Safety and Tolerability of Tapentadol Extended Release in Moderate to Severe Chronic Osteoarthritis or Low Back Pain Management: Pooled Analysis of Randomized Controlled Trials
Introduction This analysis of pooled data from four randomized, controlled-dose adjustment, phase 3 studies (three 15-week, double-blind, placebo- and active-controlled studies and a 1-year, open-label, active-controlled safety study) in patients with chronic osteoarthritis hip or knee pain or low b...
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| Veröffentlicht in: | Advances in therapy 2014-06, Vol.31 (6), p.604-620 |
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| creator | Etropolski, Mila Kuperwasser, Brigitte Flügel, Maren Häufel, Thomas Lange, Bernd Rauschkolb, Christine Laschewski, Frank |
| description | Introduction
This analysis of pooled data from four randomized, controlled-dose adjustment, phase 3 studies (three 15-week, double-blind, placebo- and active-controlled studies and a 1-year, open-label, active-controlled safety study) in patients with chronic osteoarthritis hip or knee pain or low back pain evaluated the safety and tolerability of tapentadol extended release (ER) for the management of moderate to severe, chronic pain.
Methods
In the three 15-week studies, patients were randomized (1:1:1) to twice-daily (bid) doses of placebo, tapentadol ER (100–250 mg), or oxycodone hydrochloride (HCl) controlled release (CR; 20–50 mg). In the 1-year safety study, patients were randomized (4:1) to tapentadol ER (100–250 mg bid) or oxycodone HCl CR (20–50 mg bid). Adverse events (AEs) and discontinuations were recorded in each study; pooled results were analyzed by treatment group.
Results
In the placebo (
n
= 993), tapentadol ER (
n
= 1,874), and oxycodone CR (
n
= 1,224) groups, respectively, 40.7%, 48.4%, and 62.3% of patients discontinued treatment prematurely and 58.7%, 79.0%, and 86.6% of patients experienced ≥1 treatment-emergent AE (TEAE). Incidences of gastrointestinal TEAEs in the placebo, tapentadol ER, and oxycodone CR groups, respectively, were 26.6%, 47.3%, and 65.4%; incidences of nervous system TEAEs were 22.5%, 42.6%, and 45.1%, respectively. Moderate or severe gastrointestinal TEAEs were reported for 10.9% of patients who received placebo, 25.3% of patients who received tapentadol ER, and 42.3% of patients who received oxycodone CR, and moderate or severe nervous system TEAEs were reported for 10.6%, 22.1%, and 25.2% of patients, respectively. In the placebo, tapentadol ER, and oxycodone CR groups, respectively, incidences of gastrointestinal TEAEs leading to study discontinuation were 2.1%, 8.3%, and 24.1%; incidences of nervous system TEAEs leading to discontinuation were 1.4%, 7.9%, and 16.3%, respectively.
Conclusion
Results from this large patient population showed that tapentadol ER (100–250 mg bid) had improved gastrointestinal tolerability compared with oxycodone CR, based on the overall incidence of gastrointestinal TEAEs, the incidence of moderate or severe gastrointestinal TEAEs, and the incidence of gastrointestinal TEAEs leading to discontinuation. |
