Preprint review article letter to all pharmacist 2016 pharmaceutical care la...
Research paper 2
1. Running head: MULTIPLE SCLEROSIS 1
Multiple Sclerosis
Breanna Hernandez
California Baptist University
Author’s Note
This paper is presented to Professor Jetton in partial fulfillment for the requirements of
Research and Writing, NUR 375A, on February 26nd, 2015
2. MULTIPLE SCLEROSIS 2
Multiple Sclerosis
According to Brunetti and Hunter, over 20 years have passed since the first disease-
modifying therapies (DMTs) were approved in the treatment of Multiple Sclerosis (MS). There
is an importance for clinicians to stay up to date and familiar on new updates of treatment
options to be most effective in treating patients with diagnosed MS (Brunneti & Hunter, 2014).
There are several treatment options for MS and every patient has their individualized plan of
care, but two main treatments include the Natalizumab therapy (NAT) and Fingolimod therapy
(FTY) (Hoepner et al., 2014). Because no cure currently exists, these treatment options aim to
reduce the frequency of exacerbations and also reduce the progression of the disease to increase
the quality of life (Brunneti & Hunter, 2014). This paper will analyze the research of Hoepner et
al. (2014), synthesize the same research with Putzki et al. (2009) and Lanzillo et al. (2013), and
show how the research can be applied in practice.
Research Article Analysis
Research was done by Hoepner, et al. (2014) to determine the risk factors for the
recurrence of relapses after switching from Natalizumab (NAT) therapy to Fingolimod (FTY)
therapy in relapsing-remitting multiple sclerosis (RRMS). The purpose of the research was to
identify the clinical risk factors that could help identify responses to FTY after NAT was
discontinued (Hoepner et al. , 2014). The research was also done to find out the effectiveness of
FTY and the parameters that might show higher relapse risk (Hoepner et al. , 2014).
The sample size for this retrospective observational study conducted by Hoepner et al.
had 33 patients with a diagnosis of RRMS chosen from electronic databases. Other inclusion
factors listed are having at least 12 months of NAT therapy, switching from NAT to FTY within
24 weeks, and following up for at least a period of 12 months thereafter (Hoepner et al. , 2014).
3. MULTIPLE SCLEROSIS 3
Six patients were excluded because they had switched from NAT to FTY after 24 weeks or had
followed up less than 12 months after switching to FTY (Hoepner et al. , 2014).
A few different methods were used in this research to measure variables. The methods
used to identify predictors in response to FTY was univariate logistic regression analysis and the
Expanded Disability Status scale (EDSS) (Hoepner et al. , 2014). When analyzing the variable
for a significant difference in patients with or without relapse during FTY the Mann-Whitney-
Exact Test was used (Hoepner et al., 2014).
This study found that an increase of disease activity occurred after discontinuing NAT
and it didn’t matter whether they switched during the 24 week period. After the discontinuation
of NAT, 61% (20) relapsed but only 48% (16) relapsed during FTY treatment. Of that 16, 63%
had relapsed during NAT and 87.5% relapsed during the switching period (Hoepner et al., 2014).
The only significant value that was found to predict the occurrence of relapse activity during
FTY was the last EDSS done during the switching period from NAT to FTY (Hoepner et al.,
2014). Other significant data pointed to an increase of annual relapse rate (ARR) in the first year
after switching from NAT to FTY (Hoepner et al., 2014).
Hoepner et al.’s research explains that the size of the population in the study was not big
enough to make the decision to switch to FTY or other alternate therapies. Further studies
should be done to improve the individual risk-benefit assessment. Also, the retrospective design,
and lack of MRI data in the electronic data bases was a concern in choosing to implement the use
of FTY after discontinuing NAT (Hoepner et al. , 2014). What the research of Hoepner et al.
does indicated is that patients with a low EDSS seem to be safe and switching from NAT to FTY
is effective.
4. MULTIPLE SCLEROSIS 4
Synthesis
Research done by Hoepner et al. (2014) showed that switching from Natalizumab (NAB)
to Fingolimod (FTY) was ineffective in reducing the amount of disease activity in Multiple
Sclerosis (MS). Additional studies by Lanzillo et al. (2013) and Putzki et al. (2009) both showed
that switching to NAT from another disease modifying therapy (DMT) is effective in reducing
relapse in MS. Studies done by Hoepner et al. and Putzki et al. were conducted in Germany
while the study done by Lanzillo et al. was conducted in Italy.
Sample
The research done by Hoepner et al. had 33 patients and Putzki et al. had 31 but Lanzillo et al.
was also very similar in that it had 50 patients. All research had in common that the population
sizes were very small. The inclusion criteria for all three studies included, patients previously
using a DMT and those with relapsing remitting multiple sclerosis (RRMS). The difference in
inclusion criterion was that in Hoepner et al. patients were on NAB prior to switching to FTY.
