For people who have had a heart attack, taking a high dose of atorvastatin (up to 40mg/day) has no added benefit over a moderate dose (10mg/day) a study has shown.
In a two year clinical trial involving more than 1300 patients with acute coronary syndromes (ACS), cardiologists from the Second Xiangya Hospital of Central South University, Changsha, found that the dose of statin had no impact on the primary end points of cardiac death, non-fatal acute myocardial infarction, revascularization, ischaemic stroke and unstable angina or severe heart failure requiring emergency hospitalization. The patients' lipid levels were low initially (mean LDL cholesterol level of 2.7mmol/L) and declined by 20% in the moderate dose statin group and 27% in the intensive statin group, respectively.
"For ACS patients with a relatively low baseline LDL cholesterol level who received optimized current medication and interventional therapy, the incremental LDL cholesterol reduction of 6.4% achieved by double-dose statin did not bring significant clinical effectiveness," the researchers concluded.
The findings are published in Atherosclerosis.
Showing posts with label clinical trials. Show all posts
Showing posts with label clinical trials. Show all posts
Monday, 10 March 2014
Tuesday, 17 December 2013
Acarbose the first line drug for type 2 diabetes in rice-eating populations: Chinese study
by Michael Woodhead
Although metformin is the first line treatment for type 2 diabetes, the α-glucosidase inhibitor acarbose has been shown in a major Chinese trial be be a worthy alternative in patients with a marked postprandial glucose changes.
In The Lancet Diabetes & Endocrinology, Professor Yang Wenying and colleagues from the Department of Endocrinology, China-Japan Friendship Hospital, Beijing, report the findings of a randomised controlled trial that compared the α-glucosidase inhibitor acarbose with metformin as initial treatment for type 2 diabetes.
In a study known as the MARCH (Metformin and AcaRbose in Chinese as the initial Hypoglycaemic treatment) trial they recruited 788 adult Chinese patients who were newly diagnosed with type 2 diabetes. Patients were randomly assigned to receive metformin (up to 1500 mg sustained release preparation) or acarbose (titrated gradually up to a maximum of 100 mg three times a day). At the end of the 48-week study period, acarbose was found to be as effective as metformin in terms of its HbA1c-lowering effect , and both treatment regimens achieved weight loss, although patients in the acarbose group lost slightly more weight (−0·63 kg). Patients assigned to the acarbose group also had a more favourable lipid profile, with improved HDL and lower triglycerides at 48 weeks. As expected, treatment with acarbose was associated with less postprandial hyperinsulinaemia than with metformin.
An accompanying editorial says alpha-glucosidase inhibitors remain most popular in Asian countries such as China, where rice forms a major component of the diet and the dietary contribution of carbohydrate is high.
“The results of this large study indicate that the efficacy of acarbose could be related to the carbohydrate content in the patients' diet, which suggests that acarbose would be more effective in populations with a high carbohydrate intake,” it said.
Source: The Lancet Diabetes & Endocrinology
Although metformin is the first line treatment for type 2 diabetes, the α-glucosidase inhibitor acarbose has been shown in a major Chinese trial be be a worthy alternative in patients with a marked postprandial glucose changes.
In The Lancet Diabetes & Endocrinology, Professor Yang Wenying and colleagues from the Department of Endocrinology, China-Japan Friendship Hospital, Beijing, report the findings of a randomised controlled trial that compared the α-glucosidase inhibitor acarbose with metformin as initial treatment for type 2 diabetes.
In a study known as the MARCH (Metformin and AcaRbose in Chinese as the initial Hypoglycaemic treatment) trial they recruited 788 adult Chinese patients who were newly diagnosed with type 2 diabetes. Patients were randomly assigned to receive metformin (up to 1500 mg sustained release preparation) or acarbose (titrated gradually up to a maximum of 100 mg three times a day). At the end of the 48-week study period, acarbose was found to be as effective as metformin in terms of its HbA1c-lowering effect , and both treatment regimens achieved weight loss, although patients in the acarbose group lost slightly more weight (−0·63 kg). Patients assigned to the acarbose group also had a more favourable lipid profile, with improved HDL and lower triglycerides at 48 weeks. As expected, treatment with acarbose was associated with less postprandial hyperinsulinaemia than with metformin.