| doi_str_mv | 10.1007/s12325-014-0128-6 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_1543281342</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>1543281342</sourcerecordid><originalsourceid>FETCH-LOGICAL-c399t-8a9044b829ced024eb1970accdc74c216adc24c971e17e4cbf96d73ce0e0dee3</originalsourceid><addsrcrecordid>eNp9kctuFDEQRS0EIkPgA9ggb5DYNNhu94tdGIWHNChR0gt2VrVdnTh02xPbAwxfxSfi1gywY1EqqXxu3ZIvIc85e80Za95ELkpRFYzLXKIt6gdkxdu6KnKJh2TFGskLUbZfTsiTGO8YE6yp2sfkRMiurSRnK_LrGkZMewrO0N5PGGCwk80DP9IetugSGD_R8x8JnUFDr3BCiEito5-9yXhCmjy9xm8YkK5vg3dW04uY0ENIt8EmG6kPdOO_03egv9JLWKTg4AbnvP0tvfTZ1tAzB9M-LvBIr_I1frY_83jtXQp-Wog-WJjiU_JozA2fHfsp6d-f9-uPxebiw6f12abQZdelooWOSTm0otNomJA48K5hoLXRjdSC12C0kLprOPIGpR7GrjZNqZEhM4jlKXl1WLsN_n6HManZRo3TBA79LipeyVK0vJQio_yA6uBjDDiqbbAzhL3iTC05qUNOKueklpxUnTUvjut3w4zmr-JPMBl4eQQgapjGAE7b-I9rq67m7WIuDlzMT-4Gg7rzu5D_Mv7H_TeF7K5h</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1543281342</pqid></control><display><type>article</type><title>Safety and Tolerability of Tapentadol Extended Release in Moderate to Severe Chronic Osteoarthritis or Low Back Pain Management: Pooled Analysis of Randomized Controlled Trials</title><source>MEDLINE</source><source>SpringerLink Journals - AutoHoldings</source><creator>Etropolski, Mila ; Kuperwasser, Brigitte ; Flügel, Maren ; Häufel, Thomas ; Lange, Bernd ; Rauschkolb, Christine ; Laschewski, Frank</creator><creatorcontrib>Etropolski, Mila ; Kuperwasser, Brigitte ; Flügel, Maren ; Häufel, Thomas ; Lange, Bernd ; Rauschkolb, Christine ; Laschewski, Frank</creatorcontrib><description>Introduction
This analysis of pooled data from four randomized, controlled-dose adjustment, phase 3 studies (three 15-week, double-blind, placebo- and active-controlled studies and a 1-year, open-label, active-controlled safety study) in patients with chronic osteoarthritis hip or knee pain or low back pain evaluated the safety and tolerability of tapentadol extended release (ER) for the management of moderate to severe, chronic pain.
Methods
In the three 15-week studies, patients were randomized (1:1:1) to twice-daily (bid) doses of placebo, tapentadol ER (100–250 mg), or oxycodone hydrochloride (HCl) controlled release (CR; 20–50 mg). In the 1-year safety study, patients were randomized (4:1) to tapentadol ER (100–250 mg bid) or oxycodone HCl CR (20–50 mg bid). Adverse events (AEs) and discontinuations were recorded in each study; pooled results were analyzed by treatment group.
Results
In the placebo (
n
= 993), tapentadol ER (
n
= 1,874), and oxycodone CR (
n
= 1,224) groups, respectively, 40.7%, 48.4%, and 62.3% of patients discontinued treatment prematurely and 58.7%, 79.0%, and 86.6% of patients experienced ≥1 treatment-emergent AE (TEAE). Incidences of gastrointestinal TEAEs in the placebo, tapentadol ER, and oxycodone CR groups, respectively, were 26.6%, 47.3%, and 65.4%; incidences of nervous system TEAEs were 22.5%, 42.6%, and 45.1%, respectively. Moderate or severe gastrointestinal TEAEs were reported for 10.9% of patients who received placebo, 25.3% of patients who received tapentadol ER, and 42.3% of patients who received oxycodone CR, and moderate or severe nervous system TEAEs were reported for 10.6%, 22.1%, and 25.2% of patients, respectively. In the placebo, tapentadol ER, and oxycodone CR groups, respectively, incidences of gastrointestinal TEAEs leading to study discontinuation were 2.1%, 8.3%, and 24.1%; incidences of nervous system TEAEs leading to discontinuation were 1.4%, 7.9%, and 16.3%, respectively.
