***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
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    Input: Pancreatic enzyme replacement may fail to achieve a beneficial effect because of enzyme inactivation by gastric acid . In this controlled r and omized study , 8 hospitalized patients with severe exocrine pancreatic insufficiency and considerable steatorrhoea ( greater than 15 g faecal fat/day ) were treated with a conventional pancreatic enzyme preparation ( Pankreon 700 ; 3 X 3 dragees daily ) , with ( 300 mg ) and without cimetidine before meals , and with a new pH-sensitive enzyme preparation ( Kreon ; 3 X 6 capsules daily ) comprising acid-protected granules . Both conventional enzyme replacement plus cimetidine , and acid-protected pancreatin were significantly ( p less than 0.05 ) more effective than conventional enzyme therapy alone . Since both regimens are equally potent in overcoming gastric acid-induced enzyme inactivation , it is concluded that therapy with acid-protected pancreatin may simplify and improve treatment of exocrine pancreatic insufficiency in the presence of gastric hyper- or normo-acidity OBJECTIVES : Pancreatic-enzyme replacement therapy ( PERT ) is the st and ard of care to prevent maldigestion , malnutrition , and excessive weight loss in patients with exocrine pancreatic insufficiency ( EPI ) due to chronic pancreatitis ( CP ) or pancreatic surgery ( PS ) . Our objective was to assess the efficacy and safety of a new formulation of pancrelipase ( pancreatin ) delayed-release 12,000-lipase unit capsules ( CREON ) in patients with EPI due to CP or PS . METHODS : This was a double-blind , r and omized , multicountry , placebo-controlled , parallel-group trial enrolling patients ≥18 years old with confirmed EPI due to CP or PS conducted in clinical research centers or hospitals . After a 5-day placebo run-in period ( baseline ) , patients were r and omized to pancrelipase ( 72,000 lipase units per meal ; 36,000 per snack ) or placebo for 7 days . All patients received an individually design ed diet to provide at least 100 g of fat per day . The primary efficacy measure was the change in coefficient of fat absorption ( CFA ) from baseline to end of the double-blind period , analyzed using non-parametric analysis of covariance . Secondary outcomes included the coefficient of nitrogen absorption ( CNA ) , clinical symptoms , and safety parameters . RESULTS : In total , 25 patients ( median age of 54 years , 76 % male ) received pancrelipase and 29 patients ( median age of 50 years , 69 % male ) received placebo . The mean±s.d . change from baseline in CFA was significantly greater with pancrelipase vs. placebo : 32.1±18.5 % vs. 8.8±12.5 % ( P<0.0001 ) . Similarly , the mean±s.d . change from baseline in CNA was greater for pancrelipase vs. placebo : 97.7±82.3 % vs. 24.4±101.0 % ( P=0.0013 ) . Greater improvements from baseline in stool frequency , stool consistency , abdominal pain , and flatulence were observed with pancrelipase vs.  placebo . Treatment-emergent adverse events ( TEAEs ) were reported in five patients ( 20.0 % ) in the pancrelipase group and in six ( 20.7 % ) in the placebo group ; the most common were gastrointestinal ( GI ) events and metabolism/nutrition disorders . There were no treatment discontinuations due to TEAEs . CONCLUSIONS : Pancrelipase delayed-release 12,000-lipase unit capsules were effective in treating fat and nitrogen maldigestion with a TEAE rate similar to that of placebo in patients with EPI due to CP or PS Pancreatic enzymes ( PE ) are prepared as pH-sensitive enteric coated microspheres [ Pancrease , Alipase in France ( P ) ] , to prevent gastric inactivation of orally administered enzymes . The efficacy and tolerability of P were compared to those of Eurobiol ( E ) ( PE lacking enteric coating ) in patients with exocrine pancreatic insufficiency ( PI ) via an open crossover study conducted at 16 centers in France . Pancreatic insufficiency was diagnosed in patients with signs of chronic pancreatitis who showed steatorrhea ( fecal fat excretion greater than 8.0 g/24 h ) . The dosage of P was 9 capsules/d and that of E , 3 vials/d . Stools were collected for 3 consecutive days at each of the following periods : after 10 d without any PE , and after 21 d of P and E administration . Results were analyzed statistically by the method of Hills and Armitage . Chronic pancreatitis was alcohol-induced in 33 of 35 patients ( 94 % ) who entered the study . The group that received P before E ( n = 20 ) was comparable to the group that received E before P ( n = 15 ) in patient and disease characteristics . Eight of 35 patients failed to complete the study for the following reasons : adverse reactions 2 cases , lost to followup 4 cases , dropped out of study 2 cases . The degree of steatorrhea was similar after P and E. However , symptomatic improvement was noted far more frequently with P than with E. Moreover , patients preferred P to E because of drug taste ( p less than 10(-4 ] and ease of drug administration ( p less than 10(-3 ) . Drug safety was comparable in the two groups of patients Background : Oral pancreatic enzyme supplements should be properly administered in order to ensure an adequate gastric mixing with the food and simultameous gastric emptying with the chyme In a double-blind , r and omized crossover study , the hypotheses were tested that more powerful inhibition of gastric acid secretion by adjuvant omeprazole further improves the efficacy of pancreatic enzyme replacement therapy compared to adjuvant cimetidine and that excluding the influence of pH-related factors , by virtually complete inhibition of gastric acid secretion with 60 mg omeprazole daily , does not lead to total elimination of steatorrhea . During both adjuvant cimetidine and omeprazole treatment , fecal fat excretion was significantly lower compared to pancreatin monotherapy ( P<0.01 ) . Omeprazole showed a trend towards a more favorable decrease of fecal fat excretion compared to cimetidine but no statistically significant difference . Steatorrhea was almost never abolished , even during 60 mg omeprazole daily . Generally , pH-related factors are