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Yasuo Ohashi - One of the best experts on this subject based on the ideXlab platform.
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long acting neuraminidase inhibitor laninamivir Octanoate versus oseltamivir for treatment of influenza a double blind randomized noninferiority clinical trial
Clinical Infectious Diseases, 2010Co-Authors: Akira Watanabe, Shanchwen Chang, Yasuo OhashiAbstract:Background. A single administration of laninamivir Octanoate, a long-acting neuraminidase inhibitor, against influenza infection has been proven effective in nonclinical studies. This study evaluated the clinical efficacy of laninamivir Octanoate for the treatment of adult influenza patients. Methods. A double-blind, randomized controlled trial examined whether laninamivir Octanoate was noninferior to oseltamivir. A total of 1003 patients aged ≥20 years with febrile influenza symptoms for no more than 36 h were randomized to receive either 40 mg of laninamivir Octanoate, 20 mg of laninamivir Octanoate, or oseltamivir. Laninamivir Octanoate was inhaled once on day 1, and oseltamivir (75 mg) was administered orally twice daily for 5 days. The primary end point was the time to illness alleviation. Results. A total of 996 patients were included in the primary analysis (40-mg laninamivir Octanoate, n = 334; 20-mg laninamivir Octanoate, n = 326; and oseltamivir, n = 336). The median time to illness alleviation in the 40-mg laninamivir Octanoate, 20-mg laninamivir Octanoate, and oseltamivir groups was 73.0, 85.8, and 73.6 h, respectively. The difference between laninamivir Octanoate and oseltamivir was —0.6 h (95% confidence interval, -9.9 to 6.9 h) for the 40-mg group and 12.2 h (95% confidence interval, -1.5 to 17.2 h) for the 20-mg group. The upper limits of the 95% confidence intervals were less than the prespecified noninferiority margin (18 h). The proportion of patients shedding virus at day 3 was significantly lower in the 40-mg laninamivir Octanoate group than in the oseltamivir group (P = .006). Conclusions. A single inhalation of laninamivir Octanoate is effective for the treatment of seasonal influenza, including that caused by oseltamivir-resistant virus, in adults.
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long acting neuraminidase inhibitor laninamivir Octanoate versus oseltamivir for treatment of influenza a double blind randomized noninferiority clinical trial
Clinical Infectious Diseases, 2010Co-Authors: Akira Watanabe, Shanchwen Chang, Min Ja Kim, Daniel Waising Chu, Yasuo OhashiAbstract:BACKGROUND A single administration of laninamivir Octanoate, a long-acting neuraminidase inhibitor, against influenza infection has been proven effective in nonclinical studies. This study evaluated the clinical efficacy of laninamivir Octanoate for the treatment of adult influenza patients. METHODS A double-blind, randomized controlled trial examined whether laninamivir Octanoate was noninferior to oseltamivir. A total of 1003 patients aged ≥ 20 years with febrile influenza symptoms for no more than 36 h were randomized to receive either 40 mg of laninamivir Octanoate, 20 mg of laninamivir Octanoate, or oseltamivir. Laninamivir Octanoate was inhaled once on day 1, and oseltamivir (75 mg) was administered orally twice daily for 5 days. The primary end point was the time to illness alleviation. RESULTS A total of 996 patients were included in the primary analysis (40-mg laninamivir Octanoate, n = 334; 20-mg laninamivir Octanoate, n = 326; and oseltamivir, n = 336). The median time to illness alleviation in the 40-mg laninamivir Octanoate, 20-mg laninamivir Octanoate, and oseltamivir groups was 73.0, 85.8, and 73.6 h, respectively. The difference between laninamivir Octanoate and oseltamivir was -0.6 h (95% confidence interval, -9.9 to 6.9 h) for the 40-mg group and 12.2 h (95% confidence interval, -1.5 to 17.2 h) for the 20-mg group. The upper limits of the 95% confidence intervals were less than the prespecified noninferiority margin (18 h). The proportion of patients shedding virus at day 3 was significantly lower in the 40-mg laninamivir Octanoate group than in the oseltamivir group (P = .006). CONCLUSIONS A single inhalation of laninamivir Octanoate is effective for the treatment of seasonal influenza, including that caused by oseltamivir-resistant virus, in adults. CLINICAL TRIALS REGISTRATION NCT00803595.
