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Biomedical subjects

D Lebo

Publications and source records attributed to D Lebo.

6 recordsLinked to original sources
PubMed2001

Breakthrough cancer pain: a randomized trial comparing oral transmucosal fentanyl citrate (OTFC) and morphine sulfate immediate release (MSIR).

Oral transmucosal fentanyl citrate (OTFC); Actiq) is a drug delivery formulation used for management of breakthrough cancer pain. Previous studies with open-label comparisons indicated OTFC was more effective than patients' usual opioid for breakthrough pain. The objective of this study was to compare OTFC and morphine sulfate immediate release (MSIR) for management of breakthrough pain in patients receiving a fixed scheduled opioid regimen. This double-blind, double-dummy, randomized, multiple crossover study was conducted at 19 US university- and community-based hospitals and clinics and comprised 134 adult ambulatory cancer patients. Patients were receiving a fixed scheduled opioid regimen equivalent to 60-1000 mg/day oral morphine or 50-300 microg/h transdermal fentanyl, were using a 'successful' MSIR dose (15-60 mg) as defined by entry criteria, and were experiencing 1-4 episodes of breakthrough pain per day. In open-label fashion, OTFC was titrated such that a single unit (200-1600 microg) provided adequate pain relief with acceptable side effects. Successfully titrated patients entered the double-blind phase of the study and received ten prenumbered sets of randomized capsules and oral transmucosal units. Five sets were the successful OTFC dose paired with placebo capsules, and five sets were placebo OTFC paired with capsules containing the successful MSIR dose. Patients took one set of study medication for each episode of target breakthrough pain. Pain intensity (PI), pain relief (PR) and global performance of medication (GP) scores were recorded. Pain intensity differences (PID) were calculated and 15-min PID was the primary efficacy variable. Adverse events were recorded. Sixty-nine percent of patients (93/134) found a successful dose of OTFC. OTFC yielded outcomes (PI, PID, and PR) at all time points that were significantly better than MSIR. GP also favored OTFC and more patients opted to continue with OTFC than MSIR following the study. Somnolence, nausea, constipation, and dizziness were the most common drug-associated side effects. In conclusion, OTFC was more effective than MSIR in treating breakthrough cancer pain.

Administration, Oral↗
PubMed1982

Ion transport by the pig colon: effects of theophylline and dietary sodium restriction.

The effect of theophylline on colonic electrolyte transport was examined in an isolated, static loop system of the pig colon. The presence of theophylline abolished the net absorption of Na and water and increased the net secretion of HCO3. The net absorption of C1 or acetate was unaffected. In pigs adapted to a saltfree diet, the net absorption of Na was increased twofold from that observed in pigs fed the normal diet; however, the basal rate of net HCO3 secretion was unchanged. In the presence of theophylline, the saltfree diet restored net Na absorption to control levels, whereas the theophylline-induced increase in the rate of net HCO3 secretion was sustained. Results suggest that the relative rates of net Na and HCO3 transport are partially controlled by independent systems and indicate that normal rates of net absorption can be restored in the presence of a parallel secretory process.

Acetates↗
PubMed1980

Ion transport by the pig colon: effects of time and anesthesia.

A method for temporarily isolating a 50-cm loop of ascending spiral colon in the pig allowed a study of the effect of halothane anesthesia on colonic absorption without complications of acute surgical trauma, and provided a means to obtain timed samples of the colonic solution. Test solutions instilled into the loop consisted of a volatile fatty acid solution, similar in composition to normal colonic contents, and a Ringer solution. Ther was no apppreciable change in the rate of net solute absorption in conscious or anesthetized animals in repeated 1-hour determinations over a 6-hour period, provided the cardiovascular and arterial acid base variables remained stable. Net rates and direction of individually transported solutes and H20 were essentially unaffected by anesthesia during 2-hour experimental periods. However, net solute changes in this closed-loop system were not constant during individual absorption periods. These changes were due to a volume dependence on the rate of net absorption and a rapid dissipation of the driving forces initially present. Failure to recognize these time-dependent changes may leas to serious misinterpretations of the results.

Anesthesia, Inhalation↗