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12,240,783 |
A multicenter study of the tolerability of tirofiban versus placebo in patients undergoing planned intracoronary stent placement.
|
Juergens Craig P CP, White Harvey D HD, Belardi Jorge A JA, Macaya Carlos C, Soler-Soler Jordi J, Meyer Beat J BJ, Levy Richard D RD, Bunt Ton T, Menten Joris J, Herrmann Howard C HC, Adgey A A Jennifer AA, Tarnesby Georgia G
|
Clinical therapeutics . Vol. 24, No. 8, 2002 Aug
|
BACKGROUND: The use of intravenous glycoprotein IIb/IIIa-receptor antagonists has been shown to improve outcomes in patients undergoing percutaneous transluminal coronary angioplasty (PTCA). Tirofiban has shown benefit in a wide range of patients presenting with acute coronary syndromes. Although this agent has been used in patients undergoing percutaneous coronary intervention, a literature search identified no prospective data comparing tirofiban with placebo in patients undergoing planned intracoronary stent placement. OBJECTIVE: This study examined the tolerability of tirofiban in patients undergoing percutaneous intervention with planned intracoronary stent placement. METHODS: This was a multinational, multicenter, prospective, randomized, double-blind, placebo-controlled trial in patients scheduled to undergo PTCA with planned intracoronary stent placement. Patients were randomized in a 3:2 ratio to receive tirofiban as an intravenous bolus (10 microg/kg over 3 minutes) and maintenance infusion (0.10 microg/kg per minute for 36 hours) or a bolus and infusion of placebo. All patients received periprocedural aspirin and heparin and an optional postprocedural thienopyridine (ticlopidine or clopidogrel). Laboratory and safety monitoring were performed throughout the 36 hours after the procedure and at hour 40 or hospital discharge. The primary end point was the proportion of patients with bleeding, defined according to Thrombolysis in Myocardial Infarction (TIMI) trial criteria. The number of patients with cardiac events (death, myo- cardial infarction, urgent revascularization) during the first 30 days after stent placement was also assessed. RESULTS: Eight hundred ninety-four patients (536 tirofiban, 358 placebo) were enrolled, all of whom received aspirin and heparin periprocedurally and optional ticlopidine or clopidogrel after the procedure. No significant between-group differences were observed in the incidence of TIMI major bleeding (0.2% tirofiban, 0.6% placebo) or any TIMI bleeding (3.2% and 1.7%, respectively). The incidence of TIMI minor bleeding was higher with tirofiban than with placebo (2.8% vs 0.6%). The 30-day incidence of the composite end point of any cardiac event was 3.9% in both groups. CONCLUSIONS: On a background of concomitant aspirin, heparin, and a thienopyridine, tirofiban was generally well tolerated in patients undergoing PTCA with planned intracoronary stent placement. Further investigation is needed to ascertain the optimal dosing of tirofiban and heparin to achieve reductions in ischemic complications of intracoronary stenting with an acceptable incidence of bleeding complications.
|
https://pubmed.ncbi.nlm.nih.gov/12240783/
|
[
"Clinical Trial",
"Journal Article",
"Multicenter Study",
"Randomized Controlled Trial"
] |
12240783
|
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12,240,780 |
A multicenter, open-label, randomized comparison of levofloxacin and azithromycin plus ceftriaxone in hospitalized adults with moderate to severe community-acquired pneumonia.
|
Frank Elliott E, Liu Jing J, Kinasewitz Gary G, Moran Gregory J GJ, Oross Margaret P MP, Olson William H WH, Reichl Veronica V, Freitag Susan S, Bahal Neelam N, Wiesinger Barbara A BA, Tennenberg Alan A, Kahn James B JB
|
Clinical therapeutics . Vol. 24, No. 8, 2002 Aug
|
BACKGROUND: Changing etiologic patterns and the growing problem of antimicrobial resistance, particularly an increase in macrolide-resistant pneumococcal bacteremia, are causing physicians to adopt new approaches to the treatment of community-acquired pneumonia (CAP). OBJECTIVE: The relative efficacy and tolerability of levofloxacin monotherapy and azithromycin and ceftriaxone combination therapy were assessed in hospitalized adults with moderate to severe CAP. METHODS: This Phase IV, multicenter, open-label, randomized trial compared 2 treatment regimens: (1) levofloxacin 500 mg PO or IV q24h, and (2) azithromycin 500 mg IV q24h for > or = 2 days plus ceftriaxone 1 g IV q24h for 2 days, followed by an optional transition to azithromycin 500 mg PO q24h at the investigator's discretion. The total duration of therapy was to be a minimum of 10 days in both treatment groups. Ceftriaxone was included in the initial azithromycin regimen to ensure coverage against pneumococcal bacteremia. RESULTS: Of 236 patients in the intent-to-treat population, completion or withdrawal information was available for 110 patients in the levofloxacin group and 114 in the azithromycin group. Baseline demographic and disease characteristics were comparable between groups. At the end of treatment, the clinical success rate (cured + improved) in clinically evaluable patients was 94.1% in the levofloxacin group and 92.3% in the azithromycin group. The respective posttherapy microbiologic eradication rates were 89.5% and 92.3%. Levofloxacin was as well tolerated as azithromycin, with an incidence of drug-related adverse events (AEs) for all body systems of 5.3% and 9.3%, respectively. None of the drug-related AEs were considered serious [corrected]. CONCLUSIONS: In this study in hospitalized patients with moderate to severe CAP, levofloxacin monotherapy was at least as effective as a combination regimen of azithromycin and ceftriaxone in providing coverage against the current causative pathogens in CAP. In addition, levofloxacin was as well tolerated as the combination of azithromycin and ceftriaxone.
