Rivastigmine Patches With or Without Memantine Compared With Memantine Alone In Adults With Moderate To Severe Alzheimer’s Disease: Systematic Review of The Literature

A297

VA L U E I N H E A LT H 1 9 ( 2 0 1 6 ) A 1 - A 3 1 8

disease area of interest. Through the use of creative techniques and input from patients, successful development of COAs in rare diseases can be achieved.

Selected Health Care Treatment Studies medical device/diagnostics – Clinical Outcomes Studies PMD1 Rivastigmine Patches With or Without Memantine Compared With Memantine Alone In Adults With Moderate To Severe Alzheimer’s Disease: Systematic Review of The Literature García C 1, Castañeda C 2, Rosselli D 3 Universidad Javeriana, Medical School, Bogota, Colombia, 2Neuroeconomix, Bogota, Colombia, 3Pontificia Universidad Javeriana, Bogota, Colombia .

.

.

diagnostic odyssey (i.e., a prolonged and complex diagnostic journey), informing prognosis, treatment selection and patient management. Physicians surveyed indicated prolonged diagnostic odyssey prior to making a definitive diagnosis of genetic etiology may result in uncontrolled disease for longer than necessary, suboptimal or potentially harmful treatments, undue healthcare resource use and, in some cases, adverse impact on development and cognition, as well as increased risk of physical injury such as from falls, aspiration, and anoxic brain damage.  Conclusions: Optimized use of multigene sequencing panels could allow for earlier and more efficient diagnosis of underlying causes of seizure disorders. Information provided facilitates clinical management decisions, potentially improving clinical outcomes and quality-of-life, and reducing healthcare resource utilization for pediatric patients. Multigene sequencing panel testing offers a more cost-efficient method to obtain an earlier diagnosis for patients with epilepsy.

1Pontificia

Objectives: Alzheimer’s disease (AD) is an irreversible, progressive neurodegenerative condition and is the most common cause of dementia. Several studies show it generates a high economic burden. The aim of this study was to conduct a systematic literature review to determine the safety and efficacy of rivastigmine patch alone or in combination with memantine compared with memantine monotherapy in the treatment of moderate to severe AD.  Methods: A systematic search of the literature was conducted in Medline, Embase, Cochrane Database of Systematic Reviews, Lilacs, Cochrane Central Register of Randomized Controlled Trials, Cochrane Database of Abstracts of Reviews of Effects, Clinicaltrials.gov and WHO ICTRP platform. Included studies were randomized controlled trials of patients diagnosed with moderate to severe AD (diagnosed by standardized criterio), evaluating outcomes of effectiveness and safety.  Results: Original search yielded 5022 references, 66 full-text articles were checked by two independent reviewers. Finally 14 studies (8 of them randomized clinical trials) were included for analysis (8 from the US, 2 from Germany, and 1 each from Italy, Japan, Korea and Thailand). The results of experimental studies comparing doses of rivastigmine patches indicate a possible difference in some of the outcomes of effectiveness such as performance in activities of daily living, instrumental activities, and overall functioning in patients with moderate and severe AD, without significant difference in safety outcomes. A trend in favor of combination therapy in some of the outcomes as change in Mini Mental State Examination score and instrumental daily activities was observed.  Conclusions: The available evidence supports the use of rivastigmine, and the association with memantine seems an appropriate therapeutic option in selected cases. PMD2 French Prospective Multi-Center Cohort on The Decision Impact Assessment Michaud P 1, Mouysset J 2, Dohollou N 3, Laplaige P 4, Lafuma A 5, Fignon A 6 1OncoCentre, Orleans, France, 2Centre Ressource, Aix-en-Provence, France, 3Polyclinique Bordeaux Nord Aquitaine, Bordeaux, France, 4Polyclinique de Blois, La Chaussee St Victor, France, 5CemkaEval, Bourg la Reine, France, 6Clinique de l’Alliance, St-Cyr-sur-Loire, France .

.

.

.

.

.