Conclusion
Results from this large patient population showed that tapentadol ER (100–250 mg bid) had improved gastrointestinal tolerability compared with oxycodone CR, based on the overall incidence of gastrointestinal TEAEs, the incidence of moderate or severe gastrointestinal TEAEs, and the incidence of gastrointestinal TEAEs leading to discontinuation.</description><identifier>ISSN: 0741-238X</identifier><identifier>EISSN: 1865-8652</identifier><identifier>DOI: 10.1007/s12325-014-0128-6</identifier><identifier>PMID: 24985410</identifier><language>eng</language><publisher>Heidelberg: Springer Healthcare</publisher><subject><![CDATA[Adult ; Aged ; Analgesics - administration & dosage ; Analgesics - adverse effects ; Biological and medical sciences ; Bones, joints and connective tissue. Antiinflammatory agents ; Cardiology ; Chronic Pain - diagnosis ; Chronic Pain - drug therapy ; Delayed-Action Preparations - administration & dosage ; Delayed-Action Preparations - adverse effects ; Diseases of the osteoarticular system ; Double-Blind Method ; Drug-Related Side Effects and Adverse Reactions - diagnosis ; Drug-Related Side Effects and Adverse Reactions - etiology ; Drug-Related Side Effects and Adverse Reactions - prevention & control ; Endocrinology ; Female ; Health technology assessment ; Humans ; Internal Medicine ; Low Back Pain - diagnosis ; Low Back Pain - drug therapy ; Male ; Medical sciences ; Medicine ; Medicine & Public Health ; Middle Aged ; Oncology ; Original Research ; Osteoarthritis ; Osteoarthritis, Hip - diagnosis ; Osteoarthritis, Hip - drug therapy ; Osteoarthritis, Knee - diagnosis ; Osteoarthritis, Knee - drug therapy ; Oxycodone - administration & dosage ; Oxycodone - adverse effects ; Pain Management - methods ; Pain Measurement ; Pharmacology. Drug treatments ; Pharmacology/Toxicology ; Phenols - administration & dosage ; Phenols - adverse effects ; Randomized Controlled Trials as Topic ; Receptors, Opioid, mu - agonists ; Rheumatology ; Treatment Outcome]]></subject><ispartof>Advances in therapy, 2014-06, Vol.31 (6), p.604-620</ispartof><rights>Springer Healthcare 2014</rights><rights>2015 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c399t-8a9044b829ced024eb1970accdc74c216adc24c971e17e4cbf96d73ce0e0dee3</citedby><cites>FETCH-LOGICAL-c399t-8a9044b829ced024eb1970accdc74c216adc24c971e17e4cbf96d73ce0e0dee3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s12325-014-0128-6$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s12325-014-0128-6$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,780,784,27924,27925,41488,42557,51319</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=28596182$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/24985410$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Etropolski, Mila</creatorcontrib><creatorcontrib>Kuperwasser, Brigitte</creatorcontrib><creatorcontrib>Flügel, Maren</creatorcontrib><creatorcontrib>Häufel, Thomas</creatorcontrib><creatorcontrib>Lange, Bernd</creatorcontrib><creatorcontrib>Rauschkolb, Christine</creatorcontrib><creatorcontrib>Laschewski, Frank</creatorcontrib><title>Safety and Tolerability of Tapentadol Extended Release in Moderate to Severe Chronic Osteoarthritis or Low Back Pain Management: Pooled Analysis of Randomized Controlled Trials</title><title>Advances in therapy</title><addtitle>Adv Ther</addtitle><addtitle>Adv Ther</addtitle><description>Introduction
This analysis of pooled data from four randomized, controlled-dose adjustment, phase 3 studies (three 15-week, double-blind, placebo- and active-controlled studies and a 1-year, open-label, active-controlled safety study) in patients with chronic osteoarthritis hip or knee pain or low back pain evaluated the safety and tolerability of tapentadol extended release (ER) for the management of moderate to severe, chronic pain.
Methods
In the three 15-week studies, patients were randomized (1:1:1) to twice-daily (bid) doses of placebo, tapentadol ER (100–250 mg), or oxycodone hydrochloride (HCl) controlled release (CR; 20–50 mg). In the 1-year safety study, patients were randomized (4:1) to tapentadol ER (100–250 mg bid) or oxycodone HCl CR (20–50 mg bid). Adverse events (AEs) and discontinuations were recorded in each study; pooled results were analyzed by treatment group.
Results
In the placebo (
n
= 993), tapentadol ER (
n
= 1,874), and oxycodone CR (
n
= 1,224) groups, respectively, 40.7%, 48.4%, and 62.3% of patients discontinued treatment prematurely and 58.7%, 79.0%, and 86.6% of patients experienced ≥1 treatment-emergent AE (TEAE). Incidences of gastrointestinal TEAEs in the placebo, tapentadol ER, and oxycodone CR groups, respectively, were 26.6%, 47.3%, and 65.4%; incidences of nervous system TEAEs were 22.5%, 42.6%, and 45.1%, respectively. Moderate or severe gastrointestinal TEAEs were reported for 10.9% of patients who received placebo, 25.3% of patients who received tapentadol ER, and 42.3% of patients who received oxycodone CR, and moderate or severe nervous system TEAEs were reported for 10.6%, 22.1%, and 25.2% of patients, respectively. In the placebo, tapentadol ER, and oxycodone CR groups, respectively, incidences of gastrointestinal TEAEs leading to study discontinuation were 2.1%, 8.3%, and 24.1%; incidences of nervous system TEAEs leading to discontinuation were 1.4%, 7.9%, and 16.3%, respectively.
