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PubMed1993

Effect of ibuprofen on monocyte activation by liposome-encapsulated muramyl tripeptide phosphatidylethanolamine (CGP 19835A): can ibuprofen reduce fever and chills without compromising immune stimulation?

The purpose of this study was to determine the effects of ibuprofen on the ability of liposome-encapsulated muramyl tripeptide phosphatidylethanolamine (L-MTP-PE) to activate human blood monocytes in vitro. We undertook these experiments because the major toxic side-effects following L-MTP-PE infusion, fever and chills, could be prevented when ibuprofen was given orally immediately before L-MTP-PE infusion. It was therefore important to determine whether ibuprofen interfered with the macrophage-activation properties of L-MTP-PE. Peripheral blood monocytes were isolated from normal donors, then incubated with L-MTP-PE in the presence or absence of ibuprofen. The cytotoxic properties of the monocytes were assessed by a radioisotope-release assay against A375 cells. Ibuprofen at dose levels of 40 micrograms/ml suppressed the generation of the cytotoxic phenotype but did not interfere with the killing process once the cells were activated. Interleukin-1 (IL-1) and tumor necrosis factor alpha (TNF alpha) production, as well as the mRNA expression of these cytokines, was suppressed by 40 micrograms/ml ibuprofen. Since IL-1 and TNF play a crucial role in the cytotoxic function of monocytes, these findings may explain the mechanism by which ibuprofen inhibited the generation of the cytotoxic phenotype by L-MTP-PE. By contrast, ibuprofen dose levels up to 10 micrograms/ml had no effect on the generation of monocyte-mediated cytotoxicity by L-MTP-PE and no effect on the production, secretion, or mRNA expression of TNF and IL-1. Therefore, we concluded that if ibuprofen is to be used to control the side-effects of L-MTP-PE, blood levels of up to 10 micrograms/ml are desirable. In two of three patients, we determined that an oral dose of 200 mg given immediately before L-MTP-PE infusion could achieve these desired blood levels.

Acetylmuramyl-Alanyl-Isoglutamine↗
PubMed1991

Effect of racemic ibuprofen dose on the magnitude and duration of platelet cyclo-oxygenase inhibition: relationship between inhibition of thromboxane production and the plasma unbound concentration of S(+)-ibuprofen.

1. Four healthy male subjects received racemic ibuprofen (200, 400, 800 and 1200 mg), orally, on four occasions, 2 weeks apart, according to a four-way Latin-square design, in order to investigate the influence of increasing dose of ibuprofen on the magnitude and duration of its antiplatelet effect as well as on the relationship between such effect and drug concentration. 2. The antiplatelet effect of ibuprofen was assessed by measuring the inhibition of platelet thromboxane B2 (TXB2) generation during the controlled clotting of whole blood. The plasma unbound concentration of S(+)-ibuprofen, the enantiomer shown in an in vitro study to be responsible for the inhibitory effect of platelet TXB2 generation, was measured using an enantioselective method. 3. The maximum percentage inhibition of TXB2 generation increased significantly with dose from a mean +/- s.d. of 93.4 +/- 1.2% after the 200 mg dose to 98.8 +/- 0.3% after the 1200 mg dose, and there was an increase with dose in the duration of inhibition of TXB2 generation. The effect of ibuprofen on platelet TXB2 generation was transient and mirrored the time-course of unbound S(+)-ibuprofen in plasma; on all but one of the 16 occasions, serum TXB2 concentrations returned to at least within 10% of the pretreatment concentrations within 24 h of ibuprofen administration. 4. For each subject, the relationship between the percentage inhibition of TXB2 generation and the unbound concentration of S(+)-ibuprofen in plasma was modelled according to a sigmoidal Emax equation. The mean plasma unbound concentration of S(+)-ibuprofen required to inhibit platelet TXB2 generation by 50% (EC50) was 9.8 +/- 1.0 micrograms l-1.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed2000

Evaluation of the efficacy and dose-response relationship of dexibuprofen (S(+)-ibuprofen) in patients with osteoarthritis of the hip and comparison with racemic ibuprofen using the WOMAC osteoarthritis index.

