Pub Date : 2015-07-06DOI: 10.4172/2167-065X.1000138
M. Trivedi, G. Nayak, S. Patil, R. M. Tallapragada, S. Jana, R. Mishra
In the present study, the influence of biofield treatment on physical and thermal properties of Casein Enzyme Hydrolysate (CEH) and Casein Yeast Peptone (CYP) were investigated. The control and treated samples were characterized by Fourier transform infrared (FT-IR) spectroscopy, differential scanning calorimetry (DSC), Thermo Gravimetric Analysis (TGA), particle size and surface area analysis. The FTIR results revealed that biofield treatment has caused reduction of amide group (amide-I and amide-II) stretching vibration peak that is associated with strong intermolecular hydrogen bonding in treated CEH as compared to control. However, no significant changes were observed in FTIR spectrum of treated CYP. The TGA analysis of treated CEH showed a substantial improvement in thermal stability which was confirmed by increase in maximum thermal decomposition temperature (217°C) as compared to control (209°C). Similarly, the treated CYP also showed enhanced thermal stability as compared to control. DSC showed increase in melting temperature of treated CYP as compared to control. However the melting peak was absent in DSC of treated CEH which was probably due to rigid chain of the protein. The surface area of treated CEH was increased by 83% as compared to control. However, a decrease (7.3%) in surface area was observed in treated CYP. The particle size analysis of treated CEH showed a significant increase in average particle size (d50) and d99 value (maximum particle size below which 99% of particles are present) as compared to control sample. Similarly, the treated CYP also showed a substantial increase in d50 and d99 values which was probably due to the agglomeration of the particles which led to formation of bigger microparticles. The result showed that the biofield treated CEH and CYP could be used as a matrix for pharmaceutical applications.
{"title":"Evaluation of the Impact of Biofield Treatment on Physical and Thermal Properties of Casein Enzyme Hydrolysate and Casein Yeast Peptone","authors":"M. Trivedi, G. Nayak, S. Patil, R. M. Tallapragada, S. Jana, R. Mishra","doi":"10.4172/2167-065X.1000138","DOIUrl":"https://doi.org/10.4172/2167-065X.1000138","url":null,"abstract":"In the present study, the influence of biofield treatment on physical and thermal properties of Casein Enzyme Hydrolysate (CEH) and Casein Yeast Peptone (CYP) were investigated. The control and treated samples were characterized by Fourier transform infrared (FT-IR) spectroscopy, differential scanning calorimetry (DSC), Thermo Gravimetric Analysis (TGA), particle size and surface area analysis. The FTIR results revealed that biofield treatment has caused reduction of amide group (amide-I and amide-II) stretching vibration peak that is associated with strong intermolecular hydrogen bonding in treated CEH as compared to control. However, no significant changes were observed in FTIR spectrum of treated CYP. The TGA analysis of treated CEH showed a substantial improvement in thermal stability which was confirmed by increase in maximum thermal decomposition temperature (217°C) as compared to control (209°C). Similarly, the treated CYP also showed enhanced thermal stability as compared to control. DSC showed increase in melting temperature of treated CYP as compared to control. However the melting peak was absent in DSC of treated CEH which was probably due to rigid chain of the protein. The surface area of treated CEH was increased by 83% as compared to control. However, a decrease (7.3%) in surface area was observed in treated CYP. The particle size analysis of treated CEH showed a significant increase in average particle size (d50) and d99 value (maximum particle size below which 99% of particles are present) as compared to control sample. Similarly, the treated CYP also showed a substantial increase in d50 and d99 values which was probably due to the agglomeration of the particles which led to formation of bigger microparticles. The result showed that the biofield treated CEH and CYP could be used as a matrix for pharmaceutical applications.","PeriodicalId":10410,"journal":{"name":"Clinical Pharmacology & Biopharmaceutics","volume":"71 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2015-07-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76545329","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2015-04-25DOI: 10.4172/2167-065X.1000137
M. MidoriSoda, Y. Shibata, M. Yasue, M. Fujimura, H. Takahashi, S. Nakamura, A. Suzuki, T. Hara, H. Tsurumi, Y. Ito, K. Kitaichi
Antifungal caspofungin (CPFG) was approved for the treatment of febrile neutropenia (FN) as the empiric treatment. However, the relationship between pharmacokinetic properties of CPFG and its clinical effects in patients with FN has not been fully established yet. Thus, in the present study, we tried to establish the simple and quantitative HPLC method to measure CPFG in human plasma with liquid-liquid extraction. CPFG in human plasma was extracted by liquid-liquid extraction and was separated by 5C18 column with mobile phase containing 20 mM phosphate buffer (pH 2.5) and acetonitrile (65:35). CPFG and p-hydroxybenzoate ethyl ester, used as an internal standard (IS), were detected by a fluorescence detector (Ex: 224 nm, Em: 304 nm) and by UV-VIS (254 nm), respectively. CPFG and IS were detected with retention times of 17.0 and 9.5 min, respectively, which were separated from matrix compounds. The calibration curves were linear from 1.0 to 20 μg/mL (R2>0.99). The limit of detection, the limit of quantification and the lower limit of quantification were 0.53 μg/mL, 0.89 μg/mL and 1.0 μg/mL, respectively. The validation study revealed that the intra- and inter-day accuracy and precision were within the acceptable range and that CPFG was fairly stable after freezing and thawing, reconstitution, in autosampler and in stock solution at ambient temperature up to 8-24 h. These results suggest that our established method to measure CPFG in human plasma would be applicable to measure plasma CPFG in patients with FN in order to establish the evidence for appropriate drug therapy.
