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   Table of Contents - Current issue
Coverpage
January-March 2021
Volume 12 | Issue 1
Page Nos. 1-28

Online since Monday, July 5, 2021

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RESEARCH PAPERS  

Efficacy and safety comparison between pioglitazone and linagliptin in combination with metformin among patients with Type 2 diabetes mellitus: A meta-analysis of randomized controlled trials p. 1
Omaimah Toufiq, Syed Wasif Gillani, Farhanah Mohamed, Nafis Pasha, Muhsina Chiraparambil, Affana Parveen
DOI:10.4103/jpp.JPP_154_20  
Objective: To compare the safety and efficacy of linagliptin with pioglitazone in combination therapy of metformin for the management of type 2 diabetes mellitus (T2DM). Materials and Methods: A meta-analayis research design is applied to evaluate the primary and secondary outcomes. Literature search was carried out using databases such as PubMed, Cochrane Library, MEDLINE Complete, Scopus, Clinical Trial Registry, and Web of Science. Studies were considered eligible if the eligibility criteria were met. Cochrane Collaboration Tool was used to assess the risk of bias in randomized clinical trials. Results: A total of 170 citations were identified during the database search. Further evaluation of articles confirmed 16 clinical trials suitable for the research which were randomized, double-blinded, and published as full articles. The articles were evaluated with low risk of bias and high-quality evidence. The mean baseline hemoglobin A1c (HbA1c) ranged from 6.93% to 9.99% and 7.1% to 8.89% for linagliptin with metformin and pioglitazone with metformin groups, respectively. Two among the 12 groups show a slight increase in the mean HbA1c levels which is nonsignificant due to their sample size. Overall, the combination therapy of linagliptin with metformin led to a reduction of 1.35% which is significantly higher than pioglitazone combined with metformin which led to a 1.27% reduction. The mean baseline values of fasting plasma glucose levels varied from 158.2 mg/dl to 198.0 mg/dl in linagliptin plus metformin group, whereas in pioglitazone plus metformin group, the values varied from 137.0 mg/dL to 212.4 mg/dL. The high heterogeneity could refer to the inconsistencies between the studies. The combination of linagliptin with metformin showed a significant reduction of 0.56% in body mass index, whereas pioglitazone with metformin led to a 0.37% reduction. Conclusion: The findings showed better efficacy profiling of lingaliptin–metformin combination compared with pioglitazone combination therapy.
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Comparison of intravenous ramosetron and ondansetron as prophylaxis for postoperative nausea and vomiting following general anesthesia p. 10
Sonali Opneja, Shirley Ann D Souza, Roopesh Sureshan, Pabitra Ghoshal
DOI:10.4103/jpp.JPP_163_20  
Objective: To compare the efficacy and side effects of 5HT3 antagonists, ramosetron, and ondansetron as prophylaxis for postoperative nausea and vomiting (PONV) following general anesthesia. Materials and Methods: One hundred and ten patients of the American Society of Anesthesiology Grade I–II, between the age group of 18 to 60 years weighing 40 to 70 kg, undergoing general anesthesia were studied. Group 1 received ramosetron 0.3 mg intravenous (IV) and Group 2 received ondansetron 8 mg IV 15 min before the end of surgery. The incidence of PONV, need for rescue antiemetic, and side effects were evaluated in both the groups. QTc interval prolongation was also evaluated in both the groups by taking electrocardiograms at regular intervals. Results: This study showed that there was no statistically significant difference in the incidence of PONV between the ondansetron group and the ramosetron group during the first 24 h after surgery. For PONV score of ≥2 during the first 6 h, the incidence was 3.59% and 1.81% for ramosetron and ondansetron, respectively, and during 6–24 h, the incidence was 1.81% for both the drugs. Conclusion: IV ramosetron 0.3 mg is as effective as IV ondansetron 8 mg in preventing PONV in patients undergoing general anesthesia.
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Effect of HMG-Co-A reductase inhibitors on cardiac autonomic neuropathy in diabetic patients p. 14
Aarya Jitendra Kshirsagar, Yogita Karandikar, Leena Phadake
DOI:10.4103/jpp.JPP_166_20  
Objective: To observe the effect of statins on cardiac autonomic neuropathy in patients with diabetes and to study the correlation between cardiac autonomic neuropathy as assessed by cardiac autonomic reflex tests (CARTs) and by Composite Autonomic Symptom Scale (COMPASS)-31. Materials and Methods: A cross-sectional observational study was conducted on 62 patients having Type 2 diabetes mellitus for more than 5 years. Patients were randomized into two groups, one group received standard antidiabetic therapy and other group received standard antidiabetic along with statin medication at least for more than 1 year. Each patient underwent CART and heart rate variability to assess autonomic dysfunction. In addition, COMPASS 31 questionnaire was used to evaluate symptoms subjectively. Statin Experience Assessment Questionnaire was used to note adverse effects of statins. Chi-square test, Spearman correlation test, and Mann–Whitney U-test were used for statistical analysis. Results: A significant difference in severity of cardiac autonomic dysfunction was observed between two groups as measured by CART (P = 0.016) and COMPASS-31 questionnaire (P = 0.008). Moreover, COMPASS score of >16 was observed in patients with advanced cardiac autonomic neuropathy. A significant correlation was found between COMPASS 31 score and CART results (r = 0.29, P = 0.02). Conclusion: Our study highlights the potential utility of statins in curbing progression of cardiac autonomic neuropathy and can be safely administered in patients with Type 2 diabetes mellitus. COMPASS 31 questionnaire can be used as an effective screening tool for CART referral, facilitating the early detection of cardiac autonomic neuropathy.
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RESEARCH LETTER Top

