Summary of Key MiraLAX ® Clinical Studies and Analyses

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Including Safety and Efficacy Data Points

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  • Patients meeting modified Rome functional constipation criteria evaluated daily use of 17 gm PEG 3350 (n= 311). A total of 184 patients (59.2%) completed 12 months of therapy, and only 4.0% discontinued due to lack of efficacy
  • At office visits at 2, 4, 6, 9, and 12 months, 80%-88% of patients reported complete or considerable relief of constipation, and 85%-92% no longer met the Rome functional constipation criteria
  • The frequency of individual GI adverse effects was: diarrhea 10.6%, flatulence 7.4%, nausea 5.5%, and abdominal pain 5.2%
  • No clinically significant changes in laboratory test results including hematology or blood chemistry (electrolytes) were reported

DiPalma JA, Cleveland M VB, McGowan J, Herrera JL. An open-label study of chronic polyethylene glycol laxative use in chronic constipation. Aliment Pharmacol Ther. 2006;25:703-708. [6]

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  • Patients taking medications causing a >3% incidence of constipation were randomized to treatment with 17 gm PEG 3350 daily or placebo for 28 days (n =100)
  • The primary efficacy variable was based on relief the presence of no more than one of the following: straining, lumpy/hard stool, incomplete evacuation, anorectal obstruction, or manual movements in >25% of bowel movements; or < 3 bowel movements per week over the last 7 days of treatment
  • PEG 3350 was significantly superior (P < 0.001) to placebo for:
    • - Increased bowel movement frequency
    • - Improved stool consistency
    • - Less straining
    • - Patient and investigator rated effectiveness and acceptability
  • The frequency of individual GI adverse effects was similar to placebo, and no clinically significant changes in laboratory test results were reported

DiPalma JA, Cleveland MVB, McGowan J, Herrera JL. A comparison of polyethylene glycol laxative and placebo for relief of constipation from constipating medications. South Med J. 2007; 100(11):1085-1090. [12]

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  • Patients with modified Rome functional constipation criteria of <3 satisfactory bowel movements per week, with straining in >25% of defecations, hard or lumpy stools in >25% of defecations, and/or sensation of incomplete evacuation in >25% of defecations for a 3-month period were randomized to treatment with 17 gm PEG 3350 daily or placebo (n= 304)
  • The primary efficacy variable was based on relief of the modified Rome criteria defined above with no rescue laxative use. Significantly more PEG 3350 patients (52%) were successfully treated compared to placebo (11%, P<0.001)
  • PEG 3350 was significantly superior (P<0.001) to placebo for:
    • - The number of bowel movements per week
    • - Satisfactory bowel movements per week
    • - Complete spontaneous bowel movements
  • The frequency of individual GI adverse effects did not differ significantly from placebo.
  • The combined frequency of diarrhea, flatulence, loose stools, and nausea occurred more often with PEG 3350 than with placebo (40% vs 25%, P<0.015)
  • No clinically significant changes in laboratory test results were reported

DiPalma JA, Cleveland MVB, McGowan J, Herrera JL. A randomized, multicenter, placebo-controlled trial of polyethylene glycol laxative for chronic treatment of chronic constipation. Am J Gastroenterol. 2007;102;1436-1441. [7]

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  • Evaluated the safety and effectiveness of MiraLAX laxative in people with constipation
  • Twenty three patients with constipation were given the normal daily dose (17 g) of MiraLAX or a placebo and were watched for any changes in how often they had bowel movements
  • After 14 days, patients given MiraLAX had significantly (P=.0001) more bowel movements than those on placebo, and they had no serious side effects

Cleveland MV, Flavin DP, Ruben RA, Epstein RM, Clark GE. New polyethylene glycol laxative for treatment of constipation in adults: a randomized double-blind, placebo-controlled study. South Med J. 2001;94(5):478-481. [4]

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  • Evaluated the safety and effectiveness of MiraLAX in 151 people with constipation
  • Patients were given either MiraLAX or a placebo, and kept track of any changes in how often they had bowel movements as well as changes to the bowel movement itself
  • After 2 weeks, patients who took MiraLAX had significantly (P<.001) more bowel movements than those who were given a placebo, and also had less cramping and gas

DiPalma JA, DeRidder PH, Orlando RC, Kolts BE, Cleveland MB. A randomized, placebo-controlled, multicenter study of the safety and efficacy of a new polyethylene glycol laxative. Am J Gastroenterol. 2000;95(2):446-450. [9]

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  • Evaluated the safety and effectiveness of MiraLAX laxative in 50 people with constipation
  • Study participants were either ambulatory outpatients or living in long-term care facilities
  • Patients received a placebo or a high (34 grams) or low (17 grams) dose of MiraLAX (later reduced to 12 and 6 grams, respectively, in long-term care patients)
  • All patients given MiraLAX had increases in how often they had bowel movements and improvement in the quality of the bowel movement, with no severe side effects
  • The higher doses of MiraLAX yielded better bowel movements more often versus lower doses, and people given either dose of MiraLAX had better outcomes than those on placebo

DiPalma JA, MacRae DH, Reichelderfer M, et al. Braintree polyethylene glycol (PEG) laxative for ambulatory and long-term care facility constipation patients. Online J Dig Health. 1999;1(2).1-10. [10]

  • Clinical trials conducted between 1966 and 2003 to evaluate the safety and efficacy of laxatives were studied and compared to make guideline recommendations for their use
  • Polyethylene glycol and tegaserod received Level 1, Grade A ratings
    • Level 1 - consistent results from well-designed, well-conducted studies
    • Grade A - good evidence in support of the use of a modality in the treatment of constipation
  • Considerable evidence also supported the use of psyllium and lactulose

Ramkumar D, Rao SS. Efficacy and safety of traditional medical therapies for chronic constipation: systematic review. Am J Gastroenterol. 2005;100(4):936-971. [14]

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  • The authors of this analysis identified and reviewed all randomized controlled trials comparing the use of lactulose and polyethylene glycol in the management of fecal impaction and chronic constipation (Rome III criteria). Both monotherapy and crossover studies were reviewed
  • The authors concluded that polyethylene glycol is better than lactulose in outcomes of stool frequency per week, form of stool, relief of abdominal pain, and the need for additional products

Lee-Robichaud H, Thomas K, Morgan J, Nelson RL. Lactulose versus polyethylene glycol for chronic constipation. The Cochrane Library. 2010; Issue 7:1-38. [15]

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The patients studied in MiraLAX clinical studies were selected based on modified Rome III criteria. There is no clinical differentiation between the symptoms of chronic and occasional constipation. Occasional constipation is the term used in the over-the-counter (OTC) setting as a condition that can be self-diagnosed by consumers. Use of an OTC laxative for periods longer than 7 days may mask an underlying condition that requires medical diagnosis and treatment.
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The #1 GI recommended laxative [2] Use as directed for occasional constipation.