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At least 19 recordsLinked to original sources
PubMed2000

A comparison of the efficacy and tolerance of pancrelipase and placebo in the treatment of steatorrhea in cystic fibrosis patients with clinical exocrine pancreatic insufficiency.

OBJECTIVE: The safety and efficacy of Minimicrospheres, which are enteric-coated, delayed-release pancrelipase capsules, on fat absorption in pediatric/adolescent and adult cystic fibrosis (CF) patients was assessed. Exocrine pancreatic insufficiency, common in CF patients, causes steatorrhea due to insufficient release of pancreatic enzymes. METHODS: In the open-label phase, 97 CF patients with pancreatic insufficiency and steatorrhea were stabilized on a high-fat diet and administered pancrelipase. Seventy-four patients with >80% coefficient of fat absorption received placebo or pancrelipase in the double-blind phase. Fat intake and excretion, stool frequency and consistency, and clinical global improvement were recorded. RESULTS: Average daily fat intake was comparable between treatment groups within each age group (adults vs pediatric/adolescent), but placebo patients had a significant (p < 0.001) mean decrease in coefficient of fat absorption (adult, 36.9 percentage points; pediatric/adolescent, 34.9 percentage points) from open-label to double-blind treatment compared to pancrelipase patients (adult, 2 percentage points; pediatric/adolescent, 3.25 percentage points); this difference was caused by a greater (p < or = 0.001) increase in mean fecal fat excretion (grams per day) in the placebo groups compared to pancrelipase groups (adult: 61.9 vs 2.3; pediatric/adolescent: 45.4 vs 4.1). Change in mean stool frequency from open-label to double-blind phases was significantly different (p < or = 0.002) between treatment groups, with increases in placebo groups and no difference (adult) or decrease (pediatric/adolescent) in pancrelipase groups. Pancrelipase patients' stool consistency remained about the same from open-label to double-blind. Placebo patients' stool consistency decreased (became softer) from open-label pancrelipase to double-blind placebo. Clinical global improvement data showed that > or =83% of pancrelipase patients improved or remained unchanged. CONCLUSIONS: Enteric-coated, delayed-release (Minimicrospheres) pancrelipase capsules are an effective treatment for steatorrhea associated with pancreatic insufficiency in patients with cystic fibrosis.

Adult↗
PubMed2006

An enteric-coated high-buffered pancrelipase reduces steatorrhea in patients with cystic fibrosis: a prospective, randomized study.

OBJECTIVE: Enteric-coated (EC) high-buffered (2.5 mEq [2.5 mmol] bicarbonate per capsule) pancrelipase microsphere enzymes were compared to EC-nonbuffered pancreatic enzymes for efficacy in reducing steatorrhea in patients with cystic fibrosis. DESIGN: Prospective, randomized, controlled trial using a crossover design with each subject as his/her own control. SUBJECTS/SETTING: Eighteen subjects with cystic fibrosis, who had pancreatic insufficiency and required large enzyme doses, were studied over two consecutive 7-day treatment periods. INTERVENTION: Each 7-day period consisted of 3 days at home followed by 4 days in a general clinical research center for careful control of diets, enzyme lipase doses (given at approximately 50% of the subject's usual lipase dose), and carmine red-labeled stool collections for 72-hour fecal fat balance studies. MAIN OUTCOME MEASURE: Fecal fat excretion. STATISTICAL ANALYSES PERFORMED: Differences in fat excretion, when each subject received EC-high-buffered pancrelipase vs EC-nonbuffered enzymes, were compared using linear modeling. RESULTS: Mean fat excretion decreased significantly in each subject during periods when given EC-high-buffered pancrelipase compared with periods when given EC-nonbuffered enzymes (fat excretion 18.2% vs 24.9% or fat absorption 81.8% vs 75.1%, respectively; P=0.01). Thirteen of 18 subjects (72%) excreted less fat when receiving EC-high-buffered pancrelipase whereas 10 (56%) decreased fat excretion by more than 5%, and five subjects did not respond. CONCLUSIONS: EC-high-buffered pancrelipase decreased fat excretion, symbolizing improved fat absorption, when compared with EC-nonbuffered pancreatic enzymes given at equivalent, reduced (approximately 50% of usual) lipase doses in nourished subjects with cystic fibrosis and mild pulmonary disease.