Antibacterial use in admitted patients of a super speciality hospital in Western India p. 20
Sharan Shyam, Sanjay Jaiswal
DOI:10.4103/jpp.JPP_156_20  
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CASE REPORT Top

Protamine-induced hypotension and pulmonary arterial hypertension p. 23
Nidheesh Chooriyil, Doyce Jom, Prabitha Panattil, Syam Sreedharan
DOI:10.4103/jpp.JPP_157_20  
Protamine is a routinely used safe antidote for heparin reversal in cardiovascular surgeries. Protamine was first introduced to prolong the action of insulin preparations. As protamine interacts with platelets and fibrinogen and has an anticoagulant effect of its own, minimal amount is given to neutralize heparin present in plasma. Although infrequent, protamine is associated with serious adverse drug reactions (ADRs), especially in patients with previous history of protamine hypersensitivity. Here, we report a case of protamine-induced pulmonary arterial hypertension and peripheral vascular collapse in a 60-year-old diabetic male patient who had undergone on-pump coronary artery bypass grafting in a tertiary care center. This was a definite, nonpreventable, severe ADR as per causality, preventability, and severity assessment scale. This patient had no previous history of protamine hypersensitivity and was not on any insulin preparations. Despite precise timely treatment and other resuscitative measures, the patient expired subsequent to these ADRs. This case report throws light on the grave requirement in urgent evolvement of pharmacogenetic and pharmacokinetic tools to detect patients who are at risk of precipitating these ADRs and thus to take precautions to prevent them.
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MOLECULES OF MILLENNIUM Top

Relugolix: A novel gonadotropin-releasing hormone antagonist for prostate cancer p. 26
Merin Babu, Keechilat Pavithran
DOI:10.4103/jpp.jpp_170_20  
Androgen deprivation therapy (ADT) is currently the mainstay of treatment for advanced prostate cancer. The peptide formulations of gonadotropin-releasing hormone (GnRH) antagonists need to be given subcutaneously every month. This led to the development of an oral, nonpeptide GnRH antagonist formulation relugolix which promptly lowers the levels of testosterone, luteinizing hormone, and follicular-stimulating hormone. On December 18, 2020, the US Food and Drug Administration approved relugolix for the treatment of adult advanced prostate cancer. The recommended loading dose of 360 mg on the 1st day of treatment, followed by 120 mg once daily orally, approximately the same time each day. The maximum plasma concentration (Tmax) is obtained within 2.25 h and is metabolized to a major extent by CYP3A mediated mechanism. Hot flushes, musculoskeletal pain, and fatigue are some of its common adverse effects. High rates of testosterone suppression with a limited adverse event profile make it an ideal therapy for the treatment of advanced prostate cancer.
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