OBJECTIVE: Treatment with non-steroidal anti-inflammatory drugs is the most common pharmacological therapy of rheumatic diseases. For the symptomatic treatment of painful disorders a dose-response relationship of the NSAID should be a basic requirement, which is difficult to be proven in studies because rheumatic diseases are heterogenous in terms of clinical involvement. The aim of this double-blind randomized trial was to compare the isolated active enantiomer dexibuprofen (S(+)-ibuprofen) with the double dose of racemic ibuprofen and to show a dose-response relationship of dexibuprofen in painful osteoarthritis of the hip. METHODS: 178 patients were randomly assigned to dexibuprofen 600/1,200 mg or racemic ibuprofen 2,400 mg daily. The primary endpoint was the improvement of the WOMAC osteoarthritis index after 15 days of therapy. The analysis was by intention to treat. RESULTS: The evaluation of the WOMAC OA index showed statistically significant equivalence of dexibuprofen 400 mg t.i.d. compared with racemic ibuprofen 800 mg t.i.d. by a Mann-Whitney statistic of 0.578 and the corresponding lower bound of the 95% confidence interval of 0.498. The test for superiority of dexibuprofen was borderline significant with p = 0.055. Dexibuprofen 400 mg t.i.d. and dexibuprofen 200 mg t.i.d. showed a statistically significant dose-response relationship in improving the WOMAC OA index (p = 0.023). Patients suffered from adverse drug reactions, mainly gastrointestinal disorders, 13.34% on dexibuprofen 200 mg, 15.25% on dexibuprofen 400 mg and 16.94% on racemic ibuprofen 800 mg. CONCLUSIONS: The active enantiomer dexibuprofen (S(+)-ibuprofen) proved to be an effective non-steroidal anti-inflammatory drug with a significant dose-response relationship in patients with painful osteoarthritis of the hip. Compared with racemic ibuprofen half of the daily dose of dexibuprofen shows at least equivalent efficacy. In contrast to pharmacokinetic data, the additional administration of R(-)-ibuprofen in form of racemate does not contribute to the clinical efficacy of racemic ibuprofen.

Anti-Inflammatory Agents, Non-Steroidal↗
PubMed1992

Ibuprofen plus codeine, ibuprofen, and placebo in a single- and multidose cross-over comparison for coxarthrosis pain.

The analgesic efficacy of 200 mg ibuprofen plus 30 mg codeine, 200 mg ibuprofen and placebo was investigated in a new analgesic evaluation model using single- and repeated-dose administration. The study was a double-blind randomized cross-over investigation in 26 coxarthrosis patients with persistent pain. After a washout period of at least 2 days with paracetamol available as rescue analgesic, each of the 3 treatments was administered in a total of 6 doses during 24 h. The hourly pain intensity was recorded on a 100-mm visual analogue scale (VAS) for 8 h after the 1st and the 6th dose. The pretreatment VAS score was 31-37 mm. After the 1st dose the 8-h mean pain intensity values were 25, 27, and 26 mm after ibuprofen plus codeine, ibuprofen, and placebo, respectively. Following another 5 doses every 4 h the corresponding values were 10, 17 and 29 mm. Repeated administration of both active drugs reduced the pain intensity significantly. The analgesic efficacy of ibuprofen plus codeine was significantly superior to that of ibuprofen which was, in turn, superior to that of placebo. In conclusion, analgesic efficacy was better differentiated after repeated-dose than after single-dose administration. The present study design was able to differentiate between 200 mg ibuprofen plus 30 mg codeine and 200 mg ibuprofen alone in a relatively small number of patients.

Adult↗
PubMed1996

Ibuprofen compared with ibuprofen plus caffeine after third molar surgery.

OBJECTIVES: To compare the relative merits of single doses of ibuprofen and ibuprofen plus caffeine in the treatment of pain after third molar removal. DESIGN: Randomised, double-blind, placebo-controlled, single-dose parallel-group comparison of placebo, ibuprofen 200 and 400 mg with ibuprofen 200 mg plus 50, 100 or 200 mg of caffeine. SUBJECTS: 161 patients undergoing lower third molar removal. RESULTS: All active treatments produced significant analgesia and mood elevation compared with placebo. There was no significant difference in the effects of 200 and 400 mg of ibuprofen. Adding caffeine to 200 mg ibuprofen produced significantly more analgesic effect at 45 and 60 min than ibuprofen 200 mg alone. Ten patients reported 11 adverse effects, none in the highest caffeine dose group. CONCLUSIONS: Caffeine increased the analgesic effect of ibuprofen 200 mg, through an earlier onset of analgesic effect. This was achieved in this single dose context without problematic adverse effects.

