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Biomedical subjects

C A Heller

Publications and source records attributed to C A Heller.

14 recordsLinked to original sources

Safety profile of Lansoprazole: the US clinical trial experience.

OBJECTIVE: Lansoprazole has undergone extensive clinical evaluation for the treatment of acid-peptic diseases. The aim of this study was to define the safety profile of lansoprazole and compare it to that of other therapeutic agents evaluated in the same controlled trials. METHODS: The clinical safety profile of lansoprazole and comparative agents (placebo, ranitidine and omeprazole) was reviewed for 3281 patients who participated in short term (up to 8 weeks) and long term (up to 56 months) clinical trials conducted in the US. Adverse events, laboratory value changes and gastric biopsy changes that occurred during treatment were compared statistically for differences between treatments. RESULTS: The incidence of adverse events and number of patients discontinuing treatment because of adverse events was similar for lansoprazole and comparative agents. Other than elevated serum gastrin levels, a known effect of proton pump inhibitors, no trends in laboratory changes were observed. Median values for gastrin levels remained within the normal range; about 2% of patients had gastrin levels >400 pg/ml at any time, while <1% had 2 or more gastrin values >500 pg/ml. Values returned to baseline levels after therapy was discontinued. No significant changes in gastric endocrine cell growth from baseline to final visit were observed, nor was there evidence of dysplasia or neoplasia. CONCLUSION: Lansoprazole is well tolerated for both short and long term treatment of acid-related disease. The tolerability of lansoprazole is comparable to that of ranitidine, omeprazole and placebo in the treatment of these diseases.

2-Pyridinylmethylsulfinylbenzimidazoles↗

The hypo-echoic cortical rim in lupus nephritis.

Hypo-echoic cortical rims are an unusual ultrasound finding in patients with renal disease. A case report is presented of a patient with lupus nephritis who demonstrated hypo-echoic cortical rims. A brief review of the pathological causes of hypo-echoic cortical rims is given.

Adolescent↗

Serological and clinical remission in systemic lupus erythematosus.

The frequency of a combined clinical and serological remission in patients with systemic lupus erythematosus (SLE) was examined. Thirteen (4%) of 305 patients had both a seroconversion from a positive to a negative ANA and became asymptomatic in respect to their SLE. These remissions lasted from 6 months to 13 years. It is not clear what role, if any, therapy played in these remissions. Nevertheless, these remissions provided hope for the patients and their physicians.

Adolescent↗

Value of x ray examinations of the cervical spine.

The value of x ray examination of the cervical spine was studied. In one district general hospital it has been estimated that such examinations occupy one radiographer and one room for four hours a week. Eighty-five per cent of patients aged 60 or more who had been referred for an x ray examination of the neck in one year were reported as having cervical spondylosis, and there were no unexpected findings of infection or malignancy at any age. The reports of patients referred for x ray examination of the cervical spine were compared with those of control patients who had originally attended for barium studies. There was no significant difference in the prevalence of cervical spondylosis between the two groups, although the severity of the disc changes was greater among cases than controls. There were no consistent relations between symptoms and changes seen on x ray films. It is suggested that x ray examinations should be performed only when there is a clinical suspicion of malignancy or infection, after trauma, or when surgery may be indicated. There is little point in taking x ray films of the neck to diagnose cervical spondylosis.

Adult↗

Pyridoxine deficiency and peripheral neuropathy associated with long-term phenelzine therapy.

A 51-year-old, nonalcoholic, nondiabetic woman with sensorimotor peripheral neuropathy and pyridoxine deficiency associated with long-term phenelzine therapy is described. Since phenelzine, like hydralazine and isoniazid, is a hydrazine capable of reducing pyridoxine levels in the rat, it is suggested that phenelzine, like hydralazine and isoniazid, may cause a pyridoxine-responsive peripheral neuropathy in humans.

Adenocarcinoma↗

Risk stratification after acute myocardial infarction.

One hundred patients admitted to the hospital with acute myocardial infarction who lived 10 days and agreed to enroll were studied. Data from the history, hospital course and a 24 hour Holter electrocardiographic recording were related to cardiac mortality in the 6 months after enrollment. Fifteen cardiac deaths occurred during this period; 12 of these were sudden. The univariates with the strongest association with mortality were (in descending order): blood urea nitrogen level, serum creatinine level, serum uric acid level, enlarged heart 2 weeks after infarction, ventricular tachycardia 2 weeks after infarction, peak creatine kinase level and left ventricular failure in the coronary care unit. The odds of dying if one of these factors was present rather than absent ranged from 3.6 to 11.5. Groups with two or these univariates had up to 20 times the odds of dying in 6 months. A period of greately enhanced risk for cardiac death persists for about 6 months after acute myocardial infarction. Relatively simple clinical variables can identify the groups at highest and lowest risk. This information is useful for designing management strategies.

Acute Disease↗

Nonsteroidal antiinflammatory drugs and aspirin--analyzing the scores.

We reviewed 103 controlled clinical trials that compared the antiarthritic efficacy and tolerance of previously and currently marketed nonsteroidal antiinflammatory drugs (NSAIDs) and aspirin. Of 52 studies, 35 had data sufficient to calculate an NSAID efficacy index (the ratio of mean improvement in NSAID-treated patients to that in aspirin-treated patients) based on subjective and/or objective criteria. The mean indexes (obtained from all studies from which an index could be calculated) indicated no statistically significant difference in efficacy between aspirin and the NSAIDs as a group; the indexes tended to become less variable as the number of study subjects increased. Tolerance, assessed from the percentage of patients who discontinued the drug because of side effects, was significantly greater for NSAIDs than for aspirin. The NSAIDs had greater efficacy but not greater toxicity at increased doses. Efficacy differences described among NSAIDs in some studies were attributable either to comparisons at nonequivalent doses or to chance.

Anti-Inflammatory Agents↗