Adolescent↗
PubMed1982

Comparison of two forms of enteric-coated pancrelipase In six teenagers with cystic fibrosis.

The digestive efficiency of two forms of enteric-coated pancrelipase, Cotazym-STM and Pancrease, was compared in three boys and three girls, aged 12 through 15, with cystic fibrosis. Each patient served as his or her own control, taking one type of pancrelipase for half of the two-week study and the other type for the second half of the study. Monitoring of the patients' oral intake (calories, protein, fat, carbohydrate), collection and analysis of their stools (volume, nitrogen, fat, fat loss, protein loss), and tests of their urine (creatinine, uric acid), blood (24 determinations), and pulmonary function revealed no significant differences in any of the measures between patients taking Cotazym-S and those taking Pancrease.

Adolescent↗
PubMed2002

Ranitidine and omeprazole as adjuvant therapy to pancrelipase to improve fat absorption in patients with cystic fibrosis.

BACKGROUND: Inadequate treatment of pancreatic insufficiency in patients with cystic fibrosis (CF) causes malabsorption of nutrients with significant sequelae. The objective of this study was to measure the effect of acid suppressant therapy on fat absorption in patients with CF who received a pH-sensitive, enteric-coated microtablet enzyme product. METHODS: A double-blind, placebo-controlled crossover study of 12 children and 10 adults with pancreatic insufficient CF was performed. All subjects were receiving pancrelipase therapy (Pancrease MT10 and MT16; Ortho-McNeil, Springhouse, PA, U.S.A.) and for the study also received either placebo or ranitidine (Zantac; Glaxo-Wellcome, Research Triangle Park, NC U.S.A.) 5 mg/kg or 10 mg/kg daily. The adult subjects also received omeprazole therapy (Prilosec; AstraZeneca/Merck, Wilmington, DE, U.S.A.), 20 mg daily, as adjuvant therapy to pancreatic enzymes. Serial 3-day fat-balance studies were performed in the Clinical Research Center. The data were analyzed using individual paired t tests that compared each treatment with placebo and two repeated-measures, general linear model F tests. RESULTS: The linear model for all subjects showed no overall adjuvant drug effect on fat absorption, P = 0.32. A second linear model F test analysis of adult subjects, comparing all four drug treatments (placebo, ranitidine 5 and 10 mg/kg daily and omeprazole), also showed no difference in fat absorption, P = 0.15. Paired t test subgroup analysis of the adults showed an improvement of 4.97% (P = 0.003) in mean fat absorption comparing low-dose ranitidine to placebo. All other t test analyses showed no significant change in fat absorption between placebo and acid suppressant treatment. There was marked intersubject and intrasubject variability in fat absorption. CONCLUSIONS: No overall significant improvement in fat absorption could be demonstrated with adjuvant therapy. Fat absorption measured by 3-day fat-balance studies varied greatly even when comparing the same subject for placebo and baseline treatments, despite identical dietary fat and enzyme intakes. The large variability limited our ability to test for a difference in fat absorption and has significant implication for the use of this test, considered the gold standard, for determining enzyme dosage adequacy.

Adolescent↗
PubMed1990

Treatment failure after substitution of generic pancrelipase capsules. Correlation with in vitro lipase activity.

Pancreatic enzyme products are formulated, manufactured, and sold without submitting efficacy or bioavailability data to the Food and Drug Administration because of a quirk in the law. We documented therapeutic failures in three patients with cystic fibrosis after pharmacists substituted generic pancrelipase capsules for the Pancrease brand. Gastrointestinal symptoms and fat malabsorption rapidly resolved after therapy was reinstituted with brand name products. In vitro analysis indicated that after 1 hour of exposure to simulated gastric fluid, lipase activity was less than 200 U per capsule from all three generic capsules dispensed to the patients compared with 6820 U per capsule from Pancrease. These data indicate that the enteric coating of the generic product was defective and that the substituted product was not bioequivalent to the prescribed brand. We conclude that the Food and Drug Administration should institute regulations over this group of products.

