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Biomedical subjects

N Baber

Publications and source records attributed to N Baber.

18 recordsLinked to original sources
PubMed2005

Should domperidone be used for the treatment of gastro-oesophageal reflux in children? Systematic review of randomized controlled trials in children aged 1 month to 11 years old.

AIM: To determine whether there is robust evidence of efficacy for domperidone in reducing the symptoms of gastro-oesophageal reflux (GOR) and gastro-oesophageal reflux disease (GORD) in children. METHODS: Systematic review of randomized controlled trials (RCTs). A search was made of the Cochrane Library Issue 2004 (Central Register of Controlled Trials and Database of Systematic Reviews), Medline (Pub-med) 1966 to present and Embase from 1974 to 2004, and reference citations of the RCTs that had been found electronically. RESULTS: Four RCTs were identified. Only the two older trials showed any benefits of domperidone on clinical symptoms of GORD in older children, which were the primary outcome measures. In the trial undertaken by Clara, a good or excellent result was obtained in 93% of the domperidone group compared with 33% of the controls (P < 0.05). In the trial undertaken by de Loore, after 2 weeks of treatment 75% of patients treated with domperidone were found not to be vomiting, compared with 43% in the metoclopramide group and 7% in the placebo group. The trial by Corraccio gave no detailed results regarding the primary outcomes of effect of domperidone on symptoms but simply reported 'cured', 'improved' or 'unchanged'. The secondary pH-metric outcome of the number of reflux episodes, was reduced with domperidone. CONCLUSION: From the limited evidence available, there was no robust evidence of efficacy for the treatment of GOR with domperidone in young children. Given the usually benign nature of the condition, the widespread use of unlicensed medicines for GOR is not warranted.

Antiemetics↗
PubMed1992

Clinical pharmacology of ondansetron in postoperative nausea and vomiting.

Ondansetron is a 5-HT3 receptor antagonist which is effective and well tolerated as an antiemetic for emesis induced by cancer chemotherapy and radiation therapy, and in the prevention and treatment of postoperative nausea and vomiting. Ondansetron is rapidly absorbed after oral administration (tmax 1.9 h) with an absolute bioavailability of around 60%. Its terminal elimination half-life is 3.5 h and it is extensively hepatically metabolized. Plasma clearance is 0.38 litre h-1 kg-1 and volume of distribution is 1.8 litre kg-1. Plasma clearance is reduced by age (31% reduction) and hepatic failure (80% reduction in severe failure). In patients undergoing general anaesthesia there is a slight prolongation of terminal half-life, which is not of clinical significance. Ondansetron is very well tolerated in volunteer studies. Headache, mild abdominal pain, and constipation occur infrequently. There is no evidence for effects of ondansetron on cardiac function (electrocardiogram, cardiac output, blood pressure and heart rate), and haemostatic function in volunteers and patients. Respiratory depression induced during general anaesthesia is not potentiated by ondansetron. No drug interactions have been noted with temazepam, atracurium, alfentanil and alcohol in man. There are also no interactions seen in animal studies using pentobarbitone, morphine, neostigmine, prednisolone and diazepam.

Humans↗
PubMed1982

A clinical and pharmacokinetic study of indomethacin in standard and slow release formulations.

Fifteen patients with rheumatoid arthritis received indomethacin in three treatment schedules; indomethacin retard 75 mg twice daily; indomethacin capsules 50 mg three times daily; and indomethacin 100 mg suppository at night with 50 mg by mouth each morning. The study was a double-blind, double-dummy one with each treatment being given for 2 weeks after a washout period of 3 days. After the washout period, and at the end of each 2 week active treatment period, blood samples were taken during a dosage interval for assay of indomethacin concentrations in plasma. Clinical assessments were also performed. All three treatment period produced significant clinical improvements in the assessments compared with the placebo washout period. However, no differences were seen between the treatments. Side effects occurred with equal frequency in all three periods, and the anticipated reduction in central nervous system side effects during the indomethacin retard period was not seen. Plasma concentrations of indomethacin were significantly higher during indomethacin retard therapy with a peak concentration of 2500 +/- 25 ng ml-1 during indomethacin retard therapy (mean +/- s.d.) and 1900 +/- 200 ng ml during conventional oral therapy. Indomethacin retard is as effective as the other formulations of indomethacin but appears to offer no significant advantages.

Aged↗
PubMed1980

Indomethacin in rheumatoid arthritis: comparison of oral and rectal dosing.

1 Indomethacin 100 mg nightly for 1 week has been administered to 13 patients with rheumatoid arthritis by both oral and rectal routes in a double-blind, randomized, cross-over study. 2 Clinical assessments were performed at 09.00 and 14.00 h on the last 3 days of each active treatment period and compared to the results on the last 2 days of the placebo control period. 3 Indomethacin produced significant improvements in the clinical assessments at both 09.00 and 14.00 h compared to placebo but not differences were seen between the two routes of administration. 4 No significant difference was seen in the side effects experienced in the two periods. 5 The mean (+/- s.e. mean) plasma indomethacin concentration at 09.00 h in the oral period was 200.3 +/- 27.4 ng/ml, not significantly different from that in the suppository period (220.0 +/- 28.9 ng/ml). 6 Indomethacin 100 mg nightly by mouth is as effective as a 100 mg suppository and easier to administer.

