NEWS HIGHLIGHTS
Published Studies Related to Viokase (Lipase / Amylase / Protease)
An enteric-coated high-buffered pancrelipase reduces steatorrhea in patients with cystic fibrosis: a prospective, randomized study. [2006.08]
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... 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.
Ranitidine and omeprazole as adjuvant therapy to pancrelipase to improve fat absorption in patients with cystic fibrosis. [2002.07]
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... 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.
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. [2000.08]
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... CONCLUSIONS: Enteric-coated, delayed-release (Minimicrospheres) pancrelipase capsules are an effective treatment for steatorrhea associated with pancreatic insufficiency in patients with cystic fibrosis.
Comparative evaluation of a high lipase pancreatic enzyme preparation and a standard pancreatic supplement for treating exocrine pancreatic insufficiency in chronic pancreatitis. [1996.07]
OBJECTIVE: To compare the efficacy and safety of two enzyme-containing preparations, Pancrease HL (Cilag) containing 25,000 units of lipase per capsule and Creon (Triosol) with 8000 units of lipase per capsule, in patients with chronic pancreatitis and exocrine insufficiency. DESIGN: The study is a monocentric open crossover prospective study including 25 patients entered from March 1993 to May 1994. PATIENTS: Chronic pancreatitis was alcohol-related in 23 patients, previous surgery was performed in 9, 16 had diabetes and all had steatorrhoea (fat balance > 10g/24h)... CONCLUSION: Pancrease HL with high lipase activity provides effective pancreatic enzyme replacement therapy in patients with chronic pancreatitis at an appreciably lower number of capsules per day than with standard preparations.
Comparison of a high lipase pancreatic enzyme extract with a regular pancreatin preparation in adult cystic fibrosis patients. [1994.12]
BACKGROUND: Malabsorption due to exocrine pancreatic insufficiency is the main gastrointestinal problem in cystic fibrosis. Despite high doses of pancreatic enzyme supplements it is often not possible to normalize fat absorption. We compared a new high lipase pancreatic enzyme preparation (Pancrease-HL; Cilag, Brussels, Belgium), containing enteric coated microspheres with 25,000 U of lipase, 22,500 U of amylase and 1250 U of protease per capsule, with regular Pancrease capsules, containing 5000 U of lipase, 2900 U of amylase and 330 U of protease per capsule... CONCLUSIONS: One capsule of Pancrease-HL appears to be equivalent to four capsules of regular Pancrease. Treatment with less capsules per day with the same efficacy may facilitate patient compliance.
Clinical Trials Related to Viokase (Lipase / Amylase / Protease)
Assessment of Insulin Production From Native Pancreas in Patients With Pancreas Transplants [Completed]
This study will examine whether insulin-producing cells in the pancreas (beta cells) can
recover in patients with type 1 diabetes who have had a pancreas transplant. In type 1
diabetes, the body's immune system destroys the beta cells. Patients are treated with
insulin shots or a pancreas transplant to control their blood sugar. Some experiments suggest
that the pancreas may have the capacity to recover some of its insulin-producing capacity,
but that ability is negated by factors such as the continuing immune attack and erratic blood
sugar levels in patients.
Patients who have had a pancreas transplant may be in a unique situation to allow their own
pancreas to regrow beta cells for two reasons: 1) the medicines they take to prevent
rejection of the transplanted pancreas weaken their immune system; and 2) they have
near-normal blood sugar levels because of their functioning transplanted pancreas. This study
will test this hypothesis by sampling blood from patients' hepatic vein, which drains the
liver and native pancreas and from their iliac vein, which drains the transplanted pancreas.
This will determine whether insulin is coming from the transplanted pancreas (iliac vein) or
the liver and native pancreas (hepatic vein).
Patients 18 years of age and older who have had stable pancreatic transplant function for
more than 5 years may be eligible for this study. Candidates are screened with a medical
history and physical examination.
Participants are admitted to the hospital for 2 days for a full medical examination, blood
tests and procedures to determine insulin production. The procedures will include the
placement of catheters in the neck and groin for blood sampling. Participants will be
closely monitored after the procedures and discharged home if there are no complications.
Two-Layer Method Preservation and Resuscitation of the Cadaveric Pancreas Before Transplantation [Enrolling by invitation]
The purpose of this project is to compare the effect of oxygenated preservation of the
pancreas before transplantation using the "Two-Layer Method" (TLM) against outcomes
previously experienced with organs preserved using only standard University of Wisconsin (UW)
storage solution. It is our hypothesis that TLM preservation will reduce the frequency and
severity of complications of pancreas transplantation, increase the number of organs
acceptable for transplantation, and spare individual patients and their families suffering
and hardship.
An Effectiveness, Safety, and Palatability Study of Pancrelipase Microtablets in Infants and Toddlers With Cystic Fibrosis and Fat Malabsorption [Completed]
The purpose of this study is to evaluate the effectiveness and safety of PANCREASE MT
(pancrelipase microtablets) to improve steatorrhea (excessive excretion of fat in feces) in
infants and toddlers with cystic fibrosis who have pancreatic insufficiency, and to assess
whether the consistency of the microtablets is acceptable for swallowing in infants and
toddlers
An Open-Label Study to Evaluate the Intraduodenal Delivery of Enzymes From Administration of VIOKASE16 in Exocrine Pancreatic Insufficiency (EPI) [Recruiting]
EPI leading to maldigestion is a frequent finding in many diseases of the pancreas, such as
chronic pancreatitis (CP). Steatorrhea is the most important digestive manifestation in EPI.
The current treatment of EPI includes enzyme supplementation with porcine pancreatic enzyme
concentrate, consisting mainly of lipase, amylase and protease. An enzyme preparation able
to deliver appropriate enzyme levels to the duodenum instead of the mid gut or distal small
bowel, would appear to be clinically efficacious for the treatment of steatorrhea in
subjects with CP suffering from EPI.
Evaluation of the Safety and Efficacy of Pancrecarb® MS-16 in Cystic Fibrosis [Recruiting]
The primary objective of this study is to determine if PANCRECARB® MS-16 (pancrelipase) is
safe and effective in reducing steatorrhea (as measured by 72-hour stool fat determinations)
in children and adults with cystic fibrosis and pancreatic insufficiency.
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