Navarro_Layout 1 28/09/2009 10:39 Page 14
Endoscopy
One study, which included a subgroup analysis of patients aged 70 In our review, the proportion of patients with at least adequate
years and over, demonstrated that SPMC was at least as effective as bowel cleansing was statistically or numerically higher with SPMC
Kleen-Prep
®
(based on polyethylene glycol) in achieving adequate than other bowel cleansing agents in four of the nine comparative
cleansing prior to barium enema in an elderly population.
5
studies included in the current review. These four studies did not
include a study in which bowel cleansing was used prior to bowel
In a paediatric population (18 months to 16 years), SPMC was surgery. However, this use of SPMC may not be appropriate in any
statistically significantly more effective (p<0.01) than Bisacodyl
®
case, since the utility and safety of any bowel cleansing prior to
plus sodium phosphate enema in achieving adequate cleansing bowel surgery has been questioned.
20
prior to colonoscopy.
6
SPMC was generally well tolerated and, where assessed,
Overall, the percentage of patients with at least adequate bowel tolerability and acceptability rates were favourable relative to
cleansing was higher with SPMC for patients undergoing colonoscopy other bowel cleansing agents, including high-volume polyethylene
or barium enema, but not for those undergoing bowel surgery (see glycol-based preparations and low-volume osmotic laxatives used
Figure 1 and Table 2). alone. Better tolerability would tend to promote good patient
compliance. The literature review also showed that both elderly
Tolerability and paediatric populations demonstrated good efficacy and
SMPC was generally well tolerated in all studies. In two studies where tolerability with SPMC.
patient preference was assessed, patients indicated a preference for
bowel preparation with SPMC over bowel cleansing with Kleen-Prep
5
The benefits of combining sodium picosulphate and magnesium
or Fleet Phospho-soda.
10
citrate for bowel cleansing prior to investigations of the large bowel
are supported by the results of this review. To obtain more
Five of the studies included in the comparative analysis in Table 2 information on how to optimise the use of this combination in
undertook a statistical comparison of the incidence of adverse events clinical practice, further clinical trials are planned that will
between treatments. The results of these analyses are summarised in investigate alternative dosing regimens, including timing of the
Table 3, which indicates that SPMC was better tolerated than the dose in relation to bowel procedure, as well as comparative
comparator in all five of the studies. One of the studies
6
was carried out efficacy, safety and patient acceptability with other available
in children (18 months to 16 years of age) and one study demonstrated proprietary preparations. n
that the side effect profile associated with SPMC was similarly better
than that of Kleen-Prep in patients ≥70 and <70 years of age.
5
Angel Navarro is Director of European Medical Affairs
at Laboratories Casen Fleet SLU, focusing his activities
Adverse events that occurred significantly more often with the on the fields of gastroenterology, paedriatics and
comparator agent than with SPMC were abdominal bloating (p<0.01),
5 gynaecology in both epidemiological and clinical
research and supporting business development
abdominal pain (p<0.01 in both trials),
5,8
nausea (p<0.01,
5
p<0.001
10
),
activities. He has 12 years of experience in clinical
sleep interruptions (p<0.01),
8
vomiting (p=0.044,
1
p<0.001
10
) and taste practice in cardiology units and intensive care
problems (p<0.001
10
).
hospitals, and 15 years of experience in the
pharmaceutical industry in various areas of medical
affairs and clinical research at several pharmaceutical laboratories:
Conclusion GlaxoSmithKline, Bristol Myers Squibb, Wyeth Lederle and Recordati.
This literature review has found that SPMC, administered according to
Peter T Hession is an independent pharmaceutical
the manufacturers’ instructions in the EU, provides effective bowel
physician based in the UK. He has been providing
cleansing prior to bowel procedures. When all of the included studies consultancy services to the pharmaceutical industry
were considered together, the clinical effectiveness of SPMC (at least
through Mediplex Ltd since 1998, and specialises in
the areas of regulatory affairs and medical writing.
adequate bowel cleansing) was found to be 82% both overall and prior
Previously, he worked for a decade in medical
to colonoscopy (see communications and contract research. Dr Hession isTable 1). In comparison, results from a much larger
prospective European study (5,832 patients) reported adequate bowel
a Member of the Faculty of Pharmaceutical Medicine
of the Royal Colleges of Physicians and lectures on
cleansing with various agents prior to colonoscopy in 74% of patients.
14
the post-graduate course in pharmaceutical medicine run by the University of
Similarly, results from a retrospective database review in the US on Wales. He studied medicine at Oxford and London Universities and worked in
93,004 colonoscopies reported adequate bowel preparation in 77% of
hospital medicine before entering the pharmaceutical industry.
these procedures.
15
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14 EUROPEAN GASTROENTEROLOGY & HEPATOLOGY REVIEW
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