Matching articles for "chronic kidney disease"
Tenapanor (Xphozah) for Hyperphosphatemia in Chronic Kidney Disease
The Medical Letter on Drugs and Therapeutics • March 4, 2024; (Issue 1697)
The FDA has approved the sodium/hydrogen
exchanger 3 (NHE3) inhibitor tenapanor (Xphozah –
Ardelyx) to reduce serum phosphorus in adults with
chronic kidney disease (CKD) on dialysis as add-on
therapy...
The FDA has approved the sodium/hydrogen
exchanger 3 (NHE3) inhibitor tenapanor (Xphozah –
Ardelyx) to reduce serum phosphorus in adults with
chronic kidney disease (CKD) on dialysis as add-on
therapy when phosphate binders are ineffective or
as monotherapy when phosphate binders cannot be
tolerated. Tenapanor is the first NHE3 inhibitor to be
approved in the US for hyperphosphatemia. It was
previously approved as Ibsrela to treat irritable bowel
syndrome with constipation (IBS-C).
In Brief: Severe Hypocalcemia with Denosumab (Prolia) in Chronic Kidney Disease
The Medical Letter on Drugs and Therapeutics • March 4, 2024; (Issue 1697)
The FDA is requiring a boxed warning in the label
of denosumab (Prolia – Amgen), a monoclonal
antibody that inhibits osteoclasts, about an
increased risk of severe hypocalcemia in patients
with advanced...
The FDA is requiring a boxed warning in the label
of denosumab (Prolia – Amgen), a monoclonal
antibody that inhibits osteoclasts, about an
increased risk of severe hypocalcemia in patients
with advanced chronic kidney disease (CKD;
eGFR <30 mL/min/1.73 m2), particularly those on
dialysis. FDA-approved indications for Prolia are
listed in Table 1.
Daprodustat (Jesduvroq) for Anemia of Chronic Kidney Disease
The Medical Letter on Drugs and Therapeutics • February 19, 2024; (Issue 1696)
The FDA has approved daprodustat (Jesduvroq –
GSK), a hypoxia-inducible factor prolyl hydroxylase
inhibitor (HIF-PHI), for oral treatment of anemia due
to chronic kidney disease (CKD) in adults who...
The FDA has approved daprodustat (Jesduvroq –
GSK), a hypoxia-inducible factor prolyl hydroxylase
inhibitor (HIF-PHI), for oral treatment of anemia due
to chronic kidney disease (CKD) in adults who have
been on dialysis for at least 4 months. It is the first
HIF-PHI and the first oral drug to be approved in the
US for this indication.
In Brief: Empagliflozin (Jardiance) for Chronic Kidney Disease
The Medical Letter on Drugs and Therapeutics • November 13, 2023; (Issue 1689)
The sodium-glucose cotransporter 2 (SGLT2) inhibitor
empagliflozin (Jardiance – Boehringer Ingelheim/Lilly) is now FDA-approved to reduce the risk of
sustained eGFR decline, end-stage kidney...
The sodium-glucose cotransporter 2 (SGLT2) inhibitor
empagliflozin (Jardiance – Boehringer Ingelheim/Lilly) is now FDA-approved to reduce the risk of
sustained eGFR decline, end-stage kidney disease,
cardiovascular death, and hospitalization in adults with
chronic kidney disease (CKD) at risk of progression.
It is also approved to improve glycemic control in
patients ≥10 years old with type 2 diabetes, to reduce
the risk of cardiovascular death and hospitalization
for heart failure (HF) in adults with HF, and to reduce
the risk of cardiovascular death in adults with type 2
diabetes and established cardiovascular disease.
In Brief: Finerenone (Kerendia) for Diabetic Kidney Disease
The Medical Letter on Drugs and Therapeutics • January 23, 2023; (Issue 1668)
Recently published guidelines from the American
Diabetes Association (ADA) and the Kidney Disease:
Improving Global Outcomes (KDIGO) Diabetes Work
Group recommend addition of the oral...
Recently published guidelines from the American
Diabetes Association (ADA) and the Kidney Disease:
Improving Global Outcomes (KDIGO) Diabetes Work
Group recommend addition of the oral nonsteroidal
mineralocorticoid receptor antagonist (MRA)
finerenone (Kerendia) to standard treatment in
patients with type 2 diabetes and chronic kidney
disease (CKD).
Difelikefalin (Korsuva) for Chronic Kidney Disease-Associated Pruritus
The Medical Letter on Drugs and Therapeutics • February 7, 2022; (Issue 1643)
Difelikefalin (Korsuva – Vifor), an IV kappa opioid
receptor (KOR) agonist, has been approved by the
FDA for treatment of moderate to severe pruritus
associated with chronic kidney disease (CKD) in
adults...