{"title":"Simple HPLC Method for the Determination of Caspofungin in Human Plasma","authors":"M. MidoriSoda, Y. Shibata, M. Yasue, M. Fujimura, H. Takahashi, S. Nakamura, A. Suzuki, T. Hara, H. Tsurumi, Y. Ito, K. Kitaichi","doi":"10.4172/2167-065X.1000137","DOIUrl":"https://doi.org/10.4172/2167-065X.1000137","url":null,"abstract":"Antifungal caspofungin (CPFG) was approved for the treatment of febrile neutropenia (FN) as the empiric treatment. However, the relationship between pharmacokinetic properties of CPFG and its clinical effects in patients with FN has not been fully established yet. Thus, in the present study, we tried to establish the simple and quantitative HPLC method to measure CPFG in human plasma with liquid-liquid extraction. CPFG in human plasma was extracted by liquid-liquid extraction and was separated by 5C18 column with mobile phase containing 20 mM phosphate buffer (pH 2.5) and acetonitrile (65:35). CPFG and p-hydroxybenzoate ethyl ester, used as an internal standard (IS), were detected by a fluorescence detector (Ex: 224 nm, Em: 304 nm) and by UV-VIS (254 nm), respectively. CPFG and IS were detected with retention times of 17.0 and 9.5 min, respectively, which were separated from matrix compounds. The calibration curves were linear from 1.0 to 20 μg/mL (R2>0.99). The limit of detection, the limit of quantification and the lower limit of quantification were 0.53 μg/mL, 0.89 μg/mL and 1.0 μg/mL, respectively. The validation study revealed that the intra- and inter-day accuracy and precision were within the acceptable range and that CPFG was fairly stable after freezing and thawing, reconstitution, in autosampler and in stock solution at ambient temperature up to 8-24 h. These results suggest that our established method to measure CPFG in human plasma would be applicable to measure plasma CPFG in patients with FN in order to establish the evidence for appropriate drug therapy.","PeriodicalId":10410,"journal":{"name":"Clinical Pharmacology & Biopharmaceutics","volume":"29 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2015-04-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76446695","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2015-04-14DOI: 10.4172/2167-065X.1000136
J. Reure, P. Follana, Ferrero Jm
Background: HER 2 Metastatic Breast Cancer (MBC) is usually considered incurable. Prognosis has considerably improved over the past two decades with the advent of new therapies such as monoclonal antibodies interfering with the Her2/neu receptor. Case presentation: We present a case of 61 year old woman with Her2 positive MBC without any sign of recurrence 5 years after the end of trastuzumab and who could be potentially considered cured. Conclusion: In case of sustained response, stopping trastuzumab is possible without recurrence. We can reasonably hope that patients without recurrence after 5 years, as in our case, are definitely cured.
