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PubMed1990

HIV-1 infection: no evidence of cognitive decline during the asymptomatic stages. The Multicenter AIDS Cohort Study.

Cross-sectional studies have not adequately resolved the question of whether subjects infected with HIV-1 may suffer cognitive decline during the early, asymptomatic stages of the infection. We studied longitudinally 238 asymptomatic healthy HIV-1-infected homosexual/bisexual men (CDC groups 2 and 3) and 170 uninfected controls in the Multicenter AIDS Cohort Study with neuropsychological testing at semiannual intervals. A comparison of change in scores between visits 1 and 4 as well as a multivariate autoregressive analysis revealed no evidence of decline in test performance over time in the HIV-1-infected group compared with the seronegative controls. These findings suggest that a gradual cognitive decline does not occur during the early, asymptomatic stages of HIV infection.

Adult↗
PubMed2001

HIV-associated neurologic disease incidence changes:: Multicenter AIDS Cohort Study, 1990-1998.

This study examined the temporal trends in the incidence rates of HIV dementia, cryptococcal meningitis, toxoplasmosis, progressive multifocal leukoencephalopathy, and CNS lymphoma from January 1990 to December 1998 in the Multicenter AIDS Cohort Study. The incidence rates for HIV dementia, cryptococcal meningitis, and lymphoma decreased following the introduction of highly active antiretroviral therapy (HAART). The proportion of new cases of HIV dementia with a CD4 count in a higher range (i.e., 201 to 350) since 1996 may be increasing.

AIDS Dementia Complex↗
PubMed2004

Comparison of nifedipine retard with angiotensin converting enzyme inhibitors in Japanese hypertensive patients with coronary artery disease: the Japan Multicenter Investigation for Cardiovascular Diseases-B (JMIC-B) randomized trial.

The Japan Multicenter Investigation for Cardiovascular Diseases-B was performed to investigate whether nifedipine retard treatment was associated with a significantly higher incidence of cardiac events than angiotensin converting enzyme inhibitor treatment in Japanese patients. The study used a prospective, randomized, open, blinded endpoint (PROBE) design. Patients were enrolled at 354 Japanese hospitals specializing in cardiovascular disease. The subjects were 1,650 outpatients aged under 75 years who had diagnoses of both hypertension and coronary artery disease. There were 828 patients subjected to intention-to-treat analysis in the nifedipine retard group and 822 patients in the angiotensin converting enzyme inhibitor group. The patients were randomized to 3 years of treatment with either nifedipine retard or angiotensin converting enzyme inhibitor. The primary endpoint was the overall incidence of cardiac events (cardiac death or sudden death, myocardial infarction, hospitalization for angina pectoris or heart failure, serious arrhythmia, and coronary interventions). The primary endpoint occurred in 116 patients (14.0%) from the nifedipine retard group and 106 patients (12.9%) from the angiotensin converting enzyme inhibitor group (relative risk, 1.05; 95% confidence interval, 0.81-1.37; p = 0.75). In the Kaplan-Meier estimates, there were no significant differences between the two groups (log-rank test: p = 0.86). The incidence of cardiac events and mortality did not differ between the nifedipine retard and angiotensin converting enzyme inhibitor therapies. Nifedipine retard seems to be as effective as angiotensin converting enzyme inhibitors in reducing the incidence of cardiac events and mortality.

Aged↗
PubMed1989

Ketotifen in the prophylaxis of extrinsic bronchial asthma. A multicenter controlled double-blind study with a modified-release formulation.

