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Biomedical subjects

D M Demke

Publications and source records attributed to D M Demke.

6 recordsLinked to original sources
PubMed1995

The effects of colestipol tablets compared with colestipol granules on plasma cholesterol and other lipids in moderately hypercholesterolemic patients.

The purpose of this study was to investigate and compare the efficacy, safety, and patient acceptability of a new formulation of colestipol, colestipol tablets (T), with those of colestipol granules (G), in a randomized, double-blind, placebo-controlled, multicenter study. Three hundred and seventeen patients with primary hypercholesterolemia who were following a low-fat, low-cholesterol diet (NCEP Step I diet), and had low-density lipoprotein cholesterol (LDL-C) levels > or = 4.14 mmol/l (160 mg/dl) and < or = 6.46 mmol/l (250 mg/dl) were studied. Study medication was taken twice a day, with breakfast and supper, for 8 weeks. The six parallel treatment groups consisted of colestipol tablets 2 g b.i.d. and 8 g b.i.d., matching placebo tablets b.i.d., colestipol granules 2 g b.i.d. and 8 g b.i.d., and matching placebo granules b.i.d.. Study endpoints included absolute change and percentage change from baseline in selected lipid, lipoprotein, and apolipoprotein measurements; LDL-C lowering was the primary efficacy endpoint. Treatment with colestipol tablets and colestipol granules resulted in virtually identical, statistically significant (P < or = 0.05) reductions of LDL-C, total cholesterol (TC), TC/HDL-C, and apolipoprotein B (apo B). Compared with placebo, all active treatments (tablets 4 g/day, tablets 16 g/day, granules 4 g/day, granules 16 g/day) significantly reduced LDL-C (12%, 24%, 12%, 25%, respectively), TC (7%, 15%, 8%, 15%, respectively), TC/HDL-C (8%, 14%, 9%, 15%, respectively) and apo B (12%, 20%, 13%, 22%, respectively). All active treatments significantly increased lipoprotein particle AI (LpAI) (5%, 23%, 14%, 18%, respectively). VLDL-C and triglycerides increased significantly in the high-dose groups. The proportions of patients reporting adverse events, largely gastrointestinal-related, were not different among the active treatment groups. The treatments were well-tolerated, and no drug-related serious adverse events were reported. Patients experienced with granule medication prior to this study preferred tablets over granules. This study demonstrates that colestipol tablets are an effective treatment to reduce LDL-C in patients with primary hypercholesterolemia, are equivalent to colestipol granules, are well-tolerated, and are preferred over granules by patients.

Adult↗
PubMed1988

The effect of encapsulated, low-dose colestipol in patients with hyperlipidemia.

Colestipol is an effective cholesterol (C)-lowering agent, but it must be taken in large doses and the palatability is poor. In an open-label study, the effects of low doses (2-10 g) of encapsulated colestipol (size: 1 g or 0.65 g) were investigated. There were 16 men and 16 women with an average age of 59 +/- 11 years and with hyperlipidemias IIA, IIB, or IV. Patients were on AHA I diet and stayed in the study for up to 2 years with regular follow-up every 3 to 4 months. Colestipol was started after several months of dietary baseline; it was tolerated well with only two patients reporting mild constipation. A group mean for total cholesterol (T-C), LDL-C, HDL-C, VLDL-C and triglycerides (TG) was calculated at each of four daily dose intervals, i.e., 2 to 4 g, 4 to 6 g, 6 to 8 g and 8 to 10 g. Each patient usually received more than one of the four dosage intervals. A paired t test and a rank sum test were performed to test for significant (P less than or equal to .05) differences between baseline and drug treatment. With the exception of the lowest dose, total C was significantly decreased by all dosage ranges and LDL-C changes were similar. There was no significant effect on HDL-C and VLDL-C whereas TG levels increased at 4 to 6 g and 8 to 10 g dose. The use of diet and low colestipol doses may be considered in patients with moderate hypercholesterolemia who do not respond to diet alone.

Capsules↗
PubMed1988

Effects of a fish oil concentrate in patients with hypercholesterolemia.

