Journal of Clinical and Diagnostic Research, ISSN - 0973 - 709X

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Dr Bhanu K Bhakhri

"The Journal of Clinical and Diagnostic Research (JCDR) has been in operation since almost a decade. It has contributed a huge number of peer reviewed articles, across a spectrum of medical disciplines, to the medical literature.
Its wide based indexing and open access publications attracts many authors as well as readers
For authors, the manuscripts can be uploaded online through an easily navigable portal, on other hand, reviewers appreciate the systematic handling of all manuscripts. The way JCDR has emerged as an effective medium for publishing wide array of observations in Indian context, I wish the editorial team success in their endeavour"



Dr Bhanu K Bhakhri
Faculty, Pediatric Medicine
Super Speciality Paediatric Hospital and Post Graduate Teaching Institute, Noida
On Sep 2018




Dr Mohan Z Mani

"Thank you very much for having published my article in record time.I would like to compliment you and your entire staff for your promptness, courtesy, and willingness to be customer friendly, which is quite unusual.I was given your reference by a colleague in pathology,and was able to directly phone your editorial office for clarifications.I would particularly like to thank the publication managers and the Assistant Editor who were following up my article. I would also like to thank you for adjusting the money I paid initially into payment for my modified article,and refunding the balance.
I wish all success to your journal and look forward to sending you any suitable similar article in future"



Dr Mohan Z Mani,
Professor & Head,
Department of Dematolgy,
Believers Church Medical College,
Thiruvalla, Kerala
On Sep 2018




Prof. Somashekhar Nimbalkar

"Over the last few years, we have published our research regularly in Journal of Clinical and Diagnostic Research. Having published in more than 20 high impact journals over the last five years including several high impact ones and reviewing articles for even more journals across my fields of interest, we value our published work in JCDR for their high standards in publishing scientific articles. The ease of submission, the rapid reviews in under a month, the high quality of their reviewers and keen attention to the final process of proofs and publication, ensure that there are no mistakes in the final article. We have been asked clarifications on several occasions and have been happy to provide them and it exemplifies the commitment to quality of the team at JCDR."



Prof. Somashekhar Nimbalkar
Head, Department of Pediatrics, Pramukhswami Medical College, Karamsad
Chairman, Research Group, Charutar Arogya Mandal, Karamsad
National Joint Coordinator - Advanced IAP NNF NRP Program
Ex-Member, Governing Body, National Neonatology Forum, New Delhi
Ex-President - National Neonatology Forum Gujarat State Chapter
Department of Pediatrics, Pramukhswami Medical College, Karamsad, Anand, Gujarat.
On Sep 2018




Dr. Kalyani R

"Journal of Clinical and Diagnostic Research is at present a well-known Indian originated scientific journal which started with a humble beginning. I have been associated with this journal since many years. I appreciate the Editor, Dr. Hemant Jain, for his constant effort in bringing up this journal to the present status right from the scratch. The journal is multidisciplinary. It encourages in publishing the scientific articles from postgraduates and also the beginners who start their career. At the same time the journal also caters for the high quality articles from specialty and super-specialty researchers. Hence it provides a platform for the scientist and researchers to publish. The other aspect of it is, the readers get the information regarding the most recent developments in science which can be used for teaching, research, treating patients and to some extent take preventive measures against certain diseases. The journal is contributing immensely to the society at national and international level."



Dr Kalyani R
Professor and Head
Department of Pathology
Sri Devaraj Urs Medical College
Sri Devaraj Urs Academy of Higher Education and Research , Kolar, Karnataka
On Sep 2018




Dr. Saumya Navit

"As a peer-reviewed journal, the Journal of Clinical and Diagnostic Research provides an opportunity to researchers, scientists and budding professionals to explore the developments in the field of medicine and dentistry and their varied specialities, thus extending our view on biological diversities of living species in relation to medicine.
‘Knowledge is treasure of a wise man.’ The free access of this journal provides an immense scope of learning for the both the old and the young in field of medicine and dentistry as well. The multidisciplinary nature of the journal makes it a better platform to absorb all that is being researched and developed. The publication process is systematic and professional. Online submission, publication and peer reviewing makes it a user-friendly journal.
As an experienced dentist and an academician, I proudly recommend this journal to the dental fraternity as a good quality open access platform for rapid communication of their cutting-edge research progress and discovery.
I wish JCDR a great success and I hope that journal will soar higher with the passing time."