An accompanying editorial says alpha-glucosidase inhibitors remain most popular in Asian countries such as China, where rice forms a major component of the diet and the dietary contribution of carbohydrate is high.
“The results of this large study indicate that the efficacy of acarbose could be related to the carbohydrate content in the patients' diet, which suggests that acarbose would be more effective in populations with a high carbohydrate intake,” it said.
Source: The Lancet Diabetes & Endocrinology
Thursday, 5 December 2013
Resistant hypertension uncommon in China
by Michael Woodhead
The rate of resistant hypertension in China is much lower than previously thought, research from Beijing suggests.
Cardiologists from the Division of Hypertension, FuWai Hospital and Cardiovascular Institute, Peking Union Med College, made an analysis of resistant hypertension based on data from the Hypertension Optimal Treatment Study in China.
The study was conducted in 148 cities in mainland China in 2001- 2002 and included 54 590 hypertensive adult. Patients not achieving blood pressure (BP) target (<140/90 mmHg) within two weeks received preplanned additional drugs. Resistant hypertension was defined in the participants with uncontrolled hypertension after two weeks of treatment on Step 5.
The study found the rate of resistant hypertension was 1.9%. Patients with resistant hypertension tended to be male and younger than average be overweight and have metabolic syndrome, diabetes mellitus and history of myocardial infarction or stroke.
Study author Dr Ma Wenjun said the rate of resistant hypertension in China was much lower than the levels of around 20% previously reported by groups such as the AHA. This might be because the trial follow up period was relatively short and because a rigorous regimen of BP treatment and adherence was adopted. Neverthless, the finding that resistant BP was uncommon and occurred more in younger pateints deserves further attention, he said.
Full study: Journal of Hypertension
The rate of resistant hypertension in China is much lower than previously thought, research from Beijing suggests.
Cardiologists from the Division of Hypertension, FuWai Hospital and Cardiovascular Institute, Peking Union Med College, made an analysis of resistant hypertension based on data from the Hypertension Optimal Treatment Study in China.
The study was conducted in 148 cities in mainland China in 2001- 2002 and included 54 590 hypertensive adult. Patients not achieving blood pressure (BP) target (<140/90 mmHg) within two weeks received preplanned additional drugs. Resistant hypertension was defined in the participants with uncontrolled hypertension after two weeks of treatment on Step 5.
The study found the rate of resistant hypertension was 1.9%. Patients with resistant hypertension tended to be male and younger than average be overweight and have metabolic syndrome, diabetes mellitus and history of myocardial infarction or stroke.
Study author Dr Ma Wenjun said the rate of resistant hypertension in China was much lower than the levels of around 20% previously reported by groups such as the AHA. This might be because the trial follow up period was relatively short and because a rigorous regimen of BP treatment and adherence was adopted. Neverthless, the finding that resistant BP was uncommon and occurred more in younger pateints deserves further attention, he said.
Full study: Journal of Hypertension
Tuesday, 12 February 2013
Chinese trial shows clopidogrel better than aspirin for preventing recurrence of stroke or TIA
A relatively short course of aspirin plus clopidogrel immediately after sustaining a transient ischemic attack (TIA) or minor stroke outperforms aspirin alone in cutting the risk for a subsequent stroke, and it does this without a significant increased risk of major bleeding complications, results of a large Chinese trial show.
Results of the Clopidogrel in High-risk patients with Acute Non-disabling Cerebrovascular Events (CHANCE) trial were presented here at the International Stroke Conference (ISC) 2013 in Honolulu on Feb 8
The CHANCE trial, carried out exclusively in China, is a few steps ahead of a similar trial, the Platelet Oriented Inhibition in New TIA and stroke (POINT) trial, now enrolling mostly in the United States.
