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Improvement in aspirin-sensitive asthmatic subjects after rapid aspirin desensitization and aspirin maintenance (ADAM) treatment.

Twelve ASA-sensitive (AS) asthmatics, including nine over age 35 years and three under age 19, were successfully desensitized to the adverse effects of ASA in an average of 322 min without any serious untoward sequelae. Six subjects (50%) experienced subjective improvement, three (25%) no change, and three (25%) worsening in their asthma while on a daily maintenance dose of ASA (mean = 539 mg) for an average follow-up period of 115 days. Six subjects (50%) were able to discontinue one or more antiasthma medications, including systemic steroid in one (8%) and aerosol steroid in three (25%). The incidence of subjective improvement in asthma status (67% vs. 44%) was higher in those under 19 than in those over 35, and none of the younger vs. 30% of the older subgroup experienced worsening in their asthma. ASA desensitization (AD) followed by an ASA maintenance program (ADAM) therefore appeared to be beneficial in approximately 50% of AS asthmatics. In this study an improvement in postdesensitization peak expiratory flow rate with a repeat ASA challenge appeared to correlate best with subjective improvement in asthma and/or reduction in antiasthma medication requirement after AD. However, the number of subjects studied was relatively small and the conclusions drawn will require confirmation.

Adolescent↗

Internal analgesic, antipyretic, and antirheumatic drug products for over-the-counter human use; final rule for professional labeling of aspirin, buffered aspirin, and aspirin in combination with antacid drug products; technical amendments. Department of Health and Human Services (HHS), Public Health Service (PHS), Food and Drug Administration (FDA). Final rule; technical amendments.

The Food and Drug Administration (FDA) is amending the regulations for internal analgesic, antipyretic, and antirheumatic drug products for over-the-counter (OTC) use to correct inadvertent errors and to clarify the labeling for over-the-counter drug products written for health professionals.

Animals↗

High Pressure Coronary Stenting: Efficacy and Safety of Aspirin Versus Coumadin Plus Aspirin Ñ Preliminary Results of a Randomized Study.

The efficacy and safety of treatment after coronary stenting was examined with aspirin alone, 100 mg daily, as compared to coumadin plus aspirin. Data from the first 101 patients, 73 men and 28 women, aged 59.2 +/- 9.3 years, of a prospective randomized study are presented in this preliminary report. Forty-eight patients suffered from one-vessel disease, 32 had two- and 21 three-vessel disease. Indications for stenting were stable angina in 65 patients, unstable angina in 16, threatening myocardial infarction in 4 and restenosis in 16 patients. The stents were implanted by high pressure balloon inflation (14.5 +/- 2.2 atm), 55 of them were Palmaz-Schatz, 31 Micro, 10 Gianturco-Roubin, 2 Wiktor and 3 combined stents. Intravascular ultrasonographic guidance was not performed. The primary end point was defined as the absence of the following events: death, subacute coronary artery closure, acute myocardial infarction, emergency coronary bypass surgery, repeated PTCA, major bleeding or arterio-venous aneurysms needing transfusion or surgery. Eighty out of 101 patients (79.2%), 41 out of 47 (87.2%) in the aspirin group and 39 out of 54 (72.2%) in the coumadin plus aspirin group (p = 0.06) were free of events during hospitalization (9.5 +/- 5.7 days, median: 8 days). Forty-five out of 47 patients (95.7%) in the aspirin and 51 out of 54 (94.4%) in the coumadin plus aspirin group (p = 0.8) were without subacute closure. One death occurred in the aspirin group due to stent abscess two weeks after an angiographically successful stent recanalization. All 7 arterio-venous aneurysms with surgical interventions occurred in the coumadin group (p = 0.01). No emergency bypass surgery had to be performed. If these preliminary results will be confirmed by the final analysis, the combination of coumadin with aspirin does not show more efficacy or safety as compared with aspirin alone in the treatment after high-pressure coronary stenting during the hospital stay.

Journal Article↗

Persistence of gastric ulcers caused by plain aspirin or nonsteroidal antiinflammatory agents in patients treated with a combination of cimetidine, antacids, and enteric-coated aspirin.

