scholarly journals Lovastatin: a new “ancient” molecule for hypercholesterolaemia/dyslipidaemia treatment

2008 ◽  
Vol 2 (2) ◽  
pp. 63-74
Author(s):  
Gianlorenzo Imperiale ◽  
Claudio Marengo
Keyword(s):  
Reductase Inhibitor ◽  
Cardiovascular Prevention ◽  
Lipid Lowering ◽  
Eligibility Criteria ◽  
Italian National Health Service ◽  
Clinical Benefits ◽  
Italian National Health ◽  
Hmgcoa Reductase Inhibitor ◽  
Secondary Cardiovascular Prevention

Lovastatin is the first HMGCoA-reductase inhibitor used for the control of hypercholesterolaemia (USA, 1987). In Italy, it’s been authorized for the therapy of hypercholesterolaemia/dyslipidaemia since end 2005. Several studies, conducted both in primary and in secondary cardiovascular prevention, underline the favourable profile in reducing the risk for ischaemic events and their complications. This molecule has the capability to reduce plasmatic atherogenic lipids levels enough to induce clinical benefits. The safety and tolerability of lovastatin are proved even for high dosages, as well as for long term use. Pharmacoeconomic evaluations have shown the value of its choice, in particular for patients who need lipid-lowering treatment but don’t satisfy eligibility criteria for reimbursement by the Italian National Health Service, as outlined by AIFA in 2005.

A randomized controlled trial to evaluate laparoscopic versus open complete mesocolic excision (CME) for stage II, III colorectal cancer (CRC): First efficacy results from Japan Clinical Oncology Group Study JCOG0404.

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 656-656 ◽  
Author(s):  
Masafumi Inomata ◽  
Hiroshi Katayama ◽  
Junki Mizusawa ◽  
Masahiko Watanabe ◽  
Kenichi Sugihara ◽  
...  
Keyword(s):  
Overall Survival ◽  
Controlled Trial ◽  
Complete Mesocolic Excision ◽  
Late Complications ◽  
Stage Ii ◽  
Eligibility Criteria ◽  
Term Survival ◽  
Clinical Benefits ◽  
Mesocolic Excision

656 Background: The benefits of laparoscopic surgery (LAP) compared with open surgery (OP) have been suggested; however, the long-term survival of LAP for advanced CRC requiring CME is still unclear. We conducted a trial to confirm the non-inferiority of LAP to OP in terms of overall survival (OS). Favorable short-term complications and clinical benefits of LAP have already been demonstrated. Overall survival, the primary endpoint, and late post-operative complications are presented here. Methods: Only accredited surgeons from 30 Japanese institutions participated. Eligibility criteria included histologically proven CRC; tumor located in the cecum, ascending, sigmoid or rectosigmoid colon; T3 or deeper lesion without involvement of other organs; N0-2 and M0; tumor size =<8 cm; age 20-75 years. Patients with pathological stage III received adjuvant chemotherapy with fluorouracil plus leucovorin. The planned sample size was 1,050 patients with a power of 80%, a one-sided alpha of 5% and the non-inferiority margin of the hazard ratio (HR) as 1.366. Results: A total of 1,057 patients were randomized (OP 528, LAP 529) between October 2004 and March 2009. Conversion to OP was needed for 29 patients in LAP arm. 5-year OS was 90.4% (95% CI: 87.5-92.6%) in OP, and 91.8% (89.1-93.8%) in LAP. The non-inferiority of laparoscopic CME in OS was not demonstrated (HR: 1.06 [90% CI: 0.79-1.41(>1.366)], p=0.073). 5-year RFS was 79.7% (76.0-82.9) in OP and 79.3% (75.6-82.6) in LAP (HR: 1.07 [95%CI: 0.82-1.38]). Proportion of grade (G) 2-4 late complications was 22.6% (OP 12.5%, LAP 10.1%). Late complications (G2-G4) included constipations (OP 6.0%, LAP 4.4%), diarrhea (OP 2.9%, LAP 2.7%), paralytic ileus (OP 1.2%, LAP 1.7%), and bowel obstruction of small intestine (OP 3.1%, LAP 2.1%). Conclusions: The non-inferiority of laparoscopic CME in OS was not demonstrated for stage II, III CRC. However, since OS of both arms are almost identical and better than expected, laparoscopic CME is acceptable as a treatment option for stage II, III CRC. Clinical trial information: C000000105.

scholarly journals Valutazione economica dello studio TNT

2007 ◽  
Vol 8 (2S) ◽  
pp. 19-22
Author(s):  
Lorenzo G. Mantovani ◽  
Sabato Montella ◽  
Anna Citarella ◽  
Simona De Portu
Keyword(s):  
Coronary Heart Disease ◽  
Heart Disease ◽  
National Health Service ◽  
Health Service ◽  
National Health ◽  
Lipid Lowering ◽  
High Dose ◽  
Stable Coronary Heart Disease ◽  
Italian National Health Service ◽  
Italian National Health

Introduction: the Treating to New Targets (TNT) study showed that intensive lipid-lowering therapy with atorvastatin 80 mg/die provides significant clinical benefit beyond that afforded by atorvastatin 10 mg/die in patients with stable coronary heart disease (CHD). Objective: our aim was to investigate the economic consequence of high dose of atorvastatin in Italian patients with stable coronary heart disease (CHD). Methods: data were derived from the Intensive Lipid Lowering with Atorvastatin in Patients with Stable Coronary Disease (TNT) study. We conducted a cost-effectiveness analysis, comparing high dose of atorvastatin (80 mg/die) versus usual-dose of atorvastatin (10 mg/die) in the perspective of the Italian National Health Service. We identified and quantified medical costs: drug costs according to the Italian National Therapeutic Formulary and hospitalizations were quantified based on the Italian National Health Service tariffs (2006). Effects were measured in terms of patients free from any event. We considered an observation period of 4.9 years. The costs borne after the first 12 months were discounted using an annual rate of 3%. We conducted one and multi-way sensitivity analyses on unit cost and effectiveness. Results: the cost of atorvastatin 10 mg or 80 mg therapy over the 4.9 years period amounted to approximately € 1.6 millions and € 2.5 millions per 1,000 patients respectively. The total cost of atorvastatin high dose was about € 3.7 millions, the incremental cost per patient free from event is about € 12,600. Discussion: this evaluation found that atorvastatin therapy is cost-effective. Sensitivity analysis shows that cost consequences parameters are substantially sensitive to fluctuation.

94-LB: Long-Term Clinical Benefits of Early Combination Approach in Latin American Subpopulation of VERIFY Study

Diabetes ◽  
2020 ◽  
Vol 69 (Supplement 1) ◽  
pp. 94-LB
Author(s):  
SERGIO VENCIO ◽  
JUAN MANOSALVA ◽  
CHANTAL MATHIEU ◽  
PIETER PROOT ◽  
PAIVI M. PALDANIUS
Keyword(s):  
Latin American ◽  
Clinical Benefits ◽  
Combination Approach
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