However, although CHANCE was a "well done" trial and its results showed "a larger treatment effect," it's important to note that healthcare in China is different from that in the United States, said CHANCE co–principal investigator, S. Claiborne Johnston, MD, PhD, professor, neurology, and director, Stroke Service, University of California, San Francisco.
"Secondary prevention practices are not as robust there as they are in Europe and in North America, and that could have impacted the trial," he said. "Also, usually genetic differences don't matter, but in this case, they might because there are differences in polymorphisms that affect clopidogrel metabolism in Asian populations."
For these reasons, although American neurologists might see the CHANCE trial as a signal to go ahead and use combined therapy, "I think it's wise for us to wait for a confirmatory trial outside of China, said Dr. Johnston, who is also co–principal investigator of the POINT trial.
CHANCE co–principal investigator was Yongjun Wang, MD, professor of neurology and vice-president of Beijing TianTan Hospital, Capital Medical University, who presented the full results here.
The study enrolled 5170 patients at least 40 years of age who had sustained a TIA or minor stroke. Within 24 hours of their symptom onset, they were randomly assigned to 1 of 2 groups: aspirin (1 day loading dose of 75 to 300 mg, followed by 75 mg/day) plus placebo, or the same aspirin regimen plus clopidogrel (loading dose of 300 mg followed by 75 mg/day).
Patients in the combination group were taken off aspirin at 21 days because of the concern that Chinese patients, as with other Asian populations, are at relatively high risk for hemorrhage. "Frankly, that belief comes from epidemiological studies, but the epidemiology may just reflect underlying risk factors and not a true propensity for it," said Dr. Johnston. He pointed out that the studies testing this have not been in the acute period.
The study showed that stroke occurred less frequently in those receiving both aspirin and clopidogrel. At 90 days, the hazard ratio (HR) for survival free of stroke — either ischemic or hemorrhagic — in the combination group was 0.68 (95% confidence interval [CI], 0.57 - 0.81; P < .001).
For the secondary outcome of combined events (stroke, myocardial infarction, vascular death), the HR was 0.69 (95% CI, 0.58 - 0.82; P < .001). The risk for hemorrhagic stroke was the same in the 2 groups (0.3%).
Notably, severe bleeding events occurred at a similar rate in the 2 groups (0.2% in each). Although mild bleeding occurred more often in the combination group (1.2% versus 0.7%), Dr. Johnston noted that these events included nose bleeds. "We did not see a signal that the combination was unsafe."
Both aspirin and clopidogrel affect platelets, but through different pathways. "Together, the 2 are much more powerful than either one alone," said Dr. Johnston.
CHANCE was the first trial to focus on the acute period in TIA and minor stroke, which Dr. Johnston emphasized is not being seen nearly enough in the emergency department. "People with TIA and minor stroke are not coming in acutely or they're calling the office and being seen in clinic," he said. "We need to remind people that this really is an emergency and it should be treated right away."
Asked whether the combination therapy would be an acceptable approach for more severe strokes, Dr. Johnston said it's impossible to know "where to draw the line." The researchers will do more subgroup analyses looking at stroke severity, but Dr. Johnston pointed out that "there was no difference between the TIA and stroke in terms of rates of hemorrhagic stroke or in the efficacy of the combination."
Compared with elsewhere in the world, the risk for stroke is very high in China. "There are a whole lot more strokes in China than there are in the US and even if you add Europe, you still have more strokes in China," said Dr. Johnston.
Because the trial was so large and because standards for clinical research have improved dramatically in China, the CHANCE results are "incredibly important" and should have a major effect on public health around the world, said Dr. Johnston. However, there are important differences between healthcare in China and that in the United States.
For example, Dr. Johnston noted that about two thirds of the Chinese patients in the study had hypertension and less than half were receiving any drug for hypertension during follow-up. Undertreatment, he said, could "certainly" affect the absolute effect size that's seen in the trial.
