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See detailEfficacité, efficience, qualité : quelle évaluation pour quelle Justice ?
Ficet, Joël ULg

Conference (2009, September 18)

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See detailEFFICACITES TECHNICO-ECONOMIQUES DES SYSTEMES DE PRODUCTION AGRICOLE DANS LE CONTEXTE ACTUEL DES TRANSFORMATIONS AGRAIRES D’UNE COMMUNE DU DELTA DU FLEUVE ROUGE: LE CAS DE LA COMMUNE DE CAM HOANG, DISTRICT DE CAM GIANG, PROVINCE DE HAI HUONG
Phan Dang, Thang ULg; Vu Dinh Ton; Marc Dufumier

in Recueil des résultats des recherches du programme de coopération interuniversitaires (2008)

Ongoing the research on the agricultural and rural dynamics at Cam Hoang commune of the Hai Duong province, situated in the heart of the Red River Delta, for a better understanding the evolution of ... [more ▼]

Ongoing the research on the agricultural and rural dynamics at Cam Hoang commune of the Hai Duong province, situated in the heart of the Red River Delta, for a better understanding the evolution of agricultural systems, we have continually been realized an economic analyze. This study aims to identify and to analyze the economic-technical efficiencies of the five main polyculture-livestock farming systems at different scales, known as farming systems (SP), in the light of the agricultural developmental evolutions in the region. Only 10% of the farm households produce sufficiently for selling an important part of their agricultural production, around 76.5% of the farm households must have an extra-agricultural activity, and only 14.6% rely exclusively to their agricultural activity. One active labor’s revenue varies from 8,365 kd (thousand Vietnam dongs) in the system SP5 to 36,597 kd per year for the farmers of the group SP3b, or one important disparity from 1 to 4.4 times between the households at the same commune. This research enabled to underline a significant number of problems related to the rural development, the durability in agricultural production, but also reveals the positive dynamics within the agricultural households. [less ▲]

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See detailEfficacy and cardiovascular safety of daclizumab, mycophenolate mofetil,tacrolimus, and early steroid withdrawal in renal transplant recipients: a multicenter,prospective, pilot trial
Abramowicz, Daniel; Vanrenterghem, Yves; Squifflet, Jean-Paul ULg et al

in Clinical Transplantation (2005), 19

This single-arm, open-label, pilot study was designed to assess the efficacy and cardiovascular safety profile of daclizumab, a humanized monoclonal interleukin (IL)-2Ra antibody, in combination with ... [more ▼]

This single-arm, open-label, pilot study was designed to assess the efficacy and cardiovascular safety profile of daclizumab, a humanized monoclonal interleukin (IL)-2Ra antibody, in combination with mycophenolate mofetil (MMF), tacrolimus, and early corticosteroid withdrawal in renal transplant recipients. Seventy-nine renal allograft recipients were treated with daclizumab (1 mg/kg; five doses starting on the day before transplant and then every two weeks), MMF (1 g b.i.d.), tacrolimus (0.2 mg/kg/d), and low-dose prednisolone, which was withdrawn at day 150 after transplant. The rate of acute rejection was determined at 12 months. Lipid profile, oral glucose tolerance, and adverse events were monitored. Of the 76 patients eligible for analysis, eight (10.5%) developed biopsyproven acute rejection (BPAR). Ten (13.2%) experienced clinical and/or BPAR. Corticosteroids were withdrawn completely in 91% of patients at 12 months. Graft and patient survival were 97.5% and 98.7% respectively. Mean total cholesterol and triglycerides were significantly lower at 12 months post-transplant than at baseline (201 ± 47.5 vs. 190.8 ± 43.6 mg/dL, p ¼ 0.005 and 196.2 ± 133.2 vs. 144.5 ± 76.8 mg/ dL, p < 0.001, respectively). Mean hemoglobin A1c levels did not differ between baseline (5.54%) and 12 months (5.48%). New-onset posttransplant diabetes mellitus occurred in 6.6% of the non-diabetic transplanted patients. The proportion of patients with abnormal oral glucose tolerance test (OGTT) was 47% at 3 months and 39% at 12 months (p ¼ NS). Daclizumab induction in combination with MMF, tacrolimus, and low-dose (followed by withdrawal) prednisolone appears to be effective and safe in patients receiving renal allografts. The regimen appears to be associated with a favorable cardiovascular profile. [less ▲]