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long acting neuraminidase inhibitor laninamivir Octanoate cs 8958 versus oseltamivir as treatment for children with influenza virus infection
Antimicrobial Agents and Chemotherapy, 2010Co-Authors: Norio Sugaya, Yasuo OhashiAbstract:We conducted a double-blind, randomized controlled trial to compare a long-acting neuraminidase inhibitor, laninamivir Octanoate, with oseltamivir. Eligible patients were children 9 years of age and under who had febrile influenza symptoms of no more than 36-h duration. Patients were randomized to 1 of 3 treatment groups: a group given 40 mg laninamivir (40-mg group), a group given 20 mg laninamivir (20-mg group), and an oseltamivir group. Laninamivir Octanoate was administered as a single inhalation. Oseltamivir (2 mg/kg of body weight) was administered orally twice daily for 5 days. The primary end point was the time to alleviation of influenza illness. The primary analysis included 184 patients (61, 61, and 62 in the 40-mg group, 20-mg group, and oseltamivir group, respectively). Laninamivir Octanoate markedly reduced the median time to illness alleviation in comparison with oseltamivir in patients infected with oseltamivir-resistant influenza A (H1N1) virus, and the reductions were 60.9 h for the 40-mg group and 66.2 h for the 20-mg group. On the other hand, there were no significant differences in the times to alleviation of illness between the laninamivir groups and oseltamivir group for patients with influenza A (H3N2) or B virus infection. Laninamivir Octanoate was well tolerated. The most common adverse events were gastrointestinal events. Laninamivir Octanoate was an effective and well-tolerated treatment for children with oseltamivir-resistant influenza A (H1N1) virus infection. Further study will be needed to confirm clinical efficacy against influenza A (H3N2) or B virus infection. Its ease of administration is noteworthy, because a single inhalation is required during the course of illness.
Akira Watanabe - One of the best experts on this subject based on the ideXlab platform.
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long acting neuraminidase inhibitor laninamivir Octanoate as post exposure prophylaxis for influenza
Clinical Infectious Diseases, 2016Co-Authors: Seizaburo Kashiwagi, Mitsutoshi Uemori, Hideyuki Ikematsu, Akira Watanabe, Shinichiro AwamuraAbstract:Close contact with an influenza patient increases the risk of subsequent infection. In such cases, antiviral chemoprophylaxis should be considered for persons at high risk from serious illness or death related to influenza (the elderly, those with chronic respiratory illness or metabolic disorders including diabetes mellitus, chronic heart disease, and immunodeficiency) [1, 2]. A single administration of laninamivir Octanoate, a long-acting neuraminidase inhibitor, has been demonstrated to be an effective treatment for influenza [3–5], while oseltamivir and zanamivir need repeated administration, twice daily for 5 days. In Japan, laninamivir Octanoate has been used widely not only because of its high level of efficacy and safety but also because of its convenience [6–8]. For the post-exposure prophylaxis of influenza, the inhalation of 20 mg of laninamivir Octanoate once daily for 2 or 3 days effectively prevented the development of influenza through household contacts in a study conducted during the 2011–2012 influenza season [9]. However, it was not demonstrated that a single inhalation of laninamivir Octanoate was effective for post-exposure prophylaxis. In a study conducted during the 2009 influenza pandemic season, the inhalation of 20 or 40 mg of laninamivir Octanoate once a week reduced the proportion of patients who developed influenza (relative risk reduction [RRR] compared with placebo, 45.8% and 43.2%, respectively), but the differences with placebo were not significant [10]. A pharmacokinetics finding that a relatively high laninamivir concentration persisted in the lungs for 10 days after a single inhalation [11] suggested that a single inhalation of laninamivir Octanoate may be effective for post-exposure prophylaxis. This study was conducted to evaluate the efficacy of a single inhalation of 40 mg of laninamivir Octanoate as post-exposure prophylaxis for household contacts.