In a placebo controlled double-blind multicenter trial, 245 patients with bronchial asthma (131 male and 124 female patients) between 6 and 51 years of age were treated in two parallel groups. A slow-release oral formulation containing 2 mg of ketotifen or placebo was administered daily for a duration of 12 weeks. Over a period of four weeks before the study, 94 percent of the patients had asthmatic attacks. 78 percent had cough, and 62 percent had nasal symptoms. In the group treated with slow-release oral ketotifen, there were 3.9 asthmatic attacks (range, 0 to 20) per week, and in the placebo group, there were 2.9 (range, 0 to 12) (mean values during four weeks prior to start of treatment). At the end of treatment, asthmatic attacks were significantly reduced in the group treated with slow-release oral ketotifen compared with placebo. Significant reduction was also evident for cough and sputum production, as well as nasal discharge and obstruction; however, slow-release oral ketotifen did not significantly improve pulmonary function indices when compared to placebo. The use of concomitant medication (beta-sympathomimetic drugs) was also significantly reduced in the group receiving slow-release oral ketotifen. The overall efficacy assessed by the investigators was "very good" and "good" in 76 percent of the group receiving slow-release oral ketotifen and 30 percent in the group receiving placebo (p less than 0.001). Tolerability rated by the investigators was "very good" and "good" in 90 percent of the group with slow-release oral ketotifen and in 96 percent of the group with placebo (p less than 0.10). The most frequent side effects were "mild" and "moderate" sedation, sleepiness and drowsiness reported in 44 percent of the patients receiving slow-release oral ketotifen and in 26 percent of the patients receiving placebo. This difference was statistically significant (p less than 0.01).

Adolescent↗
PubMed2005

Endovascular repair of abdominal aortic aneurysms with a unibody stent-graft: 3-year results of the French Powerlink Multicenter Trial.

PURPOSE: To report the results of a prospective multicenter study on endovascular repair of abdominal aortic aneurysms (AAA) using the bifurcated Powerlink stent-graft. METHODS: Between June 2000 and July 2001, endovascular AAA repair using the bifurcated Powerlink stent-graft was performed at 14 centers on 64 patients (61 men; mean age 70 years, range 56-90) fit for open repair. All procedures were attended by a proctor. Data were collected prospectively, and surveillance computed tomograms were reviewed by an independent center. RESULTS: Technical success was achieved in all cases. There was no postoperative death. During a minimum 3-year follow-up (mean 40.6 months, range 1-51), there were 3 (4.7%) stent-graft migrations associated with type I endoleaks. Two (3.1%) of these patients were converted to open repair, and 1 had a proximal extension implanted. No aneurysm rupture occurred, and no stent-graft degradation was observed. Six (9.4%) patients had secondary endoleak (3 type I and 3 type II). The limb occlusion rate was 3.1%. Six (9.4%) patients had secondary procedures. At 3 years, 58 (91.0%) patients were available for follow-up (4 deaths, the 2 conversions). There was a significant decrease between preoperative and 3-year mean AAA diameter (54.6+/-7 versus 47.6+/-10 mm, respectively; p<0.001). Aneurysm sac shrinkage was observed in 32 (55.2%) patients. Twenty-five (43.1%) patients had a stable aneurysm sac diameter. CONCLUSIONS: Endovascular repair using the bifurcated Powerlink stent-graft is safe and effective. Unibody design seems to confer advantages in terms of durability. These results need to be confirmed by longer follow-up and larger series.

Aged↗
PubMed1989

Multicenter double-blind placebo-controlled study of gadopentetate dimeglumine as an MR contrast agent: evaluation in patients with cerebral lesions.