Adult↗
PubMed2004

Ibuprofen vs. acetaminophen vs. ibuprofen and acetaminophen after arthroscopically assisted anterior cruciate ligament reconstruction.

BACKGROUND AND OBJECTIVE: The analgesic potency of non-steroidal anti-inflammatory drugs and acetaminophen are still being debated. We have assessed the relative analgesic effect of ibuprofen, acetaminophen or the combination of both after orthopaedic surgery. METHODS: Sixty-one ASA I patients, scheduled for an elective anterior cruciate ligament reconstruction under general anaesthesia were randomized, in a double blind fashion, into one of three groups. The ibuprofen group (n = 17) received ibuprofen 800 mg orally 1 h before operation and again at 6 and 12 h after the initial dose. The acetaminophen group (n = 20) received of acetaminophen 1 g orally at the same time intervals. The combination group (n = 24) received both ibuprofen 800 mg and acetaminophen 1 g. Surgery was performed under general anaesthesia with propofol and fentanyl for induction and maintenance with propofol and nitrous oxide in oxygen. The patients were monitored for 24 h thereafter, and the following variables were assessed: pain by visual analogue and verbal scales, need for rescue intravenous opioid analgesia (i.e. ketobemidone) and adverse events. RESULTS: The ibuprofen group and the combination group experienced significantly less pain during the first 6 h after surgery than the acetaminophen group using the visual analogue and the verbal scales. The acetaminophen group also had a significantly higher average consumption of opioids during the first 6 and 24 h. There were no significant differences between the ibuprofen group and the combination group in respect of experienced pain or consumption of rescue analgesia. The incidence of side-effects, postoperative haemoglobin concentration and renal function, judged by creatinine clearance, were identical between the groups. CONCLUSION: Ibuprofen 800 mg thrice daily reduced pain to a greater degree than acetaminophen 1 g thrice daily, after anterior cruciate ligament reconstruction under general anaesthesia. The combination of acetaminophen and ibuprofen did not provide any superior analgesic effect.

Acetaminophen↗
PubMed1997

The effects of ibuprofen on the physiology and survival of patients with sepsis. The Ibuprofen in Sepsis Study Group.

BACKGROUND: In patients with sepsis the production of arachidonic acid metabolites by cyclooxygenase increases, but the pathophysiologic role of these prostaglandins is unclear. In animal models, inhibition of cyclooxygenase by treatment with ibuprofen before the onset of sepsis reduces physiologic abnormalities and improves survival. In pilot studies of patients with sepsis, treatment with ibuprofen led to improvements in gas exchange and airway mechanics. METHODS: From October 1989 to March 1995, we conducted a randomized, double-blind, placebo-controlled trial of intravenous ibuprofen (10 mg per kilogram of body weight [maximal dose, 800 mg], given every six hours for eight doses) in 455 patients who had sepsis, defined as fever, tachycardia, tachypnea, and acute failure of at least one organ system. RESULTS: In the ibuprofen group, but not the placebo group, there were significant declines in urinary levels of prostacyclin and thromboxane, temperature, heart rate, oxygen consumption, and lactic acidosis. With ibuprofen therapy there was no increased incidence of renal dysfunction, gastrointestinal bleeding, or other adverse events. However, treatment with ibuprofen did not reduce the incidence or duration of shock or the acute respiratory distress syndrome and did not significantly improve the rate of survival at 30 days (mortality, 37 percent with ibuprofen vs 40 percent with placebo). CONCLUSIONS: In patients with sepsis, treatment with ibuprofen reduces levels of prostacyclin and thromboxane and decreases fever, tachycardia, oxygen consumption, and lactic acidosis, but it does not prevent the development of shock or the acute respiratory distress syndrome and does not improve survival.

Acidosis, Lactic↗
PubMed2004

The efficacy of pain control following nonsurgical root canal treatment using ibuprofen or a combination of ibuprofen and acetaminophen in a randomized, double-blind, placebo-controlled study.

