Results. Table 1: Demographic and Baseline Characteristics, Open-Label Safety Population Prior Double-Blind OC/APAP ER (n=77)
|
|
- Daisy Whitehead
- 5 years ago
- Views:
Transcription
1 Open-Lbel Extension of Rndomized, Double-Blind, Plcebo-Controlled, Phse 3 Study of the Sfety nd Anlgesic Efficcy of MNK-795 Oxycodone/Acetminophen Extended-Relese (OC/APAP ER) Tblets in n Acute Pin Model Neil Singl, MD 1 ; Thoms Brrett, PhD 2 ; Lis Sisk 2 ; Kenneth Kostenbder, MD 2 ; Jim Young, PhD 2 1 Lotus Clinicl Reserch LLC, Psden, CA, USA; 2 Mllinckrodt Inc., Hzelwood, MO, USA Introduction uudespite the wide rnge of tretment options vilble for cute pin, dvnces in the mngement of cute pin re needed 1 uumultimodl therpy combining oxycodone (OC) nd cetminophen (APAP) is well-estblished pproch to the tretment of cute pin 2,3 Combining gents with different mechnisms of ction my offer dditive effects, while llowing for the mngement of pin t lower dose of ech component, potentilly reducing the risk of concentrtion-dependent dverse events 4-6 uuin ddition, formultions engineered to provide quick nd sustined relese my offer therpeutic benefit s well s reduce the pill burden 5,7 uumnk-795 (OC/APAP ER) is n extended-relese (ER) combintion OC/APAP nlgesic, nd is being designed to provide both fst onset of nlgesi within 1 hour nd sustined nlgesi over the 12-hour dosing intervl OC/APAP ER tblets employ dul-lyer biphsic delivery mechnism tht, when dministered s single dose (ie, 2 tblets), ensures the immedite-relese component delivers 3.75 mg OC/325 mg APAP nd the ER component delivers mg OC/325 mg APAP Incorportes technology designed to provide tmper resistnce nd buse deterrence uuin this pivotl clinicl tril, OC/APAP ER ws studied in n estblished cute pin model in ptients undergoing first mettrsl bunionectomy; mediction effects were evluted 48 hours post-procedure (double-blind) nd continued throughout voluntry open-lbel tretment period (up to 14 dys) Ptients Methods uptients u ged 18 to 75 yers undergoing unilterl, first mettrsl bunionectomy who reported t lest moderte or severe pin intensity nd numeric rting scle score of 4 (out of 1) between the hours of 4: AM nd 12: PM (fter cesstion of intrvenous poplitel nerve block) on the first postopertive dy were eligible for the study Study Design umulticenter, u rndomized, double-blind, plcebo-controlled, prllel group, phse 3 study of OC/APAP ER in ptients with moderte to severe cute pin Screening period of between 2 nd 3 dys before surgery, rndomized double-blind dosing phse of 2 dys (48 h) postprocedure, nd n optionl 14-dy open-lbel extension for qulified ptients (Figure 1) Figure 1: Study Design Surgery completed; b Nerve block stopped; c Erliest strt for pin ssessment nd rndomiztion; d Ltest strt for pin ssessment nd rndomiztion; e Study mediction dministered within 3 minutes of rndomiztion; f Ptients ssessed for prticiption in open-lbel extension within 48 to 52 hours of receiving first dose of study drug; g End-of-tretment evlutions performed within 3 dys of receiving lst dose of study drug; follow-up telephone cll 7±2 dys fter receiving lst dose of study drug (double-blind nd open-lbel phses). uduring u the double-blind phse of the study, ptients were rndomized to receive 2 tblets of OC/APAP ER (totl 15 mg OC/65 mg APAP) or plcebo dministered every 12 hours (, 12, 24, nd 36 h; 4 totl doses) Use of supplementl nlgesi ws permitted (ie, ibuprofen 4 mg up to 6 times per dy [24 mg/d]) during the double-blind nd open-lbel phses of the study ueligibility u criteri for the open-lbel extension phse of the study included completing the double-blind phse of the study; hving pin intensity score 3 t completion of the double-blind phse of the study, but no lter thn 52 hours fter receiving the first dose of study drug; signing n open-lbel extension consent form prior to surgery; nd greeing to prticipte in the open-lbel extension phse of the study uptients u prticipting in the open-lbel phse of the study were dischrged with instructions to tke 2 tblets of OC/APAP ER every 12 hours until no longer needed The open-lbel phse lsted up to 14 dys, with clinic visits t dys 7 nd 14 (±1 dy), followed by telephone cll 7 dys (±2 dys) fter the lst dose uexclusion u criteri included ny medicl condition tht might decrese study complince or lter the bsorption, distribution, metbolism, or excretion of the study drug (eg, severe chronic dirrhe, chronic constiption, irritble bowel syndrome, or unexplined weight loss); gstric bypss surgery or gstric bnd; history of intolernce to short-term opioid use; nd tretment with study drug or bunionectomy in previous 3 months Assessments During the Open-Lbel Extension usfety u nd tolerbility ssessments were conducted throughout the open-lbel phse of the study nd included physicl exmintions, mesurement of vitl signs (eg, sitting blood pressure, pulse rte, nd temperture), nd clinicl lbortory tests (ie, chemistry, hemtology, nd urinlysis) Adverse events were collected t ech visit nd the 7-dy follow-up phone cll uglobl u ssessment of ptient stisfction ws evluted t 48 hours or erly termintion for the blinded-dosing phse nd t every clinic visit for the open-lbel phse Results Ptient Popultion ua utotl of 329 ptients were enrolled nd received 1 dose of study drug in the blinded-dosing phse of the study 166 ptients received OC/APAP ER; 163 received plcebo 293 ptients (89.1%) completed the double-blind phse of the study 146 ptients (49.8%; prior OC/APAP ER, n=77; prior plcebo, n=69) who completed the double-blind phse of the study entered the open-lbel phse of the study, with 129 ptients (88.4%) completing the open-lbel extension 145 ptients ttended the 1-week follow-up visit, nd 36 ptients ttended the 2-week follow-up visit udemogrphic u chrcteristics of the open-lbel sfety popultion were generlly similr between groups (Tble 1) uduring u the open-lbel dosing phse, 12 ptients (82.2%) received ±2% of the expected doses Prmeter Tble 1: Demogrphic nd Bseline Chrcteristics, Open-Lbel Sfety Popultion Plcebo (n=69) All Ptients in Open-Lbel Phse (N=146) Age, y, men (SD) 39.9 (12.4) 41.4 (14.1) 4.6 (13.2) Femle sex, n (%) 67 (87.) 