A Multicenter, Randomized, Outcomes Assessor Blind, Parallel Controlled Trial to Evaluate the Effect of Oral Isosorbide Mononitrate Plus Amlodipine Antispasm Therapy on Outcomes of Radial Artery Grafts After Coronary Artery Bypass Grafting

The goal of this clinical trial is to to evaluate the effect of oral isosorbide mononitrate plus amlodipine antispasm therapy on outcomes of radial artery grafts in patients underwent primary isolated CABG.
The main question it aims to answer is:
Whether the oral isosorbide mononitrate plus amlodipine antispasm therapy could reduce the failure outcome of radial artery grafts after CABG .
Researchers will compare isosorbide mononitrate plus amlodipine to none to see if isosorbide mononitrate plus amlodipine works.
Participants will
1. Take oral isosorbide mononitrate (20-40mg daily) plus amlodipine (2.5-5mg daily) therapy for 24 weeks after CABG.
2. Clinical follow-up at Week 1, 4, 12, and 24 after CABG.
3. Protocol-driven CCTA at Week 24 after CABG.

Start Date01 Jun 2025

Sponsor / Collaborator-

ISRCTN44436843

/ RecruitingPhase 3IIT

The LACunar Intervention Trial 3 (LACI-3). Assessment of efficacy and safety of cilostazol and isosorbide mononitrate to prevent adverse outcomes in patients with cerebral small vessel disease (lacunar) ischaemic stroke.

Start Date03 Mar 2025

Sponsor / Collaborator

The University of Edinburgh

[+1]

NCT06715007

/ RecruitingNot ApplicableIIT

Antiplatelet Therapy and Endothelial-stabilizing Agents in Cerebral Small Vessel Diseases

Cerebral small vessel disease (cSVD) is a common accompaniment of aging. Recent small subcortical (or lacunar) infarcts (i.e. symptomatic cSVD) and white matter hyperintensities are typical cSVD lesions on neuroimaging. cSVD causes about a quarter of ischaemic strokes and related with cognitive dysfunction. However, few studies are available so far to especially explore the treatment of cSVD. Endothelial dysfunction plays an important part in cSVD. Cilostazol and isosorbide mononitrate have endothelial protective function. We designed this prospective cohort study in China, aiming to evaluate the effect of different antiplatelet agents (e.g. Cilostazol) on cSVD and retina in patients with cSVD (recent small subcortical infarcts or WMH, respectively).

Start Date20 Dec 2024

Sponsor / Collaborator

Third Affiliated Hospital of Nanjing Medical University

100 Clinical Results associated with Isosorbide Mononitrate

100 Translational Medicine associated with Isosorbide Mononitrate

100 Patents (Medical) associated with Isosorbide Mononitrate

2,285

Literatures (Medical) associated with Isosorbide Mononitrate

01 Jul 2025·INJURY-INTERNATIONAL JOURNAL OF THE CARE OF THE INJURED

Comparison of transverse and longitudinal incisions in tibia intramedullary nailing: Implications for pain, numbness, and functional recovery

Article

Author: Rad, Saber Barazandeh ; Pourmahmoudian, Mohammad ; Razzaghi, Zahra ; Sabaghzadeh, Amir ; Sadighi, Mehrdad ; Ebrahimpour, Adel ; Kafiabadi, Meisam Jafari ; Ghamari, Babak Toloue ; Biglari, Farsad

BACKGROUND:

The current standard of care for surgically managed tibia shaft fractures is intramedullary nailing. Chronic postoperative knee pain is the most common complication of the infrapatellar technique in intramedullary nailing. Literature suggests it may be related to infrapatellar nerve injury.

OBJECTIVE:

This study compares the incidence of anterior knee pain after tibia nail insertion between conventional longitudinal and transverse incisions.

METHODS:

This clinical trial study was conducted in our Level I trauma center from February 2022 to August 2024. Patients with closed diaphyseal tibia fractures were included in this study. All the cases were treated with reamed statically locked intramedullary nailing. The patients were randomly allocated to the longitudinal infrapatellar approach group (LIPAG) and transverse infrapatellar approach group (TIPAG). The primary outcomes measured at every follow-up included anterior knee pain by visual analog scale (VAS), numbness by monofilament test, range of motion, quality of life, and union success. Postoperative follow-up was performed at 2, 6, and 12 weeks and 6, and 12 months.