AIM: To compare ibuprofen, to an ibuprofen/acetaminophen combination in managing postoperative pain following root canal treatment. It is hypothesized that the drug combination will provide more postoperative pain relief than the placebo or ibuprofen alone. METHODOLOGY: Patients presenting at the Texas A&M Baylor College of Dentistry's graduate endodontic clinic, experiencing moderate to severe pain, were considered potential candidates. Fifty-seven patients were included based on established criteria. Following administration of local anaesthesia, a pulpectomy was performed. The patients were administered a single dose of either: (i) placebo; (ii) 600 mg ibuprofen; or (iii) 600 mg ibuprofen and 1000 mg of acetaminophen. Patients recorded pain intensity following treatment on a visual analogue scale and a baseline four-point category pain scale as well as pain relief every hour for the first 4 h then every 2 h thereafter for a total of 8 h. A general linear model (GLM) analysis was used to analyse the outcome. RESULTS: Based upon the GLM analysis, there was a significant difference between the ibuprofen and the combination drug group, and between placebo and combination drug groups. There was no significant difference between the placebo and the ibuprofen. CONCLUSION: The results demonstrate that the combination of ibuprofen with acetaminophen may be more effective than ibuprofen alone for the management of postoperative endodontic pain.

Acetaminophen↗
PubMed2004

The IPSO study: ibuprofen, paracetamol study in osteoarthritis. A randomised comparative clinical study comparing the efficacy and safety of ibuprofen and paracetamol analgesic treatment of osteoarthritis of the knee or hip.

OBJECTIVE: To compare the analgesic efficacy of single and multiple doses of ibuprofen with that of paracetamol in patients with knee or hip osteoarthritis (IPSO study). METHOD: 222 patients were randomised in a double blind, multicentre study-156 (70%) had a painful knee joint and 66 (30%) a painful hip joint. The main efficacy criterion was pain intensity assessment after a single dose (ibuprofen 400 mg, paracetamol 1000 mg). Functional disability assessment and patient global assessment were carried out over 14 days. RESULTS: The sum of the pain intensity difference over 6 hours after the first administration was significantly higher (p = 0.046) in the ibuprofen group than in the paracetamol group. Over 14 days pain intensity decreased from the first day and was significantly lower in the ibuprofen group than in the paracetamol group (p<0.05). The functional disability of the patient was assessed using the WOMAC; the ibuprofen group improved significantly over 2 weeks compared with the paracetamol group for each of the subscales: stiffness (p<0.002), pain (p<0.001), physical function (p<0.002). The drugs were equally safe. CONCLUSION: The IPSO study shows that for the treatment of osteoarthritic pain, ibuprofen 400 mg at a single and multiple dose (1200 mg/day) for 14 days is more effective than paracetamol, either as a single dose of 1000 mg or a multiple dose (3000 mg/day). Because ibuprofen and paracetamol have similar tolerability, this study indicates that the efficacy/tolerability ratio of ibuprofen is better than that of paracetamol in this indication over 14 days.

Acetaminophen↗
PubMed1996

Evaluation of different doses of soluble ibuprofen and ibuprofen tablets in postoperative dental pain.

The object of the study was to assess the comparative efficacy of three single doses (200, 400, 600 mg) of soluble ibuprofen and ibuprofen tablets after third molar surgery in 148 patients and aged 18-40 years. Outcome was measured by overall assessment of pain (AUC360) assessed from serial visual analogue scales, the number of patients taking additional analgesic and by overall assessment of medication evaluated on a five-point categorical scale. Over the 6-hour investigation period all the ibuprofen treatments with the exception of ibuprofen tablets 200 mg resulted in significantly less pain (p < 0.05) than placebo treatment. A large number of patients required additional analgesia during the investigation period, but the time to taking it was significantly earlier in the placebo group. No significant dose response (p > 0.05) was observed for either ibuprofen preparations assessed by the outcome variable of overall pain experience (AUC360) or time to additional analgesia. There was no significant difference in pain scores or time to taking additional analgesics between the respective doses of soluble and tablet formulations of ibuprofen. Both soluble and tablet formulations of ibuprofen provide effective pain control in the early postoperative period after removal of impacted third molars. There is little analgesic advantage in increasing the dose to 600 mg and only minimal benefit from using a soluble formulation of the drug.

