Canestaro, W.J.

Devine, B.

Forrester, S.

Ho, L.

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A170  VA L U E  I N  H E A LT H  1 8  ( 2 0 1 5 )  A 1 – A 3 0 7  
ment option for a disease where few options existed. Based on studies reviewed, 
sildenafil and NAC treatments did not slow disease progression as measured by 
change in percent FVC and their use in IPF should be limited.
PRS6
ImPact of change In Lung functIon and coPd-ReLated PatIent 
outcomeS on exaceRbatIonS and hoSPItaLIzatIonS: a SyStematIc 
LIteRatuRe RevIew
Donohue J.F.1, Marvel J.2, Martin A.L.3, Travers K.U.3, Cadarette S.3, Wilcox T.K.4
1University of North Carolina, School of Medicine, Chapel Hill, NC, USA, 2Novartis 
Pharmaceuticals Corporation, East Hanover, NJ, USA, 3Evidera, Lexington, MA, USA, 4Evidera, 
Castle Rock, CO, USA
Objectives: Clinical trials of chronic obstructive pulmonary disease (COPD), a pro-
gressive disease with a substantial economic burden, primarily assess exacerbation 
rates based on health resource utilization (HRU), leading payers to focus on this 
endpoint as a cost driver. The drug approval process often requires documenta-
tion of clinically relevant improvements in measures such as forced expiratory 
volume in one second (FEV1); however, their link to longer-term outcomes, such as 
exacerbations and HRU are not known. We conducted a systematic review of the 
published literature to evaluate the linkage. MethOds: We searched MEDLINE- and 
Embase-indexed English-language publications from 2002 through October 1, 2014 
for randomized controlled trials with ≥ 20 adult patients with COPD. Included trials 
described changes in FEV1or St. George’s Respiratory Questionnaire (SGRQ), as well 
as exacerbations or HRU. Results: We identified 13 trials among 1,196 publications 
reporting changes in SGRQ or FEV1 and rate of exacerbation and hospitalization. 
We combined FEV1 pre-bronchodilator values with FEV1trough values given the 
similarity of these variables. Based on the MCID value for SGRQ of 4 units, exacerba-
tions ranged from 0.414 to 5.61/person-year among those not reaching SGRQ MCID, 
compared with a range of 0.42-1.07/person-year among those reaching SGRQ MCID. 
Using a minimal clinically important difference (MCID) value for FEV1 of 100mL, the 
exacerbation rate ranged from 0.414 to 5.61/person-year among those not reaching 
FEV1 MCID, compared to 0.69 to 1.02/person-year among those reaching FEV1MCID. 
The annual hospitalization rate due to exacerbations ranged from 0.02-0.7/per-
son-year among those not reaching SGRQ MCID, and from 0.03-0.16/person-year 
among those reaching SGRQ MCID. Annual hospitalization rates due to exacerba-
tions ranged from 0.02-0.7/person-year among those not reaching FEV1 MCID, com-
pared to 0.05-0.16/person-year among those reaching FEV1MCID. cOnclusiOns: 
Preliminary results suggest a relationship between clinically meaningful improve-
ments in bronchodilation and patient-reported outcomes and annualized exacerba-
tions and hospitalizations.
PRS7
the uSe of heLIox In hoSPItaLIzed chILdRen fRom caRtagena 
coLombIa
Guzmán-Corena A.1, Morales-Payares D.2, Pinzón-Redondo H.2, Zakzuk-Sierra J.3,  
Orozco-Guardo M.4, Aristizabal G.4, Alvis-Guzman N.3
1Unidad de Cuidados Intensivos “Doña Pilar”. Hospital Infatil Napoleón Franco Pareja, Cartagena, 
Colombia, 2Hospital Infatil Napoleón Franco Pareja, Cartagena., Colombia, 3Universidad de 
Cartagena. Centro de Investigación y Docencia. Hospital Infantil Napoleón Franco Pareja, 
Cartagena de Indias, Colombia, 4Unidad de Cuidados Intensivos, Cartagena, Colombia
Objectives: To describe the use of heliox therapy in a case series of patients 
admitted to emergency department or/and intensive care unit of children hospital 
“Napoleon Franco Pareja” in Cartagena, Colombia. MethOds: We described the 
clinical features and results of heliox therapy in a series of patients admitted in 
emergency room and/or intensive care unit. For qualitative variables proportions 
were used and for numeric variables were analyzed with averages and meas-
ures of dispersion. We compared the differences in categorical variables using 
the chi-square or Fisher exact test. The aplicative Epidat 3.1 was used for data 
analysis Results: Fifty two patients were included, of whom 59.6% were male. 
The mean age was 21.2 months (SD: 25.6). The two most frequent diagnoses were 
status asthmaticus (32.7%) and acute bronchiolitis (26.9%). Mortality was 5.8%. 
