Poster Presentation Finalized

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REFERENCES 1. Sakaeda T et al, Statin-Associated Muscular and Renal Adverse Events: Data Mining of the Public Version of the FDA Adverse Event Reporting System. PLoS ONE 2011; Vol6(12): e28124 2. Tomlinson SS et al. Potential adverse effects of statins on muscle. Phys Ther. 2005;85:459 3. Kato K et al. Pravastatin-induced rhabdomyolysis and purpura fulminans in a patient with chronic renal failure. International Journal of Surgery Case Reports 8 (2015) 84 4. Stasi S L D et al. Effects of Statins on Skeletal Muscle: A Perspective for Physical Therapists. Phys Ther. 2010 Oct; 90(10): 1530 5. Mlodinow S G et al. Statin adverse effects:Sorting out the evidence. The Journal of Family Practice. Sept 2014, Vol 63, No 9, 497 CONCLUSION • The clinical manifestations of rhabdomyolysis associated with statins are nonspecific. • Rhabdomyolysis associated with rosuvastatin monotherapy is extremely rare and may result in potentially fatal myoglobinuria with acute renal failure. • Early diagnosis and treatment are essential to improve the outcome. Diagnosis requires a high degree of clinical suspicion. • The bottom line is though statins provide medical benefit, they should be always prescribed with “a pinch of salt”. RARE LIFE THREATENING PRESENTATION OF AN UNUSUAL ADVERSE EFFECT OF A STATIN - A CASE REPORT DR. UMRAN R. SHEIKH. DR. KISHALAY DATTA INTRODUCTION Rhabdomyolysis associated with the use of rosuvastatin has been demonstrated to be a rare but potentially life-threatening adverse effect of statins. Here, we report a rare case of rhabdomyolysis in a patient who had used rosuvastatin and developed acute renal failure (ARF) and hyperkalemia which necessitated the initiation of dialysis. CASE Presenting Complaint • A 62y male, with h/o progressive B/L lower limb weakness with muscle pain since 4 days along with burning micturation since 3 days and decreased urine output. Primary Survey: • Airway – Patent • Breathing: RR-22/min, Normal, sPO2 – 98% in room air • Circulation: HR- 78bpm, BP-120/80 mmHg, Peripheral pulses+ • Disability: GCS – 15/15, Pupils - B/L NSNR • Cardiac Monitor – Broad Complex QRS • GRBS – 270 mg/dL AMPLE History: • Medication : On T.Ecosprin75mg OD, T. Rosave (Rosuvastatin) 40mg OD (since one month), OHA • Past History: CAD-TVD . PTCA to RCA (Dec 2014), DM Investigations: • ECG – Broad Complex QRS with tented T waves • ABG – Partially Compensated severe metabolic acidosis Lactate 0.8 mmol/L, Na + 119mmol/L, K + 7.8mmol/L. • ECHO – Hypokinesia in RCA territory Management: • Appropriate Antihyperkalemic medical management • Urgent Hemodialysis Secondary Survey: • CNS – Conscious, Oriented, Motor- Power : U/L=4/5 , L/L=2/5 Weakness more marked in proximal muscles DTRs + Plantars –B/L Flexor • Extremities – Pedal Edema + R i s k o f M y o p a t h y F e m a l e S e x M u l t i p l e M e d i c a t i o n C o n c o m i t a n t d r u g u s e A g e > 8 0 y r s P e r i o p e r a t i v e p e r i o d s S m a l l b o d y f r a m e M u l t i s y s t e m D i s e a s e s F r a i l i t y PREHOSPITAL DAY 1 DAY 2 TLC- 20,000 TLC- 25,600, TSH - 2.18 (0.34- 5.6) CPK- 74,800 IU/L N77 L6 M2 E1 CPK - 58040 IU/L Plt- 5.29 lakh Hb-11g/dL, Blood C& S- No growth Urea – 270 mg/dL Urea-262 Ur C & S – E.Coli Creat -7.24 mg/dL Creat -7.69 Ur Myoglobin- absent Uric Acid- 9.8mg/dL S.Na + 120.3 Ur -Protein ++ LDH – 2030 IU/L Sr.Ca +2 7.9 Ur -WBC -30-50/HPF Sr.K + – 8.5 mEq/L Sr.K + 6.7 mEq/L Ur - Blood +++ Sr.Ph – 8.2mEq/dL Sr.Ph - 9.1 mEq/L Ur - RBC -20-30/HPF Ur RM-WBC-10-15 Sr.Cl - 86.4 Ur -WBC -30-50/HPF Bil T/D/I – 0.3/0.1/0.2 Alb -2.8 g/dL Globulin 4.2 g/dL SGOT-923 IU/L SGPT – 669 IU/L ALP – 140IU/L DISCUSSION What is already known on this topic? • This condition presents as myalgias, weakness, fatigue, and dark coloured urine, which usually develop within a few days of starting the treatment. • Its common to see muscular and renal adverse effects in association with statin use, among which o stronger association of muscular adverse effects like myopathy, rhabdomyolysis and increase in CPK levels have been seen with rosuvastatin use and o stronger association of acute renal failure seen with atorvastatin [1]. What this adds on to our knowledge? • For patients being managed solely with statin drugs, the incidence of muscular adverse effects is reported as 0.1% to 0.2% [2] . • However, the incidence increases to 1% to 7% for patients taking multiple medications and for those with multiple risk factors for developing adverse events [2] . • With the growing number of Drug permutations and combinations, great deal of suspicion and awareness is warranted among the emergency physicians How might this change clinical practice? • In similar ED presentation, diagnosis of statin induced rhabdomyolysis by ER physician would require vigilance. • This helps in changing the morbidity and mortality. • Current recommendation is prior baseline CK level of patients with increased risk of musculoskeletal disorders; routine monitoring only for those who experience muscle pain or weakness [5] . • Knowledge about adverse effects of individual statin may lead to change in choice of statin use and regular monitoring of CPK levels at the primary stage of initiation. • Generate awareness not only in ER physicians, but also general practioners & general public of such complications and prompt referral to the emergency department. What Research we would like to see? A large number of patients developing such adverse effects are unaware and go undiagnosed and untreated. Therefore: • What drug levels would guide the dosing, frequency and stopping & changing over to different drug. • When and how frequently should the monitoring of drug level should be done. • What drug dosage & duration of treatment would cause these derangement. Concomitant use of Fibrate Nicotinic acid/ Cyclosporine Azole antifungal Macrolide antibiotic Erythromycin and Clarithromycin HIV protease inhibitors Nefazodone Verapamil (CCB) Warfarin Digoxin Alcohol