It's probably wise to await what happens with the POINT trial before changing treatment approaches here in North America, said Dr. Johnston, who is that study's principal investigator. Interim POINT results will be available in May, he said. "That will provide an opportunity to say it's very important to continue POINT or it's not important to continue POINT."
The POINT trial, which is about a third of the way through recruitment, differs slightly from CHANCE, said Dr. Johnston. For example, it includes a higher loading dose of clopidogrel and requires enrollment within 12 hours instead of 24 hours. As well, patients in the combination group continue with aspirin for 90 days instead of stopping at 21 days as in the CHANCE study.
Dr. Johnston pointed out a graph showing times for survival free of stroke for the treatment groups. "Most of the separation in the 2 curves occurs just in the first couple of days, so certainly by 21 days, the curves are almost parallel."
POINT includes mainly centers in the United States, although some sites have been added internationally.
The idea of comparing aspirin plus clopidogrel in a North American trial dates back more than a decade, but the researchers ran into funding difficulties when the drug manufacturer pulled its backing. This, said Dr. Johnston, substantially delayed the start of the trial.
When asked about next steps for CHANCE, Dr. Johnston said the Chinese researchers will look at ancillary studies of biomarkers and subtyping based on vascular imaging. As well, they plan to provide outcomes at 1 year that will include results related to cognition.
Source: Medscape
Results of the Clopidogrel in High-risk patients with Acute Non-disabling Cerebrovascular Events (CHANCE) trial were presented here at the International Stroke Conference (ISC) 2013 in Honolulu on Feb 8
The CHANCE trial, carried out exclusively in China, is a few steps ahead of a similar trial, the Platelet Oriented Inhibition in New TIA and stroke (POINT) trial, now enrolling mostly in the United States.
However, although CHANCE was a "well done" trial and its results showed "a larger treatment effect," it's important to note that healthcare in China is different from that in the United States, said CHANCE co–principal investigator, S. Claiborne Johnston, MD, PhD, professor, neurology, and director, Stroke Service, University of California, San Francisco.
"Secondary prevention practices are not as robust there as they are in Europe and in North America, and that could have impacted the trial," he said. "Also, usually genetic differences don't matter, but in this case, they might because there are differences in polymorphisms that affect clopidogrel metabolism in Asian populations."
For these reasons, although American neurologists might see the CHANCE trial as a signal to go ahead and use combined therapy, "I think it's wise for us to wait for a confirmatory trial outside of China, said Dr. Johnston, who is also co–principal investigator of the POINT trial.
CHANCE co–principal investigator was Yongjun Wang, MD, professor of neurology and vice-president of Beijing TianTan Hospital, Capital Medical University, who presented the full results here.
The study enrolled 5170 patients at least 40 years of age who had sustained a TIA or minor stroke. Within 24 hours of their symptom onset, they were randomly assigned to 1 of 2 groups: aspirin (1 day loading dose of 75 to 300 mg, followed by 75 mg/day) plus placebo, or the same aspirin regimen plus clopidogrel (loading dose of 300 mg followed by 75 mg/day).
Patients in the combination group were taken off aspirin at 21 days because of the concern that Chinese patients, as with other Asian populations, are at relatively high risk for hemorrhage. "Frankly, that belief comes from epidemiological studies, but the epidemiology may just reflect underlying risk factors and not a true propensity for it," said Dr. Johnston. He pointed out that the studies testing this have not been in the acute period.
The study showed that stroke occurred less frequently in those receiving both aspirin and clopidogrel. At 90 days, the hazard ratio (HR) for survival free of stroke — either ischemic or hemorrhagic — in the combination group was 0.68 (95% confidence interval [CI], 0.57 - 0.81; P < .001).
For the secondary outcome of combined events (stroke, myocardial infarction, vascular death), the HR was 0.69 (95% CI, 0.58 - 0.82; P < .001). The risk for hemorrhagic stroke was the same in the 2 groups (0.3%).