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See detailEFFICACY and Characterization of THE LACTOPEROXIDASE SYSTEM, A NATURAL BIOLOGICAL PESTICIDE
Bafort, Françoise ULg; Perraudin, Jean-Paul; Jijakli, Haissam ULg

Conference (2014, September 26)

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See detailEfficacy and morbidity of a novel induction treatment for locally advanced NSCLC
Bosquee, Léon ULg; Rinken, Françoise ULg; Bustin, F. et al

in Lung Cancer (2005, July), 49(Suppl. 2), 78

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See detailEfficacy and Morbidity of a Novel Induction Treatment in Locally Advanced Non Small Cell Lung Cancer (NSCLC)
Barthelemy, Nicole ULg; Rinken, F.; Dekoster, Guy ULg et al

in International Journal of Radiation, Oncology, Biology, Physics (2006), 66(3), 476-477

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See detailEfficacy and safety of a third anti-TNF monoclonal antibody in Crohn's disease after failure of two other anti-TNF.
Allez, Matthieu; Vermeire, Severine; Mozziconacci, Nicolas et al

in Alimentary Pharmacology & Therapeutics (2009)

Adalimumab (ADA) and certolizumab pegol (CZP) have demonstrated efficacy in Crohn's disease (CD) patients previously treated with infliximab (IFX). Aim: To assess the efficacy and tolerability of a third ... [more ▼]

Adalimumab (ADA) and certolizumab pegol (CZP) have demonstrated efficacy in Crohn's disease (CD) patients previously treated with infliximab (IFX). Aim: To assess the efficacy and tolerability of a third anti-TNF in CD after failure of and/or intolerance to two different anti-TNF. Methods: CD patients who received ADA or CZP after loss of response and/or intolerance to two anti-TNF were included in this retrospective study. Data were collected using a standardized questionnaire. Clinical response, duration, safety and reasons for discontinuation were assessed. Results: Sixty-seven patients treated with CZP (n=40) or ADA (n=27) were included. A clinical response was observed in 41 (61%) at week 6 and 34 patients (51%) at week 20. The probability of remaining under treatment at 3 months, 6 months and 9 months was 68%, 60% and 45%, respectively. At the end of follow-up, the third anti-TNF had been stopped in 36 patients for intolerance (n=13), or failure (n=23). Two deaths were observed. Conclusion: Treatment, with a third anti-TNF (CZP or ADA) agent, of CD patients who have experienced loss of response and/or intolerance to two anti-TNF antibodies, has favorable short- and long-term efficacy and is an option to be considered in patients with no other therapeutic options. [less ▲]

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See detailEfficacy and safety of adalimumab as monotherapy in patients with rheumatoid arthritis for whom previous disease modifying antirheumatic drug treatment has failed
van de Putte, B. A.; Atkins, C.; Malaise, Michel ULg et al

in Annals of the Rheumatic Diseases (2004), 63(5), 508-516

Objective: To evaluate the efficacy and safety of monotherapy with adalimumab in patients with RA for whom previous DMARD treatment has failed. Methods: In a 26 week, double blind, placebo controlled ... [more ▼]