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Poster Presentation Finalized

Transcript of Poster Presentation Finalized

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REFERENCESSakaeda T et al, Statin-Associated Muscular and Renal Adverse Events: Data Mining of the Public Version of the FDA Adverse Event Reporting System. PLoS ONE 2011; Vol6(12): e28124Tomlinson SS et al. Potential adverse effects of statins on muscle. Phys Ther. 2005;85:459Kato K et al. Pravastatin-induced rhabdomyolysis and purpura fulminans in a patient with chronic renal failure. International Journal of Surgery Case Reports 8 (2015) 84Stasi S L D et al. Effects of Statins on Skeletal Muscle: A Perspective for Physical Therapists. Phys Ther. 2010 Oct; 90(10): 1530 Mlodinow S G et al. Statin adverse effects:Sorting out the evidence. The Journal of Family Practice. Sept 2014, Vol 63, No 9, 497CONCLUSIONThe clinical manifestations of rhabdomyolysis associated with statins are nonspecific. Rhabdomyolysis associated with rosuvastatin monotherapy is extremely rare and may result in potentially fatal myoglobinuria with acute renal failure.Early diagnosis and treatment are essential to improve the outcome. Diagnosis requires a high degree of clinical suspicion.The bottom line is though statins provide medical benefit, they should be always prescribed with a pinch of salt.RARE LIFE THREATENING PRESENTATION OF AN UNUSUAL ADVERSE EFFECT OF A STATIN - A CASE REPORTDR. UMRAN R. SHEIKH. DR. KISHALAY DATTA

INTRODUCTIONRhabdomyolysis associated with the use of rosuvastatin has been demonstrated to be a rare but potentially life-threatening adverse effect of statins. Here, we report a rare case of rhabdomyolysis in a patient who had used rosuvastatin and developed acute renal failure (ARF) and hyperkalemia which necessitated the initiation of dialysis.CASEPresenting Complaint A 62y male, with h/o progressive B/L lower limb weakness with muscle pain since 4 days along with burning micturation since 3 days and decreased urine output. Primary Survey: Airway PatentBreathing: RR-22/min, Normal, sPO2 98% in room airCirculation: HR- 78bpm, BP-120/80 mmHg, Peripheral pulses+Disability: GCS 15/15, Pupils - B/L NSNRCardiac Monitor Broad Complex QRS GRBS 270 mg/dL AMPLE History: Medication : On T.Ecosprin75mg OD, T. Rosave (Rosuvastatin) 40mg OD (since one month), OHAPast History: CAD-TVD . PTCA to RCA (Dec 2014), DMInvestigations: ECG Broad Complex QRS with tented T wavesABG Partially Compensated severe metabolic acidosisLactate 0.8 mmol/L, Na+ 119mmol/L, K+ 7.8mmol/L.ECHO Hypokinesia in RCA territoryManagement: Appropriate Antihyperkalemic medical managementUrgent HemodialysisSecondary Survey: CNS Conscious, Oriented, Motor- Power : U/L=4/5 , L/L=2/5 Weakness more marked in proximal musclesDTRs + Plantars B/L FlexorExtremities Pedal Edema +