55 (79.7) 122 (83.6) Rce, n (%) White Blck Asin Ntive Hwiin or other Pcific Islnder 42 (54.5) 31 (4.3) 4 (5.2) 48 (69.6) 19 (27.5) 9 (61.6) 5 (34.2) 5 (3.4) 1 (.7) Weight, kg, men (SD) 71.5 (13.1) 73.2 (12.6) 72.3 (12.8) Body mss index, kg/m 2, men (SD) 26. (4.1) 26.6 (3.4) 26.3 (3.8) Sfety nd Tolerbility uduring u the open-lbel phse, 64 ptients (43.8%) experienced 1 TEAE (Tble 2) The most frequently reported TEAEs were primrily gstrointestinl relted (nuse, vomiting, constiption) nd centrl nervous system-relted (somnolence, hedche, dizziness) Tretment-Emergent Adverse Event, n (%) Tble 2: Tretment-Emergent Adverse Events Occurring During the Open-Lbel Phse Plcebo (n=69) All Ptients (N=146) Any TEAE 25 (32.5) 39 (56.5) 64 (43.8) Nuse 8 (1.4) 18 (26.1) 26 (17.8) Vomiting 3 (3.9) 8 (11.6) 11 (7.5) Constiption 4 (5.2) 5 (7.2) 9 (6.2) Somnolence 1 (1.3) 6 (8.7) 7 (4.8) Hedche 4 (5.2) 2 (2.9) 6 (4.1) Dizziness 2 (2.6) 4 (5.8) 6 (4.1) Peripherl edem 3 (3.9) 4 (2.7) Pruritus 1 (1.3) 3 (4.3) 4 (2.7) Infection 1 (1.3) 3 (4.3) 4 (2.7) uvlues u nd chnges in vitl signs fter 7 dys of open-lbel tretment re shown in Tble 3 Vitl signs during the open-lbel phse were norml in >9% of ptients t ny visit During the open-lbel phse, 1.4% of ptients hd shifts from norml to bnorml oxygen sturtion t ny time point Vitl Sign Tble 3: Vitl Sign Mesures nd Chnges From Bseline After 7 Dys of Open-Lbel Tretment Systolic blood pressure, mm Hg Men (SD) Medin Distolic blood pressure, mm Hg Men (SD) Medin Hert rte, bets/min Men (SD) Medin Respirtory rte, breths/min Men (SD) Medin Body temperture, C Men (SD) Medin Oxygen sturtion, % Men (SD) Medin Bseline Vlue (n=146) (14.12) (9.31) (1.81) (1.94) (.5) (1.69) 98. OL Visit Dy 7 (n=145) 12.6 (14.4) (9.7) (11.62) (1.68) (.54) (1.6) 98. By Dy 14, very few ptients required pin medictions (n=36); therefore, dt from n=145 completing dy 7 re shown here. Ptient Stisfction Chnge From Bseline 3.4 (12.34) (8.45) 2..2 (1.99) (2.52) (.58) (1.76). uat u the 7-dy follow-up, more thn 88% (of 144 ptients) indicted they were "very stisfied" or "stisfied" on ll mesures (Figure 2) uat u the 14-dy follow-up, more thn 83% (of 36 ptients) indicted they were "very stisfied" or "stisfied" on ll mesures (Figure 2) Ptients (%) 1 Figure 2: Proportion of Ptients Stisfied or Very Stisfied With OC/APAP ER After 7 or 14 Dys of Open-Lbel Phse Tretment Dy 7 Dy Conclusions umultiple-dose dministrtion of OC/APAP ER ws generlly well tolerted in this 14-dy open-lbel u extension study The most frequently reported dverse events were consistent with those seen with other opioids in generl, nd specificlly, oxycodone Shifts in lbortory test results, vitl signs, nd oxygen sturtion were generlly smll nd not cliniclly significnt All chnges in clinicl lbortory tests nd vitl signs tht were outside of the defined reference rnge(s) were not cliniclly significnt ccording to the investigtor umore u thn 8% of ptients were very stisfied or stisfied with every mesure of tretment ssessed, including 94.4% for ese of dministrtion, 86.1% for time for the mediction to work, nd 83.3% for level of pin relief uoc/apap u ER is n importnt ddition to the rmmentrium for ptients with moderte to severe cute pin References 1. Apfelbum JL, Chen C, Meht SS, Gn TJ. Postopertive pin experience: results from ntionl survey suggest postopertive pin continues to be undermnged. Anesth Anlg. 23;97(2): Gmmitoni AR, Gler BS, Lcouture P, et l. Effectiveness nd sfety of new oxycodone/cetminophen formultions with reduced cetminophen for the tretment of low bck pin. Pin Med. 23;4(1): Cooper SA, Precheur H, Ruch D, et l. Evlution of oxycodone nd cetminophen in tretment of postopertive dentl pin. Orl Surg Orl Med Orl Pthol. 198;5(6): Brkin RL. Acetminophen, spirin, or ibuprofen in combintion nlgesic products. Am J Ther. 21;8(6): Rff RB. Phrmcology of orl combintion nlgesics: rtionl therpy for pin. J Clin Phrm Ther. 21;26(4): Bever WT, McMilln D. Methodologicl considertions in the evlution of nlgesic combintions: cetminophen (prcetmol) nd hydrocodone in postprtum pin. Br J Clin Phrmcol. 198;1(Suppl 2):215S-223S. 7. McCrberg BH, Brkin RL. Long-cting opioids for chronic pin: phrmcotherpeutic opportunities to enhnce complince, qulity of life, nd nlgesi. Am J Ther. 21;8(3): Disclosures Dr. Singl received grnts s clinicl investigtor from Mllinckrodt Inc. Dr. Brrett, Ms. Sisk, nd Dr. Young re employees of Mllinckrodt Inc. Dr. Kostenbder is pid consultnt to Mllinckrodt Inc. Acknowledgment Technicl editoril nd medicl writing support for the development of this poster ws provided by Sophie Bolick, PhD, Synchrony Medicl Communictions, LLC, West Chester, PA. Funding for this support ws provided by Mllinckrodt Inc., Hzelwood, MO. Objectives uuevlute the sfety of the dministrtion of multiple doses of OC/APAP ER in ptients with moderte to severe cute pin in n open-lbel extension phse of rndomized, double-blind, plcebo-controlled, phse 3 study Assessed the ptient s stisfction with tretment cross 5 dimensions, such s ese of dministrtion nd level of pin relief, on ctegoricl scle (ie, very stisfied, stisfied, neither stisfied nor disstisfied, disstisfied, or very disstisfied) Sttisticl Anlyses udescriptive u sttistics were summrized for bseline chrcteristics nd globl ssessment of stisfction umediction u dherence nd tretment-emergent dverse events (TEAEs) were summrized using frequencies nd percentges usummry u sttistics for ctul vlues nd chnges from bseline were clculted for the physicl exmintion findings, lbortory test results, vitl signs, nd pulse oximetry, nd shift nlysis exmined ctegoricl chnges from bseline to vrious time points u1 uptient reported 3 severe TEAEs, nd 1 ptient reported serious dverse event (ie, deep vein thrombosis determined by the investigtor to be unrelted to tretment with the study drug) uchnges u from bseline in lbortory vlues (ie, hemtology, serum chemistry, nd urinlysis) were generlly smll nd were similr between tretment groups during double-blind periods nd similr between the double-blind nd open-lbel periods Six ptients (4.1%) hd lnine minotrnsferse nd/or sprtte minotrnsferse 3 times the upper limit of norml vlues t lest once during the study Totl bilirubin remined within the norml reference rnge in ll 6 cses None met Hy's Lw criteri 2 Ese of Administrtion Dosing Frequency Number of Tblets Tken Time for Mediction to Work Level of Pin Relief midwest pin society 213 October Chicgo, IL
2 Introduction uudespite the wide rnge of tretment options vilble for cute pin, dvnces in the mngement of cute pin re needed 1 uumultimodl therpy combining oxycodone (OC) nd cetminophen (APAP) is well-estblished pproch to the tretment of cute pin 2,3 Combining gents with different mechnisms of ction my offer dditive effects, while llowing for the mngement of pin t lower dose of ech component, potentilly reducing the risk of concentrtion-dependent dverse events 4-6 uuin ddition, formultions engineered to provide quick nd sustined relese my offer therpeutic benefit s well s reduce the pill burden 5,7 uumnk-795 (OC/APAP ER) is n extended-relese (ER) combintion OC/APAP nlgesic, nd is being designed to provide both fst onset of nlgesi within 1 hour nd sustined nlgesi over the 12-hour dosing intervl OC/APAP ER tblets employ dul-lyer biphsic delivery mechnism tht, when dministered s single dose (ie, 2 tblets), ensures the immedite-relese component delivers 3.75 mg OC/325 mg APAP nd the ER component delivers mg OC/325 mg APAP Incorportes technology designed to provide tmper resistnce nd buse deterrence uuin this pivotl clinicl tril, OC/APAP ER ws studied in n estblished cute pin model in ptients undergoing first mettrsl bunionectomy; mediction effects were evluted 48 hours post-procedure (double-blind) nd continued throughout voluntry open-lbel tretment period (up to 14 dys) Objectives uuevlute the sfety of the dministrtion of multiple doses of OC/APAP ER in ptients with moderte to severe cute pin in n open-lbel extension phse of rndomized, double-blind, plcebo-controlled, phse 3 study
