Sun Pharma (India)

Objective: Efficacy and tolerability of fixed dose combination (FDC) of 25/50 mg Metoprolol extended release + 40 mg Telmisartan + 12.5 mg Chlorthalidone is demonstrated in Phase 3 trial in patients with hypertension and stable coronary artery disease (CAD). This study was planned to assess its effectiveness on blood pressure (BP; mmHg) and tolerability in real world setting. Design and method: This retrospective, multicentric study retrieved aggregated and anonymized data over 15 months from electronic medical records of 1,810 adult patients with essential hypertension [systolic blood BP (SBP) >= 140 and/or diastolic BP (DBP) >= 90] and stable CAD. Primary endpoint was mean change in BP from baseline to post-index (composite of FDC discontinuation, new therapy addition, or 24 ± 2 weeks treatment with FDC). Secondary endpoints included mean change in BP from baseline to 24 ± 2 weeks, proportion of patients achieving target BP (SBP<140 and DBP < 90) and incidence of adverse events. The study was registered on Clinical Trial Registry, India - CTRI/2023/11/060349) Results: Of 1,810 patients, 1,784 received this FDC for 24 ± 2 weeks. Mean age was 54.81±11.50 years and 58.78% were males. Mean SBP/DBP at baseline was 158.46 ± 15.96/94.23 ± 8.91. Mean changes in SBP (-30.02) and DBP (-12.10) from baseline to post-index in 1,810 patients were significant (p<0.001). In 1,784 patients, mean changes in SBP (30.04) and DBP (-12.07) were significant (p<0.001); 85% patients achieved target BP. Mean change in BP at 4/8/12 ± 2 week was also significant (p<0.001) (Figure 1). Fourteen patients had adverse events; hypotension being most common.Conclusions: In a real-world setting, FDC of Metoprolol + Telmisartan + Chlorthalidone demonstrated effectiveness in controlling blood pressure and was well tolerated in the treatment of hypertension and CAD. Significant reduction in both SBP and DBP, along with a high proportion of patients achieving the target BP, highlights the potential benefits of this FDC in managing hypertension and CAD.

Type 2 diabetes (T2D) is a major public health problem globally, with significant socioeconomic ramifications for healthcare systems. Diabetes unquestionably contributes to both cardiovascular disease (CVD) and chronic renal disease. Hospitalization, low quality of life, and high mortality rate are inevitable in patients with this dual burden. As a result, the emphasis in diabetes care should also be on cardiorenal health. Glycemic control, as well as optimal management of cardiorenal risk factors and comorbidities, is required to eliminate cardiovascular (CV) morbidity and mortality related to T2D. Sitagliptin is a highly efficient and selective dipeptidyl peptidase-4 inhibitor (DPP-4i) that improves glycemic control while having a low risk of hypoglycemia. It has neutral effects on body weight, low proclivity for pharmacokinetic interactions, and a favorable safety profile. Numerous clinical trials have proven that sitagliptin is CV- and renal-safe in T2D patients, even in those with obesity, old age, renal impairment (RI), and preexisting CVD. It also corrects hyperglycemia-induced osmotic diuresis and excessive filtration. In people with T2D who are at high CV risk or moderate-to-severe renal insufficiency, sitagliptin is documented as a well-tolerated treatment that does not augment the risk of CV and renal complications. Sitagliptin may effectively manage CV and renal complications in diabetes patients, considering its CV and renal safety.

Background: Since ancient times, medicinal plants have been in use in medicine and dai-ly life. Objective: To develop new antifungal compounds with low toxicity and high efficacy followed by high bioavailability, the constituents of Terminalia chebula were studied. Methods: The chemical constituents of the plant were evaluated for antifungal potential via Moler-go Virtual Docker against the enzyme 14α-demethylase. Results: The study depicted that tannins exhibited very good potential against the enzyme and could be used further for lead development. Conclusion: The study revealed that the plant possessed various constituents with potential antifun-gal properties and low toxicity.

