Aim
Oral semaglutide, an innovative orally administered GLP-1 receptor agonist for type 2 diabetes (T2D) management was herein evaluated for its effectiveness in a multi-center retrospective ...real-world study.
Methods
We included new-users of oral semaglutide from 18 specialist care centres and collected retrospective data on baseline clinical characteristics. Updated values of HbA1c and body weight were analyzed using the mixed model for repeated measures.
Results
The study included 166 individuals with T2D, predominantly men (64.5%), with a mean age of 64.4 years and a mean diabetes duration of 10.1 years. In the majority of patients (68.3%) oral semaglutide was used as a second-line drug, mostly with metformin. At baseline, mean BMI was 28.9 kg/m
2
and HbA1c was 7.5%. During the 18-month observation period, oral semaglutide demonstrated significant reductions in HbA1c, with a maximum change of − 0.9%, and 42.1% of patients achieved HbA1c values below 7.0%. Additionally, there was a substantial reduction in body weight, with an estimated change of − 3.4 kg at 18 months, and 30.3% of patients experienced a 5% or greater reduction in baseline body weight. Only 24.2% of patients reached the 14 mg dose. Subgroup analysis revealed that baseline HbA1c > 7%, persistence on drug, not being on a prior therapy with DPP-4 inhibitors, and loosing 5% or more the initial body weight were associated with greater HbA1c reductions.
Conclusion
This study supports oral semaglutide as an effective option for T2D treatment, offering improved glucose control and weight management in a real-world setting.
Preliminary studies on HCV‐cirrhotics listed for transplant suggest that sofosbuvir in combination with ribavirin is very effective in promoting viral clearance and preventing disease recurrence. ...Unfortunately, the high cost of such treatment (€46 500 per 12 weeks of treatment) makes its cost‐effectiveness questionable. A semi‐Markov model was developed to assess the cost‐effectiveness of sofosbuvir/ribavirin treatment in cirrhotic patients without HCC (HCV‐CIRRH) and with HCC (HCV‐HCC) listed for transplant. In the base‐case analysis, the incremental cost‐effectiveness ratio for 24 weeks of sofosbuvir/ribavirin was €44 875 per quality‐adjusted life‐year gained in HCV‐CIRRH and €60 380 in HCV‐HCC patients. Both results were above the willingness to pay threshold of €37 000 per quality‐adjusted life‐year. Our data also show that in order to remain cost‐effective (with a 24‐week treatment), any novel interferon‐free treatment endowed with ideal efficacy should cost less than €67 224 or €95 712 in HCV‐cirrhotics with and without HCC, respectively. The results shows that sofosbuvir/ribavirin therapy, given to patients listed for transplant, is not cost‐effective at current prices despite being very effective, and new, more effective treatments will have little economic margins to remain cost‐effective. New interferon‐free combinations have the potential to revolutionize the treatment and prognosis of HCV‐positive patients listed for transplant; however, without sustainable prices, this revolution is unlikely to happen.
The authors show that DAA‐based interferon‐free treatments in patients listed for transplantation are borderline cost‐effective at the current price, and the cost‐effectiveness estimates are critically influenced by the duration of treatment. See editorial by Brown on page 1741.
Summary
Different strategies of DAAs treatment are currently possible both pre‐ and postliver transplantation (LT). Clinical and economic consequences of these strategies still need to be adequately ...investigated; this study aims at assessing their cost‐effectiveness. A decision analytical model was created to simulate the progression of HCV‐infected patients listed for decompensated cirrhosis (DCC) or for hepatocellular carcinoma (HCC). Three DAAs treatment strategies were compared: (i) a 12‐week course of DAAs prior to transplantation (PRE‐LT), (ii) a 4‐week course of DAAs starting at the time of transplantation (PERI‐LT) and (iii) a 12‐week course of DAAs administered at disease recurrence (POST‐LT). The population was substratified according to HCC presence and, in those without HCC, according to the MELD score at listing. Data on DAAs effectiveness were estimated using a cohort of patients still followed by 11 transplant centres of the European Liver and Intestine Transplant Association and by data available in the literature. In this study, PRE‐LT treatment strategy was dominant for DCC patients with MELD<16 and cost‐effective for those with MELD16‐20, while POST‐LT strategy emerged as cost‐effective for DCC patients with MELD>20 and for those with HCC. Sensitivity analyses confirmed PRE‐LT as the cost‐effective strategy for patients with MELD≤20. In conclusion, PRE‐LT treatment is cost‐effective for patients with MELD≤20 without HCC, while treatments after LT are cost‐effective in cirrhotic patients with MELD>20 and in those with HCC. It is worth reminding, though, that the final choice of a specific regimen at the patient level will have to be personalized based on clinical, social and transplant‐related factors.
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