3 Ptients Methods uptients u ged 18 to 75 yers undergoing unilterl, first mettrsl bunionectomy who reported t lest moderte or severe pin intensity nd numeric rting scle score of 4 (out of 1) between the hours of 4: AM nd 12: PM (fter cesstion of intrvenous poplitel nerve block) on the first postopertive dy were eligible for the study Study Design umulticenter, u rndomized, double-blind, plcebo-controlled, prllel group, phse 3 study of OC/APAP ER in ptients with moderte to severe cute pin Screening period of between 2 nd 3 dys before surgery, rndomized double-blind dosing phse of 2 dys (48 h) postprocedure, nd n optionl 14-dy open-lbel extension for qulified ptients (Figure 1) Figure 1: Study Design Surgery completed; b Nerve block stopped; c Erliest strt for pin ssessment nd rndomiztion; d Ltest strt for pin ssessment nd rndomiztion; e Study mediction dministered within 3 minutes of rndomiztion; f Ptients ssessed for prticiption in open-lbel extension within 48 to 52 hours of receiving first dose of study drug; g End-of-tretment evlutions performed within 3 dys of receiving lst dose of study drug; follow-up telephone cll 7±2 dys fter receiving lst dose of study drug (double-blind nd open-lbel phses). uduring u the double-blind phse of the study, ptients were rndomized to receive 2 tblets of OC/APAP ER (totl 15 mg OC/65 mg APAP) or plcebo dministered every 12 hours (, 12, 24, nd 36 h; 4 totl doses) Use of supplementl nlgesi ws permitted (ie, ibuprofen 4 mg up to 6 times per dy [24 mg/d]) during the double-blind nd open-lbel phses of the study ueligibility u criteri for the open-lbel extension phse of the study included completing the double-blind phse of the study; hving pin intensity score 3 t completion of the double-blind phse of the study, but no lter thn 52 hours fter receiving the first dose of study drug; signing n open-lbel extension consent form prior to surgery; nd greeing to prticipte in the open-lbel extension phse of the study uptients u prticipting in the open-lbel phse of the study were dischrged with instructions to tke 2 tblets of OC/APAP ER every 12 hours until no longer needed The open-lbel phse lsted up to 14 dys, with clinic visits t dys 7 nd 14 (±1 dy), followed by telephone cll 7 dys (±2 dys) fter the lst dose uexclusion u criteri included ny medicl condition tht might decrese study complince or lter the bsorption, distribution, metbolism, or excretion of the study drug (eg, severe chronic dirrhe, chronic constiption, irritble bowel syndrome, or unexplined weight loss); gstric bypss surgery or gstric bnd; history of intolernce to short-term opioid use; nd tretment with study drug or bunionectomy in previous 3 months Assessments During the Open-Lbel Extension usfety u nd tolerbility ssessments were conducted throughout the open-lbel phse of the study nd included physicl exmintions, mesurement of vitl signs (eg, sitting blood pressure, pulse rte, nd temperture), nd clinicl lbortory tests (ie, chemistry, hemtology, nd urinlysis) Adverse events were collected t ech visit nd the 7-dy follow-up phone cll uglobl u ssessment of ptient stisfction ws evluted t 48 hours or erly termintion for the blinded-dosing phse nd t every clinic visit for the open-lbel phse Assessed the ptient s stisfction with tretment cross 5 dimensions, such s ese of dministrtion nd level of pin relief, on ctegoricl scle (ie, very stisfied, stisfied, neither stisfied nor disstisfied, disstisfied, or very disstisfied) Sttisticl Anlyses udescriptive u sttistics were summrized for bseline chrcteristics nd globl ssessment of stisfction umediction u dherence nd tretment-emergent dverse events (TEAEs) were summrized using frequencies nd percentges u usummry sttistics for ctul vlues nd chnges from bseline were clculted for the physicl exmintion findings, lbortory test results, vitl signs, nd pulse oximetry, nd shift nlysis exmined ctegoricl chnges from bseline to vrious time points
4 Results Ptient Popultion ua utotl of 329 ptients were enrolled nd received 1 dose of study drug in the blinded-dosing phse of the study 166 ptients received OC/APAP ER; 163 received plcebo 293 ptients (89.1%) completed the double-blind phse of the study 146 ptients (49.8%; prior OC/APAP ER, n=77; prior plcebo, n=69) who completed the double-blind phse of the study entered the open-lbel phse of the study, with 129 ptients (88.4%) completing the open-lbel extension 145 ptients ttended the 1-week follow-up visit, nd 36 ptients ttended the 2-week follow-up visit udemogrphic u chrcteristics of the open-lbel sfety popultion were generlly similr between groups (Tble 1) uduring u the open-lbel dosing phse, 12 ptients (82.2%) received ±2% of the expected doses Tble 1: Demogrphic nd Bseline Chrcteristics, Open-Lbel Sfety Popultion Prmeter Plcebo (n=69) All Ptients in Open-Lbel Phse (N=146) Age, y, men (SD) 39.9 (12.4) 41.4 (14.1) 4.6 (13.2) Femle sex, n (%) 67 (87.) 55 (79.7) 122 (83.6) Rce, n (%) White Blck Asin Ntive Hwiin or other Pcific Islnder 42 (54.5) 31 (4.3) 4 (5.2) 48 (69.6) 19 (27.5) 9 (61.6) 5 (34.2) 5 (3.4) 1 (.7) Weight, kg, men (SD) 71.5 (13.1) 73.2 (12.6) 72.3 (12.8) Body mss index, kg/m 2, men (SD) 26. (4.1) 26.6 (3.4) 26.3 (3.8) Sfety nd Tolerbility uduring u the open-lbel phse, 64 ptients (43.8%) experienced 1 TEAE (Tble 2) The most frequently reported TEAEs were primrily gstrointestinl relted (nuse, vomiting, constiption) nd centrl nervous system-relted (somnolence, hedche, dizziness) Tretment-Emergent Adverse Event, n (%) Tble 2: Tretment-Emergent Adverse Events Occurring During the Open-Lbel Phse Plcebo (n=69) All Ptients (N=146) Any TEAE 25 (32.5) 39 (56.5) 64 (43.8) Nuse 8 (1.4) 18 (26.1) 26 (17.8) Vomiting 3 (3.9) 8 (11.6) 11 (7.5) Constiption 4 (5.2) 5 (7.2) 9 (6.2) Somnolence 1 (1.3) 6 (8.7) 7 (4.8) Hedche 4 (5.2) 2 (2.9) 6 (4.1) Dizziness 2 (2.6) 4 (5.8) 6 (4.1) Peripherl edem 3 (3.9) 4 (2.7) Pruritus 1 (1.3) 3 (4.3) 4 (2.7) Infection 1 (1.3) 3 (4.3) 4 (2.7) u1 uptient reported 3 severe TEAEs, nd 1 ptient reported serious dverse event (ie, deep vein thrombosis determined by the investigtor to be unrelted to tretment with the study drug) uchnges u from bseline in lbortory vlues (ie, hemtology, serum chemistry, nd urinlysis) were generlly smll nd were similr between tretment groups during double-blind periods nd similr between the double-blind nd open-lbel periods Six ptients (4.1%) hd lnine minotrnsferse nd/or sprtte minotrnsferse 3 times the upper limit of norml vlues t lest once during the study Totl bilirubin remined within the norml reference rnge in ll 6 cses None met Hy's Lw criteri
