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Complications Due to
NSAIDS |
Touted as being "more safe" than aspirin, a class of drugs called non-steroidal anti-infalmmatory drugs are the biggest sellers on the market. But are they really "safe"? Read on and draw your own conclusions.
Consumption
of NSAIDs and the development of congestive heart failure in elderly
patients: an underrecognized public health problem.
Page J, Henry D.
Arch Intern Med 2000 Mar 27;160(6):777-84.
The results of this study indicate that nonsteroidal anti-inflammatory drugs (NSAIDs) are an important cause of hospitalization for congestive heart failure (CHF) in individuals with or without a history of heart disease. The study was conducted on 365 patients hospitalized for heart failure and 658 controls. Individuals who used NSAIDs in the previous week had a 2-fold increased risk of hospitalization for CHF, compared to non-users. In patients with a history of heart disease, use of NSAIDs was associated with a 10-fold increased risk of hospitalization for CHF. The risk increased with increasing doses of NSAIDs taken in the previous week, and was greater with NSAIDs of long versus short half-life. The authors concluded that NSAIDs could account for approximately 20% of hospitalizations for congestive heart failure. Heart failure affects approximately 4.6 million Americans and this condition represent the most common hospital discharge diagnosis among patients older than 65 years. If this association is casual, as the dose-response relation suggests, cardiovascular morbidity due to NSAIDs would surpass gastro-intestinal NSAID-related morbidity, which alone is responsible for a minimum of 105,000 hospitalizations and 16,500 deaths occurring each year in the U.S. The economic and health consequences of these findings are staggering.
NSAIDs
associated with increased risk of congestive heart failure in elderly
patients taking diuretics.
Heerdink ER, Leufkens HG, Herings RM,
Ottervanger JP, Stricker BH, Bakker A.
Arch Intern Med 1998 May 25;158(10):1108-12.
The results of this study, conducted on a sample population of 10,519 individuals older than 55 years taking diuretics and nonsteroidal anti-inflammatory drugs (NSAIDs), show that users of both drugs have a twofold increased risk of being hospitalized for congestive heart failure, compared to users of diuretics only.
Congestive
heart failure due to nonsteroidal anti-inflammatory drugs in the elderly.
Van den Ouweland FA, Gribnau FW,
Meyboom RH.
Age Ageing 1988 Jan;17(1):8-16.
This study indicates that the occurrence of congestive heart failure in elderly individuals with or without a history of cardiovascular disease who are taking nonsteroidal anti-inflammatory drugs (NSAIDs) is a probable treatment-related complication. Multiple factors can be involved in the etiology of this complication, including toxicity from relative overdose, alteration of cardiovascular homeostasis, and interference with anti-hypertensive treatment.
Nonsteroidal
anti-inflammatory drugs and blood pressure in an elderly population.
Chrischilles EA, Wallace RB.
J Gerontol 1993 May;48(3):M91-6.
This study shows that nonsteroidal anti-inflammatory drugs (NSAIDs) raise systolic blood pressure in elderly individuals by approximately 5 mm Hg and may antagonize the effects of antihypertensive medications. Users of NSAIDs are also twice as likely to have systolic blood pressure higher than 140 mm Hg, compared to nonusers. The authors conclude that NSAIDs may be an important reason for therapeutic failure in the treatment of hypertension.
Do nonsteroidal anti-inflammatory drugs affect blood pressure? A meta-analysis.
Johnson AG, Nguyen TV, Day RO.
Ann Intern Med 1994 Aug 15;121(4):289-300.
This study evaluated data from 38 randomized, placebo-controlled trials, to determine the effect of nonsteroidal anti-inflammatory drugs (NSAIDs) on blood pressure. The results of the analysis revealed that use of NSAIDs is associated with an increase in blood pressure levels by an average of 5.0 mm Hg, and with the neutralization of the effects of antihypertensive treatment, particularly in individuals treated with beta-blockers.
Antagonism of
antihypertensive drug therapy by nonsteroidal anti-inflammatory drugs.
Oates JA.
Hypertension 1988 Mar;11(3 Pt 2):II4-6.
This article discloses the property that certain nonsteroidal anti-inflammatory drugs (NSAIDs) have to antagonize the blood pressure lowering effects of antihypertensive treatment. Indomethacin abolishes the effects of several antihypertensive drugs, while piroxicam raises blood pressure in treated patients. The magnitude of this effect varies from patient to patient, from undetectable to dangerous increases in blood pressure.
Initiation of antihypertensive treatment during nonsteroidal anti-inflammatory drug therapy.
Gurwitz JH, Avorn J, Bohn RL, Glynn RJ,
Monane M, Mogun H.
JAMA 1994 Sep 14;272(10):781-6.