RESULTS:

In our study, significant improvements in pain, quality of life, and functionality were observed in both groups; however, only the changes in numbness sensation and numbness pattern were significantly different between the two groups. TIPAG demonstrated earlier resolution of numbness compared to the LIPAG, and the numbness region significantly differed between the two groups, with LIPAG demonstrating more lateral numbness and TIPAG demonstrating more inferolateral numbness. However, no significant difference was observed between the two groups regarding operation time, length of stay, union outcome, pain, range of motion, or quality of life.

CONCLUSION:

Transverse and longitudinal incisions for tibia IMN give comparable long-term results in pain relief, functional recovery, and quality of life.

01 Jun 2025·INTERNATIONAL ORTHOPAEDICS

Outcomes of femoral shaft fractures in Sub-Saharan Africa: A systematic review

Review

Author: Birkenhead, Paul Joseph ; Birkenhead, Patrick ; Maqungo, Sithombo ; Vella, Clara ; Graham, Simon Matthew ; Laubscher, Maritz

PURPOSE:

Femoral shaft fractures are significant injuries and if not managed appropriately can result in high complication rates and long-term disability. These complex injuries occur at a higher rate across low and middle income countries and sub-Saharan Africa is thought to have a higher incidence than other regions across the world. This study aims to summarise the most up to date evidence surrounding the treatment and associated outcomes of adult femoral shaft fractures in sub-Saharan Africa - giving a clear understanding of current practices and highlighting potential areas for further research.

METHODS:

PubMed, Google Scholar, Africa Journals Online, Cochrane, Clinicaltrial.gov were searched using Boolean search strategies. Data collected included demographics, fracture classification, interventions, union rates, time to union, patient-reported outcomes / functional outcome scores, and secondary outcomes (orthopaedic and medical complications, malunion / non-union, length of admission).

RESULTS:

Twenty-three studies reporting 2,180 patients were included-73% (1592/2180) of patients were male, with a mean age of 35 years. Overall, 59% of patients were treated with intramedullary nailing (IMN), 23% with skeletal traction, and 14% with open reduction internal fixation (ORIF). There was a heterogeneity in practice in different regions, with the highest reported rates of IMN in Tanzania (99%), and lowest in Malawi (29.4%). Union rates were highest in IMN (82.4-100%) versus traction (48 - 100%) and ORIF (83.3-87%). Intramedullary nailing demonstrated a super complication profile, with better functional outcomes, shorter hospital stays and time to mobilisation.

CONCLUSION:

Intramedullary nailing demonstrated superior clinical and functional outcomes compared to other modalities for the treatment of femur shaft fractures across sub-Saharan Africa. However, there is significant sparsity of research and variable management approaches across the region. Focused research to determine the burden of injury, current healthcare resources and cost-effective and appropriate interventions to improve outcomes are now a public health priority.

04 May 2025·Proceedings (Baylor University. Medical Center)

A comprehensive evaluation of intramedullary devices in the management of femoral metastasis: 30-day outcomes

Article

Author: Maestre, Maria Jose ; Tomey, Daniel ; Bulut, Halil

Introduction:

Bone metastases, affecting 40% to 60% of patients with metastatic disease, are a significant concern, with the femur being one of the most common sites. These metastases significantly impact quality of life and present complex treatment challenges. Intramedullary nailing (IMN) is frequently used for femoral metastases owing to its minimally invasive nature and favorable outcomes.

Methods:

A retrospective cohort analysis was performed using data from the American College of Surgeons National Surgical Quality Improvement Program database (2016-2021). Patients aged 18 and older who underwent IMN for metastatic femoral disease were included. The primary endpoints were 30-day reoperation and readmission rates. Secondary endpoints assessed 30-day postoperative complications.

Results:

The cohort primarily comprised female patients (62.7%, n = 482) with notable comorbidities such as hypertension (48.9%) and high smoking rates (71.3%). Low rates of specific reoperations (0.4%, n = 3) and unplanned reoperations (1.7%, n = 13) were observed within 30 days. The incidence of deep vein thrombosis was 1.2%, and the incidence of pulmonary embolism was 0.7%. Surgical site infections were rare (Figure 1).

Conclusion:

IMN is a safe and effective surgical option for treating metastatic femoral lesions, providing a favorable safety profile. Further research is recommended to explore thromboembolic risks and optimize preventive strategies.