Objectives: Tumour gene expression analysis is useful in predicting adjuvant chemotherapy benefit in breast cancer (BC). The 21-gene assay test is used to estimate the risk of recurrence and to predict the benefit of adjuvant chemotherapy (CT) at an early stage of hormone-receptor-positive (ER+) BC. This study aims to examine the implications of Recurrence Score (RS) testing on treatment decisions in France.  Methods: We conducted an open multicenter, cohort study, with voluntary participation, involving women with ER+, HER2-, BC. Performing the assay was left at the discretion of the oncologist. The final treatment decision was discussed among the tumor board. The therapeutic changes after knowledge of RS were collected. RS and classical BC prognostic markers were investigated in parallel with the budget impact of the assay.  Results: The study enrolled 149 patients in 38 sites. Mean age: 53.4 years, mean tumor size: 16.8 (SD 4.24). 75% of Patients had grade 2 tumor. The distribution of RS was 61.5% low, 33.1% intermediate and 5.4% high. When analyzed according to age, RS was low in 67.4% and 58.4% of patients aged <  50 and ≥  50, respectively. RS was low in 65.6% of tumor ≤  20 mm and 67.7% of tumor >  20 mm. Based on RS results, tumor board changed treatment decision for 76% of patients, avoiding CT for 75% of the population which was initially recommended for a CT and endocrine therapy. Patients with intermediate RS received CT in 47% and with low RS in 7.6%. The potential budget impact was estimated at -375 000€ .  Conclusions: Results of this “real life” study confirm that the 21-gene assay has substancial impact on treatment decision taken by tumor boards. These findings warrant further consideration for the use of this genomic assay in patients with early stage BC in France. PMD3 Clinical Utility of Early Multigene Genetic Testing In Pediatric Patients With Suspected Seizure Disorders And Syndromic Epilepsies Faulkner E C 1, Spinner D S 2, Cardeiro D 2, Stanley C M 2, Foss T R 2, Zare A S 2, Boles R G 2, Le N M 2 1Evidera, Durham, NC, USA, 2Courtagen Life Sciences, Inc., Woburn, MA, USA .

.

.

.

.

.

.

.

.

.

.

.

.

.

.

Objectives: There are approximately 300,000 pediatric epilepsy cases in the US, with 45,000 newly diagnosed cases each year. Clinical guidelines and expert consensus agree on the importance of a confirmed diagnosis including defining underlying genetic etiology. We investigated the reported diagnostic yield and clinical utility of multigene sequencing panels in identifying, confirming or ruling out genetic causes underlying pediatric epilepsy syndromes, inherited conditions with symptomatic seizures, and genes implicated in antiepileptic drug metabolism.  Methods: We conducted a targeted review of the peer-reviewed and grey literature, clinical guidelines, and payer coverage policies to identify studies and clinical consensus addressing diagnostic yield and clinical utility of multigene sequencing panels in epilepsy. In addition, we surveyed a small cohort of physicians managing pediatric epilepsy patients to capture perspectives on utility of genetic testing.  Results: Studies indicated diagnostic yield of multigene panel testing in pediatric epilepsy ranging from 10% to 50%, depending on the population tested and genes in the panel. In addition, clinical utility of identifying genetic etiology was indicated in truncated

PMD4 Feasibility Survey on Outpatient Management of Hypertension In Algeria Hammoudi-Bendib N 1, Mahi L 2, Cherif A 3, Girerd X 4 1EHS Dr.Maouche (CNMS), Alger, Algeria, 2Axelys Sante DZ, Alger, Algeria, 3Merinal Laboratoires, Alger, Algeria, 4Groupe Hospitalier Universitaire Pitié-Salpêtrière, Paris, France .

.

.

.

