NEWS HIGHLIGHTSMedia Articles Related to Tamiflu (Oseltamivir)
Full Reports From Trials Should Be Public: Regulators Respond To Tamiflu Recommendations
Source: Clinical Trials / Drug Trials News From Medical News Today [2012.04.12]
The full clinical study reports that drugs that have been authorized for use in patients should be made publicly available in order to allow independent re-analysis of the benefits and risks of such drugs, according to leading international experts who base their assertions on their experience with Tamiflu (oseltamivir)...
Cases of Tamiflu-Resistant Flu Concern Experts
Source: MedicineNet amantadine Specialty [2011.12.29]
Title: Cases of Tamiflu-Resistant Flu Concern Experts
Category: Health News
Created: 12/28/2011 6:06:00 PM
Last Editorial Review: 12/29/2011 12:00:00 AM
Published Studies Related to Tamiflu (Oseltamivir)
Oseltamivir pharmacokinetics in morbid obesity (OPTIMO trial). [2011.09]
BACKGROUND: Detailed pharmacokinetics to guide oseltamivir (Tamiflu(R)) dosing in morbidly obese patients is lacking... CONCLUSIONS: With single and multiple dosing, the systemic exposure to oseltamivir is decreased but that of oseltamivir carboxylate is largely unchanged. Based on these pharmacokinetic data, an oseltamivir dose adjustment for body weight would not be needed in morbidly obese individuals.
Effect of milk on the pharmacokinetics of oseltamivir in healthy volunteers. [2011.09]
We previously showed that oseltamivir, a prodrug of the influenza virus neuraminidase inhibitor Ro 64-0802, is a substrate of proton-coupled oligopeptide transporter (PEPT1), and its intestinal absorption in rats is markedly inhibited by administration with milk...
Oseltamivir compared with the Chinese traditional therapy maxingshigan-yinqiaosan in the treatment of H1N1 influenza: a randomized trial. [2011.08.16]
BACKGROUND: Observational studies from Asia suggest that maxingshigan-yinqiaosan may be effective in the treatment of acute H1N1 influenza. OBJECTIVE: To compare the efficacy and safety of oseltamivir and maxingshigan-yinqiaosan in treating uncomplicated H1N1 influenza... CONCLUSION: Oseltamivir and maxingshigan-yinqiaosan, alone and in combination, reduced time to fever resolution in patients with H1N1 influenza virus infection. These data suggest that maxingshigan-yinqiaosan may be used as an alternative treatment of H1N1 influenza virus infection. PRIMARY FUNDING SOURCE: Beijing Science and Technology Project and Beijing Nova Program.
Effect of oseltamivir treatment on anticoagulation: a cross-over study in warfarinized patients. [2010.12]
AIM: To investigate whether oseltamivir enhances the anticoagulant effect of warfarin and to evaluate any pharmacokinetic (PK) interaction between the agents... CONCLUSION: Concomitant administration of oseltamivir for 4.5 days to volunteers on daily warfarin had little or no effect on warfarin pharmacokinetics and no effect on pharmacodynamics. (c) 2010 The Authors. British Journal of Clinical Pharmacology (c) 2010 The British Pharmacological Society.
Long-acting neuraminidase inhibitor laninamivir octanoate versus oseltamivir for treatment of influenza: A double-blind, randomized, noninferiority clinical trial. [2010.11.15]
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... 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.
Clinical Trials Related to Tamiflu (Oseltamivir)
Evaluation of Alternative Oseltamivir (Tamiflu) Dosing Strategies. [Completed]
Objective 1: Determine the safety and toxicity profile of Tamiflu administered in
combination with probenecid in healthy adults. Objective 2: Determine the pharmacokinetic
profile of Tamiflu and probenecid in healthy adults.
Pharmacokinetics of TamifluŽ (Oseltamivir) in Patients Receiving Extracorporeal Membrane Oxygenation (ECMO)and or Continuous Venovenous Hemodialysis (CVVHD) [Recruiting]
Critically ill patients with flu may receive a drug called oseltamivir. They may also
receive medical therapies to support their lung function (extracorporeal membrane
oxygenation; ECMO) and kidney function (continuous venovenous hemodialysis; CVVHD). CVVHD
and ECMO may remove some oseltamivir from the bloodstream. The purpose of this study is to
determine how much oseltamivir gets removed by CVVHD or ECMO in critically ill patients.