|
https://pubmed.ncbi.nlm.nih.gov/12240780/
|
[
"Clinical Trial",
"Comparative Study",
"Journal Article",
"Multicenter Study",
"Randomized Controlled Trial"
] |
12240780
|
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] |
12,240,782 |
Bioavailability of lansoprazole granules administered in juice or soft food compared with the intact capsule formulation.
|
Chun Alexander H C AH, Erdman Keith K, Chiu Yi-Lin YL, Pilmer Betsy L BL, Achari Ramanuj R, Cavanaugh John H JH
|
Clinical therapeutics . Vol. 24, No. 8, 2002 Aug
|
BACKGROUND: The ability to administer the contents of an encapsulated-dose formulation in liquids or soft foods without compromising drug bioavailability is highly desirable for patients who are unable to swallow or have difficulty swallowing. OBJECTIVE: The purpose of this study was to compare the bioavailability of lansoprazole granules administered in 2 types of juice and a soft food with that of the intact capsule administered with water. METHODS: Healthy adult volunteers were eligible for this single-center, Phase I, single-dose, randomized, open-label, 4-period crossover study. Subjects received the enteric-coated granular contents of a 30-mg lansoprazole capsule in 3 test regimens (in 180 mL of orange juice, 180 mL of tomato juice, or 1 tablespoon of strained pears, each followed by 180 mL of water) and 1 reference regimen (the 30-mg intact capsule with 180 mL of water). The regimens were rotated at > or = 6-day intervals so that each subject received all 4 regimens. Blood samples for pharmacokinetic analyses were obtained during the 12 hours after each regimen. RESULTS: Twenty healthy adult volunteers (10 men, 10 women; mean age, 36 years [range, 19-53 years]) completed this study. Bioavailability of the 3 test regimens was assessed using the two 1-sided tests procedure for mean maximum plasma concentration and area under the plasma concentration-time curve (AUC) from time 0 through the last measurable concentration and AUC from time 0 to infinity. These results were compared with that of the intact capsule. This comparison indicated that the 90% CIs for all 3 test regimens were within the acceptable bioequivalence range of 0.80 to 1.25. Lansoprazole was well tolerated, with most of the adverse events being mild. Headache was the most frequently reported adverse event. CONCLUSION: The results of this study indicate that the bioavailability of lansoprazole granules, when administered in orange juice, tomato juice, or a small amount of strained pears, was similar to that of the intact capsule in these healthy adult volunteers.
|
https://pubmed.ncbi.nlm.nih.gov/12240782/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial",
"Research Support, Non-U.S. Gov't"
] |
12240782
|
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12,240,793 |
Patients have treatment preferences: a multicentre, double-blind, crossover study comparing rabeprazole and omeprazole.
