Birt, J.

Donaldson, R.

Graham-Clarke, P.

Ilo, D.

Neasham, D.

Raluy-Callado, M.

Sadasivan, R.

Zhu, Y.

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PIH99 Patient Characteristics and Medication Treatment Patterns Among Men With Erectile Dysfunction (Ed), Lower Urinary Tract Symptoms Secondary To Benign Prostatic Hyperplasia (Bph-Luts), Or Co-Occurring Ed and Bph-Luts In the Uk Primary Care Setting 

 VA L U E  I N  H E A LT H  1 7  ( 2 0 1 4 )  A 3 2 3 – A 6 8 6  A521
Objectives: To estimate the calcium levels in peri menopausal and postmeno-
pausal women and to evaluate the need for calcium supplementation among 
them. MethOds: A prospective study was conducted at gynecology department of 
a tertiary care hospital for the period of six months to estimate the serum calcium 
levels among them. Study populations were divided in to perimenopausal and post 
menopausal group. All the eligible patients were enrolled after obtaining informed 
consent. Study subjects from both the group were estimated for serum calcium 
levels to identify if they need calcium supplements. Unpaired T test was performed 
to find out any significant difference between both groups and pearson’s corre-
lation cofficient (r) was applied to assess the relation between age and calcium 
levels. Results: During the study period, 53 of 100 patients enrolled were postmen-
opausal with the mean age of 60.8±10.47 years and 47 of 100 patients enrolled were 
perimenopausal with mean age of 44.6±3.54 years. The mean calcium level of 47 
perimenopausal women was found to be 9.32±0.55 (reference level: 8.0-11.0 mg/dl) 
and 8.56±0.54 for 53 postmenopausal women. In post menopausal women there 
was highly significant drop observed in serum calcium levels with increasing age, 
compared to peri menopausal women. (CI: 95%, p< 0.0001, r: -0.81). cOnclusiOns: 
The serum concentrations of calcium in majority of our study population were 
within the normal range. There was a good source of dietary intake of calcium in 
most of the patients. The levels of calcium were lower in postmenopausal women 
compared to perimenopausal women. Since there is an negative effect of calcium 
on the bone mineral density in postmenopausal women, it can be recommended 
that calcium supplementation can be given as prophylaxis to prevent the long 
term bone loss and to decrease the risk of fracture and osteoporosis.
PIH99
PatIent CHaraCterIstICs and MedICatIon treatMent Patterns aMong 
Men WItH ereCtIle dysfunCtIon (ed), loWer urInary traCt syMPtoMs 
seCondary to BenIgn ProstatIC HyPerPlasIa (BPH-luts), or Co-
oCCurrIng ed and BPH-luts In tHe uk PrIMary Care settIng
Ilo D.1, Raluy-Callado M.2, Graham-Clarke P.3, Donaldson R.2, Birt J.4, Sadasivan R.2, Zhu Y.4, 
Neasham D.2
1Lilly UK, Hampshire, UK, 2Evidera, London, UK, 3Eli Lilly Australia Pty Ltd., NSW, Australia, 4Eli 
Lilly and Company, Inc., Indianapolis, IN, USA
Objectives: Describe patient characteristics and medication treatment 
patterns among newly diagnosed cases of BPH-LUTS, ED, and co-occurring ED 
and BPH-LUTS. MethOds: Retrospective cohort study using UK CPRD data on 
incident BPH-LUTS and incident ED patients indexed between June 2010 and 
May 2011. Patient records were analysed from 12 months pre-index and up to 
24 months post-index. Results: The cohort included 8912 men with BPH-LUTS-only, 
2589 with an ED diagnosis followed by BPH-LUTS, 8093 with ED-only and 1641 
with a BPH-LUTS diagnosis followed by ED, all aged ≥ 40 years. The majority of 
BPH-LUTS patients (~90%) were diagnosed and managed within GP practices. 
Men were diagnosed with BPH-LUTS alone at an older average age (68±11.9 years, 
IQR= 59–77) compared to men in the ED/BPH-LUTS group (67±9.5 years, IQR= 61–74, 
p= 0.002). Men were diagnosed with ED at an older average age (65±9.2 years, 
IQR= 59–72) in the BPH-LUTS/ED group compared with ED-only patients (57±9.1 
years, IQR= 50–64, p< 0.001). Time between diagnoses was longer for ED/BPH-LUTS 
patients (6.8±4.76 years) versus BPH-LUTS/ED patients (5.8±5.10 years). BPH-LUTS 
and ED treatment patterns were similar for patients with and without co-occurring 
conditions. Most patients were initially prescribed alpha-blockers (62.9% BPH-
only, 65.5% ED/BPH-LUTS) or anticholinergics (14.9% BPH-only, 14.0% ED/BPH-
LUTS). For ED, most patients were initially prescribed sildenafil (51.6% ED-only, 
49.6% BPH-LUTS/ED) or tadalafil (24.3% ED-only, 26.0% BPH-LUTS/ED). At six 
months post-diagnosis, ~47% incident BPH-LUTS patients and ~78% ED patients 