Adult↗
PubMed1995

Prophylactic oral ibuprofen or ibuprofen-codeine versus placebo for postoperative pain after primary hip arthroplasty.

The postoperative analgesic effect of ibuprofen was compared with a combination of ibuprofen and codeine versus placebo. The study was prospective, randomized, double blind with 123 consecutive hip arthroplasty operations. All the patients received oral diazepam as premedication and spinal anaesthesia with bupivacaine 5 mg/ml 3-4 ml. Postoperatively, when the spinal anaesthesia started to wear off, the patients were randomly assigned to one of three groups; the ibuprofen group (n = 48) received 800 mg of ibuprofen orally. The ibuprofen/codeine group (IC, n = 48) received 800 mg of ibuprofen combined with 60 mg of codeine. The placebo group (P, n = 25), received oral placebo medication. The patients were observed for the need of additional opioid (e.g. ketobemidone), pain score (verbal and VAS), bleeding and side effects for five hours. The patients in the placebo group (P) had significantly higher pain scores (P < 0.05) compared with the two other groups after 2 and 4 hours, with no significant differences after 1, 3 and 5 hours. The P group also received 45% more opioids (P < 0.001) compared with the two other groups during the same period. No significant differences in bleeding or side-effects were observed between the groups. There were no significant differences between the ibuprofen group and the ibuprofen/codeine group. We conclude that a prophylactic dose of 800 mg ibuprofen orally has an opioid sparing effect with a tendency of less pain experience during the first hours after hip arthroplasty.

Administration, Oral↗
PubMed1989

[Concentrations of ibuprofen and the protein and pH value of synovial fluid and plasma following oral administration of ibuprofen in patients with arthritis].

Concentrations of Ibuprofen and Protein Concentration and pH-Value in Synovial Fluid and Plasma Following Oral Administration of Ibuprofen in Patients Suffering from Arthritis. In 16 patients suffering from arthritis of the knee the concentration of ibuprofen in the synovial fluid was examined in correlation with the synovial fluid volume, cell count, pH value and protein concentration. The mean ibuprofen concentration in plasma 4 h after oral administration of 400 mg ibuprofen amounted to 15.45 micrograms/ml, the concentration in the synovial fluid was 9.4 micrograms/ml. Due to the inflammatory nature of the effusions the protein concentration in the synovial fluid was evidently increased to an average of 4.46 g/dl and thus was about 65% of the mean plasma protein concentration of 6.88 g/dl. The ibuprofen in the synovial fluid showed a correlation to the protein concentration. On the other hand, there were no significant differences between the pH value in the plasma and in the synovial fluid. There was no tendency to an acid pH. Furthermore, there was no correlation between ibuprofen concentration and cell count. The tests showed that the "accumulation" of the nonsteroidal antiinflammatory drug in the synovial fluid is positively correlated with the high protein concentration but not with the pH value.

Administration, Oral↗
PubMed1987

Tissue levels of ibuprofen after fatal overdosage of ibuprofen and acetaminophen.

Ibuprofen is a non-steroidal anti-inflammatory agent which is relatively safe and effective for the treatment of inflammatory disorders, but there are several reports of acute poisoning due to ibuprofen overdosage. Although the majority of ibuprofen overdosages are not very serious, acute renal failure, hepatic failure, and hypotension and coma have been described. We report here the case of a 48-year-old male who committed suicide by ingesting overdosages of both ibuprofen and acetaminophen. The case is unique because of the role ibuprofen played in his death, and because we were able to measure levels of ibuprofen in tissues obtained from post mortem examination. Tissue levels of ibuprofen have not previously been reported in humans.

Acetaminophen↗
PubMed1993

A controlled study comparing the effects of nabumetone, ibuprofen, and ibuprofen plus misoprostol on the upper gastrointestinal tract mucosa.