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laninamivir Octanoate for post exposure prophylaxis of influenza in household contacts a randomized double blind placebo controlled trial
Journal of Infection and Chemotherapy, 2013Co-Authors: Seizaburo Kashiwagi, Mitsutoshi Uemori, Shinichiro Awamura, Takako Okamoto, Hideyuki Ikematsu, Akira Watanabe, Katsuyasu IshidaAbstract:Laninamivir Octanoate, a long-acting neuraminidase inhibitor, is an effective treatment for influenza. However, its effectiveness for the prevention of influenza has not yet been demonstrated. We conducted a double-blind, multicenter, randomized, placebo-controlled trial to determine whether laninamivir Octanoate was superior to a placebo for post-exposure prophylaxis of influenza in household contacts. Eligible participants, who were household members who did not have influenza and were in contact with an influenza-infected index patient, were randomly assigned (1:1:1) to one of three groups: 20 mg of laninamivir Octanoate once daily for 2 days (LO-2), 20 mg of laninamivir Octanoate once daily for 3 days (LO-3), or a placebo. The primary endpoint was the proportion of participants who developed clinical influenza during a 10-day period. A total of 1711 participants were enrolled, and 1451 participants were included in the primary analysis. The proportion of participants with clinical influenza was 3.9 % (19/487) in the LO-2 group, 3.7 % (18/486) in the LO-3 group, and 16.9 % (81/478) in the placebo group (P < 0.001 for each of the laninamivir Octanoate group). The relative risk reductions, compared with the placebo group, were 77.0 % [95 % confidence interval (CI) 62.7–85.8] and 78.1 % (95 % CI 64.1–86.7 %) for the LO-2 and LO-3 groups, respectively. The incidences of adverse events in the laninamivir Octanoate groups were similar to that in the placebo group. The inhalation of 20 mg of laninamivir Octanoate once daily for 2 or 3 days was well tolerated and effectively prevented the development of influenza in household contacts.
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long acting neuraminidase inhibitor laninamivir Octanoate versus oseltamivir for treatment of influenza a double blind randomized noninferiority clinical trial
Clinical Infectious Diseases, 2010Co-Authors: Akira Watanabe, Shanchwen Chang, Yasuo OhashiAbstract:Background. A single administration of laninamivir Octanoate, a long-acting neuraminidase inhibitor, against influenza infection has been proven effective in nonclinical studies. This study evaluated the clinical efficacy of laninamivir Octanoate for the treatment of adult influenza patients. Methods. A double-blind, randomized controlled trial examined whether laninamivir Octanoate was noninferior to oseltamivir. A total of 1003 patients aged ≥20 years with febrile influenza symptoms for no more than 36 h were randomized to receive either 40 mg of laninamivir Octanoate, 20 mg of laninamivir Octanoate, or oseltamivir. Laninamivir Octanoate was inhaled once on day 1, and oseltamivir (75 mg) was administered orally twice daily for 5 days. The primary end point was the time to illness alleviation. Results. A total of 996 patients were included in the primary analysis (40-mg laninamivir Octanoate, n = 334; 20-mg laninamivir Octanoate, n = 326; and oseltamivir, n = 336). The median time to illness alleviation in the 40-mg laninamivir Octanoate, 20-mg laninamivir Octanoate, and oseltamivir groups was 73.0, 85.8, and 73.6 h, respectively. The difference between laninamivir Octanoate and oseltamivir was —0.6 h (95% confidence interval, -9.9 to 6.9 h) for the 40-mg group and 12.2 h (95% confidence interval, -1.5 to 17.2 h) for the 20-mg group. The upper limits of the 95% confidence intervals were less than the prespecified noninferiority margin (18 h). The proportion of patients shedding virus at day 3 was significantly lower in the 40-mg laninamivir Octanoate group than in the oseltamivir group (P = .006). Conclusions. A single inhalation of laninamivir Octanoate is effective for the treatment of seasonal influenza, including that caused by oseltamivir-resistant virus, in adults.