were not on any BPH-LUTS or ED treatment, respectively. cOnclusiOns: Study 
data suggests > 80% of patients are managed as either BPH-LUTS- or ED-only. 
Average age of BPH-LUTS/ED patients at ED diagnosis suggests patients may suf-
fer from ED years before seeking medical attention (p= 0.002). Presence of the 
co-occurring condition does not appear to impact treatment choice, however, 
a lower proportion of ED patients initiate treatment after diagnosis, compared 
with BPH-LUTS patients.
systeMIC dIsorders/CondItIons – Clinical outcomes studies
Psy1
PaIn InCIdenCe and analgesIC ConsuMPtIon durIng HaeModIalysIs 
sessIons: IMPaCt on HealtH-related QualIty of lIfe
Rebollo P.1, Arenas M.D.2, Castejón N.1, Reichert García J.2, Delgado Conde P.2,  
Gutierrez Rivas P.2, Gil González M.T.2
1LASER ANALYTICA, Oviedo, Spain, 2Hospital Vithas Perpetuo Socorro, Alicante, Spain
Objectives: To analyse the incidence of pain and the need of analgesics dur-
ing haemodialysis sessions, and its impact on Health-Related Quality of Life 
(HRQoL). MethOds: Data about the number of sessions in which 172 patients 
showed pain and needed analgesics were collected in 2 haemodialysis units in Spain 
during 3 months. Age, sex, comorbidities, (diabetes and cancer history), time on 
haemodialysis, pain complaints during haemodialysis sessions, intake of analgesics, 
opioids and antidepressant drugs, were collected. Generic HRQoL was assessed by 
means of the computer adaptive test CAT-Health, previously validated, through an 
iPAD. A negative score means that the HRQoL is worse than that of general popula-
tion and a positive score, indicates that it is better. Results: Mean age (S. D) was 
66.87 (13.32), being 44 patients (25.6%) aged over 75 years. 55.8% were male, 34.3% 
diabetic and 11.6% had cancer history. The median time undergoing haemodialysis 
was 51.50 months (27.75-84.50). 81 patients (47.4%) had pain during some session. 
The mean number of haemodialysis sessions with pain was 4.78 (range between 
1 and 21 sessions), which represents 12.7% of the total number of sessions. 67 
patients (39%) were usually taking analgesics, 37 (21.5%) opioids and 29 (16.9%) 
antidepressant drugs. Patients taking analgesics showed worse HRQoL: mean (S. 
Objectives: The current study looks to explore young children from high-risk fami-
lies in the Taipei City setting. High-risk social welfare intervention was investigated. 
First, differences between enrollees and non-enrollees for medical subsidy program 
among high-risk family whose cases were started in 2009 or 2010 will be looked at. 
Second, the study will try to determine the social welfare intervention’s effective-
ness in increasing application for medical subsidy program and finding any predic-
tors which may have helped or harmed application for enrollment. MethOds: The 
study sample included under 6 year old children high-risk families (n= 199). High-
risk family database and medical subsidy database were linked. Differences between 
high-risk subsidy enrollees (n= 87) and non-enrollees (n= 112) and effectiveness of a 
social welfare intervention in increasing subsidy application were investigated in a 
pre-post analysis of high-risk social welfare intervention. Individual level as well as 
relative residential level characteristics were explored. Results: Medical subsidy 
enrollment was correlated with younger age at time of a high-risk intervention and 
relative district level variables. Pre-post comparison suggests high-risk interventions 
significantly increased subsidy application by 7.4%. Logistic regression indicates 
older age at time of intervention was associated with 40% less chance of applica-
tion. cOnclusiOns: The study provides empirical evidence for potential effects of a 
high risk social welfare intervention on the accessibility to health care. Findings also 
show where policy makers can improve intervention in order to address the needs 
children at-risk, especially for different age groups.
PIH96
WHat faCtors are assoCIated WItH VaCCInatIon PrograMMe suCCess?
van Oorschot D.A.M.
Radboud University, Nijmegen, The Netherlands
Objectives: When the WHO launched the Expanded Programme on Immunisation 
(EPI) in 1974, < 5% of the world’s children were vaccinated against polio, measles, 
diphtheria, tetanus, pertussis and tuberculosis. Nowadays coverage rates are 
increasing and more vaccines have been added to the programme. This project 
aims to identify factors associated with successful programmes based on EPI cov-
erage. MethOds: The relationship between multiple socio-demographic and eco-
