ASSESSING THE POTENTIAL RISK OF SEROTONIN SYNDROME IN TAPENTADOL USERS

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was a cross-sectional, observational study of arthritis patients taking non-steroidal anti-inflammatory drugs (NSAIDs) at least 1 month. Patients were recruited at 20 nationwide hospitals from December 2012 to September 2013. Data were collected through a self-administered questionnaire and medical chart review. Standardized calculator of Risk for Events (SCORE) was employed to estimate GI risk level. SCORE consists of six predictors; age, rheumatoid arthritis, current health status, steroid use, GI side effect history, and GI complication history instead of GI hospitalization history. SCORE ranges 0-39, and GI risk levels were defined as low(≤ 10), moderate(11-15), high(16-20) and very high(≥ 20).  Results: Study included a total of 1,896 patients. Mean SCORE was 19.21±5.80, and a considerable portion of patients had high (28.9%) and very high risk (41.0%). COX-2 selective inhibitor was prescribed in 56.5% of high risk patients and 53.3% of very high risk. GI risk level and COX-2 selective inhibitor prescription rate were analyzed by age stratification of 10 years. In patients aged ≥ 40, more than 60% of the patients were categorized in high or very high risk, and their prescription rates of COX-2 selective inhibitor were remained below 40% in high risk. In very high risk, the prescription rates of patients aged ≥ 40 for COX-2 selective inhibitor were found to be 30% in 40-49 and 39.8% in 50-59 and about 50% in 60-79.  Conclusions: A majority of patients were at high or very high risk for NSAID-induced GI complications and undertreated in terms of COX-2 selective inhibitor use. Low prescription rate of COX-2 selective inhibitor could be explained by patients’ characteristics, GI protective agent use and limited reimbursement guideline. Nevertheless, GI risk should be sought more in pain control to minimize NSAID-induced GI complications.

SYSTEMIC DISORDERS/CONDITIONS – Clinical Outcomes Studies PSY1 ORAL ANTICOAGULANT USE: RESOURCE UTILIZATION AND THE OCCURRENCE OF BLEEDING EVENTS Nunna S 1, Banahan III B 1, Hardwick S P 1, Noble S 2 of Mississippi, University, MS, USA, 2Office of the Governor, Division of Medicaid, Jackson, MS, USA .

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Objectives: Two types of oral anticoagulants (OACs) are currently available in the market, traditional vitamin K antagonist (VKA) anticoagulants (warfarin) and the newer OACs which are non-vitamin K antagonist oral anticoagulants (NOACs). Current NOACs include apixaban, dabigatran, rivaroxaban, and edoxoban tosylate. In cases of abnormal bleeding, Vitamin-K is used as an antidote for warfarin. Currently no antidote for NOACs exists. This study examined all-cause and bleeding-event related resource utilization (office visits, emergency department [ED] visits, and hospital admissions) among patients on OAC therapy.  Methods: A retrospective analysis was conducted using Mississippi Medicaid pharmacy and medical claims data from January 2014 to November 2015. Beneficiaries who had a prescription for an OAC during the observation period were included in the study. Resource utilization was classified as OAC-related if the medical claim included a diagnosis code for a bleeding event. The analysis was performed for each drug strength, except for warfarin, since specific strengths of the drugs are used for different indications.  Results: A total of 3,551 patients were identified as taking OACs during the study period -- 2,823 on warfarin, 567 on rivaroxaban, 107 on apixaban, and 54 on dabigatran. The percentages of patients with bleeding related ED visits were 13.3% for warfarin, 2.6% for rivaroxaban 10mg, 11.1% for rivaroxaban 15-20mg, 9.7% for apixaban 5mg, and 4.3% for dabigatran 150mg. Rates for bleeding related hospital admissions ranged from 3.4% for rivaroxaban 10mg to 7.5% for apixaban 5mg.  Conclusions: Rates for bleeding related ED visits are lower for NOACs than for warfarin. Higher doses of rivaroxaban were related to increased risk of bleeding related ED visits, but other conclusive comparisons between NOACs could not be made due to the limited number of patients on most of the medications. PSY2 ADVERSE EVENTS ASSOCIATED WITH ANTIOBESITY MEDICATION USE: ANALYSIS OF THE FDA ADVERSE EVENT REPORTING SYSTEM FAERS 1997–2015 Yue X , Xia Y , Guo J J University of Cincinnati, Cincinnati, OH, USA .

