Safety and Effectiveness of Molnupiravir (LAGEVRIO®) Capsules in Japanese Patients with COVID-19: Interim Report of Post-marketing Surveillance in Japan

Kimata, Masahiro; Watanabe, Asuka; Yanagida, Yukiko; Kinoshita, Daisuke; Maekawa, Shinichiroh

doi:10.1007/s40121-023-00782-5

Cited by 7 publications

(10 citation statements)

References 16 publications

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“…In the MOVe-OUT study, molnupiravir reduced the risk of hospitalization or death through day 29 (7.3 vs. 14.1%; difference in percentage − 6.8, 95% CI − 11.3 to − 2.4) ( 10 ). In this survey, molnupiravir treatment resulted in a cumulative incidence of outpatient hospitalization or all-cause death of 2.34% (47/2006) through day 29, which was consistent with the figure of 2.61% (16/612) in the interim analysis ( 18 ). In addition, among inpatients treated with molnupiravir and who did not use oxygen or mechanical ventilation at baseline, oxygen initiation or all-cause death occurred in only 4.60% (38/826), and none required mechanical ventilation through day 29.…”

Section: Discussionsupporting

confidence: 87%

“…This is the largest survey conducted in routine patient care in Japan that provides safety and effectiveness data for 3179 and 2988 patients, respectively, exceeding the number of patients included in the previously published interim analysis (1031 and 884 patients, respectively) ( 18 ). The results obtained in this larger population of patients were consistent with those in the interim analysis in terms of the safety and effectiveness data ( 18 ). The frequency of ADRs as assessed by the treating physicians was 5.50% (175/3179).…”

Section: Discussionmentioning

confidence: 99%

“…To assess the real-world safety and effectiveness of molnupiravir in Japanese patients with COVID-19, we conducted nationwide post-marketing surveillance (PMS) to collect data on patients treated with molnupiravir at registered institutions in Japan. In the interim analysis, we reported the preliminary safety and effectiveness data in 1031 Japanese patients ( 18 ). Here we report the final results of the PMS of molnupiravir use in 3214 Japanese patients.…”

Section: Introductionmentioning

confidence: 99%

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Safety and Effectiveness of Molnupiravir in Japanese Patients with COVID-19: Final Report of Post-marketing Surveillance in Japan

Shinozaki,

Watanabe,

Kimata

et al. 2024

Infect Dis Ther

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Introduction Molnupiravir is an orally available prodrug of N -hydroxycytidine that received special approval for emergency treatment of coronavirus disease 2019 (COVID-19) in Japan in December 2021 and full approval in April 2023. To assess the real-world safety and effectiveness of molnupiravir in Japanese patients with COVID-19, we conducted nationwide post-marketing surveillance to collect data at registered institutions in Japan. Methods The surveillance data were collected from December 27, 2021, to May 2, 2023. All reported adverse events were collected for safety analysis. Adverse drug reactions (ADRs) were assessed by the treating physicians. Effectiveness was assessed by the composite of hospitalization or all-cause death in outpatients and the composite of oxygen/mechanical ventilation initiation or all-cause death in inpatients. The observation period was from molnupiravir initiation through day 29. Results Of 3214 patients enrolled in the survey, 3179 were analyzed for safety. At baseline, 52.31% (1663/3179) of patients were male, the median (range) age was 69.0 (18–107) years, 82.38% (2619/3179) received COVID-19 vaccines, and 95.72% (3043/3179) had risk factors for severe COVID-19 illness. COVID-19 severity at baseline was mild in 86.44% (2748/3179) and moderate I in 10.22% (325/3179). A total of 205 ADRs occurred in 5.50% (175/3179) of patients; ADRs that occurred in > 0.5% of patients were diarrhea (1.86% [59/3179]) and rash (0.69% [22/3179]). Seven serious ADRs were reported in seven patients. In the effectiveness analysis population, the incidence of all-cause death through day 29 was 1.14% (34/2988), and the incidence of death through day 29 related to COVID-19 was 0.40% (12/2988). The cumulative incidence of the composite endpoint was 2.34% (47/2006) in outpatients and 4.60% (38/826) in inpatients. Conclusions This large-scale survey showed that molnupiravir was safe and effective in real-world settings in highly vaccinated Japanese patients with COVID-19, including older patients and those with comorbidities. Supplementary Information The online version contains supplementary material available at 10.1007/s40121-023-00915-w.

