Question:
Rick, I hadn’t seen your article. Excellent, as usual, and balanced. Keep up the good work. WCB
– Hide quoted text — Show quoted text – Reddy, Good to hear from you. I continue to be interested in the new chromium studies, but cannot help but have reservations about the objectivity of research sponsored by a company, Nutrition 21, that has such a strong financial interest in chromium picolinate. In the past I have interviewed Dr. Cefalu, but my recent article on chromium, http://www.mendosa.com/chromium.htm , relied on interviews with Dr. Vincent, who has no taint of support from industry. I still don’t see any reason to revise the conclusions of my article on chromium. — Rick Mendosa: A Writer on the Web: www.mendosa.com Office: 238 Coronado Drive, Aptos, CA 95003-4011 Rick, These are labeling changes after the results of the IDNT and RENAAL trials were released. Most of us were already using the drugs for this before the trials were released. The big question is where they are better than ACE inhibitors or not. There have not been any head to head studies of ACE vs ARB for this indication. I actually find Jake’s info on chromium more intriguing. I met the people from "Nutrition 21" who had a booth at the ADA meetings in June. They told me about some of the upcoming stuff to be presented at the IDF this year in Paris. As I recall one of the papers was co-authored by William T Cefalu MD, who is a very reputable young diabetes researcher, from U of Vermont. He is a good speaker, and sounds like a Cajun when you meet him. I heard something (perhaps not accurate) about him moving back to Louisiana to join Pennington Biomedical Research Center at LSU. Perhaps you can track him down at Pennington or U Vermont Medical School for an interesting interview. http://www.nutrition21.com/Newsroom/viewnews.aspx?id=47 Nutrition 21 makes a chromium picolinate / biotin capsule (Diachrome) and plain chromium picolinate (Chromax) that seem to be well tolerated. This company is unusual in the health food industry in that they are really putting some bucks into research, and trying to demonstrate that there is a benefit to chromium. Good luck, Reddy Biggs Peanutjake, What is the source of this very interesting information? Searching the Web and news with Google doesn’t turn it up. Nor does searching Medscape or Medscape DrugInfo. Likewise searching FDA.gov. Rick Mendosa: A Writer on the Web: www.mendosa.com Office: 238 Coronado Drive, Aptos, CA 95003-4011
Response:
Reddy, Good to hear from you. I continue to be interested in the new chromium studies, but cannot help but have reservations about the objectivity of research sponsored by a company, Nutrition 21, that has such a strong financial interest in chromium picolinate. In the past I have interviewed Dr. Cefalu, but my recent article on chromium, http://www.mendosa.com/chromium.htm , relied on interviews with Dr. Vincent, who has no taint of support from industry. I still don’t see any reason to revise the conclusions of my article on chromium. — Rick Mendosa: A Writer on the Web: www.mendosa.com Office: 238 Coronado Drive, Aptos, CA 95003-4011 – Hide quoted text — Show quoted text – Rick, These are labeling changes after the results of the IDNT and RENAAL trials were released. Most of us were already using the drugs for this before the trials were released. The big question is where they are better than ACE inhibitors or not. There have not been any head to head studies of ACE vs ARB for this indication. I actually find Jake’s info on chromium more intriguing. I met the people from "Nutrition 21" who had a booth at the ADA meetings in June. They told me about some of the upcoming stuff to be presented at the IDF this year in Paris. As I recall one of the papers was co-authored by William T Cefalu MD, who is a very reputable young diabetes researcher, from U of Vermont. He is a good speaker, and sounds like a Cajun when you meet him. I heard something (perhaps not accurate) about him moving back to Louisiana to join Pennington Biomedical Research Center at LSU. Perhaps you can track him down at Pennington or U Vermont Medical School for an interesting interview. http://www.nutrition21.com/Newsroom/viewnews.aspx?id=47 Nutrition 21 makes a chromium picolinate / biotin capsule (Diachrome) and plain chromium picolinate (Chromax) that seem to be well tolerated. This company is unusual in the health food industry in that they are really putting some bucks into research, and trying to demonstrate that there is a benefit to chromium. Good luck, Reddy Biggs Peanutjake, What is the source of this very interesting information? Searching the Web and news with Google doesn’t turn it up. Nor does searching Medscape or Medscape DrugInfo. Likewise searching FDA.gov. Rick Mendosa: A Writer on the Web: www.mendosa.com Office: 238 Coronado Drive, Aptos, CA 95003-4011