considered to explain an inadequate therapeutic response during pancreatic enzyme replacement therapy . However , this study indicates thatin vivo other factors also play a significant role Objectives : Creon 10 Minimicrospheres is an enteric-coated , delayed-release pancrelipase preparation design ed to deliver active pancreatic enzymes to the small intestine . The primary objective of this study was to compare the effect of Creon 10 with placebo in the control of steatorrhea in chronic pancreatitis patients . Secondary objectives included evaluation of stool parameters and global improvement of symptoms scales . Methods : The study was a r and omized , double-blind , placebo-controlled , 2-week trial . After a placebo run-in ( " washout " ) phase , the effect on coefficient of fat absorption ( % ) , daily fat excretion before and after treatment , and stool frequency and consistency were assessed . Results : In Creon 10-treated subjects , the change in mean coefficient of fat absorption ( % ) from run-in to double-blind phase was significantly higher compared with placebo-treated subjects ( + 36.7 vs. + 12.1 , P = 0.0185 ) . Stool consistency improved significantly more with Creon 10 than with placebo ( P = 0.0102 ) result ing in more subjects with formed stool ; stool frequency decreased significantly more with Creon 10 than with placebo ( P = 0.0015 ) from 10.8 during placebo run-in to 5.2 stools per day during double-blind treatment ; and daily mean fat excretion in stool decreased significantly more ( −56.5 vs. −11.4 g/d , P = 0.0181 ) in Creon 10-treated subjects compared with placebo-treated subjects . Global disease symptom scores showed greater improvement for both physicians and subjects in the Creon 10 group relative to those receiving placebo . Between treatment difference reached statistical significance for Creon 10 ( P = 0.0435 ) for physician score and showed a trend ( P = 0.0634 ) favoring Creon for subject score . Conclusions : This r and omized , placebo-controlled trial found that Creon 10 treatment controlled steatorrhea , as reflected in reduced fat excretion , decreased stool frequency and improved stool consistency  . Creon 10 treatment was safe and well tolerated Background Chronic pancreatitis often culminates in maldigestion and diabetes . Clinical management is complex as the correction of maldigestion often disturbs diabetic control . Study In the following study , we examined the effects of a potent new commercial pancreatic enzyme on food absorption and blood glucose control .  Enzymes were manufactured in enteric-coated mini-microsphere form ( 0.7–1.6 mm ) , design ed to prevent gastric acid degradation and facilitate co-migration with food , and given in quantities calculated to cover normal digestion requirements ( four capsules with meals , two with snacks ; content/capsule : lipase 10,000 USP units , protease 37,500 units , amylase 33,200 units ) . Forty patients with chronic pancreatitis were screened during a run-in nonenzyme-supplemented phase ; only those with stool fat excretion rates over 10 g/d ( n = 29 ) were advanced to a 14-day parallel r and omized placebo versus enzyme supplement group comparison . Results Of these , 62 % were diabetic ( 50 % insulin-dependent ) and 52 % were malnourished ( body mass index less than 20 kg/m2 ) . After enzyme supplementation , stool fat and nitrogen excretion decreased , whereas fat absorption increased from 54.0 ± 9.7 % to 80.8 ± 3.8 % per day ( p = 0.002 ) and protein from 80.5 ± 3.4 % to 86.8 ± 2.2 % per day ( p = 0.004 ) . Changing treatment from active enzyme supplementation to placebo ( and vice versa ) result ed in major problems with glucose control ; blood glucose levels became abnormal in 28 of 29 patients , one patient required hospitalization for symptomatic hypoglycemia ( 0.9 mmol/L ) during placebo treatment , and one developed diabetic ketoacidosis after recommencing active enzyme supplementation . Conclusions In conclusion , high-dose pancreatin mini-microspheres improved , but did not normalize , fat absorption , possibly because of the residual influence of diabetes and malnutrition on absorptive function . In view of the brittle nature of blood glucose control in malnourished insulin-dependent patients , enzyme adjustment should be carefully supervised in-hospital 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 prospect i ve 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 ) . METHODS Patients were investigated during four periods of 2 weeks , each one corresponding to a new treatment regimen : Pancrease HL , 3 capsules/day or Creon , 9 capsules/day , with or without omeprazole 20 mg/day . Stools were collected on the last 3 days at the end of each period when the patients were on a st and ard diet with a fixed daily intake of 100 g fat/day . RESULTS Faecal fat , protein and energy excretion did not differ when both preparations were compared at roughly pharmaceutically equivalent doses . No significant improvement in fat and protein absorption was observed when omeprazole was taken with the pancreatic enzymes . However , omeprazole treatment was associated with a marked decrease in the fat-protein content ratio , suggesting an improvement in the fat digestive process but a decrease in the efficiency of protein digestion . Drug safety was comparable in the four groups of treatment . 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 st and ard preparations BACKGROUND / OBJECTIVES To assess the efficacy and safety of pancreatin ( pancrelipase ) enteric-coated minimicrospheres ( MMS ) over a one-year period in patients with pancreatic exocrine insufficiency ( PEI ) due to chronic pancreatitis ( CP ) . METHODS This was a 
    Output:
    
Follow-up studies demonstrated that PERT  increased serum nutritional parameters , improved GI symptoms and quality of life without significant adverse events .
High-dose or enteric-coated enzymes showed a trend to greater effectiveness than low-dose or non-coated comparisons , respectively .
Conclusions PERT is indicated to correct EPI and malnutrition in CP and may be improved by higher doses , enteric coating , administration during food and acid suppression .