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See detailL'etude clinique du mois. Chirurgie bariatrique: les resultats a 10 ans de la Swedish Obese Subjects Study"."
Scheen, André ULg; Letiexhe, Michel ULg; Rorive, Marcelle ULg et al

in Revue Médicale de Liège (2005), 60(2), 121-5

The 10-year results of the prospective, controlled Swedish Obese Subjects Study were recently reported in the New England Journal of Medicine by L. Sjostrom and colleagues. This trial compared obese ... [more ▼]

The 10-year results of the prospective, controlled Swedish Obese Subjects Study were recently reported in the New England Journal of Medicine by L. Sjostrom and colleagues. This trial compared obese subjects who underwent gastric surgery and contemporaneously matched, conventionally treated obese control subjects. The follow-up rate for laboratory examinations was 74.5 percent at 10 years. At that time, data of 627 patients of the control group (mean age of 48 years, body mass index of 41 kg/m2) were compared to those of 641 patients who were submitted to surgery (banding n = 156, vertical banded gastroplasty n = 451 and gastric bypass n =34). At 10 years, the body weight had increased by 1.6 percent in the control group and decreased by 16.1 percent in the surgery group (p < 0.001), and similar changes were observed for waist circumference (+2.8 percent versus -10.1 percent, respectively, p < 0.001). Energy intake was lower and the proportion of physically active subjects higher in the surgery group than in the control group throughout the observation period. Ten-year rates of recovery from diabetes, hypertriglyceridaemia, low levels of high-density lipoprotein cholesterol, hypertension, and hyperuricaemia were more favourable in the surgery than in the control group. The surgery group had lower 10-year incidence rates of diabetes, hypertriglyceridaemia, and hyperuricaemia (but not of hypertension) than the control group. In conclusion, as compared with conventional therapy, bariatric surgery appears to be a valuable option for the treatment of severe obesity, resulting in long-term weight loss, improved lifestyle, and, except for hypercholesterolaemia that was not significantly affected, amelioration in cardiovascular risk factors that were elevated at baseline. Obtaining long-term data concerning the effect of weight loss on overall mortality and on the incidence rates of myocardial infarction, stroke, and cancer remains a key-objective of this landmark study. [less ▲]

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See detailL'etude clinique du mois. Controle glycemique et morbimortalite cardio-vasculaire chez le patient diabetique de type 2. Resultats des etudes ACCORD, ADVANCE et VA-Diabetes.
Radermecker, Régis ULg; Philips, Jean-Christophe ULg; Jandrain, Bernard ULg et al

in Revue Médicale de Liège (2008), 63(7-8), 511-8

Type 2 diabetes is associated with a high risk of complications, essentially macrovascular events. Surprisingly, the effect of improved glucose control on coronary and cerebrovascular complications in ... [more ▼]

Type 2 diabetes is associated with a high risk of complications, essentially macrovascular events. Surprisingly, the effect of improved glucose control on coronary and cerebrovascular complications in this population remains questionable. Furthermore, the target level of glycated haemoglobin (HbA1c) to minimise the risk of diabetic complications is controversial. We report the results of three recent randomised control trials (ACCORD, ADVANCE, Veterans Affairs Diabetes), which assessed the impact on cardiovascular events of intensive glucose-lowering therapy. None of these studies was able to demonstrate a significant reduction of cardiovascular events in the intensive group as compared to the standard group. On the contrary, in ACCORD, the study with the most ambitious goal (HbA1c < 6%), the overall and cardiovascular mortality was greater in the intensive group. In contrast, in the ADVANCE trial, the mortality and the incidence of cardiovascular events were not statistically different between the two treatment groups, whereas the risk of microangiopathic complications, especially nephropathy, was significantly decreased in the intensive group (HbA1c < or = 6.5%, with modified release gliclazide as main treatment). Finally, VA-Diabetes showed that the effect of better glucose control on cardiovascular complications disappeared with duration of the disease and that the risk of cardiovascular events increased in patients with severe hypoglycaemic episodes. In the three studies, the hypoglycaemic risk was indeed increased in the intensive group, which may contribute to reduce the positive impact of better glucose control on cardiovascular complications. The best way to protect type 2 diabetic patients against coronary and cerebrovascular disease is to target all cardiovascular risk factors. [less ▲]