A multicenter double-blind randomized study was designed to evaluate and compare the safety and diagnostic efficacy of gadopentetate dimeglumine (Gd-DTPA) (0.1 mmol/kg) against a saline placebo for use as an IV contrast agent for MR. The randomization code provided for a 2:1 ratio of Gd-DTPA and saline patients. Six investigators studied 88 patients with signs and symptoms of a cerebral lesion. Although safety data were complete in all 88 cases, only 83 had valid efficacy data (57 received Gd-DTPA, 26 placebo). Three patients were excluded from efficacy evaluation because of incomplete scans or scans with severe motion artifacts. Two patients were excluded for protocol variations (did not have a mass lesion). The protocol required that spin-echo MR images be acquired both before and after infusion at mode 1, 500/30/2 (TR/TE/excitations), and at a single-echo mode 2 sequence within a selected range, 1500-2000/56-90/2. Additional TEs could also be used at the discretion of each investigator. Efficacy was determined by comparing post- with preinjection images for relative degree of enhancement and improvement of diagnostic ability after injection, and by comparing these results with placebo results. Enhancement was reported in 43 (75%) of 57 Gd-DTPA patients and in none of the 26 placebo patients. Improvement of diagnostic ability was noted in 37 of 57 Gd-DTPA patients and in no placebo patients. Of 17 patients receiving Gd-DTPA for whom no diagnosis could be made before infusion, nine of 17 were diagnosed after infusion. By comparison, none of five patients not diagnosed before infusion of placebo could be diagnosed after infusion. Of 43 patients in whom lesion enhancement was observed after Gd-DTPA infusion, the diagnosis changed after infusion in 16 (37%) and the number of lesions detected after infusion increased in 10 (23%). Safety studies showed no clinically significant abnormal trends. Minor changes in blood pressure, pulse, and serum iron levels were noted in a higher percentage of Gd-DTPA patients. This study confirms that Gd-DTPA is an efficacious contrast agent for use with MR and that it exhibits excellent patient tolerance. Enhancement allows for a decisive diagnosis to be made in selected cases in which such capability had previously been lacking with unenhanced MR.

Adolescent↗
PubMedDate not supplied

Treatment of sinus empyema in adults. A coordinated Nordic multicenter trial of cefixime vs. cefaclor.

In sinus empyema, H. influenzae is the most prevalent pathogen in some subpopulations and in case of therapeutic failure. Cefixime, the first oral cephalosporin of the 3rd generation, is highly potent in vitro against H. influenzae. To study the efficacy and safety of cefixime in adults with acute sinusitis, a coordinated, double-blind multicenter trial was designed for purulent cases, as confirmed by antral aspiration. A total of 364 patients were enrolled in the study with 125 cases randomized to the reference group, assigned to treatment with cefaclor. Evaluation was based on clinical outcome and on antral reaspiration (86% of the cases). No significant differences between the treatment groups were found, as regards short-term or long-term clinical outcome. However, the clinical examination overestimated the therapeutic results. Only 4% of the patients were considered as failures, but the re-aspiration demonstrated remaining suppuration in 14% of all cases (p less than 0.001). Based on re-aspiration, the failure rate among patients with initial growth of pathogens was lower for cefixime (8%) than for cefaclor (20%) (p less than 0.05). Such a difference was not found among patients with growth of H. influenzae. No serious adverse reactions were recorded, but loose stools and diarrhoea were significantly more frequent in the cefixime treatment group. Five patients (2%) in the cefixime treatment group discontinued their treatment due to adverse events.

Cefaclor↗
PubMed1988

Immunohistochemical steroid receptor detection in frozen breast cancer tissue. A multicenter investigation.

Now that monoclonal antibodies against the estrogen receptor (ER) have become available, it is possible to detect the presence of ER immunohistochemically. In order to evaluate the validity of the immunohistochemical (ERICA) method in a routine detection of ER, we have tested the method in a multicenter investigation. As reference is used a conventional biochemical assay, dextran-coated-charcoal assay (DCC). The investigation analyzes the validity of the ERICA-assay, including a semiquantitative estimation of the ER-content, when the method is used in several independent departments of pathology, and the interobserver variation of the analysis. The results show that the qualitative detection of ER, obtained by the ERICA-assay and the DCC-assay has a concordance of about 90% for all the participating departments. The concordance is around 60-70%, when a semiquantitative estimation of the ER-content is used. The interobserver variation is also very low, with full agreement in 58 of 59 cases. The ERICA-assay may, therefore, be a relevant alternative to the DCC-assay. However, its clinical importance still has to be fully elucidated.