5 uvlues u nd chnges in vitl signs fter 7 dys of open-lbel tretment re shown in Tble 3 Vitl signs during the open-lbel phse were norml in >9% of ptients t ny visit During the open-lbel phse, 1.4% of ptients hd shifts from norml to bnorml oxygen sturtion t ny time point Tble 3: Vitl Sign Mesures nd Chnges From Bseline After 7 Dys of Open-Lbel Tretment Vitl Sign Bseline Vlue (n=146) OL Visit Dy 7 (n=145) Chnge From Bseline Systolic blood pressure, mm Hg Men (SD) Medin (14.12) (14.4) (12.34) 3. Distolic blood pressure, mm Hg Men (SD) Medin 73.2 (9.31) (9.7) (8.45) 2. Hert rte, bets/min Men (SD) Medin 73.9 (1.81) (11.62) (1.99) -1. Respirtory rte, breths/min Men (SD) Medin 16.3 (1.94) (1.68) (2.52). Body temperture, C Men (SD) Medin (.5) (.54) (.58) -.2 Oxygen sturtion, % Men (SD) Medin 97.6 (1.69) (1.6) 98. By Dy 14, very few ptients required pin medictions (n=36); therefore, dt from n=145 completing dy 7 re shown here..4 (1.76). Ptient Stisfction uat u the 7-dy follow-up, more thn 88% (of 144 ptients) indicted they were "very stisfied" or "stisfied" on ll mesures (Figure 2) uat u the 14-dy follow-up, more thn 83% (of 36 ptients) indicted they were "very stisfied" or "stisfied" on ll mesures (Figure 2) Figure 2: Proportion of Ptients Stisfied or Very Stisfied With OC/APAP ER After 7 or 14 Dys of Open-Lbel Phse Tretment Dy 7 Dy Ptients (%) Ese of Administrtion Dosing Frequency Number of Tblets Tken Time for Mediction to Work Level of Pin Relief
6 Conclusions umultiple-dose dministrtion of OC/APAP ER ws generlly well tolerted in this 14-dy open-lbel u extension study The most frequently reported dverse events were consistent with those seen with other opioids in generl, nd specificlly, oxycodone Shifts in lbortory test results, vitl signs, nd oxygen sturtion were generlly smll nd not cliniclly significnt All chnges in clinicl lbortory tests nd vitl signs tht were outside of the defined reference rnge(s) were not cliniclly significnt ccording to the investigtor umore u thn 8% of ptients were very stisfied or stisfied with every mesure of tretment ssessed, including 94.4% for ese of dministrtion, 86.1% for time for the mediction to work, nd 83.3% for level of pin relief uoc/apap u ER is n importnt ddition to the rmmentrium for ptients with moderte to severe cute pin References 1. Apfelbum JL, Chen C, Meht SS, Gn TJ. Postopertive pin experience: results from ntionl survey suggest postopertive pin continues to be undermnged. Anesth Anlg. 23;97(2): Gmmitoni AR, Gler BS, Lcouture P, et l. Effectiveness nd sfety of new oxycodone/cetminophen formultions with reduced cetminophen for the tretment of low bck pin. Pin Med. 23;4(1): Cooper SA, Precheur H, Ruch D, et l. Evlution of oxycodone nd cetminophen in tretment of postopertive dentl pin. Orl Surg Orl Med Orl Pthol. 198;5(6): Brkin RL. Acetminophen, spirin, or ibuprofen in combintion nlgesic products. Am J Ther. 21;8(6): Rff RB. Phrmcology of orl combintion nlgesics: rtionl therpy for pin. J Clin Phrm Ther. 21;26(4): Bever WT, McMilln D. Methodologicl considertions in the evlution of nlgesic combintions: cetminophen (prcetmol) nd hydrocodone in postprtum pin. Br J Clin Phrmcol. 198;1(Suppl 2):215S-223S. 7. McCrberg BH, Brkin RL. Long-cting opioids for chronic pin: phrmcotherpeutic opportunities to enhnce complince, qulity of life, nd nlgesi. Am J Ther. 21;8(3): Disclosures Dr. Singl received grnts s clinicl investigtor from Mllinckrodt Inc. Dr. Brrett, Ms. Sisk, nd Dr. Young re employees of Mllinckrodt Inc. Dr. Kostenbder is pid consultnt to Mllinckrodt Inc. Acknowledgment Technicl editoril nd medicl writing support for the development of this poster ws provided by Sophie Bolick, PhD, Synchrony Medicl Communictions, LLC, West Chester, PA. Funding for this support ws provided by Mllinckrodt Inc., Hzelwood, MO.
Clinical Study Report Synopsis Drug Substance Naloxegol Study Code D3820C00018 Edition Number 1 Date 01 February 2013 EudraCT Number
EudrCT Number 2012-001531-31 A Phse I, Rndomised, Open-lbel, 3-wy Cross-over Study in Helthy Volunteers to Demonstrte the Bioequivlence of the Nloxegol 25 mg Commercil nd Phse III Formultions nd to Assess
More informationSafety and Tolerability of Subcutaneous Sarilumab and Intravenous Tocilizumab in Patients With RA
Sfety nd Tolerbility of Subcutneous Srilumb nd Intrvenous Tocilizumb in Ptients With RA Pul Emery, 1 Jun Rondon, 2 Anju Grg, 3 Hubert vn Hoogstrten, 3 Neil M.H. Grhm, 4 Ming Liu, 4 Nncy Liu, 3 Jnie Prrino,
More informationThe RUTHERFORD-2 trial in heterozygous FH: Results and implications
The RUTHERFORD-2 tril in heterozygous FH: Results nd implictions Slide deck kindly supplied s n eductionl resource by Professor Derick Rl MD PhD Crbohydrte & Lipid Metbolism Reserch Unit University of
More informationPresented at the 75 th Annual Meeting of the American Academy of Dermatology, Orlando, FL, March 3-7, 2017 METHODS INTRODUCTION OBJECTIVE
Seven-Yer Interim Results from the ESPRIT 10-Yer Postmrketing Surveillnce Registry of Adlimumb for Moderte to Severe Psorisis Frncisco Kerdel, 1 Aln Menter, 2 Jshin J. Wu, 3 Mreike Bereswill, 4 Dilek Arikn,
More informationCheckMate 153: Randomized Results of Continuous vs 1-Year Fixed-Duration Nivolumab in Patients With Advanced Non-Small Cell Lung Cancer
CheckMte 53: Rndomized Results of Continuous vs -Yer Fixed-Durtion Nivolumb in Ptients With Advnced Non-Smll Cell Lung Cncer Abstrct 297O Spigel DR, McCleod M, Hussein MA, Wterhouse DM, Einhorn L, Horn
More informationSYNOPSIS Final Abbreviated Clinical Study Report for Study CA ABBREVIATED REPORT
Finl Arevited Clinicl Study Report Nme of Sponsor/Compny: Bristol-Myers Squi Ipilimum Individul Study Tle Referring to the Dossier (For Ntionl Authority Use Only) Nme of Finished Product: Yervoy Nme of
More informationStart ORKAMBI today. INDICATIONS AND USAGE IMPORTANT SAFETY INFORMATION. Sydney Age 4
F O R H E A L T H C A R E P R O F E S S I O N A L S For ptients ge 2 yers nd older who re homozygous for the F508del muttion 1,2 Modify the course. Strt tody. Sydney Age 4 F508del/F508del INDICATIONS AND
More informationA review of the patterns of docetaxel use for hormone-resistant prostate cancer at the Princess Margaret Hospital
MEDICAL ONCOLOGY A review of the ptterns of docetxel use for hormone-resistnt prostte cncer t the Princess Mrgret Hospitl S.N. Chin MD,* L. Wng MSc, M. Moore MD,* nd S.S. Sridhr MD MSc* ABSTRACT Bckground
More informationtolerability of Stilpane and Tramacet after third molar extraction
Southern Africn Journl of Anesthesi nd Anlgesi 2015; 21(2):22-27 http://dx.doi.org/10.1080/22201181.2015.1028229 Open Access rticle distributed under the terms of the Cretive Commons License [CC BY-NC-ND
More informationSponsor / Company: Sanofi Drug substance(s): AVE0005 (aflibercept)
These results re supplied for informtionl purposes only. Prescribing decisions should be mde bsed on the pproved pckge insert in the country of prescription. Sponsor / Compny: Snofi Drug substnce(s): AVE0005
More informationProduct Monograph INDICATIONS AND USAGE IMPORTANT RISK INFORMATION WARNING: RISK OF MEDICATION ERRORS AND HEPATOTOXICITY
Product Monogrph INDICATIONS AND USAGE OFIRMEV (cetminophen) injection is indicted for the mngement of mild to moderte pin, mngement of moderte to severe pin with djunctive opioid nlgesics, nd reduction
More informationOriginal Article. T Akter 1, N Islam 2, MA Hoque 3, S Khanam 4, HA khan 5, BK Saha 6. Abstract:
Fridpur Med. Coll. J. 214;9(2):61-67 Originl Article Nebuliztion by Isotonic Mgnesium Sulphte Solution with Provide Erly nd Better Response s Compred to Conventionl Approch ( Plus Norml Sline) in Acute
More informationThe Harvard community has made this article openly available. Please share how this access benefits you. Your story matters. doi: /ajg.2012.
