Sustained-Release Vildagliptin 100 mg in Type 2 Diabetes Mellitus: A Review.

Dipeptidyl peptidase-4 inhibitors (DPP4Is) were introduced into the management of type 2 diabetes mellitus (T2DM) as they are insulinotropic and have no inherent risk of hypoglycemia and no effect on body weight. Currently, 11 drugs in this class are available for the management of diabetes. Although they have a similar mechanism of action, they differ from one other in their binding mechanisms, which influences their therapeutic and pharmacological profiles. Vildagliptin's overall safety and tolerability profile was comparable to placebo throughout clinical studies, and real-world data in a large group of T2DM patients corroborated this finding. Therefore, DPP4Is like vildagliptin is a secure alternative for treating patients with T2DM. Vildagliptin treatment given as a once-daily (QD) 100 mg sustained release (SR) formulation fits the criteria of adherence and compliance. This SR formulation, given once daily has the potential to provide glycemic control like the vildagliptin 50 mg twice-daily (BD) formulation. This comprehensive review discusses the journey of vildagliptin as 50 mg BD therapy as well as 100 mg SR QD therapy.

The Real DAPSI: A Real-World Retrospective Study on Assessing the Efficacy and Safety of a Fixed-Dose Combination of Dapagliflozin and Sitagliptin in the Indian Population.

Introduction Type 2 diabetes mellitus (T2DM) is a chronic metabolic disorder affecting millions of individuals worldwide. Effective management of T2DM is crucial to prevent complications. Dapagliflozin and sitagliptin are oral anti-diabetic agents that have been shown to provide synergistic effects in controlling blood glucose levels. However, there is limited data on the efficacy and safety of the dapagliflozin-sitagliptin fixed-dose combination (FDC) in the Indian population. This study aimed to evaluate the real-world effectiveness and safety of the dapagliflozin-sitagliptin FDC in the Indian population. Methods This was a retrospective study conducted at healthcare centers in India. The study included patients with T2DM who were prescribed a FDC of dapagliflozin and sitagliptin. Data were collected from the medical health records of patients, including demographics, baseline glycated hemoglobin (HbA1c), blood glucose levels, BMI, blood pressure, and adverse events. The primary outcome was the change in HbA1c, postprandial plasma glucose (PPG), and fasting plasma glucose (FPG) from baseline to 12 weeks after treatment initiation. Results A total of 358 patients were included in the study, with a mean age of 56.2 years. The majority of the patients were male (68.2%), and the mean baseline HbA1c was 8.9 ± 0.87%. After 12 weeks of treatment with dapagliflozin and sitagliptin, there was a significant reduction in HbA1c levels from 8.9 to 7.2 (p <0.0001). There was also a significant reduction in fasting blood glucose levels from 178.8 to 124.0 (p <0.0001) and postprandial blood glucose levels from 273.9 to 176.0 (p <0.0001). There were no serious adverse events reported during the study period. Conclusion The FDC of dapagliflozin and sitagliptin is effective and safe in reducing blood glucose levels and BMI in the Indian population with T2DM. This real-world retrospective study provides valuable insights into the clinical effectiveness and safety of dapagliflozin-sitagliptin FDC in the Indian population. These findings highlight the potential benefits of this combination therapy in managing T2DM and pave the way for optimized treatment strategies and improved patient outcomes in the Indian healthcare landscape. Clinicians may consider dapagliflozin-sitagliptin FDC as a viable treatment option for T2DM patients.

Healthcare Practitioners' Perspective of Prevailing Awareness on Diabetes Complications: A Questionnaire-Based Pan-India Study.

The increasing prevalence rate of diabetes mellitus (DM) and the associated long-term complications warrant a need to improve awareness of DM-related complications in the Indian population. Our questionnaire-based pan-India study (April 2021-March 2022) aims to capture the observations of healthcare practitioners (HCPs) on the prevailing level of knowledge and awareness regarding diabetes among their patients. We refer to this as the 90:90:90 program. It aims to achieve 90% awareness, 90% screening and detection of diabetes and prediabetes, and 90% achievement of effective treatment and control. A structured questionnaire was circulated to 1800 HCPs using Google Forms (Google, Mountain View, CA) and Zoom poll questions (Zoom Video Communications, Inc., San Jose, CA) during 125 symposiums. About half (48.6%) of the HCPs observe that less than 40% of their patients are aware of the risk factors of diabetes, and less than 60% of the patients were aware of its cardiovascular complications. About 92-95% of the HCPs recommend screening for diabetes in adults over 30 years of age and suggest the inclusion of a blood glucose estimate as a fifth vital to be tested during doctor visits. Less than 40% of patients fail to achieve the treatment goal, possibly due to lack of adherence, access to medicines, and financial constraints. Therefore, spreading awareness of DM complications and early screening for DM among adults (>30 years) could help achieve better management and treatment outcomes.

Efficacy and Safety of a Fixed-Dose Combination of Vildagliptin and Pioglitazone in Indian Patients With Type 2 Diabetes Mellitus: A Randomized, Open-Label, Comparative, Phase III Study.

