AstraZeneca marketed quetiapine to physicians (particularly those who do not treat the approved conditions) for the following unapproved uses: treatment of aggression, Alzheimer disease, anger management, anxiety, attention-deficit/hyperactivity disorder, bipolar maintenance, dementia, depression, mood disorder, post-traumatic stress disorder, and sleeplessness.
The government alleges that AstraZeneca promoted these uses by paying doctors to serve as authors of ghostwritten research articles, to travel to resort locales to "advise" the company about marketing strategies, and to give promotional lectures to other clinicians
Wednesday, April 28, 2010
Vitamin B Therapy Adversely Affects Progression of Diabetic Nephropathy
B vitamins given to lower homocysteinemia — and thereby to reduce renal and vascular complications of diabetes — don't have the desired effect, according to a JAMA study.
Researchers randomized nearly 250 patients with diabetic nephropathy to either high-dose B vitamins or placebo. The study's primary outcome measure was the change in glomerular filtration rate (GFR) between baseline and study's end.
After a mean follow-up of 32 months, GFRs declined more, on average, in the treatment group than in the control group (16.5 vs. 10.7 mL/min). A composite outcome of myocardial infarction, stroke, revascularization, and all-cause mortality also favored controls. The need for dialysis did not differ between groups. Homocysteine values, however, were significantly lower in the treatment group.
Pointing to earlier studies showing no treatment benefit, the authors conclude that "it would be prudent to discourage the use of high-dose B vitamins as a homocysteine-lowering strategy."
Researchers randomized nearly 250 patients with diabetic nephropathy to either high-dose B vitamins or placebo. The study's primary outcome measure was the change in glomerular filtration rate (GFR) between baseline and study's end.
After a mean follow-up of 32 months, GFRs declined more, on average, in the treatment group than in the control group (16.5 vs. 10.7 mL/min). A composite outcome of myocardial infarction, stroke, revascularization, and all-cause mortality also favored controls. The need for dialysis did not differ between groups. Homocysteine values, however, were significantly lower in the treatment group.
Pointing to earlier studies showing no treatment benefit, the authors conclude that "it would be prudent to discourage the use of high-dose B vitamins as a homocysteine-lowering strategy."
Friday, April 23, 2010
Folate and Vitamin B6 Lower Cardiovascular Risk
April 22, 2010 — Dietary intakes of folate and vitamin B6 reduce the risk for mortality from stroke and any cardiovascular disease in women and may reduce the risk for heart failure in men, according to a study conducted in Japan.
The findings were reported online April 15 in Stroke by Renzhe Cui, MD, from the Graduate School of Medicine at Osaka University, in Osaka, Japan, and colleagues.
"This study is the first to show that high dietary intakes of folate and vitamin B6 were associated with a reduced risk of heart failure mortality for men," the authors note.
Data from 23,119 men and 35,611 women (aged 40 - 79 years) who completed food frequency questionnaires as part of the Japan Collaborative Cohort study were analyzed. At a median 14 years of follow-up, 986 participants died from stroke, 424 died from coronary heart disease, and 2087 died from any cardiovascular disease.
Participants' intake of folate, vitamin B6, and vitamin B12 were classified into quintiles. Comparing the lowest vs the highest quintiles for each nutrient, the researchers found that higher consumption of folate and vitamin B6 was associated with significantly fewer deaths from heart failure in men, and significantly fewer deaths from stroke, heart disease, and any cardiovascular diseases in women. By contrast, vitamin B12 intake was not associated with reduced mortality risk.
The protective effects of folate and vitamin B6 remained significant after adjustment for the presence of cardiovascular risk factors and also after exclusion of supplement users (n = 7334) from the analysis.
The hazard ratios (HRs) of coronary heart disease for the highest vs the lowest quintiles were 0.62 (95% confidence interval [CI], 0.42 - 0.89) for folate, 0.51 (95% CI, 0.29 - 0.91) for vitamin B6, and 1.35 (95% CI, 0.80 - 2.27) for vitamin B12. The HRs of heart failure for the highest vs the lowest quintiles were 0.76 (95% CI, 0.51 - 1.13) for folate, 0.60 (95% CI, 0.32 - 1.13) for vitamin B6, and 1.57 (95% CI, 0.90 - 2.73) for vitamin B12.