Success of heliox therapy was 76.9%. The route of administration was not related 
to the type of response. The duration of heliox therapy averaged 5.9 hours (SD 
4.1) in patients who did not respond favorably and 8.0 hours (SD 5.6) in those 
who responded to heliox. Fifty percent off patients did not need endotracheal 
intubation and all responded favorably to heliox therapy. cOnclusiOns: A 
high success rate with heliox therapy was found in this case series. Its use is 
recommended as an adjunct therapy in the management of acute respiratory 
insufficiency.
PRS8
ReaL-woRLd obSeRvatIonaL Study of aSSocIatIon between StatIn 
medIcatIonS and coPd-SPecIfIc outcomeS
Ajmera M.R.1, Sambamoorthi U.2, Rust G.3, Pan X.4, Tworek C.2, Metzger A.2
1RTI Health Solutions, RTP, NC, USA, 2West Virginia University, Morgantown, WV, USA, 
3Morehouse School of Medicine, Atlanta, GA, USA, 4Evidera LLC, Lexington, MA, USA
Objectives: Disease modifying drugs are not yet available for the management 
of individuals with Chronic Obstructive Pulmonary Disease (COPD). Statin therapy, 
due to its anti-inflammatory properties is under consideration for the manage-
ment of COPD. This study examined the relationship between statin therapy and 
COPD-specific outcomes. MethOds: Retrospective longitudinal dynamic cohort 
design using Medicaid claims data from multiple years (2005-2008) was utilized. 
Statin therapy was identified from the prescription drug file using the National 
Drug Codes (NDC). COPD-specific outcomes such as hospitalizations, emergency 
room and outpatient visits were identified based on a primary diagnosis of COPD. 
Multivariable logistic regressions with Inverse Probability Treatment Weights (IPTW) 
were used to examine the relationship between statin therapy and COPD-specific 
outcomes. The relationship between multimorbidity, statin medications and COPD-
specific outcomes was tested using an interaction term. Secondary analyses with 
Objectives: Pneumonia-related 30-day readmission rates are publically reported 
as part of the Hospital Readmissions Reduction Program to improve quality of 
care for Medicare beneficiaries. We estimated the impact of pneumonia on inpa-
tient mortality and 30-day readmission rates in mechanically ventilated (MV) 
patients. MethOds: We performed a cohort study of MV patients using the 
Premier Inpatient database (July 2012 to June 2013). Patients on MV for > = 1 day 
were included and classified based on those with a pneumonia-related diagno-
sis code and those without. Patients were followed for the entire period of their 
hospitalization. Inpatient mortality and rates of readmission for the thirty days 
post discharge were compared between the two groups using generalized linear 
models (GLMs). We estimated both outcomes using the binomial distribution, 
controlling for patient demographics, 3M™ All Patient Refined Diagnosis Related 
Group Severity and Mortality indices, and hospital characteristics. Results: A 
total of 65,246 patients met criteria, of which 15,421 (23.6%) carried a pneumonia 
diagnosis. Pneumonia patients were older (64.2 vs 58.0 years, p< 0.0001), more 
likely to be male (46.8% vs 45.3%, p= 0.0012), white (72.4% vs 66.9%, p< 0.0001), and 
on public insurance (75.6% vs 65.2%, p< 0.0001). Comparing outcomes, pneumo-
nia patients experienced significantly higher rates of mortality (25.5% vs. 18.1%, 
p< 0.0001) and 30-day readmission (15.3% vs. 12.9%, p< 0.0001). After adjustment 
for patient and institutional factors in the GLM regressions the risk of both out-
comes remained statistically significant with odds ratios of 1.05 (95% CI: 1.01 to 
1.10) for mortality and 1.11 (95% CI: 1.05 to 1.17) for 30-day readmission (p= 0.024 
and 0.0002, respectively). cOnclusiOns: Pneumonia in MV patients increases the 
risk of mortality and 30-day readmissions. With penalties as high as 3% across all 
Medicare payments for readmission, efforts should continue to carefully evaluate 
the care of mechanically ventilated patients with pneumonia.
PRS4
muLtImoRbIdIty and coPd medIcatIon ReceIPt among medIcaId 
benefIcIaRIeS wIth newLy-dIagnoSed coPd
Ajmera M.R.1, Sambamoorthi U.2, Dwibedi N.2, Rust G.3
1RTI Health Solutions, RTP, NC, USA, 2West Virginia University, Morgantown, WV, USA, 
3Morehouse School of Medicine, Atlanta, GA, USA
Objectives: Multimorbidity is highly prevalent among individuals with Chronic 
Obstructive Pulmonary Disease (COPD). The association between multimorbidity and 
