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Withdrawals of several COX inhibitors were based on studies that demonstrated a significantly increased risk of adverse cardiovascular events with use of these COXselective agents. After the withdrawal of rofecoxib and valdecoxib, it soon became evident in subsequent studies that the cardiovascular risk may not only be limited to selective COX-2 inhibitors but also, to nonselective NSAIDs. Despite published American Heart Association guidelines that warn against the use of NSAIDs, and the addition of a black box warning for the NSAID celecoxib, 7 the results of these studies have led to a generalization of risk across diverse cardiovascular events.
However, while the risk of MI is the most strongly supported by the literature, limited work has focused on an association between NSAID use and risk of other vascular events, specifically stroke. Thus, a critical review of the literature with regard to specific risk of stroke events is warranted. These agents affect the balance of various prostaglandins, thromboxane, and prostacyclin, and their action on vascular function, platelet aggregation, and smooth muscle proliferation.
Prostacyclin is the primary product of COX-2 and is responsible for vasodilation, inhibition of smooth muscle cell proliferation, and platelet inhibition. It has been proposed from the literature that an imbalance between thromboxane and prostacyclin can influence the relative adverse vascular effects of NSAIDs Table 1. Foremost, there has been significant variability in the determination of COX selectivity by different assay methodologies.
Additionally, the concept that only COX-2 is expressed in the endothelium driving endothelial adverse effects has been recently challenged. Adapted with permission Cryer B, Feldman M.
Cyclooxygenase-1 and cyclooxygenase-2 selectivity of widely used nonsteroidal anti-inflammatory drugs. Am J Med. All NSAIDs, to some degree, affect vasoconstriction and sodium excretion, which can lead to hypertension, a risk factor for cerebrovascular events. Although studies have suggested an association between blood pressure increase and NSAID use, the focus was primarily on short-term duration with use less than 30 days.
Much of the initial suggestions of an association between NSAIDs and cardiovascular risk came from prospective studies 4 , 27 that were not specifically designed to assess adverse vascular events.
The majority of these studies focused primarily on comparing the efficacy of various NSAIDs with regard to prevention of colon adenomas, prevention of gastrointestinal side effects, or the prevention of dementia. In these early studies, which led to the withdrawal of rofecoxib and valdecoxib, the risk of cardiovascular events, particularly MI, was readily apparent.
However, the absolute incidence of stroke events compared with coronary events was significantly less, thus making interpretation of any analyses difficult. Within these studies, there was a suggestion of an association between NSAIDs, particularly with rofecoxib, and stroke, although the results were not consistent. The APPROVe trial, in , documented relatively few stroke events and demonstrated a trend toward increased stroke risk with rofecoxib, but this did not reach statistical significance.
This same higher dose of celecoxib was actually associated with fewer stroke events as compared with either diclofenac or ibuprofen in another study. As the stroke event rate within the previously mentioned studies of NSAIDs for dementia and cancer prevention was insufficient to perform detailed analyses, much of the data specifically demonstrating an association between NSAID use and stroke events are based on observational studies.
An early study performed in by Bak et al, of over 4, patients, demonstrated no increase in the risk of either hemorrhagic or ischemic stroke with any NSAID. The most consistent signal of elevated risk has been with rofecoxib 31 — 33 and valdecoxib. Another study by Andersohn et al 32 of over , patients, studied in a nested case-control analysis, found that use of rofecoxib and etoricoxib, but not celecoxib, was associated with an increased risk of ischemic stroke.
This study estimated an additional 21 stroke events for rofecoxib and 41 stroke events for etoricoxib per 10, exposed persons per year. The risk of stroke has also been suggested to be proportional to the relative degree of COX-2 selectivity. They found that the incidence of stroke increased proportionately to the degree of COX-2 selectivity and that the use of highly selective agents was significantly associated with stroke compared with poorly selective agents.
As questions remain regarding the association between NSAIDs and the risk of vascular events, several recent meta-analyses have sought to better characterize an association through pooled analyses. The evaluation of these data again demonstrates the paucity of stroke events. In a network meta-analysis by Trelle et al, of the 31 studies included, 26 provided stroke data, with only observed events.