"Mechanisms for these observed associations may involve the effects of these vitamin intakes on reduction of blood homocysteine concentrations," the researchers suggest.
This study has received grant funding from the Ministry of Education, Science, Sports and Culture of, Japan (Monbusho), Japanese Ministry of Education, Culture, Sports, Science, and Technology. The study authors have disclosed no relevant financial relationships.
The findings were reported online April 15 in Stroke by Renzhe Cui, MD, from the Graduate School of Medicine at Osaka University, in Osaka, Japan, and colleagues.
"This study is the first to show that high dietary intakes of folate and vitamin B6 were associated with a reduced risk of heart failure mortality for men," the authors note.
Data from 23,119 men and 35,611 women (aged 40 - 79 years) who completed food frequency questionnaires as part of the Japan Collaborative Cohort study were analyzed. At a median 14 years of follow-up, 986 participants died from stroke, 424 died from coronary heart disease, and 2087 died from any cardiovascular disease.
Participants' intake of folate, vitamin B6, and vitamin B12 were classified into quintiles. Comparing the lowest vs the highest quintiles for each nutrient, the researchers found that higher consumption of folate and vitamin B6 was associated with significantly fewer deaths from heart failure in men, and significantly fewer deaths from stroke, heart disease, and any cardiovascular diseases in women. By contrast, vitamin B12 intake was not associated with reduced mortality risk.
The protective effects of folate and vitamin B6 remained significant after adjustment for the presence of cardiovascular risk factors and also after exclusion of supplement users (n = 7334) from the analysis.
The hazard ratios (HRs) of coronary heart disease for the highest vs the lowest quintiles were 0.62 (95% confidence interval [CI], 0.42 - 0.89) for folate, 0.51 (95% CI, 0.29 - 0.91) for vitamin B6, and 1.35 (95% CI, 0.80 - 2.27) for vitamin B12. The HRs of heart failure for the highest vs the lowest quintiles were 0.76 (95% CI, 0.51 - 1.13) for folate, 0.60 (95% CI, 0.32 - 1.13) for vitamin B6, and 1.57 (95% CI, 0.90 - 2.73) for vitamin B12.
"Mechanisms for these observed associations may involve the effects of these vitamin intakes on reduction of blood homocysteine concentrations," the researchers suggest.
This study has received grant funding from the Ministry of Education, Science, Sports and Culture of, Japan (Monbusho), Japanese Ministry of Education, Culture, Sports, Science, and Technology. The study authors have disclosed no relevant financial relationships.
PTU Gets Boxed Warning for Potential Liver Injury
A boxed warning has been added to the hyperthyroidism drug propylthiouracil (PTU) to alert clinicians about the drug's risk for severe liver injury, the FDA announced on Wednesday.
The new labeling is based in part on postmarketing safety reports of severe liver injury — including 15 deaths — in 23 adult and 11 pediatric patients taking PTU. A warning about the potential dangers of the drug was issued by the agency last June.
The FDA recommends that PTU only be used in patients who cannot tolerate methimazole or other treatments for hyperthyroidism and in women just before and during their first trimester of pregnancy.
Patients will now receive a medication guide upon filling a prescription for PTU.
The new labeling is based in part on postmarketing safety reports of severe liver injury — including 15 deaths — in 23 adult and 11 pediatric patients taking PTU. A warning about the potential dangers of the drug was issued by the agency last June.
The FDA recommends that PTU only be used in patients who cannot tolerate methimazole or other treatments for hyperthyroidism and in women just before and during their first trimester of pregnancy.
Patients will now receive a medication guide upon filling a prescription for PTU.