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long acting neuraminidase inhibitor laninamivir Octanoate versus oseltamivir for treatment of influenza a double blind randomized noninferiority clinical trial
Clinical Infectious Diseases, 2010Co-Authors: Akira Watanabe, Shanchwen Chang, Min Ja Kim, Daniel Waising Chu, Yasuo OhashiAbstract:BACKGROUND A single administration of laninamivir Octanoate, a long-acting neuraminidase inhibitor, against influenza infection has been proven effective in nonclinical studies. This study evaluated the clinical efficacy of laninamivir Octanoate for the treatment of adult influenza patients. METHODS A double-blind, randomized controlled trial examined whether laninamivir Octanoate was noninferior to oseltamivir. A total of 1003 patients aged ≥ 20 years with febrile influenza symptoms for no more than 36 h were randomized to receive either 40 mg of laninamivir Octanoate, 20 mg of laninamivir Octanoate, or oseltamivir. Laninamivir Octanoate was inhaled once on day 1, and oseltamivir (75 mg) was administered orally twice daily for 5 days. The primary end point was the time to illness alleviation. RESULTS A total of 996 patients were included in the primary analysis (40-mg laninamivir Octanoate, n = 334; 20-mg laninamivir Octanoate, n = 326; and oseltamivir, n = 336). The median time to illness alleviation in the 40-mg laninamivir Octanoate, 20-mg laninamivir Octanoate, and oseltamivir groups was 73.0, 85.8, and 73.6 h, respectively. The difference between laninamivir Octanoate and oseltamivir was -0.6 h (95% confidence interval, -9.9 to 6.9 h) for the 40-mg group and 12.2 h (95% confidence interval, -1.5 to 17.2 h) for the 20-mg group. The upper limits of the 95% confidence intervals were less than the prespecified noninferiority margin (18 h). The proportion of patients shedding virus at day 3 was significantly lower in the 40-mg laninamivir Octanoate group than in the oseltamivir group (P = .006). CONCLUSIONS A single inhalation of laninamivir Octanoate is effective for the treatment of seasonal influenza, including that caused by oseltamivir-resistant virus, in adults. CLINICAL TRIALS REGISTRATION NCT00803595.
Hideyuki Ikematsu - One of the best experts on this subject based on the ideXlab platform.
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long acting neuraminidase inhibitor laninamivir Octanoate as post exposure prophylaxis for influenza
Clinical Infectious Diseases, 2016Co-Authors: Seizaburo Kashiwagi, Mitsutoshi Uemori, Hideyuki Ikematsu, Akira Watanabe, Shinichiro AwamuraAbstract:Close contact with an influenza patient increases the risk of subsequent infection. In such cases, antiviral chemoprophylaxis should be considered for persons at high risk from serious illness or death related to influenza (the elderly, those with chronic respiratory illness or metabolic disorders including diabetes mellitus, chronic heart disease, and immunodeficiency) [1, 2]. A single administration of laninamivir Octanoate, a long-acting neuraminidase inhibitor, has been demonstrated to be an effective treatment for influenza [3–5], while oseltamivir and zanamivir need repeated administration, twice daily for 5 days. In Japan, laninamivir Octanoate has been used widely not only because of its high level of efficacy and safety but also because of its convenience [6–8]. For the post-exposure prophylaxis of influenza, the inhalation of 20 mg of laninamivir Octanoate once daily for 2 or 3 days effectively prevented the development of influenza through household contacts in a study conducted during the 2011–2012 influenza season [9]. However, it was not demonstrated that a single inhalation of laninamivir Octanoate was effective for post-exposure prophylaxis. In a study conducted during the 2009 influenza pandemic season, the inhalation of 20 or 40 mg of laninamivir Octanoate once a week reduced the proportion of patients who developed influenza (relative risk reduction [RRR] compared with placebo, 45.8% and 43.2%, respectively), but the differences with placebo were not significant [10]. A pharmacokinetics finding that a relatively high laninamivir concentration persisted in the lungs for 10 days after a single inhalation [11] suggested that a single inhalation of laninamivir Octanoate may be effective for post-exposure prophylaxis. This study was conducted to evaluate the efficacy of a single inhalation of 40 mg of laninamivir Octanoate as post-exposure prophylaxis for household contacts.