{"title":"Her2 Positive Metastatic Breast Cancer Patient without Any Sign of Recurrence 5 years after Cessation of Trastuzumab: A Case Report","authors":"J. Reure, P. Follana, Ferrero Jm","doi":"10.4172/2167-065X.1000136","DOIUrl":"https://doi.org/10.4172/2167-065X.1000136","url":null,"abstract":"Background: HER 2 Metastatic Breast Cancer (MBC) is usually considered incurable. Prognosis has considerably improved over the past two decades with the advent of new therapies such as monoclonal antibodies interfering with the Her2/neu receptor. \u0000Case presentation: We present a case of 61 year old woman with Her2 positive MBC without any sign of recurrence 5 years after the end of trastuzumab and who could be potentially considered cured. \u0000Conclusion: In case of sustained response, stopping trastuzumab is possible without recurrence. We can reasonably hope that patients without recurrence after 5 years, as in our case, are definitely cured.","PeriodicalId":10410,"journal":{"name":"Clinical Pharmacology & Biopharmaceutics","volume":"11 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2015-04-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88605793","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2015-04-06DOI: 10.4172/2167-065X.1000135
R. Bloomer, D. Melcher, R. Benjamin
Introduction: Methylsulfonylmethane (MSM) is a commonly used dietary supplement for the alleviation of joint and muscle pain. It is known primarily for its anti-inflammatory and antioxidant properties. While it is believed to have excellent bioavailability, little is known about its serum concentrations following chronic ingestion. Methods: 20 healthy men were supplemented with 3 grams of MSM daily for four weeks. Blood was collected at baseline and after two and four weeks of supplementation. Serum was analyzed for MSM concentration using Nuclear Magnetic Resonance (NMR) spectroscopy. Results: All baseline samples but one (0.028 mM) was below the limit of quantification for the NMR assay (0.002 mM). Serum MSM values increased across time (p 0.05). A total of 13 of the 20 men demonstrated higher serum MSM values at week 4 as compared to week 2. and eight of these men demonstrated an increase at week 4 of at least 25% above what was observed at week 2. Conclusions: Serum MSM concentrations increase following oral MSM supplementation, in somewhat of a timedependent manner in selected subjects. The pattern of increase varies somewhat from subject to subject, although all individuals experience an increase of approximately 1-3 mM after 2-4 weeks of supplementation.
{"title":"Serum MSM Concentrations Following One Month of MSM Treatment in Healthy Men","authors":"R. Bloomer, D. Melcher, R. Benjamin","doi":"10.4172/2167-065X.1000135","DOIUrl":"https://doi.org/10.4172/2167-065X.1000135","url":null,"abstract":"Introduction: Methylsulfonylmethane (MSM) is a commonly used dietary supplement for the alleviation of joint and muscle pain. It is known primarily for its anti-inflammatory and antioxidant properties. While it is believed to have excellent bioavailability, little is known about its serum concentrations following chronic ingestion. Methods: 20 healthy men were supplemented with 3 grams of MSM daily for four weeks. Blood was collected at baseline and after two and four weeks of supplementation. Serum was analyzed for MSM concentration using Nuclear Magnetic Resonance (NMR) spectroscopy. Results: All baseline samples but one (0.028 mM) was below the limit of quantification for the NMR assay (0.002 mM). Serum MSM values increased across time (p 0.05). A total of 13 of the 20 men demonstrated higher serum MSM values at week 4 as compared to week 2. and eight of these men demonstrated an increase at week 4 of at least 25% above what was observed at week 2. Conclusions: Serum MSM concentrations increase following oral MSM supplementation, in somewhat of a timedependent manner in selected subjects. The pattern of increase varies somewhat from subject to subject, although all individuals experience an increase of approximately 1-3 mM after 2-4 weeks of supplementation.","PeriodicalId":10410,"journal":{"name":"Clinical Pharmacology & Biopharmaceutics","volume":"76 1","pages":"1-4"},"PeriodicalIF":0.0,"publicationDate":"2015-04-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80125130","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2015-03-16DOI: 10.4172/2167-065X.1000130
T. Kryczka, P. Grieb
Pressure ulcers remain a major health problem in immobilized patients, both hospitalized and staying at nursing or private homes. Malnutrition is a significant risk factor for their development and dietary supplementation is a potentially valuable method of supportive treatment. However, clinical data showing specific efficacy of supplements in pressure ulcers are scanty. The present short review compares effects of two dietary supplements which have been tested as an addition to standard treatment of pressure ulcers in non-malnourished patients: Cubitan (Nutricia) which is a complex protein and vitamin formulation, and carnosine, a dipeptide naturally present in meat, which may exert significant pharmacologic effects