Dr Saumya Navit
Professor and Head
Department of Pediatric Dentistry
Saraswati Dental College
Lucknow
On Sep 2018




Dr. Arunava Biswas

"My sincere attachment with JCDR as an author as well as reviewer is a learning experience . Their systematic approach in publication of article in various categories is really praiseworthy.
Their prompt and timely response to review's query and the manner in which they have set the reviewing process helps in extracting the best possible scientific writings for publication.
It's a honour and pride to be a part of the JCDR team. My very best wishes to JCDR and hope it will sparkle up above the sky as a high indexed journal in near future."



Dr. Arunava Biswas
MD, DM (Clinical Pharmacology)
Assistant Professor
Department of Pharmacology
Calcutta National Medical College & Hospital , Kolkata




Dr. C.S. Ramesh Babu
" Journal of Clinical and Diagnostic Research (JCDR) is a multi-specialty medical and dental journal publishing high quality research articles in almost all branches of medicine. The quality of printing of figures and tables is excellent and comparable to any International journal. An added advantage is nominal publication charges and monthly issue of the journal and more chances of an article being accepted for publication. Moreover being a multi-specialty journal an article concerning a particular specialty has a wider reach of readers of other related specialties also. As an author and reviewer for several years I find this Journal most suitable and highly recommend this Journal."
Best regards,
C.S. Ramesh Babu,
Associate Professor of Anatomy,
Muzaffarnagar Medical College,
Muzaffarnagar.
On Aug 2018




Dr. Arundhathi. S
"Journal of Clinical and Diagnostic Research (JCDR) is a reputed peer reviewed journal and is constantly involved in publishing high quality research articles related to medicine. Its been a great pleasure to be associated with this esteemed journal as a reviewer and as an author for a couple of years. The editorial board consists of many dedicated and reputed experts as its members and they are doing an appreciable work in guiding budding researchers. JCDR is doing a commendable job in scientific research by promoting excellent quality research & review articles and case reports & series. The reviewers provide appropriate suggestions that improve the quality of articles. I strongly recommend my fraternity to encourage JCDR by contributing their valuable research work in this widely accepted, user friendly journal. I hope my collaboration with JCDR will continue for a long time".



Dr. Arundhathi. S
MBBS, MD (Pathology),
Sanjay Gandhi institute of trauma and orthopedics,
Bengaluru.
On Aug 2018




Dr. Mamta Gupta,
"It gives me great pleasure to be associated with JCDR, since last 2-3 years. Since then I have authored, co-authored and reviewed about 25 articles in JCDR. I thank JCDR for giving me an opportunity to improve my own skills as an author and a reviewer.
It 's a multispecialty journal, publishing high quality articles. It gives a platform to the authors to publish their research work which can be available for everyone across the globe to read. The best thing about JCDR is that the full articles of all medical specialties are available as pdf/html for reading free of cost or without institutional subscription, which is not there for other journals. For those who have problem in writing manuscript or do statistical work, JCDR comes for their rescue.
The journal has a monthly publication and the articles are published quite fast. In time compared to other journals. The on-line first publication is also a great advantage and facility to review one's own articles before going to print. The response to any query and permission if required, is quite fast; this is quite commendable. I have a very good experience about seeking quick permission for quoting a photograph (Fig.) from a JCDR article for my chapter authored in an E book. I never thought it would be so easy. No hassles.
Reviewing articles is no less a pain staking process and requires in depth perception, knowledge about the topic for review. It requires time and concentration, yet I enjoy doing it. The JCDR website especially for the reviewers is quite user friendly. My suggestions for improving the journal is, more strict review process, so that only high quality articles are published. I find a a good number of articles in Obst. Gynae, hence, a new journal for this specialty titled JCDR-OG can be started. May be a bimonthly or quarterly publication to begin with. Only selected articles should find a place in it.
An yearly reward for the best article authored can also incentivize the authors. Though the process of finding the best article will be not be very easy. I do not know how reviewing process can be improved. If an article is being reviewed by two reviewers, then opinion of one can be communicated to the other or the final opinion of the editor can be communicated to the reviewer if requested for. This will help one’s reviewing skills.
My best wishes to Dr. Hemant Jain and all the editorial staff of JCDR for their untiring efforts to bring out this journal. I strongly recommend medical fraternity to publish their valuable research work in this esteemed journal, JCDR".