PREHOSPITAL DAY 1 DAY 2 TLC- 20,000 TLC- 25,600, TSH - 2.18 (0.34-5.6) CPK- 74,800 IU/L N77 L6 M2 E1 CPK - 58040 IU/LPlt- 5.29 lakh Hb-11g/dL, Blood C& S- No growth Urea 270 mg/dL Urea-262 Ur C & S E.Coli Creat -7.24 mg/dL Creat -7.69 Ur Myoglobin-absent Uric Acid- 9.8mg/dL S.Na+ 120.3 Ur -Protein ++ LDH 2030 IU/L Sr.Ca +2 7.9Ur -WBC -30-50/HPF Sr.K+ 8.5 mEq/L Sr.K+ 6.7 mEq/LUr - Blood +++ Sr.Ph 8.2mEq/dL Sr.Ph - 9.1 mEq/LUr - RBC -20-30/HPF Ur RM-WBC-10-15Sr.Cl- 86.4 Ur -WBC -30-50/HPF Bil T/D/I 0.3/0.1/0.2 Alb -2.8 g/dL Globulin 4.2 g/dL SGOT-923 IU/L SGPT 669 IU/L ALP 140IU/L DISCUSSIONWhat is already known on this topic?This condition presents as myalgias, weakness, fatigue, and dark coloured urine, which usually develop within a few days of starting the treatment. Its common to see muscular and renal adverse effects in association with statin use, among which stronger association of muscular adverse effects like myopathy, rhabdomyolysis and increase in CPK levels have been seen with rosuvastatin use and stronger association of acute renal failure seen with atorvastatin[1].What this adds on to our knowledge?For patients being managed solely with statin drugs, the incidence of muscular adverse effects is reported as 0.1% to 0.2%[2]. However, the incidence increases to 1% to 7% for patients taking multiple medications and for those with multiple risk factors for developing adverse events[2].With the growing number of Drug permutations and combinations, great deal of suspicion and awareness is warranted among the emergency physiciansHow might this change clinical practice?In similar ED presentation, diagnosis of statin induced rhabdomyolysis by ER physician would require vigilance. This helps in changing the morbidity and mortality.Current recommendation is prior baseline CK level of patients with increased risk of musculoskeletal disorders; routine monitoring only for those who experience muscle pain or weakness[5].Knowledge about adverse effects of individual statin may lead to change in choice of statin use and regular monitoring of CPK levels at the primary stage of initiation.Generate awareness not only in ER physicians, but also general practioners & general public of such complications and prompt referral to the emergency department.What Research we would like to see?A large number of patients developing such adverse effects are unaware and go undiagnosed and untreated. Therefore:What drug levels would guide the dosing, frequency and stopping & changing over to different drug.When and how frequently should the monitoring of drug level should be done.What drug dosage & duration of treatment would cause these derangement.

Concomitant use of FibrateNicotinic acid/ CyclosporineAzole antifungalMacrolide antibioticErythromycin and ClarithromycinHIV protease inhibitorsNefazodoneVerapamil (CCB)WarfarinDigoxinAlcohol

RARE LIFE THREATENING PRESENTATION OF AN UNUSUAL ADVERSE EFFECT OF A STATIN - A CASE REPORTDR. UMRAN R. SHEIKH, DR.SANGRAM SHINDE, DR. KISHALAY DATTA

REFERENCESSakaeda T et al, Statin-Associated Muscular and Renal Adverse Events: Data Mining of the Public Version of the FDA Adverse Event Reporting System. PLoS ONE 2011; Vol6(12): e28124Tomlinson SS et al. Potential adverse effects of statins on muscle. Phys Ther. 2005;85:459Kato K et al. Pravastatin-induced rhabdomyolysis and purpura fulminans in a patient with chronic renal failure. International Journal of Surgery Case Reports 8 (2015) 84Stasi S L D et al. Effects of Statins on Skeletal Muscle: A Perspective for Physical Therapists. Phys Ther. 2010 Oct; 90(10): 1530 Mlodinow S G et al. Statin adverse effects:Sorting out the evidence. The Journal of Family Practice. Sept 2014, Vol 63, No 9, 497CONCLUSIONThe clinical manifestations of rhabdomyolysis associated with statins are nonspecific. Rhabdomyolysis associated with rosuvastatin monotherapy is extremely rare and may result in potentially fatal myoglobinuria with acute renal failure.Early diagnosis and treatment are essential to improve the outcome. Diagnosis requires a high degree of clinical suspicion.The bottom line is though statins provide medical benefit, they should be always prescribed with a pinch of salt.How might this change clinical practice?In similar ED presentation, diagnosis of statin induced rhabdomyolysis by ER physician would require vigilance. This helps in changing the morbidity and mortality.Current recommendation is prior baseline CK level of patients with increased risk of musculoskeletal disorders; routine monitoring only for those who experience muscle pain or weakness[5].Knowledge about adverse effects of individual statin may lead to change in choice of statin use and regular monitoring of CPK levels at the primary stage of initiation.Generate awareness not only in ER physicians, but also general practioners & general public of such complications and prompt referral to the emergency department.What Research we would like to see?A large number of patients developing such adverse effects are unaware and go undiagnosed and untreated. Therefore:What drug levels would guide the dosing, frequency and stopping & changing over to different drug.When and how frequently should the monitoring of drug level should be done.What drug dosage & duration of treatment would cause these derangement.