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See detailEtude clinique du mois. Effets du valsartan dans l'insuffisance cardiaque chronique: l'etude Val-HeFT
Pierard, Luc ULg

in Revue Médicale de Liège (2002), 57(1), 57-9

Current guidelines recommend drugs which reduce neurohormonal activation as standard therapy for heart failure: angiotensin converting-enzyme (ACE) inhibitors, beta-blockers and spironolactone. The ... [more ▼]

Current guidelines recommend drugs which reduce neurohormonal activation as standard therapy for heart failure: angiotensin converting-enzyme (ACE) inhibitors, beta-blockers and spironolactone. The Valsartan Heart Failure Trial (Val-HeFT) tested the efficacy of the angiotensin-receptor blocker valsartan in addition to prescribed therapy. A total of 5010 patients with heart failure of NYHA class II, III or IV were randomly assigned to receive 160 mg of valsartan or placebo twice daily. Further angiotensin antagonism by valsartan did not improve survival but was beneficial in terms of morbidity and mortality, because of reduced rate of hospitalization, significant improvements in NYHA class, ejection fraction, signs and symptoms of heart failure, and quality of life. Valsartan had highly favourable effects in patients not receiving ACE inhibitors but an adverse effect in patients receiving both ACE inhibitors and beta-blockers. The effects of adding valsartan are depending on the importance of previous neurohormonal inhibition. [less ▲]

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See detailL'etude clinique du mois. Essais de preservation des cellules B a la phase initiale du diabete de type 1: resultats negatifs avec l'insuline retard, mais prometteurs avec un anticorps monoclonal anti-CD3.
Philips, Jean-Christophe ULg; Scheen, André ULg

in Revue Médicale de Liège (2002), 57(6), 413-7

Type 1 diabetes is an autoimmune disease leading to a progressive exhaustion of the insulin secretion and a destruction of the B-cells. Attempts of preservation of insulin-producing B-cells can be ... [more ▼]

Type 1 diabetes is an autoimmune disease leading to a progressive exhaustion of the insulin secretion and a destruction of the B-cells. Attempts of preservation of insulin-producing B-cells can be performed at an early, most often silent, stage of the disease in well-selected at high risk subjects or during the period immediately following the clinical diagnosis based upon classical signs of hyperglycaemia. In the "Diabetes Prevention Trial-Type 1", the prophylactic subcutaneous administration of low-dose ultralente insulin was not able to prevent the development of type 1 diabetes nor to preserve residual insulin secretion in young relatives at very high-risk of diabetes, selected upon genetic, immunological and metabolic criteria. In contrast, a pilot randomized trial shows that a treatment with a nonactivating humanized monoclonal antibody against CD3 mitigates the deterioration in insulin production and improves metabolic control, with lower dose of exogenous insulin, during the first year of type 1 diabetes mellitus in 9 out of 12 treated patients. Besides a better understanding of the natural history of the disease, these clinical trials open new perspectives for prevention of type 1 diabetes mellitus, currently assessed by the Belgian Diabetes Registry. [less ▲]

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See detailL'etude clinique du mois. Etudes cliniques a long terme (1-2 ans) avec l'orlistat, nouveau medicament pour le traitement de l'obesite.
Scheen, André ULg

in Revue Médicale de Liège (1999), 54(8), 707-9

Orlistat (Xenical), whose original mechanism of action consists of the selective inhibition of gastrointestinal lipases, has been recently commercialized for the treatment of obesity. Despite its recent ... [more ▼]