Dr. Mamta Gupta
Consultant
(Ex HOD Obs &Gynae, Hindu Rao Hospital and associated NDMC Medical College, Delhi)
Aug 2018




Dr. Rajendra Kumar Ghritlaharey

"I wish to thank Dr. Hemant Jain, Editor-in-Chief Journal of Clinical and Diagnostic Research (JCDR), for asking me to write up few words.
Writing is the representation of language in a textual medium i e; into the words and sentences on paper. Quality medical manuscript writing in particular, demands not only a high-quality research, but also requires accurate and concise communication of findings and conclusions, with adherence to particular journal guidelines. In medical field whether working in teaching, private, or in corporate institution, everyone wants to excel in his / her own field and get recognised by making manuscripts publication.


Authors are the souls of any journal, and deserve much respect. To publish a journal manuscripts are needed from authors. Authors have a great responsibility for producing facts of their work in terms of number and results truthfully and an individual honesty is expected from authors in this regards. Both ways its true "No authors-No manuscripts-No journals" and "No journals–No manuscripts–No authors". Reviewing a manuscript is also a very responsible and important task of any peer-reviewed journal and to be taken seriously. It needs knowledge on the subject, sincerity, honesty and determination. Although the process of reviewing a manuscript is a time consuming task butit is expected to give one's best remarks within the time frame of the journal.
Salient features of the JCDR: It is a biomedical, multidisciplinary (including all medical and dental specialities), e-journal, with wide scope and extensive author support. At the same time, a free text of manuscript is available in HTML and PDF format. There is fast growing authorship and readership with JCDR as this can be judged by the number of articles published in it i e; in Feb 2007 of its first issue, it contained 5 articles only, and now in its recent volume published in April 2011, it contained 67 manuscripts. This e-journal is fulfilling the commitments and objectives sincerely, (as stated by Editor-in-chief in his preface to first edition) i e; to encourage physicians through the internet, especially from the developing countries who witness a spectrum of disease and acquire a wealth of knowledge to publish their experiences to benefit the medical community in patients care. I also feel that many of us have work of substance, newer ideas, adequate clinical materials but poor in medical writing and hesitation to submit the work and need help. JCDR provides authors help in this regards.
Timely publication of journal: Publication of manuscripts and bringing out the issue in time is one of the positive aspects of JCDR and is possible with strong support team in terms of peer reviewers, proof reading, language check, computer operators, etc. This is one of the great reasons for authors to submit their work with JCDR. Another best part of JCDR is "Online first Publications" facilities available for the authors. This facility not only provides the prompt publications of the manuscripts but at the same time also early availability of the manuscripts for the readers.
Indexation and online availability: Indexation transforms the journal in some sense from its local ownership to the worldwide professional community and to the public.JCDR is indexed with Embase & EMbiology, Google Scholar, Index Copernicus, Chemical Abstracts Service, Journal seek Database, Indian Science Abstracts, to name few of them. Manuscriptspublished in JCDR are available on major search engines ie; google, yahoo, msn.
In the era of fast growing newer technologies, and in computer and internet friendly environment the manuscripts preparation, submission, review, revision, etc and all can be done and checked with a click from all corer of the world, at any time. Of course there is always a scope for improvement in every field and none is perfect. To progress, one needs to identify the areas of one's weakness and to strengthen them.
It is well said that "happy beginning is half done" and it fits perfectly with JCDR. It has grown considerably and I feel it has already grown up from its infancy to adolescence, achieving the status of standard online e-journal form Indian continent since its inception in Feb 2007. This had been made possible due to the efforts and the hard work put in it. The way the JCDR is improving with every new volume, with good quality original manuscripts, makes it a quality journal for readers. I must thank and congratulate Dr Hemant Jain, Editor-in-Chief JCDR and his team for their sincere efforts, dedication, and determination for making JCDR a fast growing journal.
Every one of us: authors, reviewers, editors, and publisher are responsible for enhancing the stature of the journal. I wish for a great success for JCDR."



