Articles Tagged With: Pharmacology
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What Happens if Post-Approval Studies Are Delayed or Do Not Show Benefit?
Essentially, the ethical issues are how to consider the interests of patients today, who are willing to accept uncertainty in the hopes a drug works because they do not have time to wait, and the interests of patients tomorrow, who would prefer to have stronger evidence about what works and what does not.
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Understanding Statin-Related Muscle Pain and Cardiovascular Benefits
A review of large-scale, randomized, double-blind trials of statin therapy suggested statins are responsible for only a small excess of muscle pain symptoms in patients taking these drugs.
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Betibeglogene Autotemcel Suspension (Zynteglo)
The FDA has approved the first cell-based gene therapy to treat adult and pediatric patients with beta-thalassemia who require regular blood transfusions.
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Hot Trials from the European Society of Cardiology Annual Congress
Below are some highlights from four key studies presented in Barcelona, Spain, between Aug. 26 and Aug. 29, 2022, along with Dr. Crawford’s personal commentary on each.
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Statins Plus Ezetimibe vs. Statins Alone
A comparison of rosuvastatin 10 mg/day plus ezetimibe (10 mg/day) to 20 mg/day of rosuvastatin alone showed non-inferiority in three-year major cardiovascular outcomes, with lower LDL cholesterol levels and fewer episodes of drug discontinuation or dose reductions in the combination therapy group.
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Are SGLT2 Inhibitors Effective for HFpEF Patients Without Diabetes?
After comparing empagliflozin to placebo for patients with heart failure and preserved left ventricular ejection fraction, researchers found no differences in the significant reduction of the primary outcome of cardiovascular death or heart failure hospitalization over 36 months based on whether patients were diabetic.
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Health Systems Start Transition to New Approach for Treating Ischemic Stroke
Alteplase has been a mainstay to treat ischemic stroke. When given within hours of an episode, evidence has shown the clot-busting medication can improve outcomes. But what if there was a drug that could deliver similar, and possibly even better, outcomes for a subset of stroke patients without some of the logistical hurdles associated with alteplase?
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The Trouble with Electronically Tracking Study Medications
Digital pills allow data to be recorded automatically about patients’ medication adherence, but patients and providers have expressed significant ethical concerns.
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Are SGLT2 Inhibitors Effective for HFpEF Patients Without Diabetes?
After comparing empagliflozin vs. placebo for patients with heart failure and preserved left ventricular ejection fraction, researchers found no differences in the significant reduction of the primary outcome of cardiovascular death or heart failure hospitalization over 36 months based on whether patients were diabetic.
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Predicting the Tolerability of Sacubitril/Valsartan in Advanced Heart Failure
An analysis of the sacubitril/valsartan run-in period for chronic, advanced heart failure patients showed 18% could not tolerate the lowest dose, usually because of hypotension or renal dysfunction. Investigators identified six predictors of non-tolerance, which may help clinicians choose the best candidates.