Notably, severe bleeding events occurred at a similar rate in the 2 groups (0.2% in each). Although mild bleeding occurred more often in the combination group (1.2% versus 0.7%), Dr. Johnston noted that these events included nose bleeds. "We did not see a signal that the combination was unsafe."
Both aspirin and clopidogrel affect platelets, but through different pathways. "Together, the 2 are much more powerful than either one alone," said Dr. Johnston.
CHANCE was the first trial to focus on the acute period in TIA and minor stroke, which Dr. Johnston emphasized is not being seen nearly enough in the emergency department. "People with TIA and minor stroke are not coming in acutely or they're calling the office and being seen in clinic," he said. "We need to remind people that this really is an emergency and it should be treated right away."
Asked whether the combination therapy would be an acceptable approach for more severe strokes, Dr. Johnston said it's impossible to know "where to draw the line." The researchers will do more subgroup analyses looking at stroke severity, but Dr. Johnston pointed out that "there was no difference between the TIA and stroke in terms of rates of hemorrhagic stroke or in the efficacy of the combination."
Compared with elsewhere in the world, the risk for stroke is very high in China. "There are a whole lot more strokes in China than there are in the US and even if you add Europe, you still have more strokes in China," said Dr. Johnston.
Because the trial was so large and because standards for clinical research have improved dramatically in China, the CHANCE results are "incredibly important" and should have a major effect on public health around the world, said Dr. Johnston. However, there are important differences between healthcare in China and that in the United States.
For example, Dr. Johnston noted that about two thirds of the Chinese patients in the study had hypertension and less than half were receiving any drug for hypertension during follow-up. Undertreatment, he said, could "certainly" affect the absolute effect size that's seen in the trial.
It's probably wise to await what happens with the POINT trial before changing treatment approaches here in North America, said Dr. Johnston, who is that study's principal investigator. Interim POINT results will be available in May, he said. "That will provide an opportunity to say it's very important to continue POINT or it's not important to continue POINT."
The POINT trial, which is about a third of the way through recruitment, differs slightly from CHANCE, said Dr. Johnston. For example, it includes a higher loading dose of clopidogrel and requires enrollment within 12 hours instead of 24 hours. As well, patients in the combination group continue with aspirin for 90 days instead of stopping at 21 days as in the CHANCE study.
Dr. Johnston pointed out a graph showing times for survival free of stroke for the treatment groups. "Most of the separation in the 2 curves occurs just in the first couple of days, so certainly by 21 days, the curves are almost parallel."
POINT includes mainly centers in the United States, although some sites have been added internationally.
The idea of comparing aspirin plus clopidogrel in a North American trial dates back more than a decade, but the researchers ran into funding difficulties when the drug manufacturer pulled its backing. This, said Dr. Johnston, substantially delayed the start of the trial.
When asked about next steps for CHANCE, Dr. Johnston said the Chinese researchers will look at ancillary studies of biomarkers and subtyping based on vascular imaging. As well, they plan to provide outcomes at 1 year that will include results related to cognition.
Source: Medscape
Tuesday, 5 February 2013
Chinese trial will answer question of whether to treat pre-hypertension
There's an air of impatience clouding the 2013 International Conference on Prehypertension and Cardiometabolic Syndrome. Most patients diagnosed with higher-than-optimal blood pressure will go on to develop hypertension, but there are no good data to suggest if or how this can be averted.
That frustrates experts gathered here, some of whom say they can't wait for results from ongoing clinical trials—they are proceeding with low-dose pharmacological treatment in select high-risk patients.
"If we wait for the evidence, we'll all be buried before the evidence is in," Dr Flavio Fuchs (Hospital de Clinicas de Port Alegre, Brazil) pronounced. "Four out of five prehypertensives will be hypertensive by age 60. . . . For my [prehypertensive] patients, I am offering the option of using low-dose drugs if they are close to becoming hypertensive."
Dr Stevo Julius (University of Michigan, Ann Arbor) put it more bluntly: "If your brother had prehypertension, you would treat him."