Thanking you
With sincere regards
Dr. Rajendra Kumar Ghritlaharey, M.S., M. Ch., FAIS
Associate Professor,
Department of Paediatric Surgery, Gandhi Medical College & Associated
Kamla Nehru & Hamidia Hospitals Bhopal, Madhya Pradesh 462 001 (India)
E-mail: drrajendrak1@rediffmail.com
On May 11,2011




Dr. Shankar P.R.

"On looking back through my Gmail archives after being requested by the journal to write a short editorial about my experiences of publishing with the Journal of Clinical and Diagnostic Research (JCDR), I came across an e-mail from Dr. Hemant Jain, Editor, in March 2007, which introduced the new electronic journal. The main features of the journal which were outlined in the e-mail were extensive author support, cash rewards, the peer review process, and other salient features of the journal.
Over a span of over four years, we (I and my colleagues) have published around 25 articles in the journal. In this editorial, I plan to briefly discuss my experiences of publishing with JCDR and the strengths of the journal and to finally address the areas for improvement.
My experiences of publishing with JCDR: Overall, my experiences of publishing withJCDR have been positive. The best point about the journal is that it responds to queries from the author. This may seem to be simple and not too much to ask for, but unfortunately, many journals in the subcontinent and from many developing countries do not respond or they respond with a long delay to the queries from the authors 1. The reasons could be many, including lack of optimal secretarial and other support. Another problem with many journals is the slowness of the review process. Editorial processing and peer review can take anywhere between a year to two years with some journals. Also, some journals do not keep the contributors informed about the progress of the review process. Due to the long review process, the articles can lose their relevance and topicality. A major benefit with JCDR is the timeliness and promptness of its response. In Dr Jain's e-mail which was sent to me in 2007, before the introduction of the Pre-publishing system, he had stated that he had received my submission and that he would get back to me within seven days and he did!
Most of the manuscripts are published within 3 to 4 months of their submission if they are found to be suitable after the review process. JCDR is published bimonthly and the accepted articles were usually published in the next issue. Recently, due to the increased volume of the submissions, the review process has become slower and it ?? Section can take from 4 to 6 months for the articles to be reviewed. The journal has an extensive author support system and it has recently introduced a paid expedited review process. The journal also mentions the average time for processing the manuscript under different submission systems - regular submission and expedited review.
Strengths of the journal: The journal has an online first facility in which the accepted manuscripts may be published on the website before being included in a regular issue of the journal. This cuts down the time between their acceptance and the publication. The journal is indexed in many databases, though not in PubMed. The editorial board should now take steps to index the journal in PubMed. The journal has a system of notifying readers through e-mail when a new issue is released. Also, the articles are available in both the HTML and the PDF formats. I especially like the new and colorful page format of the journal. Also, the access statistics of the articles are available. The prepublication and the manuscript tracking system are also helpful for the authors.
Areas for improvement: In certain cases, I felt that the peer review process of the manuscripts was not up to international standards and that it should be strengthened. Also, the number of manuscripts in an issue is high and it may be difficult for readers to go through all of them. The journal can consider tightening of the peer review process and increasing the quality standards for the acceptance of the manuscripts. I faced occasional problems with the online manuscript submission (Pre-publishing) system, which have to be addressed.
Overall, the publishing process with JCDR has been smooth, quick and relatively hassle free and I can recommend other authors to consider the journal as an outlet for their work."



Dr. P. Ravi Shankar
KIST Medical College, P.O. Box 14142, Kathmandu, Nepal.
E-mail: ravi.dr.shankar@gmail.com
On April 2011

Important Notice

Original article / research
Year : 2010 | Month : October | Volume : 4 | Issue : 5 | Page : 3144 - 3149

The Efficacy And The Safety Of A Fixed Dose Combination Of Amlodipine And Atorvastatin In Hypertensives With Dyslipidaemia

MUKTA N C*, PRABHA A**, ASHOK S K***, NITHYANANDA C K****

*MD Associate Professor of Pharmacology, Kasturba Medical College, Mangalore, Manipal University; **MD Professor of Medicine, Kasturba Medical College, Mangalore, Manipal University; ***MD Professor of Pharmacology, Kasturba Medical College, Mangalore, Manipal University; ****MD Additional Professor of Medicine, Kasturba Medical College, Mangalore, Manipal University, Departments of Pharmacology and Medicine, Kasturba Medical College, Mangalore, Manipal University