Objective: To evaluate the efficacy and safety of monotherapy with adalimumab in patients with RA for whom previous DMARD treatment has failed. Methods: In a 26 week, double blind, placebo controlled, phase III trial, 544 patients with RA were randomised to monotherapy with adalimumab 20 mg every other week, 20 mg weekly, 40 mg every other week, 40 mg weekly, or placebo. The primary efficacy end point was greater than or equal to 20% improvement in the ACR core criteria (ACR20 response). Secondary efficacy end points included ACR50, ACR70, EULAR responses, and the Disability Index of the Health Assessment Questionnaire (HAQ DI). Results: After 26 weeks, patients treated with adalimumab 20 mg every other week, 20 mg weekly, 40 mg every other week, and 40 mg weekly had significantly better response rates than those treated with placebo: ACR20 (35.8%, 39.3%, 46.0%, 53.4%, respectively v 19.1%; pless than or equal to 0.01); ACR50 (18.9%, 20.5%, 22.1%, 35.0% v 8.2%; pless than or equal to 0.05); ACR70 (8.5%, 9.8%, 12.4%, 18.4% v 1.8%; pless than or equal to 0.05). Moderate EULAR response rates were significantly greater with adalimumab than with placebo (41.5%, 48.2%, 55.8%, 63.1% v 26.4%; pless than or equal to 0.05). Patients treated with adalimumab achieved better improvements in mean HAQ DI than those receiving placebo (-0.29, -0.39, -0.38, -0.49 v -0.07; pless than or equal to 0.01). No significant differences were found between adalimumab and placebo treated patients for serious adverse events, serious infections, or malignancies. Injection site reaction occurred in 10.6% and 0.9% of adalimumab and placebo treated patients, respectively (pless than or equal to 0.05). Conclusion: Among patients with RA for whom previous DMARD treatment had failed, adalimumab monotherapy achieved significant, rapid, and sustained improvements in disease activity and improved physical function and was safe and well tolerated. [less ▲]

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See detailEfficacy and safety of avocado soybean unsaponifiable (ASU)at two different daily doses in treatment of symptomatic osteoarthritis of the knee (KOA)
Appelboom, T; Reginster, Jean-Yves ULg; Schuermans, J et al

in Osteoarthritis and Cartilage (1999), 7(SA), 117

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See detailEfficacy and safety of currently marketed anti-osteoporosis medications
Reginster, Jean-Yves ULg; NEUPREZ, Audrey ULg; Dardenne, Nadia ULg et al

in Best Practice & Research. Clinical Endocrinology & Metabolism (2014), 28

During the past 2 decades, many interventions were proven effective in the management of postmenopausal osteoporosis. The objective of an anti-osteoporosis treatment is to reduce fracture rates, ideally ... [more ▼]

During the past 2 decades, many interventions were proven effective in the management of postmenopausal osteoporosis. The objective of an anti-osteoporosis treatment is to reduce fracture rates, ideally at all skeletal sites (i.e. spine, hip, and other non-spine). The armamentarium against osteoporosis includes anti-resorptive agents (i.e. bisphosphonates, selective estrogen receptor modulators and denosumab), bone-forming agents (i.e. peptides from the parathyroid hormone family) and one agent with a dual mechanism of action (i.e. strontium ranelate). All these medications combine anti-fracture efficacy with a reasonable benefit/risk profile. However, the choice of a particular chemical entity, in one individual patient is based on the knowledge and expertise of the physician. Prioritization of drugs should be based on the individual profile of the patient, the severity of osteoporosis and the specific contraindications, warnings and precautions of use of the various available medications. [less ▲]

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See detailEfficacy and Safety of Drugs for Paget's Disease of Bone
Reginster, Jean-Yves ULg; Lecart, M. P.

in BONE (1995), 17(5 Suppl), 485-488

Paget's disease of bone is characterized by an anarchic bone turnover starting with excessive resorption caused by structural and functional abnormalities involving osteoclasts. Calcitonin and ... [more ▼]

