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Journal of Pain Research Volume 16, 2023 - Issue
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CLINICAL TRIAL REPORT

Lasmiditan in Japanese Patients with Common Migraine Comorbidities or Concomitant Medications: A Post Hoc Safety and Efficacy Analysis from the MONONOFU Study

Shigekazu Kitamura1 Department of Neurology, Konan Kakogawa Hospital, Hyogo, JapanORCID Iconhttps://orcid.org/0000-0001-7162-4265View further author information
ORCID Icon,
Noboru Imai2 Department of Neurology, Japanese Red Cross Shizuoka Hospital, Shizuoka, JapanORCID Iconhttps://orcid.org/0000-0002-8745-0391View further author information
ORCID Icon,
Yuka Tanji3 Japan Drug Development and Medical Affairs, Eli Lilly Japan K.K., Kobe, JapanView further author information
,
Akichika Ozeki3 Japan Drug Development and Medical Affairs, Eli Lilly Japan K.K., Kobe, JapanORCID Iconhttps://orcid.org/0000-0001-5510-4219View further author information
ORCID Icon &
Mika Komori3 Japan Drug Development and Medical Affairs, Eli Lilly Japan K.K., Kobe, JapanCorrespondence[email protected]
ORCID Iconhttps://orcid.org/0000-0003-1887-1296View further author information
ORCID Icon
Pages 1725-1738 | Received 02 Dec 2022, Accepted 08 May 2023, Published online: 25 May 2023

Figures & data

Table 1 Most Common Comorbidities (Occurring in ≥10% of Any Lasmiditan Dose Group) by MedDRA Preferred Term (Safety Population)

Table 2 Incidence of TEAEs in Patients Who Reported Comorbiditiesa (Safety Population)

Figure 1 TEAE incidence: Forest plot of ORs (All LTN group vs PBO) for each of the most common comorbidity groups (safety population). Larger ORs indicate a higher incidence of TEAEs in the All LTN group compared with PBO. Dotted line indicates OR = 1. The interaction p-values shown are for the treatment-by-comorbidity interaction.

Abbreviations: CI, confidence interval; LTN, lasmiditan; OR, odds ratio; PBO, placebo; TEAE, treatment-emergent adverse event.
Figure 1 TEAE incidence: Forest plot of ORs (All LTN group vs PBO) for each of the most common comorbidity groups (safety population). Larger ORs indicate a higher incidence of TEAEs in the All LTN group compared with PBO. Dotted line indicates OR = 1. The interaction p-values shown are for the treatment-by-comorbidity interaction.

Figure 2 Efficacy: Forest plot of ORs (All LTN group vs PBO) for each of the most common comorbidity groups (mITT population). Larger ORs indicate a higher proportion of patients with pain freedom at 2 hours in the All LTN group compared with PBO. Dotted line indicates OR = 1.

Abbreviations: CI, confidence interval; LTN, lasmiditan; mITT, modified intent-to-treat; OR, odds ratio; PBO, placebo.
Figure 2 Efficacy: Forest plot of ORs (All LTN group vs PBO) for each of the most common comorbidity groups (mITT population). Larger ORs indicate a higher proportion of patients with pain freedom at 2 hours in the All LTN group compared with PBO. Dotted line indicates OR = 1.

Table 3 Concomitant Medicationa Groups of Special Interest (Safety Population)

Figure 3 Most common TEAEs (≥5% in the All LTN group) in the MONONOFU studyCitation11 and their incidence in the concomitant medication groups (safety population).

Abbreviations: ACE, acetaminophen; CNS, central nervous system; LTN, lasmiditan; NSAID, nonsteroidal anti-inflammatory drug; PBO, placebo; TEAE, treatment-emergent adverse event.
Figure 3 Most common TEAEs (≥5% in the All LTN group) in the MONONOFU studyCitation11 and their incidence in the concomitant medication groups (safety population).

Figure 4 TEAE incidence: Forest plot of ORs (All LTN group vs PBO) for each of the concomitant medication groups (safety population). Larger ORs indicate a higher incidence of TEAEs in the All LTN group compared with PBO. Dotted line indicates OR = 1. The interaction p-values shown are for the treatment-by-concomitant medication interaction. Bold indicates concomitant medication groups and plain type indicates subgroups.

Abbreviations: ACE, acetaminophen; CI, confidence interval; CNS, central nervous system; LTN, lasmiditan; NSAID, nonsteroidal anti-inflammatory drug; OR, odds ratio; PBO, placebo; TEAE, treatment-emergent adverse event.
Figure 4 TEAE incidence: Forest plot of ORs (All LTN group vs PBO) for each of the concomitant medication groups (safety population). Larger ORs indicate a higher incidence of TEAEs in the All LTN group compared with PBO. Dotted line indicates OR = 1. The interaction p-values shown are for the treatment-by-concomitant medication interaction. Bold indicates concomitant medication groups and plain type indicates subgroups.

Table 4 Occurrence of Special Interest TEAEsa with and without CNS Depressant Use (Safety Population)

Table 5 Occurrence of Special Interest TEAEsa with or without Triptan or Serotonergic Medication Use (Safety Population)

Table 6 Occurrence of Special Interest TEAEsa with and without Antiemetic Medication Use (Safety Population)

Table 7 Occurrence of Special Interest TEAEsa with and without Antihypertensive Medication Use (Safety Population)

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