A randomized, double-blind, placebo-controlled trial of ibuprofen lysinate in comparison to ibuprofen acid for acute postoperative dental pain

Basic data
OCA1. Surname awarded to the assessed person	Kyselovič
OCA2. Name awarded to the assessed person	Ján
OCA3. Degrees awarded to the assessed person	Prof. , Pharm.D., CSc.
OCA4. Hyperlink to the entry of the person in the Register of university staff	https://www.portalvs.sk/regzam/detail/3738
OCA5. Area of assessment	study programme pharmacy (joint study programme) · I. + II. degree
OCA6. Category of the research/artistic/other output
OCA7. Year of publication of the research/artistic/other output	2020
OCA8. ID of the record in the Central Registry of Publication Activity (CRPA) or the Central Registry of Artistic Activity (CRAA)	179620
OCA9. Hyperlink to the record in CRPA or CRAA	https://app.crepc.sk/?fn=detailBiblioForm&sid=E800E35B75A4A8F935082F3FB2
Characteristics of the output that is not registered in CRPA or CRAA
OCA10. Hyperlink to the record in another publicly accessible register, catalogue of research/ artistic/other outputs
OCA11. Characteristics of the output in the format of the CRPA or the CRAA bibliographic record, if the output is not available in a publicly accessible register or catalogue of outputs	A randomized, double-blind, placebo-controlled trial of ibuprofen lysinate in comparison to ibuprofen acid for acute postoperative dental pain
OCA12. Type of the output (if the output is not registered in CRPA or CRAA)	article
OCA13. Hyperlink to the webpage where the output is available (full text, other documentation, etc.)
OCA14. Characteristics of the author's contribution	member of the international scientific team
OCA15. Annotation of the output with contextual information concerning the description of creative process and the content of the research/artistic/other activity, etc.	Ibuprofen acid is poorly soluble in the stomach, thus reaching maximum plasma levels at approximately 90 min post-dose. Ibuprofen lysinate has been developed to accelerate absorption of ibuprofen to shorten the time to analgesic efficacy. This study compared analgesic efficacy and onset of effect of a single dose of ibuprofen lysinate or ibuprofen acid in patients undergoing third molar extraction. Randomized, double-blind, placebo-controlled, multi-center, parallel-group single-dose study. Adults (18–60 years) undergoing extraction of ≥ 1 third molar were randomized 2:2:1 to ibuprofen lysinate, ibuprofen acid, or placebo postoperatively. Pain relief (PAR, 5-point scale, 0 = none to 4 = complete pain relief) and pain intensity (PI, 100 mm visual analog scale) were assessed between 15 and 360 min post-dose. The primary endpoint was the weighted sum of PAR scores at 6 h (TOTPAR). Time to onset of effect, global assessment of efficacy, and adverse events were also assessed. Overall, 351 patients received ibuprofen lysinate (N = 141), ibuprofen acid (N = 139), or placebo (N = 71). Both active treatments significantly reduced pain compared with placebo, from 15 min post-dose to 6 h (TOTPAR: ibuprofen lysinate: 19.57; ibuprofen acid: 19.96; placebo: 8.27). Ibuprofen lysinate was significantly more effective than placebo, but non-inferior to ibuprofen acid, at providing pain relief over 6 h. There was no significant difference between ibuprofen lysinate and ibuprofen acid for onset of analgesia. Both ibuprofen formulations were well tolerated; all adverse events were mild to moderate and considered unrelated to treatment. A single dose of ibuprofen lysinate is non-inferior to ibuprofen acid in terms of analgesic efficacy, onset of action, and tolerability in patients who have recently undergone dental surgery.
Other data
OCA16. Annotation of the output in English	Ibuprofen acid is poorly soluble in the stomach, thus reaching maximum plasma levels at approximately 90 min post-dose. Ibuprofen lysinate has been developed to accelerate absorption of ibuprofen to shorten the time to analgesic efficacy. This study compared analgesic efficacy and onset of effect of a single dose of ibuprofen lysinate or ibuprofen acid in patients undergoing third molar extraction. Randomized, double-blind, placebo-controlled, multi-center, parallel-group single-dose study. Adults (18–60 years) undergoing extraction of ≥ 1 third molar were randomized 2:2:1 to ibuprofen lysinate, ibuprofen acid, or placebo postoperatively. Pain relief (PAR, 5-point scale, 0 = none to 4 = complete pain relief) and pain intensity (PI, 100 mm visual analog scale) were assessed between 15 and 360 min post-dose. The primary endpoint was the weighted sum of PAR scores at 6 h (TOTPAR). Time to onset of effect, global assessment of efficacy, and adverse events were also assessed. Overall, 351 patients received ibuprofen lysinate (N = 141), ibuprofen acid (N = 139), or placebo (N = 71). Both active treatments significantly reduced pain compared with placebo, from 15 min post-dose to 6 h (TOTPAR: ibuprofen lysinate: 19.57; ibuprofen acid: 19.96; placebo: 8.27). Ibuprofen lysinate was significantly more effective than placebo, but non-inferior to ibuprofen acid, at providing pain relief over 6 h. There was no significant difference between ibuprofen lysinate and ibuprofen acid for onset of analgesia. Both ibuprofen formulations were well tolerated; all adverse events were mild to moderate and considered unrelated to treatment. A single dose of ibuprofen lysinate is non-inferior to ibuprofen acid in terms of analgesic efficacy, onset of action, and tolerability in patients who have recently undergone dental surgery.
OCA17. List of maximum 5 most significant citations corresponding to the output	2021: Wertli, M.M. - Flury, J.S. - Streit, S. - Limacher, A. - Schuler, V. - Ferrante, A.N. - Rimensberger, C. - Haschke, M.: BMJ Open, vol. 11, no. 10, 2021, art. no. e048531 -- SCI ; SCOPUS 2021: Kunow, C. - Langer, B.: Clinicoeconomics and Outcomes Research, vol. 13, 2021, s. 843-851 -- SCI ; SCOPUS 2021: Schmidt, M. - Bendas, G.: Deutsche Apotheker Zeitung, vol. 161, no. 24, 2021, nestr. -- SCOPUS 2022: Farkouh, A. - Hemetsberger, M. - Noe, C.R. - Baumgärtel, C.: Pharmaceutics, vol. 14, no. 10, 2022, art. no. 2240 -- SCI ; SCOPUS
OCA18. Characteristics of the output's impact on socio-economic practice	contribution of new knowledge to the issue
OCA19. Characteristics of the output and related activities' impact on the educational process	research in the field