Navarro_Layout 1 01/10/2009 10:31 Page 11
Endoscopy
Efficacy and Tolerability of Sodium Picosulphate/Magnesium Citrate as a
Bowel-cleansing Agent – Results from a Literature Review
Angel Navarro
1
and Peter T Hession
2
1. Medical Affairs, Laboratorios Casen-Fleet, SLU; 2. Independent Pharmaceutical Physician, Mediplex Ltd
Abstract
The primary aim of this study was to undertake a review of studies reported in the literature that evaluated the efficacy of sodium
picosulphate/magnesium citrate (SPMC) for bowel cleansing. A literature search for clinical trials with SPMC was performed in May 2007
using Medline, Embase and the Cochrane library databases. The benefits of combining SPMC for bowel cleansing prior to investigations of
the large bowel are supported by the results of this review. When all of the included studies were considered together, the clinical
effectiveness of SPMC was found to be 82% both overall and prior to colonoscopy. SPMC was generally well tolerated and, where assessed,
tolerability and acceptability rates were favourable relative to other bowel-cleansing agents. Better tolerability would tend to promote good
patient compliance.
Keywords
Sodium picosulphate, magnesium citrate, bowel preparation, efficacy, safety
Disclosure: Angel Navarro is an employee of Casen-Fleet. Peter T Hession’s work on this review and the article was funded by Casen-Fleet.
Acknowledgements: The authors would like to thank Stephanie Blick of Wolters Kluwer Health for assistance in the preparation of this article. This assistance was funded
by Casen Fleet.
Received: 15 June 2009 Accepted: 2 July 2009
Correspondence: Angel Navarro, Laboratorios Casen Fleet SLU, Via de las dos Castillas 33, 3 Atica Edificio 7, 28224 Pozuelo de Alarcon, Madrid, Spain. E:
anavarro@casenfleet.com
Effective colon cleansing without compromising patient comfort is There are also preparations that combine agents from more than one
regarded as a prerequisite to achieving optimal, safe investigation of of these three groups, most usually the combination of a stimulant
the large bowel.
1–3
In the UK, France and Canada, poor bowel and a low-volume osmotic laxative. In theory, combining different
preparation prevents completion of colonoscopies in approximately laxatives with complementary mechanisms of action should enhance
20–30% of failed procedures.
2,3
Although many clinical trials have efficacy while avoiding an adverse impact on tolerability that could be
investigated the efficacy and safety of available bowel-cleansing associated with an increased dose of a single agent alone. A well-
agents, it remains unclear which is the best therapeutic option.
2–4
tolerated preparation that is easy to administer in accordance with
the manufacturer’s instructions should also encourage compliance
There is a wide variety of bowel cleansing agents available in Europe and therefore maximise efficacy. One bowel-cleansing agent that has
and they generally fall into one of three groups.
2,3
The first group is the been in widespread clinical use in the UK and the Republic of Ireland
low-volume osmotic laxatives, such as magnesium citrate and sodium since the 1980s is the low-volume oral combination of sodium
phosphates. These act by drawing extracellular fluid across the bowel picosulphate (a stimulant laxative) and magnesium citrate (an osmotic
wall into the lumen by osmosis. Fluid accumulation produces laxative), which is marketed as Picolax
®
(Ferring). This combination
distension, which promotes peristalsis and bowel evacuation. has recently been approved for use in these and other countries in
Another group is the high-volume osmotic laxatives, which are the EU as CitraFleet
®
(Casen-Fleet, Eisai).
preparations of polyethylene glycol administered with a high volume
of a dilute electrolyte solution. The electrolyte solution is retained in Aim
the lumen due to the osmotic effect of the polymer, and this promotes The primary aim of this study was to undertake a review of studies
peristalsis and evacuation, as with low-volume osmotic laxatives. reported in the literature that evaluated the efficacy of sodium
There is little fluid exchange across the bowel wall with high-volume picosulphate/magnesium citrate (SPMC) when used according to the
osmotic laxatives, thereby limiting the potential for systemic recommended dose and dose regimen in the EU for bowel cleansing.
electrolyte disturbance. However, the high volume of these laxatives The secondary aim of this study was to compare the efficacy and
decreases compliance and is associated with nausea and bloating. safety of SPMC with that of other bowel-cleansing agents within the
The third group of bowel-cleansing agents is the stimulant laxatives, identified studies.
such as sodium picosulphate and bisacodyl. These are low-volume
agents that work principally by enhancing intestinal motility, and so Methods
are often associated with abdominal cramping; they also increase the A literature search for clinical trials with SPMC was performed in May
amount of fluid in the bowel by a low-grade inflammatory effect. 2007 using Medline, Embase and the Cochrane library databases. The
© TOUCH BRIEFINGS 2009 11
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60 |
Page 61 |
Page 62 |
Page 63 |
Page 64 |
Page 65 |
Page 66 |
Page 67 |
Page 68 |
Page 69 |
Page 70 |
Page 71 |
Page 72 |
Page 73 |
Page 74 |
Page 75 |
Page 76