Orlistat (Xenical), whose original mechanism of action consists of the selective inhibition of gastrointestinal lipases, has been recently commercialized for the treatment of obesity. Despite its recent launch and when compared to common anorectic agents, it has been much better evaluated in long-term trials carried out according to the rules of Good Clinical Practice. We will summarize the four recently published randomized, placebo-controlled, double-blind clinical trials lasting up to 1 to 2 years and evaluating the effects of orlistat 3 x 120 mg/day in obese patients (BMI > or = 28 kg/m2). [less ▲]

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See detailL'etude clinique du mois. Insulino-independance prolongee apres transplantation d'ilots de langerhans chez le patient diabetique de type 1: l'aboutissement d'un reve?
Scheen, André ULg

in Revue Médicale de Liège (2000), 55(8), 803-5

A Canadian research team recently reported a series of 7 consecutive patients with type 1 brittle diabetes who could achieve sustained excellent metabolic control in the absence of insulin therapy after ... [more ▼]

A Canadian research team recently reported a series of 7 consecutive patients with type 1 brittle diabetes who could achieve sustained excellent metabolic control in the absence of insulin therapy after successful islet transplantation. This exceptional success, which contrasts with previous less favourable results, is probably due to the transplantation of a higher number of islets of good quality and to the use of a new glucocorticoid-free immunosuppressive regimen. These remarkable results which provide proof of the principle that islet transplantation can be reproducibly successful, at least for one year, may raise new hope in patients with type 1 diabetes. However, the problem of supply and demand of islets is huge and will require a careful, and probably difficult, selection of the best candidates to benefit from this new therapeutic approach. [less ▲]

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See detailL'etude clinique du mois. Interet d'augmenter un taux de cholesterol HDL bas en prevention secondaire de la coronaropathie: resultats de l'etude VA-HIT.
Scheen, André ULg

in Revue Médicale de Liège (1999), 54(9), 773-5

The "Veterans Affairs Cooperative Studies Program High-Density Lipoprotein Cholesterol Intervention Trial" (VA-HIT) is a large randomised, double-blind, placebo-controlled clinical trial for the secondary ... [more ▼]

The "Veterans Affairs Cooperative Studies Program High-Density Lipoprotein Cholesterol Intervention Trial" (VA-HIT) is a large randomised, double-blind, placebo-controlled clinical trial for the secondary prevention of coronary heart disease. It demonstrates that a fibrate treatment (gemfibrozil) significantly reduces the relative risk of major coronary (-22%, p = 0.006) and cardiovascular (-24%, p < 0.001) events in men with coronary heart disease whose primary lipid abnormality is a low HDL cholesterol level. These findings suggest that, in such a population, the rate of coronary events is reduced under gemfibrozil therapy by raising HDL cholesterol levels (+6%) and lowering levels of triglycerides (-31%) without lowering LDL cholesterol concentrations. [less ▲]

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See detailL'etude clinique du mois. INTERHEART": la preuve par 9. Neuf facteurs de risque predisent neuf infarctus du myocarde sur dix."
Scheen, André ULg; Kulbertus, Henri ULg

in Revue Médicale de Liège (2004), 59(11), 676-9

INTERHEART is a standardised case-control study of acute myocardial infarction in 52 countries representing every inhabited continent. 15152 cases and 14820 controls were enrolled. Collectively, 9 factors ... [more ▼]

INTERHEART is a standardised case-control study of acute myocardial infarction in 52 countries representing every inhabited continent. 15152 cases and 14820 controls were enrolled. Collectively, 9 factors accounted for 90% of myocardial infarctions in men and 94% in women. These factors were 6 risk factors (dyslipidaemia characterized by high apoB/apoA1 ratio, smoking, hypertension, diabetes mellitus, abdominal obesity and stressful psychosocial factors) and 3 protective factors (daily consumption of fruits and vegetables, regular alcohol consumption, and regular physical activity). These findings suggest that interventions targeting these 9 factors have the potential to prevent most premature cases of myocardial infarction and that these strategies should be implemented worldwide. [less ▲]