{"title":"Supportive Treatment of Pressure Ulcers with Dietary Supplementation","authors":"T. Kryczka, P. Grieb","doi":"10.4172/2167-065X.1000130","DOIUrl":"https://doi.org/10.4172/2167-065X.1000130","url":null,"abstract":"Pressure ulcers remain a major health problem in immobilized patients, both hospitalized and staying at nursing or private homes. Malnutrition is a significant risk factor for their development and dietary supplementation is a potentially valuable method of supportive treatment. However, clinical data showing specific efficacy of supplements in pressure ulcers are scanty. The present short review compares effects of two dietary supplements which have been tested as an addition to standard treatment of pressure ulcers in non-malnourished patients: Cubitan (Nutricia) which is a complex protein and vitamin formulation, and carnosine, a dipeptide naturally present in meat, which may exert significant pharmacologic effects","PeriodicalId":10410,"journal":{"name":"Clinical Pharmacology & Biopharmaceutics","volume":"14 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2015-03-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90439212","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2015-02-26DOI: 10.4172/2167-065X.1000133
Muhammad Adnan, S. Karim, Shamshir Khan, A. Sabir, Abdul Rahman Lafi Al-Banagi, Q. M. Jamal, N. Wabel
Objective: The aims of this study were to evaluate the student’s knowledge, awareness and the reasons behind self medication in two higher education institutes in Al Qassim region of Saudi Arabia. Subjects and method: This pre-validated anonymous questionnaire was used in English and Arabic language that contains both open ended and close ended questions and it was distributed among students of two higher education institutes of Al Qassim region i.e. Buraidah Private Colleges and Qassim University. A total number of 61 students from Buraydah Private Colleges studying in different levels belong to pharmacy, dentistry and nursing college participated in this study and 71 students of final year medical college in Qassim University participated in the study. The data has been analyzed by descriptive statistics and summarized in frequencies and percentages. Results: Self medications were very common among students of Qassim University (QU) and Buraydah Private Colleges (BPC) and about more than two third students have practiced self medication in past year prior to this study. Majority of participants in our study self medicate for one week to treat self-recognized or self-diagnosed conditions and most of them obtained their medication from pharmacy. About one half of BPC students and slightly more than one half QU students used antibiotic as self medication. The awareness of rational use of medicine was found 63.3% among QU students and 45 % in BPC students. The highly significant difference (p< 0.05) was observed between the students of QU and BPC about the rational use of medication. The main reason for self medication in our study was found to be non serious health problems and quick relief. Conclusion: The self medication practice among students of two higher educational institutes of Al Qassim region was high and often inappropriate. There was an alarming self medication of antibiotics among students that was obtained from local pharmacies without prescription
{"title":"Evaluation of Self-Medication Practices and Awareness among Students in Al Qassim Region of Saudi Arabia","authors":"Muhammad Adnan, S. Karim, Shamshir Khan, A. Sabir, Abdul Rahman Lafi Al-Banagi, Q. M. Jamal, N. Wabel","doi":"10.4172/2167-065X.1000133","DOIUrl":"https://doi.org/10.4172/2167-065X.1000133","url":null,"abstract":"Objective: The aims of this study were to evaluate the student’s knowledge, awareness and the reasons behind self medication in two higher education institutes in Al Qassim region of Saudi Arabia. Subjects and method: This pre-validated anonymous questionnaire was used in English and Arabic language that contains both open ended and close ended questions and it was distributed among students of two higher education institutes of Al Qassim region i.e. Buraidah Private Colleges and Qassim University. A total number of 61 students from Buraydah Private Colleges studying in different levels belong to pharmacy, dentistry and nursing college participated in this study and 71 students of final year medical college in Qassim University participated in the study. The data has been analyzed by descriptive statistics and summarized in frequencies and percentages. Results: Self medications were very common among students of Qassim University (QU) and Buraydah Private Colleges (BPC) and about more than two third students have practiced self medication in past year prior to this study. Majority of participants in our study self medicate for one week to treat self-recognized or self-diagnosed conditions and most of them obtained their medication from pharmacy. About one half of BPC students and slightly more than one half QU students used antibiotic as self medication. The awareness of rational use of medicine was found 63.3% among QU students and 45 % in BPC students. The highly significant difference (p< 0.05) was observed between the students of QU and BPC about the rational use of medication. The main reason for self medication in our study was found to be non serious health problems and quick relief. Conclusion: The self medication practice among students of two higher educational institutes of Al Qassim region was high and often inappropriate. There was an alarming self medication of antibiotics among students that was obtained from local pharmacies without prescription","PeriodicalId":10410,"journal":{"name":"Clinical Pharmacology & Biopharmaceutics","volume":"61 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2015-02-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86478681","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2015-01-31DOI: 10.4172/2167-065X.1000132
C. Bondi, Rahul Khairnar, K. Kamal, P. Witt‐Enderby