Conclusion
Results from this large patient population showed that tapentadol ER (100–250 mg bid) had improved gastrointestinal tolerability compared with oxycodone CR, based on the overall incidence of gastrointestinal TEAEs, the incidence of moderate or severe gastrointestinal TEAEs, and the incidence of gastrointestinal TEAEs leading to discontinuation.</description><subject>Adult</subject><subject>Aged</subject><subject>Analgesics - administration & dosage</subject><subject>Analgesics - adverse effects</subject><subject>Biological and medical sciences</subject><subject>Bones, joints and connective tissue. Antiinflammatory agents</subject><subject>Cardiology</subject><subject>Chronic Pain - diagnosis</subject><subject>Chronic Pain - drug therapy</subject><subject>Delayed-Action Preparations - administration & dosage</subject><subject>Delayed-Action Preparations - adverse effects</subject><subject>Diseases of the osteoarticular system</subject><subject>Double-Blind Method</subject><subject>Drug-Related Side Effects and Adverse Reactions - diagnosis</subject><subject>Drug-Related Side Effects and Adverse Reactions - etiology</subject><subject>Drug-Related Side Effects and Adverse Reactions - prevention & control</subject><subject>Endocrinology</subject><subject>Female</subject><subject>Health technology assessment</subject><subject>Humans</subject><subject>Internal Medicine</subject><subject>Low Back Pain - diagnosis</subject><subject>Low Back Pain - drug therapy</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Middle Aged</subject><subject>Oncology</subject><subject>Original Research</subject><subject>Osteoarthritis</subject><subject>Osteoarthritis, Hip - diagnosis</subject><subject>Osteoarthritis, Hip - drug therapy</subject><subject>Osteoarthritis, Knee - diagnosis</subject><subject>Osteoarthritis, Knee - drug therapy</subject><subject>Oxycodone - administration & dosage</subject><subject>Oxycodone - adverse effects</subject><subject>Pain Management - methods</subject><subject>Pain Measurement</subject><subject>Pharmacology. Drug treatments</subject><subject>Pharmacology/Toxicology</subject><subject>Phenols - administration & dosage</subject><subject>Phenols - adverse effects</subject><subject>Randomized Controlled Trials as Topic</subject><subject>Receptors, Opioid, mu - agonists</subject><subject>Rheumatology</subject><subject>Treatment Outcome</subject><issn>0741-238X</issn><issn>1865-8652</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2014</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kctuFDEQRS0EIkPgA9ggb5DYNNhu94tdGIWHNChR0gt2VrVdnTh02xPbAwxfxSfi1gywY1EqqXxu3ZIvIc85e80Za95ELkpRFYzLXKIt6gdkxdu6KnKJh2TFGskLUbZfTsiTGO8YE6yp2sfkRMiurSRnK_LrGkZMewrO0N5PGGCwk80DP9IetugSGD_R8x8JnUFDr3BCiEito5-9yXhCmjy9xm8YkK5vg3dW04uY0ENIt8EmG6kPdOO_03egv9JLWKTg4AbnvP0tvfTZ1tAzB9M-LvBIr_I1frY_83jtXQp-Wog-WJjiU_JozA2fHfsp6d-f9-uPxebiw6f12abQZdelooWOSTm0otNomJA48K5hoLXRjdSC12C0kLprOPIGpR7GrjZNqZEhM4jlKXl1WLsN_n6HManZRo3TBA79LipeyVK0vJQio_yA6uBjDDiqbbAzhL3iTC05qUNOKueklpxUnTUvjut3w4zmr-JPMBl4eQQgapjGAE7b-I9rq67m7WIuDlzMT-4Gg7rzu5D_Mv7H_TeF7K5h</recordid><startdate>20140601</startdate><enddate>20140601</enddate><creator>Etropolski, Mila</creator><creator>Kuperwasser, Brigitte</creator><creator>Flügel, Maren</creator><creator>Häufel, Thomas</creator><creator>Lange, Bernd</creator><creator>Rauschkolb, Christine</creator><creator>Laschewski, Frank</creator><general>Springer Healthcare</general><general>Springer</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>20140601</creationdate><title>Safety and Tolerability of Tapentadol Extended Release in Moderate to Severe Chronic Osteoarthritis or Low Back Pain Management: Pooled Analysis of Randomized Controlled Trials</title><author>Etropolski, Mila ; Kuperwasser, Brigitte ; Flügel, Maren ; Häufel, Thomas ; Lange, Bernd ; Rauschkolb, Christine ; Laschewski, Frank</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c399t-8a9044b829ced024eb1970accdc74c216adc24c971e17e4cbf96d73ce0e0dee3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2014</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Analgesics - administration & dosage</topic><topic>Analgesics - adverse effects</topic><topic>Biological and medical sciences</topic><topic>Bones, joints and connective tissue. Antiinflammatory agents</topic><topic>Cardiology</topic><topic>Chronic Pain - diagnosis</topic><topic>Chronic Pain - drug therapy</topic><topic>Delayed-Action Preparations - administration & dosage</topic><topic>Delayed-Action Preparations - adverse effects</topic><topic>Diseases of the osteoarticular system</topic><topic>Double-Blind Method</topic><topic>Drug-Related Side Effects and Adverse Reactions - diagnosis</topic><topic>Drug-Related Side Effects and Adverse Reactions - etiology</topic><topic>Drug-Related Side Effects and Adverse Reactions - prevention & control</topic><topic>Endocrinology</topic><topic>Female</topic><topic>Health technology assessment</topic><topic>Humans</topic><topic>Internal Medicine</topic><topic>Low Back Pain - diagnosis</topic><topic>Low Back Pain - drug therapy</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Middle Aged</topic><topic>Oncology</topic><topic>Original Research</topic><topic>Osteoarthritis</topic><topic>Osteoarthritis, Hip - diagnosis</topic><topic>Osteoarthritis, Hip - drug therapy</topic><topic>Osteoarthritis, Knee - diagnosis</topic><topic>Osteoarthritis, Knee - drug therapy</topic><topic>Oxycodone - administration & dosage</topic><topic>Oxycodone - adverse effects</topic><topic>Pain Management - methods</topic><topic>Pain Measurement</topic><topic>Pharmacology. Drug treatments</topic><topic>Pharmacology/Toxicology</topic><topic>Phenols - administration & dosage</topic><topic>Phenols - adverse effects</topic><topic>Randomized Controlled Trials as Topic</topic><topic>Receptors, Opioid, mu - agonists</topic><topic>Rheumatology</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Etropolski, Mila</creatorcontrib><creatorcontrib>Kuperwasser, Brigitte</creatorcontrib><creatorcontrib>Flügel, Maren</creatorcontrib><creatorcontrib>Häufel, Thomas</creatorcontrib><creatorcontrib>Lange, Bernd</creatorcontrib><creatorcontrib>Rauschkolb, Christine</creatorcontrib><creatorcontrib>Laschewski, Frank</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Advances in therapy</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Etropolski, Mila</au><au>Kuperwasser, Brigitte</au><au>Flügel, Maren</au><au>Häufel, Thomas</au><au>Lange, Bernd</au><au>Rauschkolb, Christine</au><au>Laschewski, Frank</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Safety and Tolerability of Tapentadol Extended Release in Moderate to Severe Chronic Osteoarthritis or Low Back Pain Management: Pooled Analysis of Randomized Controlled Trials</atitle><jtitle>Advances in therapy</jtitle><stitle>Adv Ther</stitle><addtitle>Adv Ther</addtitle><date>2014-06-01</date><risdate>2014</risdate><volume>31</volume><issue>6</issue><spage>604</spage><epage>620</epage><pages>604-620</pages><issn>0741-238X</issn><eissn>1865-8652</eissn><abstract>Introduction
This analysis of pooled data from four randomized, controlled-dose adjustment, phase 3 studies (three 15-week, double-blind, placebo- and active-controlled studies and a 1-year, open-label, active-controlled safety study) in patients with chronic osteoarthritis hip or knee pain or low back pain evaluated the safety and tolerability of tapentadol extended release (ER) for the management of moderate to severe, chronic pain.