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See detailL'étude clinique du mois. JUPITER : diminution par la rosuvastatine des accidents cardio-vasculaires et de la mortalité chez des sujets sains normolipémiques avec C-réactive protéine accrue
Scheen, André ULg

in Revue Médicale de Liège (2008), 63(12), 749-753

SUMMARY : High levels of high-sensitivity C-reactive protein (hs-CRP) are an independent cardiovascular marker, which may be reduced by statin therapy. JUPITER is a randomised clinical trial that compares ... [more ▼]

SUMMARY : High levels of high-sensitivity C-reactive protein (hs-CRP) are an independent cardiovascular marker, which may be reduced by statin therapy. JUPITER is a randomised clinical trial that compares the effects of rosuvastatin 20 mg (n = 8901) and placebo (n = 8901) in apparently healthy individuals, <br />without hyperlipidaemia (LDL < 130 mg/dl ; median 108 mg/dl), but with moderately elevated hs-CRP levels (> 2 mg/l ; median 4.25 mg/l). Rosuvastatin reduced LDL cholesterol by 50 % (to a median of 55 mg/dl) and hs-CRP by 37 %. The trial, which should last 5 years, was stopped after a median follow-up of 1.9 years because of an imbalance in favour of the rosuvastatin group. Indeed, when compared to placebo, rosuvastatin <br />was associated with a relative risk reduction in the composite primary end point of 44 %, in myocardial infarction of 54 %, in stroke of 48 %, in revascularization procedures or hospitalisations for unstable angina of 47 %, in major cardiovascular <br />events (myocardial infarction, stroke and death) of 47 % and in deaths from any cause of 20 %. Consistent effects were observed in all subgroups evaluated. The only adverse event was a higher incidence of physician-reported diabetes in the rosuvastatin group compared to the placebo group. This study demonstrates that rosuvastatin 20 mg reduces the incidence <br />of cardiovascular events, including total mortality, in apparently healthy persons without hyperlipidaemia, but with elevated hs-CRP. However, the design of the trial does not allow discriminating which part of the favourable effect results from the drastic reduction in LDL cholesterol and which part results from the reduction in hs-CRP stricto sensu. [less ▲]

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See detailL'etude clinique du mois. L'apres DCCT, l'etude EDIC.
Scheen, André ULg

in Revue Médicale de Liège (2000), 55(3), 187-9

The "Diabetes Control and Complications Trial" (DCCT) demonstrated that intensive insulin therapy, by reducing HbA1c levels by about 2%, delays the onset and slows the progression of microangiopathic ... [more ▼]

The "Diabetes Control and Complications Trial" (DCCT) demonstrated that intensive insulin therapy, by reducing HbA1c levels by about 2%, delays the onset and slows the progression of microangiopathic complications (by at least 50%) in patients with type 1 diabetes. The "Epidemiology of Diabetes Interventions and Complications" (EDIC) study recently showed that the reduction in the risk of progressive retinopathy and nephropathy resulting from intensive therapy during the DCCT not only persists, but is amplified for at least 4 years (reduction by about 80% when compared to diabetic patients previously treated with conventional therapy during the DCCT). [less ▲]

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See detailL'etude clinique du mois. L'etude ADOPT: quel antidiabetique oral initier chez le patient diabetique de type 2?
Scheen, André ULg

in Revue Médicale de Liège (2007), 62(1), 48-52

ADOPT ("A Diabetes Outcome Progression Trial") is a double-blind, controlled clinical trial that aims at assessing the efficacy of rosiglitazone, as compared to metformin or glibenclamide, in maintaining ... [more ▼]