Adult↗
PubMed1993

Comparative in vitro and in vivo studies of enteric-coated pancrelipase preparations for pancreatic insufficiency.

We evaluated three acid-resistant pancreatic enzyme preparations by in vitro assays, and by comparing degree of steatorrhea, creatorrhea, fecal wet weight, and stool energy losses in a randomized crossover study of patients with pancreatic insufficient cystic fibrosis. Aims of the study were to assess (a) the most practicable and reliable indicator of malabsorption; (b) the variation in enzyme batch potency; (c) the decline in enzyme batch potency with prolonged shelf life; and (d) the relative bioefficacy of the different preparations. In the in vivo study, absorption of energy, nitrogen, and fat did not differ when comparing the three preparations at roughly pharmaceutically equivalent doses, but when expressed per capsule of pancreatic supplement ingested, absorption reflected relative enzyme content, favoring the higher potency preparations. Although steatorrhea was reasonably controlled by these preparations, stool energy losses varied from 800 to 1,100 kJ per day, suggesting greater attention be paid to overall energy absorption rather than absorption of individual nutrients. In addition, fecal energy loss correlated more closely with fecal wet weight (r = 0.81; p < 0.05) than with steatorrhea (r = 0.40; ns), such that 1 g wet feces = 8.37 kJ (+/- 0.14). In vitro enzyme potency varied markedly between batches of the same brand, and also a decline of up to 20% in amylase, lipase, and trypsin activity was noted over an 8-month period for each batch. Both observations have clinical implications at times of represcription. Finally, the higher potency preparations were more effective per capsule and reduced capsule dosage is therefore attainable.

Amino Acid Sequence↗
PubMed1988

Correction of malnutrition and maldigestion with enzyme supplementation in patients with surgical suppression of exocrine pancreatic function.

We studied the occurrence and extent of malnutrition and maldigestion in 13 patients who underwent pancreatoduodenectomy (PD) and injection of Neoprene (polychloroprene) (NI) into the duct of Wirsung, which results in sclerosis of hte acinar pancreatic tissue, but spares the endocrine function. At discharge, patients under took an enzyme supplementation regimen with pancreatin (18, 00 United States Pharmacopoeia units of lipase per meal). Patients were rehospitalized 24.9 months after PD plus NI to undergo nutritional and metabolic evaluation (hospital control). Nutritional status was evaluated by measuring the serum albumin level, total iron binding capacity and total lymphocyte count. Digestive function was assessed by the D-xylose tolerance test and determination of fecal fat excretion. Patients were then discharged with pancrelipase, enteric-coated microspheres (ECM) supplementation (16,050 United States Pharmacopoeia units of lipase per meal). Malnutrition, defined as the occurrence of at least two abnormal nutritional parameters, was observed in six patients at hospital control. After six months on pancrelipase ECM, the nutritional status was re-evaluated in nine patients (three previously malnourished) who were all well nourished. The mean body weight was 84.7 per cent of usual body weight at discharge after PD plus NI and raised to 88.0 per cent at the hospital control (p less than 0.01) and to 93.7 per cent )p less than 0.05) after six months on pancrelipase ECM. At hospital control, results from the D-xylose test were normal in all patients, and steatorrhea dropped from 33.6 grams per day without enzyme supplementation to 15.3 grams per day with pancrelipase ECM (16,050 United States Pharmacopoeia units of lipase per meal). Steatorrhea was incompletely but satisfactorily corrected by pancrelipase ECM. On supplementation therapy with pancrelipase ECM, patients recover a good deal of the body weight and normalize the biochemical indices of malnutrition.

Adult↗
PubMed2004

In vitro studies of the effects of HAART drugs and excipients on activity of digestive enzymes.