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Objectives: Many antiobesity drugs were withdrawn from the market because of considerable adverse effects affecting tolerability and safety in the past two decades. Recently sibutramine was voluntarily withdrawn in 2010 due to increased risk of cardiovascular adverse events (AEs).The purpose of this study was to evaluate and describe the AEs associated with antiobesity medication.  Methods: The primary data source was the FDA Adverse Event Reporting System (FAERS) from September 1997 to June 2015.A retrospective, descriptive analysis was conducted to analyze all reported AEs associated with antiobesity medications.The study antiobesity drugs included long-term medicines (Sibutramine, Orlistat, lorcaserin and Qsymias) and short-term medicines (Phentermine, Diethylpropion, Benzphetamine, and Phendimetrazine).The total numbers of reports, cases, adverse reactions, and outcomes were calculated for each study drug annually.The mean age and gender for patients were compared among drugs. The outcome measures included death, hospitalization, life-threatening, disability, and required intervention, or congenital anomaly.  Results: There were a total of 36,255 unique adverse events associated with antiobesity medications use representing 30,937 patients during the study period. The mean age was 46.2 years, while the majority of patients were female (accounted for 84.2% all cases). The cardiovascular AEs were sizable, including 3,295 reports (15.6%) for sibutramine, 14,184 reports (16%) for phentermine. The FAERS database had 24,074 unique outcomes involving antiobesity medication use, including 632 deaths (fatality ratio of 2.8%), 5,544 (27.5%) hospitalization, 1,173 (6.5%) disability, and 745 (4.1%) life-threatening events. Of those death cases, 15.3% were associated with Sibutramine use.Sibutramine use had the highest percentage of serious adverse events (46.1%), hospitalization (34.6%), and fatality (5.4%) among all the other eight antiobesity medications. Phentermine use has the lowest percentage of serious adverse events, whereas sibutramine use has the highest percentage of

fatality, serious adverse events,and hospitalization.  Conclusions: There are sizable adverse events associated with antiobesity medication use.Drug safety about antiobesity medication should be warrant. PSY3 ASSESSING THE POTENTIAL RISK OF SEROTONIN SYNDROME IN TAPENTADOL USERS Gressler L E , Kathe N , Painter J T University of Arkansas for Medical Sciences, Little Rock, AR, USA .

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Objectives: The pharmacokinetic characteristics of tapentadol, marketed as Nucynta, put patients at higher risk of developing serotonin syndrome when prescribed concomitantly with other serotonergic medications. This research aims to examine the potential risk of serotonin syndrome by quantifying the concurrent use of tapentadol and other serotonergic medications.  Methods: This was a retrospective cohort study. All patients with tapentadol claims were identified in the IMS Lifelink database from 2008 to 2014. The main outcome measure was the percentage of tapentadol patients with serotonergic medication usage overlap. This was compared to tramadol and oxycodone, opioids that have little or no association with serotonin syndrome. Statistical comparisons were performed using t-tests. Results: There were 9882 unique tapentadol patients, of which 5819 patients had indications for a serotonergic medication. 424 (7.29%) patients indicated for tapentadol and a serotonergic medication experienced an overlap. There were 266,132 unique tramadol patients, of which 117,862 (44.3%) have had an indication for a serotonergic medication. 7,032 (5.97%) of patients indicated for tramadol and a serotonergic medication experienced an overlap. A t-test showed that there was a significant difference between the percentages with a p-value of 0.0009. There were 472,999 oxycodone patients, of which 179,549 had indications for serotonergic medication. 5139 (2.86%) patients experienced overlap.  Conclusions: Patients indicated for tapentadol and a serotonergic medication are more likely to experience an overlap than patients indicated for tramadol and a serotonergic medication. Due to this concomitant use, Tapentadol patients may experience a higher risk of developing serotonin syndrome. These findings can be used to help regulators recommend label changes for tapentadol and guide healthcare providers in prescribing decision-making in patients with indications for opioids and serotonergic medication. PSY4 ANALYSIS OF THE RESULTS OBTAINED WHEN TREATING PATIENTS WITH ANKYLOSING SPONDYLITIS WITH BIOLOGICAL THERAPY IN THE COSTA RICAN SOCIAL SECURITY SYSTEM (CAJA COSTARRICENSE DE SEGURO SOCIAL - CCSS) Castro Cordero J A , Ching Fung S M , Marin Piva H Caja Costarricense de Seguro Social, San Jose, Costa Rica .

