More Bad News About Vitamins: vitamins B6, B9 and B12 found harmful!

Combination therapy with vitamins B6, B9 and B12 is a therapeutic intervention to decrease levels of plasma homocysteine and the risk of cardiovascular disease. However, a recent trial found that cosupplementation with these vitamins exacerbated the decline in renal function and increased the risk of vascular disease in patients with diabetic nephropathy. Confidence in this high-dose vitamin supplement is shaken.

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Please click here for full Prescribing Information

NEXIUM is indicated for short-term treatment in healing of Erosive Esophagitis

Important Safety Information SCROLL HERE

NEXIUM is contraindicated in patients with known hypersensitivity to any component of the formulation or to substituted benzimidazoles.

The most frequently reported adverse events with NEXIUM include headache, diarrhea, and abdominal pain.

Symptomatic response to therapy does not preclude the presence of gastric malignancy.

Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long term with omeprazole, of which NEXIUM is an enantiomer.

Long-term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine.

Patients treated with proton pump inhibitors and warfarin concomitantly may need to be monitored for increases in INR and prothrombin time. Esomeprazole may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (eg, ketoconazole, iron salts, and digoxin).

Concomitant use of NEXIUM and atazanavir or nelfinavir is not recommended because the plasma concentrations and therapeutic effects of those antiretroviral drugs may be reduced.

NEXIUM may increase the plasma levels of saquinavir. Dose reduction of saquinavir should be considered.

Combined inhibitor of CYP 2C19 and 3A4 may raise esomeprazole levels.

NEXIUM may increase systemic exposure of cilostazol and an active metabolite. Consider dose reduction.

NEXIUM should only be used for the conditions, dosages, and durations specified in the Prescribing Information.

Approved Uses
NEXIUM 40 mg and 20 mg are indicated for short-term treatment (4 to 8 weeks) in healing and symptomatic resolution of diagnostically confirmed erosive esophagitis (EE). NEXIUM 20 mg is indicated to maintain symptom resolution and healing of EE (controlled studies did not extend beyond 6 months), and for short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with GERD.

Please click here for the full Prescribing Information.

305859   8/10

More Preferred formulary coverage for NEXIUM® than before.*†1

Find formulary status for NEXIUM for up to 10 plans at a time.

Please click here for full Prescribing Information

NEXIUM is indicated for short-term treatment in healing of Erosive Esophagitis

Important Safety Information SCROLL HERE

NEXIUM is contraindicated in patients with known hypersensitivity to any component of the formulation or to substituted benzimidazoles.

The most frequently reported adverse events with NEXIUM include headache, diarrhea, and abdominal pain.

Symptomatic response to therapy does not preclude the presence of gastric malignancy.

Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long term with omeprazole, of which NEXIUM is an enantiomer.

Long-term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine.

Patients treated with proton pump inhibitors and warfarin concomitantly may need to be monitored for increases in INR and prothrombin time. Esomeprazole may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (eg, ketoconazole, iron salts, and digoxin).

Concomitant use of NEXIUM and atazanavir or nelfinavir is not recommended because the plasma concentrations and therapeutic effects of those antiretroviral drugs may be reduced.

NEXIUM may increase the plasma levels of saquinavir. Dose reduction of saquinavir should be considered.

Combined inhibitor of CYP 2C19 and 3A4 may raise esomeprazole levels.

NEXIUM may increase systemic exposure of cilostazol and an active metabolite. Consider dose reduction.

NEXIUM should only be used for the conditions, dosages, and durations specified in the Prescribing Information.

Approved Uses
NEXIUM 40 mg and 20 mg are indicated for short-term treatment (4 to 8 weeks) in healing and symptomatic resolution of diagnostically confirmed erosive esophagitis (EE). NEXIUM 20 mg is indicated to maintain symptom resolution and healing of EE (controlled studies did not extend beyond 6 months), and for short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with GERD.

Please click here for the full Prescribing Information for NEXIUM.

*Based on the percent of covered lives with access at Tier 1 or Tier 2 status, measured monthly from June 2006 through December 2009. “Covered lives” includes commercial, Medicare, and Medicaid coverage. Formulary coverage will vary by health plan. Preferred coverage is based on data showing coverage of NEXIUM at Tier 1 or Tier 2, and may include prior authorization, quantity limits, step therapy, and other restrictions.
Source: Fingertip Formulary® database (last accessed June 7, 2010). The formulary information reported by Fingertip Formulary covers 95% of the covered lives in the US.

Reference: 1. Data on file, eSTaR #294430: Fingertip Formulary (last accessed June 7, 2010).

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From Nature Reviews Endocrinology

Vitamin B6, B9 and B12 in Diabetic Nephropathy—Beware

Paul J. Thornalley; Naila Rabbani

Posted: 11/01/2010; Nat Rev Endocrinol. 2010;6(9):477-478. © 2010 Nature Publishing Group

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Abstract and Introduction

Abstract

Combination therapy with vitamins B6, B9 and B12 is a therapeutic intervention to decrease levels of plasma homocysteine and the risk of cardiovascular disease. However, a recent trial found that cosupplementation with these vitamins exacerbated the decline in renal function and increased the risk of vascular disease in patients with diabetic nephropathy. Confidence in this high-dose vitamin supplement is shaken.

Introduction

High concentrations of plasma total homocysteine are known to be associated with the risk of developing diabetes-related cardiovascular disease, nephropathy and proliferative retinopathy. Cosupplementation of pyridoxine (vitamin B6), folic acid (vitamin B9) and vitamin B12 has been used to decrease levels of plasma homocysteine and the risk of cardiovascular disease. A study by House et al.[1] has now shown substantial adverse outcomes associated with high-dose vitamin B6, B9 and B12 cosupplementation in patients with advanced diabetic nephropathy. Unless other explanations come to light in further analyses of this study, these findings make repetition of a similar trial in this high-risk patient group unethical.

Read more at www.medscape.com

 

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