PURPOSE: Side effects of diarrhea and steatorrhea diminish the therapeutic value of highly active antiretroviral therapy (HAART). We report in vitro studies of the effect of HAART drugs on the activity of pancrelipase, trypsin, and enterokinase and restoration of activity by subsequent addition of excess pancrelipase or colipase. METHODS: Commercial formulations of sixteen HAART drug formulations with solvent and four excipients were mixed with substrate. Activity of pancrelipase was recorded after addition of the enzyme; restoration of activity was monitored after addition of excess pancrelipase or colipase to the reaction mixture. RESULTS: Five protease inhibitors (Agenerase solution, Agenerase capsules, Norvir, Viracept, Kaletra, and Fortovase) and the excipient TPGS (d-alpha-tocopheryl polyethylene glycol 1000 succinate) inhibited lipase significantly at or below physiological concentrations. Neither nucleoside reverse transcriptase inhibitors nor non-nucleoside reverse transcriptase inhibitors showed significant lipase inhibition at physiological levels. Addition of excess pancrelipase to the medium completely reversed inhibition by Agenerase, Fortovase, Norvir, and TPGS and reactivated lipase; it diminished inhibition by Kaletra and Viracept but did not completely restore activity. Addition of colipase reversed inhibition by Agenerase solution, Agenerase capsules, and TPGS; inhibition by Kaletra and Fortovase recovered slightly. No compounds tested inhibited trypsin or enterokinase. CONCLUSIONS: These results justify evaluating protocols involving coadministration of buffered pancrelipase with protease inhibitors to reduce or eliminate diarrhea and steatorrhea in individuals being treated for HIV.

Antiretroviral Therapy, Highly Active↗
PubMed1992

Enteral pancreatic enzyme feedback inhibition of the exocrine secretion of the human transplanted pancreas.

The mechanism of regulation of negative feedback inhibition of the exocrine pancreas and its possible role in decreasing the exocrine secretion of the grafted human pancreas is unknown. To evaluate this we studied the effect of oral pancreatic enzymes on the stimulated transplanted pancreatic exocrine secretion in eight patients with allograft pancreaticocystostomies. After an 8-hr fast, all graft exocrine secretions via graft stent, fistula, and urinary anastomosis were collected for a 1-hr basal period. A standard 300-ml Lundh test meal was then ingested, and all exocrine secretions were collected in 30-min intervals for 3 hr. This test was repeated with 6 capsules of pancrelipase (24,000 units of lipase, 120,000 units of amylase, and 150,000 units of protease) given with the Lundh test meal. Stent, urine and fistula volume, amylase, and pH were measured for each collection period. The total 3-hr amylase secreted after the test meal and the test meal plus pancrelipase were compared. The period of peak amylase secretion after the test meal alone was compared with the same period after the test meal plus pancrelipase and the premeal basal period. The total amylase decreased 34% from 5550 +/- 1000 to 3680 +/- 740 IU/3 hr (P < .03) with pancrelipase. The peak amylase secretion decreased 63% from 1520 +/- 271 to 567 +/- 185 IU/30 min (P < .02) with the addition of pancrelipase to the test meal. Pancrelipase eliminated all meal-stimulated amylase secretion with the mean secretion 16% below the basal secretion of 674 +/- 117 IU/30 min. We conclude that pancreatic negative feedback inhibition significantly decreases meal-stimulated and basal exocrine secretion in the transplanted human pancreas.

Amylases↗
PubMed1989

Pancreatic enzyme replacement therapy in post-pancreatectomy patients.