Wednesday, April 21, 2010
High-dose thiamine therapy for patients with type 2
Aims/hypothesis High-dose supplements of thiamine prevent
the development of microalbuminuria in experimental
diabetes. The aim of this pilot study was to assess whether
oral supplements of thiamine could reverse microalbuminuria
in patients with type 2 diabetes.
Methods Type 2 diabetic patients (21 male, 19 female) with
microalbuminuria were recruited at the Diabetes Clinic, Sheikh
Zayed Hospital, Lahore, Pakistan, and randomised to placebo
and treatment arms. Randomisation was by central office in
sequentially numbered opaque, sealed envelopes. Participants,
caregivers and those assessing the outcomes were blinded to
group assignment. Patients were given 3×100 mg capsules of
thiamine or placebo per day for 3 months with a 2 month
follow-up washout period. The primary endpoint was change
in urinary albumin excretion (UAE). Other markers of renal
and vascular dysfunction and plasma concentrations of
thiamine were determined.
Results UAE was decreased in patients receiving thiamine
therapy for 3 months with respect to baseline (median
−17.7 mg/24 h; p<0.001, n=20). There was no significant
decrease in UAE in patients receiving placebo after 3 months
of therapy (n=20). UAE was significantly lower in patients
who had received thiamine therapy compared with those who
had received placebo (30.1 vs 35.5 mg/24 h, p<0.01) but not
at baseline. UAE continued to decrease in the 2 month
washout period in both groups, but not significantly. There
was no effect of thiamine treatment on glycaemic control,
dyslipidaemia or BP. There were no adverse effects of therapy.
Conclusions/interpretation In this pilot study, high-dose
thiamine therapy produced a regression of UAE in type 2
diabetic patients with microalbuminuria. Thiamine supplements
at high dose may provide improved therapy for
early-stage diabetic nephropathy
-http://www.springerlink.com/content/51l034044218455j/fulltext.pdf
the development of microalbuminuria in experimental
diabetes. The aim of this pilot study was to assess whether
oral supplements of thiamine could reverse microalbuminuria
in patients with type 2 diabetes.
Methods Type 2 diabetic patients (21 male, 19 female) with
microalbuminuria were recruited at the Diabetes Clinic, Sheikh
Zayed Hospital, Lahore, Pakistan, and randomised to placebo
and treatment arms. Randomisation was by central office in
sequentially numbered opaque, sealed envelopes. Participants,
caregivers and those assessing the outcomes were blinded to
group assignment. Patients were given 3×100 mg capsules of
thiamine or placebo per day for 3 months with a 2 month
follow-up washout period. The primary endpoint was change
in urinary albumin excretion (UAE). Other markers of renal
and vascular dysfunction and plasma concentrations of
thiamine were determined.
Results UAE was decreased in patients receiving thiamine
therapy for 3 months with respect to baseline (median
−17.7 mg/24 h; p<0.001, n=20). There was no significant
decrease in UAE in patients receiving placebo after 3 months
of therapy (n=20). UAE was significantly lower in patients
who had received thiamine therapy compared with those who
had received placebo (30.1 vs 35.5 mg/24 h, p<0.01) but not
at baseline. UAE continued to decrease in the 2 month
washout period in both groups, but not significantly. There
was no effect of thiamine treatment on glycaemic control,
dyslipidaemia or BP. There were no adverse effects of therapy.
Conclusions/interpretation In this pilot study, high-dose
thiamine therapy produced a regression of UAE in type 2
diabetic patients with microalbuminuria. Thiamine supplements
at high dose may provide improved therapy for
early-stage diabetic nephropathy
-http://www.springerlink.com/content/51l034044218455j/fulltext.pdf
FDA Approves Generic Losartan ap/21/2010
The FDA announced on Wednesday that it has approved the first generic versions of two drugs used to treat hypertension — Cozaar (losartan potassium) and Hyzaar (losartan potassium-hydrochlorothiazide).
Like their brand-name equivalents, both generics will carry boxed warnings against using them during the second and third trimesters of pregnancy.
Like their brand-name equivalents, both generics will carry boxed warnings against using them during the second and third trimesters of pregnancy.
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