A Study of Tamiflu (Oseltamivir) for Treatment of Influenza With a Focus on (H1N1) 2009 Flu Strain [Recruiting]
This randomized, double-blind, multi-center study of Tamiflu (Oseltamivir) will evaluate the
efficacy against viral activity, the effectiveness in resolving the disease symptoms, and
the safety and tolerability in patients with influenza. Patients with (H1N1) 2009 influenza
strain or influenza A are eligible for this study. Patients will be randomized to one of
four treatment regimens. Patients will receive oral doses of either 75 mg (adults) or 150 mg
(adults) of study drug twice daily for 5 or 10 consecutive days. The dose will be body
weight-adjusted for pediatric patients. The target sample size is 300-500 patients.
Safety and Pharmacokinetic Effects of Oseltamivir Alone or in Combination With Amantadine [Completed]
This study is designed to assess the safety and pharmacokinetic effects of oseltamivir
administration alone or in combination with amantadine in healthy volunteers.
Efficacy Study of Early vs. Late Oseltamivir Administration for Treating and Preventing Influenza [Active, not recruiting]
This study is a randomized, blinded, placebo-controlled clinical efficacy trial to assess the
duration and severity of influenza symptoms, duration of viral shedding, and household
transmission in influenza patients receiving oseltamivir early and late relative to placebo.
There are four main hypotheses:
1. The duration of influenza symptoms, severity, and duration of viral shedding are reduced
in patients who start oseltamivir treatment late (48 to 119 hours after illness onset)
compared to those receiving no antiviral therapy;
2. Antiviral effectiveness for reducing infectiousness to household contacts is at least
80% for index cases starting therapy early (<48 hours) compared to those receiving no
antiviral therapy;
3. Antiviral effectiveness for reducing infectiousness to household contacts is at least
60% when patients initiate treatment late (48 to 119 hours) compared to those receiving
no antiviral therapy;
4. Prior influenza vaccination during the same season reduces the duration of influenza
symptoms and symptom severity in patients receiving oseltamivir after adjusting for age
and timing of antiviral therapy (early vs. late).
There are two secondary hypotheses:
1. The duration of influenza symptoms, severity, and duration of viral shedding are reduced
in patients with influenza who start oseltamivir treatment early (within 48 hours) vs.
late (48 to 119 hours);
2. The incidence of secondary complications is lower in patients starting oseltamivir
therapy late relative to those receiving no antiviral therapy.
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 10 ratings/reviews, Tamiflu has an overall score of 7.20. The effectiveness score is 7.60 and the side effect score is 8. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
| | Tamiflu review by 52 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | family flu outbreak |
| Dosage & duration: | | 75mg taken twice x a day for the period of 5 days |
| Other conditions: | | none |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | My son came home from college with the flu. Student Health gave him a pack of Tamiflu and he felt better within 24 hours. When I started feeling sick 3 days later, I called my Dr and ask for Tamiflu. I felt almost back to norma lwithin 24 hours. |
| Side effects: | | none |
| Comments: | | Just took the pill and drank fluids |
|
| | Tamiflu review by 40 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Moderately Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | The flu |
| Dosage & duration: | | 75 mg capsules taken twice per day for the period of 5 days |
| Other conditions: | | none |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | This is an easy to take flu remedy that lasts only 5 days. It was good to know that as miserable as the flu was, I could finally take action to rid myself of it sooner, as compared to last year when there was no remedy available. By taking Tamiflu, I think the duration of the flu may have been shortened by 1-2 days |
| Side effects: | | none |
| Comments: | | I was hoping that I would feel my flu symptoms lessening on the first day of treatment. I didn't feel significantly better until the third day. This prescription cost close to $100. It makes me wonder if it was really worth it. |
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| | Tamiflu review by 25 year old female patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Marginally Effective |
| Side effects: | | Severe Side Effects | | |
Treatment Info |
| Condition / reason: | | i was in a risk group - frontline pharmacist |
| Dosage & duration: | | one jab (dosage frequency: once) for the period of once |
| Other conditions: | | numbness in arm, cold, fever |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | supposed prevention of catching swine flu |
| Side effects: | | sickness for 4 days, numb arm for that period of time, couldn't dress, couldn't drive. then cold anf flu followed, with stomach problams because of lack of food because of associated problems |
| Comments: | | no treatment was given except cold anf flu medication, just waited out the symptoms and side effects |
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