But Dr Yuqing Zhang (Fu Wai Hospital, Beijing, China) pointed out that it is not just the question of drug efficacy in high-normal BP, "we also need to answer the question of cost-effectiveness, because the incidence of hard outcomes is very low in these subjects, maybe 7% per 100-person years. So much lower than in those with established hypertension—this is an area where we really need to get some answers."
Zhang is one of the investigators in the largest ongoing trial in this area, the Chinese High Normal Blood Pressure (CHINOM) trial. The study has finished enrollment of 10 689 patients with blood pressure in the range of 130-139/85-89 mm Hg and at least one other cardiovascular disease risk factor (but no established diabetes, renal or hepatic dysfunction, or history of stroke or CVD).
Presenting an overview of the study here, Zhang explained that patients are being randomized to one of three parallel treatment groups: telmisartan 40 mg, indapamide 1.5 mg, or, in the third group, placebo or a combination pill of hydrochlorothiazide 12.5 mg, triamterene 12.5 mg, dihydralazine 12.5 mg, and reserpine 0.1 mg. The primary end point of the study is combined CV events (nonfatal stroke, nonfatal MI, and CVD death), while a secondary end point addresses new-onset hypertension and new-onset diabetes.
While the first results are still several years away, baseline characteristics of study subjects are already revealing. For example, he noted, 70% of subjects enrolled actually have more than one CV risk factor, with metabolic syndrome being the most common. More than three-quarters of participants are overweight or obese, 42% have high triglycerides, and over one-third have a family history of hypertension.
"This is not a benign population," he said.
Importantly, Zhang said, a family history of stroke is more than twice as common in the CHINOM cohort as a family history of MI (12% vs 5%).
Investigators plan to do an interim analysis when they've accumulated 100 events; they are just shy of 90 now, Zhang said.
Source: theheart.org
That frustrates experts gathered here, some of whom say they can't wait for results from ongoing clinical trials—they are proceeding with low-dose pharmacological treatment in select high-risk patients.
"If we wait for the evidence, we'll all be buried before the evidence is in," Dr Flavio Fuchs (Hospital de Clinicas de Port Alegre, Brazil) pronounced. "Four out of five prehypertensives will be hypertensive by age 60. . . . For my [prehypertensive] patients, I am offering the option of using low-dose drugs if they are close to becoming hypertensive."
Dr Stevo Julius (University of Michigan, Ann Arbor) put it more bluntly: "If your brother had prehypertension, you would treat him."
But Dr Yuqing Zhang (Fu Wai Hospital, Beijing, China) pointed out that it is not just the question of drug efficacy in high-normal BP, "we also need to answer the question of cost-effectiveness, because the incidence of hard outcomes is very low in these subjects, maybe 7% per 100-person years. So much lower than in those with established hypertension—this is an area where we really need to get some answers."
Zhang is one of the investigators in the largest ongoing trial in this area, the Chinese High Normal Blood Pressure (CHINOM) trial. The study has finished enrollment of 10 689 patients with blood pressure in the range of 130-139/85-89 mm Hg and at least one other cardiovascular disease risk factor (but no established diabetes, renal or hepatic dysfunction, or history of stroke or CVD).
Presenting an overview of the study here, Zhang explained that patients are being randomized to one of three parallel treatment groups: telmisartan 40 mg, indapamide 1.5 mg, or, in the third group, placebo or a combination pill of hydrochlorothiazide 12.5 mg, triamterene 12.5 mg, dihydralazine 12.5 mg, and reserpine 0.1 mg. The primary end point of the study is combined CV events (nonfatal stroke, nonfatal MI, and CVD death), while a secondary end point addresses new-onset hypertension and new-onset diabetes.
While the first results are still several years away, baseline characteristics of study subjects are already revealing. For example, he noted, 70% of subjects enrolled actually have more than one CV risk factor, with metabolic syndrome being the most common. More than three-quarters of participants are overweight or obese, 42% have high triglycerides, and over one-third have a family history of hypertension.