In the U.S., there are approximately 9 million adults with osteoporosis (OP) and an additional 43 million at-risk. By 2030, this number is expected to increase to 68 million adults. The economic impact is estimated to be $23 billion by 2025. Current drug therapies either decrease bone resorption (e.g., bisphosphonates) or stimulate bone formation (e.g., teriparatide). Melatonin may be a potential treatment option because research has shown it impacts bone metabolism by promoting osteoblast differentiation and activity and by suppressing osteoclast differentiation and activity. As shown in the Melatonin Osteoporosis Prevention Study (MOPS; NCT01152580), melatonin improved bone health in perimenopausal women by renormalizing bone marker turnover. Also, it is well-tolerated and has a high safety profile. Given the chronic nature of OP, coupled with high treatment costs, economic evaluation of melatonin with existing treatments could be very useful for those who manage and plan healthcare budgets. The objective of this work was to determine the budgetary impact of the addition of melatonin to treat and prevent OP from a payer perspective. A 1-year budget impact model with a hypothetical plan population of 1 million was utilized. Whole sale acquisition costs of melatonin and comparators were taken from Red Book; market share and prevalence data were obtained from the literature. Sensitivity analysis was performed to assess if changes in market share and drug costs affected the results. All costs are in 2013 U.S. dollars. The introduction of melatonin produced as Per Member Per Month (PMPM) change of -$0.11 for OP and a PMPM of -$0.20 for osteopenia. In conclusion, the addition of melatonin to a formulary will provide substantial cost offsets to the payer in the treatment and prevention of OP under the assumption that the effectiveness of melatonin is equal to its comparators.
{"title":"An Early Development Budget Impact Model for the Use of Melatonin in the Treatment and Prevention of Osteoporosi","authors":"C. Bondi, Rahul Khairnar, K. Kamal, P. Witt‐Enderby","doi":"10.4172/2167-065X.1000132","DOIUrl":"https://doi.org/10.4172/2167-065X.1000132","url":null,"abstract":"In the U.S., there are approximately 9 million adults with osteoporosis (OP) and an additional 43 million at-risk. By 2030, this number is expected to increase to 68 million adults. The economic impact is estimated to be $23 billion by 2025. Current drug therapies either decrease bone resorption (e.g., bisphosphonates) or stimulate bone formation (e.g., teriparatide). Melatonin may be a potential treatment option because research has shown it impacts bone metabolism by promoting osteoblast differentiation and activity and by suppressing osteoclast differentiation and activity. As shown in the Melatonin Osteoporosis Prevention Study (MOPS; NCT01152580), melatonin improved bone health in perimenopausal women by renormalizing bone marker turnover. Also, it is well-tolerated and has a high safety profile. Given the chronic nature of OP, coupled with high treatment costs, economic evaluation of melatonin with existing treatments could be very useful for those who manage and plan healthcare budgets. The objective of this work was to determine the budgetary impact of the addition of melatonin to treat and prevent OP from a payer perspective. A 1-year budget impact model with a hypothetical plan population of 1 million was utilized. Whole sale acquisition costs of melatonin and comparators were taken from Red Book; market share and prevalence data were obtained from the literature. Sensitivity analysis was performed to assess if changes in market share and drug costs affected the results. All costs are in 2013 U.S. dollars. The introduction of melatonin produced as Per Member Per Month (PMPM) change of -$0.11 for OP and a PMPM of -$0.20 for osteopenia. In conclusion, the addition of melatonin to a formulary will provide substantial cost offsets to the payer in the treatment and prevention of OP under the assumption that the effectiveness of melatonin is equal to its comparators.","PeriodicalId":10410,"journal":{"name":"Clinical Pharmacology & Biopharmaceutics","volume":"9 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2015-01-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79699013","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2015-01-23DOI: 10.4172/2167-065X.1000131
E. Ehrenpreis, A. K. Bs, A. Bsa, Smith Bsd, W. Bas
Background: Tardive dyskinesia (TD) is a severe neurologic adverse reaction occurring with long-term use of metoclopramide. Aim: To examine all reported legal cases involving metoclopramide-induced TD prior to June 16, 2014 in an effort to inform physicians and practitioners of the current legal risks associated with the prescription of metoclopramide. Methods: A search of the Westlaw database for cases that contained the terms metoclopramide and tardive dyskinesia was performed. This dataset was then queried for cases brought against physicians or practitioners. Full length reports were obtained and information was pulled regarding plaintiff demographics, medical specialty of the defendant, plaintiff’s TD symptoms, lawsuit claims, and case outcome. Results: There were ninety-six cases in which patients filed a claim that met our search criteria. Eighty-five cases (88.5%) were brought against the brand name and/or generic medicine manufacturers as failure to warn claims. There were eleven cases brought against physicians or practitioners. Eight of eleven lawsuits (72%), of cases were either dismissed, settled or were in the process of settlement. There has also been an increase in the number of malpractice cases filed related to metoclopramide induced TD since the FDA issued its black box warning in February, 2009. Conclusions: There have been a small number of cases directed at physicians related to the prescription of metoclopramide and the development of TD, most of which were either dismissed or settled.