Correspondence Address :
Dr. Nithyananda Chowta
Associate Professor of Medicine,
Kasturba Medical College, Mangalore PIN-575001
Manipal University
Karnataka state, India.
Phone: 0824-2431122
Facsimile number: 0824-2425092
E-mail: muktachowta@yahoo.co.in

Abstract

Introduction:It was claimed that the amlodipine/atorvastatin combination improved the patient’s achievement of national-guideline-recommended blood pressure and lipid target levels and exhibited a safety profile consistent with its parent compounds. The present study has been undertaken to evaluate the efficacy and the safety of a fixed dose combination of amlodipine with atorvastatin in the Indian population.
Methods: The study was designed as a prospective, open labeled, noncomparative trial in 35 adult patients of mild to moderate essential hypertension with dyslipidaemia. The blood pressure criteria for inclusion was >140/90mmHg and less than 180/110mmHg. The dyslipidaemia criteria was LDL cholesterol>130mg/dl and triglycerides more than 150mg/dl. The patients were screened at baseline visit (Day 0) and at visit 2 (Day 4). The supine blood pressure was recorded by taking the mean of three readings. The blood pressure was measured again after a week during the placebo period (visit 3, day 10, week 1). The active medication (Combination of 5mg of amlodipine and 10mg of atorvastatin) started at visit 4 (day 17, week 2). The blood pressure was measured again during visit 5 (day 31, week 4), visit 6 (day 45, week 6) and visit 7 (day 60, week 8) by using the same instrument at all visits.
Results: A total of 35 patients were included in the study, out of which 27 were males and eight were females. The average decrease of supine blood pressure from the baseline recording was 10.3+ 3.62mmHg at the end of treatment, which was statistically highly significant (p=0.005). The average decrease of diastolic blood pressure was 9.51+2.13mmHg at the end of the treatment, which was also statistically highly significant (p=0.0002). A statistically significant decrease in the levels of total cholesterol and LDL cholesterol were observed during the treatment. The most common adverse events were hyponatraemia (25.93%), head ache (22.22%) and hypoglycaemia (22.22%).
Conclusion: To conclude, the concomitant administration of amlodipine and atorvastatin is well tolerated and effective in reducing both blood pressure and lipid levels and in helping patients achieve their goals in cases of hypertension and dyslipidaemia.
Key words: Amlodipine, atorvastatin, hypertension, dyslipidaemia.

Introduction:
The benefits of lowering blood pressure (BP) in patients with hypertension and lowering cholesterol in patients with dyslipidaemia are well known and well studied. However, worldwide, many patients with hypertension have concomitant dyslipidaemia, which places them at a greater risk for cardiovascular disease as compared to patients with just one risk factor. In order to prevent cardiovascular events, it is essential to effectively manage the overall risk of cardiovascular disease(1). However, despite guideline recommendations to this effect, the current management of the major, modifiable cardiovascular risk factors such as hypertension and dyslipidaemia is disconnected and patient adherence to therapy is poor. This is particularly important for patients with multiple cardiovascular risk factors, who are often prescribed multiple medications. Polypharmacy and complex treatment regimens have been identified as important, modifiable risk factors for medication noncompliance. The use of fixed-dose combinations in this regard may have advantages(2) like simplification of therapy, increased patient compliance, reduction of total daily dose and adverse effects and the reduction of the overall cost of therapy. These fixed-dose combinations are valuable only when they have been developed, based on sound rational pharmacokinetic and pharmacodynamic criteria and when claims for their benefits have been supported by evidence-based data and well-designed clinical studies.
Amlodipine/atorvastatin is a combination of two drugs, amlodipine, a long acting dihydropyridine calcium channel blocker and atorvastatin, a synthetic HMG-CoA reductase inhibitor. The amlodipine/atorvastatin combination is indicated for patients who require simultaneous treatment with both drugs. Clinical trials have demonstrated that amlodipine plus atorvastatin can be safely co-administered across the dose range. Single-pill amlodipine/atorvastatin reduces both BP and cholesterol and may help to improve the management of patients with concomitant hypertension and dyslipidaemia(3),(4). It was claimed that the amlodipine/atorvastatin combination improved the patient’s achievement of national-guideline-recommended blood pressure and lipid target levels and exhibited a safety profile consistent with its parent compounds. The present study has been undertaken to evaluate the efficacy and the safety of a fixed dose combination of amlodipine with atorvastatin in the Indian population.
Methods:
The study was designed as a prospective, open labeled, noncomparative trial in 35 adult patients of mild to moderate essential hypertension with dyslipidaemia. The study protocol was approved by the institutional ethics committee and the written informed consent was taken from each patient. The study included both sexes, newly diagnosed hypertensives, as well as those who were on antihypertensive therapy. Freshly diagnosed patients of dyslipidaemia, as well as those who showed inadequate response to the previous therapy were included in the study. The blood pressure criteria for inclusion was >140/90mmHg and less than 180/110mmHg. The dyslipidaemia criteria was LDL cholesterol>130mg/dl and triglycerides more than 150mg/dl. Patients with severe hypertension, cardiac failure, acute myocardial infarction, stroke, uncontrolled diabetes mellitus, grade III retinopathy, papilloedema, renal/hepatic impairment, psychiatric illness, history of major surgery during the previous 3 months, known hypersensitivity to amlodipine or statins and those who are on concurrent NSAIDs were excluded from the study. Women of child bearing potential, as well as lactating mothers were also not included in the study.