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Objectives: Since 2011, CCSS offers treatment with biological therapy (BT) to the patients with Ankylosing spondylitis (AS) refractory to treatment. This study aims to assess the effectiveness of the treatment with BT in patients with AS.  Methods: Applied observational study with a prescription-indication approach according to the standard methodology for drug utilization research. We used data from the central data base of drug prescriptions from CCSS between January 1st 2013 and April 30th 2014, and then obtained the following information from the medical records: birth date, gender, diagnosis, BASDAI value at the beginning of treatment, at 3, 6, 12 months and at the moment of the last medical evaluation, and response to therapy. Technological tool: Microsoft Excel®.  Results: 108 patients received prescription of biological therapy for AS: 92 (85%) Etanercept, 16 (15%) Adalimumab. 93 (86%) continue treatment. 15 (14%) suspended treatment, 10 (67%) due to treatment failure, 2 (13%) didn’t continue BT, the other 13 (87%) switch to Adalimuab (10) or Etanercept (3). BASDAI at the beginning of treatment was in average 7.2, with 97% over 4. At 12 months was registered a mean reduction respect to base level of 4.7 (IC95% 4.1 to 5.3) and at the last medical evaluation was 5.0 (IC95% 4.4 to 5.6), without statistical significant difference between treatments. At the time of the last evaluation 85% of patients had a BASDAI < 4. 56% of patients have a BASDAI reduction > 2 points or from at least 50% of basal value reduction. Patients have been in treatment an average of 3.3 years.  Conclusions: Treatment of AS with biological therapy in CCSS has been effective in a majority of patients, without differences between therapies. PSY5 TREATMENT OUTCOMES IN LUPUS NEPHRITIS CLASS 3 AND 4 Prabhu R A 1, Prasad N S 1, Kosuru S 1, Rangaswamy D 1, Mareddy A S 1, Madken M 1, Kaza S 1, Rao S P 1, Shenoy S 1, Saraf K 1, Nair S 2, Kunhikatta V 2 1Kasturba Medical College Manipal, Manipal University, Manipal, Udupi, Karnataka, India, 2Manipal College of Pharmaceutical Sciences, Manipal University, Manipal, India .

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Objectives: To assess outcomes to treatment modalities in lupus nephritis (LN) class 3 and 4.  Methods: A prospective observational study of newly diagnosed LN class 3 and 4 between August 2012 and June 2015. Baseline demographic data, clinical, laboratory and histopathological features were collected. Patients received either of pulse cyclophosphamide(Cyc) in escalating doses starting with 750 mg/m2 up to one gram/m2 titrated to nadir leukocyte count and kidney function or low dose Mycophenolate mofetil (MMF) i.e. two grams/day or equivalent Mycophenolic acid. Both therapies were given as induction followed by maintenance after six months. Six months minimum follow up was considered for inclusion and patients who switched therapies or received other modalities were excluded. Complete response was defined as return of renal function to normal or baseline and decline of proteinuria to less than 500 mg /day or equivalent urine protein to creatinine ratio and partial response as improvement in kidney function but not to normal or baseline and decline in proteinuria by 50 % and less than 3000 mg/day if originally in nephrotic range and analyzed for partial or complete response. Statistical analyses were done on SPSS version 16.  Results: Among the 54 patient with LN, 49 (91%) were females, 17 (31.4%) were class 3 and 37 were (68.6%) class 4. Mean age was 26.2 years. Pulse cyclophosphamide was given to 36 (67%) and MMF to 18 (33%). Overall response was seen in 94.4% to both Cyc and MMF. Adverse effects were observed