Paget's disease of bone is characterized by an anarchic bone turnover starting with excessive resorption caused by structural and functional abnormalities involving osteoclasts. Calcitonin and bisphosphonates are now considered as the main therapeutic approaches for this disease. Daily parenteral administration of calcitonin to patients with Paget's disease of bone results in a significant fall in serum alkaline phosphatase and urinary hydroxyproline levels. This treatment has also been reported to be effective in relieving clinical symptoms of the disease, mainly bone pain. The drawbacks of injectable calcitonin have stimulated interest in alternative routes of delivery. Substantial evidence of calcitonin bioavailability and bioefficacy equivalent to those of parenteral administration is currently available for only two alternative routes: nasal spray and rectal suppository. Since many results have been published showing a dramatic effect of several bisphosphonates in Paget's disease of bone, nasal and rectal calcitonin are no longer considered as the treatments of choice in this condition. A major advantage of the use of bisphosphonates over calcitonin in Paget's disease is that biochemical and histologic suppression of disease activity may persist for many years after the cessation of treatment. Oral etidronate and intravenous pamidronate have been extensively used and have provided satisfactory benefits to the patient. Since the risk/benefit ratio of alendronate does not appear to be completely positive, it is likely that the future of treatment of Paget's disease of bone will be based on the oral formulation of the new bisphosphonates, including tiludronate, risedronate or dimethyl-pamidronate. [less ▲]

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See detailEfficacy and safety of etravirine in treatment-experienced, HIV-1 patients: pooled 48 week analysis of two randomized, controlled trials.
Katlama, Christine; Haubrich, Richard; Lalezari, Jacob et al

in AIDS (2009), 23(17), 2289-300

OBJECTIVE: To evaluate the efficacy, safety and virologic resistance profile of etravirine (TMC125), a next-generation nonnucleoside reverse transcriptase inhibitor, over 48 weeks in treatment-experienced ... [more ▼]

OBJECTIVE: To evaluate the efficacy, safety and virologic resistance profile of etravirine (TMC125), a next-generation nonnucleoside reverse transcriptase inhibitor, over 48 weeks in treatment-experienced adults infected with HIV-1 strains resistant to a nonnucleoside reverse transcriptase inhibitor and other antiretrovirals. DESIGN: DUET-1 (NCT00254046) and DUET-2 (NCT00255099) are two identically designed, randomized, double-blind phase III trials. METHODS: Patients received twice-daily etravirine 200 mg or placebo, each plus a background regimen of darunavir/ritonavir, investigator-selected nucleoside/nucleotide reverse transcriptase inhibitors and optional enfuvirtide. Eligible patients had documented nonnucleoside reverse transcriptase inhibitor resistance, at least three primary protease inhibitor mutations at screening and were on a stable but virologically failing regimen for at least 8 weeks, with plasma viral load more than 5000 copies/ml. Pooled 48-week data from the two trials are presented. RESULTS: Patients (1203) were randomized and treated (n = 599, etravirine; n = 604, placebo). Significantly more patients in the etravirine than in the placebo group achieved viral load less than 50 copies/ml at week 48 (61 vs. 40%, respectively; P < 0.0001). Significantly fewer patients in the etravirine group experienced at least one confirmed or probable AIDS-defining illness/death (6 vs. 10%; P = 0.0408). Safety and tolerability in the etravirine group was comparable to the placebo group. Rash was the only adverse event to occur at a significantly higher incidence in the etravirine group (19 vs. 11%, respectively, P < 0.0001), occurring primarily in the second week of treatment. CONCLUSION: At 48 weeks, treatment-experienced patients receiving etravirine plus background regimen had statistically superior and durable virologic responses (viral load less than 50 copies/ml) than those receiving placebo plus background regimen, with comparable tolerability and no new safety signals reported since week 24. [less ▲]

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See detailEfficacy and safety of Jentadueto(R) (linagliptin plus metformin).
SCHEEN, André ULg

in Expert Opinion on Drug Safety (2013), 12(2), 275-89

INTRODUCTION: Metformin is the first-choice drug in the management of type 2 diabetes. However, most patients require a combined therapy to reach and/or maintain targets of glucose control. Dipeptidyl ... [more ▼]