Administration, Oral↗
PubMed1980

The effect of indomethacin on renal function in man.

Twenty-one patients with rheumatoid arthritis were given indomethacin 25 mg t.i.d. by mouth for 3 weeks followed by indomethacin 25 mg t.i.d. plus a 100 mg suppository at night, after a 5-day period on placebo capsules. The mean (+/- S.E.) 24-hour creatinine clearance was 57.8 +/- 5.7 ml/min in the placebo period and was not significantly altered during indomethacin therapy, 53.1 +/- 5.5 ml/min in the oral period and 56.6 +/- 6.4 ml/min in the oral plus suppository period (P greater than 0.1). In 6 volunteers, duplicate 2-hour creatinine clearances were performed after a single oral dose of 50 mg indomethacin. After placebo capsules the mean creatinine clearance was 133.7 +/- 9.5 ml/min and after 50 mg indomethacin it was 126.5 +/- 8.9 ml/min (P greater than 0.1). In 4 of the volunteers the mean creatinine clearance after 8 days on indomethacin 25 mg q.i.d. was 117.1+/- 5.3 ml/min (P greater than 0.1). Indomethacin plasma concentrations were in the usual range for the dose given. Indomethacin caused no reduction in the creatinine clearance in spite of causing significant inhibition of prostaglandin E synthesis.

Administration, Oral↗
PubMed1979

Indomethacin in rheumatoid arthritis: clinical effects, pharmacokinetics, and platelet studies in responders and nonresponders.

Twenty patients with definite or classical rheumatoid arthritis entered and completed a sequential study of placebo for 1 week, oral indomethacin 25 mg 3 times a day for 3 weeks, and oral indomethacin 25 mg 3 times a day plus 100 mg indomethacin suppository at night for 3 weeks. Twelve of the patients had previously been classified as responders and eight as nonresponders to indomethacin by an independent assessor. At the end of each period patients were assessed by a blind observer for duration of morning stiffness, pain score, digital joint size, grip strength, articular index, analgesic tablet usage, and the patient's own overall global assessment and comparative global assessment. In 8 of the 9 tests used responders improved on indomethacin in comparison with placebo, while nonresponders did not improve. There were no significant differences between responders and nonresponders in the plasma half-life, plasma clearance of indomethacin, protein binding of indomethacin, or urinary excretion of free or conjugated indomethacin. There were no significant differences between responders and nonresponders in the urinary excretion of 7HDPA or in the platelet aggregation or platelet malonyldialdehyde production tests. In responders there was a significant positive correlation between the plasma indomethacin concentration (r=0.44, P<0.05) and the percentage inhibition of malonyldialdehyde production by the platelets. However, in nonresponders this correlation, while significant (P<0.05), was negative (r=-0.498). Both for responders and nonresponders there was a significant correlation between plasma indomethacin concentration and the percentage reduction in 7HDPA. There was no correlation between the clinical response and the plasma concentration of indomethacin. There appears to be a biochemical difference between responders and nonresponders, which, while not necessarily causally linked with the clinical response to indomethacin, is worthy of further study.

Adult↗
PubMed1978

Quantitative gas-liquid chromatographic method for the determination of indomethacin in biological fluids.

A sensitive and specific gas chromatographic method for the analysis of indomethacin has been developed. After extraction of the drug from blood or urine with ethylene dichrloride a derivative is formed with pentafluorobenzyl bromide. 5-Fluoro-indomethacin is used as an internal standard. The overall recovery of indomethacin is 85.1 +/- 2.3% and the method can detect 10 ng indomethacin in a 1 ml plasma or urine sample. No interference in the method is seen with some commonly used drugs. The method has been used to measure plasma indomethacin concentrations in 20 patients with rheumatoid arthritis, being treated with 25 mg indomethacin three times daily. The plasma concentration ranged from 168-596 ng/ml.

Animals↗
PubMed1978

The interaction between indomethacin and probenecid. A clinical and pharmacokinetic study.

The interaction between indomethacin and probenecid has been studied in 17 patients with rheumatoid arthritis with the use of a specific gas-liquid chromatographic method for the assay of indomethacin in plasma and urine. Probenecid in a dose of 0.5 gm twice daily improved the therapeutic response to indomethacin administered in a dose of 25 mg 3 times daily for a 3-wk period. There was an increase in the mean AUC of indomethacin in plasma from 2,553 +/- 213 hr ng/ml to 4,181 +/- 384 hr ng/ml when probenecid was given, but there was no change in the plasma half-life of indomethacin. There was a reduction in the mean plasma clearance of indomethacin from 174 +/- 21 ml/kg/hr to 107 +/- 14 ml/kg/hr when probenecid was added to the indomethacin therapy and a decrease in the apparent volume of distribution from 0,927 +/- 0.16 L/kg to 0.613 +/- 0.13 L/kg. There was no change in the amount of free indomethacin excreted in the urine during probenecid therapy but there was a reduction in the urinary excretion of free plus glucuronide conjugate of indomethacin from 8,967 +/- 867 microgram/day to 4,760 +/- 674 microgram/day, with a fall in the mean renal clearance of indomethacin glucuronide from 271 +/- 48 ml/min to 126 +/- 57.0 ml/min. The changes in the plasma indomethacin concentration profile during probenecid therapy are due to a decrease in the nonrenal clearance of indomethacin possibly because of reduced biliary clearance.

Adult↗