Review: long-term parenteral nutrition
`
`
`
`
`l B en
`(cm), mean (range)
`
`Outcomes (P 2 0.05)
`
`Reference
`
`Factor
`
`numbers
`
`Design
`
`Teduglutide
`(0.05 mg/kg/day)
`
`86
`
`Multicentre
`double-blind
`parallel group
`study (24 weeks)
`
`
`76 (3—343)
`
`Significantly
`more responders
`(>20% decrease
`in PN requirements)
`
`
`144
`
`
`
`Teduglutide l
`1
` Open multicentre
`(0.03/0.10/0.15
`safety study
`(21 days)
`mg/kg/day)
`
` ND (40-150)
`
` No advs effcs
`
`related to the drug
`
`
`
`containing a total of 79 patients.”8 This meta—analysis
`suggested a significant increases in weight (mean differ-
`ence, 1.66; 95% CI, 0.69-2.63), lean body mass (mean
`difference, 1.93; 95% Cl, 097-29), energy absorption
`(mean difference, 4.42; 95% CI, 0.26-8.58) and fat
`absorption (mean difference, 5.02; 95% Cl, 0.2l—9.82).148
`Adverse
`events
`including peripheral oedema
`(77%),
`arthralgia (10%) and carpel tunnel syndrome (32%) were
`reported. Overall, due to the limited numbers of patients
`assessed in each small RCT, the authors did not feel that
`
`this group did display a trend towards higher baseline
`parenteral volume, which may have biased the outcome.
`Teduglutide treatment (0.05 mg/kg/day) had no signifi-
`cant effect on body fat mass, but a modest increase in
`lean body mass as assessed by DEXA scanning.145
`A further study then assessed teduglutide at a dose of
`0.05 mg/kg/day in 86 patients over 24 weeks with
`aggressive reductions in parenteral support
`(10—30%) at
`two weekly intervals if urine volume increased by more
`than 10% from baseline.“ This demonstrated both a
`
`there was adequate evidence to support
`
`the use of
`
`growth hormone for the indication of short bowel syn-
`drome. There is also concern about a potential increased
`
`risk of colorectal cancer in patients receiving growth hor-
`mone, which may have limited further research.”9"5°
`Perhaps the most promise currently rests with tedu—
`
`statistically significant improvement in the primary end
`point,
`a
`>20% reduction
`in
`parenteral
`support
`(P = 0.002) as well as an increased plasma citrulline. The
`mean reduction in parenteral volumes achieved was
`
`4.4 L in teduglutide-treated patients and 2.3 L in pla-
`cebo-treated patients (P < 0.001).'44
`
`recently
`long-acting GLP—2 analogue has
`a
`glutide,
`received a licence for the treatment of short bowel syn-
`
`Quality of life
`
`drome from the European medicines agency (Revestive,
`Nycomed, Zurich, Switzerland) and the Food and Drugs
`Administration (Gattex, NPS Pharmaceuticals, Bedmin-
`
`ster, USA). This has recently been assessed in two multi-
`national double-blind parallel group studies.”4’ 145 The
`first of these phase 3 studies assessed 83 patients on
`long-term HPN. This demonstrated that 16/35 (46%)
`patients receiving 0.05 mg/kg/day teduglutide showed
`a > 20% reduction in parenteral support over 24 weeks
`compared with 1/16 (6%) patients receiving placebo.”
`Three patients were weaned from parenteral support.
`
`Higher doses (0.1 mg/kg/day teduglutide) did not show
`a significant reduction in parenteral support, although
`
`Patients on long-term PN have been shown to have signif-
`icantly lower SF36 QoL instrument scores than normal
`healthy controls.83’ 15' Many patients with IF may never
`eat or drink again without suffering severe abdominal dis-
`comfort and most need to infuse intravenous feed 5-7
`
`nights per week. Thus, while long-term PN may offer
`many patients a lifeline, not determined dependency can
`have a detrimental effect on QoL. Enabling home adminis-
`tration of PN therapy and discharge from hospital HPN
`significantly reduces the cost of carem and can allow
`some patients to return to work.153 Other factors demon-
`strating statistically significant effects on QoL include nar-
`cotic use, oral fluid volumes, nocturia, the presence of a
`
`Aliment Pharmacol Ther 2013; 37: 587-603
`© 2013 Blackwell Publishing Ltd
`
`NPS Ex. 2165
`
`Part 2
`
`CFAD v. NPS
`
`IPR20l5-00990
`
`595
`
`Page 9
`
`Page 9
`
`NPS Ex. 2165
`Part 2
`CFAD v. NPS
`IPR2015-00990
`
`

`
`M. Dibb et al.