Objectives: Hypertension (HT) is a prevalent condition, contributing risk factor to heart failure, heart attack and stroke. Ambulatory blood pressure monitoring (ABPM) is important for improving the diagnosis and management of HT as recommended by the guidelines published by the NICE in the UK in 2011. However there is a lack of data on the follow up of theses guidelines in the Maghreb countries. We aimed in this survey to assess the management of HT and usage of ABPM in daily practices in Algeria.  Methods: A declarative survey was performed on a panel of 80 cardiologists from private and hospital settings who accepted to answer to a questionnaire on their daily practices on the management of HT.  Results: Seventy questionnaires were analyzed with a response rate of 87.5% (64% male), mainly from physicians of private practices 88% (62/70). All the physicians reported having patients with HT (100%). Among them 94% (66/70) estimated the frequency of HT between 30 to 50%. Calculated median frequency is 35%. ABPM is used by 88% of the cardiologists, mainly to confirm a diagnosis of hypertension after initial screening in patients with diabetes (64%), untretaed essential HT (63%), masked HT (34%), gestational HT (34%), “white-coat” effect (28%) and resistant HT (17%). Blood Pressure is routinely and systematically explored by 94% of the physicians. Office measurement of blood pressure is most commonly performed with a manual or automated sphygmomanometer. Cardio-vascular risk factors are systematically explored by all the physicians. After initiation of treatment, patients are followed up at one month and three months by 81% and 14% of the physicians, respectively.  Conclusions: The results of this survey suggest that in Algeria the use of ABPM for the management of hypertensive patients are consisistent with international guidelines. PMD5 Accuracy of Tests For Identifying Latent Tuberculosis Infection In Children, Immunocompromised, And Recently Arrived People From Countries With High Tuberculosis Burden Auguste P , Madan J , Tsertsvadze A , Court R , Pink J University of Warwick, Coventry, UK .

.

.

.

.

Objectives: In the absence of a reference standard for the diagnosis of latent tuberculosis infection (LTBI), studies have mainly provided associations of tuberculin skin test (TST) and/or interferon gamma release assays (IGRAs) results with measures of prior TB exposure, and test agreement between TST and IGRAs. It is still unclear whether IGRAs are more accurate than TST in identifying LTBI among children, immunocompromised, and recently arrived people from high TB burden countries. Our aim was to derive the prevalence of LTBI, as well as sensitivity and specificity of IGRA and TST for predicting the progression of LTBI to TB.  Methods: A systematic search was undertaken of key electronic databases from 2009 up to June 2015 to identify relevant studies. We pooled prospective studies on progression to TB following testing with commercial IGRAs and/or TST in an untreated LTBI population. A Bayesian framework was developed in WinBUGS using fixed and random effects models to derive summary estimates (and 95% credible intervals) for prevalence, sensitivity and specificity.  Results: The prevalence of LTBI that progresses to TB was 0.03 in children, 0.02 in immunocompromised and 0.03 in recently arrived people. In a children, TST(≥ 5mm) had a sensitivity and specificity of 72.80% and 49.03% compared to QFT-GIT with a sensitivity and specificity of 68.84% and 61.03%. In an immunocompromised population, TST(≥ 5mm) had a sensitivity and specificity of 34.95% and 70.16% and QFT-GIT had a sensitivity and specificity of 56.62% and 80.47%. In the recently arrived, TST(≥ 5mm) had a sensitivity and specificity of 93.56% and 50.11% compared to QFT-GIT with sensitivity and specificity of 59.15% and 79.29%.  Conclusions: Information on the progression from LTBI to TB in prospective studies is sparse. It appeared that TST(≥ 5mm) is better than IGRAs at identifying LTBI that progresses to TB in the child and recently arrived while in immunocompromised IGRA outperformed TST. PMD6 Assessment of Risk of Diabetes Using Indian Diabetes Risk Score In Healthy Postgraduate Students of India Boya C 1, Gudala K 2, Bansal D 3 1National institute of pharmaceutical education and research, Mohali, India, 2National Institute of Pharmaceutical Education and Research, Mohali, India, 3National Institute of Pharmaceuitical Education and Research, Mohali, India .

.

.

Objectives: India leads the world with largest number of diabetic subjects earning the dubious distinction of being termed the “diabetes capital of the world”. Therefore a diabetes risk score will help us to device effective screening strategies to unmask hidden burden of the disease. The aim of the study is to assess the risk of the development of diabetes in healthy volunteers of India. This study also aims