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laninamivir Octanoate for post exposure prophylaxis of influenza in household contacts a randomized double blind placebo controlled trial
Journal of Infection and Chemotherapy, 2013Co-Authors: Seizaburo Kashiwagi, Mitsutoshi Uemori, Shinichiro Awamura, Takako Okamoto, Hideyuki Ikematsu, Akira Watanabe, Katsuyasu IshidaAbstract:Laninamivir Octanoate, a long-acting neuraminidase inhibitor, is an effective treatment for influenza. However, its effectiveness for the prevention of influenza has not yet been demonstrated. We conducted a double-blind, multicenter, randomized, placebo-controlled trial to determine whether laninamivir Octanoate was superior to a placebo for post-exposure prophylaxis of influenza in household contacts. Eligible participants, who were household members who did not have influenza and were in contact with an influenza-infected index patient, were randomly assigned (1:1:1) to one of three groups: 20 mg of laninamivir Octanoate once daily for 2 days (LO-2), 20 mg of laninamivir Octanoate once daily for 3 days (LO-3), or a placebo. The primary endpoint was the proportion of participants who developed clinical influenza during a 10-day period. A total of 1711 participants were enrolled, and 1451 participants were included in the primary analysis. The proportion of participants with clinical influenza was 3.9 % (19/487) in the LO-2 group, 3.7 % (18/486) in the LO-3 group, and 16.9 % (81/478) in the placebo group (P < 0.001 for each of the laninamivir Octanoate group). The relative risk reductions, compared with the placebo group, were 77.0 % [95 % confidence interval (CI) 62.7–85.8] and 78.1 % (95 % CI 64.1–86.7 %) for the LO-2 and LO-3 groups, respectively. The incidences of adverse events in the laninamivir Octanoate groups were similar to that in the placebo group. The inhalation of 20 mg of laninamivir Octanoate once daily for 2 or 3 days was well tolerated and effectively prevented the development of influenza in household contacts.
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laninamivir Octanoate a new long acting neuraminidase inhibitor for the treatment of influenza
Expert Review of Anti-infective Therapy, 2011Co-Authors: Hideyuki Ikematsu, Naoki KawaiAbstract:Oseltamivir and zanamivir are well-established and well-researched drugs for the treatment of influenza in Japan and the rest of the world. A new neuraminidase inhibitor, laninamivir Octanoate, has...
Shanchwen Chang - One of the best experts on this subject based on the ideXlab platform.