Other research done by Lanzillo et al. and Putzki et al. had patients previously on another DMT
prior to the switch to NAB for 12 months.
Methodology
Hoepner et al. research as well as Lanzillo et al. were retrospective studies, while the research
done by Putzki et al. was a prospective observational study. Hoepner et al. and Lanzillo both
assessed annual relapse rate (ARR) and Expanded Disability Status scale scores (EDSS) but
Lanzillo also assessed the reduction if contrast enhancing lesions (CELs). Hoepner et al.,
Lanzillo et al., and Putzki all got patients from MS center database centers from universities.
Findings
5. MULTIPLE SCLEROSIS 5
Hoepner et al. concluded that more research needs to be done to use FTY as second line therapy
effectively but significant data showed that those with a low grade disbitlty had a smaller relapse
rate after switching from NAT to FTY. Putzki et al had significant data that showed mean EDDS
scores at basline decreased. Lanzillo et al. showed that the ARR at all time points was significant
because it did not drastically change over time. Putzki et al. and Lanzillo et al. both came to the
conclusion that NAT is effective as treatment in reducing disease symptoms of MS for at least 12
months after the use of another DMT or the failed use of a DMT.
Application to Practice
When patients are deciding on the treatment of multiple sclerosis they should be
completely informed to accurately make the best choice for their situation. The effectiveness,
risks, and side effects of the best treatments should be explained thoroughly. To best educate a
patient on treatment options, the patient’s needs, goals, preferences and concerns should all be
met during teaching rounds (Weinberger, Johnson & Ness, 2014). According to Weinberger,
Johnson & Ness (2014) it is also important to include families in teaching so that if needed a
family can make a decisions to together. The concerns and questions of all family members
present should also be addressed to provide a more effective teaching approach (Weinberger,
Johnson & Ness, 2014).
Nurses and other health care personal should be implementing individualized care with
patients while helping them make informed decisions (Suhonen et al., 2014). According to
Suhonen et al. it is important to find ways to understand people in their life situations, what they
prefer, and the amount of effort they will put into their care or the level of desire they wish to put
into their. Understanding these concepts for each individual patient can help direct health
personal into what to teach and how to teach it with different patients. Different treatment
6. MULTIPLE SCLEROSIS 6
therapies of multiple sclerosis (MS) can be emphasized or even more thoroughly looked at if the
health care provider is informed of the patient’s life. Nurses can help with implementing a
certain therapy over another by learning as much about the patient as possible to choose the best
option for them to provide the highest level of patient care (Suhonen et al., 2014).
When the health provider knows the patient individualizing the care is made easier.
Teaching the patient then becomes more organized because treatment can be taught in a way that
helps the patient fully understand its effects (Suhonen et al., 2014). If switching from Fingolimod
(FTY) to Natalizumab (NAT) to reduce relapse in MS is a likely option for a patient, an
informed decision can be made by the medical/nursing staff, the patient, and family/friends. The
health provider, whether a doctor or nurse practitioner can apply the research of Lanzillo et al.
(2013) and Putzki et al. (2009) by prescribing NAT as a second line therapy for MS (Buckley et
al. 2012).
Conclusion
Studies by Hoepner et al. (2014), Putzki et al.. (2009) and Lanzillo et al. (2013)
demonstrate that some secondary disease modifying treatments (DMT’s) in Multiple Sclerosis
(MS) can be beneficial in the prevention of relapse and other symptoms, while others are still not
adequately researched to be certain of their effect. Research done by Hoepner et al. indicated that
Fingolimod (FTY) as a secondary treatment after the discontinued use of Natalizumab (NAT)
needs to be studied more over greater populations to prove its effectiveness. Other research
performed by Lanzillo et al. and Putzki et al., did show that switching to NAT from another
DMT, rather than FTY was much more effective in reducing symptoms associated with relapse.
Subject size was very small among all studies and shows that it may not be generalized to all
population groups rather only those specifically with the same inclusion criteria. These findings
7. MULTIPLE SCLEROSIS 7
can however, be used in practice by having nurse practioners prescribe NAT as a secondary line
therapy because it is effective in reducing relapse in patients with MS. Also, individualized care
and patient teaching can be implemented when making decisions on treatmeant options and plans
of care. Finding other ways to implement the research of Hoepner et al., Putzki et al., and
Lanzillo et al. into practice raises the potential for improving the quality of life of those
individuals with MS greatly.
8. MULTIPLE SCLEROSIS 8
References
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