INTRODUCTION: Metformin is the first-choice drug in the management of type 2 diabetes. However, most patients require a combined therapy to reach and/or maintain targets of glucose control. Dipeptidyl peptidase-4 (DPP-4) inhibitors offer new options for combined therapy with metformin. Linagliptin shares a similar pharmacodynamic (PD) profile with other gliptins, but has a unique pharmacokinetic (PK) profile characterized by negligible renal excretion. AREAS COVERED: An extensive literature search was performed to analyze the potential PK/PD interactions between linagliptin and metformin. They are not prone to PK drug-drug interactions. The two compounds may be administered together, either separately or using a fixed-dose combination (FDC) as shown by bioequivalence studies. The addition of linagliptin in patients not well controlled with metformin alone has proven its efficacy in improving glucose levels with a good safety profile. Initial co-administration of linagliptin plus metformin improves glucose control more potently than either compound separately, without hypoglycemia, weight gain or increased metformin-related gastrointestinal side effects. EXPERT OPINION: The linagliptin plus metformin combination may offer some advantages over the classical sulfonylurea-metformin combination. Even if linagliptin is safe in patients with renal impairment, the use of metformin (and thus of the linagliptin plus metformin FDC) is still controversial in this population. [less ▲]

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See detailEfficacy and safety of maribavir dosed at 100 mg orally twice daily for the prevention of cytomegalovirus disease in liver transplant recipients: a randomized, double-blind, multicenter controlled trial.
Winston, D. J.; Saliba, F.; Blumberg, E. et al

in American Journal of Transplantation (2012), 12(11), 3021-30

Maribavir is an oral benzimidazole riboside with potent in vitro activity against cytomegalovirus (CMV), including some CMV strains resistant to ganciclovir. In a randomized, double-blind, multicenter ... [more ▼]

Maribavir is an oral benzimidazole riboside with potent in vitro activity against cytomegalovirus (CMV), including some CMV strains resistant to ganciclovir. In a randomized, double-blind, multicenter trial, the efficacy and safety of prophylactic oral maribavir (100 mg twice daily) for prevention of CMV disease were compared with oral ganciclovir (1000 mg three times daily) in 303 CMV-seronegative liver transplant recipients with CMV-seropositive donors (147 maribavir; 156 ganciclovir). Patients received study drug for up to 14 weeks and were monitored for CMV infection by blood surveillance tests and also for the development of CMV disease. The primary endpoint was Endpoint Committee (EC)-confirmed CMV disease within 6 months of transplantation. In a modified intent-to-treat analysis, the noninferiority of maribavir compared to oral ganciclovir for prevention of CMV disease was not established (12% with maribavir vs. 8% with ganciclovir: event rate difference of 0.041; 95% CI: -0.038, 0.119). Furthermore, significantly fewer ganciclovir patients had EC-confirmed CMV disease or CMV infection by pp65 antigenemia or CMV DNA PCR compared to maribavir patients at both 100 days (20% vs. 60%; p < 0.0001) and at 6 months (53% vs. 72%; p = 0.0053) after transplantation. Graft rejection, patient survival, and non-CMV infections were similar for maribavir and ganciclovir patients. Maribavir was well-tolerated and associated with fewer hematological adverse events than oral ganciclovir. At a dose of 100 mg twice daily, maribavir is safe but not adequate for prevention of CMV disease in liver transplant recipients at high risk for CMV disease. [less ▲]

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See detailEfficacy and safety of monofluorophosphate and calcium in postmenopausal osteoporosis
Reginster, Jean-Yves ULg; Zegels, Brigitte ULg; Meurmans, L et al

in Revista Espanola de Reumatologia : Organo Oficial de la Sociedad Espanola de Reumatologia (1993), 20(S1), 186

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See detailEfficacy and safety of oral strontium ranelate for the treatment of knee osteoarthritis: rationale and design of randomised, double-blind, placebo-controlled trial.
Cooper, Cyrus; REGINSTER, Jean-Yves ULg; Chapurlat, Roland et al

in Current Medical Research & Opinion (2012), 28(2), 231-9

Abstract Objective: The osteoporosis drug strontium ranelate dissociates bone remodelling processes. It also inhibits subchondral bone resorption and stimulates cartilage matrix formation in vitro ... [more ▼]

