Pitavastatin lowers risk of major adverse cardiovascular events in human immunodeficiency virus-infected persons

A recent study found that pitavastatin lowers the risk of cardiovascular disease among persons with human immunodeficiency virus (HIV) infection. This study’s results were published in The New England Journal of Medicine.

This phase 3, randomized trial included 7769 participants with HIV infection, having low-to-moderate risk of cardiovascular disease. The antiretroviral therapy was replaced by pitavastatin calcium daily at a dose of 4mg or placebo. The primary outcome included the occurrence of a major cardiovascular event, defined as a mix of myocardial infarction, stroke, peripheral arterial ischemia, cardiovascular death, transient ischemic attack, hospitalization for unstable angina, revascularization, or death due to unknown reasons.

The median CD4 count was found to be 621 cells per cubic millimetre while HIV RNA value was below quantification in 5250 of 5997 participants. In the pitavastatin and placebo group, the incidence of a major cardiovascular event was noted as 4.81 per 1000 person-years and 7.32 per 1000 person-years, respectively. 91 participants in the pitavastatin group and 53 in the placebo group showed muscle-related symptoms while diabetes was reported in 206 and 155 participants, respectively.

Based on the above results, it can be concluded that pitavastatin may lower the risk of major adverse cardiovascular events in persons with HIV infection.

Improved anemia status with sacubitril/valsartan compared to enalapril seen in patients with heart failure

According to a recent study, it was found that patients with heart failure and reduced ejection fraction, had reduced incidence of anemia with sacubitril/valsartan. This study’s findings were published in the Journal of the American College of Cardiology.

This randomized controlled trial enrolled 1,677 anemic patients who were having <130 g/L and <120 g/L levels of hemoglobin in men and women, respectively at the time of screening. The participants were either given sacubitril/valsartan or enalapril. Clinical outcomes based on the change in hemoglobin levels from baseline, incidence of anemia, and anemia status were assessed.

Patients with anemia are more prone to severe heart failures, but those on sacubitril/valsartan showed a decreased risk of cardiovascular death or hospitalization due to heart failure in patients with or without anemia. During the time between baseline to one year, hemoglobin lowered by 1.5 g/L with sacubitril/valsartan while it was 2.3 g/L with enalapril. Also, at 12 months those on sacubitril/valsartan were less likely to develop anemia compared to those on enalapril.

It was observed that hemoglobin levels reduced less in patients randomized with sacubitril/valsartan and so did the incidence of new anemia. Thus, based on these findings, it may be concluded that sacubitril/valsartan lowers mortality and hospitalization, irrespective of anemia status in patients with heart failure

Pembrolizumab monotherapy linked to overall better survival in patients with advanced gastric cancer

Pembrolizumab monotherapy was linked to numerically better overall survival and a better tolerability profile in patients with advanced gastric cancer/gastroesophageal junction cancer who were positive for programmed death ligand 1, says a recent study. This study was published in the journal, Japanese Journal of Clinical Oncology.

This was a randomized controlled trial that included 187 participants who were divided into three groups: pembrolizumab 200mg, pembrolizumab plus chemotherapy (cisplatin + 5-fluorouracil or capecitabine), and placebo plus chemotherapy Q3W in 1:1:1 ratio. The overall survival in populations with combined positive scores of ≥1 and ≥10 was the  primary endpoint, while safety and tolerability were the secondary endpoints .

According to the findings, the median overall survival was numerically longer with pembrolizumab than chemotherapy (22.7 vs 13.8 months) and pembrolizumab plus chemotherapy compared to chemotherapy (16.5 vs 13.8 months), in the programmed death ligand 1 combined positive score ≥1 and ≥10 population.

Therefore, patients with advanced gastric cancer and positive for programmed death ligand-1 had better overall survival and tolerability profiles with pembrolizumab monotherapy, compared to chemotherapy.

Safety and efficiency of modified tissue-selecting therapy stapler combined with complete anal canal epithelial preservation operation in circumferential mixed hemorrhoids

A recent study suggested that a modified tissue-selecting therapy stapler combined with complete anal canal epithelial preservation operation (M-TST-CACP) was safe and efficient for use in the treatment of circumferential mixed hemorrhoids. This study was published in the journal, Langenbeck’s Archives of Surgery.

The trial was a single-center, statistical-analyst blinded, and randomized controlled trial (RCT) that included 306 patients. The statistical difference between the M-TST-CACP group and the procedure for prolapse and hemorrhoids (PPH) group was noted using the t-test or Mann-Whitney U test.

It was seen that the M-TST-CACP group showed a higher cure rate, lower recurrence and anal incontinence score, and lower rate of anal stenosis than the PPH group. Thus, the above results showed that M-TST-CACP may have better efficiency and safety than PPH and can be adopted by surgeons to treat circumferential mixed hemorrhoids.

Higher doses of oral semaglutide superior to lower dose in treating type 2 diabetes

A recent study suggests that higher investigational doses of oral semaglutide was superior to lower dose in treating type 2 diabetes. This study findings were published in the journal, Lancet.

The study was a global, multicenter, phase 3b, randomized, double-blind trial carried out among 1606 adult patients with type 2 diabetes, glycated haemoglobin (HbA1c) 8·0-10·5% (64-91 mmol/mol), a BMI of 25·0 kg/m2 or greater. The participants were randomly assigned in a 1:1:1 ratio to receive 14 mg (n=536), 25 mg (n=535), or 50 mg (n=535) of once-daily oral semaglutide for 68 weeks. The primary endpoint was change in HbA1c, from baseline to week 52.