BackgroundAntipsychotic medications are the primary treatment for schizophrenia, with olanzapine being an effective medication for schizophrenia. The economic cost for each individual with schizophrenia is high, with antipsychotic medication being a major expense. This study aims to develop an economic decision model that compares different treatment options for schizophrenia patients, including olanzapine Orally Dispersible Tablets (ODT), olanzapine [ODT + Standard Oral Tablet (SOT)], risperidone (ODT + SOT), and aripiprazole (ODT + SOT), to determine their cost-effectiveness with an objective to optimize healthcare resource allocation in Morocco.MethodsThe study used published medical literature and a clinical expert panel to develop a decision analytic model. This model was designed to capture parameters such as adherence levels, treatment discontinuation, relapse with and without hospitalization, quality-adjusted life years (QALYs), treatment-related adverse events, healthcare resource utilization, and associated costs. The main outcomes of interest included the total annual direct cost per treatment, QALYs, and incremental cost-effectiveness ratio (ICER) per 1 QALY gained. One-way and probabilistic sensitivity analyses were employed to account for parameter uncertainty.ResultsAccording to the simulation model, the ODT and ODT + SOT as a group form of olanzapine was the most effective treatment option in terms of the lowest percentages of inpatient relapse, and patients who remained stable (11% and 79% respectively) than risperidone (19% and 62% respectively) and aripiprazole ODT (26% and 50% respectively) and ODT + SOT formulation groups. Olanzapine (ODT + SOT) therapy group was cost-effective when compared to the combined group of ODT + SOT forms of risperidone [ICER: Moroccan Dirham (MAD) 103,907], and aripiprazole (ICER: MAD 65,047). Additionally, olanzapine ODT was found to be cost-effective compared to olanzapine SOT with an ICER of MAD 3921, risperidone ODT with an ICER of MAD 1,02,298, risperidone SOT with an ICER of MAD 31,088, and aripiprazole ODT or SOT formulations. All the above ICERs fall under the willingness-to-pay threshold in Morocco of MAD 250,832.40. Sensitivity analyses confirmed the reliability of the findings.ConclusionsThe model concluded that olanzapine ODT is the most cost-effective first-line treatment option for schizophrenia in Morocco when compared to other atypical antipsychotic medications in ODT and SOT formulations.

Objective: We conducted real world study to assess effectiveness (on blood pressure [BP; mmHg]) and tolerability of fixed dose combination (FDC) of 25/50 mg Metoprolol + 40 mg Telmisartan + 12.5 mg Chlorthalidone in treating hypertension and stable coronary artery disease (CAD). Body mass index (BMI) is one of the factors that affects hypertension and CAD. Hence, we performed this subgroup analysis to assess effectiveness of the FDC based on patients’ BMI. Design and method: A retrospective, multicenter study retrieved data over 15 months from electronic medical records of 1,810 adult patients with systolic BP greater or equal to 140 and/or diastolic BP greater or equal to 90 and stable CAD; 1,784 were treated with FDC for 24 ± 2 weeks. Mean change in BP from baseline, proportion of patients achieving target BP (systolic BP &lt; 140 and diastolic BP &lt; 90) and incidence of adverse events were analyzed in patients with BMI &lt; 18.5 kg/m2 (underweight n= 9); 18.5-22.9 kg/m2 (normal n= 249), 23.0-24.9 kg/m2 (overweight n= 464) and greater or equal to 25 kg/m2 (obese n=1,062). Results: Mean changes in systolic (underweight, -33.6; normal, -29.9; overweight, -27.7; obese, -31) and diastolic BP (underweight, -12.2; normal, -11.5; overweight, -12; obese, -12.2) from baseline to 24 ± 2 weeks were significant (p&lt;0.001), Fig 1. Proportion of patients achieving target BP at 24 ± 2 weeks in all except underweight category was &gt;84%. Fourteen patients had adverse events; hypotension being most common. Conclusions: In a real-world setting, the FDC of Metoprolol + Telmisartan + Chlorthalidone was effective in reducing blood pressure and was well-tolerated in treating hypertension with CAD across all BMI categories. The study demonstrated significant reductions in both systolic and diastolic BP for patients with different BMI levels, highlights the potential benefits of FDC in managing hypertension in various body weight groups.