Antibodies, Monoclonal↗
PubMed1989

Preliminary report of cardiac study: cross-sectional multicenter study on dietary factors of cardiovascular diseases. CARDIAC Study Group.

The International cooperative 'Cardiovascular Diseases and Alimentary Comparison Study' (CARDIAC Study) was designed to study the relationship of dietary factors to blood pressure (BP) and other major cardiovascular diseases (CVD) in widely different populations of both industrialized and developing countries. The primary aim of the research was to test specific hypotheses linking the intake of certain dietary constituents, e.g., sodium (Na), potassium (K), calcium (Ca) and protein, to BP ('Core' Study); in some centers the relationship between dietary factors and mortality from CVD was also examined ('Complete' Study). The final aim of this multicenter research was to contribute to the scientific information base required to guide the formulation of dietary goals for the primary prevention of major CVD. Forty centers in 20 countries are now participating in the CARDIAC Study. From each population 100 males and 100 females aged 50-54 years were selected randomly for BP measurement by an automated system, 24-hour urine collection by aliquot cups, blood sampling etc. according to CARDIAC protocol; and all samples were analyzed by the WHO Collaborating Center (Izumo) by standardized methods. Although studies are now in progress, surveys in China, Tanzania, USSR and Japan suggest the importance of Na and protein intakes, and all data so far obtained of systolic and diastolic BP, urinary Na and K excretions, serum cholesterol levels, etc. show wide distribution in different populations, so that dietary factors of CVD will be analyzed in more detail when the analyses of total samples are completed.

Blood Pressure↗
PubMed1989

Methylprednisolone therapy in patients with severe alcoholic hepatitis. A randomized multicenter trial.

STUDY OBJECTIVE: To determine the efficacy of a corticosteroid in reducing the short-term mortality of patients with severe alcoholic hepatitis. DESIGN: Randomized, double-blind, placebo-controlled multicenter trial. SETTING: Four university teaching hospitals. PATIENTS: We enrolled 66 patients with alcoholic hepatitis and either spontaneous hepatic encephalopathy or a discriminant function value greater than 32, calculated using the formula: 4.6 (prothrombin time - control time) + serum bilirubin [in mumol/L]/17.1. Fifty-nine patients (89%) completed the study. Two patients withdrew from the trial. The other 64 patients were hospitalized for the duration of the trial; however, treatment was discontinued in 5 patients because of potential drug toxicity. INTERVENTIONS: Patients were randomly assigned to receive either methylprednisolone (32 mg) or placebo within 7 days of admission. Treatment was given for 28 days. The doses were then tapered over 2 weeks and discontinued. MEASUREMENTS AND MAIN RESULTS: The endpoint of the study was death. Of the 31 recipients of placebo, 11 (35%) died within 28 days of randomization compared with 2 (6%) of the 35 patients given methylprednisolone (P = 0.006). The 95% CI for the difference in mortality was 12% to 70%. In the patients with spontaneous hepatic encephalopathy at entry, 9 of 19 recipients of placebo died (47%) compared with 1 (7%) of the 14 patients given methylprednisolone (P = 0.02). The 95% CI for the difference in mortality was 14% to 66%. The Cox proportional hazards regression model showed the advantage of methylprednisolone over placebo after adjustment for other potentially important prognostic variables (P = 0.004). CONCLUSIONS: Methylprednisolone therapy decreases short-term mortality in patients with severe alcoholic hepatitis manifested either by spontaneous hepatic encephalopathy or a markedly elevated discriminant function value.

Adult↗
PubMed2002

Multicenter prospective, randomized, double-masked, placebo-controlled study of Rheopheresis to treat nonexudative age-related macular degeneration: interim analysis.

