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K Agre

Publications and source records attributed to K Agre.

10 recordsLinked to original sources
PubMed1987

An overview of the safety and efficacy of nicardipine in clinical trials.

Nicardipine is currently being evaluated in clinical trials as a treatment for angina and hypertension. Over 2,000 patients have received nicardipine, most at dosages of 20 to 40 mg 3 times daily. In 12 double-blind, parallel-group studies (4 of them placebo-controlled) the efficacy of nicardipine was evaluated in mild to moderate hypertension; supine systolic blood pressure was lowered by 10 to 15 mm Hg and supine diastolic blood pressure by 10 mm Hg. A clear dose response is present at dosages from 10 to 40 mg 3 times daily. Patients with angina were treated in 9 double-blind, crossover design studies: 4 of these were placebo-controlled; 3 were comparison studies with beta blockers; 2 were comparisons with nifedipine. Treadmill exercise tests were the major measure of efficacy. Results of these studies showed consistent, statistically significant improvement in exercise tolerance and time to onset of angina, and clinical improvement in patients with chronic stable angina. The effective dosages of nicardipine were 30 or 40 mg 3 times daily. A placebo-controlled study demonstrated remarkable efficacy in patients with vasospastic angina. No deaths or serious adverse reactions were attributed to nicardipine during clinical trials. The most common side effects reported were flushing, palpitations, headache and pedal edema. These appeared to be due to the drug's pharmacologic property of vasodilatation.

Angina Pectoris↗
PubMed1985

Chymodiactin in patients with herniated lumbar intervertebral disc(s). An open-label, multicenter study.

To extent the safety information for Chymodiactin (chymopapain for injection), 37 neurologic and orthopedic surgeons conducted an open-label, multicenter, phase 3 clinical study. A total of 1,498 patients with one or two herniated lumbar intervertebral discs were enrolled. Therapeutic results were generally favorable, with the percentages of patients achieving either excellent or good (or successful) results ranging from 79.6% to 88.9%, depending on criteria employed in the tabulation. There were 13 cases of anaphylaxis, and 2 of these patients died of complications of anaphylaxis. Two additional patients experienced serious neurologic problems. The first of these two patients developed transverse myelitis and paraplegia approximately 3 weeks following chemonucleolysis. Transdural discograms at three levels had been done approximately 2 days prior to chemonucleolysis, in violation of the protocol. The second patient developed acute cauda equina syndrome, and, despite emergency laminectomy, had permanent neurologic sequelae. Back spasm and stiffness/soreness were the most frequently encountered adverse experiences.

Adolescent↗
PubMed1976

A review of results of clinical trials with amikacin.

Case records of 1,098 patients treated with amikacin at 79 research centers in 10 countries in a program of worldwide clinical trials were reviewed. Of the 697 patients eligible for use in evaluation of efficacy of the drug, 81% were cured, as evidenced by clinical remission and eradication of the infecting pathogen. The usual dosage was 7.5 mg/kg administered intramuscularly at 12-hr intervals. This dosage was modified in patients with renal impairment. Amikacin was effective in 90% of 322 patients with genitourinary infections, 85% of 97 patients with septicemia, 70% of 73 patients with infections of skin, soft tissue, or bone (excluding burns), and 69% of 68 patients with infections of the lower respiratory tract. Amikacin was effective in treatment of 88% of 85 infections due to gentamicin-resistant pathogens. The drug was generally well tolerated, and no side effects were reported in 80.6% of the 1,098 patients evaluated. Amikacin shares with other aminoglycosides the risk of ototoxicity and nephtotoxicity; previous exposure to gentamicin was a major factor in the development of such adverse effects. Other adverse reactions were relatively infrequent and in most cases were characterized as mild and transient.

Adolescent↗
PubMedDate not supplied

Chymodiactin postmarketing surveillance. Demographic and adverse experience data in 29,075 patients.

Postmarketing surveillance data on 29,075 patients who received Chymodiactin (Smith Laboratories' formulation of chymopapain) intradiscal injections for a herniated lumbar intervertebral disc are summarized and tabulated. The serious adverse reactions reported include death, anaphylaxis, paraplegia, and discitis. Similar problems also have been reported for Discase (Baxter-Travenol's formulation of chymopapain). Of 11 deaths reported following Chymodiactin administration, only 3 appear to be related to the drug or procedure. Two of these three were due to anaphylaxis and the third to bacterial discitis with resultant meningitis. Paraplegia appeared to be primarily due to needle trauma or injection of contrast agent and enzyme into the subarachnoid space. Careful patient selection and needle placement are essential for avoiding serious problems.

Adolescent↗