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Endoscopy
Table 1: Search Strategy sodium phosphate, 32 randomised controlled trials comparing OSP
with other bowel cleansing agents were identified, together with the
Key Search Terms trials identified by our searches for safety only.
3,25–53,54,55
No clinically
Laxatives (MeSH term)/phosphosoda (tx) and subheadings:
relevant renal adverse effects were identified from a total of 6,580
MEDLINE EMBASE patients in these trials.
/adverse effects /side effect
/poisoning /adverse drug reaction
Epidemiological Studies
/toxicity /drug toxicity
We identified a total of seven retrospective studies with data on renal
/chemically induced /complication
events and OSP (see Table 2). The cohort studies included a total of
/contraindications
9,702 patients administered OSP and 4,255 patients given other
/complications
laxatives, mostly polyethylene glycol (PEG). The sample size and
methodologies differed between the studies in important ways. One
The US Food and Drug Administration (FDA) issued an alert in study did not exclude patients with pre-existing renal impairment,
11
December 2008 stating that OTC OSP products should not be labelled which is a known contraindication for OSP. However, pre-existing chronic
or promoted as bowel cleansers prior to medical procedures. Health renal disease was reported in only two of 618 patients administered
Canada issued an alert in March 2009 requesting the use of OSP OSP.
11
Equally importantly, the timing of the assessment of renal
products as bowel cleansers only with the recommendation of a impairment ranged from 14 days
56
to nine years post-colonoscopy,
11
and
healthcare practitioner. In Europe, however, the regulatory situation is within six months
57,58
to 12 months
9,56,59,60
pre-colonoscopy. The degree of
different, with clear and updated guidance for healthcare change in creatinine or glomerular filtration rate that represented renal
professionals and patients provided in the SPC and Patient Information injury was different in the various studies (see Table 2).
Leaflet, respectively, independently of the prescription or non-
prescription status granted by the Health Authority of each country. Several studies found no difference in the risk of renal events between
use of OSP and PEG.
11,58,60
The one study that reported an incontrovertible
For more than 100 years OSPs have been shown to be effective when increased risk of renal injury based on clinically significant increases in
used as directed, with a favourable risk–benefit ratio. Therefore, the aim creatinine for OSP compared with PEG did not exclude patients with pre-
of this review was to systematically evaluate the published evidence on existing renal impairment; all patients had a pre-colonoscopy glomerular
renal impairment following OSP use from all types of study design. filtration rate (GFR) of <60ml/minute.
56
Some studies found only slight
increases in creatinine levels that are not considered clinically significant
Methods
A literature search was conducted followed by the application of
explicit criteria looking over the titles and abstracts found by the
Reports of renal damage in Europe are
search. The details of the search strategy are described in Table 1. The
distilled list provided the basis for seeking the full articles to be further
rarer, which may result from their different
reviewed for eligibility and the same inclusion criteria were again
regulatory statutes as prescription drugs
applied at this stage. The reference list of the full articles retrieved was
also searched for further references. Those full articles remaining
in Europe versus over-the-counter
eligible were reviewed and relevant data were abstracted and
products in North America.
tabulated. Reasons for rejection were documented. Additionally, the
Fleet company adverse events database was used to calculate
reporting rates for Fleet
®
Phospho-soda
®
. Searches were conducted (25% increase in creatinine from pre-therapy levels).
9
Another study that
in Medline from 1952 and Embase from 1974. Fleet company sources used a highly biased control group (patients who did not undergo a
were also searched for relevant publications and safety data. The colonoscopy) and inappropriate statistical methods found a statistically
following inclusion criteria were used in the review: renal failure, significant difference in the mean levels of GFR in elderly patients taking
nephropathy or nephrocalcinosis and Phospho-soda (or oral sodium OSP compared with PEG.
57
The Hurst study found an increased risk of
phosphate; OSP) in humans in English and Spanish publications. renal injury for OSP versus PEG.
59
Results No patient characteristics were found that interacted with OSP to
A total of 114 abstracts and references were reviewed from a search identify particular subgroups of patients at increased risk of renal
of both Medline and Embase. From the list, 58 were excluded based injury. Patient characteristics that increased the risk of renal injury in
on a reading of the title or abstract. From the 56 full articles that were both the OSP- and other laxative-treated groups were variably
retrieved, 13 were excluded after the application of eligibility criteria identified in the studies (see Table 2). Age was identified as a risk factor
leaving 43 publications eligible for review. From the reference in three studies.
11,59,60
Female sex was identified as a risk factor in one
sections of these articles and Fleet internal sources, we retrieved 63 study.
58
The level of GFR was a risk factor in two studies.
60,56
It must be
more papers. A detailed reading of the 106 papers resulted in emphasised that ‘normal’ serum creatinine levels do not always
excluding 53 due to ineligibility criteria and duplicates. A total of 53 full indicate normal renal function, especially in the elderly,
61
suggesting
publications were reviewed. that quite a few elderly patients may have had pre-existing subclinical
renal insufficiency. High blood pressure was identified as a risk factor
Randomised Controlled Trials in two studies.
11,60
Heart failure was identified as a risk factor in two
Based on randomised trials identified from meta-analyses
24,57
that studies.
58,59
Diuretics were identified as a risk factor in two studies.
58,60
examined the efficacy and tolerability, as well as the safety, of ACE-I and ARBs were identified as a risk factor in two studies.
57,60
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