Twenty-three patients chronically ingesting plain aspirin or nonsteroidal antiinflammatory drugs, who had endoscopically proven solitary or multiple gastric ulcers, were treated for eight weeks with cimetidine and antacids. Plain aspirin and nonsteroidal antiinflammatory drugs were discontinued in all patients. Seven patients received enteric-coated aspirin throughout the treatment phase and continuously for the entire study period (2.5-12 months). The remainder of patients (N = 16) did not receive enteric-coated aspirin. An endoscopy was performed to assess ulcer healing. None of seven patients receiving enteric-coated aspirin had complete healing of their ulcer(s) while 15 of 16 patients not receiving enteric-coated aspirin demonstrated complete healing of their ulcer(s) (P less than 0.001). An eight-week course of cimetidine and antacids is ineffective in completely healing gastric ulcers caused by plain aspirin or nonsteroidal antiinflammatory drugs while enteric-coated aspirin is continued.

Antacids↗

Effects of copper aspirinate and aspirin on tissue copper, zinc, and iron concentrations following chronic oral treatment in the adjuvant arthritic rat.

Concentrations of copper, zinc, and iron were analyzed and compared in a number of tissues of adjuvant arthritic rats following 22 d of chronic treatment (per os) with either vehicle, aspirin or copper aspirinate, at doses of 100 mg/kg, 200 mg/kg, or 400 mg/kg. Such chronic treatment resulted in a negative balance in copper, zinc, and iron in many tissues. Among the tissues examined, liver and kidney exhibited the greatest changes in metal concentrations; brain and skeletal muscle exhibited the least. Arthritis-induced changes in the concentrations of all three metals in the liver were reversed upon treatment with aspirin. Treatment with copper aspirinate, on the other hand, resulted in an extremely high accumulation of copper in the liver. Arthritis-induced changes in copper, zinc, and iron concentrations in the pancreas and copper concentration in the plasma were generally not reversed upon treatment with either aspirin or copper aspirinate. Among the three metals examined, the degree of change observed as a result of drug treatments was greatest for iron and least for zinc. Finally, it appeared that the effects of aspirin and copper aspirinate on tissue metal concentrations were independent of the antiarthritic effects of these compounds.

Administration, Oral↗

A randomized comparison of clopidogrel and aspirin versus ticlopidine and aspirin after coronary stent implantation.

BACKGROUND: The combination of a thienopyridine and aspirin has become the standard of care after intracoronary stenting. Clopidogrel appears to be better tolerated than ticlopidine but may be associated with more adverse cardiac events. We assessed the tolerability and efficacy of 2 weeks of therapy with ticlopidine and aspirin in comparison to clopidogrel and aspirin after coronary stent implantation. METHODS: Patients with successful intracoronary stent implantation at our institution were randomly assigned, in addition to aspirin, to receive either ticlopidine or clopidogrel. Loading doses were administered immediately after the procedure, and the drugs were continued for 2 weeks. RESULTS: Three hundred seven patients were randomly assigned: 154 patients to clopidogrel and 153 to the ticlopidine group. The primary end point of early drug discontinuation occurred in 5 patients (3.3%) in the ticlopidine group and 1 patient (0.6%) in the clopidogrel group (P =.121). Within 30 days, thrombotic stent occlusion occurred in 1 patient (0.7%) in the ticlopidine group and 3 patients (1.9%) in the clopidogrel group (P =.623). A major adverse cardiac event occurred in 3 patients (approximately 1.9%; P = 1.00) in each group. CONCLUSIONS: There was a nonsignificant trend to improved tolerability of a 2-week regimen of clopidogrel and aspirin when compared with ticlopidine and aspirin in patients undergoing intracoronary stent implantation. The combination of clopidogrel and aspirin results in a comparably low incidence of major adverse cardiac events when compared with ticlopidine and aspirin.

Angioplasty, Balloon, Coronary↗

Short-term prevention of thromboembolic complications in patients with atrial fibrillation with aspirin plus clopidogrel: the Clopidogrel-Aspirin Atrial Fibrillation (CLAAF) pilot study.