A 12-Week, Rndomized, Controlled Tril with 4-Week Rndomized Withdrwl Period to Evlute the Efficcy nd Sfety of Linclotide in Irritble Bowel Syndrome with Constiption The Hrvrd community hs mde this rticle
More informationAbstract. Background. Aim. Patients and Methods. Patients. Study Design
Impct of the Use of Drugs nd Substitution Tretments on the Antivirl Tretment of Chronic Heptitis C: Anlysis of Complince, Virologicl Response nd Qulity of Life (CHEOBS). Melin, 1 J.-. Lng, D. Ouzn, 3 M.
More informationTR Spitzer 1, CJ Friedman 2, W Bushnell 2, SR Frankel 3, J Raschko 4. Summary:
(2000) 26, 203 210 2000 Mcmilln Publishers Ltd All rights reserved 0268 3369/00 $15.00 www.nture.com/bmt Double-blind, rndomized, prllel-group study on the efficcy nd sfety of orl grnisetron nd orl ondnsetron
More informationCommunity. Profile Big Horn County. Public Health and Safety Division
Community Helth Profile 2015 Big Horn County Public Helth nd Sfety Division Tble of Contents Demogrphic Informtion 1 Communicble Disese 3 Chronic Disese 4 Mternl nd Child Helth 10 Mortlity 12 Behviorl
More informationPatient-Controlled Transdermal Fentanyl Versus Intravenous Morphine Pump After Spine Surgery
Ptient-Controlled Trnsderml Fentnyl Versus Intrvenous Morphine Pump After Spine Surgery Emily M. Lindley, PhD; Kenneth Millign, BS; Ryn Frmer, MD; Evlin L. Burger, MD; Viks V. Ptel, MD bstrct Ptient-controlled
More informationOnset of Action and Efficacy of Ibuprofen Liquigel as Compared to Solid Tablets: A Systematic Review and Meta-Analysis
Onset of Action nd Efficcy of Ibuprofen Liquigel s Compred to Solid Tblets: A Systemtic Review nd Met-Anlysis Hnn Al Lwti nd Fkhreddin Jmli Fculty of Phrmcy & Phrmceuticl Sciences, University of Albert,
More informationA Randomized Phase III Clinical Trial of Plecanatide, a Uroguanylin Analog, in Patients With Chronic Idiopathic Constipation
ORIGINAL CONTRIBUTIONS 3 see relted editoril on pge x A Rndomized Phse III Clinicl Tril of Plecntide, Urogunylin Anlog, in Ptients With Chronic Idiopthic Constiption Philip B. Miner Jr, MD, Willim D. Koltun,
More informationCommunity. Profile Powell County. Public Health and Safety Division
Community Helth Profile 2015 Powell County Public Helth nd Sfety Division Tble of Contents Demogrphic Informtion 1 Communicble Disese 3 Chronic Disese 4 Mternl nd Child Helth 10 Mortlity 12 Behviorl Risk
More informationLarry Alphs 1*, Cynthia A Bossie 1, Jennifer K Sliwa 1, Yi-Wen Ma 2 and Norris Turner 1. Abstract
PRIMARY RESEARCH Open Access Onset of efficcy with cute long-cting injectble pliperidone plmitte tretment in mrkedly to severely ill ptients with schizophreni: post hoc nlysis of rndomized, double-blind
More informationCommunity. Profile Yellowstone County. Public Health and Safety Division
Community Helth Profile 2015 Yellowstone County Public Helth nd Sfety Division Tble of Contents Demogrphic Informtion 1 Communicble Disese 3 Chronic Disese 4 Mternl nd Child Helth 10 Mortlity 12 Behviorl
More informationCommunity. Profile Anaconda- Deer Lodge County. Public Health and Safety Division
Community Helth Profile 2015 Ancond- Deer Lodge County Public Helth nd Sfety Division Tble of Contents Demogrphic Informtion 1 Communicble Disese 3 Chronic Disese 4 Mternl nd Child Helth 10 Mortlity 12
More informationEfficacy of Pembrolizumab in Patients With Advanced Melanoma With Stable Brain Metastases at Baseline: A Pooled Retrospective Analysis
Efficcy of Pembrolizumb in Ptients With Advnced Melnom With Stble Brin Metstses t Bseline: A Pooled Retrospective Anlysis Abstrct 1248PD Hmid O, Ribs A, Dud A, Butler MO, Crlino MS, Hwu WJ, Long GV, Ancell
More informationCommunity. Profile Missoula County. Public Health and Safety Division
Community Helth Profile 2015 Missoul County Public Helth nd Sfety Division Tble of Contents Demogrphic Informtion 1 Communicble Disese 3 Chronic Disese 4 Mternl nd Child Helth 10 Mortlity 12 Behviorl Risk
More informationCommunity. Profile Lewis & Clark County. Public Health and Safety Division
Community Helth Profile 2015 Lewis & Clrk County Public Helth nd Sfety Division Tble of Contents Demogrphic Informtion 1 Communicble Disese 3 Chronic Disese 4 Mternl nd Child Helth 10 Mortlity 12 Behviorl
More informationEffect of Preoperative Intravenous Methocarbamol and Intravenous Acetaminophen on Opioid Use After Primary Total Hip and Knee Replacement
Feture Article Effect of Preopertive Intrvenous Methocrbmol nd Intrvenous Acetminophen on Opioid Use After Primry Totl Hip nd Knee Replcement THOMAS D. LOOKE, MD, PHD; CAMERON T. KLUTH, MBA bstrct Between
More informationAntiviral Therapy 2015; 20: (doi: /IMP2920)
Antivirl Therpy 2015; 20:397 405 (doi: 10.3851/IMP2920) Originl rticle Sfety, tolerbility nd phrmcokinetics of dorvirine, novel HIV non-nucleoside reverse trnscriptse inhibitor, fter single nd multiple
More informationCommunity. Profile Carter County. Public Health and Safety Division
Community Helth Profile 2015 Crter County Public Helth nd Sfety Division Tble of Contents Demogrphic Informtion 1 Communicble Disese 3 Chronic Disese 4 Mternl nd Child Helth 10 Mortlity 12 Behviorl Risk
More informationTarget: 10 mg/day within several days Schizophrenia in adolescents (2.1)
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include ll the informtion needed to use ZYPREXA sfely nd effectively. See full prescribing informtion for ZYPREXA. ZYPREXA (olnzpine) Tblet
More informationIntroduction. These patients benefit less from conventional chemotherapy than patients identified as MMR proficient or microsatellite stable 3-5
Nivolumb + Ipilimumb Combintion in Ptients With DNA Mismtch Repir-Deficient/Microstellite Instbility-High Metsttic Colorectl Cncer: First Report of the Full Cohort From CheckMte-142 Abstrct 553 André T,
More informationOlanzapine for the prophylaxis and rescue of chemotherapyinduced nausea and vomiting (CINV): a retrospective study