At baseline, mean (SD) HbA1c was 9·0% and mean bodyweight was found to be 96.4kg. At week 52, mean changes (SE) in HbA1c were found to be -1·5 percentage points with 14mg oral semaglutide, -1·8 percentage points with 25mg, and -2·0 percentage points with 50 mg. Mild to moderate gastrointestinal disorders occurred more commonly in 25mg and 50 mg groups.

This study demonstrated that oral semaglutide at 25mg and 50mg were superior to 14mg dosage in reducing HbA1c and bodyweight in adults with inadequately controlled type 2 diabetes.

Adding low-dose tremelimumab to durvalumab and chemotherapy improves overall survival in metastatic NSCLC

A latest study reported that the addition of low-dose tremelimumab to durvalumab and chemotherapy (TMC) improves overall survival rate in patients with metastatic non-small-cell lung cancer (mNSCLC). This study was published in the Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology.

This phase III, randomized open-label study included 1,013 patients with wild-type mNSCLC who were randomly assigned (1:1:1) to receive tremelimumab 75 mg plus durvalumab 1,500 mg and platinum-based chemotherapy (T + D + CT) for about four 21-day cycles, followed by durvalumab once every 4 weeks until progression and one additional tremelimumab dose; durvalumab plus chemotherapy for up to four 21-day cycles, followed by durvalumab once every 4 weeks until progression; or chemotherapy for up to six 21-day cycles. Primary and secondary endpoints assessed were progression-free survival (PFS) and overall survival (OS) for D + CT versus CT, and PFS and OS for T + D + CT versus CT.

At the end of the study, PFS was significantly improved with D+ CT compared with CT. PFS (median, 6.2 v 4.8 months) and OS (median, 14.0 v 11.7 months) were significantly improved with T + D + CT versus CT.

Based on the results of the study, it can be concluded that the addition of low-dose tremelimumab to durvalumab and chemotherapy improves overall survival in metastatic non-small-cell lung cancer.

Sacubitril/valsartan reduces plasma NT-proBNP levels in heart failure patients

A recent study found that sacubitril/valsartan (angiotensin-neprilysin inhibitors) is effective in reducing plasma pro-B type natriuretic peptide (NT-proBNP) in patients with ejection fraction >40%, following a recent worsening heart failure (WHF) event. This study’s findings were published in the Journal of the American College of Cardiology.

This randomized, double-blinded study included 466 patients with EF>40%, who were randomized to receive sacubitril/valsartan (n=233) or valsartan (n=233) within 30 days of a WHF event. The primary and secondary hierarchical outcomes assessed were a time-averaged proportional change in NT-proBNP from baseline to weeks 4 and 8, and cardiovascular death, HF hospitalizations, emergency HF visits and change in the NT-proBNP, respectively.

At the end of the study, the time-averaged reduction in NT-proBNP was significant with sacubitril/valsartan. Sacubitril/valsartan reduced the worsening of renal function and also showed beneficial effects in the subgroup with EF ≤60% for NT-proBNP change and hierarchical outcome.

Based on the results of the study, it can be concluded that sacubitril/valsartan may reduce plasma NT-proBNP levels compared to valsartan alone in heart failure patients.

RSVPreF3 OA vaccine can prevent respiratory infections in older adults

AS01E-adjuvanted RSV prefusion F protein-based vaccine (RSVPreF3 OA) displayed an acceptable safety profile and prevented acute respiratory infections associated with respiratory syncytial virus (RSV), reduced respiratory tract diseases in the elderly according to a new study. This study was published in the New England Journal of Medicine.

24,966 participants were randomized to receive a single dose of either the RSVPreF3-OA vaccine or placebo. Efficacy was evaluated for severe RSV-related lower respiratory tract disease and RSV-related acute respiratory infection, and safety was evaluated.

The vaccine efficacy against RSV-related lower respiratory tract disease was 82.6% with 7 cases in the vaccine group and 40 cases in the placebo group. Vaccine efficacy was 94.1% against severe RSV-related lower respiratory tract disease and 71.7% against RSV-related acute respiratory infection. High vaccine efficacy was observed in various age groups and in participants with coexisting conditions. The RSVPreF3 OA vaccine was found to be more reactogenic compared to the placebo.

According to this study, a single dose of the RSVPreF3 OA vaccine had acceptable safety profile, prevented RSV-related acute respiratory infection and RSV-related lower respiratory tract disease regardless of RSV subtype and the presence of underlying coexisting conditions in older adults (≥ 60 years).

Vitamin C decreases postoperative catheter-related bladder discomfort

A recent study suggests that administration of Vitamin C has a lower incidence of moderate to severe postoperative catheter-related bladder discomfort (CRBD) in patients with bladder tumor. The results of this study were published in the Journal of clinical anesthesia.

In this double-blind, randomized controlled trial, out of the 118 patients who underwent transurethral resection of bladder tumor, 59 were assigned to receive 1 gm of Vitamin C intravenously. The control group (n=59), was administered normal saline after the induction of anesthesia. The primary endpoint of the study included moderate or severe CRBD immediately postoperatively. The secondary endpoints were moderate or severe CRBD, measured at 1, 2, and 6h after the surgery.

While moderate CRBD symptoms included flailing limbs, intense verbal reactions, and attempts to remove the catheter, more severe forms of CRBD were related to patient behavioral responses. The group receiving Vitamin C showed lower incidence of moderate or severe CRBD immediately after surgery compared to the placebo group. The intervention group also showed significantly lower rates of moderate-to-severe CRBD at 1 and 2 hours postoperatively. Additionally, higher patient satisfaction scores were seen in the group receiving Vitamin C.

Based on the above findings, it can be concluded that Vitamin C administration plays a significant role in decreasing postoperative discomfort related to CRBD in patients with bladder tumor.