Background Type 2 diabetes mellitus (T2DM) arises due to a range of pathological abnormalities, necessitating a combination therapy to achieve optimal glycemic control. Vildagliptin, an effective and selective DPP-4 inhibitor, and pioglitazone, an insulin sensitizer, offer distinct mechanisms of action. Hence, the integration of these medications represents a logical and justified therapeutic strategy Objective To compare the efficacy, safety, and tolerability of vildagliptin and pioglitazone 50 mg/15 mg fixed-dose combination (FDC) tablets with individual monotherapy vildagliptin 50 mg and pioglitazone 15 mg tablets in Indian T2DM patients who were inadequately controlled on metformin monotherapy. Methods This was a randomized, open-label, comparative, multicenter, phase III study involving 195 T2DM patients with inadequate glycemic control on metformin ≥ 1000 mg/day. Patients were randomly assigned in a 1:1:1 ratio to the test product group (n=65) (vildagliptin 50 mg + pioglitazone 15 mg FDC tablets), reference product group 1 (n=65) (vildagliptin 50 mg tablet), or reference product group 2 (n=65) (pioglitazone 15 mg tablet reference product). The primary endpoint was the mean change in HbA1c levels from baseline to end of the study visit (12 weeks (84 days ±2)). The secondary endpoints were the mean change in fasting plasma glucose (FPG) and 2-hr postprandial plasma glucose (2-hr PPG) levels. Safety parameters were assessed till the end of the study. Results A total of 178 patients completed the study. At 12 weeks, the mean HbA1c level in the test group reduced to 6.85 ± 1.27%, in the reference product 1 group to 7.56 ± 1.72%, and in the reference product 2 groups to 7.37 ± 1.59%. The mean change in Hb1Ac from baseline in the test group was statistically significant compared to the reference groups (p=0.037). Similarly, the mean changes in the FPG and 2hr-PPG with the test product were statistically significant compared to reference products (p=0.041). The adverse events were comparable across all the treatment groups. Conclusion In Indian T2DM patients inadequately controlled on a daily maximum dose of metformin, treatment with vildagliptin and pioglitazone FDC showed better glycemic control than either vildagliptin or pioglitazone along with a good tolerability profile.

Efficacy of Cilnidipine (L/N-type Calcium Channel Blocker) in Treatment of Hypertension: A Meta-Analysis of Randomized and Non-randomized Controlled Trials.

INTRODUCTION:  Hypertension is one of the most common cardiovascular diseases, and the prevalence of hypertension continues to rise across the globe. National and international guidelines recommend angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs), calcium channel blockers (CCBs), diuretics, and beta-blockers for the management of hypertension. CCBs are among the most used antihypertensive medications and Cilnidipine is a newer dihydropyridine CCB shown to have a prolonged antihypertensive property. OBJECTIVE:  This meta-analysis of comparative randomized and non-randomized clinical trials evaluated the effect of Cilnidipine monotherapy or combination therapy on systolic blood pressure (SBP), diastolic blood pressure (DBP), and pulse rate (PR) over 48 weeks of therapy. STUDY DESIGN:  PubMed (MEDLINE) and Google scholar databases were searched to identify studies designed to evaluate the effects of Cilnidipine in the treatment of hypertensive patients. The study criteria for inclusion into the meta-analysis were all prospective, randomized, and non-randomized clinical studies published till March 2021, studies published in a peer-reviewed journal, the inclusion of patients with hypertension, assessment of blood pressure and heart rate, and a follow-up of four weeks or longer. The initial search identified 82 potential articles; of these, 24 met the inclusion criteria. Studies with <4 weeks treatment period and those not having a CCB were excluded. OUTCOMES:  Change in SBP, DBP, and PR from baseline at the end of therapy compared between the Cilnidipine and other CCB's. RESULTS: Cilnidipine caused a significant reduction (p<0.05) in SBP, DBP, and PR at end of therapy, whereas the reduction in SBP, DBP, and PR with Cilnidipine was similar to other CCB's (p>0.05). The results of this meta-analysis revealed that there were no significant differences in the efficacy in the treatment of hypertensive patients with Cilnidipine and the other therapies. CONCLUSION:  Cilnidipine has similar anti-hypertensive effects compared with other first-line antihypertensive drugs commonly used in practice. We recommend Cilnidipine as a novel first-line CCB for the management of hypertension either as a monotherapy or as a combination therapy.

Impact of different controlled ovarian stimulation protocols on the physical and psychological burdens in women undergoing in vitro fertilization/intra cytoplasmic sperm injection.

