687 men (49%) and 2,776 women (51%) aged 70 +/- 7 years. Only 252 pts (5%) were excluded for non valid SBPM (207 pts < 15 measurements, 106 pts < 6 measurements in the morning and 205 pts < 6 measurements in the evening). 5,211 pts (95%) with valid SBPM were included. The distribution of pts according to the number of measurements performed is the following: [table: see text] The number of measurements performed in the morning is highly related to the number of measurements performed in the evening. None of the following variables is significantly associated with the poor compliance of measurement protocol: age, gender, CV history, CV risk factors, hypertension duration. In a large cohort of elderly hypertensive living in the community, SBPM is easily performed both in the morning and in the evening by most of the pts. If the SHEAF study demonstrates the prognostic value of SBPM, this would provide the basis for the use of this measurement method by a majority of elderly hypertensives.

Age Factors↗

PubMed1999

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.

Aged↗

PubMed1999

[Current aspects of arterial hypertension. Prognostic value of self-monitoring blood pressure measurements in aged hypertensive patients: a SHEAF study protocol].

HOW TO MEASURE BLOOD PRESSURE: Studies conducted in large series have established the prognostic value of blood pressure measured by conventional methods. This measurement technique has however a certain number of limitations and alternative systems have been proposed, including self-monitoring methods. A preliminary study suggested that the prognostic value of self-monitoring blood pressure measurements would be superior to those obtained with conventional methods. These findings require confirmation. A LARGE SCALE STUDY: The primary objective of the SHEAF study is to determine the prognostic value of self-monitoring blood pressure measurements in terms of cardiovascular mortality in a population of hypertensive elderly subjects living in France. The study protocol projects to include 5,000 hypertensive patients, whether treated or not, aged 60 and over. Baseline pressures are to be measured by a physician using a mercury sphygmomanometer (3 successive measurements at 2 visits) and by the participants using a self-monitoring device in their home (3 measurements in the morning and evening for 4 consecutive days). The patients will be followed for 3 years and all cardiovascular events will be recorded, including: death, myocardial infarction, cerebral vascular events, transitory ischemic events, hospitalization for angina, episodes of angina, heart failure, angioplasy or coronary bypass. The results of this large-scale epidemiology study should be available in 2002. METHODOLOGICAL PRECAUTIONS: The SHEAF study will analyze the patient's usual blood pressures, whatever the treatment at study inclusion, rather than blood pressures observed after treatment withdrawal. Efforts will be made to limit the number of drop-outs.

Aged↗

PubMed1999

Epidemiology of myocardial infarction in France: therapeutic and prognostic implications of heart failure during the acute phase.

BACKGROUND: The aim of this study was to assess the 1-year outcome of acute myocardial infarction, in current practice, according to the presence or absence of heart failure. This was an epidemiologic, prospective survey involving 2152 patients recruited in November 1995 from 312 French coronary care units. METHODS AND RESULTS: All consecutive patients admitted within 48 hours for confirmed acute myocardial infarction to the participating centers in November 1995 were included. For each patient, baseline parameters, as well as clinical course and therapeutic treatment during the first 5 days, were collected. For the purpose of this study, the diagnosis of heart failure required a left ventricular ejection fraction </=35% and/or a Killip class >1. During the 1-year follow-up, date and cause of death were recorded. Kaplan-Meier survival curves were analyzed with the log rank test. Cox multivariate analyses were used to assess the independent prognostic factors among 5-day survivors. Eight hundred twenty-one (38%) patients exhibited heart failure during the first 5 days after myocardial infarction. Patients with heart failure were 10 years older and were more likely to be hypertensive or diabetic; use of primary revascularization (33% vs 47%, P <.001) and beta-blockers (40% vs 79%, P <.001) was less frequent, whereas prescription of angiotensin-converting enzyme (ACE) inhibitors was enhanced (56% vs 41%, P <.001). Mortality rate was strongly related to both left ventricular ejection fraction (P <. 001) and Killip class (P <.001). One-year mortality rate was 39.7% in patients with heart failure compared with 7.1% in patients without heart failure (P <.001). A significant reduction in mortality rates was observed with beta-blockers (risk ratio 0.63 [0. 45 to 0.89], P =.01) and ACE inhibitors (risk ratio 0.73 [0.54 to 0. 99], P =.04). It was more pronounced in patients with heart failure. CONCLUSIONS: Results of this French observational survey are in line with previous epidemiologic studies and with major therapeutic trials. Patients with heart failure after acute myocardial infarction constitute a high-risk group. They appear to derive a greater benefit from treatment with both beta-blockers and ACE inhibitors than from each class on its own.

Acute Disease↗

PubMed1999

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.

Age Factors↗

PubMed1998

[Prognosis after myocardial infarct in a diabetic patient: results of coronary intensive care unit epidemiological study].