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long acting neuraminidase inhibitor laninamivir Octanoate versus oseltamivir for treatment of influenza a double blind randomized noninferiority clinical trial
Clinical Infectious Diseases, 2010Co-Authors: Akira Watanabe, Shanchwen Chang, Yasuo OhashiAbstract:Background. A single administration of laninamivir Octanoate, a long-acting neuraminidase inhibitor, against influenza infection has been proven effective in nonclinical studies. This study evaluated the clinical efficacy of laninamivir Octanoate for the treatment of adult influenza patients. Methods. A double-blind, randomized controlled trial examined whether laninamivir Octanoate was noninferior to oseltamivir. A total of 1003 patients aged ≥20 years with febrile influenza symptoms for no more than 36 h were randomized to receive either 40 mg of laninamivir Octanoate, 20 mg of laninamivir Octanoate, or oseltamivir. Laninamivir Octanoate was inhaled once on day 1, and oseltamivir (75 mg) was administered orally twice daily for 5 days. The primary end point was the time to illness alleviation. Results. A total of 996 patients were included in the primary analysis (40-mg laninamivir Octanoate, n = 334; 20-mg laninamivir Octanoate, n = 326; and oseltamivir, n = 336). The median time to illness alleviation in the 40-mg laninamivir Octanoate, 20-mg laninamivir Octanoate, and oseltamivir groups was 73.0, 85.8, and 73.6 h, respectively. The difference between laninamivir Octanoate and oseltamivir was —0.6 h (95% confidence interval, -9.9 to 6.9 h) for the 40-mg group and 12.2 h (95% confidence interval, -1.5 to 17.2 h) for the 20-mg group. The upper limits of the 95% confidence intervals were less than the prespecified noninferiority margin (18 h). The proportion of patients shedding virus at day 3 was significantly lower in the 40-mg laninamivir Octanoate group than in the oseltamivir group (P = .006). Conclusions. A single inhalation of laninamivir Octanoate is effective for the treatment of seasonal influenza, including that caused by oseltamivir-resistant virus, in adults.
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long acting neuraminidase inhibitor laninamivir Octanoate versus oseltamivir for treatment of influenza a double blind randomized noninferiority clinical trial
Clinical Infectious Diseases, 2010Co-Authors: Akira Watanabe, Shanchwen Chang, Min Ja Kim, Daniel Waising Chu, Yasuo OhashiAbstract:BACKGROUND A single administration of laninamivir Octanoate, a long-acting neuraminidase inhibitor, against influenza infection has been proven effective in nonclinical studies. This study evaluated the clinical efficacy of laninamivir Octanoate for the treatment of adult influenza patients. METHODS A double-blind, randomized controlled trial examined whether laninamivir Octanoate was noninferior to oseltamivir. A total of 1003 patients aged ≥ 20 years with febrile influenza symptoms for no more than 36 h were randomized to receive either 40 mg of laninamivir Octanoate, 20 mg of laninamivir Octanoate, or oseltamivir. Laninamivir Octanoate was inhaled once on day 1, and oseltamivir (75 mg) was administered orally twice daily for 5 days. The primary end point was the time to illness alleviation. RESULTS A total of 996 patients were included in the primary analysis (40-mg laninamivir Octanoate, n = 334; 20-mg laninamivir Octanoate, n = 326; and oseltamivir, n = 336). The median time to illness alleviation in the 40-mg laninamivir Octanoate, 20-mg laninamivir Octanoate, and oseltamivir groups was 73.0, 85.8, and 73.6 h, respectively. The difference between laninamivir Octanoate and oseltamivir was -0.6 h (95% confidence interval, -9.9 to 6.9 h) for the 40-mg group and 12.2 h (95% confidence interval, -1.5 to 17.2 h) for the 20-mg group. The upper limits of the 95% confidence intervals were less than the prespecified noninferiority margin (18 h). The proportion of patients shedding virus at day 3 was significantly lower in the 40-mg laninamivir Octanoate group than in the oseltamivir group (P = .006). CONCLUSIONS A single inhalation of laninamivir Octanoate is effective for the treatment of seasonal influenza, including that caused by oseltamivir-resistant virus, in adults. CLINICAL TRIALS REGISTRATION NCT00803595.
Shinichiro Awamura - One of the best experts on this subject based on the ideXlab platform.