|
Johnson Martin M, Guilford Sandra S, Libretto Susan E SE,
|
Current medical research and opinion . Vol. 18, No. 5, 2002
|
It is increasingly common practice to change patients from one medication in a drug class to another, often as part of a general formulary change. The underlying assumption and accepted wisdom is that all compounds within a class are identical. To our knowledge, there has been no published investigation into the patients' views on such changes or on the individual medications. These views may be affected by positive side-effects, not normally sought in clinical trials, as well as negative side-effects, which are always reported. The objectives of this study were to determine whether patients whose primary symptoms were already controlled by a proton pump inhibitor (PPI) could distinguish between rabeprazole and omeprazole; to determine the incidence of positive, as well as negative, side-effects; to elicit patients' opinions on changing medication within a class, and on the importance of certain characteristics of medication. The design was a double-blind, double-dummy, randomised, crossover trial, set in five general practice research centres in the UK and Ireland. 240 eligible patients were randomised to receive daily treatment, first for 4 weeks with omeprazole 20 mg/day, and then for reverse order. Each phase of 4 weeks was separately assessed by patients through questionnaires and by non-directed questioning about positive and negative side-effects. At the end of the 8 weeks, patients compared the two medications in seven treatment characteristics. Patients were further asked their attitude to changing medication within a class. Data were collected by a web-based electronic data capture system. Results showed that the majority of patients could be switched to another PPI therapy, predictably without noticeable difference in maintenance of primary symptom control. About one-quarter to one-half of patients were able to express a preference for one or other of the treatments dependent on the variable assessed. For 'absence of unwanted side-effects' and 'presence of positive side-effects' a statistically significant difference in favour of rabeprazole was detected (p = 0.0467 and p = 0.0188, respectively). In terms of the total treatment preference score, the primary outcome variable, there was no statistically significant difference between the two PPIs (p = 0.0754). This finding is mainly attributable to the two PPIs providing similar relief of primary mask the findings for the other variables assessed. However, there were numerically more patients (10 vs. 3) who reported 'marked' positive side-effects on rabeprazole. On direct questioning, patients indicated that tablets (rabeprazole) were more easily swallowed than capsules (omeprazole) (p < 0.0001), but less easily handled than capsules (p = 0.0003). These analyses may however have been confounded by the fact that the omeprazole medication had to be over-encapsulated to allow blinding for this double-dummy, blinded study. There was no difference in tolerability between rabeprazole and omeprazole, with 52.6% and 51% of patients reporting at least one adverse event, respectively. Of the patients controlled and maintained on omeprazole before the study, 33.9% reported adverse events on omeprazole during the study and seven discontinued the study for that reason. Patients thought the most important drug characteristics for treating this condition were rapid and lasting control of pain. Most (83.6%) would be willing to try an alternative medication within a drug class. In conclusion, most patients already controlled by a PPI would be willing to try another. An individual patient may have a strong preference for one PPI over another, and this difference may be important if treatment is to be long term.
|
https://pubmed.ncbi.nlm.nih.gov/12240793/
|
[
"Clinical Trial",
"Comparative Study",
"Journal Article",
"Multicenter Study",
"Randomized Controlled Trial",
"Research Support, Non-U.S. Gov't"
] |
12240793
|
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] |
12,240,794 |
Effect of food on early drug exposure from extended-release stimulants: results from the Concerta, Adderall XR Food Evaluation (CAFE) Study.
|
Auiler J F JF, Liu K K, Lynch J M JM, Gelotte C K CK
|
Current medical research and opinion . Vol. 18, No. 5, 2002
|
Stimulant therapy is the mainstay of treatment for children, adolescents and adults with attention-deficit/hyperactivity disorder (ADHD). Once-daily, extended-release oral formulations offer long acting control of symptoms by modifying drug delivery and absorption. In particular, consistency in early drug exposure is important for symptom control during school or work hours. Because these once-daily formulations are usually taken in the morning, the timing of the doses with breakfast is important. This study compared the effect of a high-fat breakfast on early drug exposure from a morning dose of two extended-release stimulant formulations: the osmotic-controlled OROS tablet of methylphenidate HCI (CONCERTA) and the capsule containing extended-release beads of mixed amphetamine salts (ADDERALL XR). The study had a single-dose, open-label, randomised, four-treatment, crossover design in which healthy subjects received either 36 mg CONCERTA or 20 mg ADDERALL XR in the morning after an overnight fast or a high-fat breakfast. Serial blood samples were collected over 28h to determine plasma concentrations of methylphenidate and amphetamine. The food effect on early drug exposure and the pharmacokinetic profiles up to 8 h after dosing of the two extended-release stimulants were directly compared using partial area (AUC(p4h), AUC(p6h) and AUC(p8h)) fed/fasted ratios. Amphetamine concentrations were markedly lower when the subjects had eaten breakfast, resulting in lower early drug exposures (p < 0.0001). By contrast, methylphenidate concentrations over the same 8 h were unaffected by breakfast, providing consistent levels of early drug exposure. Therefore, as a child's or adult's eating pattern varies, methylphenidate exposure over the first 8 h would be expected to have less day-to-day variation compared with amphetamine exposure. The osmotic-controlled OROS tablet provides a reliable and consistent delivery of methylphenidate HCI, independent of food, for patients with ADHD.
|
https://pubmed.ncbi.nlm.nih.gov/12240794/
|
[
"Clinical Trial",
"Journal Article",
"Randomized Controlled Trial"
] |
12240794
|
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12,240,812 |
Fetal health surveillance: a community-wide approach versus a tailored intervention for the implementation of clinical practice guidelines.