The occurrence of malnutrition and maldigestion was studied in nine patients who underwent pancreatoduodenectomy and sclerosis of the residual pancreatic stump with neoprene. The operation causes a complete loss of exocrine pancreatic function, but spares islet cell function. Upon discharge from the hospital, patients received pancreatin powder as a dietary enzyme supplement (18,000 lipase U/meal). Patients were again hospitalized 2 y after surgery for evaluation of nutritional status and digestive function (hospital checkup). Nutritional status was evaluated by measuring serum albumin, total iron binding capacity, and total lymphocytes. Digestive function was assessed by the D-xylose tolerance test and determination of fecal fat excretion. Patients were then discharged with pancrelipase enteric-coated microspheres (ECM) as a dietary enzyme supplement (16,050 lipase U/meal). Malnutrition, defined as the occurrence of at least two abnormal nutritional parameters, was observed in three patients at the time of the hospital checkup. Upon reevaluation of nutritional status after 6 mo on pancrelipase ECM, all patients were well nourished. The mean body weight, which had been 52.8 Kg immediately after surgery, increased to 54.9 Kg at the time of the hospital checkup (p less than 0.01) and to 58.0 Kg after six months of pancrelipase ECM therapy (p less than 0.05). At the hospital checkup, the D-xylose test was normal in all patients and steatorrhea had decreased from a mean of 32.8 g/d without enzyme supplementation to 16.7 g/d with pancrelipase therapy (16,050 lipase U/meal). The complete loss of exocrine pancreatic function following surgery was well tolerated. In fact, when patients were on pancrelipase therapy, much of the original body weight was recovered and the biochemical indices of malnutrition were normalized.

Adult↗
PubMed1983

Recurrent gastric bezoars. A new approach to treatment and prevention.

A recurrent gastric phytobezoar was successfully dispersed using an endoscopically directed intermittent jet of dilute papain. Dissolution analysis of a retrieved bezoar fragment showed pancrelipase and Adolph's Meat Tenderizer to be effective specific solvents. The patient remained free of symptoms while on a prophylactic regimen of pancrelipase taken daily. However, when the patient discontinued his medication, the bezoar recurred. The dissolution process was successfully repeated. Selecting a reagent on the basis of demonstrated effectiveness should enhance the chance of successful dissolution of a phytobezoar, whereas prophylactic doses of the reagent may prevent its recurrence.

Adult↗
PubMed1993

Fat absorption and gastroenteric pH profile in postsurgical pancreatic insufficiency: role of the association of H2-receptor antagonists with pancreatic enzymes.

The complete control of steatorrhea in post-surgical exocrine pancreatic insufficiency is difficult. The aim of this study was to evaluate the effect of the association of ranitidine with pancrelipase om fecal fat excretion in patients who had undergone a pancreatoduodenectomy with suppression of the exocrine pancreatic secretion by Neoprene injection. Ten patients were studied 1 year after surgery. Steatorrhea was measured as an integrated test of 3-day stools, while patients were kept on a diet of 100 g lipid/day, with their usual enzyme supplementation therapy (16,050 USP units of lipase/meal). A basal 24-h gastroenteric pH profile was also obtained. In the following month, patients had ranitidine (150 mg twice a day) in addition to pancrelipase. Then steatorrhea and gastroenteric pH were reassessed. Mean fecal fat was 26.9 (SD 13.7) g/day without ranitidine and 30.5 (SD 13.9) g/day during combined treatment. Body weight and nutritional parameters did not show any significant variation after ranitidine administration. Even in the absence of ranitidine, postprandial gastroenteric pH values were always > 4; the H2-receptor antagonist only reduced fasting gastric acidity. In conclusion, the gastroenteric pH and fecal fat determinations showed that ranitidine is not useful in patients with total postsurgical exocrine pancreatic insufficiency.

Adult↗
PubMed1990

Postoperative management of patients with total exocrine pancreatic insufficiency.

The occurrence of maldigestion and malnutrition was studied in 14 patients who had undergone pancreaticoduodenectomy and occlusion of the Wirsung duct with Neoprene. Before discharge patients were put on a 70 g/day dietary fat intake. Mean faecal fat excretion was 32.9 g/day without enzyme replacement and fell to 14.2 g/day with pancrelipase supplementation. At discharge all patients were underweight (88 per cent of the usual mean body-weight) and nine patients showed alteration in laboratory nutritional parameters. At the time of discharge a low-fat diet (50 g/day) was prescribed. Six months after surgery, mean faecal fat excretion decreased further to 8.3 g/day (P less than 0.01) and all patients but one gained weight, reaching 93 per cent of the usual mean body-weight with normalized nutritional parameters. Our data show that the combination of enzyme replacement therapy and low-fat diet allows good correction of steatorrhoea and a significant improvement in nutritional status.

Adult↗