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Efficacy and Tolerability

Movicol has been providing constipation relief for more than 25 years. From paediatrics to adults and the elderly, see how the Movicol range is supported by clinically proven efficacy and tolerability.

Clinically proven efficacy in a range of patients

1-2 year olds

In a study of 35 children aged <2 years with constipation, Movicol Paediatric Plain resulted in:1

  • Increased stools per week from 2.3 pre-treatment to 7.3 post-treatment (p<0.001; mean duration of 4.6 months)
  • Constipation resolution in 77% of patients after 4 weeks, increasing to 94% after 8 weeks* and 97% after 12 weeks*

*Varied doses.

In a study of 62 patients aged 1-17 years with chronic constipation, Movicol Paediatric Plain (PEG+E) vs PEG resulted in:2

  • Increased stools per week from 1.7 at baseline to 5.5 at week 12 vs an increase from 1.6 to 4.7 for PEG
  • Decreased proportion of patients with hard stools to 5% at week 12 vs 9% for PEG
1-2 year olds

An extensive, real-world, retrospective study of Movicol Paediatric Plain in 13,235 children aged <2 years with constipation suggests good symptom control in this age group.3

Paediatrics

Constipation

In a study of 78 children aged 2–11 years with chronic constipation, Movicol Paediatric Plain demonstrated:4

  • An increase in mean weekly spontaneous defaecations from 1.4 at baseline to 6.8 at 14 days, which continued to improve to 7.1 at 12 weeks (p<0.001)

Faecal impaction

In a 12-week study of 63 children aged 2–11 years with faecal impaction, MOVICOL treatment in 58 children with disimpaction resulted in:5

  • 0% re-impaction rate vs 23% for lactulose (p=0.011)
  • 0% of patients using rescue medication vs 31% for lactulose (p=0.002)

Mean weekly spontaneous defaecations

Baseline
1.4
14 days of using Movicol Paediatric Plain
6.8

Adults

In a 4-week randomised trial of 115 adults with chronic constipation, MOVICOL was significantly more effective than lactulose, demonstrating:6

Greater stool frequency

44%
greater stool
frequency

44% greater mean stool frequency per day over 4 weeks (1.3 vs 0.9/day; p=0.005)

Improvement rating

42%
improvement
rating

42% increase in mean overall improvement rating after 4 weeks (7.4 vs 5.2; p<0.001)*

Sachets per day

1.6 vs 2.1
sachets/day

Significant reductions in daily dosing during the last 2 weeks

  • 1.6 vs 2.1 sachets/day; p<0.001
  • 56% vs 36% of patients reduced their dosage

*Based on visual analogue scale ratings.
Patients were free to adjust daily dosage during the last 2 weeks of the study.

Elderly

Toilet

In a 3-month study of 30 hospitalised older patients with chronic constipation, Movicol demonstrated effective relief, with:7

  • Optimum mean dosage of 1.7 sachets/day
  • A mean of 1 stool/day

100%

In 11 patients with refractory constipation and faecal impaction, Movicol resulted in:7

  • 100% cumulative complete resolution by day 3
  • 81% of patients reporting complete relief

Clinically proven tolerability in a range of patients

Rotating cog

1-2-year olds

In a study of 35 children aged <2 years with constipation, Movicol Paediatric Plain (PEG+E vs PEG) resulted in:1

  • 14% of patients experiencing diarrhoea, which was manageable by dose adjustment

In a study of 62 patients aged 1–17 years with chronic constipation, Movicol Paediatric Plain (PEG+E) vs PEG resulted in:2

  • Only 2 adverse events (AEs) that did not improve on dose reduction (abdominal pain and flatulence) vs 1 for PEG (diarrhoea)
  • >1 electrolyte disturbance in 56% of patients vs 83% for PEG, none of which were clinically relevant

An extensive, real-world, retrospective study of Movicol Paediatric Plain in 13,235 children aged <2 years has demonstrated no new safety concerns in this age group.3

Paediatrics

In a study of 78 children aged 2–11 with chronic constipation on MOVICOL Paediatric Plain:4

82%

  • 82% of the 318 AEs reported were considered mild
  • 76% of AEs were deemed unrelated to MOVICOL

In a study of 83 children aged 2–17 with chronic constipation on PEG for >12 weeks:8

100%

  • 100% of children preferred PEG to previously used laxatives
  • 90% of children were rated as having ‘good’ daily compliance

Adults

In a 4-week study of 115 adults with chronic constipation, Movicol demonstrated an acceptable tolerability profile vs lactulose:6

Liquid Stools
2.1
NSLiquid Stools
4.1
Abdominal Pain
6.8
p=0.08Abdominal Pain
3.9
Bloating
8.9
NSBloating
5.6
Flatus
9.2
p=0.01Flatus
3.8
Rumbling
4.1
NSRumbling
2.4
Movicol droplet
Movicol
Baseline droplet
Lactulose

NS = Not significant
n = 115
Mean number of days with a patient-reported clinical symptom score >1 (0=absence; 3=severe)

In a 4-week observational study of 2,029 patients aged 17–99 years with chronic constipation:9

  • 99% of doctors and 98% of patients rated tolerability of Movicol as ‘very good’ or ‘good’

Elderly

In a 3-month study of 30 hospitalised older patients with chronic constipation, MOVICOL was well tolerated7

  • No water or electrolyte imbalances were recorded
References
  1. Bautista-Casasnovas A et al. Publicado en Acta Pediatr Esp 2013;71:213–217 (Accessed October 2020).
  2. Llerena E et al. An Pediatr (Barc) 2016;85:34–40 (Accessed October 2020).
  3. Norgine Ltd. DOF-MOVIC-012. August 2020 (Accessed October 2020).
  4. Hardikar W et al. J Paediatr Child Health 2007;43:527–531 (Accessed October 2020).
  5. Candy DCA et al. J Paediatr Gastroenterol Nutr 2006;43:65–70 (Accessed October 2020).
  6. Attar A et al. Gut 1999;44:226–230 (Accessed October 2020).
  7. Alix E et al. Le Revue de Geriatrie 2001;26:65–72 (Accessed October 2020).
  8. Pashankar DS et al. Arch Pediatr Med 2003;157:661–664 (Accessed October 2020).
  9. Gruß H & Teucher T. Der Allgemeinarzt 1999;21:1342–1350 (Accessed October 2020).