Response:
Rick, These are labeling changes after the results of the IDNT and RENAAL trials were released. Most of us were already using the drugs for this before the trials were released. The big question is where they are better than ACE inhibitors or not. There have not been any head to head studies of ACE vs ARB for this indication. I actually find Jake’s info on chromium more intriguing. I met the people from "Nutrition 21" who had a booth at the ADA meetings in June. They told me about some of the upcoming stuff to be presented at the IDF this year in Paris. As I recall one of the papers was co-authored by William T Cefalu MD, who is a very reputable young diabetes researcher, from U of Vermont. He is a good speaker, and sounds like a Cajun when you meet him. I heard something (perhaps not accurate) about him moving back to Louisiana to join Pennington Biomedical Research Center at LSU. Perhaps you can track him down at Pennington or U Vermont Medical School for an interesting interview. http://www.nutrition21.com/Newsroom/viewnews.aspx?id=47 Nutrition 21 makes a chromium picolinate / biotin capsule (Diachrome) and plain chromium picolinate (Chromax) that seem to be well tolerated. This company is unusual in the health food industry in that they are really putting some bucks into research, and trying to demonstrate that there is a benefit to chromium. Good luck, Reddy Biggs
– Hide quoted text — Show quoted text – Peanutjake, What is the source of this very interesting information? Searching the Web and news with Google doesn’t turn it up. Nor does searching Medscape or Medscape DrugInfo. Likewise searching FDA.gov. Rick Mendosa: A Writer on the Web: www.mendosa.com Office: 238 Coronado Drive, Aptos, CA 95003-4011
Response:
Peanutjake, What is the source of this very interesting information? Searching the Web and news with Google doesn’t turn it up. Nor does searching Medscape or Medscape DrugInfo. Likewise searching FDA.gov. Rick Mendosa: A Writer on the Web: www.mendosa.com Office: 238 Coronado Drive, Aptos, CA 95003-4011
http://www.medscape.com/viewarticle/442812_3 PJ
Response:
Peanutjake, What is the source of this very interesting information? Searching the Web and news with Google doesn’t turn it up. Nor does searching Medscape or Medscape DrugInfo. Likewise searching FDA.gov. Rick Mendosa: A Writer on the Web: www.mendosa.com Office: 238 Coronado Drive, Aptos, CA 95003-4011
US FDA NOTES Avapro (irbesartan) Tablets Manufacturer: Bristol-Myers Squibb Drug Approval Classification: Supplemental New Drug Application (Approval New Indication:Avapro (irbesartan) is indicated for the treatment of
diabetic nephropathy with an elevated serum creatinine and proteinuria ( 300 mg/day) in patients with type 2 diabetes and hypertension. In this population, Avapro reduces the rate of progression
of nephropathy as measured by the occurrence of doubling of serum creatinine or end-stage renal
disease (need for dialysis or renal transplantation). The FDA approved Cozaar (losartan potassium) for the supplemental
indication for the treatment of patients with type 2 diabetic nephropathy (see Cozaar below). Dosing: The recommended target maintenance dose for the treatment of
diabetic nephropathy in patients with type 2 diabetes is 300 mg once daily. There are no data on
the clinical effects of lower doses of Avapro on diabetic nephropathy. Clinical Summary: Previously to this new supplemental indication, Avapro
was indicated for the treatment of hypertension. The FDA approval is based on results from the Irbesartan Diabetic
Nephropathy Trial (IDNT). IDNT studied 1715 patients with high blood pressure, type 2 diabetes, and
evidence of kidney disease. Patients were randomized to irbesartan 300 mg daily or amlodipine 10 mg
daily or placebo. Patients in the irbesartan group had a 20% lower risk of progression of their
nephropathy or death than that of the placebo (control) group (P = .02) and a 23% lower risk than the