|
Davies Barbara B, Hodnett Ellen E, Hannah Mary M, O'Brien-Pallas Linda L, Pringle Dorothy D, Wells George G,
|
CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne . Vol. 167, No. 5, 2002 Sep 03
|
BACKGROUND: The decreased use of electronic fetal monitoring (EFM) for healthy women in labour and the increased provision of professional support to all women in labour is recommended by experts. We evaluated the effectiveness of a community-wide approach to transferring research results to practice using a regional committee, newsletter articles and annual conference presentations compared with an additional tailored hospital intervention involving workshops to enhance self-efficacy for nurses, policy review, multidisciplinary meetings, rounds and unit discussions. METHODS: We compared the proportion of women at low risk who received EFM and the proportion of nurses' time spent providing labour support before and after the intervention within each of 4 hospitals (2 tertiary and 2 secondary). One hospital of either type was randomly selected to receive the tailored intervention. Randomly selected charts (n = 200) were reviewed for the use of EFM at each hospital before (1995) and after (1996) the intervention. Trained observers at randomly selected times recorded the nurses' activities, including time spent providing labour support before and after the intervention. RESULTS: At the intervention secondary hospital, there was a large decrease in the use of EFM, from 90.1% before to 41.0% after the intervention (p < 0.001), but no change in nurses' time spent providing labour support. At the intervention tertiary hospital there was no change in EFM rates, but there was a small, statistically significant increase in time spent providing labour support (23.5% to 29.8%, p < 0.001). A negative effect on time spent providing labour support was found at the control secondary hospital (decrease from 19.6% to 12.8%, p < 0.001), with no change in the EFM rate. At the control tertiary hospital there was a small decrease in the use of EFM, from 99.5% to 91.4% (p < 0.001), but no change in time spent providing labour support. INTERPRETATION: The results are mixed, and the tailored intervention thus appeared to have limited effects. No association was found between the reduction in the use of EFM and an increase in nurses' time spent providing labour support.
|
https://pubmed.ncbi.nlm.nih.gov/12240812/
|
[
"Clinical Trial",
"Journal Article",
"Multicenter Study",
"Randomized Controlled Trial",
"Research Support, Non-U.S. Gov't"
] |
12240812
|
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12,240,890 |
Diet medications and valvular heart disease: the current evidence.
|
Barasch Andrei A, Safford Monika M MM
|
Special care in dentistry : official publication of the American Association of Hospital Dentists, the Academy of Dentistry for the Handicapped, and the American Society for Geriatric Dentistry . Vol. 22, No. 3
|
Since 1997, the appetite suppressant drugs fenfluramine-phentermine (fen-phen) and dexfenfluramine have been associated with the development of valvular heart disease. As a result, the drugs have been withdrawn from the market and interim recommendations for evaluation and treatment of exposed patients were issued. However, subsequent studies showed lower prevalence rates for valve abnormalities than were initially reported, and the possibility of such drug-induced lesions resolving has been raised. This article reviews relevant evidence and discusses concerns for the dental practitioner.
|
https://pubmed.ncbi.nlm.nih.gov/12240890/
|
[
"Journal Article",
"Meta-Analysis"
] |
12240890
|
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] |
12,240,905 |
Leptin levels in patients with type 1 diabetes receiving intensive insulin therapy compared with those in patients receiving conventional insulin therapy.
|
Azar S T ST, Zalloua P A PA, Zantout M S MS, Shahine C H CH, Salti I I
|
Journal of endocrinological investigation . Vol. 25, No. 8, 2002 Sep
|
Several reports suggest that insulin may have a role in the regulation of serum leptin levels, and this is related to the fact that serum leptin levels generally indicate the amount of body fat. Studies show that leptin levels are low in newly diagnosed patients with Type-1 diabetes (T1 DM) and increase after institution of insulin therapy. This study was designed to test whether serum leptin levels are higher in patients receiving intensive insulin therapy (IIT) compared to conventional insulin therapy (CIT). Young patients with T1 DM were studied, 23 on IIT and 23 on CIT. The patients were matched for age (19+/-3 and 20+/-5 yr, respectively), duration of diabetes (8+/-5 and 10+/-6 yr, respectively) and BMI (24+/-4 and 23+/-3 kg/m2, respectively). Leptin levels were higher in IIT compared to CIT (13+/-12 vs 7+/-7 ng/ml, respectively, p<0.05). The results of this study demonstrate that patients on IIT have higher leptin levels than patients on CIT. This increase in leptin level in IIT patients is independent of changes in bw and is probably due to the stimulatory effect of insulin on leptin production.
|
https://pubmed.ncbi.nlm.nih.gov/12240905/
|
[
"Clinical Trial",
"Controlled Clinical Trial",
"Journal Article"
] |
12240905
|
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