Difelikefalin (Korsuva – Vifor), an IV kappa opioid
receptor (KOR) agonist, has been approved by the
FDA for treatment of moderate to severe pruritus
associated with chronic kidney disease (CKD) in
adults on hemodialysis. It is the first drug to be
approved for this indication and the first KOR agonist
to become available in the US. Difelikefalin has not
been studied in patients on peritoneal dialysis.
Finerenone (Kerendia) for Chronic Kidney Disease
The Medical Letter on Drugs and Therapeutics • August 23, 2021; (Issue 1631)
Finerenone (Kerendia – Bayer), an oral nonsteroidal
mineralocorticoid receptor antagonist (MRA), has
been approved by the FDA to reduce the risk of
sustained eGFR decline, end-stage renal...
Finerenone (Kerendia – Bayer), an oral nonsteroidal
mineralocorticoid receptor antagonist (MRA), has
been approved by the FDA to reduce the risk of
sustained eGFR decline, end-stage renal disease,
nonfatal MI, hospitalization for heart failure (HF), and
cardiovascular death in adults with chronic kidney
disease (CKD) associated with type 2 diabetes. It is the
first nonsteroidal MRA to be approved in the US.
In Brief: Dapagliflozin (Farxiga) for Chronic Kidney Disease
The Medical Letter on Drugs and Therapeutics • July 26, 2021; (Issue 1629)
The sodium-glucose cotransporter 2 (SGLT2) inhibitor
dapagliflozin (Farxiga – AstraZeneca) has been
approved by the FDA for treatment of adults with
chronic kidney disease (CKD) at risk of...
The sodium-glucose cotransporter 2 (SGLT2) inhibitor
dapagliflozin (Farxiga – AstraZeneca) has been
approved by the FDA for treatment of adults with
chronic kidney disease (CKD) at risk of progression
(not defined in the label). Dapagliflozin is the first
SGLT2 inhibitor to be approved in the US for treatment
of CKD.
Safety of Long-Term PPI Use
The Medical Letter on Drugs and Therapeutics • August 14, 2017; (Issue 1527)
Proton pump inhibitors (PPIs), which are used for
treatment of gastroesophageal reflux disease (GERD)
and for prevention of upper gastrointestinal adverse
effects caused by NSAIDs and aspirin, are one...
Proton pump inhibitors (PPIs), which are used for
treatment of gastroesophageal reflux disease (GERD)
and for prevention of upper gastrointestinal adverse
effects caused by NSAIDs and aspirin, are one of
the most commonly prescribed classes of drugs in
the US. All PPIs are similarly effective and generally
well tolerated, but their long-term use has been
associated with a number of safety concerns.
Recommendations addressing these concerns have
recently been published.
Triferic for Iron Replacement
The Medical Letter on Drugs and Therapeutics • March 27, 2017; (Issue 1517)
The FDA has approved ferric pyrophosphate
citrate solution (Triferic – Rockwell Medical) to
maintain hemoglobin concentrations in adults with
hemodialysis-dependent chronic kidney disease.
Triferic is the...
The FDA has approved ferric pyrophosphate
citrate solution (Triferic – Rockwell Medical) to
maintain hemoglobin concentrations in adults with
hemodialysis-dependent chronic kidney disease.
Triferic is the first iron replacement product that is
added into the hemodialysis solution at each dialysis
procedure.
Extended-Release Calcifediol (Rayaldee) for Secondary Hyperparathyroidism
The Medical Letter on Drugs and Therapeutics • February 27, 2017; (Issue 1515)
The FDA has approved extended-release (ER)
calcifediol (25-hydroxyvitamin D3; Rayaldee –
Opko), a prohormone of calcitriol, the active form of
vitamin D3. It is indicated for treatment of...
The FDA has approved extended-release (ER)
calcifediol (25-hydroxyvitamin D3; Rayaldee –
Opko), a prohormone of calcitriol, the active form of
vitamin D3. It is indicated for treatment of secondary
hyperparathyroidism (SHPT) in adults with stage 3 or
4 chronic kidney disease (CKD) who have serum total
25-hydroxyvitamin D levels <30 ng/mL.
Peginesatide (Omontys) for Anemia in Chronic Kidney Disease
The Medical Letter on Drugs and Therapeutics • June 11, 2012; (Issue 1392)
The FDA has approved the erythropoiesis-stimulating
agent (ESA) peginesatide (Omontys – Affymax/Takeda),
a synthetic peptide analog of erythropoietin, for treatment
of anemia in patients with chronic...
The FDA has approved the erythropoiesis-stimulating
agent (ESA) peginesatide (Omontys – Affymax/Takeda),
a synthetic peptide analog of erythropoietin, for treatment
of anemia in patients with chronic kidney disease
(CKD) who are on dialysis. Peginesatide is the third ESA
to become available in the US.Overuse of the other two,
which have broader indications, has been a concern.
