CLINICAL UPDATES :
Here, in order of anticipated importance, are the Cleveland Clinic’s list of top 10 medical innovations for 2020.
1. DUAL-ACTING OSTEOPOROSIS DRUG ROMOSOZUMAB
In April, the US Food and Drug Administration (FDA) approved romosozumab (Evenity, Amgen), the first drug for osteoporosis that both increases bone formation and decreases bone resorption.
It is indicated for postmenopausal women with a history of osteoporotic fracture or multiple risk factors for fracture, or those who have failed or are intolerant to other osteoporosis therapies. Romosozumab gives patients with osteoporosis more control in preventing additional fractures, the expert panel concluded.
2. EXPANDED USE OF MINIMALLY INVASIVE MITRAL VALVE SURGERY
About one in 10 individuals over the age of 75 will suffer from mitral valve regurgitation. Minimally invasive mitral valve repair with the MitraClip (Abbott) gained initial approval in the United States in 2013 for treatment of patients with primary mitral regurgitation who were not eligible for open-heart surgery.
In March, the FDA broadened its approval of the device to include patients with secondary mitral regurgitation, providing an important new treatment option, the panel said.
3. INAUGURAL TREATMENT FOR TRANSTHYRETIN AMYLOID CARDIOMYOPATHY
Transthyretin-mediated amyloidosis cardiomyopathy (ATTR-CM) is a rare, progressive, and often fatal disease caused by deposition of amyloid fibrils in the myocardium.
Following fast-track and breakthrough designations, the FDA this year approved the first-ever medication for treatment of adults with ATTR-CM. Pfizer’s tafamidis meglumine (Vyndaqel ) and tafamidis (Vyndamax) have been shown to prevent misfolding of the deposited protein and significantly reduce risk for death.
4. THERAPY FOR PEANUT ALLERGIES
In September, an FDA panel overwhelmingly recommended peanut (Arachis hypogaea) allergen powder (Palforzia, Aimmune Therapeutics) for children who are allergic to peanuts. If approved, the peanut allergen powder will be the first-in-class oral immunotherapy treatment for patients with peanut allergy. It will be available as an oral powder that is given once daily by mixing it with food.
Though not a cure, the breakthrough treatment lessens the worry of accidental exposure, easing the minds of parents who live in constant fear, the panel concluded.
5. CLOSED-LOOP SPINAL CORD STIMULATION
Chronic back and leg pain is common and a large reason for prescription of opioid medication. Spinal cord stimulation is a popular treatment for chronic pain, with use of an implantable device that provides electrical stimulus to the spinal cord.
But unsatisfactory outcomes due to subtherapeutic or overstimulation events are common. The innovation of closed-loop stimulation allows for better communication between the device and the spinal cord. With this technology, patients are getting measurable pain relief, sleeping better, and taking less medication. Pending approval, closed-loop stimulation could be a saving grace for chronic pain patients, the Cleveland Clinic said.
6. BIOLOGICS IN ORTHOPEDIC REPAIR
Biologics — cells, blood components, growth factors, and other natural substances — have the power to replace or harness the body’s own power to promote healing of anterior cruciate ligament (ACL) tears and decrease inflammation and are increasingly finding their way into orthopedic care, allowing for the possibility of expedited improved outcomes.
The new technique uses a sponge injected with biologic factors in combination with the patient’s own blood to stimulate healing of the ACL, preserving the tissue rather than cutting it. A trial using this technique is ongoing. It also has potential for rotator cuff repair and as a coating for implant devices to reduce the risk for infection.
Biologics hold the potential to provide every orthopedic patient a more natural, more effective, speedy recovery, the Cleveland Clinic said.
7. ANTIBIOTIC ENVELOPE FOR CARDIAC IMPLANTAB
LE DEVICE INFECTION PREVENTION
Worldwide, about 1.5 million patients receive an implantable cardiac electronic device every year. But infections occur in 1% to 4% of cardiac device implantations. The recent innovation of an implantable antibiotic envelope ensures delivery of two antimicrobial drugs locally in the pocket for 7 days after implantation, minimizing the risk for infection.
The absorbable envelope received FDA clearance in 2013, but healthcare professionals were anxiously awaiting results of the landmark worldwide randomized WRAP-IT trial. The findings, published in March, show a 40% reduction in major infections, making cardiac implantable device procedures safer for patients, the Cleveland Clinic said.
8. BEMPEDOIC ACID FOR CHOLESTEROL LOWERING IN STATIN-INTOLERANT PATIENTS
Cholesterol-lowering statins cause muscle pain in up to 10% of patients who take them. A new agent, bempedoic acid, provides an alternative cholesterol-lowering approach that avoids these side effects.
Unlike statins, bempedoic acid does not accumulate in muscle, reducing the likelihood of muscle pain.
In clinical trials, bempedoic acid reduced LDL-C levels by an average of about 25%. If approved by the FDA, bempedoic acid could be another addition to the arsenal of cholesterol-lowering treatments available to patients, the panel noted.
9. PARP INHIBITORS FOR Maintenance Therapy IN OVARIAN CANCER
Poly-ADP ribose polymerase (PARP) inhibitors are one of the most recent important advances in ovarian cancer treatment, the panel concluded. These drugs have improved progression-free survival and are now being approved for first-line maintenance therapy in advanced disease.
In March, an analysis of the phase 3 NOVA trial strengthened earlier findings that the PARP inibitor niraparib (Zejula, Tesaro) provides meaningful clinical benefit for patients with platinum-sensitive, recurrent ovarian cancer compared with placebo by prolonging time without symptoms or toxicity until disease progression.
Several additional large-scale trials are under way, with PARP inhibitors set to make great strides in improving outcomes in cancer therapy, the panel said.
10. DRUGS FOR HEART FAILURE WITH PRESERVED EJECTION FRACTION
There currently are no drug therapies specifically indicated for treatment of heart failure with preserved ejection fraction (HFpEF). Management is directed at accompanying conditions and symptom relief.
However, sodium glucose cotransporter 2 (SGLT2) inhibitors, used for type 2 diabetes, are now being explored for HFpEF in several ongoing trials. Interest in SGLT2 inhibitors for HF was fueled by the observation that they reduced the risk for cardiovascular death and heart failure hospitalization in a cohort of patients with type 2 diabetes.
SGLT2 inhibitors showed similar results in nondiabetic individuals with heart failure and reduced ejection fraction.
With an FDA decision anticipated in 2020, these drugs, among others, are introducing potential new treatment options for patients with this heart failure subtype, the Cleveland Clinic noted.
Top 10 Medical Innovations for 2020, According to Cleveland Clinic – Medscape – Nov 07, 2019.