BACKGROUND: This study was developed to compare the incidence of endoscopically diagnosed ulcers in elderly patients taking nabumetone, ibuprofen, or concomitant ibuprofen/misoprostol. Further research is indicated to better establish the clinical relevance of these endoscopy findings. METHODS: We conducted a prospective, multicenter, randomized, endoscopist-blinded, 12-week study involving 171 patients with osteoarthritis aged 60 years and older. Patients were randomized to receive nabumetone, 1000 mg (n = 58); ibuprofen, 600 mg four times daily (n = 53); or ibuprofen, 600 mg four times daily, administered concomitantly with misoprostol, 200 micrograms four times daily (n = 60). Endoscopy was performed at baseline and at weeks 2, 6, and 12. Endoscopy results were scored on a scale of 1 to 9. Significant ulcers were defined as breaks in the mucosa greater than 5 mm with appreciable depth. RESULTS: Of the 171 randomized patients, 148 completed the study. There was no significant difference in the incidence of significant ulcers between the nabumetone group and the ibuprofen/misoprostol group (one vs zero). There were significantly fewer significant ulcers in the nabumetone and ibuprofen/misoprostol groups than in the ibuprofen monotherapy group (one and zero vs eight; P < .01). There also was a significant difference in the time to ulcer development, with a greater risk of developing an ulcer sooner with ibuprofen treatment (P < .01) than either nabumetone or ibuprofen/misoprostol treatment. The severity of osteoarthritis, based on physicians' assessments, improved in 64% of patients in the nabumetone group, 55% of those in the ibuprofen group, and 63% of those in the ibuprofen/misoprostol group. CONCLUSIONS: Nabumetone is equivalent in ulcerogenicity to concomitant ibuprofen/misoprostol and is significantly less ulcerogenic than ibuprofen alone.

Aged↗
PubMed2003

Cognitive and motor function after administration of hydrocodone bitartrate plus ibuprofen, ibuprofen alone, or placebo in healthy subjects with exercise-induced muscle damage: a randomized, repeated-dose, placebo-controlled study.

RATIONALE: Medications combining hydrocodone bitartrate and non-steroidal anti-inflammatory agents appear more beneficial than anti-inflammatory medications alone in treating pain and inflammation from acute soft tissue trauma, but opiate side effects may include sedation and impaired cognitive and motor performance. OBJECTIVE: Performance on complex cognitive and motor tasks was evaluated in healthy subjects with exercise-induced muscle damage who were treated with a hydrocodone-ibuprofen combination, ibuprofen alone, or placebo. METHODS: This double-blind, randomized, placebo-controlled, repeated-dose clinical trial compared the effects of hydrocodone bitartrate (7.5 mg) plus ibuprofen (200 mg), ibuprofen alone, and placebo on cognitive and motor function in 72 healthy college men. Muscle damage in the quadriceps of each subject's dominant leg was induced by an eccentric exercise protocol. Subjects took the study medication four times daily (every 4-6 h) for 5 days. Forty minutes after medication ingestion at the same time each day, subjects underwent tests of attention/concentration, motor performance, and reaction time. Four trained assessors rotated among subjects so that none tested the same participant on more than three occasions. RESULTS: Repeated measures analyses of covariance revealed no between-group differences on a complex memory and cognition task or complex reaction time. Subjects using hydrocodone bitartrate plus ibuprofen performed significantly less well on a simple tracking task and made significantly more errors on a simple reaction-time task than the other two groups. These deficits were found to be highly transitory and not related to confusion or fatigue. CONCLUSION: Hydrocodone plus ibuprofen was not associated with deterioration in complex cognition but was related to very transitory decrements in tasks involving simple hand-eye coordination.

Adolescent↗
PubMed1986

Development of capillary gas chromatographic-mass spectrometric methodology for the simultaneous determination of ibuprofen and [ar-2H4]ibuprofen in serum: demonstration of kinetic equivalence in the beagle.

A capillary gas chromatographic-mass spectrometric method for the determination of ibuprofen and tetra-deuterated ibuprofen in serum is described. Ibuprofen, [ar-2H4]ibuprofen and the internal standard, [ar-2H4,3,3,3-2H3]ibuprofen, are extracted (after acidification) from serum onto a cross-linked styrene divinyl benzene resin by an automated sample processor. After elution and evaporation of the organic phase, samples are reconstituted with solvent and analyzed without derivatization by capillary gas chromatography-mass spectrometry. This methodology was used to evaluate possible kinetic isotope effects after the coadministration of an equimolar mixture of ibuprofen and the deuterium-labeled covariant in the beagle. No significant differences in absorption or elimination were observed.