OBJECTIVE: To evaluate the safety and efficacy of Rheopheresis blood filtration to treat intermediate- to late-stage preangiogenic age-related macular degeneration (AMD) with soft drusen. DESIGN: Multicenter, prospective, randomized, double-masked, placebo-controlled clinical trial. PARTICIPANTS: First 43 randomized patients (28 Rheopheresis and 15 placebo-control patients) with available baseline and 3-month postbaseline best corrected visual acuity (BCVA) measurements and intermediate- to late-stage preangiogenic AMD with multiple large soft drusen and elevated serum levels of targeted macromolecules. INTERVENTION: Patients were randomly assigned to receive eight Rheopheresis or eight placebo procedures over 10 weeks. MAIN OUTCOME MEASURES: ETDRS BCVA measurements at baseline, 3, 6, 9, and 12 months postbaseline. RESULTS: In primary eyes, the mean LogMAR line difference between Rheopheresis and placebo-control eyes was 1.6 lines at 12 months postbaseline; the difference was significant throughout the first posttreatment year (P = .0011, repeated measures analysis). Thirteen percent of Rheopheresis compared with 0% of placebo-control eyes had a > or = 3-line improvement in BCVA at 12 months postbaseline. Four percent of Rheopheresis compared with 18% of placebo-control eyes had a > or = 3-line loss in BCVA. The subgroup of patients whose primary eyes had baseline BCVA worse than 20/40 demonstrated a mean LogMAR difference between Rheopheresis and placebo-control eyes equaling 3.0 lines at 12 months postbaseline; the difference was significant throughout the first posttreatment year (P = .0014, repeated measures analysis). Sixteen percent of Rheopheresis compared with 0% of the placebo-control eyes had a > or = 3-line improvement in BCVA at 12 months postbaseline. Five percent of Rheopheresis compared with 29% of placebo-control eyes had a > or = 3-line loss in BCVA. Fifty-eight percent of Rheopheresis eyes improved to 20/40 or better, compared with 14% of placebo-control eyes. No serious treatment-related adverse events were observed. CONCLUSIONS: Rheopheresis demonstrated statistically significant and clinically relevant effects on BCVA when compared with placebo controls for the 12-month study interval. Untreated patients with BCVA worse than 20/40 with intermediate- to late-stage preangiogenic AMD, soft drusen, and elevated blood factors were at risk for substantial visual loss. A sample size larger than 43 patients is important to provide a basis for widespread adoption of novel therapeutic options for AMD such as Rheopheresis. Therefore, enrollment to 150 patients is continuing.

Aged↗
PubMed2003

Prognostic value of normal exercise and adenosine (99m)Tc-tetrofosmin SPECT imaging: results from the multicenter registry of 4,728 patients.

UNLABELLED: Event rates associated with a normal or low-risk myocardial perfusion SPECT imaging study have been shown by numerous investigators to be associated with <1%/y of follow-up. Thus, the aim of this study was to evaluate the prognostic value of a normal (99m)Tc-tetrofosmin study in a geographically diverse registry of patients undergoing stress myocardial perfusion SPECT. A total of 4,728 consecutively tested patients who underwent stress (99m)Tc-tetrofosmin SPECT at 5 U.S. hospitals were included in this series. METHODS: Patients were monitored for the occurrence of major cardiac events and hospitalizations. Uniform methods of data collection and standardized epidemiologic methods for follow-up were used at all centers. We used a risk-adjusted, Cox proportional hazards model to assess time to cardiac death. RESULTS: Of the 4,728 patients, one third underwent adenosine stress SPECT and two thirds underwent treadmill exercise. The observed annualized survival rate for those patients with a normal (99m)Tc-tetrofosmin study was 0.6%. Similarly, excellent survival rates were noted for the male and female subsets of this population as well as for patients who could exercise and for those undergoing pharmacologic stress testing. Compared with prior published outcomes studies on stress (201)Tl or (99m)Tc-sestamibi SPECT, the overall survival rates were similar and ranged from 99.3% to 99.7%. CONCLUSION: Results from this large multicenter registry provide further supportive evidence that the excellent prognosis associated with a normal SPECT scan is independent of the radiopharmaceutical used.