The patients were screened at baseline visit (Day 0) and blood samples for haematology, hepatic/renal function tests and lipid profile were collected. The presence of any concomitant diseases and concomitant medications were recorded. At visit 2 (Day 4), supine blood pressure was recorded by taking the mean of three readings. The patients were advised to discontinue their previous antihypertensive and lipid lowering medications and they were put on placebo tablets for 2 weeks. Dietary modifications also advised during this visit. Blood pressure was measured again after a week during the placebo period (visit 3, day 10, week 1). Active medication (Combination of 5mg amlodipine and 10mg atorvastatin) started at visit 4 (day 17, week2). At this visit, the patients were withdrawn from the study if their blood pressure and lipid profile were within the normal limits. Blood pressure was measured again during visit 5 (day 31, week 4), visit 6 (day 45, week 6) and visit 7 (day 60, week 8) by using the same instrument at all visits. The patients were advised to get the used container of study medication during each visit to check for compliance. The adverse events reported or detected during examination were recorded with all the relevant details. All laboratory investigations were repeated again at the end of the study i.e. at visit 7.

Statistical analysis was done by using the Student’s ‘t’test. P values less than 0.05 were considered as statistically significant.

Results

A total of 35 patients were included in the study, out of which 27 were males and eight were females. (Table/Fig 1) shows the demographic characteristics of the patients. The mean age of the patients was 60.43+ 2.25 years. The mean body mass index was 24.84+0.52kg/m2.

(Table/Fig 1): Demographic characteristics of the patients
All values are expressed as mean+ SE

The average duration of hypertension is 2.96 years. 23 patients were diabetic and 7 had ischaemic heart disease. 28 patients entered into active medication visit, out of which one was withdrawn at visit 6 due to adverse events. Two patients were withdrawn at visit 2, as their BP and lipids were normal after placebo. One of the patients was withdrawn at visit 2 because of adverse events. Three patients were lost to follow up after visit 3.

The mean blood pressure and mean lipid values at different visits are shown in (Table/Fig 2) and (Table/Fig 3) respectively. (Table/Fig 4) shows the mean changes in blood pressure and (Table/Fig 5) shows the mean changes in the lipid profile at different visits from the baseline to the end of treatment.
(Table/Fig 2): Changes in blood pressure from baseline to end of treatment
Values were expressed as mean+ SE t=Student ‘t’ test*Significant ** Very highly significant
The average decrease of supine blood pressure from the baseline recording was 10.3+ 3.62mmHg at the end of the treatment, which was statistically very highly significant (p=0.000). The average decrease of diastolic blood pressure was 9.51+2.13mmHg at the end of the treatment, which was also statistically very highly significant (p=0.000). Significant blood pressure reduction was evident 6 weeks onwards.
(Table/Fig 3): Changes in lipid levels from baseline to the end of treatment
Values were expressed as mean+ SE t=Student ‘t’ test*Significant ** Very highly significant
A statistically significant decrease in the levels of total cholesterol, LDL cholesterol and triglycerides were observed during the treatment. At the end of the treatment, the decrease in total cholesterol level was found to be 78.15+ 8.31 mg/dl, in LDL cholesterol level was found to be 63.74 +8.26mg/dl and in triglyceride levels was found to be 58.51+17.91mg/dl. HDL levels were found to be increased by 4.9+1.44mg/dl at the end of the treatment, which was statistically significant (p=0.03).
(Table/Fig 4). Mean changes in blood pressure from baseline to end of the treatment.
All values are expressed as mean+ SE

(Table/Fig 5). Mean changes in lipid levels from baseline to end of treatment.
All values are expressed as mean+ SE

The decrease in total cholesterol and LDL cholesterol was very highly significant (p=0.000), whereas the drop in triglyceride levels was also showed statistical significance (p=0.03). 59.26% patients achieved blood pressure goals and 77.77% of the patients achieved low-density lipoprotein cholesterol goals.