CONTEXT: Infertility treatment involves a considerable amount of physical and psychological burden which may impact the outcome. AIM: The objective was to understand the amount of physical and psychological burden in women undergoing their first in vitro fertilization (IVF)/intra cytoplasmic sperm injection (ICSI) cycles. SETTING AND DESIGN: Multi-center, prospective, parallel, observational study. MATERIALS AND METHODS: The study was conducted across 12 IVF centers in India. A total of 692 women undergoing controlled ovarian stimulation as a part of the first cycle IVF/ICSI completed the trial. Women were recruited in 2 groups based on type of treatment (Group A - gonadotropin-releasing hormone [GnRH] antagonist; Group B - GnRH agonist) and were asked to fill questionnaires during the 2 treatment visits. RESULTS: The mean changes between Visit 1 (baseline) and Visit 2 in anxiety and depression (Hospital Anxiety and Depression Scale) scores in Group A for anxiety and depression were -0.5 (3.67), -0.1 (3.57) respectively and for Group B were -0.4 (3.68), 0.1 (3.67) respectively, which was not statistically significant. In Group A, the mean (±standard deviation [SD]) Hopkins Symptom Check List (HSCL) score was 17.9 (±5.17) in visit 1 and 19.1 (±5.45) Visit 2. The change between visits was 1.1 (P < 0.0001) with higher score reflecting higher somatic distress symptoms. In Group B, the mean (±SD) HSCL score was 18.2 (±5.19) in Visit 1 and 18.8 (±5.23) in visit 2. The change between visits was 0.6 (P < 0.0014). The difference of the mean change in physical burden between Group A and Group B was not statistically significant. CONCLUSION: A significant impact in both treatment protocols with respect to the physical burden was found between Visit 1 and Visit 2 but no difference in physical or psychological burden between the two treatment groups was observed.

Impact of structured counseling on the selection of hormonal contraceptive methods: results of a multi-centric, observational study in India.

OBJECTIVE: To determine the influence of "structured contraception counseling" on Indian women's selection of contraceptive methods. METHODS: Women (≥18 and ≤40 years) requesting contraception were enrolled at 36 sites. "Structured contraception counseling" was provided by a health care professional on the available contraceptive methods. Questionnaires on the women's pre- and post-counseling contraceptive choice, her perceptions, and the reasons behind her post-counseling decision were filled. RESULTS: Significant reductions were observed in the proportion of women who were indecisive (n = 260; 31.5 % pre-counseling vs. n = 30; 3.6 %, post-counseling [P < 0.001]) and women opting for non-hormonal method (24.6 % pre-counseling vs. 6.8 % post-counseling, [P < 0.001]). Of all the women counseled (n = 825), 89.6 % (739/825) of women chose a hormonal contraceptive method. There were significant difference (P < 0.001) in the women's choice of contraceptive in the pre- and post-counseling sessions, respectively (combined oral contraceptive: 30.8 vs. 40.7 %; vaginal ring: 1.8 vs. 14.1 %; progestogen only pills: 1.6 vs. 7.9 %; injectable-depot medroxyprogesterone acetate: 5.9 vs. 13.6 %; levonorgestrel-intrauterine system: 3.8 vs. 13.3 %). CONCLUSIONS: Structured contraception counseling using standardized protocol and aids resulted in a significant increase in the selection of modern contraceptive methods. Post-counseling majority of women opted for hormonal methods with an increase in selection of pills and newer alternatives.

Multicenter Study of Contraceptive Vaginal Ring (NuvaRing(®)) in Normal Daily Practice in Indian Women.

OBJECTIVE: This was the first Indian multicenter study at six specialty hospitals, to assess the real-life usage of the vaginal ring in daily clinical practice. METHODS: This open-label, prospective, single-arm, nonrandomized, interventional study enrolled 252 women aged >18 years, seeking contraception with no contraindications to the use of combined hormonal contraceptive. Women were provided the ring with a monthly follow-up schedule for three cycles. Cycle control, acceptability, tolerability, and safety assessments were recorded at each visit. RESULTS: Regular menstrual bleeding was reported by 76.2 % (192/252) at baseline. In study completers, regular bleeding was seen in 94.1 % (192/204), 97.5 % (199/204), and 98 % (200/204) in the 1st, the 2nd, and the 3rd cycles, respectively. Most (94.2 % [195/207]) women were very satisfied or satisfied with the ring, and 93.2 % (193/207) would recommend it to others. No pregnancies or serious adverse events were reported. CONCLUSION: The study demonstrated that NuvaRing(®) is a highly effective contraceptive method with an excellent cycle control. It is well tolerated and accepted by Indian women.

Kinetics studies of synthesis of biodiesel from waste frying oil using a heterogeneous catalyst derived from snail shell.

Waste frying oil was used to produce biodiesel using calcined snail shell as a heterogeneous base catalyst. Trans esterification reactions were carried out and the yield and conversion of the product were optimized by varying the methanol to oil molar ratio, catalyst amount, reaction temperature, and time. A biodiesel conversion of 99.58% was obtained with a yield of 87.28%. The reaction followed first order kinetics. The activation energy (E(A)) was 79kJ/mol and the frequency factor (A) was 2.98×10(10)min(-1). The fuel properties of the biodiesel were measured according to ASTM D 6751 and found to be within the specifications. Snail shell is a novel source for the production of heterogeneous base catalyst that can be successfully utilized for synthesis of biodiesel of high purity.