The effects of a fish oil supplement on lipid and lipoprotein levels, platelet function, and vital signs were investigated in 31 hypercholesterolemic patients. Thirteen patients took 5 g of encapsulated fish oil per day and 18 patients took 5 g of encapsulated safflower oil "placebo" per day for 28 days. Diet and exercise patterns were kept as constant as possible during the study. The fish oil group had significant increases in several lipid/lipoprotein values at the end of the treatment, including an increase of total cholesterol of 14% (P = 0.0001), LDL of 16% (P = 0.003), HDL of 13% (P = 0.015) and HDL2 of 36% (P = 0.009). The triglyceride level fell 24%, a nonsignificant change (P = 0.217). The ratios of total cholesterol/HDL and LDL/HDL were increased at the end of fish oil treatment, and returned to baseline 30 days after fish oil was stopped. The placebo group had no significant changes in any of the lipid/lipoprotein values. Neither the fish oil nor the placebo group had significant changes in vital signs or platelet function tests (bleeding time, thromboxane B2, platelet factor 4 and beta-thromboglobulin) during the study. These results suggest that fish oil supplements may have an adverse effect on lipid/lipoprotein values in hypercholesterolemic patients.

Adolescent↗
PubMed1987

The effect of itazigrel and aspirin on the mucosa of the esophagus, stomach, and duodenum of normal subjects.

The effects of aspirin, itazigrel (U-53,059; a new antiplatelet drug), and placebo on the mucosa of the esophagus, stomach, and duodenum were evaluated in this double-blind, randomized, placebo-controlled study. Six normal male subjects were included in each of five treatment groups: aspirin (325 mg each morning for five doses), aspirin (325 mg tid for 12 doses), itazigrel (25 mg each morning for five doses), itazigrel (50 mg tid for 12 doses), and placebo. Aspirin and itazigrel, at all doses investigated, significantly inhibited ex vivo, ionophore (A23187)-stimulated thromboxane B2 synthesis. Collagen-induced platelet aggregation was significantly inhibited on day 3 (P = .021) and day 5 (P = .002) in both aspirin and itazigrel groups as compared with placebo. Upper gastrointestinal endoscopy was performed before the first dose of drug (day 1) and two hours after the last dose (day 5) for each subject. A rating scale was used to score the amount of mucosal damage. The baseline (day 1) endoscopic scores revealed no significant differences between groups. On day 5, neither placebo nor itazigrel treatment groups showed any significant change compared with baseline. On day 5, both aspirin groups had significantly (P less than .001) more mucosal damage than the placebo group and either itazigrel group. It is concluded that in this relatively acute study, at doses that produce comparable inhibition of platelet aggregation and platelet cyclo-oxygenase, itazigrel was superior to aspirin in terms of toxicity to the upper gastrointestinal tract.

Adolescent↗
PubMed1987

Holter monitor ST segment evaluation in hospitalized patients with unstable angina.

The correlation of angina attacks with ST segment changes detected during ambulatory Holter monitoring was evaluated in patients with unstable angina. Forty hospitalized patients had one to three 24-hour Holter recordings each. Twenty-three patients had a cardiac catheterization, confirming significant coronary artery disease. The Holter recordings, scanned blindly by computer, were evaluated for ST segment shifts (defined as +/- 1.5 mm from baseline, lasting 60 seconds or longer). Angina attacks were carefully logged. Over the total forty patient experience, only 15 of 74 (20.3%) angina attacks had corresponding ST segment shifts on the Holter recordings. Nine of 34 (26.5%) angina attacks in the 23 patients who had a cardiac catheterization had corresponding ST segment shifts. A total of 159 ST segment shifts were recorded on these forty patients, but only 15 (9.4%) ST shifts corresponded to a time when the patients were actually experiencing angina attacks. The performance of the test procedure was quantified by use of Youden's J statistic. The aggregate J, over all patients, was 0.203 (J = 1.0 is perfect, J = 0.0 is useless). When consideration was restricted to patients with cardiac catheterization, the aggregate experience J was 0.263. Dealing with only the patients who had angina attacks during the monitoring, and computing the J statistic for each individual patient, the resulting mean J statistic was 0.146, with SEM = 0.0731. The Holter monitoring worked reasonably well in only 2 of the 14 patients who gave clear tests of the procedure. In an attempt to improve the performance of the procedure, 21 Holter recordings in eight patients were reread for ST segment shifts of only +/- 1 mm from baseline, lasting 30 seconds or longer. In these eight patients with rescanned Holter recordings, only five of 17 (29.4%) angina attacks resulted in an ST segment shift. In conclusion, ambulatory Holter recordings proved not to be a suitable method of documenting ST segment shifts during angina attacks in this study.

Adult↗