Ketoprofen

MONDAY, April 17, 2023 -- Arthritis is a common disease that causes pain and inflammation in different body joints, making it difficult to enjoy everyday tasks and physical activity. Fortunately, there are many different medications for arthritis. Depending on what type of arthritis you have and its severity, an arthritis medication may help you manage pain and other symptoms. Here is a breakdown of the most common arthritis medications, how they work and their potential side effects. The Arthritis Foundation lists the following as the medications used to treat arthritis: Analgesics including acetaminophen (Tylenol) and opioids Nonsteroidal anti-inflammatory drugs (NSAIDs) Corticosteroids Disease-modifying antirheumatic drugs (DMARDs) including biologics and targeted DMARDs Analgesics The Arthritis Foundation reports that analgesics may help with mild to moderate pain, but they will not help with the inflammation associated with arthritis. Analgesics work in the nervous system and alter how your brain perceives pain. They can be used to treat the pain associated with any type of arthritis, although more effective options are available. Analgesics can be opioid, non-opioid or a combination. Common analgesics are: Acetaminophen (Tylenol) Codeine Oxycodone Fentanyl Hydrocodone Potential side effects: Kidney damage Liver damage Addiction Constipation Gastrointestinal bleeding Use caution when taking these medications; take only as prescribed. NSAIDs NSAIDs work by blocking prostaglandin. According to the Cleveland Clinic , one role prostaglandins play is forming clots and causing inflammation at the site of an injury. NSAIDs are used to treat the pain and inflammation associated with rheumatoid arthritis and osteoarthritis . Common over-the-counter (OTC) NSAIDs are: Aspirin (Bayer, St. Joseph, Anacin, Excedrin and more) Ibuprofen (Motrin, Advil) Naproxen sodium (Aleve) Prescription NSAIDs are: Celecoxib (Celebrex) Diclofenac (Voltaren, available by brand name in topical form) Fenoprofen (Nalfon) Indomethacin (Indocin, available by brand name in liquid form) Ketorolac tromethamine (Toradol) Meclofenamate sodium (Meclomen) Diflunisal (Dolobid) Tolmetin (Tolectin) Ketoprofen (Orudis) Flurbiprofen (Ansaid) Potential side effects of NSAIDs are: Increased risk of stomach and bowel issues like ulcers and bleeding Increased risk of stroke Heart problems Stomach pain Nausea Diarrhea/constipation Corticosteroids According to the Arthritis Foundation , corticosteroids mimic cortisol, a hormone your body produces naturally. They are used to treat inflammatory types of arthritis, including rheumatoid arthritis and psoriatic arthritis. They are great for short-term relief of inflammation but are not recommended for long-term use because of their side effects. Your doctor may prescribe a lower dose if you require them for long-term use. Common corticosteroids: Prednisone (Deltasone, Prednicot, Cotolone) Prednisolone (Orapred, Omnipred) Cortisone (Cortone) Hydrocortisone (Cortef, Hydrocort) Triamcinolone (Aristocort) Dexamethasone (Decadron) Common side effects of corticosteroids: Blood sugar spikes Weight gain Bone loss Risk of cataracts High blood pressure Infections Mood changes DMARDs The Arthritis Foundation says that DMARDs work with the body to “stop or slow the disease process in inflammatory forms of arthritis.” They work by blocking inflammation. There are many different DMARDs on the market, and they all have different ways of working in the body. Conventional DMARDs work by broadly suppressing the immune system. Often they are used in combination with other therapies. Targeted DMARDs block specific pathways inside immune cells. Biologic DMARDs are produced by live cells and work on specific immune proteins called cytokines. Common DMARDs: Apremilast (Otezla) Baricitinib (Olumiant) Cyclophosphamide (Cytoxan) Cyclosporine (Gengraf, Neoral) Hydroxychloroquine (Plaquenil) Leflunomide (Arava) Methotrexate (Otrexup, Rasuvo, RediTrex) Mycophenolate mofetil (CellCept) Sulfasalazine (Azulfidine) Tofacitinib (Xeljanz, Xeljanz XR) According to the Cleveland Clinic , common side effects of traditional DMARDs include: Loss of appetite Nausea Diarrhea Abdominal pain Rash, allergic reaction Liver problem Increased risk of infection Low blood cell counts Common side effects of biologic DMARDs include: Increased risk of common and serious infections Reactivation of tuberculosis, herpes zoster, and hepatitis B and C Increased cholesterol levels, increased liver enzymes