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long acting neuraminidase inhibitor laninamivir Octanoate as post exposure prophylaxis for influenza
Clinical Infectious Diseases, 2016Co-Authors: Seizaburo Kashiwagi, Mitsutoshi Uemori, Hideyuki Ikematsu, Akira Watanabe, Shinichiro AwamuraAbstract:Close contact with an influenza patient increases the risk of subsequent infection. In such cases, antiviral chemoprophylaxis should be considered for persons at high risk from serious illness or death related to influenza (the elderly, those with chronic respiratory illness or metabolic disorders including diabetes mellitus, chronic heart disease, and immunodeficiency) [1, 2]. A single administration of laninamivir Octanoate, a long-acting neuraminidase inhibitor, has been demonstrated to be an effective treatment for influenza [3–5], while oseltamivir and zanamivir need repeated administration, twice daily for 5 days. In Japan, laninamivir Octanoate has been used widely not only because of its high level of efficacy and safety but also because of its convenience [6–8]. For the post-exposure prophylaxis of influenza, the inhalation of 20 mg of laninamivir Octanoate once daily for 2 or 3 days effectively prevented the development of influenza through household contacts in a study conducted during the 2011–2012 influenza season [9]. However, it was not demonstrated that a single inhalation of laninamivir Octanoate was effective for post-exposure prophylaxis. In a study conducted during the 2009 influenza pandemic season, the inhalation of 20 or 40 mg of laninamivir Octanoate once a week reduced the proportion of patients who developed influenza (relative risk reduction [RRR] compared with placebo, 45.8% and 43.2%, respectively), but the differences with placebo were not significant [10]. A pharmacokinetics finding that a relatively high laninamivir concentration persisted in the lungs for 10 days after a single inhalation [11] suggested that a single inhalation of laninamivir Octanoate may be effective for post-exposure prophylaxis. This study was conducted to evaluate the efficacy of a single inhalation of 40 mg of laninamivir Octanoate as post-exposure prophylaxis for household contacts.
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laninamivir Octanoate for post exposure prophylaxis of influenza in household contacts a randomized double blind placebo controlled trial
Journal of Infection and Chemotherapy, 2013Co-Authors: Seizaburo Kashiwagi, Mitsutoshi Uemori, Shinichiro Awamura, Takako Okamoto, Hideyuki Ikematsu, Akira Watanabe, Katsuyasu IshidaAbstract:Laninamivir Octanoate, a long-acting neuraminidase inhibitor, is an effective treatment for influenza. However, its effectiveness for the prevention of influenza has not yet been demonstrated. We conducted a double-blind, multicenter, randomized, placebo-controlled trial to determine whether laninamivir Octanoate was superior to a placebo for post-exposure prophylaxis of influenza in household contacts. Eligible participants, who were household members who did not have influenza and were in contact with an influenza-infected index patient, were randomly assigned (1:1:1) to one of three groups: 20 mg of laninamivir Octanoate once daily for 2 days (LO-2), 20 mg of laninamivir Octanoate once daily for 3 days (LO-3), or a placebo. The primary endpoint was the proportion of participants who developed clinical influenza during a 10-day period. A total of 1711 participants were enrolled, and 1451 participants were included in the primary analysis. The proportion of participants with clinical influenza was 3.9 % (19/487) in the LO-2 group, 3.7 % (18/486) in the LO-3 group, and 16.9 % (81/478) in the placebo group (P < 0.001 for each of the laninamivir Octanoate group). The relative risk reductions, compared with the placebo group, were 77.0 % [95 % confidence interval (CI) 62.7–85.8] and 78.1 % (95 % CI 64.1–86.7 %) for the LO-2 and LO-3 groups, respectively. The incidences of adverse events in the laninamivir Octanoate groups were similar to that in the placebo group. The inhalation of 20 mg of laninamivir Octanoate once daily for 2 or 3 days was well tolerated and effectively prevented the development of influenza in household contacts.