News (Medical) associated with Isosorbide Mononitrate

30 Apr 2025

·www.prnewswire.com

Navamedic Q1 2025: Strong start of the year and well-positioned for future growth

OSLO, Norway, April 30, 2025 /PRNewswire/ -- In the first quarter of 2025, Navamedic ASA (OSE: NAVA) , a Nordic pharma company and trusted supplier of high-quality prescription, consumer health, and hospital products to hospitals and pharmacies, reported revenues of NOK 132.0 million, representing a 9.2 per cent increase from the same period in 2024. EBITDA reached NOK 12.8 million, up from NOK 8.5 million last year. Gross margin improved to 40.7per cent, compared to 38.7per cent in Q1 2024. The strong performance was primarily driven by the Hospital area, particularly the antibiotics portfolio, supported by two long-term Nordic tenders secured in 2024. The company also experienced double-digit revenue growth in its Prescription Drugs (RX) area, contributing to the overall growth. "After investing in several strategic growth initiatives last year, we are pleased to see strong results already in the first quarter of 2025. The positive impact of the Nordic tender wins for our antibiotics portfolio has just begun to materialize. In addition, several products, including Mysimba® and Imdur® from our Prescription Drugs (RX) segment, delivered strong performance in the quarter," said Kathrine Gamborg Andreassen, CEO of Navamedic. "We are also pleased to announce the renewal of our agreement with TopRidge Pharma, securing the exclusive rights to market and sell Imdur® for another eight years. Over the past few years, we have systematically expanded and matured our product portfolio while investing in initiatives to drive future growth. The strong start to 2025 confirms the progress we are making," she added. Business area update and Q1 key figures During the first quarter, the Prescription Drugs (up 11.5 per cent YoY) and Hospital (up 15.2 per cent YoY) business areas delivered strong growth. Consumer Health had a steady development in the period (up 0.3 per cent YoY). As part of the Prescription Drugs area, revenues of Mysimba® increased by 7.3 per cent YoY. During the quarter, the European Medicines Agency's Human Medicines Committee also announced its review of Mysimba®. It affirmed that the benefits continue to outweigh the risks for weight management in adults with obesity or overweight. Imdur® and Nitrolingual® performed well in the quarter and were up 54 per cent and 22 per cent, respectively. Flexilev®, the company's unique treatment for Parkinson's Disease, delivered sales growth of 13 per cent YoY. Forlax® had a revenue decrease of 45 per cent due increased competition. For the Hospital area, the two tender wins drove sales growth in the antibiotics portfolio, which is up 32 per cent YoY, whilst the Medical Nutrition portfolio maintained steady sales. The company's third business area, Consumer Health, delivered stable results. Revenues of Modifast were steady during Q1, whilst Absolut Torr (up 49 per cent YoY) and ThermaCare (up 8 per cent YoY) experienced strong growth. Eroxon® saw a 9 per cent decrease in revenues, which is explained by a stock build-up in Q1 2024. Operating results (EBIT) for the first quarter of 2025 amounted to NOK 9.1 million, compared to NOK 4.9 million in 2024. Operating costs ended at NOK 40.9 million, compared to NOK 38.3 million last year. Net financial items ended at negative NOK 11 million and profit before tax was negative NOK 1.8 million. Outlook Navamedic continues to see strong growth and new expansion opportunities and reiterates its mid-term ambition of building a NOK 1 billion revenue company. "We have had a strong start to 2025. We have several key hero products across our three business areas, many of which have the potential to succeed internationally. Part of our work moving forward will be to identify growth opportunities for these products to support future growth," Andreassen concluded. Presentation Navamedic will present the results for the first quarter of 2025 at 08.30 today. CEO Kathrine Gamborg Andreassen and CFO Lars Hjarrand will host the presentation, which will take place at Haakon VIIs gate 2 in Oslo. It will be webcast at the following link: Note: EBITDA and other alternative performance measures (APMs) are defined and reconciled to the IFRS financial statements as a part of the APM section in the attached presentation. For further information, please contact: Kathrine Gamborg Andreassen, CEO, Navamedic Mobile: +47 951 78 680 E-mail: [email protected] Lars Hjarrand, CFO, Navamedic Mobile: +47 917 62 842 E-mail: [email protected] About Navamedic Navamedic ASA is a Nordic pharmaceutical company dedicated to enhancing people's quality of life by being a reliable supplier of high-quality prescription, consumer health, and hospital products to hospitals and pharmacies. Our growing product portfolio has been carefully selected to meet current public health concerns, such as obesity, Parkinson's disease, antibiotics and metabolism, to empower people to live healthier and more fulfilling lives. What sets us apart is our deep-rooted commitment to understanding the needs and requirements of the countries where we are present. Our local insight and competence enable us to understand the specific needs of each country where we operate and ultimately to gain market access. This makes us a preferred partner for international companies expanding their footprint across the Nordics and Benelux regions, through either in-licensing or out-licensing. Navamedic has been listed on the Oslo Stock Exchange since 2006 (ticker: NAVA) and is headquartered in Oslo, Norway. For more information, please visit Navamedic.com. This information is subject to the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act. This information was brought to you by Cision The following files are available for download: WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Financial Statement