"This is not a benign population," he said.
Importantly, Zhang said, a family history of stroke is more than twice as common in the CHINOM cohort as a family history of MI (12% vs 5%).
Investigators plan to do an interim analysis when they've accumulated 100 events; they are just shy of 90 now, Zhang said.
Source: theheart.org
Thursday, 31 January 2013
Enterovirus vaccine safe and effective against hand foot and mouth disease, Chinese trial shows
A trial conducted in Jiangsu has provided major step forward in the development of a vaccine against enterovirus 71 - a member of the Picornaviridae family of viruses associated serious and fatal outbreaks of hand, foot, and mouth disease across Asia.
Published in The Lancet, the results of a phase 2 trial of an enterovirus vaccine in more than 1100 infants and children in Jiangsu found that the vaccine had good immunogenicity and a low incidence of adverse effects.
The inactivated EV71 vaccine developed by Beijing Vigoo Biological used the EV71 strain was given in two doses a month apart, injected intramuscularly into the deltoid region in children aged 12—36 months and into the anterolateral side of thigh in infants aged 6—11 months.
The trial compared four different doses of vaccine, and all procuced good antibody responses, with the best seen with an adjuvant 320 U formulation.
Antibody titres had significantly declined by eight months, suggesting a need for a booster shot. Generally, the vaccine had a good safety profile in all participants. Most reactions were mild or moderate and severe adverse reactions were uncommon.
Researchers say an enterovirus vaccine is a public health priority because mortality rates with enterovirus 71 are as high as 82—94% in severe cases and the incidence of hand, foot, and mouth disease seems to be increasing across the Asia region
As a result of our findings, the adjuvant 320 U formulation has been selected for larger multicentre, randomised, double-blind, placebo-controlled trial in about 10 000 participants aged six—35 months.
Source: Lancet
Published in The Lancet, the results of a phase 2 trial of an enterovirus vaccine in more than 1100 infants and children in Jiangsu found that the vaccine had good immunogenicity and a low incidence of adverse effects.
The inactivated EV71 vaccine developed by Beijing Vigoo Biological used the EV71 strain was given in two doses a month apart, injected intramuscularly into the deltoid region in children aged 12—36 months and into the anterolateral side of thigh in infants aged 6—11 months.
The trial compared four different doses of vaccine, and all procuced good antibody responses, with the best seen with an adjuvant 320 U formulation.
Antibody titres had significantly declined by eight months, suggesting a need for a booster shot. Generally, the vaccine had a good safety profile in all participants. Most reactions were mild or moderate and severe adverse reactions were uncommon.
Researchers say an enterovirus vaccine is a public health priority because mortality rates with enterovirus 71 are as high as 82—94% in severe cases and the incidence of hand, foot, and mouth disease seems to be increasing across the Asia region
As a result of our findings, the adjuvant 320 U formulation has been selected for larger multicentre, randomised, double-blind, placebo-controlled trial in about 10 000 participants aged six—35 months.
Source: Lancet
Friday, 7 December 2012
Medical officials sacked for unethical GM rice clinical trial
 |
| Clinical trial was run without informed consent by officials from the Zhejiang Academy of Medical Sciences |
The officials were punished for "violating relevant regulations, scientific ethics and academic integrity," according to a statement jointly released by Chinese Center for Disease Control and Prevention (China CDC), Zhejiang Academy of Medical Sciences, and Hunan provincial CDC.
The officials include Yin Shi'an from China CDC, Wang Yin from Zhejiang Academy of Medical Sciences and Hu Yuming from Hunan provincial CDC.
Earlier, the Ministry of Health ordered China CDC to investigate whether dozens of children in Hunan were used in 2008 as test subjects in a U.S.-China joint research project that included GM food Golden Rice.
Greenpeace broke the news on the controversial test in late August this year, saying that the joint research involved feeding Golden Rice, which is genetically modified to be rich in beta carotene, to 25 children aged between six and eight in Hunan.