This case-control study, conducted on over 9,400 patients aged 65 or older with newly diagnosed hypertension, shows that users of NSAIDs have a 66% increased risk of starting antihypertensive treatment, compared to nonusers. The risk increases with increasing doses of NSAIDs. The adverse effects on blood pressure levels can have a major impact on public health, particularly since approximately 20 millions Americans are currently taking both class of drugs.
The impact of nonsteroidal anti-inflammatory drugs on hypertension: alternative analgesics for patients at risk.
Ruoff GE.
Clin Ther 1998 May-Jun;20(3):376-87; discussion 375.
This article highlights that in the U.S., approximately 20 million individuals and 12% of those aged 60 years and older, use concurrently both nonsteroidal anti-inflammatory drugs (NSAIDs) and antihypertensive drugs. Since NSAIDs limit the efficacy of antihypertensive therapy, their use, unless deemed really necessary, should be avoided, and substituted with other class of analgesics.
Gastrointestinal toxicity of nonsteroidal antiinflammatory drugs.
Wolfe MM, et al.
N Engl J Med. 1999 Jun 17;340(24):1888-99. Review.
This review presents current knowledge on nonsteroidal antiinflammatory drugs (NSAID)-related gastrointestinal toxicity. NSAIDs were developed in the 1970s as an alternative to aspirin and its side effects, most notably gastric ulcers, and became in the following decades one of the most frequently used class of drugs. Every year, in the U.S., over 70 million prescriptions are written for NSAIDs, and over 30 billion tablets are sold over-the-counter. Toxicity from these drugs is substantial. Particularly affected is the gastrointestinal system. Dyspepsia occurs in 5-50% of patients, and causes discontinuation of treatment within 6 months of initiation in 5-15% of individuals. It has been estimated that for every 1000 rheumatoid arthritis patients using NSAIDs for a year, there are 13 hospitalizations for serious gastrointestinal complications. There are approximately 13 million individuals who use NSAIDs by prescription. Extrapolation of these data reveals that every year in the U.S., at least 103,000 individuals are hospitalized for serious gastrointestinal toxicity from NSAID use, and an estimated 16,500 will not survive the complication. Based on these estimates, death from gastrointestinal complications of NSAIDs represents the 15th cause of death in the U.S. This means that every year NSAIDs kill approximately the same number of people as does AIDS, and considerably more people than does asthma, cervical cancer and Hodgkin's disease combined. These figures are conservative since they do not take in account users of over-the-counter NSAIDs. What is even more worrisome is that patients are by large, unaware of the risks associated with the use of these drugs. A recent survey revealed that 75% of patients taking NSAIDs regularly, were not aware or were not preoccupied with the possibility of gastrointestinal complications, and almost two thirds of them incorrectly believed that there would be warning signs preceding the insurgence of gastrointestinal complications. The cost of NSAID gastrointestinal toxicity is high. Each hospitalization costs approximately $15,000 to $20,000, leading to total annual health care expenses exceeding $2 billion.
Recent
considerations in nonsteroidal anti-inflammatory drug gastropathy.
Singh G.
Am J Med, 105(1B):31S-38S 1998 Jul 27.
The results of this study show that each year, approximately 107,000 individuals are hospitalized for gastrointestinal (GI) complications derived from nonsteroidal anti-inflammatory drug (NSAID) use and that, among arthritis patients alone, at least 16,500 die as a consequence of NSAID use. Eighty percent of serious GI events occur without warning symptoms and the risk of this complication increases in patients taking gastro-protective medications.
Nonsteroidal
anti-inflammatory drug use and increased risk for peptic ulcer disease in
elderly persons.
Griffin MR; Piper JM; Daugherty JR;
Snowden M; Ray WA.
Ann Intern Med, 114(4):257-63 1991 Feb 15.
The results of this study, conducted on a cohort of 1,415 patients of 65 or more years of age hospitalized for peptic ulcer, show that use of nonsteroidal antiinflammatory drugs is associated with a fourfold increased risk of peptic ulcer compared to nonuse. This could mean that, in this sample population, approximately a third of all peptic ulcers resulted from use of these drugs.
Nonsteroidal
anti-inflammatory drugs and the incidence of hospitalizations for peptic
ulcer disease in elderly persons.
Smalley WE; Ray WA; Daugherty JR;
Griffin MR.
Am J Epidemiol, 141(6):539-45 1995 Mar 15.
This study, performed on a sample population of 103,954 elderly individuals, documented a fourfold increased rate of hospitalization for serious ulcer disease among nonsteroidal anti-inflammatory drug (NSAID) users compared to nonusers. Among new users, the risk of hospitalization was found to be increased by a factor of 6.
Upper
gastrointestinal lesions in elderly patients presenting for endoscopy:
relevance of NSAID usage.