(Table/Fig 6) Incidence of adverse events

Both the goals were achieved in 55.55% of the patients. The mean blood pressure reduction was 10.3/9.5 mm Hg and the mean LDL-C reduction was 63.74mg/dl (41.4%) after 8 weeks of treatment.

The adverse events which were reported were minor. The incidence of the adverse events (AEs) is shown in (Table/Fig 6). The most common AEs were hyponatraemia (25.93%), head ache (22.22%) and hypoglycaemia (22.22%).

Among the patients who developed hyponatraemia, 2 were receiving diuretics and 3 were on ACE inhibitors. The patients who presented with hypoglycaemia were diabetics on insulin/oral hypoglycaemic agents. Other less common AEs which were reported were pedal oedema, giddiness, myalgia, arthalgia, flatulence, weakness, hypokalaemia and elevated serum creatinine.

Discussion

Guidelines stress the importance of the simultaneous management of multiple cardiovascular risk factors. This can in part be achieved by the coadministration of lipid-lowering and antihypertensive treatments. Adherence to treatment notably improved when therapy was initiated simultaneously(5). Amlodipine and atorvastatin have been demonstrated in numerous clinical trials to be highly effective in lowering blood pressure and low-density lipoprotein cholesterol. The amlodipine/atorvastatin single pill has been shown to achieve national-guideline-recommended blood pressure and lipid target levels and exhibits a safety profile which is consistent with its parent compounds(4),(6),(7).
The results of the present study have shown that the combination of atorvastatin and amlodipine is well tolerated and is effective in reducing blood pressure, as well as in improving lipid profile. A statistically highly significant reduction in both systolic and diastolic blood pressure, as well as a highly significant reduction in LDL cholesterol was observed at the end of 8 weeks of treatment. Atorvastatin and amlodipine have each been shown to have beneficial effects on the endothelium in vitro and they may have a greater effect on blood pressure reduction(8). The results of Atorvastatin and Amlodipine in patients with elevated lipids and hypertension (the AVALON study(6)) showed that 5 mg of amlodipine, administered once daily in combination with 10 mg of atorvastatin I was an effective treatment for concomitant hypertension/dyslipidaemia. AVALON was the first of a series of trials of concomitant cholesterol/blood pressure lowering with atorvastatin plus amlodipine, but the last in which the 2 agents were administered separately. In subsequent trials, a single-pill, dual-therapy approach, combining amlodipine and atorvastatin was used and this combination was approved by the United States Food and Drug Administration.
Results from an international study program showed that the single-pill fixed-dose combination of the amlodipine/atorvastatin therapy was an effective treatment that simultaneously reduced two modifiable risk factors, hypertension and low-density lipoprotein cholesterol levels and reduced the calculated risk for a fatal cardiovascular event by 29%-52%.(8) The present study showed that 59.26% of the patients achieved blood pressure goals and 77.77% of the patients achieved low-density lipoprotein cholesterol goals, as defined by the sixth report of the Joint National Committee on the Prevention, Detection, and the Treatment of High Blood Pressure (JNC VI)(9) or their LDL-cholesterol goals, as defined by the National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) III,(10). Both the goals were achieved in 55.55% of the patients in the present study. In agreement with our results, the GEMINI study showed that 57.7% of the patients achieved both blood pressure and low-density lipoprotein cholesterol goals, 62.9% of the subjects in the JEWEL I study and 50.6% of the patients in the JEWEL II study achieved both country-specific blood pressure and LDL-cholesterol goals after 16 weeks of treatment with the same combination(7). Neutel GM etal(11) showed that dual goal attainment was significantly greater with amlodipine/atorvastatin as compared with placebo at week 4, with further improvements at week 8. Erdine S et al (12) showed that after 14 weeks treatment, 55.2% of patients reached both blood pressure and lipid goals, 61.3% patients reached the blood pressure goal and 87.1% patients reached the lipid goal (34.0% were at lipid goal at baseline). They observed mean blood pressure reduction was 20.2/11.4 mm Hg and the mean reduction in LDL-C was 41.0%. In contrast to these results, our study showed lesser mean blood pressure reduction (10.3/9.5 mm Hg) and mean LDL-C reduction of 63.74mg/dl (41.4%) after 8 weeks of treatment. Comparatively, the shorter duration of the study may be responsible for a lesser reduction in the mean blood pressure in our study.
Earlier studies have demonstrated that amlodipine/atorvastatin has the same safety profile as its individual components and can be administered safely across the dosage range(4),(5),(6),(7),(11),(12). The side effects of amlodipine/atorvastatin are similar to those for each component, most commonly abdominal pain, constipation, dyspepsia, oedema, flatulence and headache. The serious but rare side effects included hepatotoxicity and rhabdomyolysis, Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme and cardiac failure. In the GEMINI study(12), 64.1% of patients reported at least one adverse event. The most commonly reported adverse events were respiratory tract infection (11.9%), peripheral oedema (8.8%), headache (5.4%) and myalgia (4.2%). The incidence of serious adverse events during the study appeared to be low (2.7%), with no events attributable to the study drug. There were no serious events that correlated with myopathy, myositis, rhabdomyolysis or abnormal/increase in alanine aminotransferase, aspartate aminotransferase or creatinine phosphokinase. Our study has also shown a similar pattern of adverse events. One of the commonest adverse event seen in the present study was hyponatraemia, which was not observed in the earlier studies. Among the 7 patients who presented with hyponatraemia, 2 patients were on diuretics and 3 were on ACE inhibitors, which could have been the cause of the hyponatraemia. In the remaining two patients, the cause of hyponatraemia could not be identified. Hyponatraemia could not be attributed to the environmental conditions, as the study was conducted during the winter season. Hence, the relationship of hyponatraemia with the study medication may be possible. As per the literature, amlodipine was not associated with hyponatraemia. Serious adverse events did not occur in the present study. Though the incidence of hypoglycaemia was also more in the present study, this cannot be attributed to the study medication, as these patients were diabetics who were on insulin/oral hypoglycaemic agents.
The limitations of the present study should be considered. The number of patients in the study was very small to draw any valid conclusions. The duration of treatment was comparatively shorter in our study.