`
`stoma, age and the number of infusions required per
`week.l6’ 56‘ 154’
`'55 Thus, any reduction in the latter that
`may be afforded by the use of trophic factors will be wel-
`corned.
`
`Survival
`
`Retrospective cohorts from large European and North
`American centres have reported 5-year survival
`rates
`between 60% and 78% in unselected patients on PN
`(Table 3).46' 48’ 49' 83‘
`'52’ “(H58 Survival
`is principally
`determined by underlying disease; patients with inflam-
`matory bowel disease for example demonstrate a high 5-
`year survival of 92%,157 whereas patients with motility
`disorders have the poorest 5-year survival at 48%.157
`Multivariate analysis of survival data from single centres
`has also demonstrated lower survival rates in patients
`with end-enterostomieslsé’ 153 or a small bowel length of
`<50 cm.l56
`
`The survival of patients receiving PN for advanced
`malignancy is poor with median time to death of between
`5 and 6.5 months.” '59 The majority of deaths from
`HPN (both malignant and nonmalignant) are related to
`
`the underlying disease with separate centres reporting only
`9% of patients dying of HPN—related complications.“ 157
`Deaths related to the underlying disease tend to occur dur-
`ing the first 2 years of treatment, whereas HPN—related
`deaths often occur after this.16°
`
`SURGICAL ALTERNATIVES TO LONG-TERM PN
`
`lntestinal transplantation
`
`Three types of IT): are possible: isolated intestine, com-
`bined liver—intestine and multivisceral
`transplantation.
`Definitive indications for ITx are still an evolving area of
`
`debate, although criteria have been developed by the
`American Gastroenterology Association and the Ameri-
`can Society for transplantation (Table l).16H53
`A recent prospective 5-year cross-sectional multicen-
`
`tre European study has further evaluated the role of
`ITX in 545 patients
`(73% adults)
`that were either
`deemed to be candidates or noncandidates
`for
`ITx
`
`based on current American criteria. The 5-year survival
`rate was 87% in noncandidates, 73% in candidates with
`
`HPN failure and 54% in intestinal recipients; in candi-
`dates, the l-IRs were increased in patients with desmoids
`or liver failure. In candidates with catheter-related com-
`
`rate was
`the survival
`plications or ultra—short bowel,
`83% in those who remained on HPN and 78% after
`
`transplantation. The authors concluded that HPN was
`confirmed as the treatment of choice for IF and that
`
`HPN-associated liver disease and desmoids represented
`
`clear indications for a life-saving transplant. However,
`as the survival rate was 100% for patients in whom the
`
`the
`low PN acceptance,
`indication was
`transplant
`authors did not
`feel
`that poor QoL on HPN should
`form an indication for transplantation. Moreover,
`the
`authors felt
`that CVC complications and ultra—short
`
`bowel might be reasonable indications for a transplant
`
`in selected patients, pending future cost—utility and QoL
`studies. A caveat to this conclusion was raised in a sub-
`
`sequent editorial where it was noted that the survival in
`
`large volume USA transplant units may approach 75%,
`perhaps reflecting greater experience and/or the poor
`medical
`condition or
`late
`referral of
`transplanted.