ADOPT ("A Diabetes Outcome Progression Trial") is a double-blind, controlled clinical trial that aims at assessing the efficacy of rosiglitazone, as compared to metformin or glibenclamide, in maintaining long-term glycaemic control in patients with recently diagnosed type 2 diabetes. It randomized 4,360 patients who were followed for a median of 4.0 years. The cumulative incidence of monotherapy failure (defined as a confirmed level of fasting plasma glucose level of more than 180 mg/dl) averaged at 5 years 15% with rosiglitazone, 21% with metformin, and 34% with glibenclamide. This represents a risk reduction for rosiglitazone of 32% as compared to metformin and 63% as compared to glibenclamide (P < 0.001 for both comparisons). Rosiglitazone was associated with more weight gain and edema, metformin with a higher incidence of gastrointestinal events and glibenclamide with a higher risk of hypoglycaemia (P < 0.001). In conclusion, ADOPT showed better glycaemic durability with rosiglitazone monotherapy, compared to metformin or glibenclamide. The potential risks and benefits, the profile of adverse events, and the costs of the three drugs should all be considered to help inform the choice of pharmacotherapy for patients with type 2 diabetes. [less ▲]

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See detailL'etude clinique du mois. L'etude ALLHAT-LLT.
Kulbertus, Henri ULg; Scheen, André ULg

in Revue Médicale de Liège (2003), 58(1), 53-8

ALLHAT-LLT was part of the ALLHAT study. The purpose was to determine whether pravastatin compared with usual care reduces all-cause mortality in older, moderately hypercholesterolaemic, hypertensive ... [more ▼]

ALLHAT-LLT was part of the ALLHAT study. The purpose was to determine whether pravastatin compared with usual care reduces all-cause mortality in older, moderately hypercholesterolaemic, hypertensive patients with at least one additional coronary heart disease (CHD) risk factor. 10,355 ambulatory patients, aged 55 years or more, with LDL cholesterol of 120-189 mg/dl (or, 100-129 mg/dl if known CHD) and triglycerides < 350 mg/dl, were randomised to pravastatin (40 mg/d; n = 5,170), or usual care (n = 5,185). Mean age was 66 years; 49% were women; 38% were black and 23% hispanic; 14% had a history of CHD and 35%, type 2 diabetes. Baseline mean total cholesterol was 224 mg/dl; LDL-C, 146 mg/dl; HDL-C, 48 mg/dl, and triglycerides, 152 mg/dl. Mean follow-up was 4.8 years. Among usual care patients, 32% of those with known CHD and 29% of those without CHD started taking lipid-lowering drugs. At year 4, total cholesterol was reduced by 17.2% with pravastatin and by 7.6% with usual care. A random sample had their LDL-C levels assessed: there was a reduction of 28% with pravastatin and of 11% with usual care. All-cause mortality was similar in the two groups (RR, 0.99; 95% CI, 0.89-1.11; p = 0.88), with 6-year mortality rates of 14.9% (pravastatin) and 15.3% (usual care). CHD event-rates were not different between the two groups (RR, 0.91; 95% CI, 0.79-1.04; p = 0.16); 6-year CHD event rates were 9.3% (pravastatin) and 10.4% (usual care), respectively. These results are likely due to the small differential in total cholesterol (9.6%) and LDL-C (16.7%) between pravastatin and usual care, compared with prior statin trials. Such an unusual differential essentially results from the open table of the study and from the possibility of prescribing a statin in the usual care group. [less ▲]

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See detailL'etude clinique du mois. L'etude CALM ou interet de combiner un inhibiteur de l'enzyme de conversion et un antagoniste du recepteur de type 1 de l'angiotensine II dans le traitement de la nephropathie diabetique.
Philips, Jean-Christophe ULg; Weekers, Laurent ULg; Scheen, André ULg

in Revue Médicale de Liège (2001), 56(2), 126-8

The main objective of the CALM (Candesartan And Lisinopril Microalbuminuria) study is to assess the effect of a dual blockade of the renin-angiotensin system--using both an angiotensin converting enzyme ... [more ▼]

