Start with MiraLAX®, proven effective in multiple clinical trials

GradeALevel1

MiraLAX® Grade A recommendation, Level I evidence, is a higher rating than fibers or stool softeners

PEG = polyethylene glycol.

*A systematic review across PubMed and Embase of randomized controlled trials (≥4-week duration) that evaluated OTC constipation preparations between 2004 and 2020. Studies meeting the following selection criteria were included: 1) randomized controlled trial (placebo or active comparator); 2) parallel or crossover design; 3) established definition of constipation (preferably ROME criteria); 4) minimum duration of 4 weeks of active treatment; 5) well-defined clinical endpoints. Studies were scored using US Preventive Services Task Force criteria (0-5 scale) including randomization, blinding, and withdrawals. The strengths of evidence were adjudicated within each therapeutic category, and recommendations were graded (A, B, C, D, or I) based on level of evidence (Level I, good; Level II, fair; or III, poor).

 

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In another clinical study, patients taking MiraLAX® reported relief in half the time of that reported by those who waited.2

  • Based on patient-reported complete satisfactory bowel movements (CSBM) during week 1. For patients taking MiraLAX® (n=148), the median number of days to first experience a CSBM was significantly fewer (half) than that of patients taking placebo (n=64), P=0.001.

Summary of key MiraLAX® clinical studies and analyses

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    • The safety and effectiveness of MiraLAX® were evaluated 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 associated subjective symptoms

    • After 2 weeks, patients who took MiraLAX® had significantly (P<0.001) more bowel movements as well as significantly less severe cramping and gas (P<0.001)

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    • The safety and effectiveness of MiraLAX® were evaluated in people with constipation

    • Twenty-three patients with constipation were given the normal daily dose (17 g) of MiraLAX® or a placebo, after which they recorded each bowel movement and associated symptoms in a diary and watched for any changes in frequency

    • After 14 days, patients given MiraLAX® had significantly more bowel movements than those on placebo (7.0 vs 3.6, respectively, in week 2; P<0.001), and they had no serious side effects

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    • Patients taking constipation-inducing medications (≥3% incidence of constipation) were randomized to treatment with 17 g PEG 3350 (n=50) daily or placebo (n=50) for 28 days

    • The primary efficacy variable of treatment success was based on the presence of no more than one of the following in 25% of bowel movements or <3 bowel movements per week over the last 7 days of treatment:
         - Straining
         - Lumpy/hard stool
         - Incomplete evacuation
         - Anorectal obstruction
         - Manual maneuvers

    • PEG 3350 was significantly superior vs placebo in the primary efficacy endpoint of treatment success: 78.3% vs 39.1% (P<0.001), respectively

    • Statistically significant differences in favor of PEG 3350 over placebo were observed:

              - After first week of treatment:
                    - Total number of bowel movements per week
                    - Number of complete bowel movements
                    - Number of satisfactory bowel movements
             - For all treatment weeks:
                    - Straining
                    - Stool consistency
                    - There were no statistically significant treatment-emergent adverse events, including GI complaints

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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, or sensation of incomplete evacuation in >25% of defecations for a 3-month period were randomized to treatment with 17 g PEG 3350 (n=204) daily or placebo (n=100)

    • The primary efficacy variable of treatment success was defined as no rescue laxative use, ≥3 satisfactory stools per week, and ≤1 remaining symptom of the modified Rome criteria defined above

    • Significantly more PEG 3350 patients (52%) were successfully treated compared with placebo (11%, P<0.001)

    • PEG 3350 was significantly superior (P<0.001) to placebo for:
          - Number of bowel movements per week
          - Satisfactory bowel movements per week
          - Complete spontaneous bowel movements

    • While the individual GI adverse events did not differ significantly than with placebo, when combined, these GI events (diarrhea, flatulence, loose stools, and nausea) occurred significantly more often with PEG than with placebo (40% vs 25%, P<0.015)

    • No clinically significant changes in laboratory test results were reported

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    • A 2011 Cochrane review 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) in adults and children. Both monotherapy and crossover studies were reviewed

    • The findings of this meta-analysis indicate 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

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    References: 1. Rao SSC, Brenner DM. Efficacy and safety of over-the-counter therapies for chronic constipation: an updated systematic review. Am J Gastroenterol. 2021;116(6):1156-1181. doi:10.14309/ajg.0000000000001222 2. Data on file. Bayer. 3. DiPalma JA, Cleveland MB, 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. doi:10.1097/SMJ.0b013e318157ec8f 4. Cleveland MvB, 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. 5. 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. doi:10.1111/j.1572-0241.2007.01199.x 6. Lee-Robichaud H, Thomas K, Morgan J, Nelson RL. Lactulose versus polyethylene glycol for chronic constipation. Cochrane Database Syst Rev. 2010;(7):CD007570. doi:10.1002/14651858.CD007570.pub2

    Start with MiraLAX®: A first-line OTC laxative recommendation across constipation clinical guidelines

    Constipation management guidelines from multiple professional organizations recommend PEG, the active ingredient in MiraLAX®, as a first-line treatment1-3

    • Guidelines either don’t mention stool softeners like docusate or don’t recommend them prominently

    Recommendations

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    AAFP=American Academy of Family Physicians; ACG=American College of Gastroenterology; AGA=American Gastroenterological Association; ASCRS=American Society of Colon and Rectal Surgeons; Rome IV 2016=the Rome Foundation’s 2016 publication in Gasteroenterology.

    *Consistent, good-quality, patient-oriented evidence.

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      References: 1. DiPalma JA, DeRidder PH, Orlando RC, et al. 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. doi:10.1111/j.1572-0241.2000.01765.x 2. DiPalma JA, Cleveland MB, 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. 3. Cleveland MvB, 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. Paquette IM, Varma M, Ternent C, et al. The American Society of Colon and Rectal Surgeons’ Clinical Practice Guidelines for the Evaluation and Management of Constipation. Dis Colon Rectum. 2016;59(6):479-492. doi:10.1097/DCR.0000000000000599 5. Bharucha AE, Dorn SD, Lembo A, Pressman A. American Gastroenterological Association medical position statement on constipation. Gastroenterology. 2013;144(1):211-217. doi:10.1053/j.gastro.2012.10.029 6. Ford AC, Moayyedi P, Lacy BE, et al. American College of Gastroenterology monograph on the management of irritable bowel syndrome and chronic idiopathic constipation. Am J Gasteroenterol. 2014;109(Suppl 1):S2-S26. 7. Lacy BE, Mearin F, Chang L, et al. Bowel disorders. Gastroenterology. 2016;150(6):1393-1407. doi:10.1053/j.gastro.2016.02.031 8. Mounsey A, Raleigh M, Wilson A. Management of constipation in older adults. Am Fam Physician. 2015;92(6):500-504.