`patients within Europe."’‘’' 165
`As worldwide experience of IT); improves and immu-
`nosuppressive regimens evolve,
`there is no doubt
`that
`
`the indications for transplantation for patients with type
`
`
`
`Centre Location
`
`Year
`
`Number
`of patients
`
`Patients
`with active
`cancer (%)
`
`1-year
`survival (%)
`
`S-year
`survival (%)
`
`10-year
`survival (%)
`
`Reference
`
`91
`NR
`156
`Belgium/France
`O (0)
`217
`1995
`-_
`sh
`ff‘,
`_
`‘
`"7'
`..”‘-
`Fm-
`.,;,..,7;‘
`
`
`
`
`
`
`The percentages of patients treated for active cancer are shown. NR, not reported.
`.4
`. -It
`
`Aliment Pharmacol Ther 2013; 37: 587-603
`© 2013 Blackwell Publishing Ltd
`
`Page 10
`
`Page 10
`
`

`
`I with high morbidity or low acptce ofP I
`
`Congenital mucosal disorders
`
`atient‘s unwillingness to accept long term PN
`
`3 IF will increase. In the face of evolving and sometimes
`contentious
`indications,
`it
`is vital
`that
`all patients
`referred for transplantation should be carefully evaluated
`in a multidisciplinary setting that involves IF and trans-
`plant experts (Table 4).
`
`Review: long-term parenteral nutrition
`
`resultsdéfklfig The two main surgical operations are the
`Bianchi and the serial
`transverse enteroplasty (STEP)
`procedure. The Bianchi procedure (Figure 2a)
`involves
`splitting the small bowel down the middle and anasto-
`
`mosing the two pieces end to end thus creating a smaller
`diameter, but longer length small bowel; this has allowed
`successful weaning of PN in children with short bowel
`syndrome.166 The STEP procedure (Figure 2b) involves
`stapling dilated small
`intestine into smaller segments
`
`serially along the long axis of the bowel. Data supporting
`the use of these procedures in adults are sparse. The
`largest published series included both paediatric (n = 50)
`
`and adult (n = 14) patients undergoing intestinal length-
`ening procedures and that 69% of the patients in this
`
`series were able to wean HPN completely, although this
`did include eight patients who required ITx.17° Recently,
`Yannam et alm reported the results of intestinal length-
`ening procedures in adult patients,
`including 6 Bianchi
`and 15 STEP procedures: PN independence was achieved
`in 59% and a further 18% demonstrated improved ent-
`eral caloric intake.
`
`Autologous gastrointestinal reconstruction
`
`CONCLUSlONS
`
`Intestinal
`
`lengthening procedures have been used for
`
`The use of long-term PN as a treatment for IF has
`
`some
`
`time
`
`in children on HPN with promising
`
`evolved over the last half-century. It has allowed high
`
`Aliment Pharmacol Ther 2013; 37: 587-603
`© 2013 Blackwell Publishing Ltd
`
`597
`
`Page 11
`
`Page 11
`
`

`
`M. Dibb et al.
`
`quality, low morbidity care that improves patients’ sur-
`vival, QoL and functioning. Fundamental
`to this is a
`
`although evolving modalities such as ITX and autologous
`gastrointestinal reconstruction appear promising.
`
`IF doctors;
`patient—centred multidisciplinary team of
`reconstructive and transplant surgeons, specialist nurses,
`
`AUTHORSHIP
`
`dieticians, pharmacists, psychologists and home—care PN
`providers. Engagement of patients, and where appropriate
`relatives, with structured training programmes enabling
`
`safe independent PN administration leads to lower health
`costs and improved QoL. Complications of treatment
`should be actively sought, assessed and treated. Teams
`
`should meet regularly to optimise PN regimens, assess
`health and psychosocial issues and identify potential can
`didates for alternative treatments. PN is likely to remain
`the bedrock of treatment for most patients with type 3 IF,
`
`Guarantor of the article: M. Dibb.
`Author
`contributions: MD performed
`
`a
`
`literature
`
`search, analysed the data and wrote the article. VT per-
`formed the literature search and wrote sections of the
`
`article. AT, JS and SL reviewed and adapted the manu-
`
`script. All authors approved the final version of the
`manuscript.
`
`ACKNOWLEDGEMENT
`
`Declaration of personal and funding interests: None.
`
`
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