The main objective of the CALM (Candesartan And Lisinopril Microalbuminuria) study is to assess the effect of a dual blockade of the renin-angiotensin system--using both an angiotensin converting enzyme inhibitor (ACE-I) and an angiotensin II type 1 receptor blocker--in patients with type 2 diabetes, high blood pressure and microalbuminuria. The study included 200 patients randomized to receive candesartan 16 mg or lisinopril 20 mg for 12 weeks, followed by 12 weeks of the same monotherapy or a combination treatment. Main outcomes are the reduction of microalbuminuria and blood pressure. All three of the treatments are effective, but the dual blockade is respectively 18%, 8 mmHg and 5 mmHg more effective in reducing microalbuminuria, systolic and diastolic blood pressure. No comparison is made between this "new" association and the more frequently used biotherapy (i.e. ACE-I plus thiazidic diuretic) and therefore its usefulness in regular practice is still to be determined. [less ▲]

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See detailL'etude clinique du mois. L'etude CAPPP: "The Captopril Prevention Project".
Scheen, André ULg

in Revue Médicale de Liège (1999), 54(3), 197-9

The Captopril Prevention Project (CAPPP) was a prospective, randomized, open trial which aimed at comparing the prevention by captopril (n = 5492) or by a conventional treatment (n = 5493; diuretics or ... [more ▼]

The Captopril Prevention Project (CAPPP) was a prospective, randomized, open trial which aimed at comparing the prevention by captopril (n = 5492) or by a conventional treatment (n = 5493; diuretics or beta-blockers) of cardiovascular morbidity and mortality in patients with hypertension (diastolic blood pressure > 100 mmHg). After a mean follow-up of 6.1 years, the results regarding the primary endpoint and most secondary endpoints were not significantly different between the two therapeutic modalities. The only differences (perhaps due to a randomisation bias) were a slightly higher incidence of stroke, but a lower risk of diabetes mellitus, in the captopril group than in the group receiving conventional treatment. In conclusion, the CAPPP study demonstrates, for the first time, that captopril, an angiotensin-converting-enzyme inhibitor, is as effective as conventional treatment with diuretics or beta-blockers, two drugs whose efficacy has already been demonstrated when compared to placebo, in the prevention of cardiovascular morbidity and mortality in hypertensive patients. [less ▲]

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See detailL'étude clinique du mois. L'étude CHARISMA: à la recherche de la meilleure stratégie antiagrégante plaquettaire en prévention cardio-vasculaire.
Scheen, André ULg

in Revue Médicale de Liège (2006), 61(9), 656-61

The CHARISMA ("Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilization, Management, and Avoidance") trial compared the effects of a dual antiplatelet therapy with clopidogrel plus low dose ... [more ▼]

The CHARISMA ("Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilization, Management, and Avoidance") trial compared the effects of a dual antiplatelet therapy with clopidogrel plus low dose aspirin with those of a monotherapy with aspirin (75-162 mg/day) on the incidence of cardiovascular events in 15,603 patients at high risk for atherothrombotic events followed for a median of 28 months. The primary efficacy endpoint, a composite of myocardial infarction, stroke, or death from cardiovascular causes, was not significantly different between the two treatment arms. The secondary principal efficacy endpoint, which included all hospitalizations for ischaemic events, was slightly reduced in the group with clopidogrel-aspirin as compared to the group with placebo-aspirin. In a subgroup analysis, among so-called "symptomatico" patients (79 % of the studied population), the dual antiplatelet therapy was associated with a significantly lower incidence of events than aspirin alone, including the primary efficacy end point. On the contrary, in "asymptomatic" patients, such a favourable effect was not observed. Unexpectedly, in this subgroup, a paradoxical increase in the mortality rate was observed with the clopidogrel-aspirin combination. As far as safety was concerned, the risk of severe (difference not significant) and moderate (difference significant) bleeding was higher in patients with the clopidogrel-aspirin combination. In conclusion, acetylsalicylic acid (aspirin) is the first choice drug and the only antiplatelet agent to be used in prvention of cardiovascular disease. In secondary prevention, the addition of clopidogrel may reinforce the cardiovascular protection given by aspirin in "symptomatic" patients, but at the expense of a slightly higher bleeding rate. [less ▲]