Abstract Objective: The osteoporosis drug strontium ranelate dissociates bone remodelling processes. It also inhibits subchondral bone resorption and stimulates cartilage matrix formation in vitro. Exploratory studies in the osteoporosis trials report that strontium ranelate reduces biomarkers of cartilage degradation, and attenuates the progression and clinical symptoms of spinal osteoarthritis, suggesting symptom- and structure-modifying activity in osteoarthritis. We describe the rationale and design of a randomised trial evaluating the efficacy and safety of strontium ranelate in knee osteoarthritis. Research design, methods, and results: This double-blind, placebo-controlled trial (98 centres, 18 countries) includes ambulatory Caucasian men and women aged >/=50 years with primary knee osteoarthritis of the medial tibiofemoral compartment (Kellgren and Lawrence grade 2 or 3), joint space width (JSW) 2.5 to 5 mm, and knee pain on most days in the previous month (intensity >/=40 mm on a visual analogue scale). Patients are randomly allocated to three groups (strontium ranelate 1 or 2 g/day, or placebo). Follow-up is expected to last 3 years. The primary endpoint is radiographic change in JSW from baseline in each group versus placebo. The main clinical secondary endpoint is WOMAC score at the knee. Safety is assessed at every visit. It is estimated that 1600 patients are required to establish statistical significance with power >90% (0.2 mm +/- 10% between-group difference in change in JSW over 3 years). Recruitment started in April 2006. The results are expected in spring 2012. Clinical trial registration: The trial is registered on www.controlled-trials.com (number ISRCTN41323372). Conclusions: This randomised, double blind, placebo-controlled study will establish the potential of strontium ranelate in improving structure and symptoms in patients with knee osteoarthritis. [less ▲]

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See detailEfficacy and safety of piroxicam revisited. A global meta-analysis of randomised clinical trials.
Richy, F.; Scarpignato, C.; Lanas, A. et al

in Pharmacological Research (2009), 60

BACKGROUND: The relative efficacy/safety profiles of traditional (non-selective) NSAIDs (t-NSAIDs) have been repeatedly challenged. To better understand the efficacy and safety profile of piroxicam, a ... [more ▼]

BACKGROUND: The relative efficacy/safety profiles of traditional (non-selective) NSAIDs (t-NSAIDs) have been repeatedly challenged. To better understand the efficacy and safety profile of piroxicam, a widely used NSAID, a meta-analysis of comparative RCTs was carried out according to the QUOROM guidance. METHODS: A systematic comprehensive research (years 1980-2006) of any comparative randomised controlled trial (of over 7-day duration) with piroxicam for the treatment of osteoarticular conditions was conducted. Conservative analyses were stratified by comparator, outcome, indication, duration, and doses. Publication bias and robustness were exhaustively investigated. RESULTS: Seventy-five comparative trials were ultimately included for analyses. Regarding global efficacy, piroxicam was more effective than naproxen [OR=1.37 (1.05; 1.77)] and nabumetone [OR=1.72 (1.26; 2.34)], while equivalent to other NSAIDS [OR=1.06 (0.96; 1.18)]. For pain and articular swelling, piroxicam was statistically equivalent to all other NSAIDs. For mobility, piroxicam appeared to be more effective than indomethacin, while equivalent to all other NSAIDs. Piroxicam was globally safer than other NSAIDs OR=0.84 [0.73; 0.96], notably indomethacin [OR=0.53 (0.43; 0.64], naproxen [OR=0.75 (0.65; 0.85)] and salicylates [OR=0.36 (0.17; 0.75)]. From a global GI safety point of view, piroxicam was better tolerated than indomethacin [OR=0.46 (0.36; 0.58)], naproxen [OR=0.66 (0.53; 0.83)] and salicylates [OR=0.45 (0.27; 0.78)] while less tolerated when compared to meloxicam [OR=1.49 (1.05; 2.13)]. Major GI effects were comparable among piroxicam users as in comparator drugs users [OR=1.33 (0.96; 1.84)], except for meloxicam [OR=2.37 (1.13; 4.97)]. The skin safety of piroxicam was statistically comparable to those of comparators [OR=1.01 (0.68; 1.51)]. CONCLUSION: This meta-analysis of RCTs support a similar to more favourable efficacy/safety profile of piroxicam as compared to other t-NSAIDs. [less ▲]