group treated with amlodipine (P = .006). Adverse Effects: No new adverse events were reported in the Avapro-treated patients in IDNT. Patients on Avapro experienced more orthostatic symptoms and increases in
serum potassium vs the control group. References Avapro (Irbesartan) labeling. Lewis EJ, Hunsicker LG, Clarke WR, et al, for the Collaborative Study
Group. Renoprotective effect of the angiotensin-receptor antagonist irbesartan in patients with
nephropathy due to type 2 diabetes. N Engl J Med. 2001;345:851-860. Abstract Medscape DrugInfo Avapro (irbesartan) Cozaar (losartan potassium) Tablets Manufacturer: Merck & Co, Inc Drug Approval Classification: Supplemental New Drug Application (Approval New Indication:Cozaar (losartan potassium) is indicated for the treatment
of diabetic nephropathy with an elevated serum creatinine and proteinuria (urinary albumin to
creatinine ratio /= 300 mg/g) in patients with type 2 diabetes and a history of hypertension. In this
population, Cozaar reduces the rate of progression of nephropathy as measured by the occurrence of
doubling of serum creatinine or end-stage renal disease (need for dialysis or renal transplantation) The FDA approved Avapro (irbesartan) for the supplemental indication for
the treatment of patients with type 2 diabetic nephropathy (see Avapro above) Dosing: For the treatment of type 2 diabetic nephropathy, the usual
starting dose is 50 mg once daily. The dose could be increased to 100 mg once daily based on blood
pressure response. Cozaar may be administered with insulin and other commonly used hypoglycemic agents (eg, sulfonylureas, glitazones, and glucosidase inhibitors). Clinical Summary: Prior to this new supplemental indication, Cozaar was
indicated for the treatment of hypertension. The basis for approval of Cozaar for the treatment of nephropathy in
patients with type 2 diabetes is the Reduction of Endpoints in NIDDM with the Angiotensin II Receptor
Antagonist Losartan (RENAAL) study. RENAAL was a randomized, placebo-controlled, double-blind,
multicenter study in 1513 patients with type 2 diabetes with nephropathy. Patients were randomized to Cozaar
50 mg daily or placebo. Patients were followed for 3 1/2 years. Patients treated with Cozaar had a
16% risk reduction in the primary end point, defined as the time to first occurrence of any 1 of the following events: doubling of serum creatinine, end-stage renal disease (need for dialysis
or transplantation), or death. Cozaar reduced the occurrence of sustained doubling of serum
creatinine by 25% and end-stage renal disease by 29%. No effect on mortality was seen in the RENAAL study. Adverse Effects: No new adverse effects were seen with Cozaar in the RENAAL study. The discontinuation rate due to adverse events was 19% for Cozaar-treated
patients vs 24% in placebo – Hide quoted text — Show quoted text – patients. Reference Cozaar (losartan potassium) labeling. Medscape DrugInfo Cozaar (losartan potassium)
Response:
US FDA NOTES Avapro (irbesartan) Tablets Manufacturer: Bristol-Myers Squibb New Indication:Avapro (irbesartan) is indicated for the treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria ( 300 mg/day) in patients with type 2 diabetes and hypertension. In this population, Avapro reduces the rate of progression of nephropathy as measured by the occurrence of doubling of serum creatinine or end-stage renal disease (need for dialysis or renal transplantation). The FDA approved Cozaar (losartan potassium) for the supplemental indication for the treatment of patients with type 2 diabetic nephropathy (see Cozaar below). Dosing: The recommended target maintenance dose for the treatment of diabetic nephropathy in patients with type 2 diabetes is 300 mg once daily. There are no data on the clinical effects of lower doses of Avapro on diabetic nephropathy. Clinical Summary: Previously to this new supplemental indication, Avapro was indicated for the treatment of hypertension. The FDA approval is based on results from the Irbesartan Diabetic Nephropathy Trial (IDNT). IDNT studied 1715 patients with high blood pressure, type 2 diabetes, and evidence of kidney disease. Patients were randomized to irbesartan 300 mg daily or amlodipine 10 mg daily or placebo. Patients in the irbesartan group had a 20% lower risk of progression of their nephropathy or death than that of the placebo (control) group (P = .02) and a 23% lower risk than the group treated with amlodipine (P = .006). Adverse Effects: No new adverse events were reported in the Avapro-treated patients in IDNT. Patients on Avapro