In Brief: Ezetimibe/Simvastatin (Vytorin) in Chronic Kidney Disease
The Medical Letter on Drugs and Therapeutics • January 9, 2012; (Issue 1381)
An FDA advisory committee has voted in favor of approving ezetimibe/simvastatin (Vytorin – Merck) for prevention of major cardiovascular events in patients with chronic kidney disease who are not on dialysis....
An FDA advisory committee has voted in favor of approving ezetimibe/simvastatin (Vytorin – Merck) for prevention of major cardiovascular events in patients with chronic kidney disease who are not on dialysis. The FDA itself is expected to make a decision on this potential new indication in the first quarter of 2012.
The manufacturer’s application for this new indication was based on a double-blind, randomized trial (SHARP) that compared the combination of ezetimibe 10 mg and simvastatin 20 mg with placebo in 9270 patients with chronic kidney disease who did not have a history of myocardial infarction or coronary revascularization.1 About one-third of patients were already on hemodialysis at the start of the trial. Over a median of 4.9 years, a major atherosclerotic event (the primary endpoint) occurred in 526 patients (11.3%) taking the active drugs and in 619 (13.4%) taking placebo. Myopathy occurred in 9 patients (0.2%) randomized to ezetimibe/simvastatin and in 5 (0.1%) of those in the placebo group, not a significant difference.
Whether simvastatin alone, which would cost much less, would similarly improve outcomes in such patients remains to be determined. The FDA advisory committee did not recommend approval of Vytorin for patients who were on hemodialysis.2 Previous trials with a statin alone in patients with end-stage renal disease on hemodialysis failed to show significant benefits in clinical outcomes.3,4
1. C Baigent et al. The effects of lowering LDL cholesterol with simvastatin plus ezetimibe in patients with chronic kidney disease (Study of Heart and Renal Protection): a randomised placebo-controlled trial. Lancet 2011; 377: 2181.
2. S Sutter. Merck’s bid for Vytorin CV benefit claim muddled by earlier statin failures in dialysis patients. The Pink Sheet, November 7, 2011.
3. C Wanner et al. Atorvastatin in patients with type 2 diabetes mellitus undergoing hemodialysis. N Engl J Med 2005; 353:238.
4. BC Fellström et al. Rosuvastatin and cardiovascular events in patients undergoing hemodialysis.N Engl J Med 2009; 360:1395.
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The manufacturer’s application for this new indication was based on a double-blind, randomized trial (SHARP) that compared the combination of ezetimibe 10 mg and simvastatin 20 mg with placebo in 9270 patients with chronic kidney disease who did not have a history of myocardial infarction or coronary revascularization.1 About one-third of patients were already on hemodialysis at the start of the trial. Over a median of 4.9 years, a major atherosclerotic event (the primary endpoint) occurred in 526 patients (11.3%) taking the active drugs and in 619 (13.4%) taking placebo. Myopathy occurred in 9 patients (0.2%) randomized to ezetimibe/simvastatin and in 5 (0.1%) of those in the placebo group, not a significant difference.
Whether simvastatin alone, which would cost much less, would similarly improve outcomes in such patients remains to be determined. The FDA advisory committee did not recommend approval of Vytorin for patients who were on hemodialysis.2 Previous trials with a statin alone in patients with end-stage renal disease on hemodialysis failed to show significant benefits in clinical outcomes.3,4
1. C Baigent et al. The effects of lowering LDL cholesterol with simvastatin plus ezetimibe in patients with chronic kidney disease (Study of Heart and Renal Protection): a randomised placebo-controlled trial. Lancet 2011; 377: 2181.
2. S Sutter. Merck’s bid for Vytorin CV benefit claim muddled by earlier statin failures in dialysis patients. The Pink Sheet, November 7, 2011.
3. C Wanner et al. Atorvastatin in patients with type 2 diabetes mellitus undergoing hemodialysis. N Engl J Med 2005; 353:238.
4. BC Fellström et al. Rosuvastatin and cardiovascular events in patients undergoing hemodialysis.N Engl J Med 2009; 360:1395.
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Correction: Ferumoxytol (Feraheme)
The Medical Letter on Drugs and Therapeutics • April 19, 2010; (Issue 1336)
In the Medical Letter article on Ferumoxytol (Feraheme) - A New Parenteral Iron Formulation (2010; 52:23), the last sentence of the Dosage, Administration and Cost paragraph should have listed the cost of 1...
In the Medical Letter article on Ferumoxytol (Feraheme) - A New Parenteral Iron Formulation (2010; 52:23), the last sentence of the Dosage, Administration and Cost paragraph should have listed the cost of 1 gram of sodium ferric gluconate (Ferrlecit) as about $600.
