The American journal of medicine
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Determining if a medication is effective should be easy: Either the condition is or is not improved. However, the truth is often more complex than that, including in the antiarrhythmic drug (AAD) management of atrial fibrillation. In clinical trials, AAD efficacy is usually determined by the time to first atrial fibrillation recurrence. ⋯ In clinical practice AADs, for atrial fibrillation, are prescribed to reduce symptoms/improve quality of life, which usually correlate with reduced atrial fibrillation frequency, duration, and beneficial hemodynamic effects in certain patient subgroups. Time to first recurrence is not a reliable predictor of clinical efficacy endpoints in practice. This article presents a review for the practitioner of AAD efficacy endpoints in clinical trials versus those in clinical practice and why such differences are present.
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In 2021, the US Food and Drug Administration (FDA) approved 50 novel drugs. Thirty-seven of the 50 (74%) novel drug approvals were reviewed and approved through an expedited review pathway, and 26 of the 50 (52%) were approved for treatment of a rare disease. This review includes a summary of the novel drugs approved by the FDA in 2021.
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Vertebral compression fractures are the most common complication of osteoporosis, with 700,000 cases reported every year in the United States. Vertebral compression fractures typically present with abrupt-onset low back pain with or without a history of trauma, although more than two-thirds are detected incidentally. ⋯ Magnetic resonance imaging is also the modality of choice to determine if the fracture is acute vs chronic in nature. Patients can be managed with a combination of nonsurgical modalities including medications, bracing, and physical therapy, although when indicated, kyphoplasty or vertebroplasty may be considered to provide symptom relief.