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   2018| October-December  | Volume 9 | Issue 4  
    Online since October 4, 2018

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Effect of telmisartan on blood pressure in patients of type 2 diabetes with or without complications
Pradeep Gadge, Roshani Gadge, Nikita Paralkar, Preeti Jain, Vrunda Tanna
October-December 2018, 9(4):155-160
DOI:10.4103/picr.PICR_93_17  PMID:30319944
Introduction: Telmisartan is one of the preferred choices of antihypertensive in patients of diabetes with hypertension (HTN) and lowers blood pressure (BP) effectively. Objective: The objective of the study was to determine BP-lowering efficacy of telmisartan monotherapy in patients of Stage I HTN with or without complications of type 2 diabetes mellitus (T2DM). Materials and Methods: In this retrospective study, patients of T2DM without (Group A) or with (Group B) complications who had Stage I HTN and were prescribed telmisartan (20–80 mg/day) treatment were identified from database. Patients included were adults 18 years and above with BP ≥140/80 mmHg but <160/100 mmHg. Data related to demographics, systolic and diastolic BP, blood glucose parameters, and weight before initiation of telmisartan and at the end of 12 weeks treatment were compared with appropriate statistics. Results: In 132 patients included, 28 (21.2%) patients had one or more complications of T2DM. Mean age in Group A and B was similar whereas mean duration of diabetes was significantly higher in Group B than Group A (10.0 ± 5.8 vs. 7.1 ± 5.9, P = 0.023). Telmisartan 40 mg was most frequently used strength (97.1% and 100.0% patients in two groups). Change from baseline in systolic BP in Groups A and B was −19.5 mmHg (95% confidence interval [CI] −16.3, −22.7; P < 0.0001) and −24.9 mmHg (95% CI −17.3, −32.5; P < 0.0001), respectively. Reduction in diastolic BP was also significant in two groups. There were no significant differences in adjusted means of systolic and diastolic BP in two groups. In Group A and B, change from baseline in fasting glucose was −3.7 mg/dL (P = 0.647) and −8.4 mg/dL (P = 0.593); in postmeal glucose was −14.8 mg/dL (P = 0.280) and −36.9 mg/dL (P = 0.046), respectively. Conclusion: Telmisartan is effective in lowering BP and improving metabolic parameters in patients of T2DM with or without complications. A larger and long duration study is needed to substantiate our findings.
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Study designs: Part 1 – An overview and classification
Priya Ranganathan, Rakesh Aggarwal
October-December 2018, 9(4):184-186
DOI:10.4103/picr.PICR_124_18  PMID:30319950
There are several types of research study designs, each with its inherent strengths and flaws. The study design used to answer a particular research question depends on the nature of the question and the availability of resources. In this article, which is the first part of a series on “study designs,” we provide an overview of research study designs and their classification. The subsequent articles will focus on individual designs.
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Comparison of efficacy and safety of topical 1% nadifloxacin and tretinoin 0.025% combination therapy with 1% clindamycin and tretinoin 0.025% combination therapy in patients of mild-to-moderate acne
Swapnil Narayan Deshmukh, Vandana Avinash Badar, Manali Mangesh Mahajan, D Sujata Dudhgaonkar, Dharmendra Mishra
October-December 2018, 9(4):161-164
DOI:10.4103/picr.PICR_109_17  PMID:30319945
Background: Topical retinoids in combination with antimicrobials have been proven to reduce acne lesions faster and to a greater degree than antimicrobial therapy alone . Aims and Objectives: To compare the efficacy and safety of topical combination of 1% Nadifloxacin [NAD] and 0.025% Tretinoin [Tr] with 1% Clindamycin [CLN] and 0.025% Tr in patients of mild to moderate acne vulgaris of the face. Material and Methods: There were two groups (40 patients in each group): Group A received (NAD+Tr) combination therapy and group B received (CLN+Tr) combination therapy. Efficacy was assessed by any reduction in the mean number of inflammatory lesions(IL), non-inflammatory lesions(NIL) and/or total lesions(TL) as well as by using Evaluator's Global Severity Scale (EGSS) of acne and safety was assessed by adverse effects of study medications at 0, 6 and at 12 weeks follow-up. Results: Both the study groups showed statistically significant intragroup reduction in NIL, IL and TL after 12 weeks of therapy. There was no statistically significant reduction at the end of 6 weeks of therapy in both the groups. At the end of 12 weeks of therapy there was a statistically significant reduction in IL, NIL and TL in group A. There was no statistically significant difference in the occurrence of adverse effects in both the groups. Conclusion: Overall the study proved better efficacy of NAD+Tr compared to CLN+Tr. Medications of both the groups were safe and well tolerated.
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Materiovigilance: An Indian perspective
Bikash Ranjan Meher
October-December 2018, 9(4):175-178
DOI:10.4103/picr.PICR_26_18  PMID:30319948
Materiovigilance is the coordinated system of identification, collection, reporting, and analysis of any untoward occurrences associated with the use of medical devices and protection of patient's health by preventing its recurrences. Postmarketing surveillance of medical devices has been initiated in many countries, but it is still not as developed and robust as that of medicines. Materiovigilance program of India was launched on July 6, 2015, at Indian Pharmacopeia Commission with objectives to track the adverse events associated with the use of medical devices, to generate safety data, create awareness among the different stakeholders, and recommend the best practices and interventions to improve the patient's safety.