BACKGROUND: We evaluated the short-term safety and efficacy of aspirin-plus-clopidogrel as antithrombotic therapy in nonvalvular atrial fibrillation (AF). METHODS AND RESULTS: Thirty patients (11 women, 45 to 75 years of age) with non-high-risk permanent (n = 12) or persistent AF awaiting cardioversion (n = 18) underwent transesophageal echocardiography to exclude left heart thrombi and were then randomly assigned to receive warfarin (international normalized ratio, 2 to 3 for 3 weeks) or aspirin (100 mg/d alone for 1 week)-plus-clopidogrel (75 mg/d added to aspirin for 3 weeks). Bleeding time and serum thromboxane B2 were measured at entry and at 3 weeks. Bleeding time, not affected by warfarin, was prolonged by 71% by aspirin (P <.05) and further, by 144%, by adding clopidogrel (P <.01 vs aspirin alone; +319%, P <.01, vs baseline). Thromboxane B2, not affected by warfarin, was reduced by aspirin (-98%, P <.01) but not further by clopidogrel. No thrombi or dense spontaneous echo-contrast were found at the 3-week transesophageal echocardiography. Seven of 9 patients receiving warfarin and 7 of 9 patients receiving aspirin-plus-clopidogrel, undergoing electrical cardioversion, achieved sinus rhythm. No thromboembolic or hemorrhagic events occurred in both arms throughout the 3-week treatment and a further 3-month follow-up. CONCLUSIONS: Aspirin-plus-clopidogrel and warfarin were equally safe and effective in preventing thromboembolism in this small group of patients with non-high-risk AF.

Aged↗

Tacrolimus reduces urinary excretion of leukotriene E(4) and inhibits aspirin-induced asthma to threshold dose of aspirin.

BACKGROUND: The exact mechanism of aspirin-induced asthma is not clear. It has been postulated that precipitation of asthma attacks by aspirin is linked to inhibition of COX activity and massive release of cysteinyl leukotriene into the airway. Tacrolimus, a macrolide-derived immunosuppressant, is used for immunosuppression in organ transplantation and also for allergic diseases such as atopic dermatitis. OBJECTIVE: We evaluated the effects of tacrolimus in aspirin-induced asthma by using a double-blind, crossover study design. METHODS: Twelve patients with aspirin-induced asthma (male:female, 3:9; mean age +/- SD, 36.7 +/- 7.2 years) received either tacrolimus (0.1 mg/kg) or placebo 2 hours before the threshold dose of oral aspirin. RESULTS: In the placebo arm, oral aspirin significantly decreased FEV 1 concomitant with significant increases in sputum eosinophilic cationic protein and urinary leukotriene E(4) levels. Tacrolimus significantly inhibited bronchoconstriction and abrogated aspirin-induced increase in both sputum eosinophilic cationic protein and urinary leukotriene E(4) levels. CONCLUSION: The current study suggested that tacrolimus inhibited bronchoconstriction to a threshold dose of aspirin by inhibition of cysteinyl leukotriene excretion.

ATP Binding Cassette Transporter, Subfamily B↗

Antiphospholipid antibody-associated recurrent pregnancy loss: treatment with heparin and low-dose aspirin is superior to low-dose aspirin alone.

OBJECTIVE: The purpose of this study was to compare the use of low-dose aspirin alone with heparin and low-dose aspirin in the treatment of the antiphospholipid antibody syndrome. STUDY DESIGN: A prospective, single-center trial included 50 patients who were alternately assigned to treatment. Each patient had at least three consecutive spontaneous pregnancy losses, positive antiphospholipid antibodies on two occasions, and a complete evaluation. Data were compared by chi(2) analysis and Fisher's exact test. RESULTS: Viable infants were delivered of 11 of 25 (44%) women treated with aspirin and 20 of 25 (80%) women treated with heparin and aspirin (p < 0.05). There were no significant differences between the low-dose aspirin and the heparin plus low-dose aspirin groups with respect to gestational age at delivery (37.8 +/- 2.1 vs 37.2 +/- 3.4 weeks), number of cesarean sections (18% vs 20%), or complications. CONCLUSION: Heparin plus low-dose aspirin provides a significantly better pregnancy outcome than low-dose aspirin alone does for antiphospholipid antibody-associated recurrent pregnancy loss.

Abortion, Habitual↗