{"title":"A Survey of Lawsuits Filed for the Complaint of Tardive Dyskinesia Following Treatment with Metoclopramide","authors":"E. Ehrenpreis, A. K. Bs, A. Bsa, Smith Bsd, W. Bas","doi":"10.4172/2167-065X.1000131","DOIUrl":"https://doi.org/10.4172/2167-065X.1000131","url":null,"abstract":"Background: Tardive dyskinesia (TD) is a severe neurologic adverse reaction occurring with long-term use of metoclopramide. Aim: To examine all reported legal cases involving metoclopramide-induced TD prior to June 16, 2014 in an effort to inform physicians and practitioners of the current legal risks associated with the prescription of metoclopramide. Methods: A search of the Westlaw database for cases that contained the terms metoclopramide and tardive dyskinesia was performed. This dataset was then queried for cases brought against physicians or practitioners. Full length reports were obtained and information was pulled regarding plaintiff demographics, medical specialty of the defendant, plaintiff’s TD symptoms, lawsuit claims, and case outcome. Results: There were ninety-six cases in which patients filed a claim that met our search criteria. Eighty-five cases (88.5%) were brought against the brand name and/or generic medicine manufacturers as failure to warn claims. There were eleven cases brought against physicians or practitioners. Eight of eleven lawsuits (72%), of cases were either dismissed, settled or were in the process of settlement. There has also been an increase in the number of malpractice cases filed related to metoclopramide induced TD since the FDA issued its black box warning in February, 2009. Conclusions: There have been a small number of cases directed at physicians related to the prescription of metoclopramide and the development of TD, most of which were either dismissed or settled.","PeriodicalId":10410,"journal":{"name":"Clinical Pharmacology & Biopharmaceutics","volume":"106 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2015-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87926797","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2015-01-09DOI: 10.4172/2167-065X.1000129
S. Cho
Objective: Organic Cation Transporter 1 (OCT1) plays a key role in the disposition of metformin in hepatocytes; a recent non-clinical study reported that the peroxisome-proliferator activated receptor γ agonist pioglitazone increased the expression of Slc22a1 (Oct1) by 3.1-fold as well as its transporting function. We therefore evaluated the effect of pioglitazone on the glucose-lowering effect of metformin in 15 human participants using the Oral Glucose Tolerance Test (OGTT) and measuring the mRNA levels of OCT1, as well as those of Glucose Transporter 1 (GLUT 1) and GLUT4, which are also important in glucose utilization, in peripheral blood cells. Research design and methods: The glucose-lowering effects of metformin were evaluated by the OGTT before and after metformin treatment on Days 1 and 2 of the study and again on Days 18 and 19 after a 14-day course of pioglitazone 30 mg/day. Differences in maximum glucose levels (ΔGmax) and the areas under the glucose-time curve during the first 60 min after glucose ingestion (ΔAUCgluc60) and the entire 180-min test (ΔAUCgluc) caused by metformin treatment were determined before and after pioglitazone administration. Results: Pioglitazone increased ΔGmax by 50.0% (P=0.021), ΔAUCgluc60 by 88.1% (P=0.020), and ΔAUCgluc by 266%. Pioglitazone did not increase OCT1 and GLUT1 mRNA levels in peripheral blood cells. Conclusion: OCT1 induction plays a limited role in the synergistic effect of pioglitazone on the glucose-lowering activity of metformin. However, this synergistic effect lasted 3 days after pioglitazone treatment ended, which warrants further clinical investigation.