Originl Article Olnzpine for the prophylxis nd rescue of chemotherpyinduced nuse nd vomiting (CINV): retrospective study Leonrd Chiu, Nichols Chiu, Ronld Chow, Liying Zhng, Mrk Psetk, Jordn Stinson, Brenne
More informationIMpower133: Primary PFS, OS, and safety in a Ph1/3 study of 1L atezolizumab + carboplatin + etoposide in extensive-stage SCLC
IMpower133: Primry PFS, OS, nd sfety in Ph1/3 study of 1L tezolizumb + crbopltin + etoposide in extensive-stge SCLC S. V. Liu, 1 A. S. Mnsfield, 2 A. Szczesn, 3 L. Hvel, 4 M. Krzkowski, 5 M. J. Hochmir,
More informationPNEUMOVAX 23 is recommended by the CDC for all your appropriate adult patients at increased risk for pneumococcal disease 1,2 :
PNEUMOVAX 23 is recommended y the CDC for ll your pproprite dult ptients t incresed risk for pneumococcl disese 1,2 : Adults ged
More informationExcessive sleepiness is a cardinal symptom of many sleep disorders,
SCIENTIFIC INVESTIGATIONS Evlution of the Sfety of Modfinil for Tretment of Excessive Sleepiness Thoms Roth, Ph.D. 1 ; Jonthn R.L. Schwrtz, M.D. 2 ; Mx Hirshkowitz, Ph.D. 3 ; Milton K. Ermn, M.D. 4 ; Jeffrey
More informationChilblains (pernio, perniosis) are cold-induced, painful or itching
Nifedipine vs Plcebo for Tretment of Chronic Chilblins: A Rndomized Controlled Tril Ibo H. Souwer, MD 1 Jcobus H. J. Bor, BSc (Mth) 2 Pul Smits, MD, PhD 3 Antoine L. M. Lgro-Jnssen, MD, PhD 1 1 Deprtment
More informationAntiviral Therapy 2015; 20: (doi: /IMP2874)
Antivirl Therpy 25; 2:79 79 (doi:.385/imp2874) Originl rticle Single dose permivir for the tretment of cute sesonl influenz: integrted nlysis of efficcy nd sfety from two plcebo-controlled trils Richrd
More informationOriginal Article. Diabetes Metab J 2011;35:26-33 doi: /dmj pissn eissn
Originl Article Dibetes Metb J 211;35:26-33 doi: 1.493/dmj.211.35.1.26 pissn 2233-679 eissn 2233-687 D I A B E T E S & M E T A B O L I S M J O U R N A L Comprison of the Efficcy of Glimepiride, Metformin,
More informationXALKORI (crizotinib) Is Available Through Specialty Pharmacies
XALKORI (crizotinib) Is Avilble Through Specilty Phrmcies Specilty Phrmcy Ordering Process The Provider s Office Submits XALKORI prescriptions to the specilty phrmcy vi: Phone Fx Internet Submits ny supporting
More informationInvasive Pneumococcal Disease Quarterly Report. July September 2017
Invsive Pneumococcl Disese Qurterly Report July September 2017 Prepred s prt of Ministry of Helth contrct for scientific services by Rebekh Roos Helen Heffernn October 2017 Acknowledgements This report
More informationA Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of the Safety and Analgesic Efficacy of MNK-795 Controlled-Release
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of the Safety and Analgesic Efficacy of MNK-795 Controlled-Release Oxycodone/Acetaminophen Tablets (CR OC/APAP) in an Acute Pain Model Neil
More informationINVEGA SUSTENNA (paliperidone palmitate) extended-release injectable
(pliperidone plmitte) extended-relese injectble suspension, for intrmusculr use HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include ll the informtion needed to use sfely nd effectively.
More informationAnalysis of alternatives for insulinizing patients to achieve glycemic control and avoid accompanying risks of hypoglycemia
284 Anlysis of lterntives for izing ptients to chieve glycemic control nd void ccompnying risks of hypoglycemi JIALIN GAO 1,2*, QIANYIN XIONG 1,2*, JUN MIAO 1*, YAO ZHANG 2,3, LIBING XIA 1, MEIQIN LU 1,
More informationOpioid Use and Survival at the End of Life: A Survey of a Hospice Population
532 Journl of Pin nd Symptom Mngement Vol. 32 No. 6 December 2006 NHPCO Originl Article Opioid Use nd Survivl t the End of Life: A Survey of Hospice Popultion Russell K. Portenoy, MD, Un Sibircev, BA,
More informationINVEGA SUSTENNA (paliperidone palmitate) extended-release injectable
(pliperidone plmitte) extended-relese injectble suspension, for intrmusculr use HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include ll the informtion needed to use sfely nd effectively.
More informationIsoetharinewith PhenylephrineAerosol in Asthma
J Clin Phrmcol. 1983; 23:82-88. Comprison of Fenoterol,Isoproterenol,od Isoethrineith PhenylephrineAerosol in Asthm GEORGE G. SPELLMAN, JR., M.D.,* BARBARA J. GRUEBEL, M.D., JOEL D. EPSTEIN, M.D., HAROLD
More informationEfficacy of Sonidegib in Patients With Metastatic BCC (mbcc)
AAD 216 eposter 3368 Efficcy of Sonidegib in Ptients With Metsttic BCC (mbcc) Colin Morton, 1 Michel Migden, 2 Tingting Yi, 3 Mnish Mone, 3 Dlil Sellmi, 3 Reinhrd Dummer 4 1 Stirling Community Hospitl,
More informationSafety of Ocrelizumab in Multiple Sclerosis: Updated Analysis in Patients With Relapsing and Primary Progressive Multiple Sclerosis
Sfety of Ocrelizumb in Multiple Sclerosis: Updted Anlysis in Ptients With Relpsing nd Primry Progressive Multiple Sclerosis SL Huser, L Kppos, X Montlbn, H Koendgen, C Chognot, C Li, C Mrcillt, A Prdhn,
More informationBody mass index, waist-to-hip ratio, and metabolic syndrome as predictors of middle-aged men's health
Originl Article - Sexul Dysfunction/Infertility pissn 2005-6737 eissn 2005-6745 Body mss index, wist-to-hip rtio, nd metbolic syndrome s predictors of middle-ged men's helth Jung Hyun Prk *, In-Chng Cho
More informationAddendum to the Evidence Review Group Report on Aripiprazole for the treatment of schizophrenia in adolescents (aged years)
Addendum to the Evidence Review Group Report on Aripiprzole for the tretment of schizophreni in dolescents (ged 15-17 yers) Produced by Authors Correspondence to Southmpton Helth Technology Assessments
More informationDiabetes affects 29 million Americans, imposing a substantial
CLINICAL Comprtive Effectiveness nd Costs of Insulin Pump Therpy for Dibetes Ronld T. Ackermnn, MD, MPH; Amish Wlli, MD, MS; Rymond Kng, MA; Andrew Cooper, MPH; Theodore A. Prospect, FSA, MAAA; Lewis G.