29 Apr 2025

·www.pharmaindustrial-india.com

Navamedic Extends Imdur Distribution Agreement Until 2032

Navamedic ASA has signed a renewed distribution agreement with TopRidge Pharma Limited (TopRidge) for Imdur®, valid until June 2032, including options for new products to be added to the agreement. "It is a pleasure to announce that we have agreed with our great partner TopRidge Pharma, to revise and renew the distribution agreement for Imdur until 2032. Imdur is our second largest single brand and is currently marketed by us in the Nordics, the Netherlands, the Baltics, Greece and Cyprus. Although there is generic competition in this field, the original product is highly valued by the patients who often stay on the treatment for a long period of time," said Kathrine Gamborg Andreassen, Chief Executive Officer of Navamedic. Imdur® (isosorbide mononitrate), is a prescription medication used to prevent angina pectoris due to heart disease. It was first launched in Europe in 1985. Navamedic commenced distribution of the product as part of a strategic partnership and long-term distribution agreement with TopRidge Pharma Limited in 2016. "Imdur® remains an important product to Navamedic, and we appreciate the efforts made by TopRidge to update the Marketing Authorisations and to secure steady supplies to our markets. With the renewal of this agreement, we look forward to exploring further collaboration opportunities for additional products in the future," added Gamborg Andreassen.

Drug ApprovalLicense out/in

29 Apr 2025

·www.prnewswire.com

Navamedic ASA: Imdur® distribution agreement extended to 2032

OSLO, Norway, April 29, 2025 /PRNewswire/ -- Navamedic ASA (OSE: NAVA) today announced it has signed a renewed distribution agreement with TopRidge Pharma Limited (TopRidge) for Imdur®, valid until June 2032, including options for new products to be added to the agreement. "It is a pleasure to announce that we have agreed with our great partner TopRidge Pharma, to revise and renew the distribution agreement for Imdur until 2032. Imdur is our second largest single brand and is currently marketed by us in the Nordics, the Netherlands, the Baltics, Greece and Cyprus. Although there is generic competition in this field, the original product is highly valued by the patients who often stay on the treatment for a long period of time." says Kathrine Gamborg Andreassen, Chief Executive Officer of Navamedic. Imdur® (isosorbide mononitrate), is a prescription medication used to prevent angina pectoris due to heart disease. It was first launched in Europe in 1985. Navamedic commenced distribution of the product as part of a strategic partnership and long-term distribution agreement with TopRidge Pharma Limited in 2016. "Imdur® remains an important product to Navamedic, and we appreciate the efforts made by TopRidge to update the Marketing Authorisations and to secure steady supplies to our markets. With the renewal of this agreement, we look forward to exploring further collaboration opportunities for additional products in the future," Gamborg Andreassen concludes. The effective date of the agreement is 1 January 2025, and the revised terms of the agreement are implemented from this date even though the signature date is 29 April 2025. For further information, please contact: Kathrine Gamborg Andreassen, CEO, Navamedic Mobile: +47 951 78 680 E-mail: [email protected] Lars Hjarrand, CFO, Navamedic Mobile: +47 917 62 842 E-mail: [email protected] About Navamedic Navamedic ASA is a Nordic pharmaceutical company dedicated to enhancing people's quality of life by being a reliable supplier of high-quality prescription, consumer health, and hospital products to hospitals and pharmacies. Our growing product portfolio has been carefully selected to meet current public health concerns, such as obesity, Parkinson's disease, antibiotics and metabolism, to empower people to live healthier and more fulfilling lives. What sets us apart is our deep-rooted commitment to understanding the needs and requirements of the countries where we are present. Our local insight and competence enable us to understand the specific needs of each country where we operate and ultimately to gain market access. This makes us a preferred partner for international companies expanding their footprint across the Nordics and Benelux regions, through either in-licensing or out-licensing. Navamedic has been listed on the Oslo Stock Exchange since 2006 (ticker: NAVA) and is headquartered in Oslo, Norway. For more information, please visit Navamedic.com. This information is subject to the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act. This information was brought to you by Cision WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug ApprovalLicense out/in

100 Deals associated with Isosorbide Mononitrate

External Link

KEGG	Wiki	ATC	Drug Bank
D00630	Isosorbide Mononitrate	C01DA14	DB01020

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Heart Failure	China	Livzon Group Livzon Pharmaceutical Factory	01 Jan 1993
Angina Pectoris	United States	Promius Pharma LLC	30 Dec 1991

