An Italian chart for cardiovascular risk prediction. Its scientific basis.

A risk chart for primary prediction of major coronary and cerebrovascular events based on Italian population data was created. Material from three Italian population studies was available: the Italian Rural Areas of the Seven Countries Study (no. 1712), the Gubbio Study (no. 3061) and the ECCIS Study (no. 4998) for a total of 9771 men and women aged 35 to 74 years and followed-up from 5 to 15 years, for a total of over 55,000 person/years. Sex, age, diabetes, cigarette smoking, systolic blood pressure and serum cholesterol were selected as risk factors, while the endpoint was established as the occurrence of the first major coronary or cerebrovascular event in 10 years. The accelerated failure time model was used as the predictive model. Two models were adopted, i.e., for relatively younger subjects (45-59 years) and for relatively older subjects (60-74 years). Both produced highly significant coefficients for each of the selected risk factors. The two models carried a satisfactory discriminating power, with 40% to more than 50% of all events located in the upper quintile of the estimated risk. Sex, age (6 classes), diabetes, cigarette smoking (4 classes), systolic blood pressure (4 classes) and serum cholesterol (5 classes) were considered for the creation of a risk map derived from multivariate models. A total of 1920 cells were filled with different colors corresponding to 6 classes of absolute risk. A similar set of cells was filled with another color scale for the estimate of the relative risk versus subjects of the same age and sex carrying Italian mean levels of risk factors. The chart is being distributed to the Italian medical profession as a practical tool to select high-risk individuals for the primary prevention of major cardiovascular diseases.

Effects of oral alendronate and intranasal salmon calcitonin on bone mass and biochemical markers of bone turnover in postmenopausal women with osteoporosis.

The main objective of this study was to determine the effect of daily oral alendronate treatment on bone mass in postmenopausal women affected by osteoporosis. The efficacy of intranasal salmon calcitonin was also examined. Nine centers in Italy enrolled 286 postmenopausal women between the ages of 48 and 76 with spinal bone mineral density > or = 2 SD below adult mean peak in the two-year, double-blind, randomized, placebo-controlled trial. Patients were randomized to one of four treatment arms: double-blind placebo, alendronate 10 mg/day, alendronate 20 mg/day, or open-label intranasal salmon calcitonin 100 IU/day; all patients received 500 mg Ca++ supplements. Bone mass was measured by dual-energy x-ray absorptiometry every six months for two years. Patients who received alendronate 10 or 20 mg experienced significant increases in bone mass at all sites measured. At the end of the second year, the mean percent changes, for alendronate 10 and 20 mg relative to placebo, were 5.2% and 7.3% at the lumbar spine, 3.8% and 4.6% at the femoral neck, and 7.1% and 7.5% at the trochanter, respectively. In contrast, intranasal salmon calcitonin failed to increase bone mineral mass significantly at any site. Both alendronate doses significantly decreased serum alkaline phosphatase, serum osteocalcin, and urinary pyridinolines, markers of bone turnover, whereas placebo and intranasal calcitonin did not. Alendronate was generally well tolerated and no serious adverse events were attributed to its use.(ABSTRACT TRUNCATED AT 250 WORDS)

Treatment of postmenopausal osteoporosis with continuous daily oral alendronate in comparison with either placebo or intranasal salmon calcitonin.

Alendronate sodium (ALN) is a potent amino bisphosphonate which specifically inhibits osteoclastic bone resorption and has been found to reverse bone loss in several animal models. To determine if daily oral ALN treatment could prevent or reverse bone loss in osteoporotic postmenopausal women, and to compare ALN to intranasal salmon calcitonin (CT), a 2-year, double-masked, randomized, placebo-controlled study was initiated at 9 clinical centers in Italy. Two hundred and eighty six postmenopausal women (age 48-76) with spinal bone mineral density (BMD) > or = 2 SD below adult mean peak, with or without vertebral crush fractures, were randomized to one of four treatment arms: ALN 10 mg daily, ALN 20 mg daily or matching placebo (these groups all double-masked), or CT 100 IU daily (open label) for 2 years. All patients received supplemental calcium (as carbonate) 500 mg daily. Bone mass was measured by dual-energy X-ray absorptiometry of the PA lumbar spine (LS) and proximal femur (femoral neck and trochanter) at 6-month intervals. Subject safety was measured through sequential clinical and laboratory evaluation. A planned 1-year interim analysis of this ongoing study was performed centrally in a manner that maintains the double-mask for all subjects receiving oral study drug. Relative to PBO, ALN at either 10 mg or 20 mg daily increased LS BMD by 4.7% and 6.1%, respectively; each increased femoral neck BMD by 3.1% and increased trochanter BMD by 3.3% and 3.8% respectively. In contrast, CT failed to significantly increase BMD of either the spine, femoral neck or trochanter, either relative to baseline or to PBO.(ABSTRACT TRUNCATED AT 250 WORDS)