and low blood cell counts Increased risk of clotting When prescribed DMARDs, inform your doctor of any other medications, including over-the-counter medicines, you are taking to avoid drug interactions. Some of these medications can cause teratogenicity (defects in a developing fetus.) Writing recently in the Journal of the American Academy of Physician Assistants (JAAPA ), physician assistant Michelle DiBiase and Dr. Samantha Kohn remind people that "The mainstay of pharmacologic therapy is early intervention with use of nonbiologic and biologic DMARDs together with adjunctive medications such as NSAIDs, oral and intra-articular corticosteroids, and analgesic medications, including opioids." Your primary care provider or rheumatologist will work closely with you to determine which medications are best for your treatment. It is vital to keep them apprised of any side effects and let them know if the treatment is ineffective. They can work with you to find a treatment that helps relieve the pain and inflammation caused by arthritis. Posted April 2023

Courtesy of Sarah Silbiger/Getty Images In an 8-3 decision, the FDA's Cardiovascular and Renal Drugs Advisory Committee voted against California-based Cytokinetics, Inc., finding that the benefits of its heart failure hopeful omecamtiv mecarbil (OM) didn’t outweigh its risks. In a briefing document sent to the panel, an issue was cited with the mixed efficacy results backing OM, muddled further by safety concerns. The FDA is expected to reach a final decision on OM in the coming months. The PDUFA target action date is on Feb. 28, 2023. Cytokinetics backed its regulatory bid for OM with one Phase III study: the GALACTIC-HF trial, which, with more than 8,250 patients enrolled, is among the largest trials in heart failure. The study employed a composite endpoint of cardiovascular death or heart failure events as its primary efficacy measure. Compared with the placebo, OM slashed this risk by 8%, a statistically significant effect with a p-value of 0.025. Cytokinetics further drew confidence in its heart failure candidate from a pre-specified sub-group analysis. In patients with a left ventricular ejection fraction not exceeding 28%, a typical hallmark of worsening heart failure, OM reduced the likelihood of the primary endpoint by 16%, with a stronger p-value of 0.003. OM consistently demonstrated higher treatment effects in sicker patients. For instance, the drug cut the risk of the composite endpoint by 17% in those hospitalized in the last three months and 23% in patients with elevated levels of the N-terminal-pro brain natriuretic peptide. These results are “the most biologically plausible,” given the drug’s mechanism of action of increasing myocardial contractility to boost cardiac function, according to the FDA. Not Enough Evidence, Risks of Toxicity and an Unapproved Test Still, the FDA’s advisers said that the evidence supporting OM was too thin. While the drug did satisfy its primary efficacy measure, the overall treatment effect was small, and none of the secondary endpoints were met. “The small treatment effect, with a p-value that is not very persuasive for a single trial, without established effects on any of the secondary efficacy endpoints, calls into question whether the statutory requirement for substantial evidence of effectiveness has been met,” stated the briefing document. For the potential efficacy signals in patients with LVEF worse than 28%, the experts wrote that “there is no scientific basis for this differential effect.” Regarding safety, the advisory committee conceded that the risk of dose-limiting cardiotoxicity due to OM’s mechanism of action was generally contained in GALACTIC-HF. However, Cytokinetics employed a pharmacokinetic-guided dosing approach in the study, which the company proposed to do away with in the real world. Without measuring plasma OM concentrations for dose adjustment, patients could be subjected to higher drug exposure levels, which “could increase the potential risk of OM-associated cardiotoxicity,” according to the FDA. Cytokinetics has subsequently agreed to a guided dosing strategy but has proposed to use a lab-based test not approved by the FDA. The advisory committee also saw this as an issue, pointing out that the agency cannot rely on data from uncleared tests. If pharmacokinetic-guided dosing is crucial to determine whether OM is safe and effective, then the test “should be cleared or approved contemporaneously with OM,” the expert panel stated.