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Section: Discussionsupporting

confidence: 87%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Safety and Effectiveness of Molnupiravir in Japanese Patients with COVID-19: Final Report of Post-marketing Surveillance in Japan

Shinozaki,

Watanabe,

Kimata

et al. 2024

Infect Dis Ther

Self Cite

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“…Vein thrombosis [30][31] Paxlovid (Nirmatrelvir-Ritonavir) Inhibition of viral replication Headache, diarrhea, vomiting dysgeusia [32] Molnupiravir (Lagevrio) Inhibition of virus multiplying Dizziness, rash, diarrhea, nausea [33][34] Kineret (anakinra) Inhibition of interleukin-1 (IL-1) receptor Reaction in injection site, enhancement of liver enzymes, hypertension [35][36] Gohibic (Vilobelimab) Vilobelimab as an antagonist od complement component 5a (C5-a) receptor, acts as anti-inflammatory agent Hypertension, pneumonia, pulmonary embolism, delirium, and sepsis [37] Prioritizing Potential Candidates for Anti-SARS-CoV-2 Drug Development and Discovery from Phytochemicals and Plant Secondary Metabolites…”

Section: Remdesivir (Veklury)mentioning

confidence: 99%

“…The repurposed antiviral drugs used to treat COVID-19 may provide protection against infection or speed up recovery, but all COVID-19 antiviral drugs currently on the market have drawbacks that may prevent their use by the general public [23][24][25][26][27][28][29][30][31][32][33][34][35][36][37]. For example, remdesivir administration led to mild to moderate undesirable outcomes, including but not restricted to liver toxicity, queasiness, anemia, kidney impairment, low blood pressure, respiratory collapse, and constipation, among other things [38][39][40][41][42].…”

Section: Introductionmentioning

confidence: 99%

The Potential of Anti-coronavirus Plant Secondary Metabolites in COVID-19 Drug Discovery as an Alternative to Repurposed Drugs: A Review

Alipour,

Zarezadeh,

Ghotbi-Ravandi

2023

Planta Med

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In early 2020, a global pandemic was announced due to the emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), known to cause COVID-19. Despite worldwide efforts, there are only limited options regarding antiviral drug treatments for COVID-19. Although the vaccines are now available, issues such as declining efficacy against different SARS-CoV-2 variants and aging of vaccine-induced immunity highlight the importance of finding more antiviral drugs as a second line of defense against the disease. Drug repurposing has been used to rapidly find COVID-19 therapeutic options. Due to the lack of clinical evidence for the therapeutic benefits and certain serious side effects of repurposed antivirals, the search for an antiviral drug against SARS-CoV-2 with fewer side effects continues. In recent years, numerous studies have included antiviral chemicals from a variety of plant species. A better knowledge of the possible antiviral natural products and their mechanism against SARS-CoV-2 will help to develop stronger and more targeted direct-acting antiviral agents. The aim of the present study was to compile the current data on potential plant metabolites that can be investigated in COVID-19 drug discovery and development. This review represents a collection of plant secondary metabolites and their mode of action against SARS-CoV and SARS-CoV-2.

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2024

Planta Med

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Safety and Effectiveness of Molnupiravir (LAGEVRIO®) Capsules in Japanese Patients with COVID-19: Interim Report of Post-marketing Surveillance in Japan

Cited by 7 publications

References 16 publications

Safety and Effectiveness of Molnupiravir in Japanese Patients with COVID-19: Final Report of Post-marketing Surveillance in Japan

Safety and Effectiveness of Molnupiravir in Japanese Patients with COVID-19: Final Report of Post-marketing Surveillance in Japan

The Potential of Anti-coronavirus Plant Secondary Metabolites in COVID-19 Drug Discovery as an Alternative to Repurposed Drugs: A Review

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