More information10-15 mg/day 15 mg/day 30 mg/day. 2-5 mg/day 5-10 mg/day 15 mg/day. 2 mg/day 5-10 mg/day 15 mg/day. 30 mg/day injected IM
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include ll the informtion needed to use ABILIFY sfely nd effectively. See full prescribing informtion for ABILIFY. Tblets ABILIFY DISCMELT
More informationImpact of Pharmacist Intervention on Diabetes Patients in an Ambulatory Setting
Impct of Phrmcist Intervention on Dibetes Ptients in n Ambultory Setting Julie Stding, PhrmD, CDE, Jmie Herrmnn, PhrmD, Ryn Wlters, MS, Chris Destche, PhrmD, nd Aln Chock, PhrmD Dibetes is the seventh-leding
More informationAssessment of Depression in Multiple Sclerosis. Validity of Including Somatic Items on the Beck Depression Inventory II
Assessment of Depression in Multiple Sclerosis Vlidity of Including Somtic Items on the Beck Depression Inventory II Peggy Crwford, PhD; Noh J. Webster, MA Signs nd symptoms of multiple sclerosis (MS)
More informationShort-term therapy with lasting relief 2
# 1 PRESCRIBED MEDICATION APPROVED FOR IBS-D 1 * Short-term therpy with lsting relief 2 provided up to 6 months of symptom relief with 2-week tretment 2 Rnge of 6 to 24 weeks; medin of 10 weeks. Convenient
More information58 % 50 % REDUCTION IN RISK OF OVERT HE RECURRENCE 1
FOR ADULT PATIENTS WITH OVERT HEPATIC ENCEPHALOPATHY (HE) significntly reduced the risk of overt HE recurrence nd HE-relted hospitliztions 1 58 % 50 % REDUCTION IN RISK OF OVERT HE RECURRENCE 1 REDUCTION
More informationBudesonide Multimatrix Is Efficacious for Mesalamine-refractory, Mild to Moderate Ulcerative Colitis: A Randomised, Placebo-controlled Trial
Journl of Crohn's nd Colitis, 2017, 785 791 doi:10.1093/ecco-jcc/jjx032 Advnce Access publiction Mrch 4, 2017 Originl Article Originl Article Budesonide Multimtrix Is Efficcious for Meslmine-refrctory,
More informationSupplementary Online Content
Supplementry Online Content Zulmn DM, Pl Chee C, Ezeji-Okoye SC, et l. Effect of n intensive outptient progrm to ugment primry cre for high-need Veterns Affirs ptients: rndomized clinicl tril. JAMA Intern
More informationBlood Pressure and Heart Rate Effects, Weight Loss and Maintenance During Long-Term Phentermine Pharmacotherapy for Obesity
nture publishing group rticles Blood Pressure nd Hert Rte Effects, Weight Loss nd Mintennce During Long-Term Phentermine Phrmcotherpy for Obesity Ed J. Hendricks 1,2, Frnk L. Greenwy 3, Eric C. Westmn
More informationDebra A. Ignaut, R.N., B.S., C.D.E., and Haoda Fu, Ph.D.
Journl of Dietes Science nd Technology Volume 6, Issue 2, Mrch 2012 Dietes Technology Society TECHNOLOGY REPORT Comprison of Insulin Diluent Lekge Postinjection Using Two Different Needle Lengths nd Injection
More informationPROVEN ANTICOCCIDIAL IN NEW FORMULATION
PROVEN ANTICOCCIDIAL IN NEW FORMULATION Coxidin 100 microgrnulte A coccidiosttic dditive for roilers, chickens rered for lying nd turkeys Contins 100 g of monensin sodium per kg Aville s homogenous grnules
More informationPharmacokinetic Characterization of the Novel Pulmonary Delivery Excipient Fumaryl Diketopiperazine
Journl of Dibetes Science nd Technology Volume 4, Issue 5, September 2010 Dibetes Technology Society ORIGINAL ARTICLES Phrmcokinetic Chrcteriztion of the Novel Pulmonry Delivery Excipient Fumryl Diketopiperzine
More informationY. Yazici 1, D. Moniz Reed 2, C. Klem 2, L. Rosenblatt 2, G. Wu 2, J.M. Kremer 3
Greter remission rtes in ptients with erly versus long-stnding disese in biologic-nive rheumtoid rthritis ptients treted with btcept: post hoc nlysis of rndomised clinicl tril dt Y. Yzici 1, D. Moniz Reed
More informationEffect on Glycemic, Blood Pressure, and Lipid Control according to Education Types
Originl Article http://dx.doi.org/10.4093/dmj.2011.35.6.580 pissn 2233-6079 eissn 2233-6087 D I A B E T E S & M E T A B O L I S M J O U R N A L Effect on Glycemic, Blood Pressure, nd Lipid Control ccording
More information2.3. with type 1 diabetes <3 years of age. (8.4)
1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include ll the informtion needed to use HUMALOG sfely nd effectively. See full prescribing informtion for HUMALOG. HUMALOG (insulin lispro
More informationRevised: 6/2018 History of severe hypersensitivity reaction to pemetrexed. (4)
HIGHLIGHTS OF PRESCRIBING INFORMATION ------------------------ WARNINGS AND PRECAUTIONS ----------------------- These highlights do not include ll the informtion needed to use ALIMTA sfely nd effectively.
More informationThe Acute Time Course of Concurrent Activation Potentiation
Mrquette University e-publictions@mrquette Exercise Science Fculty Reserch nd Publictions Exercise Science, Deprtment of 1-1-2010 The Acute Time Course of Concurrent Activtion Potentition Luke Grceu Mrquette
More informationHealth Coaching: A Preliminary Report on the Effects in Traumatic Brain Injury/Polytrauma Patients
ORIGINAL RESEARCH Helth Coching: A Preliminry Report on the Effects in Trumtic Brin Injury/Polytrum Ptients Esmerld Mdrigl, MSW; Mx Gry, BA; Molly A. Timmermn, DO; Ttin Orozco, PhD; Dine Cowper Ripley,
More informationEmerging Options for Thromboprophylaxis After Orthopedic Surgery: A Review of Clinical Data
Emerging Options for Thromboprophylxis After Orthopedic Surgery: A Review of Clinicl Dt Bob L. Lobo, Phrm.D. In four rndomized, controlled studies of ptients undergoing orthopedic surgery, the ntithrombotic
More informationClinicalTrials.gov Identifier: NCT
Efficcy of Drtumumb, Lenlidomide, nd Dexmethsone Versus Lenlidomide nd Dexmethsone in Relpsed or Refrctory Multiple Myelom Ptients With to 3 Prior Lines of Therpy: Updted Anlysis of POLLUX Sd Z. Usmni,
More informationGemmis Injection 38 mg/ml
Gemmis Injection 8 mg/ml Gemcitbine (Gemcitbine HCl) is nucleoside nlogue tht exhibits nti-tumor ctivity. The empiricl formul for Gemcitbine HCl is C 9H 11F 2N O.HCl. It hs moleculr weight of 299.66. Gemcitbine
More informationSee 17 for PATIENT COUNSELING INFORMATION and FDAapproved. Revised: 01/2019
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include ll the informtion needed to use ALIMTA sfely nd effectively. See full prescribing informtion for ALIMTA. ALIMTA (pemetrexed for injection),
More informationSee 17 for PATIENT COUNSELING INFORMATION and FDAapproved patient labeling. Revised: 6/2016 FULL PRESCRIBING INFORMATION: CONTENTS*
1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include ll the informtion needed to use BASAGLAR sfely nd effectively. See full prescribing informtion for BASAGLAR BASAGLAR (insulin glrgine
More informationSee 17 for PATIENT COUNSELING INFORMATION and FDAapproved
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include ll the informtion needed to use ALIMTA sfely nd effectively. See full prescribing informtion for ALIMTA. ALIMTA (pemetrexed for injection),
More informationEffects of physical exercise on working memory and prefrontal cortex function in post-stroke patients
Effects of physicl exercise on working memory nd prefrontl cortex function in post-stroke ptients M Moriy, C Aoki, K Sktni Grdute School of Helth Sciences Reserch, Mjor of Physicl Therpy, TeikyoHeisei