It cited a paper published in the August edition of The American Journal of Clinical Nutrition.
The paper claimed that Golden Rice is effective in providing vitamin A to children.
The research, approved by the National Institutes of Health of the United States in December 2002, was led by Tang Guangwen, director of the Carotenoid and Health Laboratory of Tufts University in the United States. It was intended to explore ways in preventing deficiency of Vitamin A in children.
Tang conducted the research in cooperation with Yin Shi'an from China CDC and Wang Yin from Zhejiang Academy of Medical Sciences.
In 2008, the test was conducted on 80 pupils in Hengnan County of Hunan Province, with 25 of them being fed 60 grams of Golden Rice on June 2.
The research team had informed parents of the tested children about the experiment but withheld the truth that GM rice would be used.
Source: China Daily
Tuesday, 20 November 2012
Adding liraglutide is better than increasing insulin dose in type 2 diabetes
Liraglutide is an injectable glucagon-like-peptide-1 (GLP-1) receptor agonist that can be taken once daily to improve glycaemic control in adults with type 2 diabetes.
In a newly published study, researchers from Tianjin Medical University have shown that adding liraglutide to established insulin therapy is better than increasing the insulin dose in Chinese patients with poorly controlled type 2 diabetes and abdominal obesity.
They conducted a 12-week, randomised, parallel-group study in 84 patients who were randomly assigned to either the liraglutide-added group or the insulin-increasing dose while continuing current insulin based treatment.
They found that addition of liraglutide to abdominally obese, insulin-treated patients led to improvement in glycemic control similar to that achieved by increasing insulin dosage, but with a lower daily dose of insulin and fewer hypoglycemic events.
Adding liraglutide to insulin also induced a significant reduction in body weight and waist circumference.
"Liraglutide combined with insulin may be the best treatment option for poorly controlled type 2 diabetes and abdominal obesity," they conclude.
Editor's note: The FDA has note potential safety concerns with liraglutide - see this NEJM summary.
Read more: Cardiovascular Diabetology
Thursday, 15 November 2012
Clinical trials "crash and burn" in China due to poor communication
Zoe Doran, head of clinical research for Oxford University’s diabetes trials unit, told attendees at PCT Europe about the difficulties faced in the on-going Acarbose Cardiovascular Evaluation (ACE) end-point study in China. She said a lack of connection between hospital sites and therapeutic departments means many trials “crash and burn”,and that the situation is off-putting for contract research organisations (CROs). “People don’t talk to each other there,” she said.
“There is no connection between departments in the same hospital site, so it’s especially difficult to get communication between the therapy areas on different hospital sites.”
Big differences in the way CROs run clinical sites also present issues for sponsors, for instance in trial funding. Doran explained that giving funding to a site does not necessarily mean they will resource the study as in any other country, and that access to money is not limited to an administrative overhead.
“This admin site could take the whole lot. Or if they’re going to give money to the study team it won’t be until the end of the trial,” she said adding that physicians may even syphon money considering it “additional income rather than extra funding.”
Poor stability in local CROs, which have a tendency to change clinical research analysts (CRAs) every three months, also hinders sponsor-vendor relationships.
Read more: Outsourcing Pharma
“There is no connection between departments in the same hospital site, so it’s especially difficult to get communication between the therapy areas on different hospital sites.”
Big differences in the way CROs run clinical sites also present issues for sponsors, for instance in trial funding. Doran explained that giving funding to a site does not necessarily mean they will resource the study as in any other country, and that access to money is not limited to an administrative overhead.
“This admin site could take the whole lot. Or if they’re going to give money to the study team it won’t be until the end of the trial,” she said adding that physicians may even syphon money considering it “additional income rather than extra funding.”
Poor stability in local CROs, which have a tendency to change clinical research analysts (CRAs) every three months, also hinders sponsor-vendor relationships.
Read more: Outsourcing Pharma
Subscribe to:
Posts (Atom)