{"title":"The Synergistic Effects of Pioglitazone on the Glucose-Lowering Action of Metformin in Relation to OCT1 and Gluts m-RNA Expression in Healthy Volunteer","authors":"S. Cho","doi":"10.4172/2167-065X.1000129","DOIUrl":"https://doi.org/10.4172/2167-065X.1000129","url":null,"abstract":"Objective: Organic Cation Transporter 1 (OCT1) plays a key role in the disposition of metformin in hepatocytes; a recent non-clinical study reported that the peroxisome-proliferator activated receptor γ agonist pioglitazone increased the expression of Slc22a1 (Oct1) by 3.1-fold as well as its transporting function. We therefore evaluated the effect of pioglitazone on the glucose-lowering effect of metformin in 15 human participants using the Oral Glucose Tolerance Test (OGTT) and measuring the mRNA levels of OCT1, as well as those of Glucose Transporter 1 (GLUT 1) and GLUT4, which are also important in glucose utilization, in peripheral blood cells. Research design and methods: The glucose-lowering effects of metformin were evaluated by the OGTT before and after metformin treatment on Days 1 and 2 of the study and again on Days 18 and 19 after a 14-day course of pioglitazone 30 mg/day. Differences in maximum glucose levels (ΔGmax) and the areas under the glucose-time curve during the first 60 min after glucose ingestion (ΔAUCgluc60) and the entire 180-min test (ΔAUCgluc) caused by metformin treatment were determined before and after pioglitazone administration. Results: Pioglitazone increased ΔGmax by 50.0% (P=0.021), ΔAUCgluc60 by 88.1% (P=0.020), and ΔAUCgluc by 266%. Pioglitazone did not increase OCT1 and GLUT1 mRNA levels in peripheral blood cells. Conclusion: OCT1 induction plays a limited role in the synergistic effect of pioglitazone on the glucose-lowering activity of metformin. However, this synergistic effect lasted 3 days after pioglitazone treatment ended, which warrants further clinical investigation.","PeriodicalId":10410,"journal":{"name":"Clinical Pharmacology & Biopharmaceutics","volume":"48 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2015-01-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81494696","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2015-01-01DOI: 10.4172/2167-065X.1000141
C. Cantisani, G. Paolino, F. Passarelli, E. Cigna, L. Rota, S. Pallotta, C. Bangrazi, R. Lisi, P. Corsetti, S. Calvieri
A 66 year-old Caucasian patient presented to our attention complaining for an heliotrope rash and large diffuse erythematous itching with pustular-like lesions on his trunk, upper arms, involving the upper gluteus, with a yellowish necrotic like surface (Figure 1A,1B). Brown-to-purple lesions were also present on the right side of his back associated to muscle weakness. His personal medical history was positive for diabetes, hypertension and a 14 months history of squamous cell carcinoma of the lung. After 45 days of a sequential chemotherapic combination, with carboplatin/gemcitabine/taxotere/ bevacizumab regimen the patient referred the onset of the skin reaction.
{"title":"Unusual Skin Toxicity after a Chemotherapic Combination","authors":"C. Cantisani, G. Paolino, F. Passarelli, E. Cigna, L. Rota, S. Pallotta, C. Bangrazi, R. Lisi, P. Corsetti, S. Calvieri","doi":"10.4172/2167-065X.1000141","DOIUrl":"https://doi.org/10.4172/2167-065X.1000141","url":null,"abstract":"A 66 year-old Caucasian patient presented to our attention complaining for an heliotrope rash and large diffuse erythematous itching with pustular-like lesions on his trunk, upper arms, involving the upper gluteus, with a yellowish necrotic like surface (Figure 1A,1B). Brown-to-purple lesions were also present on the right side of his back associated to muscle weakness. His personal medical history was positive for diabetes, hypertension and a 14 months history of squamous cell carcinoma of the lung. After 45 days of a sequential chemotherapic combination, with carboplatin/gemcitabine/taxotere/ bevacizumab regimen the patient referred the onset of the skin reaction.","PeriodicalId":10410,"journal":{"name":"Clinical Pharmacology & Biopharmaceutics","volume":"16 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2015-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88415186","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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