Bellary SV; Isaacs PE; Lee FI.
Am J Gastroenterol, 86(8):961-4 1991 Aug.
The results of this study, performed on a sample population of 511 consecutive patients admitted for endoscopic evaluation due to upper gastrointestinal disease, show that nonsteroidal antiinflammatory drug (NSAID) users have an over threefold higher incidence of gastric erosions and gastric ulcers and a twofold higher incidence of hemorrhage, compared to nonusers.
Individual
nonsteroidal antiinflammatory drugs and other risk factors for upper
gastrointestinal bleeding and perforation.
Gutthann SP; Garc´ia Rodr´iguez LA;
Raiford DS.
Epidemiology, 8(1):18-24 1997 Jan.
The results of this study, performed on a cohort of over 11,000 individuals, show that nonsteroidal antiinflammatory drug (NSAID) users have a 4.3-fold increased risk of upper gastrointestinal bleeding and death, and a 17-fold increased risk of upper gastrointestinal perforations, compared to NSAID abstainers. Current use of NSAIDs in women of 80 or more years of age was associated with a 9-fold increased risk of experiencing severe complications.
Ulcer bleeding
and perforation: non-steroidal anti-inflammatory drugs or Helicobacter
pylori.
Svanes C; Ovrebø K; Søreide O.
Scand J Gastroenterol Suppl, 220():128-31 1996.
This article shows that use of non-steroidal anti-inflammatory drugs (NSAIDs) is associated with a 5- to 8-fold increased risk of ulcer perforation. Overall, exposure to NSAIDs accounts for about 20% to 40% of all gastric perforations and ulcer bleedings.
Association of
upper gastrointestinal toxicity of non-steroidal anti-inflammatory drugs
with continued exposure: cohort study.
MacDonald TM; et al.
BMJ, 315(7119):1333-7 1997 Nov 22.
This study, performed on a sample population of 52,293 individuals of 50 or more years of age and 73,792 controls, found that, over a three-year period, 2% of non-steroidal anti-inflammatory drug (NSAID) users and 1.4% of nonusers were hospitalized for upper gastrointestinal (GI) events. The risk of GI perforation and bleeding remained constant during continuous NSAIDs exposure.
Nonsteroidal
antiinflammatory drugs and dyspepsia in the elderly.
Talley NJ; Evans JM; Fleming KC;
Harmsen WS; Zinsmeister AR; Melton LJ 3rd.
Dig Dis Sci, 40(6):1345-50 1995 Jun.
This study shows that nonsteroidal antiinflammatory drug use in the elderly is associated with a 60% and 80% increased risk of dyspepsia and/or heartburn, respectively.
Nonsteroidal
anti-inflammatory drug-associated gastropathy: incidence and risk factor
models.
Fries JF, Williams CA, Bloch DA, Michel
BA.
Am J Med 1991 Sep;91(3):213-22.
The results of this study, performed on a cohort of 2,747 rheumatoid arthritis patients, show that users of nonsteroidal anti-inflammatory drugs have a 5.2-fold increased risk of hospitalization for gastrointestinal events, compared to nonusers.
Nonsteroidal
anti-inflammatory drug-related gastrointestinal toxicity: definitions and
epidemiology.
McCarthy D.
Am J Med, 105(5A):3S-9S 1998 Nov 2.
In this article, gastrointestinal (GI) bleeding and perforations are described as the two most frequent cause of death from nonsteroidal anti-inflammatory drug (NSAID)-related GI toxicity, the risk of these complications being highest during the first month of use. Other adverse effects such as heartburn, dyspepsia and pain occur frequently in users of this class of drugs, but their presence is unrelated with the insurgence of more severe GI complications, which, in the majority of cases, occur without warning signs.
Toxicity of
nonsteroidal anti-inflammatory drugs in the large intestine.
Davies NM.
Dis Colon Rectum, 38(12):1311-21 1995 Dec.
This review article explains that
nonsteroidal anti-inflammatory drug (NSAID)-related toxicity involves not
only the upper gastrointestinal tract, but also the large intestine, where
it can manifest as diarrhea, colonic blood loss and anemia, strictures,
ulcerations, perforations, worsening of inflammatory bowel disease and
ulcerative colitis, and death.
Damage to the intestinal lining seems to be mediated by the inhibition of
prostaglandin synthesis. It is important that clinicians and patients be
fully aware of the risk of these complications among users of NSAIDs.
Nonsteroidal
anti-inflammatory drug-associated toxicity of the liver, lower
gastrointestinal tract, and esophagus.
Bjorkman D.
Am J Med, 105(5A):17S-21S 1998 Nov 2.