Ferumoxytol (Feraheme) - A New Parenteral Iron Formulation
The Medical Letter on Drugs and Therapeutics • March 22, 2010; (Issue 1334)
Ferumoxytol (Fer yoo mox’ i tole; Feraheme – AMAG), an intravenous (IV) iron replacement product, has been approved by the FDA for treatment of iron deficiency anemia in adults with chronic kidney disease....
Ferumoxytol (Fer yoo mox’ i tole; Feraheme – AMAG), an intravenous (IV) iron replacement product, has been approved by the FDA for treatment of iron deficiency anemia in adults with chronic kidney disease. Iron deficiency anemia is common in chronic kidney disease and may be associated with decreased absorption from the gastrointestinal tract, limiting the usefulness of oral iron replacement. IV iron replacement can lower the dose requirement for erythropoiesis-stimulating drugs, particularly in patients on dialysis
In Brief: Sevelamer-Based Phosphate Binders
The Medical Letter on Drugs and Therapeutics • February 25, 2008; (Issue 1280)
Sevelamer carbonate (Renvela – Genzyme), a buffered form of the anion-exchange resin sevelamer hydrochloride (Renagel – Genzyme),1 has been approved by the FDA for use in patients with chronic kidney...
Sevelamer carbonate (Renvela – Genzyme), a buffered form of the anion-exchange resin sevelamer hydrochloride (Renagel – Genzyme),1 has been approved by the FDA for use in patients with chronic kidney disease on dialysis. According to the manufacturer, Renvela will replace Renagel, which has been shown to induce or exacerbate metabolic acidosis in patients on dialysis. Two randomized, crossover studies found the two sevelamer salts equivalent in their ability to lower serum phosphate.2,3 Patients taking the carbonate had higher serum bicarbonate concentrations and fewer gastrointestinal adverse effects. Sevelamer carbonate, which is available in 800-mg tablets, can be substituted for the hydrochloride salt gram for gram. Recent studies in patients beginning hemodialysis have suggested a possible mortality benefit for sevelamer compared to less expensive calcium- based phosphate binders,4,5 but some critics are skeptical.6
1. Phosphate binders. Med Lett Drugs Ther 2006; 48:15.
2. J Delmez et al. A randomized, double-blind, crossover design study of sevelamer hydrochloride and sevelamer carbonate in patients on hemodialysis. Clin Nephrol 2007; 68:386.
3. S Fan et al. Renvela (sevelamer carbonate) powder and Renagel (sevelamer hydrochloride) tablets: report of a randomized, cross-over study in chronic kidney disease (CKD) patients on hemodialysis (poster). American Society of Nephrology Renal Week. October 31- November 5 2007. San Francisco.
4. GA Block et al. Mortality effect of coronary calcification and phosphate binder choice in incident hemodialysis patients. Kidney Int 2007; 71:438.
5. AM Borzecki et al. Survival in end stage renal disease: calcium carbonate vs. sevelamer. J Clin Pharm Ther 2007; 32:617.
6. J Silver. The details bedevil DCOR. Kidney Int 2007; 72:1041.
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1. Phosphate binders. Med Lett Drugs Ther 2006; 48:15.
2. J Delmez et al. A randomized, double-blind, crossover design study of sevelamer hydrochloride and sevelamer carbonate in patients on hemodialysis. Clin Nephrol 2007; 68:386.
3. S Fan et al. Renvela (sevelamer carbonate) powder and Renagel (sevelamer hydrochloride) tablets: report of a randomized, cross-over study in chronic kidney disease (CKD) patients on hemodialysis (poster). American Society of Nephrology Renal Week. October 31- November 5 2007. San Francisco.
4. GA Block et al. Mortality effect of coronary calcification and phosphate binder choice in incident hemodialysis patients. Kidney Int 2007; 71:438.
5. AM Borzecki et al. Survival in end stage renal disease: calcium carbonate vs. sevelamer. J Clin Pharm Ther 2007; 32:617.
6. J Silver. The details bedevil DCOR. Kidney Int 2007; 72:1041.
Download U.S. English
Erythropoietin Safety Concerns
The Medical Letter on Drugs and Therapeutics • May 7, 2007; (Issue 1260)
The erythropoiesis-stimulating agents (ESAs) epoetin alfa (Epogen, Procrit) and darbepoetin alfa (Aranesp) are widely used for treatment of anemia and to reduce the need for red blood cell transfusions. Based...
The erythropoiesis-stimulating agents (ESAs) epoetin alfa (Epogen, Procrit) and darbepoetin alfa (Aranesp) are widely used for treatment of anemia and to reduce the need for red blood cell transfusions. Based on the results of recent clinical trials indicating an increased risk of serious adverse events and death associated with ESAs, particularly when used to achieve a hemoglobin concentration ≥12 g/dL, the FDA has revised the prescribing information for these drugs to include a black box warning.