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See detailEfficacy and safety of rimonabant for improvement of multiple cardiometabolic risk factors in overweight/obese patients: pooled 1-year data from the Rimonabant in Obesity (RIO) program.
Van Gaal, Luc; Pi-Sunyer, Xavier; Despres, Jean-Pierre et al

in Diabetes Care (2008), 31 Suppl 2

OBJECTIVE: To better define the efficacy and safety of rimonabant, the first selective cannabinoid type 1 (CB(1)) receptor antagonist, in a large population of overweight and obese patients using pooled ... [more ▼]

OBJECTIVE: To better define the efficacy and safety of rimonabant, the first selective cannabinoid type 1 (CB(1)) receptor antagonist, in a large population of overweight and obese patients using pooled efficacy data from three Phase III nondiabetes Rimonabant in Obesity and Related Metabolic Disorders (RIO) studies, selected efficacy data from the RIO-Diabetes study, and pooled safety data for all four RIO studies. RESEARCH DESIGN AND METHODS: The RIO studies enrolled patients who were either overweight (BMI >27 kg/m(2)) with at least one comorbidity (i.e., hypertension, dyslipidemia, or, for RIO-Diabetes, type 2 diabetes) or obese. All patients received daily treatment with rimonabant (5 or 20 mg) or placebo for 1 year plus a hypocaloric diet (600 kcal/day deficit) and advice on increased physical activity. RIO-Europe (n = 1,508), RIO-North America (n = 3,045), and RIO-Lipids (n = 1,036) excluded patients with type 2 diabetes; untreated dyslipidemia was an entry requirement for RIO-Lipids. RIO-Diabetes (n = 1,047) required the presence of type 2 diabetes inadequately controlled by sulfonylurea or metformin monotherapy. RESULTS: The pooled intention-to-treat population comprised 5,580 patients without diabetes (3,165 completed treatment) and 1,047 patients with diabetes (692 completed treatment). Most efficacy measures improved during the 4-week placebo run-in period, except that HDL cholesterol decreased as expected in the early phase of a hypocaloric diet. After 1 year of randomized treatment, changes from baseline with 20 mg rimonabant in the nondiabetic population were as follows: body weight -6.5 kg, waist circumference -6.4 cm, HDL cholesterol +16.4%, triglycerides -6.9%, fasting insulin -0.6 muU/ml, and homeostasis model assessment for insulin resistance (HOMA-IR) -0.2 (all P < 0.001 vs. placebo). In the diabetic population, 20 mg rimonabant reduced A1C levels by 0.6% (P < 0.001 vs. placebo). Regression analysis of change in HDL cholesterol, triglycerides, adiponectin (in RIO-Lipids), and A1C (in RIO-Diabetes) versus body weight at 1 year by ANCOVA suggested that 45-57% of the effect of rimonabant could not be explained by the observed weight loss. At 1 year, adverse events more frequently reported with rimonabant were gastrointestinal, neurological, and psychiatric in nature. Serious adverse events were infrequent and almost equivalent to placebo. Overall discontinuation rates were similar across treatment groups, except discontinuation from adverse events, which occurred more frequently with 20 mg rimonabant versus placebo (most commonly, depressive disorders [1.9 vs. 0.8%], nausea [1.4 vs. 0.1%], mood alterations with depressive symptoms [1.0 vs. 0.6%], and anxiety [1.0 vs. 0.3%]). A thorough review of psychiatric and neurological adverse events was performed. CONCLUSIONS: In overweight/obese patients, 20 mg/day rimonabant produced weight loss and significant improvements in multiple cardiometabolic risk factors such as waist circumference, A1C, HDL cholesterol, and triglycerides. Rimonabant was generally well tolerated, with more frequently reported adverse events being gastrointestinal, neurological, and psychiatric in nature. [less ▲]

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