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See detailEtude clinique du mois. L'etude DREAM: prevention du diabete de type 2 par le ramipiril et/ou la rosiglitazone chez les personnes dysglycemiques sans maladie cardio-vasculaire.
Scheen, André ULg

in Revue Médicale de Liège (2006), 61(10), 728-32

DREAM ("Diabetes Reduction Assessment with ramipril and rosiglitazone Medication") is a double-blind randomised placebo-controlled clinical trial with a 2-by-2 factorial design aiming to study the effects ... [more ▼]

DREAM ("Diabetes Reduction Assessment with ramipril and rosiglitazone Medication") is a double-blind randomised placebo-controlled clinical trial with a 2-by-2 factorial design aiming to study the effects of an ACE inhibitor (ramipril 15 mg/day) and/or a thiazolidinedione (rosiglitazone 8 mg/day) on the development of diabetes or death (primary outcome) and on the regression to normoglycaemia (secondary outcome) in 5269 adults aged 30 years or more with impaired fasting glucose and/or impaired glucose tolerance, and no previous cardiovascular disease. There was no statistical evidence of an interaction between the ramipril and the rosiglitazone arms. After a mean follow up of 3 years, the use of ramipril does not significantly reduce the incidence of diabetes or death but does significantly increase regression to normoglycaemia. In contrast, the treatment with rosiglitazone reduces by almost 60% the incidence of type 2 diabetes and increases the likelihood (+70%) of regression to normoglycaemia. Whether it is a true prevention effect or simply a treatment effect remains to be determined when participants will be retested after a washout period. Cardiovascular event rates were rather low and much the same in all treatment groups, except a higher rate of heart failure in the rosiglitazone group. These results suggest that the routine inhibition of the renin-angiotensin system for the express purpose of preventing diabetes is not indicated in individuals not at high risk for cardiovascular disease and appear to confirm the promises of the glitazone use in the very early stage of the natural history of type 2 diabetes. [less ▲]

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See detailL'etude clinique du mois. L'etude EUROPA: protection cardio-vasculaire avec le perindopril chez les patients avec coronaropathie stable.
Scheen, André ULg; Legrand, Victor ULg

in Revue Médicale de Liège (2003), 58(11), 713-6

The multicentre placebo-controlled double-blind "EUropean trial on Reduction Of cardiac events with Perindopril in patients with stable coronary Artery disease" (EUROPA) assessed whether the angiotensin ... [more ▼]

The multicentre placebo-controlled double-blind "EUropean trial on Reduction Of cardiac events with Perindopril in patients with stable coronary Artery disease" (EUROPA) assessed whether the angiotensin-converting-enzyme inhibitor perindopril reduces cardiovascular risk in a population with stable coronary heart disease and no apparent heart failure, whatever the associated cardiovascular risk. Patients were randomly assigned perindopril 8 mg once daily (n = 6110) or matching placebo (n = 6108). After a mean follow-up of 4.2 years, a relative risk reduction of 20% (95% CI 9-29, p = 0.0003) was observed in the combined primary endpoint (cardiovascular death, myocardial infarction, or cardiac arrest) in the group treated with perindopril as compared to placebo. About 50 patients needed to be treated for a period of 4 years to prevent one major cardiovascular event. This benefit was consistent in all predefined subgroups. According to these results, treatment with perindopril, on top of other preventive medications, should be considered in all patients with stable coronary heart disease. [less ▲]