Stroke events are generally characterized as either ischemic or hemorrhagic, with the majority of strokes being ischemic. Although NSAIDs have generally been predominantly associated with gastrointestinal bleeding, understanding of their effects on platelet function suggests that NSAID use could lead to an increased risk of hemorrhagic stroke, as well as ischemic stroke, through mediation of thrombosis.
As the overall numbers of events have been limited within the prospective trials, the majority of stroke events quoted in various studies were not differentiated with respect to stroke subtypes.
What little can be inferred of a potential for differential risk comes again from observational studies. A study by Johnsen et al found no increased risk of intracranial hemorrhage with NSAID exposure when subjects were stratified by gender, age, and history of hypertension.
Within the literature, there is some suggestion that COX-2 selectivity is proportional to an increased risk of stroke events. However, although some of the most highly COXselective agents have been associated with increased stroke risk, 32 , 34 the evidence with celecoxib is perhaps too divergent to draw any conclusions. Although the literature regarding MI events and celecoxib did not lead to its withdrawal, it did lead to a black box warning.
The evidence behind celecoxib and stroke events is not nearly as supportive. As celecoxib is the only remaining COXselective agent available on the United States market, it is important to critically analyze the data regarding any association. The previously mentioned study by Abraham et al 31 found that the incidence of stroke increased proportionately with the degree of COX-2 selectivity. Additionally, the use of highly selective agents was significantly associated with stroke when compared with poorly selective agents.
However, the use of moderately selective agents, such as celecoxib, was not significant compared with poorly selective agents. Americans consume more than 15 billion aspirin tablets a year. Here's a guide to some of the most commonly used pain relief medications:. Marijuana — There's been a growing acceptance of marijuana as a legitimate pain reliever.
The American Medical Association supports making marijuana a Schedule I controlled substance in order to promote research into its therapeutic abilities. Doctors in some states may prescribe it to ease chronic pain that comes from arthritis, migraines, Crohn's disease or other ongoing pain issues where other medicines have failed.
It works by blocking the pain sensations felt by peripheral nerves. The cannabinoids in marijuana bind to endocannabinoid receptors throughout the body and can reduce pain but also give the feeling of being high. Some research shows that it can also slow cancer development and increase appetite. Forty states and the District of Columbia allow some legal uses of marijuana, mostly for medicinal purposes.
Hydrocodone — Hydrocodone is available only in combination with other ingredients, with different products prescribed for different uses. Some products are used to relieve moderate to severe pain, while others combat a cough, according to the National Institutes of Health. An opiate narcotic analgesic, hydrocodone relieves pain by changing the way the brain and nervous system respond to it. It may be habit-forming, and abuse of drugs, including hydrocodone, has become a concern in recent years.
Now, in order to use these drugs, patients will have to get a written prescription from a doctor -- instead of one submitted orally by phone. And refills are prohibited; patients would have to check in with their doctors to get another prescription.
Fentanyl — Fentanyl is a prescription-only pain medication often given to cancer patients. They must be at least 18 years old to take it, or at least 16 for lozenges branded as Actiq, and they should also be taking regular doses of another narcotic pain medication. Patients must also be accustomed to the effects of narcotics. Fentanyl itself is a narcotic and changes the way the brain and nervous system respond to pain, according to the National Institutes of Health.
This drug comes in the form of a lozenge, a tablet under the tongue, a film and a buccal between the gum and cheek tablet, as well as in injectable form. It is designed for sudden episodes of pain and should not be used more than four times a day.
Overdose can cause drowsiness, dizziness, confusion, breathing problems or smaller pupils. The FDA has said there is growing concern about illicit fentanyl use, particularly in conjunction with heroin.
Morphine — Patients take morphine for moderate to severe pain. It is an opiate narcotic analgesic and changes the way the brain and nervous system react to pain. Forms of morphine include tablet and solution, which are taken every four hours, as needed.
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