Efficacy, tolerability and influence on "quality of life" of nifedipine GITS versus amlodipine in elderly patients with mild-moderate hypertension.

OBJECTIVE: The main purpose of this study was to compare efficacy, tolerability and influence on quality of life (QOL) of nifedipine gastrointestinal therapeutic system (NI) 30-60 mg once a day vs amlodipine (AM) 5-10 mg once a day in elderly patients with mild-moderate hypertension. DESIGN: This was a randomized, double-blind, parallel-group, multicenter study. After a 2-week single-blind placebo run-in, patients were randomized to either NI 30 mg or AM 5 mg. Responders continued on the same dosage for 16 additional weeks, while non-responders were titrated to 60 mg NI or 10 mg AM. METHODS: Blood pressure was measured by mercury sphygmomanometer and efficacy equivalence of NI and AM tested by covariance analysis. Diastolic blood pressure (DBP) was the primary efficacy parameter, its baseline value being taken as covariate while centers effect and treatment interaction were included as fixed effects in the analysis model. The secondary efficacy variables systolic blood pressure (SBP) and scores for QOL were analyzed according to the same model. RESULTS: At the end of the study, overall mean DBPs, calculated as least-square means (LSMEANS), in the "by protocol" population were 87.5 mmHg for NI and 86.7 for AM (difference 0.8 mmHg with 90% CI -1.2 to 2.8 mmHg). In the "by intention to treat" (ITT) population LSMEANS were 87.6 mmHg for NI and 86.4 mmHg for AM (difference 1.2 mmHg with 90% CI -0.6 to 3.1 mmHg). SBP LSMEANS in the "by protocol" population were 147.7 mmHg for NI and 147.3 mmHg for AM (difference 0.3 mmHg, with 90% CI -3.7 to 4.3); corresponding values in the "by ITT" population were 148.0 mmHg for NI and 147.2 for AM (difference 0.8 mmHg, with 90% CI -2.8 to 4.6). Mean values for QOL parameters were not significantly different. A total of 173 episodes of adverse events were documented in 54 patients (26 NI and 28 AM), dropouts were 15 (20% of group) on NI and 21 (28%) on AM. CONCLUSIONS: NI 30-60 mg was shown to be as efficacious and safe as AM 5-10 mg in elderly patients with mild-moderate hypertension. QOL improved compared to baseline with no significant difference between the two drugs, thus confirming a positive class effect for calcium antagonists.

Prevalence of NIDDM and impaired glucose tolerance in Italy: an OGTT-based population study.

To provide complete prevalence data on diabetes mellitus in Italy (diagnosed and undiagnosed), a population survey was performed in the Health District of Cremona, a representative area of the Po river (north Italy). The survey is characterised by particular attention being paid to methodology, non-responders being investigated for possible selection biases affecting diagnosed and undiagnosed diabetes prevalence estimations. Out of a population aged 44 years or older from three municipalities, a random sample of 3097 subjects was selected to undergo an oral glucose tolerance test. In addition, past medical history, clinical and laboratory data were collected. A total of 1797 subjects participated (58%), and information on known diabetes status was obtained for 2618 persons (85%), also including 826 interviewed non-participating subjects. Overall rates were age-standardised according to the 1991 Italian census. Overall prevalence and 95% confidence interval of diagnosed diabetes was 8.5% (6.9-10.1) in males and 7.9% (6.7-9.3) in females over the age of 44 years; previously undiagnosed diabetes was 2.5% (1.4-3.6) in males and 3.4% (2.1-4.7) in females; glucose intolerance was 7.7% (5.7-9-7) in males and 8.9% (7.0-10.8) in females. Total diabetes prevalence above age 44 years, developed-world age, and sex standardised, was 10.7%. This study provides the first reliable prevalence estimation of impaired glucose tolerance, diagnosed and undiagnosed diabetes in Italy, according to World Health Organization criteria, and one of the few figures for Southern Europe. The role of body mass index on both prevalence of diabetes and cluster of cardiovascular risk factors is considered, with implications for prevention.

[Familial pheochromocytoma: a family studied for 3 generations]. / Feocromocitoma familiare: una famiglia studiata per tre generazioni.

A family with a very high prevalence of pheochromocytoma (62%, i.e. 100% in the 1st generation and 75% of the second one) is described. The proband was a 19-year-old woman with a 30 g right-side tumor, who died at 24 years because of a heart failure. Both sisters of the proband developed a right-side pheochromocytoma at 13 and respectively 14 years of age and are now normotensive after surgical exeresis. One of them had 3 sons: 2 with pheochromocytoma and a third one dead at 9 years of age for pulmonary oedema. Accuracy is needed in studying relation of all subjects with pheochromocytoma.

An Italian population-based study of the prevalence of diabetes: some methodological aspects.

The aim of the present study, which is part of a larger population survey, is to provide an Italian estimate of the total prevalence of diabetes taking into account the fraction of known diabetes among the non-responders. The study consists of a population survey. Out of the population aged over 40 ys. of two municipalities, Casalbuttano and Vescovato, in the Health District of Cremona, a random sample of 2,229 subjects was selected to undergo an OGTT. In addition, a series of anamnestic, clinical, and laboratory data were collected for each individual. Overall response rate was 63%. Prevalence of known diabetes was 7.8% (6.5%-9.1%, 95% CI), (F = 7.9%, M = 7.6%). The comparison between responders and the telephone-interviewed non-responders showed an unpredictable and age- and sex-dependently varying frequency of known diabetes, even if the overall differences were not statistically significant. This suggests that, to avoid biases, many efforts should be spent to collect information about diabetes also for non-responders. Prevalence of unknown diabetes was 3.2% (2.2%-4.2%, 95% CI), (F = 4.0%, M = 1.8%) and total diabetes was 10.9% (9.3%-12.5%, 95% CI) (F = 11.9%, M = 9.4%). In contrast to other countries, the relationship between unknown and known diabetes was less than 1 to 2, and the proportion of unknown diabetes was almost negligible below the age of 70. A positive family history and a lower level of triglycerides were associated with awareness of the disease (p = 0.0005 and p = 0.006, respectively), thus suggesting different behaviour towards one's own health between known and unknown diabetic subjects.

Cyclophosphamide, epirubicin, high-dose folinic acid and 5-fluorouracil (super-FEC) as first-line chemotherapy for advanced breast cancer: preliminary results.

Forty patients with metastatic breast cancer were treated with a new combination regimen consisting of cyclophosphamide, epirubicin, high-dose folinic acid and 5-fluorouracil (super-FEC). A major objective response was observed in 32 patients (80%). Among these, 11 patients (27%) experienced a complete remission. The median duration of response was 10+ and 12+ months for CR and PR, respectively. The most common side-effect was oral mucositis (Grade III = nine patients; grade IV = two patients), while haematological toxicity was virtually absent. Considering the high-risk characteristics of the vast majority of the enrolled patients (75% had dominant visceral disease), these preliminary results suggest that super-FEC has a powerful activity in poor-prognosis metastatic breast cancer with an acceptable degree of toxicity.