Randomized controlled trial to investigate the effects of a newly developed formulation of phentermine diffuse‐controlled release for obesity

Kang, Jun Goo; Park, C.-Y.; Kang, Jae Heon; Park, Y.-W.; Park, S. W.

doi:10.1111/j.1463-1326.2010.01242.x

Cited by 97 publications

(63 citation statements)

References 14 publications

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“…The adverse effects were typical of the sympathomimetics, for example, dry mouth and insomnia, but importantly there were no drug-related increases in systolic blood pressure (SBP) or diastolic blood pressure (DBP). 64 Although these results need confirmation and extension in larger and longer pivotal trials, DCR-phentermine would appear to offer greater efficacy than some of the newer drug candidates that are awaiting approval. The issue of drug dependence is an important consideration for drugs of this type.…”

Section: New Cns Approachesmentioning

confidence: 99%

“…In this small (74 subjects), 12-week, randomised, double-blind, placebo-controlled trial, DCR-phentermine produced a placebo-subtracted weight loss of 6.4 kg with 75% and 59% of subjects achieving X5% and X10% reductions from baseline body weight, respectively. 64 The decreased obesity was accompanied by reductions in waist circumference, low-density lipoprotein cholesterol and total cholesterol. The adverse effects were typical of the sympathomimetics, for example, dry mouth and insomnia, but importantly there were no drug-related increases in systolic blood pressure (SBP) or diastolic blood pressure (DBP).…”

Section: New Cns Approachesmentioning

confidence: 99%

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A review of late-stage CNS drug candidates for the treatment of obesity

2012

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Obesity is an important causative factor in morbidity, disability and premature death. Increasing levels of obesity will impose enormous health, financial and social burdens on worldwide society unless effective interventions are implemented. For many obese individuals, diet and behavioural modification need to be supplemented by pharmacotherapy. Preclinical research has revealed a greater understanding of the complex nature of the hypothalamic regulation of food intake and has generated a wide range of new molecular targets for the development of drug candidates for obesity treatment. As shown by the clinical results that have been obtained with this next generation of therapies, some approaches, for example, fixed-dose drug combinations, have already demonstrated an ability to deliver levels of efficacy that are not achievable with the current antiobesity drug therapies. The regulatory and marketing landscape for development, registration and commercialisation of novel centrally acting drugs for treatment of obesity and related metabolic disorders has changed substantially in recent years. Now a much greater emphasis is placed on tolerability and safety, as well as efficacy. In this review we briefly describe the therapeutic approaches to tackle obesity that are in late-stage clinical development. We then discuss drugs in late-stage development for the treatment of obesity and also future directions.

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Section: New Cns Approachesmentioning

confidence: 99%

Section: New Cns Approachesmentioning

confidence: 99%

A review of late-stage CNS drug candidates for the treatment of obesity

2012

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“…The drug stimulates primarily the release of norepinephrine, but to lower extent also dopamine and serotonine. Depending on the dose (which is typically between 30 and 37.5 mg/d) the placebo-subtracted weight loss attributed to treatment with phentermine (30 mg/d) is in the range of 4-8 kg after 12 weeks of treatment (Kim et al, 2006;Kang et al, 2010;Moldovan et al, 2016). Phentermine is generally well tolerated with little to no abusive potential, even when used chronically for up to 21 years (Hendricks et al, 2009).…”

Section: B 24-dinitrophenolmentioning

confidence: 99%

Anti-Obesity Therapy: from Rainbow Pills to Polyagonists

et al. 2018

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“…Otherwise there was no significant increase in blood pressure in the treatment group [Kang et al 2010].…”

Section: Phenterminementioning

confidence: 73%

Safety of antiobesity drugs

Cheung

Samaranayake

2013

Therapeutic Advances in Drug Safety

130

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Obesity is a major health problem worldwide. Although diet and physical activity are crucial in the management of obesity, the long-term success rate is low. Therefore antiobesity drugs are of great interest, especially when lifestyle modification has failed. As obesity is not an immediate life-threatening disease, these drugs are required to be safe. Antiobesity drugs that have been developed so far have limited efficacies and considerable adverse effects affecting tolerability and safety. Therefore, most antiobesity drugs have been withdrawn. Fenfluramine and dexfenfluramine were withdrawn because of the potential damage to heart valves. Sibutramine was associated with an increase in major adverse cardiovascular events in the Sibutramine Cardiovascular Outcomes (SCOUT) trial and it was withdrawn from the market in 2010. Rimonabant was withdrawn because of significant psychiatric adverse effects. Orlistat was approved in Europe and the United States for long-term treatment of obesity, but many patients cannot tolerate its gastrointestinal side effects. Phentermine and diethylpropion can only be used for less than 12 weeks because the long-term safety of these drugs is unknown. Ephedrine and caffeine are natural substances but the effects on weight reduction are modest. As a result there is a huge unmet need for effective and safe antiobesity drugs. Recently lorcaserin and topiramate plus phentermine have been approved for the treatment of obesity but long-term safety data are lacking.

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Randomized controlled trial to investigate the effects of a newly developed formulation of phentermine diffuse‐controlled release for obesity

Cited by 97 publications

References 14 publications

A review of late-stage CNS drug candidates for the treatment of obesity

A review of late-stage CNS drug candidates for the treatment of obesity

Anti-Obesity Therapy: from Rainbow Pills to Polyagonists

Safety of antiobesity drugs

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