experienced more orthostatic symptoms and increases in serum potassium vs the control group. References Avapro (Irbesartan) labeling. Lewis EJ, Hunsicker LG, Clarke WR, et al, for the Collaborative Study Group. Renoprotective effect of the angiotensin-receptor antagonist irbesartan in patients with nephropathy due to type 2 diabetes. N Engl J Med. 2001;345:851-860. Abstract Medscape DrugInfo Avapro (irbesartan) Cozaar (losartan potassium) Tablets Manufacturer: Merck & Co, Inc New Indication:Cozaar (losartan potassium) is indicated for the treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria (urinary albumin to creatinine ratio /= 300 mg/g) in patients with type 2 diabetes and a history of hypertension. In this population, Cozaar reduces the rate of progression of nephropathy as measured by the occurrence of doubling of serum creatinine or end-stage renal disease (need for dialysis or renal transplantation) The FDA approved Avapro (irbesartan) for the supplemental indication for the treatment of patients with type 2 diabetic nephropathy (see Avapro above) Dosing: For the treatment of type 2 diabetic nephropathy, the usual starting dose is 50 mg once daily. The dose could be increased to 100 mg once daily based on blood pressure response. Cozaar may be administered with insulin and other commonly used hypoglycemic agents (eg, sulfonylureas, glitazones, and glucosidase inhibitors). Clinical Summary: Prior to this new supplemental indication, Cozaar was indicated for the treatment of hypertension. The basis for approval of Cozaar for the treatment of nephropathy in patients with type 2 diabetes is the Reduction of Endpoints in NIDDM with the Angiotensin II Receptor Antagonist Losartan (RENAAL) study. RENAAL was a randomized, placebo-controlled, double-blind, multicenter study in 1513 patients with type 2 diabetes with nephropathy. Patients were randomized to Cozaar 50 mg daily or placebo. Patients were followed for 3 1/2 years. Patients treated with Cozaar had a 16% risk reduction in the primary end point, defined as the time to first occurrence of any 1 of the following events: doubling of serum creatinine, end-stage renal disease (need for dialysis or transplantation), or death. Cozaar reduced the occurrence of sustained doubling of serum creatinine by 25% and end-stage renal disease by 29%. No effect on mortality was seen in the RENAAL study. Adverse Effects: No new adverse effects were seen with Cozaar in the RENAAL study. The discontinuation rate due to adverse events was 19% for Cozaar-treated patients vs 24% in placebo patients. Reference Cozaar (losartan potassium) labeling. Medscape DrugInfo Cozaar (losartan potassium)
Response:
Chromium Supplements Appear to Improve Glucose Sensitivity in Diabetics Ed Susman Aug. 29, 2003 (Paris) – The dietary supplement chromium picolinate may help patients with type 2 diabetes control their disease, according to a series of presentations here at the 18th International Diabetes Foundation Congress. The presentations described the genetic and molecular mechanisms of how chromium picolinate reduces glucose resistance, as well as how the supplement can reduce glucose levels. "I’m not diabetic," said Dr. Zhong Wong, MD, research assistant professor at the University of Vermont in Burlington, "but I sometimes have higher glucose levels that I want. I have been taking chromium myself because I think it helps." Dr. Wong used gene microarray GeneChip technology from Affymetrix to determine which genes are upregulated and downregulated in human skeletal muscle. "That gene expression analysis suggests that chromium picolinate may down-regulate genes in human skeletal muscle that are potentially involved in cellular insulin action, specifically tumor necrosis factor (TNF)AIP6 and ubiquitin-associated proteins," he said those proteins are implicated in dysfunctional insulin production. "We think that chromium picolinate can influence a person’s diabetic treatment so that levels of insulin required may be reduced," he said. In another presentation, researchers from the Netherlands studied the effects of chromium picolinate intake on metabolic control in 52 patients with type 2 diabetes, in a double-blind, placebo-controlled study. The six-month study enrolled patients who had hemoglobin (HbA1c) levels greater than 8 percent and were prescribed more than 50 IU of insulin per day. In addition to their usual oral antidiabetic medication, patients were also given 500