Methods
In the three 15-week studies, patients were randomized (1:1:1) to twice-daily (bid) doses of placebo, tapentadol ER (100–250 mg), or oxycodone hydrochloride (HCl) controlled release (CR; 20–50 mg). In the 1-year safety study, patients were randomized (4:1) to tapentadol ER (100–250 mg bid) or oxycodone HCl CR (20–50 mg bid). Adverse events (AEs) and discontinuations were recorded in each study; pooled results were analyzed by treatment group.
Results
In the placebo (
n
= 993), tapentadol ER (
n
= 1,874), and oxycodone CR (
n
= 1,224) groups, respectively, 40.7%, 48.4%, and 62.3% of patients discontinued treatment prematurely and 58.7%, 79.0%, and 86.6% of patients experienced ≥1 treatment-emergent AE (TEAE). Incidences of gastrointestinal TEAEs in the placebo, tapentadol ER, and oxycodone CR groups, respectively, were 26.6%, 47.3%, and 65.4%; incidences of nervous system TEAEs were 22.5%, 42.6%, and 45.1%, respectively. Moderate or severe gastrointestinal TEAEs were reported for 10.9% of patients who received placebo, 25.3% of patients who received tapentadol ER, and 42.3% of patients who received oxycodone CR, and moderate or severe nervous system TEAEs were reported for 10.6%, 22.1%, and 25.2% of patients, respectively. In the placebo, tapentadol ER, and oxycodone CR groups, respectively, incidences of gastrointestinal TEAEs leading to study discontinuation were 2.1%, 8.3%, and 24.1%; incidences of nervous system TEAEs leading to discontinuation were 1.4%, 7.9%, and 16.3%, respectively.
Conclusion
Results from this large patient population showed that tapentadol ER (100–250 mg bid) had improved gastrointestinal tolerability compared with oxycodone CR, based on the overall incidence of gastrointestinal TEAEs, the incidence of moderate or severe gastrointestinal TEAEs, and the incidence of gastrointestinal TEAEs leading to discontinuation.</abstract><cop>Heidelberg</cop><pub>Springer Healthcare</pub><pmid>24985410</pmid><doi>10.1007/s12325-014-0128-6</doi><tpages>17</tpages></addata></record> |
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| ispartof | Advances in therapy, 2014-06, Vol.31 (6), p.604-620 |
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| source | MEDLINE; SpringerLink Journals - AutoHoldings |
| subjects | Adult Aged Analgesics - administration & dosage Analgesics - adverse effects Biological and medical sciences Bones, joints and connective tissue. Antiinflammatory agents Cardiology Chronic Pain - diagnosis Chronic Pain - drug therapy Delayed-Action Preparations - administration & dosage Delayed-Action Preparations - adverse effects Diseases of the osteoarticular system Double-Blind Method Drug-Related Side Effects and Adverse Reactions - diagnosis Drug-Related Side Effects and Adverse Reactions - etiology Drug-Related Side Effects and Adverse Reactions - prevention & control Endocrinology Female Health technology assessment Humans Internal Medicine Low Back Pain - diagnosis Low Back Pain - drug therapy Male Medical sciences Medicine Medicine & Public Health Middle Aged Oncology Original Research Osteoarthritis Osteoarthritis, Hip - diagnosis Osteoarthritis, Hip - drug therapy Osteoarthritis, Knee - diagnosis Osteoarthritis, Knee - drug therapy Oxycodone - administration & dosage Oxycodone - adverse effects Pain Management - methods Pain Measurement Pharmacology. Drug treatments Pharmacology/Toxicology Phenols - administration & dosage Phenols - adverse effects Randomized Controlled Trials as Topic Receptors, Opioid, mu - agonists Rheumatology Treatment Outcome |
| title | Safety and Tolerability of Tapentadol Extended Release in Moderate to Severe Chronic Osteoarthritis or Low Back Pain Management: Pooled Analysis of Randomized Controlled Trials |
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