OBJECTIVE: Determine early and mid-term mortality in diabetic patients with myocardial infarction and ascertain whether diabetes is an independent prognosis factor. PATIENTS AND METHODS: All patients admitted to an intensive care unit within 48 hours of the first signs of myocardial infarction were included in the study. Diabetic status was recorded at admission. Early mortality (5 day) and 1-year mortality was compared between diabetic and non-diabetic patients. Multivariate analysis was used to determine the predictive value of diabetic status as an independent factor. RESULTS: 2527 patients, including 440 diabetics (17%) and 2087 non-diabetics (83%) were followed at 5 days; 2125 patients, including 364 diabetics (17%) and 1761 non-diabetics (83%) were followed to 1 year. Diabetes was more frequent in older patients and in women. Mortality in diabetic patients was higher than in non-diabetics. At 5 days, mortality was 10.4% versus 17.6% (p < 0.001). Multivariate analysis did not confirm diabetic status as an independent risk factor for death at 5 days. Inversely, at 1 year, diabetic status was an independent risk factor (RR = 1.4; 95% CI = 1.1 -1.8; p = 0.004). CONCLUSION: Diabetes is associated with poor prognosis after myocardial infarction. After correction for other risk factors, diabetes is an independent risk factor which must be taken into account when managien after myocardial infarction.

Aged↗

PubMed1998

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.

Adult↗

PubMed1998

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.

Albuminuria↗

PubMed1998

Superiority of home blood pressure measurements over office measurements for testing antihypertensive drugs.

OBJECTIVE: To compare the effects on office blood pressure and home blood pressure of placebo and active drug administration. DESIGN: After a 2-week wash-out period, patients with mild-to-moderate hypertension entered a 2-week single-blind placebo period and then a 4-week double-blind period. Patients were randomly assigned to be administered either 2 mg trandolapril once daily or its placebo in a 2:1 proportion. Office blood pressure was measured by a physician at the end of each period, using a mercury sphygmomanometer (mean of three consecutive measurements). Home blood pressure was measured during the last week of each period according to standard procedure carefully taught to each patient by the physician. Compliance was checked by using electronic pill boxes. RESULTS: Data for 34 of the 44 patients who entered the study were eligible for analysis. Baseline systolic blood pressure/diastolic blood pressure were significantly (P = 0.0001/P = 0.0001) higher for office blood pressure (161/101 mmHg) than they were for home blood pressure (145/93 mmHg). There was no statistically significant difference between the placebo and active-treatment groups at baseline. During the single-blind period, blood pressures measured at the office and at home did not change significantly. Office blood pressure decreased by 2.7 +/- 10 mmHg for systolic blood pressure and by 0.5 +/- 4 mmHg for diastolic blood pressure whereas home blood pressure increased by 0.8 +/- 6 mmHg for systolic blood pressure and by 0.7 +/- 4 mmHg for diastolic blood pressure. During the double-blind period, office blood pressure fell significantly with trandolapril treatment (systolic by 10.2 +/- 12 mmHg, diastolic by 8.3 +/- 6 mmHg; P = 0.0005/0.0001, versus single-blind placebo period) but this decrease was not significantly different (P = 0.45/0.92) from the fall in members of the placebo group (systolic by 6.9 +/- 9 mmHg, diastolic by 8.0 +/-6 mmHg; P = 0.04/0.002, versus single-blind placebo period). Thus, no antihypertensive effect of trandolapril was demonstrated. The fall lin home blood pressure with trandolapril treatment was significant (systolic by 10.7 +/- 8 mmHg, diastolic by 5.8 +/- 5 mmHg; both P = 0.0001, versus single-blind placebo period) and was significantly greater (P = 0.0004/0.004) than the minimal change observed with placebo (systolic fell by 0.2 +/- 5mmHg, diastolic fell by 0.6 +/- 4 mmHg; P = 0.90/0.62, respectively, versus single-blind placebo period). The evening decrease in home blood pressure was similar to the morning decrease in home blood pressure in members of the trandolapril-treated group. The resulting morning:evening decrease in blood pressure ratio was 0.83 for diastolic blood pressure and 0.95 for systolic blood pressure. For the subgroup of responders, mean of individual ratios was 0.77 +/- 0.43 for diastolic blood pressure and 0.70 +/- 0.39 for systolic blood pressure. CONCLUSION: The placebo effect observed with office blood pressure measurements does not occur with home blood pressure measurements. Expected treatment effect can alter a physician's blood pressure readings. The precision of measurements is greater with home blood pressure (there is a lower SD). Use of home blood pressure measurements increases the power of comparative trials, allowing one either to study fewer subjects or to detect a smaller difference in blood pressure.

Journal Article↗

PubMed1998

[Epidemiology of myocardial infarction in France. One-year survival in the Usik study].