Animals↗
PubMed1987

Ibuprofen interferes with the efficacy of antihypertensive drugs. A randomized, double-blind, placebo-controlled trial of ibuprofen compared with acetaminophen.

STUDY OBJECTIVE: To assess the effects of ibuprofen on blood pressure control in patients being treated with antihypertensive drugs. DESIGN: Randomized, blinded, placebo-controlled, parallel trial of ibuprofen compared with acetaminophen and with placebo in 3-week treatment periods. SETTING: A general internal medicine clinic at a university hospital. PATIENTS: Forty-five patients with essential hypertension controlled by treatment with at least two antihypertensive drugs were enrolled. Of these, 41 completed the study; treatment was discontinued in 3 of the 15 patients in the ibuprofen group due to breakage of the drug capsules, and after randomization in 1 of the 14 patients in the placebo group due to unstable angina. All 15 patients in the acetaminophen group completed the study. INTERVENTIONS: All previous antihypertensive regimens were continued. During the 3-week treatment, ibuprofen, 400 mg, was administered orally every 8 hours; acetaminophen, 1 g, orally every 8 hours; or placebo, 2 capsules, orally every 8 hours. MEASUREMENTS AND MAIN RESULTS: In the ibuprofen group, the mean increase from baseline after 3 weeks of treatment was significant in the average supine diastolic blood pressure (6.4 mm Hg; 95% confidence interval [CI], 1.05 to 11.75; p = 0.0239); supine mean arterial pressure (6.6 mm Hg; 95% CI, 1.25 to 11.95; p = 0.0205); and sitting mean arterial pressure (5.8 mm Hg; 95% CI, 1.57 to 10.04; p = 0.0123). The mean increase in blood pressure variables in the ibuprofen group was significantly different compared with the mean increase in the variables in the placebo group after 3 weeks of treatment: supine systolic blood pressure (7.1 mm Hg compared with -4.5 mm Hg; 95% CI for the difference in means, 2.5 to 20.6; p = 0.0133); supine diastolic pressure (6.4 mm Hg compared with 0.0; 95% CI for difference in means, 0.87 to 12.4; p = 0.0250); supine mean arterial pressure (6.6 mm Hg compared with -1.5; 95% CI for difference in means, 2.0 to 14.2; p = 0.0110); sitting systolic pressure (6.8 mm Hg compared with -3.7; 95% CI for difference in means, 2.0 to 19.0; p = 0.0169); sitting diastolic pressure (5.3 mm Hg compared with -1.1; 95% CI for difference in means, 0.76 to 12.1; p = 0.0273); and sitting mean arterial pressure (5.8 mm Hg compared with -2.0; 95% CI for difference in means, 1.5 to 14.1; p = 0.0169).(ABSTRACT TRUNCATED AT 400 WORDS)

Acetaminophen↗
PubMed1994

A study to compare ibuprofen effervescent granules with ibuprofen tablets in the treatment of acute dental pain.

PURPOSE OF STUDY: To compare both the speed of onset and efficacy of the analgesia produced by the effervescent granule formulation with that produced by the conventional-release tablet formulation of ibuprofen in patients suffering acute dental pain and to record the incidence and severity of any adverse events. POPULATION STUDIED: Dental out-patients of either sex and over 16 years of age requiring surgical removal of unilateral or bilateral lower third molar teeth under general anaesthesia as day cases. METHODS: A total of 50 patients received the effervescent granules formulation of ibuprofen 600 mg (Brufen Granules) as study treatment and 50 received the 600 mg tablet formulation in this investigator-blind, parallel-group multiple-dose study. Surgery was performed under general anaesthesia by one or two dental surgeons. Patients received either one sachet of ibuprofen granules or one tablet of ibuprofen at six-hourly intervals for up to 24 hours once post-operative pain became moderate to severe. FINDINGS: Both treatments were shown to be efficacious in treating post-operative dental pain. The granules were found to give significantly better pain relief in the first 30 minutes following the first dose. This may be owing to a more rapid absorption from the granules formulation in these patients and/or a local action of ibuprofen in solution in the mouth. CONCLUSION: The effervescent soluble form of ibuprofen (Brufen Granules) is preferable to the conventional tablet form in managing the immediate dental pain experienced post-operatively by most patients because of its faster onset of action.

Acute Disease↗