Adenosine↗
PubMed2003

Stenting small coronary arteries: The Multi-Link PIXEL Multicenter Italian Registry.

BACKGROUND: Published data regarding stenting small coronary arteries are still limited and controversial. The Multi-Link Pixel stent is a new, corrugated ring, stainless-steel stent specifically designed for small vessels. The feasibility, safety and efficacy of implantation of the Pixel coronary stent in vessels with reference diameter 2.5 mm were prospectively studied with a multicenter Italian registry. METHODS AND RESULTS: A total of 231 patients (243 lesions) were included in the study. The risk profile of the study population was high (41% of cases were treated for unstable angina, 20% had diabetes and 52% had multivessel disease). Forty percent of lesions had unfavorable characteristics (type B2 or C) and 10% were chronic total occlusions. Successful stent deployment was achieved in all lesions. Minimal lumen diameter significantly increased from 0.71 0.32 mm to 2.32 0.40 mm and diameter stenosis decreased from 67.20 12.49% to 6.68 10.68%. The acute lumen gain was 1.58 0.25 mm. There were no major in-hospital complications and no cases of acute or subacute stent thrombosis. The rate of major adverse cardiac events was 0.4% at 14 days and 9.6% at 6 months. Target lesion revascularization was 0.4% at 14 days and 7.4% at 6 months. Most patients improved in their clinical symptoms. CONCLUSION: This initial experience indicates that implantation of the Multi-Link Pixel stent appears to be safe and effective in the treatment of complex coronary lesions in small vessels and is associated with a remarkably low target vessel revascularization rate.

Adult↗
PubMed2004

A double blind, randomized, multicenter, parallel group study of the effectiveness and tolerance of intraarticular hyaluronan in osteoarthritis of the knee.

OBJECTIVE: To investigate the efficacy and tolerability of a course of 5 injections of hyaluronan (HA) given at intervals of one week in patients with symptomatic, mild to moderate osteoarthritis (OA) of the knee. METHODS: A double blind, randomized, parallel group, multicenter (17 centers), saline vehicle-controlled study was conducted over 18 weeks. Patients received either 25 mg (2.5 ml) HA in a phosphate buffered solution or 2.5 ml vehicle containing only the buffer by intraarticular injection. Five injections were given at one week intervals and the patients were followed for a further 13 weeks. The Western Ontario McMaster (WOMAC) OA instrument was used as the primary efficacy variable and repeated measures analysis of covariance was used to compare the 2 treatments over Weeks 6, 10, 14, and 18. RESULTS: Of 240 patients randomized for inclusion in the study, 223 were evaluable for the modified intention to treat analysis. The active treatment and control groups were comparable for demographic details, OA history, and previous treatments. Scores for the pain and stiffness subscales of the WOMAC were modestly but significantly lower in the HA-treated group overall (Weeks 6 to 18; p < 0.05) and the statistically significant difference from the control was not apparent until after the series of injections was complete. The physical function subscale did not reach statistical significance (p = 0.064). Tolerability of the procedure was good and there were no serious adverse events that were considered to have a possible causal relationship with the study treatment. CONCLUSION: Intraarticular HA treatment was significantly more effective than saline vehicle in mild to moderate OA of the knee for the 13 week postinjection period of the study.

Adjuvants, Immunologic↗
PubMed1990

Optimal felodipine dose when combined with metoprolol in arterial hypertension: a Swedish multicenter study within primary health care. Swedish General Practitioner Felodipine Study Group.