COPD medication management is not well researched. This study sought to examine 
the association between multimorbidity and receipt of COPD medications among 
Medicaid beneficiaries with newly diagnosed COPD. MethOds: Retrospective lon-
gitudinal dynamic cohort design was used and data were extracted from multiple 
years (2005-2008) of Medicaid Analytic eXtract (MAX) files. Medicaid beneficiaries with 
newly diagnosed COPD (N = 19,060) were identified using International Classification 
of Diseases Codes (ICD-9-CM) codes for COPD. ICD-9-CM codes for commonly co-
occurring conditions with COPD were used to create multimorbidity variable. These 
conditions included arthritis, cardiovascular diseases (CVD), depression, diabetes, 
hypertension, hyperlipidemia and osteoporosis. Medicaid beneficiaries with newly 
diagnosed COPD were categorized into following multimorbidity categories: 1) physi-
cal multimorbidity only; 2) mental multimorbidity only; 3) both physical and mental 
multimorbidity and 4) no multimorbidity. Receipt of COPD medications (short-act-
ing, long-acting bronchodilators and inhaled corticosteroids) was identified using 
National Drug Codes. Bivariate relationships between multimorbidity and COPD 
medication receipt were tested using chi-square test of independence. The associa-
tions between multimorbidity and COPD medication receipt were analyzed with logis-
tic and multinomial logistic regressions. Results: Among Medicaid beneficiaries 
with newly diagnosed COPD, 74.9% had at least one co-occurring chronic condition. 
After controlling for patient characteristics, adults with multimorbidity were less 
likely to receive COPD medications compared to those without any multimorbidity. 
For example those with physical multimorbidity were less likely to receive short-
acting bronchodilators (AOR: 0.82; 95% CI: 0.75, 0.89), long-acting bronchodilators 
(AOR: 0.86; 95% CI: 0.79, 0.93) and inhaled corticosteroids (AOR: 0.81; 95% CI: 0.75, 0.88) 
compared to those with no inflammation-related multimorbidity. cOnclusiOns: 
Prevalence of multimorbidity is very high among Medicaid beneficiaries with newly 
diagnosed COPD. Our study findings suggest poor COPD medication management 
among those with multimorbidity.
PRS5
dRug theRaPy foR tReatment of IdIoPathIc PuLmonaRy fIbRoSIS: a 
SyStematIc RevIew and netwoRk meta-anaLySIS
Canestaro W.J.1, Forrester S.2, Ho L.1, Devine B.1
1University of Washington, Seattle, WA, USA, 2Group Health Cooperative, Seattle, WA, USA
Objectives: Idiopathic pulmonary fibrosis (IPF) is a rare, progressive form of 
fibrosing interstitial pneumonia which results in loss of lung function and pre-
mature mortality. The FDA first approved treatments for IPF in late 2014. The aim 
of this systematic review and network meta-analysis (NMA) is to perform a mixed 
treatment comparison of the efficacy of available pharmacologic treatments for 
IPF. MethOds: Medline, EMBASE, CENTRAL, and PROSPERO were searched for ran-
domized clinical trials in patients with IPF and supplemented with hand searches. 
Only randomized trials consisting exclusively of IPF patients were included. All stud-
ies were independently abstracted by two analysts. The primary outcome of interest 
was the standardized mean difference between treatment and control of change in 
percent predicted forced vital capacity (FVC) from baseline to one year. Results: 
Literature review identified 1,191 records of which 36 met our inclusion criteria. 
Fixed effects pairwise comparisons of the standardized mean difference (SMD) of 
intervention versus placebo suggested better performance of nintendanib rela-
tive to other treatments with a 4.9% (95%CI: 3.8-6.0) standardized improvement 
relative to placebo in %FVC . This falls comfortably within the range of minimal 
clinically important difference for this endpoint as measured by other authors. 
The data structure for pirfenidone did not allow for comparison of %FVC. Sildenafil, 
N-acetylcysteine (NAC), and azathioprine did not show statistically significant 
improvement relative to placebo. cOnclusiOns: Nintenadib offers a new treat-


PRS5 Drug Therapy for Treatment of Idiopathic Pulmonary Fibrosis: A Systematic Review And Network Meta-Analysis 

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PRS5 Drug Therapy for Treatment of Idiopathic Pulmonary Fibrosis: A Systematic Review And Network Meta-Analysis

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