The initial phase of the epidemiological USIK study has recensed data concerning 2,563 patients admitted to hospital for acute myocardial infarction. The second phase of this study has documented the 1 year survival of 2,152 patients (84%). The population comprised 1,533 men and 619 women with a mean age of 67 years. Severe left ventricular dysfunction (LVEF < 35%) was observed in 18% of patients and clinical signs of cardiac failure were present in 35% of patients in the first 5 days of infarction. The mortality was 8.2% at 5 days, 13.2% at 28 days and 19.5% at one year. In multivariate analysis, the principal predictive factor of mortality at 1 year was age (RR = 1.06, p = 0.0001): the mortality increased by 6% per year of age. In survivors 5 days after the onset of infarction, the 1 year prognosis was significantly correlated with age (RR = 1.05, p = 0.0001) and with cardiac failure (LVEF: RR = 1.57, p = 0.0001) and Killip class (RR = 1.66, p = 0.0001). The prescription of an ACE inhibitor or a betablocker in the first 5 days of infarction was associated with a reduction in 1 year mortality of 27% (p = 0.04) and 37% (p = 0.01) respectively. In conclusion, this study has determined the features of patients admitted to the Intensive Care Unit for acute myocardial infarction in France and to identify the factors influencing 1 year survival.

Age Factors↗

PubMed1997

[Circadian rhythm in myocardial infarct in France. Results of the USIK study].

OBJECTIVES: To analyze the circadian pattern of the first signs of myocardial infarction in France. METHODS: The USIK study was conducted in November 1995 among patients hospitalized in cardiac intensive care units within 48 hours after the first signs of confirmed myocardial infarction. This prospective study recorded the day and hour of onset for each eligible patient. RESULTS: Three hundred seventy-three centers throughout France participated, including 2563 patients (71% men), mean age 68 years, with confirmed myocardial infarction. The day of the week in which the first signs occurred was recorded between November 3 and 30, 1995. The pattern did not show any peaks, notably on Monday as reported in the literature. The hour of onset was known in 2468 patients (96.3%). Demographic features and past history did not vary for the overall population. Hour of onset was: between midnight and 6 a.m. 20.1%; between 6 and 12 a.m. 30.6%; between noon and 6 p.m. 25.7%; between 6 p.m. and midnight 23.6% (p < 0.001). This pattern was also studied in several subgroups of patients defined by age, sex, presence or absence of different cardiovascular risk factors or pertinent cardiovascular history. Univariate analysis showed that the distribution in the 6 a.m.-noon period was significantly different by age group. Older patients had a higher morning peak than younger patients (32.6% versus 28.7%; p = 0.03). Inversely, this peak was lower in smokers compared with non-smokers (26.7% versus 32.4%; p = 0.005); likewise, in patients with recurrent infarction compared with first infarction patients (24.7% versus 31.9%; p = 0.003). Other variables did not affect the circadian pattern. After multivariate analysis, only 2 of these 3 factors had an influence on distribution in the 6-12 a.m. period: smoking habits (odds ratio = 0.75; p < 0.01) and prior myocardial infarction (odds ratio = 0.70; p < 0.01). CONCLUSION: This large epidemiology study confirms that there is a morning peak in the circadian pattern of myocardial infarction in France. Smoking and past history of infarction significantly affect the circadian pattern.

Aged↗

PubMed1997

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.

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PubMed1997

[Characteristics of patients hospitalized for myocardial infarction in France with respect to left ventricular dysfunction. Results of the USIK study].

Patients admitted in coronary care units, in november 1995, for confirmed acute myocardial infarction within 48 hours of symptoms onset were included in this study. The choice of measurement of left ventricular ejection fraction (LVEF) was left to the physician in charge. Only investigations performed within the first 8 days were taken into consideration. In cases with multiple investigations, the following order of preference was applied: a) angiographic LVEF, b) isotopic LVEF, c) echocardiographic ejection fraction by Simpson's method, d) echocardiographic ejection fraction by Berning's method, e) semi-quantitative visual echocardiographic evaluation. 2563 patients were included (1827 males and 736 females, mean age 67 years). A quantitative evaluation of LVEF was obtained in 1477 patients (57%) whereas 2 053 patients (80%) underwent at least a semi-quantitative evaluation. The average LVEF was 50% and 17% of patients had an ejection fraction < or = 35%. Patients with LVEF < or = 35% were older, less likely males, non smokers and diabetics. Prior heart failure, previous myocardial infarction and anterior location in infarction were more frequent. Heart failure was more frequent in patients with LVEF < or = 35% (75 vs 23%, p < 0.001). One hundred and ninety-seven patients (7.7%) died in the five first days following the onset of symptoms. A left ventricular ejection fraction < or = 35% multiplied the risk of death by 8.1 (Confidence interval: 5.7-11.4, p < 0.001). The presence of clinical heart failure increased the risk even more.

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