In a multicenter study comprising 23 Swedish primary health care centers, felodipine extended-release (ER) tablets in doses of 5, 10, and 20 mg were compared double-blind with placebo when given in addition to metoprolol controlled-release (CR) tablets 100 mg. All medication was given once daily in the morning. Altogether, 251 hypertensive patients with a diastolic blood pressure greater than 95 mm Hg after 4 weeks of treatment with placebo in combination with metoprolol CR 100 mg were randomized to four parallel groups. After 4 weeks of treatment, there were significantly greater reductions in blood pressure with all doses of felodipine ER than with placebo, both 2 and 24 h after intake of the tablets. Twelve patients were withdrawn because of adverse reactions. Of these, one patient was taking placebo, one 5 mg of felodipine ER, four 10 mg of felodipine ER, and six patients 20 mg of felodipine ER. When combined with metoprolol, 5 mg of felodipine ER seemed to be less effective than higher doses, but was very well tolerated. Adding 10 mg of felodipine ER to the basal metoprolol appeared to be optimal if both the effect and adverse reactions were taken into consideration.

Adult↗
PubMed1990

Multicenter study with isradipine and diuretics against atherosclerosis. US MIDAS Research Group.

Hypertension is a major risk factor for atherosclerosis. Although antihypertensive drug treatment can reduce morbidity and mortality from stroke, there is no consistent benefit on ischemic heart disease. It may be that subtle adverse effects of the drugs used in these clinical trials may have blunted the beneficial effects of treatment. Isradipine, a new calcium antagonist of the dihydropyridine class, is a potent antihypertensive drug with pronounced antiatherogenic properties, at least in animal studies. Thus, isradipine may be a suitable drug for assessing the efficacy of antihypertensive treatment in retarding the progression of atherosclerosis. The Multicenter Isradipine/Diuretic Atherosclerosis Study (MIDAS) is a clinical trial to compare the efficacy of isradipine (2.5-5.0 mg b.i.d.) and hydrochlorothiazide (12.5-25 mg b.i.d.) in retarding atherosclerosis in carotid arteries. Carotid atherosclerosis will be monitored using B-mode ultrasonography. The sample size is 800 men and women aged 40 years and over. The power of the design is 90% to detect a 30% difference in the progression of plaque size between the isradipine- and hydrochlorothiazide-treated groups with a significance level of 5% (p = 0.05).

Arteriosclerosis↗
PubMed1990

The use of somatostatin in acute pancreatitis--results of a multicenter trial.

This study involves a multicenter trial aimed at evaluating the comparative beneficial therapy of somatostatin and traditional symptomatic therapy in the management of acute pancreatitis. According to our final data somatostatin has not proved to be any better than traditional medical treatment. Nevertheless, in our opinion, the advantage of a single and expeditious therapy makes somatostatin administration preferable to the combined employment of several therapeutic measures usually applied in these circumstances.

Acute Disease↗
PubMed1990

Misoprostol in the prevention of NSAID-induced gastric ulcer: a multicenter, double-blind, placebo-controlled trial.

A multicenter, double-blind, placebo-controlled trial was undertaken to evaluate the efficacy of the synthetic prostaglandin E1 analog misoprostol in preventing and healing gastric ulcer induced by nonsteroidal antiinflammatory drugs (NSAID) in patients receiving chronic NSAID therapy for osteoarthritis (OA). A total of 420 patients with OA and NSAID-associated abdominal pain who were receiving ibuprofen, piroxicam or naproxen were enrolled in the study. Endoscopy was performed at study entry and after 1, 2 and 3 months of continuous therapy with misoprostol 100 micrograms, misoprostol 200 micrograms or placebo given q.i.d. while NSAID therapy was continued. Treatment failure was defined as development of gastric ulcer (greater than 0.3 cm in diameter). The occurrence of ulcer in each misoprostol group (5.6% and 1.4% for 100 micrograms and 200 micrograms, respectively) was significantly lower (p less than 0.001) than that in the placebo group (21.7%). The statistically significant difference persisted when comparisons were restricted to development of ulcer greater than 0.5 cm in diameter (12.3, 4.2 and 0.7% for placebo, misoprostol 100 micrograms q.i.d. and misoprostol 200 micrograms q.i.d., respectively). Mild-to-moderate, self-limiting diarrhea was the most frequently reported adverse event attributed to misoprostol use.

Alprostadil↗