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See detailL'etude clinique du mois. L'etude FIELD de protection cardio-vasculaire avec le fenofibrate chez le patient diabetique de type 2.
Radermecker, Régis ULg; Scheen, André ULg

in Revue Médicale de Liège (2005), 60(12), 957-61

FIELD ("Fenofibrate Intervention and Events Lowering in Diabetes") study compared the incidence of coronary and cardiovascular events in 4895 patients with type 2 diabetes treated with fenofibrate ... [more ▼]

FIELD ("Fenofibrate Intervention and Events Lowering in Diabetes") study compared the incidence of coronary and cardiovascular events in 4895 patients with type 2 diabetes treated with fenofibrate (micronized fomulation, 200 mg/day) and in 4900 patients treated with placebo. After a mean 5-year follow-up, the fenofibrate group did not have less coronary events (primary endpoint), neither present a significant reduction in cardiovascular or total mortality as compared to the placebo group. However, it had significantly less non-fatal myocardial infarctions and cardiovascular events in general as well as less coronary and total revascularization procedures (secondary endpoints). The higher rate of starting statin therapy in patients allocated placebo might have masked a larger treatment benefit of fenofibrate on macrovascular complications. The tolerance of fenofibrate was good, even in combination with statins. More surprisingly, fenofibrate exerted a favourable effect on microangiopathy complications, with less albuminuria progression and less retinopathy needing laser treatment (tertiary endpoints). [less ▲]

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See detailL'etude clinique du mois. L'etude HOPE, un essai clinique bicephale aux resultats contrastes.
Scheen, André ULg

in Revue Médicale de Liège (2000), 55(2), 121-4

The results of the HOPE ("Heart Outcomes Prevention Evaluation") study, recently published in the New England Journal of Medicine, demonstrated a highly significant cardiovascular protection by an ... [more ▼]

The results of the HOPE ("Heart Outcomes Prevention Evaluation") study, recently published in the New England Journal of Medicine, demonstrated a highly significant cardiovascular protection by an angiotensin converting enzyme inhibitor, ramipril at a dose of 10 mg/day, after a mean follow-up of 4.5 years, but not of vitamin E supplements at a dose of 400 UI/day in high-risk patients (> 55 years old) who had evidence of vascular disease (secondary prevention) or combined diabetes mellitus and another cardiovascular risk factor (primary prevention). [less ▲]

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See detailL'etude clinique du mois. L'etude IDEAL comparant simvastatine 20-40 mg versus atorvastatine 80 mg en prevention apres un infarctus du myocarde: entre deux idees de l'ideal.
Scheen, André ULg

in Revue Médicale de Liège (2006), 61(1), 53-9

The IDEAL ("Incremental Decrease in End Points Through Aggressive Lipid Lowering") study compared the effects of two strategies of lipid lowering on the risk of cardiovascular disease among patients with ... [more ▼]

The IDEAL ("Incremental Decrease in End Points Through Aggressive Lipid Lowering") study compared the effects of two strategies of lipid lowering on the risk of cardiovascular disease among patients with a previous myocardial infarction. In this prospective, randomized, open-label, blinded end-point evaluation trial, patients were randomly assigned to receive a high dose of atorvastatin (80 mg/day; n = 4439), or an usual dose of simvastatin (20 mg/day, titrated up to 40 mg/day if necessary; n = 4449). During treatment, mean LDL cholesterol levels were 104 mg/dl in the simvastatin group and 81 mg/dl in the atorvastatin group (p < 0.001). After a median follow-up of 4.8 years, no significant difference was observed in the primary outcome of major coronary events (defined as coronary death, confirmed nonfatal acute myocardial infarction, or cardiac arrest with resuscitation), but the risk of other composite secondary end points (i.e., major cardiovascular events, all cardiovascular events, all coronary events) was statistically reduced in the atorvastatin group compared to the simvastatin group. There were no differences in cardiovascular or all-cause mortality between the two groups. In conclusion, patients with myocardial infarction may benefit from intensive lowering of LDL cholesterol without an increase in noncardiovascular mortality or other serious adverse reactions. [less ▲]

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