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Comparative evaluation of pharmacovigilance regulation of the United States, United Kingdom, Canada, India and the need for global harmonized practices
Mohit Hans, Suresh Kumar Gupta
October-December 2018, 9(4):170-174
DOI:10.4103/picr.PICR_89_17  PMID:30319947
The primary focus of the pharmacovigilance (PV) practice has been on the collection, assessment, and reporting of the adverse drug reactions to medicinal products. Globalization of the pharmaceutical industry has prompted efforts to toward harmonization of PV practices worldwide to enable improved knowledge of medicine's benefit-risk profile and risk communication. Even as PV has evolved over the past decade, there still exist few areas of discordance across global PV practices. This article compares the PV legislation in the United States, United Kingdom, Canada, and India with a view to understand areas of harmony in the current legislation across regions and further compare health authorities' requirements with recommendations made by international organizations. Identification of potential areas of disharmony would pave the way to design solutions and strategies toward creation of a comprehensive PV system, which can be easily implemented across the globe, thus promoting the safer use of medicines.
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Evaluation of treatment outcome and adverse drug reaction of directly observed treatment (DOT) plus regimen in multidrug-resistant tuberculosis (MDR-TB) patients at district tuberculosis centre Rajkot
Kiran Gordhanbhai Piparva, Gaurav Jansari, Anil P Singh
October-December 2018, 9(4):165-169
DOI:10.4103/picr.PICR_165_17  PMID:30319946
Background: The emergence of drug-resistant mycobacteria becomes a significant public health problem globally creating an obstacle to effective tuberculosis (TB) control. Gujarat, Maharashtra, and Andhra Pradesh DRS survey estimated that the proportion of multidrug-resistant TB (MDR-TB) is 2.1% (in new TB cases) and 15% (in previously treated cases). Programmatic management of MDR-TB implemented under Revised National Tuberculosis Control Programme in India in 2007. Objectives: The objective of this study is to evaluate treatment outcome and adverse drug reactions (ADRs) of category IV. Materials and Methods: A total of 108 MDR-TB patients were analyzed retrospectively who registered and received treatment during the year of 2014 and 2015 at district TB centre, Rajkot. MDR patients who died or transferred out or defaulter before completion of intensive phase were excluded from the analysis. Results: Of total 108 patients majority patients (64.81%) were in young (20–39 years) with m:f: 2:1. All MDR-TB patients were retreated cases and 69.44% were “undernutrition category”. Culture conversion rate was 86.91% at 4 months of treatment. Cure rate was 50.93% while defaulter rate and died rate was same (17.59%). Failure rate was 18.51%. Weight improvement was significantly associated with cure rate. The incidence of ADR was 32.71%. Most frequent ADRs were related to gastrointestinal system (34.42%), ototoxicity (13.11%), and central nervous system (8.1%). Aminoglycosides, cycloserine, and ethambutol were discontinued due to ADR. Majority ADRs (77.04%) were “possible” category by causality assessment and “mild” in severity assessment. Ototoxicity was only severe ADRs observed. Conclusion: Cure rate was improved than previous years at same center. Attention should be paid for defaulters.
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Investigator-initiated studies: Challenges and solutions
Mahanjit Konwar, Debdipta Bose, Nithya J Gogtay, Urmila M Thatte
October-December 2018, 9(4):179-183
DOI:10.4103/picr.PICR_106_18  PMID:30319949
Investigator-initiated studies (IISs) help by generating data on effectiveness and safety of a drug in the real-world setting and attempt to answer questions that clinicians face in their day-to-day practice. These are studies that are initiated and managed by a nonpharmaceutical company researcher/s who could be an individual investigator, an institution or a group of institutions, and a collaborative study group or a cooperative group. They are largely driven by questions that arise beyond the completion of Phase III studies that have not been studied during Phases I–III of drug development. The benefits of doing IISs are often offset by the myriad challenges posed by an IIS. These include finances, regulatory submissions, continuous oversight, training of study personnel, lack of expertise in statistics, data management, and medical writing Nonetheless, doing an IIS is extremely rewarding for the investigator and has the capacity to contribute to evidence and eventually impact policy. The present article presents both a brief literature review of IISs and a personal narrative of experience gained during the conduct several IISs in the last two decades. Challenges and potential solutions are described.
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Drug-resistant tuberculosis – A ticking time bomb!
Srikanth Krishnamurthy
October-December 2018, 9(4):153-154
DOI:10.4103/picr.PICR_116_18  PMID:30319943
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From “Glivec®” to “Prevnar 13®”: How strong is the Indian drug patenting system?
Gerard Marshall Raj
October-December 2018, 9(4):187-188
DOI:10.4103/picr.PICR_102_18  PMID:30319951
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