To conclude, the concomitant administration of amlodipine and atorvastatin is well tolerated and effective in reducing both blood pressure and lipid levels and in helping patients achieve their goals in cases of hypertension and dyslipidaemia. Amlodipine combined with atorvastatin has been demonstrated to reduce cardiovascular events in hypertensive patients at high cardiovascular risk and the single-pill formulation has the potential to improve adherence and decrease prescription costs. These potential benefits are associated with important implications because hypertensive patients with additional risk factors represent a large proportion of those at risk for cardiovascular events.

References

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Panda J, Tiwari P, Uppal R. Evaluation of the rationality of some FDCs: Focus on antihypertensive drugs. Indian J Pharm Sci 2006;68:649-653.
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Curran MP. Amlodipine/Atorvastatin: a review of its use in the treatment of hypertension and dyslipidaemia and the prevention of cardiovascular disease. Drugs 2010;70(2):191-213.
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Richard Hobbs FD, Gensini G, John Mancini GB, Manolis AJ, Bauer B, Genest J, Feldman RD, Harvey P, Jenssen TG, da Silva PM; JEWEL Study Group. International open-label studies to assess the efficacy and safety of single-pill amlodipine/atorvastatin in attaining blood pressure and lipid targets recommended by country-specific guidelines: the JEWEL programme. Eur J Cardiovasc Prev Rehabil. 2009;16(4):472-80.
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Cohn JN, Neutel J, Houston M, et al. Early improvements in vascular compliance following coadministration of amlodipine and atorvastatin in patients with concomitant hypertension and dyslipidemia. The Avalon Arterial Wall Compliance (AWC) trial. Program and abstracts from the 20th Annual Scientific Meeting of the American Society of Hypertension; San Francisco, California. Late Breaking Clinical Trials;2005;99-112
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