Domperidone in the management of symptoms of diabetic gastroparesis: efficacy, tolerability, and quality-of-life outcomes in a multicenter controlled trial

Silvers, David; Kipnes, Mark; Broadstone, Vasti L.; Patterson, David J.; Quigley, Eamonn Martin; McCallum, Richard W.; Leidy, Nancy Kline; Farup, Christina; Liu, Yin; Joslyn, Alan F.

doi:10.1016/s0149-2918(98)80054-4

Cited by 130 publications

(99 citation statements)

References 21 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Metoclopramide can be used. Cisapride and domperidone [109,110] has been shown to be effective in some patients, although probably no more so than metoclopramide. Erythromycin given as either a liquid or suppository also can be helpful.…”

Section: Gastropathymentioning

confidence: 99%

Diabetic neuropathies

et al. 2000

View full text Add to dashboard Cite

Diabetic neuropathy is a most common and troublesome complication of diabetes mellitus, leading to the greatest morbidity and mortality and resulting in a huge economic burden for diabetes care [1,2]. It is the most common form of neuropathy in the developed countries of the world, accounts for more admission to hospital than all the other diabetic complications combined and is responsible for 50±75 % of non-traumatic amputations [2,3]. Diabetic neuropathy is a set of clinical syndromes that affect distinct regions of the nervous system, singly or combined. It can be silent and go undetected, while exercising its ravages, or be present with clinical symptoms and signs that although non-specific and insidious with slow progression also mimic those seen in many other diseases. It is, therefore, diagnosed by exclusion.Diabetic neuropathy is a heterogeneous disorder that encompasses a wide range of abnormalities affecting proximal and distal peripheral sensory and motor nerves as well as the autonomic nervous systems. For these reasons, it has been difficult to obtain precise estimates of the true prevalence and reports vary from 10 to 90 % in diabetic patients, depending on the criteria and methods used to define neuropathy [1±5]. From patients attending a diabetes clinic 25 % reported symptoms; 50 % were found to have neuropathy after a simple clinical test such as the ankle jerk or vibration perception test; almost 90 % tested positive to sophisticated tests of autonomic function or peripheral sensation [6]. Neurologic complications occur equally in Type I (insulin-dependent) and Type II (non-insulin-dependent) diabetes mellitus and additionally in various forms of acquired diabetes [5]. The major morbidity associated with somatic neuropathy is foot ulceration, the precursor of gangrene and limb loss. Neuropathy increases the risk of amputation 1.7-fold; 12-fold, if there is deformity (itself a consequence of neuropathy), and 36-fold, if there is a history of previous ulceration [7]. There are 65,000 amputations in the United States each year, one every 10 min, and neuropathy is considered to be the major contributor in 87 % of cases. It is also the most life-spoiling of the diabetic complications and has tremendous ramifications for the quality of life of the person with diabetes. Once autonomic neuropathy sets in, life can become quite dismal and the mortality rate approximates 25±50 % within 5±10 years [8,9]. In this review we present and discuss the most recent approaches to the diagnosis and treatment of diabetic neuropathy and the prospects on the horizon. ClassificationDiabetic neuropathy is not a single entity but a number of different syndromes, ranging from subclinical to clinical manifestations depending on the classes of nerve fibres involved. According to the San Antonio Convention [10], the main groups of neurologic disturbance in diabetes mellitus include: (1) subclinical neuropathy, determined by abnormalities in electrodiagnostic and quantitative sensory testing, (2) dif- Diabetologia (2000) 43:...

show abstract

Section: Gastropathymentioning

confidence: 99%

Diabetic neuropathies

et al. 2000

View full text Add to dashboard Cite

show abstract

“…When a controlled-release dosage form of a weakly basic drug having pH-dependent solubility is exposed to an environment of increasing pH, the drug in the dosage form precipitates and can no longer be released from the dosage form (6,12). There is a need for pH-independent release of domperidone so that it can be converted into a slow-release dosage form to avoid frequent dosing and to maintain blood concentration within the therapeutic range.…”

Section: Introductionmentioning

confidence: 99%

Modulation of pH-Independent Release of a Class ΙΙ Drug (Domperidone) from a Polymeric Matrix Using Acidic Excipients

Khan¹,

Iqbal²,

Khan³

et al. 2016

Dissolution Technol.

View full text Add to dashboard Cite

Drug release from polymeric matrix systems is the rate-limiting step for drug bioavailability and is determined by drug solubility; most drugs show pH-dependent solubility. Polymeric matrices remain in the gastrointestinal tract for a longer period of time and are exposed to environments of varying pH, which can adversely affect drug release. In the present study, the pH-independent drug release of domperidone was achieved by modifying the microenvironmental pH of a swollen polymeric matrix using acidic excipients (citric acid and tartaric acid). Matrices were prepared by a water-based, wet-granulation technique and evaluated for various official and unofficial parameters. In vitro drug release was studied using USP dissolution apparatus and pH 6.80 phosphate buffer as dissolution medium. Release kinetics was evaluated according to various mathematical models.Results show that domperidone release can be effectively modified by inclusion of acidic excipients in the formulations. Acidic excipients modulated microenvironmental pH and avoided the effect of dissolution medium pH on drug release. The resultant formulations are easy to prepare and scale up for commercial manufacturing. Better pH-independent release, following zero-order kinetics, was achieved with tartaric acid.

show abstract

“…These 208 individuals were included in a 4-week double-blind withdrawal study, during which they received either 20 mg domperidone q. i.d or placebo. Patients on placebo became significantly more symptomatic than those on domperidone [151].…”

Section: Treatments Aimed At Accelerating Gastric Emptyingmentioning

confidence: 87%

Diabetes mellitus and the stomach

Stacher

2001

Diabetologia

View full text Add to dashboard Cite

Domperidone in the management of symptoms of diabetic gastroparesis: efficacy, tolerability, and quality-of-life outcomes in a multicenter controlled trial

Cited by 130 publications

References 21 publications

Diabetic neuropathies

Diabetic neuropathies

Modulation of pH-Independent Release of a Class ΙΙ Drug (Domperidone) from a Polymeric Matrix Using Acidic Excipients

Diabetes mellitus and the stomach

Contact Info

Product

Resources

About