More informationULTOMIRIS is administered once every 8 weeks a
(rvulizumb-cwvz) for the tretment of dult ptients with proxysml nocturnl hemoglobinuri (PNH) is dministered once every 8 weeks PATIENTS STARTING WITH NO PRIOR TREATMENT FOR PNH THE RECOMMENDED DOSING REGIMEN
More informationDOSAGE FORMS AND STRENGTHS HIGHLIGHTS OF PRESCRIBING INFORMATION
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include ll the informtion needed to use ALIMTA sfely nd effectively. See full prescribing informtion for ALIMTA. ALIMTA (pemetrexed disodium)
More informationEffect of vitamin D on the recurrence rate of rheumatoid arthritis
1812 Effect of vitmin D on the recurrence rte of rheumtoid rthritis JUNXIA YANG 1, LIN LIU 1, QINGLIN ZHANG 2, MEIRONG LI 1 nd JINGYA WANG 1 1 Deprtment of Rheumtology, 2 Centrl Lbortory, Xuzhou Centrl
More informationEVALUATION OF MULLIGAN S TECHNIQUE FOR ADHESIVE CAPSULITIS OF THE SHOULDER
J Rehbil Med 2013; 45: 87 91 ORIGINAL REPORT EVALUATION OF MULLIGAN S TECHNIQUE FOR ADHESIVE CAPSULITIS OF THE SHOULDER Gokhn Doner, PT, MSc 1, Zeynep Guven, MD 2, Ayçe Atly, MD 2 nd Reyhn Celiker, MD
More informationHypertension, hyperinsulinaemia and obesity in middle-aged Finns with impaired glucose tolerance
Journl of Humn Hypertension (1998) 12, 265 269 1998 Stockton Press. All rights reserved 0950-9240/98 $12.00 ORIGINAL ARTICLE Hypertension, hyperinsulinemi nd obesity in middle-ged Finns with impired glucose
More informationSeasonal influenza vaccination programme country profile: Ireland
Sesonl influenz vccintion progrmme country profile: Irelnd 2012 13 Seson Bckground informtion Influenz immunistion policy nd generl fcts bout Irelnd Volume indices of GDP per cpit in 2011 nd 2013 (EU-
More informationEVALUATION OF DIFFERENT COPPER SOURCES AS A GROWTH PROMOTER IN SWINE FINISHING DIETS 1
Swine Dy 2001 Contents EVALUATION OF DIFFERENT COPPER SOURCES AS A GROWTH PROMOTER IN SWINE FINISHING DIETS 1 C. W. Hstd, S. S. Dritz 2, J. L. Nelssen, M. D. Tokch, nd R. D. Goodbnd Summry Two trils were
More informationInvasive Pneumococcal Disease Quarterly Report July September 2018
Invsive Pneumococcl Disese Qurterly Report July Septemer Introduction Since 17 Octoer 2008, invsive pneumococcl disese (IPD) hs een notifile to the locl Medicl Officer of Helth under the Helth Act 1956.
More informationOriginal Investigation. management of type 2 diabetes mellitus.
Reserch Originl Investigtion Roux-en-Y Gstric Bypss Surgery or Lifestyle With Intensive Medicl Mngement in Ptients With Type 2 Dibetes Fesibility nd 1-Yer Results of Rndomized Clinicl Tril Florenci Hlperin,
More informationEffects of 6-Month Sitagliptin Treatment on Insulin and Glucagon Responses in Korean Patients with Type 2 Diabetes Mellitus
Originl Article Others Dibetes Metb J 215;39:335-341 http://dx.doi.org/1.493/dmj.215.39.4.335 pissn 2233-679 eissn 2233-687 DIABETES & METABOLISM JOURNAL Effects of 6-Month Sitgliptin Tretment on Insulin
More informationMetabolic Syndrome and Health-related Quality of Life in Obese Individuals Seeking Weight Reduction
Metbolic Syndrome nd Helth-relted Qulity of Life in Obese Individuls Seeking Weight Reduction Adm Gilden Tsi 1, Thoms A. Wdden 1, Dvid B. Srwer 1, Robert I. Berkowitz 1, Leslie G. Womble 1, Louise A. Hesson
More informationFirst Experience in Quality of Life Analysis After Bariatric Surgery
DOI: 10.2478/v10163-010-0003-8 ACTA CHIRURGICA LATVIENSIS 2009 (9 ) ORIGINAL ARTICLE First Experience in Qulity of Life Anlysis After Britric Surgery Arturs Ozolins*,**, Mris Pvrs*, Jnis Grdovskis*,**
More informationSubcutaneous Immunotherapy with a Depigmented Polymerized Birch Pollen Extract A New Therapeutic Option for Patients with Atopic Dermatitis
Originl Pper DOI: 10.1159/000320058 Received: June 16, 2010 Accepted fter revision: August 6, 2010 Published online: Februry 2, 2011 Subcutneous Immunotherpy with Depigmented Polymerized Birch Pollen Extrct
More informationImmune-Mediated Adverse Reactions Management Guide
Immune-Medited Adverse Rections Mngement Guide INDICATIONS AND USAGE YERVOY (ipilimumb) is indicted for: Tretment of unresectble or metsttic melnom in dults nd peditric ptients (12 yers nd older) Adjuvnt
More informationPilot Trial of Osteopathic Manipulative Therapy for Patients With Frequent Episodic Tension-Type Headache
Pilot Tril of Osteopthic Mnipultive Therpy for Ptients With Frequent Episodic Tension-Type Hedche Guido Rolle, MD, DO (Itly); Lucio Tremolizzo, MD, PhD; Frncesco Somlvico, MS; Crlo Ferrrese, MD, PhD; nd
More informationSummary. Effect evaluation of the Rehabilitation of Drug-Addicted Offenders Act (SOV)
Summry Effect evlution of the Rehbilittion of Drug-Addicted Offenders Act (SOV) The Rehbilittion of Drug-Addicted Offenders Act (SOV) ws lunched on April first 2001. This lw permitted the compulsory plcement
More informationSee 17 for PATIENT COUNSELING INFORMATION. Revised: 02/2011 FULL PRESCRIBING INFORMATION: CONTENTS*
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include ll the informtion needed to use GEMZAR sfely nd effectively. See full prescribing informtion for GEMZAR. GEMZAR (gemcitbine for injection)
More informationWeight-Based Dosage Regimen: (2.1) Body Weight Range (kg) Loading Dose (mg) Maintenance Dose (mg) greater or equal to 40 to less than 60 2,400 3,000
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include ll the informtion needed to use sfely nd effectively. See full prescribing informtion for. (rvulizumb-cwvz) injection, for intrvenous
More informationSymptom Management and Supportive Care
This mteril is protected y U.S. Copyright lw. Unuthorized reproduction is prohiited. For reprints contct: Reprints@AlphMedPress.com Symptom Mngement nd Supportive Cre Erly Intervention with Epoetin Alf
More informationIf Eligible, Get EFFEXOR XR Co-Pay Card Savings on Your Branded Prescription*
If Eligible, Get EFFEXOR XR Co-Py Crd Svings on Your Brnded Prescription* REMEMBER: You must be prescribed brnd-nme EFFEXOR XR to receive the monthly svings tht come with your Co-Py Crd. *Terms nd conditions
More informationComparative Safety of Filgrastim versus Sargramostim in Patients Receiving Myelosuppressive Chemotherapy
Comprtive Sfety of Filgrstim versus Srgrmostim in Ptients Receiving Myelosuppressive Chemotherpy Gry Milkovich, B.S., Ronld J. Moleski, Phrm.D., John F. Reitn, Phrm.D., Dvid M. Dunning, M.D., Gene A. Gibson,
More informationManagement and Outcomes of Binge-Eating Disorder in Adults: Current State of the Evidence
Clinicin Summry Mentl Helth Eting Disorders Mngement nd Outcomes of Binge-Eting Disorder in Adults: Current Stte of the Evidence Focus of This Summry This is summry of systemtic review evluting the evidence
More informationAppendix J Environmental Justice Populations
Appendix J Environmentl Justice s [This pge intentionlly left blnk] Tble of Contents REFERENCES...J-2 Pge LIST OF TABLES Pge Tble J-1: Demogrphic Overview of Bruinsburg Site Project Are... J-3 Tble J-2:
More information