DISCUSSIONWhat is already known on this topic?This condition presents as myalgias, weakness, fatigue, and dark coloured urine, which usually develop within a few days of starting the treatment. Its common to see muscular and renal adverse effects in association with statin use, among which stronger association of muscular adverse effects like myopathy, rhabdomyolysis and increase in CPK levels have been seen with rosuvastatin usestronger association of acute renal failure seen with atorvastatin[1].What this adds on to our knowledge?For patients being managed solely with statin drugs, the incidence of muscular adverse effects is reported as 0.1% to 0.2%[2]. However, the incidence increases to 1% to 7% for patients taking multiple medications and those with multiple risk factors for developing adverse events[2].With the growing number of Drug permutations and combinations, great deal of suspicion and awareness is warranted among the ER physiciansINTRODUCTIONRhabdomyolysis associated with the use of rosuvastatin has been demonstrated to be a rare but potentially life-threatening adverse effect of statins. Here, we report a rare case of rhabdomyolysis in a patient who had used rosuvastatin and developed acute renal failure (ARF) and hyperkalemia which necessitated the initiation of dialysis.CASEPresenting Complaint A 62y male, with h/o progressive B/L lower limb weakness with muscle pain since 4 days along with burning micturation since 3 days and decreased urine output. Primary Survey: Airway PatentBreathing: RR-22/m, Normal, spO2-98% in room airCirculation: HR- 78bpm, BP-120/80 mmHg, Peripheral pulses+Disability: GCS 15/15, Pupils - B/L NSNRCardiac Monitor Broad Complex QRS GRBS 270 mg/dL Secondary Survey: CNS Conscious, Oriented, Motor- Power : U/L=4/5 , L/L=2/5 Weakness more marked in proximal musclesDTRs + Plantars B/L FlexorExtremities Pedal Edema +

AMPLE History: Medication : On T.Ecosprin75mg OD, T. Rosave (Rosuvastatin) 40mg OD (since one month), OHAPast History: CAD-TVD . PTCA to RCA (Dec 2014), DMInvestigations: ECG Broad Complex QRS with tented T wavesABG Partially Compensated severe metabolic acidosisLactate 0.8 mmol/L, Na+ 119mmol/L, K+ 7.8mmol/L.ECHO Hypokinesia in RCA territoryManagement: Appropriate Antihyperkalemic medical managementUrgent HemodialysisConcomitant use of FibrateNicotinic acid/ CyclosporineAzole antifungalMacrolide antibioticErythromycin and ClarithromycinHIV protease inhibitorsNefazodoneVerapamil (CCB)WarfarinDigoxinAlcoholPREHOSPITAL DAY 1 DAY 2 TLC- 20,000 TLC- 25,600, TSH - 2.18 (0.34-5.6) CPK- 74,800 IU/L N77 L6 M2 E1 CPK - 58040 IU/LPlt- 5.29 lakh Hb-11g/dL, Blood C& S- No growth Urea 270 mg/dL Urea-262 Ur C & S E.Coli Creat -7.24 mg/dL Creat -7.69 Ur Myoglobin-absent Uric Acid- 9.8mg/dL S.Na+ 120.3 Ur -Protein ++ LDH 2030 IU/L Sr.Ca +2 7.9Ur -WBC -30-50/HPF Sr.K+ 8.5 mEq/L Sr.K+ 6.7 mEq/LUr - Blood +++ Sr.Ph 8.2mEq/dL Sr.Ph - 9.1 mEq/LUr - RBC -20-30/HPF Ur RM-WBC-10-15Sr.Cl- 86.4 Ur -WBC -30-50/HPF Bil T/D/I 0.3/0.1/0.2 Alb -2.8 g/dL Globulin 4.2 g/dL SGOT-923 IU/L SGPT 669 IU/L ALP 140IU/L Factors that may increase risk of myopathy in statin users.