This article describes some of the possible adverse reactions associated with use of nonsteroidal anti-inflammatory drugs, including colitis, ulcerations, strictures, worsening of inflammatory bowel disease and hepatotoxicity, the latter being especially associated with use of aspirin, diclofenac and sulindac.
Gastrointestinal tract complications of nonsteroidal anti-inflammatory drug
treatment in rheumatoid arthritis.
A prospective observational cohort
study.
Singh G; Ramey DR; Morfeld D; Shi H; Hatoum HT; Fries JF.
Arch Intern Med, 156(14):1530-6 1996 Jul 22.
The results of this study, conducted on a cohort of 1,921 individuals treated for rheumatoid arthritis with nonsteroidal anti-inflammatory drugs (NSAIDs) and followed-up for at least 2.5 years, show that approximately 15% of them developed adverse reactions involving the gastrointestinal (GI) tract such as abdominal pain and vomiting. In addition, during the study period, 42 individuals were hospitalized for severe GI complications such as ulcers and bleeding, the majority of them without previous warning signs. Of note, prophylactic use of antacids and H2 receptor antagonists instead of exerting a protective effect, was found to be associated with an over twofold increased risk of GI complications.
Evidence of
aspirin use in both upper and lower gastrointestinal perforation.
Lanas A; Serrano P; Bajador E; Esteva
F; Benito R; S´ainz R.
Gastroenterology, 112(3):683-9 1997 Mar.
In this study, 76 consecutive patients with gastrointestinal (GI) perforation and 152 matched controls were evaluated for nonsteroidal anti-inflammatory drug (NSAID) use. Seventy-one percent of patients and 27% of controls were using NSAIDs, especially over-the-counter aspirin, suggesting a strong association between NSAID intake and GI perforation.
Variability in
risk of gastrointestinal complications with individual non-steroidal
anti-inflammatory drugs: results of a collaborative meta-analysis.
Henry D., Lim LL., et al.
BMJ, 312(7046):1563-6 1996 Jun 22.
This study evaluated the risk of severe gastrointestinal (GI) complications associated with use of different non-steroidal anti-inflammatory drugs (NSAIDs). Ibuprofen was associated with the lowest risk of GI toxicity, mainly because it is commonly used at low doses in clinical practice, with the risk of GI complications rising to that of other NSAIDs when used at higher doses. With ibuprofen used as reference, all the other NSAIDs had relative risks of inducing GI toxicity greater than one, ranking from 1.6 to 9.2. Azapropazone, tolmetin, ketoprofen, and piroxicam were associated with the highest risk of GI complications. First line treatment with low doses of NSAIDs would result in a reduction of the incidence of severe complications and death.
Nonsteroidal
antiinflammatory drugs and gastrointestinal hospitalizations in
Saskatchewan: a cohort study.
Garc´ia Rodr´iguez LA; Walker AM;
P´erez Gutthann S.
Epidemiology, 3(4):337-42 1992 Jul.
This study shows that nonsteroidal antiinflammatory drug (NSAID) users have a fourfold increased risk of hospitalization for gastrointestinal complications compared to nonusers. The risk persists after discontinuation of NSAID use, with an over 2-fold increased risk found in recent past users and a 30% increased risk shown in less recent past users.
Nonsteroidal
anti-inflammatory drugs activate quiescent inflammatory bowel disease.
Kaufmann HJ, Taubin HL.
Ann Intern Med 1987 Oct;107(4):513-6.
This article reports on the case of 4 patients who experienced activation of quiescent inflammatory bowel disease (IBD) after ingestion of nonsteroidal anti-inflammatory drugs. Since both exacerbation of this condition and de-novo occurrence of colitis and ileitis have been previously reported, extreme caution is warranted before administering this class of drugs to patients with IBD.
Gastrointestinal tolerability of meloxicam compared to diclofenac in
osteoarthritis patients. International MELISSA Study Group.
Meloxicam Large-scale International
Study Safety Assessment.
Hawkey C, Kahan A, Steinbr¨uck K, Alegre C, Baumelou E, B´egaud B, et al.
Br J Rheumatol, 37(9):937-45 1998 Sep.
This study investigated the gastrointestinal tolerability of the non-steroidal anti-inflammatory drugs meloxicam and diclofenac on a cohort of 9323 osteoarthritis patients. During a trial period of 28 days, 4635 patients received meloxicam and 4688 received diclofenac. Thirteen percent of patients on meloxicam and 19% of those on diclofenac experienced gastrointestinal (GI) adverse events. Overall, 12 patients experienced serious GI complications such as: perforations, ulcers and bleeding events. Five percent of patients on meloxicam and 8% of those on diclofenac withdrew from the study because of adverse reactions, and 80 patients on meloxicam and 49 on diclofenac discontinued treatment for lack of efficacy.
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