Objective: We conducted a real-world study to assess effectiveness (on blood pressure [BP; mmHg]) and tolerability of fixed dose combination (FDC) of 25/50 mg Metoprolol + 40 mg Telmisartan + 12.5 mg Chlorthalidone in treating hypertension and stable coronary artery disease (CAD). Considering comorbidities as risk factors for hypertension and CAD, this subgroup analysis was conducted in patients with common comorbidities. Design and method: A retrospective, multicenter study retrieved data over 15 months from electronic medical records of 1,810 adult patients with essential hypertension [systolic BP (SBP) greater than or equal to 140 and/or diastolic BP (DBP) greater than or equal to 90] and stable CAD. Of 1,784 patients who received this FDC for 24 ± 2 weeks; 1,224 had comorbidities (obesity: 1,062; diabetes mellitus: 494; dyslipidaemia: 270; hypothyroidism: 121). Results: Mean change in SBP / DBP (obese: -31.1 / -12.2; diabetes mellitus: -29.8 / -11.4; dyslipidaemia: -28.6 / -10.7; hypothyroidism: -26.4 / -8.5) from baseline to 24 ± 2 weeks was significant (p&lt;0.001, Fig 1). Proportions of patients achieving target BP (SBP &lt; 140 and DBP &lt; 90) was &gt;90% in diabetes mellitus and hypothyroidism and &gt;82% in obese and dyslipidaemia patients. Of 14 patients with adverse events (hypotension being most common), 10 had comorbidities. Conclusions: This real-world study demonstrated that the FDC of Metoprolol + Telmisartan + Chlorthalidone was effective in reducing blood pressure and well tolerated in treating patients with hypertension and CAD who had common comorbidities.

Chronic spontaneous urticaria (CSU) is a debilitating affliction that affects diverse quality of life (QoL) parameters such as sleep, self-esteem, and daily activities. Second-generation antihistamines, such as desloratadine, are more effective and safer in managing CSU. Desloratadine is a nonsedating, potent, and highly selective H1 receptor antagonist. At its daily dose of 5 mg, almost half of CSU patients do not show symptomatic improvement. European Academy of Allergy and Clinical Immunology (EAACI)/Global Allergy and Asthma European Network (GA2LEN)/European Dermatology Forum (EDF) (EuroGuiDerm)/Asia Pacific Association of Allergy, Asthma and Clinical Immunology (APAAACI) guidelines recommend increasing the dosage to up to four times in such nonresponsive patients. However, there is insufficient clinical evidence in Indian settings. We evaluated the efficacy and safety of 10 mg desloratadine (OD) in 256 nonresponsive patients with moderate to severe CSU. The primary outcome was the change in Urticaria Activity Score (UAS7) from baseline to four weeks. Additionally, change in Chronic Urticaria Quality of Life (CU-Q2oL) scores during the course of treatment was also evaluated. The mean UAS7 scores showed a significant reduction from 31.9 ± 4.8 at baseline to 18.2 ± 8.1 at the end of the study (p < 0.0001). The use of a higher dose of desloratadine also decreased the CU-Q2oL scores significantly from 59.8 ± 14.7 at baseline to 35.4 ± 10 at four weeks (p < 0.0001). The incidence of adverse events (AEs) possibly linked to the drug was low (1.6%), and no serious adverse events were reported. Results indicated improvements in the disease severity as well as its positive impact on participants' QoL. This study confirms the efficacy and safety of daily use of a twofold dose of desloratadine in nonresponsive moderate to severe CSU patients.