[Cerebrovascular episodes in chronic liver diseases and terminal nephrotic syndrome. A case of amyloidosis associated with paraproteinemia IgA-lambda]. / Da un episodio vascolare cerebrale all'epatopatia cronica e sindrome nefrosica terminale. Storia di una amiloidosi associata a paraproteinemia IgA-lambda.

The authors describe a case of amyloidosis associated with an electrophoretic picture, characterized by a monoclonal band with an M component in the alpha 2 and beta regions, in presence of para IgA-lambda. The case casually discovered in the course of a cerebral vascular manifestation and confirmed by bioptic exams, had negative results after four years due to an extremely progressive course involving intestine, liver and kidney, as a consequence of the extension of amyloidosis deposits.

Enhanced natural killer cell activity by proglumetacin, a non-steroidal anti-inflammatory drug.

In this paper we show the stimulatory effect of a new indolyl derivative drug, proglumetacin, alone and in combination with some cytokines, on natural killer cell activity.

Famotidine in the management of duodenal ulcer: experience in Italy.

A multicenter study that involved 15 Italian institutions was carried out to compare the efficacy and safety of famotidine 40 mg at bedtime, famotidine 20 mg b.i.d., famotidine 40 mg b.i.d., and ranitidine 150 mg b.i.d. in promoting the healing of acute duodenal ulcer. Two hundred and twenty-four patients with endoscopically proven duodenal ulcer were randomly allocated into four treatment groups. Efficacy results for the four groups were similar at weeks 2, 4, and 8 of therapy. At week 8, the percentage of patients healed in each group was as follows: 92% in the famotidine 40-mg bedtime group, 97% with 20 mg b.i.d., 93% with 40 mg b.i.d., and 90% with ranitidine 150 mg b.i.d. Day pain and night pain were markedly reduced in all four groups, antacid consumption fell considerably, and therapy was generally well tolerated. The adverse experiences evaluated by the investigator as possibly, probably, or definitely related to test medication were rare and moderate.

Famotidine (MK-208) in the treatment of gastric ulcer. Results of a multicenter double-blind controlled study.

The aim of the present investigation was to study the efficacy and safety of famotidine (MK-208), a new, potent, histamine H2 receptor antagonist, in promoting the healing of active gastric ulcer when compared to placebo. Of the 71 patients who took part in this multicenter double-blind study in Italy, 37 were administered famotidine 40 mg once daily and 34 placebo. Treatment duration was for up to 8 weeks, and endoscopic and clinical studies were performed at onset and week 4 and, if necessary, at weeks 6 and 8. All patients were carefully evaluated at regular intervals for adverse drug reactions by clinical and laboratory examinations. By the end of the study, 97% of the ulcers were healed in the famotidine group compared to 66% in the placebo group (p less than 0.01). Day and night pain decreased significantly more in the famotidine group than in the placebo group. Both treatments were well tolerated, and no alterations in laboratory tests were observed. Famotidine, therefore, proved effective in the treatment of gastric ulcer and was well tolerated on a short-term basis.

Proglumetacin in arthritis of the hip and the knee. Results of a post-marketing surveillance study.

An open, multicentre, outpatient study involving 77 Italian orthopaedic and rheumatology centres was conducted to evaluate the efficacy and tolerability of proglumetacin in the treatment of arthritis of the hip and of the knee. A total of 1522 patients each received 450 mg/day proglumetacin (150 mg tablets X 3) for a period of 4 weeks, with checks at the end of weeks 1, 2, 3 and 4. The evaluation of efficacy was carried out using the following parameters: pain, inactivity, stiffness, limitation of mobility. Pain was reduced by 62% from the beginning to the end of the study. Complete tolerability was demonstrated in 82.9% (1262 patients) of the study group; side-effects, mainly involving the gastrointestinal tract, were seen in only 17.1% of the study group (260 patients). Side-effects were reported in 2.2% of the patients; 5.3% of these were shown to result from proglumetacin treatment. It was concluded that proglumetacin, at the optimum dose of 450 mg/day, answers the need for an effective and well tolerated drug of first choice in the treatment of arthritis.