Evidence map›Paper›PMID 34918194›Full record

Trial reportAdvances in therapy2022

Fixed-dose Combination of Metoprolol, Telmisartan, and Chlorthalidone for Essential Hypertension in Adults with Stable Coronary Artery Disease: Phase III Study.

Gouranga Sarkar, Vijay B Gaikwad, Aradhana Sharma, Swapan K Halder, Darivemula A Kumar, Jitendra Anand, Sumit Agrawal, Avinash Kumbhar, Bhushan Kinholkar, Rishabh Mathur and 3 more

Abstract readClinical Trial, Phase IIIMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Advances in therapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.3field-weighted citation impact, top 18% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 9 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 9 institutions in 1 country.

Gouranga SarkarInstitute of Post Graduate Medical Education and Research, Kolkata, West Bengal, India.
Vijay B GaikwadGovernment Medical College, Aurangabad, Maharashtra, India.
Aradhana SharmaSMS Medical College and Hospital, Jaipur, Rajasthan, India.
Swapan K HalderNRS Medical College and Hospital, Kolkata, West Bengal, India.
Darivemula A KumarGandhi Hospital, Secunderabad, Telangana, India.
Jitendra AnandKanoria Hospital and Research Centre, Gandhinagar, Gujarat, India.
Sumit AgrawalOyster and Pearl Hospital, Pune, Maharashtra, India.
Avinash KumbharAster Aadhar Hospital (Prerana Hospital Ltd.), Kolhapur, Maharashtra, India.
Bhushan KinholkarSanjeevan Hospital, Pune, Maharashtra, India.
Rishabh MathurMarudhar Hospital, Jaipur, Rajasthan, India.
Maulik DoshiIndia Clinical Research, Sun Pharma, Mumbai, India.
Deepak BachaniIndia Medical Affairs, Sun Pharma, Mumbai, Maharashtra, India. Deepak.Bachani@sunpharma.com.
Suyog MehtaIndia Medical Affairs, Sun Pharma, Mumbai, Maharashtra, India.
Sun Pharma Advanced Research (India) · INGandhi Medical College & Hospital · INGovernment Medical College · INInstitute of Post Graduate Medical Education and Research · INLourdes Hospital · INMedical College and Hospital, Kolkata · INOyster & Pearl Hospital · INSawai ManSingh Medical College and Hospital · INSun Pharma (India) · IN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe aim of the study was to evaluate the efficacy and safety of fixed-dose combination (FDC) of metoprolol, telmisartan, and chlorthalidone in patients with essential hypertension and stable coronary artery disease (CAD) who showed inadequate response to dual therapy.

methodsIn this phase III, open-label, multicenter study, 254 adults with stable CAD having uncontrolled hypertension despite being treated with FDC of metoprolol (25/50 mg) and telmisartan (40 mg) were included. Patients received either of the following FDC for 24 weeks: metoprolol (25 mg), telmisartan (40 mg), and chlorthalidone (12.5 mg) (FDC1; n = 139) or metoprolol (50 mg), telmisartan (40 mg), and chlorthalidone (12.5 mg) (FDC2; n = 115) tablets once daily. The FDCs were developed using the novel Wrap Matrix™ platform technology. Primary endpoint assessed the mean change in seated diastolic blood pressure (SeDBP) and seated systolic blood pressure (SeSBP) from baseline to 24 weeks. Secondary efficacy endpoints included proportion of patients achieving < 90 mmHg SeDBP (SeDBP responder) and < 140 mmHg SeSBP (SeSBP responder) at weeks 12, 16, 20, and 24. Safety was assessed throughout the study.

resultsA total of 243 (95.70%) patients completed study. The mean change in BP from baseline (FDC1, 155/96 mmHg; FDC2, 165/98 mmHg) to week 24 (FDC1, 128/82 mmHg; FDC2, 131/83 mmHg) was statistically significant (both groups p < 0.0001). Within FDC1 and FDC2, the mean change from baseline to week 24 in SeDBP (82.60 mmHg and 83.09 mmHg) and SeSBP (128.07 mmHg and 131.29 mmHg) was statistically significant (both groups p < 0.0001). At week 24, in FDC1, 80.15% and 84.73% were SeDBP and SeSBP responders, respectively; in FDC2, 79.46% and 74.11% were SeDBP and SeSBP responders, respectively. No serious adverse events or deaths were reported.

conclusionTriple FDCs of metoprolol, telmisartan, and chlorthalidone were considered effective and well tolerated in patients with hypertension who respond inadequately to dual therapy. CLINICAL

trial registrationCTRI/2016/11/007491.

Indexed as

Coronary Artery DiseaseHypertensionAdultAmlodipineAntihypertensive AgentsBlood PressureChlorthalidoneDrug Therapy, CombinationEssential HypertensionHumansHydrochlorothiazideImidazolesMetoprololTelmisartanTetrazolesAmlodipineAntihypertensive AgentsChlorthalidoneHydrochlorothiazideImidazolesMetoprololTelmisartanTetrazolesChlorthalidoneCoronary artery diseaseEfficacyEssential hypertensionFixed-dose combinationMedication adherenceMetoprololSafetyTelmisartanTriple combination

Identifiers

PMID34918194
OpenAlexW4200273837

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.