nomic factors and EPI coverage (primarily obtained from the WHO and World Bank) 
was investigated using simple linear regression, Principal Component Analysis (PCA) 
to identify explanatory variables, and finally multiple linear regression analysis. 132 
countries with data on self-funded health care programmes were included in the 
analysis. These were ranked according to Gross National Income (GNI) per capita and 
lower (L), lower-middle (LM), upper-middle (UM) and upper (U) quartiles were identi-
fied. Results: Income (GNI/capita) was not significantly associated with achiev-
ing high EPI coverage rates. Within the income groups the factors trending with 
improved EPI coverage included: 5-yr mortality and corruption index in L, sanitary 
facilities in LM, 5-yr mortality, sanitary facilities, birth-rate and life-expectancy in 
UM. In U all countries achieved > 90% coverage. cOnclusiOns: Identifying simple 
predictive variables of successful vaccination programmes is complex because of 
multicollinearity. However, by exploring within homogeneous income groups, it was 
possible to identify underlying factors related to vaccination programme success. As 
the core EPI vaccines were introduced 40yrs ago one would expect introduction to 
have been fully implemented thus reducing the likelihood of a relationship between 
country income and coverage today, however it could have been expected some time 
ago. To further explore the relationship between country income and vaccination 
programme success, one could expand the analysis to include the newer vaccines 
as soon as coverage information is available for a majority of the countries.
PIH97
PatIent-rePorted outCoMes (Pro) In go/no-go deCIsIon MakIng In 
drug deVeloPMent
Ingelgard A.P.1, Nokela M.2, Cole J.C.3, Berger A.K.3
1Covance Market Access, Solna, Sweden, 2Covance Market Access Services, Solna, Sweden, 
3Covance Market Access Services, Inc., San Diego, CA, USA
Objectives: Despite existing examples of the great impact successful integration 
of PRO science and know-how may have on improving market access, PROs are typi-
cally not part of drug development decision making such as go/no-go decisions. The 
objective of this study is to identify decision making instances in drug development 
when important go/no-go decision making also could have included PROs but typically 
weren’t. Additionally, search for any strategies and activities that might better enhance 
the likelihood for senior decision makers also to integrate PRO science and knowhow 
in drug development decision making. MethOds: A literature search was carried 
out including terms such as PRO, strategy, decision-making, go/no-go decisions, drug 
development and phases I to IV. Results: Typical go/no-go decisions mentioned in the 
literature include decisions to move a drug candidate from one development phase to 
the next stage, i. e. from target-to hit to launch decisions. There were very few references 
found where go/no-go decision-making in drug development also included PROs. Many 
references also states the necessity to include the patient (e. g. listen to the patient) early 
on in drug development. However, no concrete suggestions on how to carry out these 
ambitions in practice were found. cOnclusiOns: There is little research to be found in 
the literature on go/no-go decision making in drug development where PRO science and 
knowhow are taken into account. The lack of clear practical guidance and examples on 
when and how to start inclusion of PROs science and knowhow in go/no-go 
decision making may be one impediment to their successful inclusion. Perhaps, a best 
practice rule could be as simple as including a PRO opportunity assessment in phase 
I-II go/no-go decisions where the feasibility, pros and cons for potentially including 
PRO in the clinical development program are summarized. At least, a first overview 
of PROs potential is done.
PIH98
estIMatIon of seruM CalCIuM leVel In PerI and PostMenoPausal 
WoMen: a CoMParatIVe study
Paras P.1, Shobha Rani R.1, Shobha G.2
1Al-Ameen College of Pharmacy, Bangalore, India, 2St. Philomena’s Hospital, Bangalore, India


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PIH99 Patient Characteristics and Medication Treatment Patterns Among Men With Erectile Dysfunction (Ed), Lower Urinary Tract Symptoms Secondary To Benign Prostatic Hyperplasia (Bph-Luts), Or Co-Occurring Ed and Bph-Luts In the Uk Primary Care Setting

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