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Angina, Stable	Phase 3	Brazil	Laboratórios Baldacci SA	01 Jul 2014
Myocardial Infarction	Phase 1	China	-	10 Oct 2013
Vasospasm	Phase 1	China	-	10 Oct 2013

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04310995 (ASRAB-Pilot, Pubmed \| Circ Cardiovasc Interv)	Phase 4	-	150	Nicorandil 15 mg	qirtgppkyn(ojgsadgtop) = ksngjpexav jpxhpxaeca (graqerliyp )	Positive	01 Apr 2025
				Isosorbide Mononitrate 50 mg	qirtgppkyn(ojgsadgtop) = eptaspmoym jpxhpxaeca (graqerliyp )
NCT03451591 (LACI-2, CTgov)	Phase 2/3	Stroke, Lacunar	363	Isosorbide Mononitrate XL (ISMN) (Isosorbide Mononitrate XL (ISMN))	hcnlglfgxc = ybrpfnihue chadpbgluq (zifclrbijm, ziyntyuuuu - xxgujfgwoy) View more	-	12 Nov 2024
				Cilostazol (Cilostazol)	hcnlglfgxc = ddoxkrojvx chadpbgluq (zifclrbijm, ljkbfulbgq - vqnwfbmovk) View more
NCT04310995 (ASRAB-pilot, ESC2024)	Phase 4	complication of coronary artery bypass graft	150	Nicorandil 15 mg daily	iczbnpakqp(umokneorkc) = leykdhifxw olqacazklg (vumfbtdmuf ) View more	Negative	30 Aug 2024
				Isosorbide mononitrate 50 mg daily	iczbnpakqp(umokneorkc) = mcygorfglp olqacazklg (vumfbtdmuf ) View more
NCT04051957 (CTgov)	Phase 2	Acute Kidney Injury \| Proteinuria \| Hypertension	9	Isosorbide Mononitrate (Isosorbide Mononitrate)	qrzuhvvgxi = syecoebnen dbynghmwkg (armlkparoi, zqhqehghlc - xnkvwnrvoa) View more	-	03 Aug 2022
				Placebo oral tablet (Placebo)	qrzuhvvgxi = jikxwyfbnw dbynghmwkg (armlkparoi, irsxkhfrbp - xvfkenhoqs) View more
NCT02791906 (CTgov)	Phase 2	Chronic Kidney Diseases	8	ISMN (ISMN Only)	geirzsiown(hcdmjijgnu) = ctfuvdkrdo pncikspial (vovskkdeit, 31.5) View more	-	13 Aug 2020
				Vitamin C+ISMN (ISMN AND Vitamin C)	geirzsiown(hcdmjijgnu) = viknxtjoml pncikspial (vovskkdeit, 1.26) View more
NCT02053493 (NEAT-HFpeF, CTgov)	Phase 2	Heart Failure	110	Placebo+Isosorbide Mononitrate (Isosorbide Mononitrate Crossover to Placebo)	rzvmdppebz(hbgjihmscb) = ievhfhmyme ajnuzilavk (yejwlbnspn, 4601) View more	-	28 Nov 2016
				Placebo+Isosorbide Mononitrate (Placebo Crossover to Isosorbide Mononitrate)	rzvmdppebz(hbgjihmscb) = dluzyarzfg ajnuzilavk (yejwlbnspn, 6286) View more
NCT02053493 (Pubmed \| Br Dent J \| N Engl J Med) Manual	Phase 2	Heart Failure	110	Isosorbide Mononitrate	kvgpzmwlhb(dxaupnload) = acfviwepxl uiypntslif (oadjryvpdb, -780 to 17) View more	Negative	10 Dec 2015
				Placebo	-
NCT01430780 (Pubmed \| Coron Artery Dis)	Not Applicable	Coronary Artery Disease	60	ISMN 20 mg retarded release	eqhoyawyvg(rwvfvxrsjq) = azmlubvggi tyhmfrfslo (cdufjvswyd )	Negative	01 Nov 2013
				Placebo	eqhoyawyvg(rwvfvxrsjq) = uiotbqsuul tyhmfrfslo (cdufjvswyd )
ISRCTN39772441 (IMOP study, Pubmed \| BJOG)	Not Applicable	-	-	Isosorbide mononitrate (IMN)	ibsjqqntgo(nmevjcazrl): mean difference = -1.6 (95% CI, -5.1 to 1.9), P-Value = 0.37	Positive	01 Aug 2009
				Placebo

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