Effects of low-dose, controlled-release, phentermine plus topiramate combination on weight and associated comorbidities in overweight and obese adults (CONQUER): a randomised, placebo-controlled, phase 3 trial

Gadde, Kishore M.; Allison, David B.; Ryan, Donna H.; Peterson, Craig A.; Troupin, Barbara; Schwiers, Michael; Day, Wesley W.

doi:10.1016/s0140-6736(11)60205-5

Cited by 786 publications

(630 citation statements)

References 30 publications

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“…Morbidity and mortality risk is associated with obese nutritional status due to the comorbidities of obesity (e.g., insulin resistance, glucose intolerance, diabetes mellitus, cardiovascular diseases, sleep apnea, arthritis, certain types of cancer) [59][60][61][62][63][64][65][66][67][68][69][70]. In addition, abdominal obesity was found to increase the prediction of health risk in obese nutritional status [71][72][73][74][75][76][77][78][79].…”

Section: Discussionmentioning

confidence: 99%

Body fatness and endogenous sex hormones in the menopausal transition

et al. 2016

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a b s t r a c tBackground: Age at the final menstrual period is of clinical and public health interest because the age at which natural menopause occurs may be a marker of ageing and health, and in general the menopausal transition increases the risk of many diseases, e.g. redistribution in the pattern of adiposity during the menopausal transition may increase risk of metabolic disease. The purpose of this research was to study the relationship between the menopausal status and body fatness. Subjects and methods: A random sample of 1932Hungarian women was studied. Body composition was estimated by body impedance analysis. In a subsample free estradiol and progesterone levels in saliva were quantified. Results: Body fat mass increased until the late 50s and then had a decrease through senescence. Premenopausal women who were much older than the median age at menopause had a higher amount of fat than their postmenopausal age-peers, while postmenopausal women, whose menopause occurred much earlier than the median age at menopause, had less fat than their premenopausal age-peers. The body fat mass in premenopausal women with low levels of sex hormones was always below the agemedian value of the menopausal status subgroups, while the body fat mass of postmenopausal women with high levels of sex hormone levels was above the age-median values. Conclusions: The analysis of body fatness in the menopausal transition revealed that (1) the rate of reproductive ageing and the body fat pattern were significantly related, and (2) body fat mass of women with unexpected levels of sex hormones was related more to their hormonal levels than to their menopausal status or their age. Thus future epidemiological screenings of women exposed to higher levels of menopause-related health risks should be expanded beyond the estimation of menopausal status based only on menstrual history to include sex hormone level assessment, as well as body composition analysis.

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Section: Discussionmentioning

confidence: 99%

Body fatness and endogenous sex hormones in the menopausal transition

et al. 2016

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“…This retention programme was implemented proactively and was successful at improving upon the reported 53% 1‐year retention rate in the Rio‐North American study, which studied a similar weight loss drug in patients with similar BMI but without diabetes in the USA and Canada, also over a 1‐year time period 1, 19, and even improved upon the retention rate of Phase 3 trials conducted with more recently approved weight loss agents 2, 3, 4, 5.…”

Section: Discussionmentioning

confidence: 99%

“…On average, one‐third to one‐half of participants drops out of these large trials by 1 year 1, 2, 3, 4, 5. Such high‐attrition rates result in missing data that limit the interpretation and generalizability of findings 6.…”

Section: Introductionmentioning

confidence: 99%

Maximizing retention in long‐term clinical trials of a weight loss agent: use of a dietitian support team

Delahanty

Riggs

Klioze

et al. 2016

Obesity Science & Practice

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SummaryObjectiveHigh‐attrition rates have been observed in long‐term clinical trials of weight loss agents. We evaluated the impact of an innovative retention programme on 1‐year retention.MethodsThree Phase 3 global multicentre clinical trials evaluated the efficacy and safety of a CB1 receptor antagonist in subjects with BMI ≥ or = 27 kg/m2. The impact of a multifaceted retention programme including a dietitian screening interview, a comprehensive culturally adapted lifestyle modification programme, and a dietitian support system to maximize lifestyle adherence, was evaluated in 4,410 subjects from four subpopulations (non‐US English‐speaking, non‐English‐speaking, US‐without dietitian screening and US‐with dietitian screening) comprising 208 centres from 15 countries.ResultsThe median proportion retained over the first year among subjects in three protocols was 82%. Non‐English‐speaking countries showed higher retention rates (89%) compared with the USA (73%) and non‐US English‐speaking (81%) countries. Within the USA, behavioural screening was associated with 29% reduction in dropout rate; for every five monthly teleconferences attended above 11, there was a 32% decrease in dropout rate.ConclusionsThis novel retention programme greatly improved upon reported retention rates of studies conducted with other weight loss agents in long‐term clinical trials. Its effectiveness should be confirmed in future trials.

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“…At 56 weeks, changes in bodyweight were significantly greater with both combinations than with placebo. The higher dose was associated with a slight increase in depression-and anxiety-related adverse events 72 . In a subanalysis, metformin-treated T2DM patients reported greater weight loss and reductions in HbA1c with both doses of phentermine plus topiramate than with placebo ( Table 3).…”

Section: Orlistatmentioning

confidence: 96%

“…Several RCTs demonstrated it to be effective in losing weight and improving adiposopathy-associated metabolic diseases, including dysglycaemia 71 . The efficacy and safety of two doses of phentermine plus topiramate ER combination (7.5 plus 46 mg and 15 plus 92 mg) as an adjunct to lifestyle for weight loss and metabolic risk reduction were assessed in individuals who were overweight/obese, with two or more risk factors (hypertension, dyslipidaemia, diabetes or prediabetes, or abdominal obesity) 72 . At 56 weeks, changes in bodyweight were significantly greater with both combinations than with placebo.…”

Section: Orlistatmentioning

confidence: 99%

Combating the dual burden: therapeutic targeting of common pathways in obesity and type 2 diabetes

Scheen

Gaal

2014

The Lancet Diabetes & Endocrinology

162

130

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New glucose-lowering therapies, especially glucagon-like peptide-1 receptor agonists and sodium glucose cotransporter-2 inhibitors, offer advantages over traditional antidiabetic agents by promoting weight loss while improving glucose control. . The present review will explore the overlapping pathophysiology and also how the various therapies can, alone or in combination, combat the 'dual burden' of obesity and T2DM. Word count: 249

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Effects of low-dose, controlled-release, phentermine plus topiramate combination on weight and associated comorbidities in overweight and obese adults (CONQUER): a randomised, placebo-controlled, phase 3 trial

Cited by 786 publications

References 30 publications

Body fatness and endogenous sex hormones in the menopausal transition

Body fatness and endogenous sex hormones in the menopausal transition

Maximizing retention in long‐term clinical trials of a weight loss agent: use of a dietitian support team

Combating the dual burden: therapeutic targeting of common pathways in obesity and type 2 diabetes

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